Greetings, and welcome to the NRx Pharma Second Quarter 2021 Earnings Call. At this time all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your hosts, Eric Goldstein, Managing Director, LifeSci Advisors. Thank you. You may begin.

Thank you, operator. Before we proceed with the call, I'd 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 on this call is contained in our periodic reports filed with the Securities & Exchange Commission. 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 we issued yesterday and in our Form 10-Q, which may be accessed from the Investors page of the NRx website. Joining me on today's call from NRx are Jonathan Javitt, Chairman and Chief Executive Officer, Randy Guggenheimer, Chief Business Officer, and Robert Besthof, Chief Commercial Officer. 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 on the inaugural NRx quarterly results call. As we move the company forward rapidly on many fronts, we're also formalizing our investor outreach, and we intend to host regular opportunities for interactive dialogue. We appreciate your attendance today. We look forward to answering your questions on this and future quarterly calls. Yesterday, we issued a press release outlining the encouraging progress made during our last quarter, and recently advancing our pipeline three late-stage programs with significant potential in COVID and other respiratory illnesses, in COVID vaccine and a drug for suicidal bipolar depression. I'll spend just a few brief moments summarizing each of these programs and the developments that we've made over the quarter and in recent weeks. I'll then turn the call over to Randy for a review of our second quarter results. Before we conclude the call, I'll be answering the question some of you have submitted online, as well as potential questions from analysts. Before diving into the specifics of each program, it makes sense to reflect for a moment on the change in our company from Q2 2020 through the second quarter of 2021. In 2020, we were a clinical stage biotech company with a single asset in CNS [indiscernible]. Over the subsequent 12 months, we brought a dormant drug, Aviptadil, from where it has [Indiscernible] to a candidate for emergency use authorization COVID-19 that has now completed its first Phase 2b/3 clinical trial. Last month, we were awarded worldwide rights to develop and market assessing the assets to BriLife vaccines in a competitive bidding process organized by Israel Government and our Institute for Biological Research. Along the way, we've developed an executive team and board that has learned how to manage the rapid…

Thank you, Jonathan. For our second quarter, we reported a net loss of $16 million, compared to a net loss of a $100,000 for the three months ended June 30, 2020. While this may sound like a large number for a small company, two-thirds of the G&A expenses were non-cash adjustments to earnings, associated with reconfiguring our employee option programs to meet the legal requirements of the merger, and with warrants held by the merger partner. The remaining G&A expenses were largely attributable to one-time expenses associated with the merger. Research and development expenses were $4.7 million during the second quarter, compared to $1.4 million for the prior year period. This was primarily due to an increase in clinical trials and development expenses for ZYESAMI. General and administrative expenses were $12.5 million for the second quarter, compared to $0.5 million during the prior year period. This was driven primarily by $5.5 million of consulting fees, of which $4.9 million relates to non-cash consulting fees and $4 million in stock compensation expense, of which $3.3 million relates to modification of stock options and warrants due to the merger with BRPA. As of June 30, 2021 cash and cash equivalents were $13.4 million, compared to $1.9 million as of December 31, 2020. In addition, we received $9.2 million in cash investments subsequent to June 30, 2021, from the exercise of warrants. As stated in our 10-Q, our core expenses are funded through the next 12 months. Our two major clinical trials are primarily funded by the U.S. Government, and we anticipate that the vaccine program will be co-funded by one or more commercial partners. With that, I will turn it back to Jonathan for closing remarks.

Thank you, Randy. Before taking questions, I just want to emphasize our continued commitment to rapid efficient drug development. We've made tremendous progress in our three lead programs and in an incredibly short amount of time, and have focused our resources and energies in areas of critical unmet medical needs, where we can have the most impact. We're confident that, we can realize the opportunities before us, and I look forward to updating you on our continued progress. John, we're ready to take questions.

We have a question from Kevin DeGeeter at Oppenheimer. What is the target population of ZYESAMI from EUA. The Phase 2b/3 suggest patients on a high flow nasal cannula better primary outcome. How does that impact on the patient enrollment criteria and subgroup analysis of the ongoing Activ study?

Thank you, Kevin. It's a great question. So, Phase 2b/3 trial that we conducted enrolled patients who had critical COVID-19 and respiratory failure, that included patients who were in the ICU with the step down unit, some of whom were still able to be maintained on high flow nasal oxygen, and some of whom had progressed to the point where they needed either mechanical ventilation that is a tube down your throat or non-invasive ventilation. So, the latter patients were obviously far more acutely ill than the former patients. This is something we recognized what's going to happen when we develop the protocol with the FDA. So, we said from the outset that we would stratify patients by their baseline severity of illness. And actually we said, we'd use the [9x] core. And subsequently, we discovered that simply using the baseline level of ventilation was a better way of controlling for baseline severity. Now, the data are a little complicated, and are best read rather than recited. But across the board, patients on high-flow nasal cannula, really no matter what kind of hospital they were in, did better on ZYESAMI than on placebo. And we showed substantial differences both in survival and recovery from respiratory failure. Now, it shouldn't be a surprise to anybody, that the people who were less acutely or going into the study that people on high-flow nasal cannula, did better than the people who were more acutely ill, who had already progressed to being on ventilation. In the tertiary care hospitals, the people on ventilation also did better on ZYESAMI than on placebo. But once we got to the community hospitals who were in the midst of that horrible surge between December and January, there was very little survival of patients either on drugs or placebo…

Yes, thank you. So another follow-up question from Kevin DeGeeter at Oppenheimer. What is the development plan on Inhaled ZYESAMI? Should we expect it to replace the IV formulation? Or will the two formulations target different patient populations?

Well, initially the two pocket -- the two formulations will target different populations, because the inhaled formulation is targeted for patients who can hold nebulizer and actively inhale the drug. And we expect that the drug will be effective there, because it's showing promise in other respiratory conditions. And treating the lung directly through an inhaled form of the drug is likely to actually be a more direct form of treatment than giving the drug intravenously. Now, some of the hospitals we talked to want to give the inhaled form of the drug through a ventilator. That's not something -- with nebulizers, those are FDA approved devices. We know that they create the proper dispersion of aerosolized drugs in lung. Putting -- cooking a nebulizer into a ventilator is a little bit of homemade medicine. And we don't know whether inhaled drug will ever be a good approach for somebody who's already intubated. If it turns out to be a good approach for somebody who's already intubated, that would be a major breakthrough.

Now some questions from investors. When will you get EUA?

Well, as biotech investors know, the approval conversation with FDA, it's a dynamic scientific interaction. And we're far from the only company in this EUA dialogue with FDA. But we're encouraged that FDA asked its first questions of us within a few weeks of our EUA submission. We continue to engage with FDA in providing additional statistical analyses in order to support the review, given the limited therapeutic options that are available to patients with critical COVID-19, we remain firm in our belief that the results of our Phase 2b/3 study demonstrates clearer and significant -- statistically significant improvement in patient survival and warranted grants of emergency use.

Next question. Why is the FDA taking so long?

Well, as we said, we're in a continual dynamic dialogue with FDA, and we've been responsive to their requests for additional analyses and data. There's no statutory timeline for emergency use reviews. On the other hand, I think we see that FDA is processing these emergency use reviews, actually far more quickly than it processes traditional drug approval reviews. The country urgently needs new treatments for critical COVID-19 as evidenced by the many calls we get from physicians and patients, and we think FDA recognizes that, we know FDA recognizes that and is moving uncharacteristically quickly towards approving new treatments.

Next question. What was the process for grant of EUA in the Caucasus region?

So, in the Nation of Georgia, the process was a little different from the FDA process, and that the National Physicians Society reviewed our clinical trials data and made a formal recommendation to Georgia's Prime Minister and Minister of Health in favor of emergency use authorization. That was the basis of the grant to the EUA. Other medical societies in other countries have approached us and are in the process of conducting their own independent reviews.

Okay, so we have another question here. Who owns the patent for aviptadil and why won't you face generic competition?

Well, investors have frequently asked us whether our drug is generic, given that we have no patent protection on aviptadil as such. Just like there's no patent on insulin or other natural peptides that are highly successful drugs today, especially [indiscernible]. There is a current patent on specific formulations of aviptadil using certain buffers at specific assisting ranges. However, one of the inventors on that patent advised us that use of buffers with aviptadil can inactivate the peptide and must be avoided. We've discussed that in our Security Filings. Because of this advice we formulated ZYESAMI without using any buffers. Aviptadil's never been approved as a drug in the United States, or in most other major markets. Therefore, should our drug succeed in gaining approval, we expect that it will be afforded what's called data exclusivity for some period of time by FDA and other regulators. During this period of time, the clinical data that we generate in support of approval can't be used by others to file a generic drug application. We also hope that the formulation work we've done to create ZYESAMI, which is our proprietary stable form of aviptadil, will yield patents that provide additional protection. Lastly, we've announced partnerships with two companies TFF and Mannkind, who have extensive experience in training peptides such as ours into dry powder room temperature stable products that have long-term patent protection.

What is happening in your partnership with Relief Therapeutics?

Well, we signed a collaboration agreement with Relief Therapeutics, under which Relief had the right to fund costs of development, formulation and clinical trials in return for a predetermined share of profits. All of this detailed in our public filings, including our 10-Q filed yesterday. As we've disclosed, Relief chose not to fund significant portions of the development program or to fund the inhaled use trail, therefore NRx funded those activities with other sources of capital. We remain committed to arriving at a mutually agreeable business relationship with Relief going forward.

Now we have a question on the vaccine. Why get involved in a new vaccine, isn't the world already vaccinated?

Well, unfortunately, only a portion of the world is vaccinated. And we're seeing even vaccinated patients contract, get hospitalized and die from new variants of COVID. Like the Delta variant. We believe the BriLife vaccine has potential to demonstrate more robust immunity against new variants of the disease. And we expect that the data in support of this field will be released to the public in the near future. Moreover, the BriLife vaccine is unique and that it binds to H2 receptor [Technical Difficulty] in the nose and in the lungs --

And that enables it to be delivered by nasal or inhaled dosing, and it may create what is called mucosal immunity. Most vaccines work by creating circulating antibodies and immune cells against the virus, mucosal immunity means that the cells lining the lung and respiratory tract become immune to the virus as well. We're concerned that this virus will continue to mutate and create variants that bypass any vaccine. Just like influenza, we expect that people will need to be re-vaccinated on an ongoing basis and more convenient routes of administration will be important for patients. We look forward to organizing a Science Day for analysts and interested investors in the near future to share the basis of our enthusiasm for this clinical development program, and we thank the IIBR for selecting us as its partner.

Thank you, Randy. Thanks for picking that up.

No problem.

I'm showing, no further questions in the queue at this time. This concludes the NRx second quarter results conference call. Thank you all for participating.