Greetings and welcome to the NRx Pharmaceuticals Full Year 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 host, Eric Goldstein, Managing Director, LifeSci Advisors. Thank you. You may begin.

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 on 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 a press release issued earlier today, and in the company's Form 10-K that we are filing today, which may be accessed from the investors page of the NRx Pharmaceuticals website. Joining me on today's call from NRx Pharma are Robert Besthof, Interim Chief Executive Officer, and Ira Strassberg, Chief Financial Officer and Treasurer. Robert will provide a summary of the company's progress during the year and recent weeks before turning it over to Ira 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 Robert.

Thank you, Eric. Good morning, everyone, and thank you for joining us today. It is my pleasure to host today's call as Interim CEO. We appreciate your attendance and look forward to providing you with an overview of the re-focused priorities that will guide our activities in 2022. Before beginning the agenda for today's call, I want to take a few moments to speak about the leadership transition we announced on March 8 of this year. My predecessor, Dr. Jonathan Javitt, founded NRx and led the building of a company that developed a pipeline with two Phase 3 novel therapeutics in areas of very high unmet medical needs. Under his leadership, the NRx culture was and remains patient-centric, to mitigate the suffering from COVID-19 and other respiratory diseases to providing those who have bipolar depression and suicidality, a new therapeutic solution. Recall that up to 50% of individuals with bipolar disorder attempt suicide over their lifetime or have serious thoughts about suicide. NRx went from an idea to reading out a Phase 2 study and obtaining breakthrough therapy designation and a special protocol agreement for the first drug in development for bipolar depression in patients with acute suicidal ideation and behavior. When the COVID-19 pandemic hit two years ago, the NRx team pivoted and rapidly responded to the pandemic challenge that our country and the whole world are still facing today by initiating an investigational new drug clinical study in critical COVID-19 with Aviptadil. Our team went from concept to dosing or first patient in about 12 weeks, which included filing an investigational new drug application, filing a protocol, buying active pharmaceutical ingredients to working with manufacturers and to produce clinical supplies, engaging a contract research organization and sites. This is representative of the culture that defines us today, and…

Thank you, Robert, and good morning, everyone. It's my honor to be part of the NRx team. I would like to provide an overview of our 2021 financial results. Research and Development expenses for the year ended December 31, 2021 were $20.3 million, compared to $10.6 million for the prior year. Increased ZYESAMI R&D drove this increase. General and Administrative expenses for the year ended December 31, 2021 were $74.9 million, of which $60.3 million were stock based compensation, consulting fees and warrant expense that are not settled in cash. General and Administrative expenses for the year ended December 31 2020 totaled $11.4 million, of which $5.7 million was non-cash stock based compensation, consulting fees and warrant expense. The increase was primarily due to the increase in stock-based compensation expenses, consulting fees that are not settled in cash, as well as an increase in insurance expenses due to being a public company. Settlement expense for the year ended December 31, 2021 was $21.4 million compared to $39.5 million for the prior year. If you recall, the settlement expense relates to the Gen transaction, was not settled in cash, and we do not expect to recur. Reimbursement of expenses from Relief Therapeutics was $0.8 million for the year ended December 31, 2021, compared to $10.2 million for the year ended December 31, 2020. Other income for the year ended December 31, 2021 was $22.7 million, driven primarily by a $20.9 million decrease in the earn-out cash liability, and a $1.7 million decrease in the warrant liability. Other expenses for the prior year were $0.4 million, primarily due to a loss on conversion of convertible notes payable. Net loss for the year ended December 31, 2021 was $93.1 million or $1.98 per share, compared with a net loss of $51.8 million, or $1.51 per share for the year ended December 31, 2020. The company used $37.7 million of cash for operating activities for the year ended December 31, 2021 compared with $2.3 million for the prior year. As of December 31, 2021 Cash was $27.6 million, compared to $1.9 million as of December 31, 2020. We completed a $25 million private placement financing in February of 2022. We believe we have sufficient cash to support operations for at least the next 12 months. With that, I will turn it back to Robert for closing remarks.

Thanks, Ira. Before addressing your questions, I want to emphasize that even though we had a leadership transition earlier this month, I'm proud to say that our strong leadership team has continued to rally around our strategic priority and to work tirelessly in this effort to bring hope to life. We're thrilled to drive forward our two late stage programs. This company was founded on a commitment to the application of innovative science to known molecules to address very high unmet medical needs. This continues to be our focus and we remain confident in the opportunities for that. Eric, we're ready to take some of the questions that were submitted. Let's go for those questions.

Thank you. We have time for a few investor questions. First question, what is the status with relief?

Okay. As you know, we have a commercial dispute with Relief. The parties agreed to engage in an effort to amicably resolve the dispute through mediation. We held our first mediation meeting on February 22 and we plan to hold additional mediation meeting in the coming months.

Next question, can you provide more details on the active 3b NIH study?

Yes, thank you. Great question. The study has enrolled about 465 patients out of the 640. We expect data later in the year, notwithstanding DSMB meetings that take place periodically. The next one is scheduled for the end of April. NRx is closely collaborating with the NIH. We have weekly meetings and also prepare for enrollment outside of the U.S., which could begin in Q2.

Thank you. Next question, what is the practical meaning of a pivot to U.S. medical needs?

Oh, yeah, another great question. We have two late stage Phase 3 drugs. These are the ones we believe have the potential to really make the biggest contributions towards improving patient outcomes and perhaps even change the standard of care. In the US, we understand the treatment needs and the regulatory pathway the best and have demonstrated expertise to execute studies here. This is also where the largest commercial opportunities are for us. We also think that given COVID-19 the need for psychiatry products, such as our NRX-101 franchise is potentially higher than before. Yesterday was world bipolar day, and we initiated our first clinical study site for our Phase 2 study. We're very excited for what we can do for patients in this area as well. Thank you.

Thank you, Robert. That is all the time we have for questions. Thank you, everyone for joining us this morning. This concludes the NRx Pharma 2021 results conference call. Thank you all for participating.

Thank you. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.