Release Date: August 14, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- NRX Pharmaceuticals Inc (NRXP, Financial) is poised to file two NDAs for NRX-100 and NRX-101 in the coming months.
- The company has significantly reduced operating costs and cut its loss per share by nearly 50% compared to the prior year.
- NRX Pharmaceuticals Inc (NRXP) has secured up to $16 million in new funding from Anson Partners, stabilizing its financial position.
- The company has demonstrated that NRX-101 is the first oral antidepressant to reduce symptoms of suicidality and akathisia.
- NRX Pharmaceuticals Inc (NRXP) has made substantial progress in its clinical development pipeline, particularly in addressing the national epidemic of suicidality.
Negative Points
- NRX Pharmaceuticals Inc (NRXP) did not demonstrate that NRX-101 is more effective in reducing symptoms of depression than the market-leading drug Lurasidone.
- The company still faces challenges in getting its drugs approved and commercialized, with a focus on 2025 for potential approvals.
- NRX Pharmaceuticals Inc (NRXP) has a limited cash position, with only $1.9 million in cash and cash equivalents as of June 30, 2024.
- The company has experienced an increase in general and administrative expenses, primarily due to higher consultant and legal fees.
- NRX Pharmaceuticals Inc (NRXP) is in the process of searching for a new CEO with commercial experience, which could lead to transitional challenges.
Q & A Highlights
Q: Congratulations on all the progress. It seems like your initial focus will be on the U.S. market, but have you given thought about international opportunities for both NRX-100 and 101?
A: Well, there's no question that the rest of the world is important to us, and we've consistently listed a large number of foreign patent approvals. As you know, we have Composition of Matter patent protection on NRX-101, and, so far, it's been approved in just about every jurisdiction where we've applied. So that rest of the world opportunity is something we're very much focused on. As you know, we've added Professor Marion Leboyer, who's one of the leading psychiatrists in France, the professor of psychiatry at INSERM in Paris to our advisory board, and it's something we think about on a regular basis. That said, we do anticipate that the initial launch will be in the United States.
Q: Would you please tell us more about the Hope business plan, how the funding is going to work, and what the benefits of our shareholders may be?
A: One of the things we've realized is that while there are some outstanding ketamine clinics run by dedicated psychiatrists in the US, many of the initial attempts to create ketamine clinic networks across the country have been private equity driven, focused on minimizing cost of care, but not necessarily maximizing quality and innovation of care. And what we intend to do through Hope Therapeutics is to bring together a best-of-breed ketamine and interventional psychiatric clinics, together with networks of clinics that want to learn from them, want to bring their standards up to the best possible standards. And we've seen a fair degree of investor enthusiasm for that structure. We'll certainly have more to say in the coming months, but I think you'll see Hope as a living, breathing entity in the coming quarter.
Q: How do you see NRX-101 fitting into the treatment paradigm for bipolar depression?
A: If we're able to get accelerated approval for NRX-101 in patients who have akathisia and or suicidal ideation on the current generation of 5-HT2a antagonist drugs, you're talking about Lurasidone, olanzapine, cariprazine, that family of drugs, I think you'll see NRX-101 become a preferred drug in that category. Because akathisia is -- one leading psychiatrist put to me the worst side effect of every antidepressant. It can have lethal consequences. And until now, people didn't talk about it too much because there wasn't much to do about it. All of a sudden, there is something to do about it, and we hope to be that solution.
Q: Steve mentioned that inhaled ketamine had not shown an improvement in suicidality. Why would IV be better than that?
A: It's certainly possible that a future trial will show that intranasal ketamine has improved properties against suicidality compared to placebo, although that wasn't the case either with inhaled racemic ketamine or so far hasn't been shown with inhaled esketamine. It's possible that, and some doctors have hypothesized this, the steady-state nature of an intravenous administration is important compared to the more sort of wax and wane, the more of an acute blast of ketamine that you get when it's given intranasally. Rather than focus on other people's approaches, I think if we just focus on ours and say, we've seen an important decrease in suicidality in the clinical trials that we're presenting to the FDA. And that decrease has now been echoed in a 500,000-person cohort study, that's really the important message.
Q: As you guys are planning out so many NDAs this year, a possible approval for next year, have you thought about your commercial strategy, whether you will develop your own commercial team or whether you look for commercial partners?
A: In the case of NRX-100, we already know who the customers are because it's a clinic-based drug and there's a limited number of clinics. So about 600 and it could grow to 1,000 by next year who are using the drug. And some of those clinics are going to be clinics that Hope Therapeutic zones. So there's no need for the overhead of a large commercial partner to reach customers who already want to talk to you. In the case of NRX-101, it's also a fairly compact footprint. There are approximately 1,600 psychiatrists in the United States who currently prescribe the Lurasidone class of drugs. And you can reach that number of doctors with a fairly compact sales force of about 50 people. Now I'm possibly the least qualified person in the company to talk about that. Matt Duffy started out doing that for living.
Matthew Duffy: Sure. You can look at a number of different parameters in terms of number of prescribers, in terms of geography and access to representatives. There's a number of ways to approach it, but you can very effectively get out with reps, reps in the 20 to 30 rep range or not necessarily reps, but field force and really plank at the key prescribers in actually, as Jonathan pointed out, with both of these drugs. And as you do so, really target the highest prescribing folks out there. I've done this before at Lev and Medimmune. And the targeted sales force is really a good way to go. It's very efficient, and you can really get the word out there very quickly. And those are I think the important parameters as we look into taking this really to the next level because there's just a tremendous amount of opportunity.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
