NRX Pharmaceuticals at H.C. Wainwright: Pioneering Neuropsychiatric Care

On Monday, 08 September 2025, NRX Pharmaceuticals (NASDAQ:NRXP) presented at the H.C. Wainwright 27th Annual Global Investment Conference. CEO Dr. Jonathan C. Javitt outlined the company’s innovative strategies to tackle neuropsychiatric conditions. The discussion highlighted both the promising potential of their treatments and the challenges faced in addressing the unmet needs in mental health care.

Key Takeaways

• NRX Pharmaceuticals is developing NRX-100 and NRX-101 to treat suicidal and bipolar depression.
• The company aims to integrate drug development with comprehensive care through Hope Therapeutics.
• Hope Therapeutics targets a $100 million revenue run rate and profitability by the end of 2025.
• NRX-100 offers a preservative-free ketamine alternative, addressing a $750 million market.
• CEO Dr. Javitt emphasized the critical need for effective mental health treatments.

Operational Updates

NRX Pharmaceuticals is focused on two lead programs: NRX-100 and NRX-101. NRX-100, a preservative-free ketamine, is being developed for suicidal depression, offering a safer alternative to existing ketamine products that contain benzalkonium chloride, a toxic preservative. NRX-101 combines oral d-cycloserine and lurasidone to address bipolar depression with suicidality and akathisia, conditions poorly served by current treatments.

Hope Therapeutics, NRX’s network of interventional psychiatric clinics, is central to their strategy. By integrating novel drug development with therapies like TMS and hyperbaric oxygen, Hope aims to deliver higher response rates. Dr. Javitt expressed confidence in achieving significant revenue and profitability by 2025, driven by strong demand for effective mental health solutions.

Future Outlook

NRX Pharmaceuticals positions itself uniquely by combining pharmaceutical advancements with comprehensive care delivery. This approach mirrors the model of Cancer Centers of America, aiming to revolutionize access to mental health care. The company’s focus on neuroplasticity and innovative treatments positions it to significantly impact the field of neuropsychiatry.

Dr. Javitt highlighted the vast potential market for NRX-100, noting the $750 million generic market for ketamine and the success of Johnson & Johnson’s Spravato, which achieved $1.4 billion in sales. The company’s ambition is to offer transformative treatments that can improve the lives of those affected by severe mental health conditions.

Conclusion

For a detailed understanding of NRX Pharmaceuticals’ strategies and insights shared during the conference, please refer to the full transcript below.

Full transcript - H.C. Wainwright 27th Annual Global Investment Conference:

Patrick Ralph Trucchio, Senior Healthcare Analyst, H.C. Wainwright & Co.: Good afternoon, everyone, and welcome back to H.C. Wainwright & Co.’s 27th Annual Global Investment Conference held on September 8th to September 10th, 2025. My name is Patrick Ralph Trucchio. I’m a Senior Healthcare Analyst at H.C. Wainwright & Co., and it’s my pleasure to welcome our next company. It’s NRx Pharmaceuticals. NRx is advancing neuropsychiatric treatments focused on meeting very high unmet medical needs. The company’s lead programs are NRX-100, an IV preservative-free ketamine formulation for suicidal depression, and NRX-101, a fixed-dose oral combination of d-cycloserine and lurasidone targeting bipolar depression with suicidality or akathisia. In parallel, the company is establishing Hope Therapeutics, a growing national network of interventional psychiatric clinics expected to support future commercialization and generate revenue in 2025. It’s my pleasure to introduce you to CEO Dr. Jonathan C. Javitt. Jonathan, welcome.

Jonathan C. Javitt, CEO, NRx Pharmaceuticals: Thank you.

Patrick Ralph Trucchio, Senior Healthcare Analyst, H.C. Wainwright & Co.: You’re an eye surgeon. Why did you found NRx?

Jonathan C. Javitt, CEO, NRx Pharmaceuticals: Probably the last thing I ever imagined myself doing was getting involved with a company that focused on neuropsychiatry. If you talk to anybody who went to medical school with me, they’ll tell you that I actually did quite poorly in psychiatry and fell in love with ophthalmology because it was a place where you could actually fix what was wrong. Back in 1982, when I graduated from medical school, we had just invented intraocular lenses. There was a whole new generation of therapeutics coming along, and ophthalmology was magic. Psychiatry was a sort of dismal place where the chance of people getting better was very remote. Psychiatry has changed drastically. Really what took me here was the experience of losing one of my closest friends to suicide.

A brilliant physician, first in his class at Yale College, first in his class at Harvard Medical School, wound up running the whole pain control research program for the National Institutes of Health. One of those people who was always the brightest light in the room, and nobody realized that he was actually hypomanic. That’s why he was so energetic. Every 10 years or so, he’d get depressed. The third time he had an episode of depression, they gave him an SSRI antidepressant, and it led to him hanging himself. I’ll never forget sitting with his daughter the night before the funeral saying, you know, if your dad had had a short circuit in his heart and died of it, this would be a horrible day, but nobody would be blaming him for what happened.

What we need to understand is that he had a short circuit in his brain and had no more control over what happened to him than if he died of a heart attack. In 2008, when I was saying that, the little voice in the back of my head was saying, you’re making that up. You’re just saying that. It’s now 15 years later, and it turns out that a lot of what I was saying has been borne out by scientific fact. These terrible diseases, suicidal depression kills an American every 11 minutes. Thirteen million people contemplate suicide every year. This incredibly lethal disease turns out to be a neurobiological disease, to be associated with loss of neuroplasticity, that is the ability of the brain to make new connections to other cells in the brain.

All of a sudden, we have a whole technology of drugs and therapies that restore neuroplasticity. At the heart of it, the drugs we’re developing, ketamine, d-cycloserine, are very potent neuroplastogens. The psychedelic drugs that people are so excited about are very potent neuroplastogens. Everybody talks about them as psychedelics, but there are already two molecules in phase two that are derivatives of psilocybin that don’t cause hallucinations. They’re not psychedelic, but they’re very potent neuroplastogens. Similarly, transcranial magnetic stimulation causes neuroplasticity. Hyperbaric oxygen causes neuroplasticity. If you put those things together, it’s as exciting to me as when I got involved in the first generation of drugs that inhibited VEGF and changed macular degeneration forever. When I finished my fellowship at Johns Hopkins in 1989, wet macular degeneration was considered an inevitably blinding disease.

If you saw it, you pretty much expected that person to lose their central vision within months to a year or two. Now people go on to see for most of their lives because of that generation of drugs. That’s what I think we’re seeing in neuropsychiatry today. We’re seeing a huge paradigm change that, for the first time in human history, can dramatically alter the course of these lethal diseases.

Patrick Ralph Trucchio, Senior Healthcare Analyst, H.C. Wainwright & Co.: Maybe you can talk a little bit more about NRx Pharmaceuticals’ mission to address acute suicidality and depression and why this is such a critical U.S. health priority.

Jonathan C. Javitt, CEO, NRx Pharmaceuticals: It’s a critical U.S. health priority because suicide is the second leading cause of death in young people. You’re talking about a disease that kills an American every 11 minutes. Unlike cancer that generally takes years to kill you, this is a disease that can kill you in a matter of weeks. Whereas it’s a devastating disease nationwide for first responders, for soldiers, for veterans, you’re talking about people who have four times the risk of suicide. We lose 22 veterans and active duty every day from suicide. I’m an aviator in the U.S. Coast Guard Auxiliary. Twice a month, I try to fly a search and rescue mission. Last year, the Coast Guard lost 14 shipmates to suicide. This is an organization that dangles people from cables over Arctic waters. Didn’t lose a single person from operations, 14 from suicide. Yes, this is very much a national crisis.

Patrick Ralph Trucchio, Senior Healthcare Analyst, H.C. Wainwright & Co.: How do you see the combination of novel drug development and integrated care delivery through Hope positioning NRx uniquely versus peers?

Jonathan C. Javitt, CEO, NRx Pharmaceuticals: I guess the broader question is, you know, why would a biotechnology company get involved in clinical care delivery? That’s usually somebody else’s problem. Develop a groundbreaking drug and doctors will figure out how to use it properly. The challenge here is that, at least from what I see, and I’d love to be proved wrong by some magic molecule, but from what I see, the molecules coming along have about a 70%, 60 to 70% response rate. That’s phenomenal compared to placebo, which is maybe a 20 or 30% response rate. The problem is that leaves out 30% of the people. You’ve got treatments like transcranial magnetic stimulation, incredibly powerful. For those of you who don’t know what it is, you’re taking the same strength magnet that’s used in an MRI machine, putting it outside the head, and using that to create neuroplasticity within the brain.

Also, a 70%, maybe better, but probably 70% response rate. Hyperbaric oxygen, same thing. As we talk to the people who are, you know, building the clinics that we’re in the process of acquiring, as we talk to the people who are really on the cutting edge, and they’re few and far between, because in many cases, the people who are doing ketamine clinics are very different from the people who are doing TMS, are very different from the people who are doing hyperbaric. As we talk to the pioneers who have really integrated those treatments, you know, they’re saying that they can make 90% of the people who walk in the door better. That’s a dramatic paradigm shift. That’s something that’s never been imagined in human history.

Patrick Ralph Trucchio, Senior Healthcare Analyst, H.C. Wainwright & Co.: Right. Moving on to NRX-100, for those less familiar, maybe you could walk us through NRX-100’s mechanism, the preservative-free formulation, and how it differs from generic ketamine.

Jonathan C. Javitt, CEO, NRx Pharmaceuticals: NRX-100 is our term for preservative-free ketamine. The whole story behind this actually starts with my younger brother, Dan Javitt, who’s a reasonably well-known psychiatrist. He’s one of the most published people in the field. When he was doing his residency in psychiatry in the 1980s at the Bronx Psychiatric Center, it was the height of what was called the angel dust epidemic. The angel dust epidemic was basically people were adding phencyclidine to marijuana on a routine basis because you could make a bag of pencil shavings seem like potent cannabis. The only problem was it causes acute psychosis in a certain number of people. There would be this parade of people being brought in by the police who thought they smoked a joint and wound up acutely schizophrenic. Dan asked the question, why does this drug cause psychosis? It must be binding somewhere in the brain.

If I can figure out where it’s binding in the brain, maybe we can learn something about the molecular basis of schizophrenia. That’s how Dan discovered the phencyclidine binding site in the NMDA receptor. Ketamine is the first cousin to phencyclidine. The only difference really is the binding kinetics of the two molecules. Ketamine is pretty much out of there in an hour or two, and phencyclidine can make you hallucinate for months at a time. For the first 15 years or so, it was viewed as a model for understanding schizophrenia. Rob Berman at Yale was doing a study with ketamine to see whether he could study the hallucinations, essentially. People said, this is amazing. I’ve been depressed all my life, and for the first time, I’m not depressed. Can I have some more of that? That’s how the whole ketamine discovery was made.

Everybody understands ketamine is a rapid-acting antidepressant, but it’s never been taken through the FDA. There’s a form of ketamine, S-ketamine, which is one of the mirror images of the molecule that’s been turned into a nose spray, Spravato, and it’s now a $1.4 billion drug. Plain old IV ketamine has never been taken through the FDA. It’s available to people who are willing to pay cash for the benefit of the treatment. People say extraordinarily good things about its effectiveness, but it’s not available to people who rely on health insurance. What’s pretty unique is that the VA pays for it. The VA will pay doctors to give ketamine to veterans, whereas the average American who relies on commercial health insurance or Medicare can’t get it. We are taking it through the FDA process, but in the process, we realized that every vial of ketamine sold in the U.S.

and pretty much worldwide has a toxic preservative in it called benzalkonium chloride. Everybody assumed that this is just part and parcel of the drug. The reason I looked at it differently is back in the 1990s, one of my colleagues at Johns Hopkins said, why is it that all these glaucoma patients have chronic dry eye? What is it about glaucoma that gives you chronic dry eye? It turned out that the benzalkonium chloride preservative that was in all the eye drops is toxic to the epithelial cells that cover the eye and causes chronic dry eye. People would take tears for the dry eye, and it only got worse because all the tear drops contained benzalkonium chloride. Once they went to preservative-free drops, the incidence of dry eye in glaucoma patients was vastly reduced.

I took a look at ketamine and said, wait a second, this preservative doesn’t belong in there. There’s no reason for it. Everybody said, oh, it’s an excipient. You need it to keep the ketamine stable. I said, I’m not sure. We put it up for stability. We formulated it without the preservative, and lo and behold, you can get three years or more of stability without that preservative. Benzalkonium chloride is so toxic that the FDA doesn’t even allow it to be used in hand cleansers or topical antiseptics. It is certainly not something you should be injecting intravenously.

Patrick Ralph Trucchio, Senior Healthcare Analyst, H.C. Wainwright & Co.: Right. If approved, I guess how large of a market opportunity do you think NRX-100 and suicidal depression and in general use could be?

Jonathan C. Javitt, CEO, NRx Pharmaceuticals: There are two sides to this. One is just replacing the generic market. There’s a $750 million generic market for ketamine. There’s also the innovative market. You know, as I said, J&J has a drug, Spravato, which is a nasal form of ketamine. At many of the conferences I’ve been to, doctors really prefer the intravenous form, but Spravato hit $1.4 billion last year, and it’s just beginning to scratch the surface. Probably the biggest answer, to quote the president, is huge.

Patrick Ralph Trucchio, Senior Healthcare Analyst, H.C. Wainwright & Co.: Moving on to NRX-101, this is oral d-cycloserine and lurasidone. Maybe introduce this compound and explain its dual mechanism targeting both suicidality and akathisia.

Jonathan C. Javitt, CEO, NRx Pharmaceuticals: This again goes back to Dan Javitt’s work. We understand why ketamine works. The NMDA receptor, the NMDA channel, lets ions from outside, calcium ions from outside, into the brain cell. Among other things, it kind of regulates the speed of thoughts. It’s extremely neuroplastic. It causes brain cells to spread new dendrites and make connections to other brain cells. Conor Liston’s work at Cornell pretty much shows that when you’re in models of depression, you’ve lost neuroplasticity. Once the discovery was made that ketamine is a potent antidepressant, the problem is it’s neurotoxic, it’s hallucinogenic, it’s addictive, can’t be given by mouth. Dan started to ask the question, what other drugs might have those beneficial properties without some of the side effects? He came across, and it was already known by that time that d-cycloserine is an NMDA antagonist.

He came across work that was done by a guy named Crane in 1959. Crane was sitting in the Bronx treating tuberculosis patients and figured out that d-cycloserine, which at the time was a very promising drug to treat tuberculosis, had a pretty powerful antidepressant effect. The work was never followed up on. In fact, I had to go get Crane’s papers from the paper stacks of the National Library of Medicine. It wasn’t even digitized. The main reason people didn’t follow up on it is there was another tuberculosis drug, isoniazid, that also serendipitously showed antidepressant effects and got turned into iproniazid, which was one of the first monoamine oxidase antidepressants. Probably people assumed that these tuberculosis drugs are all the same and they all are good antidepressants, and we’ve already got iproniazid, so we don’t need to go any further.

It would be another 20 years before anybody understood that d-cycloserine is an NMDA antagonist and iproniazid operated on the serotonin pathway.

Patrick Ralph Trucchio, Senior Healthcare Analyst, H.C. Wainwright & Co.: Right. How big is the unmet need in bipolar depression with suicidality and akathisia, and how do you quantify that potential addressable market?

Jonathan C. Javitt, CEO, NRx Pharmaceuticals: People with bipolar depression are 10 times more likely than people with major depressive disorder to kill themselves. It’s a well-known side effect. It’s the reason that none of the SSRI antidepressants is indicated for use in bipolar. The drugs that are tend to be atypical antipsychotics, drugs like lurasidone, but even they have suicide warnings on the label because they’re known to cause akathisia. Akathisia is very closely linked to suicide. Probably 3 million people with bipolar depression need an effective drug. We estimate that there are about 600,000 who have suicidality and akathisia despite best available therapy. There’s a substantial market out there, and it’s a substantial market of people whose only alternative today is electroshock therapy.

The other important thing to understand, and this is really late-breaking news, is that the doctors who are doing TMS have become convinced that d-cycloserine doubles or triples the effectiveness of TMS because it’s such a potent neuroplastogen that they say it’s sort of like fertilizing the field before you plant the seeds. Before you do the TMS, apply a neuroplastic drug and you’ll get a much better clinical response. I think we’re only at the beginning of understanding how big a drug, d-cycloserine, could be.

Patrick Ralph Trucchio, Senior Healthcare Analyst, H.C. Wainwright & Co.: Right. That’s interesting. Maybe just a few on Hope. Hope is targeting a $100 million revenue run rate and profitability by the end of 2025. What gives you confidence to achieve those milestones?

Jonathan C. Javitt, CEO, NRx Pharmaceuticals: When we put out that number, we said on a pro forma going forward basis, and we acquired our first couple of clinics today. We have others that we’ve announced that are in the pipeline that we hope to close by the end of the month, if not before. What we’re finding is that there’s enormous patient demand for a place people can go and actually get better. If we can follow up on that promise, if we can say, you know, give us a week and we’ll give you back your life, there’s almost endless opportunity to combine these neuroplastic drugs with TMS, with other neuroplastic therapies, and take a disease that’s as old as Hamlet, maybe even as old as King David. It’s widely thought that he suffered from depression and changed the natural course of that disease.

Patrick Ralph Trucchio, Senior Healthcare Analyst, H.C. Wainwright & Co.: Right. Maybe as a final question, what are your longer-term plans for Hope and how should investors think about the planned spin-out?

Jonathan C. Javitt, CEO, NRx Pharmaceuticals: Our plans for Hope are to acquire clinics, to start clinics, and to build an integrated network of care that patients can rely on. In the same way that Cancer Centers of America took what were essentially academic protocols, they said, look, you don’t have to go to Dana-Farber, you don’t have to go to Memorial Sloan Kettering, you don’t have to go to MD Anderson to get integrated state-of-the-art cancer care. We can bring it to your community. That’s what we aim to do with Hope.

Patrick Ralph Trucchio, Senior Healthcare Analyst, H.C. Wainwright & Co.: Terrific. Jonathan, thank you so much. Thank you to NRx Pharmaceuticals for attending. Thank you for everyone.

Jonathan C. Javitt, CEO, NRx Pharmaceuticals: Thank you.

Patrick Ralph Trucchio, Senior Healthcare Analyst, H.C. Wainwright & Co.: Have a great rest of your conference.

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