NRXP - NASDAQ

Greetings and welcome to NRX Pharmaceuticals First Quarter 2022, Earnings Conference Call. At this time, all participants are in listen-only mode. [Operator Instructions]. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Tom Johnson from Investor Relations. Sir, please go ahead.

Thank you, Operator. Before we proceed with the call, I would like to remind everyone that certain statements made during this call or forward-looking statements under U.S. Federal Securities Law. 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's speak only as of 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 earlier today. And then the company's Form 10-Q that we're filing today, which will be accessed from the investor's page of the NRX Pharmaceuticals website. Joining me on today's call from NRX Pharmaceuticals 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 -- before turning it over to Ira for review the company's financial results. Following their prepared remarks, the management team will address investor questions. I'll now turn the call over to Robert.

Thank you, Tom. Good morning, everyone and thank you for joining us today. We appreciate your attendance and look forward to summarizing our progress on our strategic priorities that are guiding our work in 2022. So let's begin. On our previous Year-End Earnings Call, we announced our new strategic focus for 2022 by concentrating on our two late-stage drug candidates. NRX-10 1 for the treatment of severe bipolar depression with acute and sub-acute suicidality, aviation and behavior for which we have reactivated Clinical Cloud development as part of our psychiatry portfolio.

Thank you, Robert. And good morning, everyone. I would like to start by providing an overview of our financial results for the first quarter of 2022. When comparing to the first quarter of 2021, please note that the company was privately held during the first quarter of 2021. Research and development expenses for the three months ended March 31st, 2022 totaled $5.5 million, compared to $2.9 million for the quarter ended March 31st, 2021. The increase was primarily driven by an increase in clinical trials and development expenses related to

Thank you, Ira. In conclusion, we're executing on our development plans for our too late-stage potentially life saving drugs. NRX-101 for bipolar depression in patients with acute in sub-acute suicidality, aviation and behavior. And

Thank you, Robert. Our first investor question is, what is your view regarding the impact of potential approval of nerves drug and also Paxlovid being used?

Okay. Both medicines are oral medicines targeted at earlier COVID-19 populations. Paxlovid has been on the market now for a few months, and unfortunately it does not work for all, and it is an oral medicine that needs to be taken quite soon after disease's onset. [Indiscernible] I'm -- hope I'm pronouncing that correct, is an oral medication that was tested in moderate and severe COVID-19 patients.

Okay. Our next question, Robert, how do you see NRX-101 in comparison to [Indiscernible] and remodels compounds which are in late phase 3?

That's quite interesting question. Well, first, their programs validate the mechanistic approach of combining an NDA antagonist with a 5 - HT2 compound. As I mentioned in my remarks before, we have positioned NRX-101 in the bipolar depression was suicidality space for which FDA awarded us breakthrough therapy designation. Their programs are focused on MDD, treatment-resistant depression, adjunctive treatment, et cetera We know that up to 50% of individuals and bipolar disorder attempts suicide or experienced serious thoughts of suicide over their lifetime. And between 11% and 20%, unfortunately succumb to suicide. We also think that it's advantageous to both NRX-101 components are not scheduled as abuse potential is of high concern. We also think that studying patients for depression and suicidality of great importance in the bipolar space, given the current drugs carry warnings about the increased risk of suicide. And also we have built a solid intellectual property position for NRX-101, including the composition of matter patents.

Okay. That's all the questions we have. Thank you, everyone. This is all the time we have for questions. Thank you, everyone for joining us this morning. This concludes the NRx Pharmaceuticals First Quarter 2022 Results Conference Call. Thank you all for participating.