Q2 2025 NRX Pharmaceuticals Inc Earnings Call

We will conduct a question and answer session. If at any time during this call. We required immediate assistance. Please press star zero for operator.

This call is being recorded on Wednesday August 22025.

I'd now like to turn the conference over to Matthew Duffy Chief Business Officer. Please go ahead Sir.

Thank you Louis and welcome everyone. 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 security laws.

Speaker #2: If at any time during this call you require immediate assistance, please press *0 for the operator. This call is being recorded on Wednesday, August 20, 2025.

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 vary from statements made on this call is contained in our periodic reports filed with the SEC.

Speaker #2: I would now like to turn the conference over to Matthew Duffy, Chief Business Officer. Please go ahead, sir.

Speaker #3: Thank you, Budi. And welcome, everyone. 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.

Ludi: Thank you, Ludi, and welcome, everyone. 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 security 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 vary 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 the press release issued Monday and in the company's Form 10-Q, which may be accessed from the investor page of the NRx Pharmaceuticals, Inc. website.

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.

Speaker #3: federal security laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations.

Information presented on this call is contained in the press release issued Monday and in the company's Form 10-Q, which may be accessed from the investor page of that Rx Pharmaceuticals, Inc website.

Speaker #3: Additional information concerning factors that could cause actual results to vary from statements made on this call is contained in our periodic reports filed with the SEC.

Joining me today on the call are Jonathan <unk>, our founder Chairman and CEO and Mike Labrum, So our chief Financial Officer Dr.

Speaker #3: Before we look at 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.

Dr. <unk> will provide an overview of our company's progress as reported in Monday's Tim Healy.

Following which Mike will review the Companys financial results.

Speaker #3: Information presented on this call is contained in the press release issued Monday and in the company's Form 10-Q, which may be accessed from the investor page of the NRX Pharmaceuticals Inc. website.

Following their prepared remarks, we will address investor questions.

Now I'll turn it over the bulk of the Jonathan Jonathan.

Thank you Matt Good morning, everyone and thank you for joining us the past several months have been nothing short of exceptional for interacts we've.

Speaker #3: Joining me today on the call are Jonathan Javitt, our founder, chairman, and CEO. And Mike Abrams, our Chief Financial Officer. Dr. Javitt will provide an overview of our company's progress as reported in Monday's 10-Q.

Ludi: Joining me today on the call are Jonathan Javitt, our founder, Chairman, and CEO, and Michael Abrams, our Chief Financial Officer. Dr. Javitt will provide an overview of our company's progress as reported in Monday's 10-Q, following which Mike will review the company's financial results. Following their prepared remarks, we will address investor questions. I will now turn over the call to Jonathan. Jonathan.

We've been in vital advances across each of our programs with free drug approval applications in progress and our evolving network of interventional psychiatry clinics hope therapeutics taking place.

Speaker #3: Following which, Mike will review the company's financial results. Following their prepared remarks, we will address investor questions. Now, I'll turn the call over to Jonathan.

At the same time as we position for near term revenue, we've reduced our quarterly operating loss by approximately 50% year over year.

Speaker #3: Jonathan?

Speaker #4: Thank you, Matt. Good morning, everyone, and thank you for joining us. The past several months have been nothing short of exceptional for NRX. We've made vital advances across each of our programs, with Free Drug Approval Applications in progress and our evolving network of interventional psychiatry clinics and Hope therapeutics taking place.

Jonathan Javitt: Thank you, Matt. Good morning, everyone, and thank you for joining us. The past several months have been nothing short of exceptional for NRx Pharmaceuticals. We have made vital advances across each of our programs, with three drug approval applications in progress and our evolving network of interventional psychiatry clinics, Hope Therapeutics, taking place. At the same time, as we position for near-term revenue, we have reduced our quarterly operating loss by approximately 50% year over year while filing more than 80,000 pages of regulatory data in the last quarter alone with a small team of dedicated scientists. As we announced on Monday, we have strengthened our balance sheet and added long-term healthcare specialist investors with extensive experience in biotechnology, as well as experience in managing multi-unit retail operations. Led by Mr.

While filing more than 80000 pages of regulatory data in the last quarter alone with a small team of dedicated scientists.

As we announced on Monday, we have strengthened our balance sheet and added long term health care specialists investors with extensive experience in biotechnology as well as experience in managing multi unit retail operations led by Mr. Brandon Moe and the B group. These investors have demonstrated their long term commitment to <unk>.

Speaker #4: At the same time, as we position for near-term revenue, we've reduced our quarterly operating loss by approximately 50% year-over-year, while filing more than 80,000 pages of regulatory data in the last quarter alone, with a small team of dedicated scientists.

Our success by way of their one year lock up agreement not to trade short or otherwise hypothecate our stock.

While also foregoing warrants and other dilutive features that are so destructive to biotechnology stocks today.

Speaker #4: As we announced on Monday, we've strengthened our balance sheet and added long-term healthcare specialist investors with extensive experience in biotechnology, as well as experience in managing multi-unit retail operations.

We then interacts look forward to their ongoing partnership.

As you can see from our balance sheet.

Substantially reduce the burden of convertible debt that was in place when I rejoined the CEO in order to create a more straightforward growth path for long term appreciation oriented investors let.

Speaker #4: Led by Mr. Brandon Mull on the B group, these investors have demonstrated their long-term commitment to our success by way of their one-year lock-up agreement not to trade short or otherwise hypothecate our stock, while also forgoing warrants and other dilutive features that are so destructive to biotechnology stocks today.

Jonathan Javitt: Brandon Mull and B Group Capital, these investors have demonstrated their long-term commitment to our success by way of their one-year lockup agreement not to trade short or otherwise hypothecate our stock, while also foregoing warrants and other dilutive features that are so destructive to biotechnology stocks today. We at NRx Pharmaceuticals look forward to their ongoing partnership. As you can see from our balance sheet, we have substantially reduced the burden of convertible debt that was in place when I rejoined as CEO in order to create a more straightforward growth path for long-term appreciation-oriented investors. Let me start with a high-level overview for each program, starting with NRX-100. Our preservative-free intravenous ketamine is following two parallel approval processes. First, however, let me take a moment to explain how this came about.

Let me start with a high level overview for each program starting within our X 100.

Our preservative free intravenous ketamine.

It's following two parallel approval processes.

Speaker #4: We at NRX look forward to our ongoing partnership. As you can see from our balance sheet, we have substantially reduced the burden of convertible debt that was in place when I rejoined as CEO in order to create a more straightforward growth path for long-term, appreciation-oriented investors.

First however, let me take a moment to explain how this came about.

As many of you know my original medical discipline as ophthalmology and for 10 years I cared for patients with chronic glaucoma first at Johns Hopkins and then a Georgetown university's.

Speaker #4: Let me start with a high-level overview for each program, starting with NRX-100. Our preservative-free intravenous ketamine is following two parallel approval processes. First, however, let me take a moment to explain how this came about.

Around 1995, one of my colleagues notice that glaucoma patients were far more likely to suffer from dry eye and tear film deficiency than most other patients. The problem was tracked down to benzyl conium chloride, a preservative that was in most glaucoma medicines.

Speaker #4: As many of you know, my original medical discipline is ophthalmology, and for ten years, I cared for patients with chronic glaucoma, first at Johns Hopkins and then at Georgetown Universities.

Jonathan Javitt: As many of you know, my original medical discipline is ophthalmology, and for 10 years, I cared for patients with chronic glaucoma, first at Johns Hopkins and then at Georgetown University. Around 1995, one of my colleagues noticed that glaucoma patients were far more likely to suffer from dry eye and tear film deficiency than most other eye patients. The problem was tracked down to benzalkonium chloride, a preservative that was in most glaucoma medicines. The problem was compounded by the presence of benzalkonium chloride in the artificial tear drops that were used to try to help the dry eye that was caused by the glaucoma drops in the first place. Clear evidence emerged that benzalkonium chloride was toxic to the epithelial cells that cover the eye and to the nerves of the cornea. That is why so many eye drops have gone preservative-free over the years.

And the problem was compounded by the presence of Benzos conium chloride in the artificial tear drops that we're used to try to help the dry eye that was caused by the glaucoma drops in the first place.

Speaker #4: Around 1995, one of my colleagues noticed that glaucoma patients were far more likely to suffer from dry eye and tear film deficiency than most other eye patients.

They were evidenced emerged that then sell conium chloride was toxic to the epithelium cells like cover the I entered the nerves of the cornea. That's why so many eyedrops have gone preservative free over the years.

Speaker #4: The problem was tracked down to benzalkonium chloride, a preservative that was in most glaucoma medicines. And the problem was compounded by the presence of benzalkonium chloride in the artificial tear drops that were used to try to help the dry eye caused by the glaucoma drops in the first place.

Well, the first cousins events iconium chloride <unk> chloride or <unk> its founding ketamine.

T is similarly toxic to epithelium surfaces it.

It was added to ketamine when the drug was first formulated 70 years ago.

Speaker #4: Clear evidence emerged that benzalconium chloride was toxic to the epithelial cells that cover the eye and to the nerves of the cornea, that's why so many eye drops have gone preservative-free over the years.

So the same veil, a drug could be used for multiple doses of drug without contaminating the bottle.

And today's hospital environment multi dose administration is increasingly frequent.

Speaker #4: Well, the first cousin of benzalconium chloride, benzethonium chloride (BZT), is found in ketamine. BZT is similarly toxic to epithelial surfaces. It was added to ketamine when the drug was first formulated 70 years ago so that the same vial of drug could be used for multiple doses without contaminating the bottle.

The BCG and ketamine may not pose much risk with ketamine is used once in the operating room for anesthesia.

Jonathan Javitt: The first cousin to benzalkonium chloride, benzetonine chloride, or BZT, is found in ketamine. BZT is similarly toxic to epithelial surfaces. It was added to ketamine when the drug was first formulated 70 years ago so that the same vial of drug could be used for multiple doses of drug without contaminating the bottle. In today's hospital environment, multi-dose administration is increasingly infrequent. The BZT in ketamine may not pose much risk when ketamine is used once in the operating room for anesthesia. The problem is patients who get ketamine for depression often get repeated administrations.

<unk> patients, who get ketamine for depression, often get repeated administrations.

As we have shown the FCA and our citizens petition.

And as you can see from the scientific paper identified in the Q and the earnings release multiple doses of ketamine with BCP preservative Ken.

Speaker #4: In today's hospital environment, multidose administration is increasingly infrequent. The BZT in ketamine may not pose much risk when ketamine is used once in the operating room for anesthesia; the problem is patients who get ketamine for depression often get repeated administrations.

Ken approach toxic doses of BCG.

That's why we filed the citizen's petition with the FDA to have visa T removed from all forms of ketamine.

Our basis for this petition is expert toxicology analysis documenting the PCT has never been shown to be safe is not on the list of preservative is generally recognized as safe that's called the Gras list by the FDA Indeed.

Speaker #4: As we have shown the FDA and our citizen's petition, and as you can see from the scientific paper identified in the Q and the earnings release, multiple doses of ketamine with BZT preservative can approach toxic doses of BZT.

Jonathan Javitt: As we have shown the FDA in our citizen petition, and as you can see from the scientific paper identified in the Q and the earnings release, multiple doses of ketamine with BZT preservatives can approach toxic doses of BZT. That is why we filed the citizen petition with FDA to have BZT removed from all forms of ketamine. Our basis for this petition is expert toxicology analysis documenting that BZT has never been shown to be safe, is not on the list of preservatives generally recognized as safe. That is called the GRAS list by the FDA. Indeed, FDA's concern about BZT is high to the point where FDA no longer allows its use in hand cleaners and topical antiseptics. Thus, we believe that BZT has no legitimate place in a parenteral drug that will be administered repeatedly. As I said, we are following two regulatory paths for ketamine.

Indeed, fda's concern about DCT as high to the point, where FDA no longer allows its use in hain cleaners and topical antiseptics.

Speaker #4: That's why we filed the citizens' petition with the FDA to have BZT removed from all forms of ketamine. Our basis for this petition is expert toxicology analysis documenting that BZT has never been shown to be safe, is not on the list of preservatives generally recognized as safe, known as the GRAS list by the FDA.

Thus, we believe that <unk> has no legitimate place in a parenteral drug that will be administered repeatedly.

As I said, we are following two regulatory paths for ketamine. The first is a new drug application, an NDA for <unk> 100, and suicidal ideation for patients with depression, including bipolar depression.

Speaker #4: Indeed, the FDA's concern about BZT is high to the point where the FDA no longer allows its use in hand cleaners and topical antiseptics. Thus, we believe that BZT has no legitimate place in a parenteral drug that will be administered repeatedly.

The second is an abbreviated new drug application or <unk> to make preservative free ketamine available for ketamine existing indications.

Data are clear in our view that <unk> hundred can offer effective and safe options for patients with suicidal depression.

Speaker #4: As I said, we're following two regulatory paths for ketamine: the first is a New Drug Application (NDA) for NRX-100 in suicidal ideation for patients with depression, including bipolar depression.

Jonathan Javitt: The first is a New Drug Application, or NDA, for NRX-100 in suicidal ideation for patients with depression, including bipolar depression. The second is an Abbreviated New Drug Application, or ANDA, to make preservative-free ketamine available for ketamine's existing indications. Data are clear in our view that NRX-100 can offer effective and safe options for patients with suicidal depression, whose only current treatment alternative is ECT, or electroconvulsive therapy. Our corporate presentations highlight randomized controlled trials demonstrating the purity of ketamine to placebo, to active comparator, along with demonstration of equivalence to ECT overall in more than 1,000 patients. We will be presenting real-world data for FDA's consideration on nearly 180,000 patients treated with both ketamine and Spravato. We aim to submit these data in support of an application for accelerated approval and have already filed the Module 3 manufacturing information and the draft proposed label.

Who is the only current treatment alternative is.

ECT or Electroconvulsive therapy.

Our corporate presentations highlight randomized controlled trials, demonstrating superiority of ketamine to placebo to active comparator <unk>.

Speaker #4: The second is an abbreviated new drug application or ANDA, to make preservative-free ketamine available for ketamine's existing indications. Data are clear in our view that NRX 100 can offer effective and safe options for patients with suicidal depression.

Along with demonstration of equivalents to ECT.

Overall and more than 1000 patients.

We will be presenting real world data for FTE as consideration on nearly 180000 patients treated with both ketamine and <unk>.

Speaker #4: Whose only current treatment alternative is ECT, or electroconvulsive therapy. Our corporate presentations highlight randomized controlled trials demonstrating the priority of ketamine to placebo, to active comparator, along with the demonstration of equivalence to ECT, overall in more than a thousand patients.

We aim to submit these data in support of an application for accelerated approval and have already filed the module three manufacturing information and the draft proposed label.

You can read about accelerated approval on the FDA website. It represents an approval pathway for fast track and breakthrough drugs, whereby intermediate clinical data are presented in support of an initial approval with a comp with a concomitant.

Speaker #4: We'll be presenting real-world data for FDA's consideration on nearly 180,000 patients treated with both ketamine and Spravato. We aim to submit these data in support of an application for accelerated approval and have already filed the Module 3 manufacturing information and the draft proposed label.

Commitment by the sponsor to present this positive clinical proof of efficacy within five years.

Last week FDA granted a major expansion of the fast track designation.

Speaker #4: You can read about accelerated approval on the FDA website. It represents an approval pathway for fast-tracking breakthrough drugs, whereby intermediate clinical data are presented in support of an initial approval, with a concomitant commitment by the sponsor to present dispositive clinical proof of efficacy within five years.

Jonathan Javitt: You can read about accelerated approval on the FDA website. It represents an approval pathway for fast-tracking breakthrough drugs whereby intermediate clinical data are presented in support of an initial approval with a concomitant commitment by the sponsor to present dispositive clinical proof of efficacy within five years. Last week, FDA granted a major expansion of the fast-track designation originally granted to NRX-100 in 2017. Whereas the initial designation was related to bipolar depression, FDA has now broadened our fast-track designation to encompass all patients with suicidal ideation in depression, including bipolar depression. The CDC estimates that 13 million Americans consider suicide each year and that an American dies from suicide every 11 minutes. Hence, FDA's broadened fast-track designation offers NRx Pharmaceuticals a tenfold greater opportunity to make a real difference in one of the largest public health crises to face our nation.

Originally granted to <unk> 100 in 2017.

Whereas the initial designation was related to bipolar depression FCA has now broadened our fast track designation to encompass all patients with suicidal ideation and depression, including bipolar depression.

The CDC estimates that 13 million Americans consider suicide, each year and that an American dies from suicide every 11 minutes.

Speaker #4: Last week, FDA granted a major expansion of the fast-track designation originally granted to NRX 100 in 2017. Whereas the initial designation was related to bipolar depression, FDA has now broadened our fast-track designation to encompass all patients with suicidal ideation in depression, including bipolar depression.

Hence FDA has broadened SaaS track designation offers an Rx a 10 fold greater opportunity to make a real difference.

And one of the largest public health crises to face our nation.

Under its new leadership.

And the Maha program.

Dramatically focused on national public health crises.

Speaker #4: The CDC estimates that 13 million Americans consider suicide each year and that an American dies from suicide every 11 minutes. Hence, the FDA's broadened fast-track designation offers NRX a tenfold greater opportunity to make a real difference in one of the largest public health crises to face our nation.

By creating the commissioners national priority voucher program that affords substantially faster review times of one to two months versus the standard 10 to 12 months review.

It provides enhanced communication throughout the review process and creates potential for accelerated approval of <unk> 100.

Speaker #4: FDA, under its new leadership, and the MAHA program, has dramatically focused on national public health crises. By creating the Commissioner's National Priority Voucher Program, that affords substantially faster review times of one to two months versus the standard 10 to 12-month review, provides enhanced communication throughout the review process, and creates potential for accelerated approval of NRX 100.

Jonathan Javitt: FDA, under its new leadership and the MAHA Program, has dramatically focused on national public health crises by creating the Commissioner's National Priority Voucher Program that affords substantially faster review times of one to two months versus the standard 10 to 12-month review, provides enhanced communication throughout the review process, and creates potential for accelerated approval of NRX-100. To receive a CNPV, a product must meet at least one of the following criteria: it must address a U.S. public health crisis, it must deliver more innovative cures for the American people, it must address a large unmet medical need, and this was noted in our fast-track designation that we do, in fact, address a large unmet medical need. It must onshore drug development and manufacturing to advance the health interests of Americans, strengthen the U.S. supply chain, or increase affordability. Our team believes that NRX-100 meets all of CNPV's criteria.

To receive a <unk> a product must meet at least one of the following criteria must address the U S public health crisis.

And must deliver more innovative cures for the American people and must address a large unmet medical need and this was noted in our fast track designation that we do in fact address the large unmet medical need.

Must onshore drug development and manufacturing to advance the health interest of Americans.

Speaker #4: To receive a CMPV, a product must meet at least one of the following criteria: it must address a U.S. public health crisis, it must deliver more innovative cures for the American people, it must address a large unmet medical need, and this was noted in our fast-track designation that we do, in fact, address a large unmet medical need.

Strength in the U S supply chain or increase affordability.

Our team believes that an Rx 100 meter all of CMT. These criteria.

On the second approval path, we file the NDA in June of this year utilizing existing manufacturing data found in module three of our suicidal depression NDA.

Speaker #4: It must onshore drug development and manufacturing to advance the health interests of Americans. Strengthen the U.S. supply chain or increase affordability. Our team believes that NRX-100 meets all of CMPV's criteria.

We have since received comments from the FDA identifying only one scientific discrepancy.

Along with some easily remediated administrative deficiencies.

Specifically FDA asked us to justify the level of a single inert ingredients in the formulation.

Were actively addressing this matter with the FDA and do not believe it would cause undue delay in the approval process.

Speaker #4: On the second approval path, we filed the ANDA in June of this year utilizing existing manufacturing data found in module three of our suicidal depression NDA.

Jonathan Javitt: On the second approval path, we filed the ANDA in June of this year, utilizing existing manufacturing data found in Module 3 of our suicidal depression NDA. We've since received comments from the FDA identifying only one scientific discrepancy, along with some easily remediated administrative deficiencies. Specifically, FDA asked us to justify the level of a single inert ingredient in the formulation. We're actively addressing this matter with FDA and do not believe it will cause undue delay in the approval process. The existing market for ketamine has been projected at approximately $750 million a year, and we believe NRX-100, made in the United States and offered without any toxic preservatives, offers patients and clinicians a superior option. Approval of the citizen petition removing benzalkonium chloride from the U.S. ketamine supply would give NRx Pharmaceuticals a substantial position in that existing $750 million generic ketamine market.

The existing market for ketamine has been projected at approximately $750 million a year.

Speaker #4: We've since received comments from the FDA, identifying only one scientific discrepancy along with some easily remediated administrative deficiencies. Specifically, FDA asked us to justify the level of a single inert ingredient in the formulation.

And we believe in our excellent hundred made in the United States and offered without any toxic preservatives.

Patients and clinicians a superior option.

Approval.

Speaker #4: We're actively addressing this matter with the FDA and do not believe it will cause undue delay in the approval process. The existing market for ketamine has been projected at approximately $750 million a year.

Of the citizens petition removing benzyl sodium chloride from the U S ketamine supply.

Given our substantial position in that existing $750 million generic ketamine market.

We will continue to work diligently with the FDA to move our applications as rapidly as possible and provide a safer version of this critical product to the American public.

Speaker #4: And we believe NRX 100, made in the United States, and offered without any toxic preservatives, offers patients and clinicians a superior option. Approval of the citizens' petition removing benzathonium chloride from the U.S.

<unk> 101, our oral product for the treatment of suicidal bipolar depression.

Recently achieved an important milestone that is the filing of the initial module known as module three of the chemistry manufacturing controls section or CMC with U S. FDA last week. This was filed under the previously granted breakthrough therapy designation awarded to <unk> 101.

Speaker #4: Ketamine supply would give NRX a substantial position in the existing $750 million generic ketamine market. We'll continue to work diligently with the FDA to move our application as rapidly as possible and provide a safer version of this critical product to the American public.

Jonathan Javitt: We'll continue to work diligently with the FDA to move our application as rapidly as possible and provide a safer version of this critical product to the American public. NRX-101, our oral product for the treatment of suicidal bipolar depression, recently achieved an important milestone, that is the filing of the initial module known as Module 3, the Chemistry Manufacturing Control Section, or CMC, with the U.S. FDA last week. This was filed under the previously granted breakthrough therapy designation awarded to NRX-101, and therefore, we anticipate rolling review of this application. We're working diligently to complete this filing and will request priority review, which, if granted, would confer a six-month review period.

And therefore, we anticipate rolling review of this application where.

Speaker #4: NRX 101, our oral product for the treatment of suicidal bipolar depression, recently achieved an important milestone: the filing of the initial module known as Module 3, the Chemistry Manufacturing Control section, or CMC, with the U.S.

We're working diligently to complete this filing and we will request priority review, which if granted would confer a six month review period.

There are more than 7 million patients suffering from bipolar depression in the U S and many of these are at risk of akathisia are terrible side effects related to serotonin active drugs that is closely related to suicide and can cause.

Speaker #4: The FDA last week processed this under the previously granted Breakthrough Therapy designation awarded to NRX-101. Therefore, we anticipate a rolling review of this application.

And irresistible need.

Speaker #4: We're working diligently to complete this filing and will request priority review, which, if granted, would confer a six-month review period. There are more than 7 million patients suffering from bipolar depression in the U.S., and many of these are at risk of akathisia—a terrible side effect related to serotonin-active drugs that is closely related to suicide and can cause an irresistible need to move, an inability to sit still, and all too often is associated with patients jumping off roofs, jumping in front of trains, and otherwise harming themselves in horrible ways.

To move inability to sit still and all too often.

It's associated with patients jumping off of roofs jumping in front of trains.

Jonathan Javitt: There are more than 7 million patients suffering from bipolar depression in the U.S., and many of these are at risk of akathisia, a terrible side effect related to serotonin-active drugs that is closely related to suicide and can cause an irresistible need to move, inability to sit still, and all too often is associated with patients jumping off of roofs, jumping in front of trains, and otherwise harming themselves in horrible ways. These patients are at tremendous risk of self-harm, and there are no current treatment options available that have been shown to reduce akathisia, although newer generations of atypical antipsychotics have demonstrated less akathisia than their predecessors. NRX-101, in our estimate, offers the only current treatment option that both reduces depression, suicidality, and akathisia in this patient group and, as an oral treatment, should generate widespread accessibility and benefit in these patients.

And otherwise harming themselves and horrible ways.

These patients are a tremendous risk of self harm and there are no current treatment options available that have been shown to reduce acre tisha.

Although.

Newer generations of atypical antipsychotics have demonstrated less acre piece than their predecessors.

And our X 101.

In our estimate offers the only current treatment option that both reduces depression suicidal at <unk> and <unk> in this patient group.

Speaker #4: These patients are at a tremendous risk of self-harm, and there are no current treatment options available that have been shown to reduce akathisia, although newer generations of atypical antipsychotics have demonstrated less akathisia than their predecessors.

And as an oral treatment.

Should generate widespread accessibility and benefit in these patients we look forward to coming interactions with the FDA on this application.

Hope Therapeutics continues to make great progress developing what we believe will be the nation's premier intervention Psychiatry clinic network.

Speaker #4: NRX-101, in our estimate, offers the only current treatment option that both reduces depression, suicidality, and akathisia in this patient group. As an oral treatment, it should generate widespread accessibility and benefit in these patients.

We expect to finalize the purchase of our first clinics and continue to evaluate new opportunities in the field. We aimed to achieve this goal some months ago, but needed to wait for a state regulatory approval.

Speaker #4: We look forward to coming into action with the FDA on this application. We hope therapeutics continues to make great progress developing what we believe will be the nation's premier interventional psychiatry clinic network.

Jonathan Javitt: We look forward to coming interactions with the FDA on this application. Hope Therapeutics continues to make great progress developing what we believe will be the nation's premier interventional psychiatry clinic network. We expect to finalize the purchase of our first clinics and continue to evaluate new opportunities in the field. We aimed to achieve this goal some months ago but needed to wait for state regulatory approval to acquire DuraMedical. That approval is now in hand, as we announced last week. With that milestone reached, we anticipate that you will shortly see closing of acquisition financing that is well along in the closing process. Our goal of delivering the most comprehensive, high-quality care possible in each of our clinics continues to drive us, and we look forward to continuing to update you on the progress of our network.

Two acquired are identical that approval is now in hand, as we announced last week with that milestone reached we anticipate that you will shortly see.

<unk> <unk> of acquisition financing that is well along in the closing process our goal of delivering the most comprehensive high quality care possible in each of our clinics continues to drive us.

Speaker #4: We expect a finalized purchase of our first clinics and continue to evaluate new opportunities in the field. We aimed to achieve this goal some months ago but needed to wait for state regulatory approval to acquire DuroMedical. That approval is now in hand, as we announced last week.

And we look forward to continuing to update you on the progress of our network.

Next we have under contract currently will provide strong revenue.

And EBITDA for the growth of our entire network.

Speaker #4: With that milestone reached, we anticipate that you will shortly see closing of acquisition financing that is well along in the closing process. Our goal of delivering the most comprehensive high-quality care possible in each of our clinics continues to drive us.

We've identified additional milestones reached in our 10-Q filing including the FDA has granted <unk> could do for fee waiver savings company for $3 million from filing fees.

Waivers are granted at the discretion of FDA to small business entities and for drugs that are deemed necessary to the public health.

Speaker #4: And we look forward to continuing to update you on the progress of our network. The clinics we have under contract currently will provide strong revenue and EBITDA for the growth of our entire network.

Jonathan Javitt: The clinics we have under contract currently will provide strong revenue and EBITDA for the growth of our entire network. We've identified additional milestones reached in our 10-Q filing, including the FDA's grant of a PDUFA fee waiver, saving the company $4.3 million in filing fees. Waivers are granted at the discretion of FDA to small business entities and for drugs that are deemed necessary to the public health. With the key milestones reached in Q2 and with the addition of a committed investor group composed of experienced biotechnology investors, we now have the balance sheet capacity to continue our quest to bring hope to life well into the coming year. I will now turn it over to Mr. Michael Abrams, our CFO, to review our financial results from the second quarter of 2025. Mike?

With the key milestones reached in Q2.

And with the addition of a committed Investor group based composed of experienced biotechnology investors.

Speaker #4: We've identified additional milestones reached in our 10-Q filing, including the FDA's grant of a PDUFA fee waiver, saving the company $4.3 million in filing fees.

We now have the balance sheet capacity to continue our quest to bring hope to life well into the coming year.

Speaker #4: Waivers are granted at the discretion of the FDA to small business entities and for drugs that are deemed necessary to public health. With the key milestones reached in Q2, and with the addition of a committed investor group composed of experienced biotechnology investors, we now have the balance sheet capacity to continue our quest to bring hope to life well into the coming year. I will now turn it over to Mr. Michael Abrams, our CFO, to review our financial results from the second quarter of 2025.

I will now turn it over to Mr. Michael Abrams, our CFO to review our financial results for the second quarter of 2025, Mike.

Thank you Jonathan.

So the first for the three months ended June 32025, the company reported a net loss of $17 $5 million versus a net loss of $7 9 million for the comparable quarter in 2020 for the.

The increase was less than the net loss was driven by approximately $12 million charge in fair value accounting regiments related to previously issued convertible notes and warrants are recorded in other expense all of which is noncash.

Speaker #4: Mike?

Speaker #5: Thank you, Jonathan. For the first three months ended June 30, 2025, the company reported a net loss of $17.5 million versus a net loss of $7.9 million for the comparable quarter in 2024.

Michael Abrams: Thank you, Jonathan. For the three months ended June 30, 2025, the company reported a net loss of $17.5 million versus a net loss of $7.9 million for the comparable quarter in 2024. The increase in the net loss was driven by an approximately $12 million charge in fair value accounting measurements related to previously issued convertible notes and warrants accorded in other expense, all of which is non-cash. For the three months ended June 30, 2025, the company reported a loss from operations, which excludes the non-cash impact of fair value accounting measurements, of $3.7 million versus a loss from operations of $7.1 million for the comparable quarter in 2024. This marks an improvement of more than $3.3 million, or 47% compared to the prior comparable quarter. As of June 30, 2025, NRx Pharmaceuticals had approximately $2.9 million in cash or cash equivalents.

For the three months ended June 30 of 2025, the company reported a loss from operations.

Glued the noncash impact of fair value accounting regimen of $3 7 million versus a loss from operations of $7 1 million for the comparable quarter in 2024.

Speaker #5: The increase in this net loss in the net loss was driven by an approximately 12 million dollar charge in fair value accounting measurements related to previously issued convertible notes and warrants recorded in other expense.

An improvement of more than $3 3 million or 47% compared to the prior comparable quarter.

As of June 32025, there are extra at approximately $2 9 million in cash and cash equivalents on.

Speaker #5: All of which is non-cash. For the three months ended June 30, 2025, the company reported a loss from operations, excluding the non-cash impact of fair value accounting measurements, of $3.7 million versus a loss from operations of $7.1 million for the comparable quarter in 2024.

On August 18th 2025, the company closed a registered direct offering with a select group of experienced long term health care and biotechnology investors led by Baker capital.

In connection with that offering the company issued approximately three 9 million shares of common stock and received net proceeds of approximately $6 5 billion.

Speaker #5: This marks an improvement of more than 3.3 million dollars or 47 percent compared to the prior comparable quarter. As of June 30th, 2025, NRX had approximately 2.9 million in cash and cash equivalents.

The shares issued in the offering are subject to a one year lockup on the terms of the offering did not include warrants pricing resets or any other structured elements and the company does not use a broker or investment bank in connection with the offer.

Speaker #5: On August 18, 2025, the company closed a registered direct offering with a select group of experienced long-term healthcare and biotechnology investors led by B Group Capital.

Michael Abrams: On August 18, 2025, the company closed a registered direct offering with a select group of experienced long-term healthcare and biotechnology investors led by B Group Capital. In connection with that offering, the company issued approximately $3.9 million shares of common stock and received net proceeds of approximately $6.5 million. The shares issued in the offering are subject to a one-year lockup, and the terms of the offering did not include warrants, pricing resets, or any other structured elements. The company did not use a broker or investment bank in connection with the offering. The company believes that its current cash position will support operations well into 2026 and provide sufficient capital to reach critical and anticipated regulatory inflection points and milestones. Our singular focus remains advancing our primary drug development initiatives and planned clinic acquisitions to build long-term value for our shareholders.

The company believes that its current cash position will support our operations well into 2026.

Speaker #5: In connection with that offering, the company issued approximately 3.9 million shares of common stock and received net proceeds of approximately 6.5 million. The shares issued in the offering are subject to a one-year lock-up, and the terms of the offering did not include warrants, pricing resets, or any other structured elements.

Can provide sufficient capital to reach critical and anticipated regulatory inflection points and milestones.

Our singular focus remains advancing our primary drug development initiatives and planned clinic acquisitions to build long term value for our shareholders with that I turn the call back over to Jonathan Cohen.

Speaker #5: The company did not use a broker or investment bank in connection with the offering. The company believes that its current cash position will support operations well into 2026 and provide sufficient capital to reach critical and anticipated regulatory inflection points and milestones.

Thank you Mike as you can see the company has made significant progress and stands at the precipice of enormous inflection points for patients and investors our goal of bringing hope to life is closer than ever.

Speaker #5: Our singular focus remains on advancing our primary drug development initiatives and planned clinic acquisitions to build long-term value for our shareholders. With that, I turn the call back over to Jonathan.

Our progress towards three potential drug approvals in the near term and continuing the development of hope Therapeutics National network for care delivery.

Our transformative steps for the company and for the treatment of mental health in the United States.

Michael Abrams: With that, I turn the call back over to Jonathan. Jonathan?

Speaker #5: Jonathan?

Speaker #4: Thank you, Mike. As you can see, the company has made significant progress and stands at the precipice of enormous inflection points for patients and investors.

Jonathan Javitt: Thank you, Mike. As you can see, the company has made significant progress and stands at the precipice of enormous inflection points for patients and investors. Our goal of bringing hope to life is closer than ever. Our progress towards three potential drug approvals in the near term and continuing the development of Hope Therapeutics' national network for care delivery are transformative steps for the company and for the treatment of mental health in the United States. I would like to thank the NRx Pharmaceuticals team, our longtime and new investors, and most importantly, the patients who participated in our clinical trials for their steadfast support of our pursuit of this vision. Operator, we are ready to take questions from the audience.

I'd like to thank the <unk> team.

Our long time, and new investors and most importantly, the patients who participated in our clinical trials for their steadfast support of our pursuit of this vision.

Speaker #4: Our goal of bringing hope to life is closer than ever. Our progress towards three potential drug approvals in the near term and continuing the development of the Hope Therapeutics National Network for care delivery are transformative steps for the company and for the treatment of mental health in the United States.

Operator, we're ready to take questions from the audience.

Thank you and ladies and gentlemen, we will now begin the question and answer session to ask a question you May press star followed by the number one on your telephone keypad, if youre using a speakerphone. Please pick up your handset before pressing cookie.

Speaker #4: I would like to thank the NRX team, our longtime and new investors, and, most importantly, the patients who participated in our clinical trials for their steadfast support of our pursuit of this vision.

So we do all your question you can press Star Q now that our first question comes from the line of Tom Shrader with BT I G. Please go ahead.

Good morning, and it really has been a lot of progress this quarter I have a couple of quick ones for 101, why are you seeing pathway accelerated approval. It seems like you have very conventional clinical endpoints that you kind of argue you've hit.

Speaker #4: Operator, we're ready to take questions from the audience.

Speaker #2: Thank you. And ladies and gentlemen, we will now begin the question and answer session. To ask a question, you may press a star followed by the number one on your telephone keypad.

Operator: Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. To ask a question, you may press a star followed by the number one on your telephone keypad. If you are using a speakerphone, please speak up your handset before pressing the keys. To withdraw your question, you can press a star two. With that, our first question comes from the line of Tom Schrader with BTIG. Please go ahead.

Speaker #2: If you're using a speakerphone, use the speaker from your handset before pressing the keys. To withdraw your question, you can press a star.

I think of accelerated approval for more biomarker type trials and a quick one on the new voucher. It looks like it's even more valuable than the older pediatric voucher is it clear it can be sold the way the other vouchers where has that been defined yet. Thank you.

Speaker #2: With that, our first question comes from the line of Tom Schrader with BTIG. Please go ahead.

Speaker #6: Good morning, and it really has been a lot of progress this quarter. I have a couple of quick ones. For 101, why is the pathway accelerated approval?

Jason Colbert: Good morning. It really has been a lot of progress this quarter. I have a couple of quick ones. For NRX-101, why is the pathway accelerated approval? It seems like you have very conventional clinical endpoints that you can argue you have hit. I think I have accelerated approval for more biomarker-type trials. A quick one on the new voucher. It looks like it is even more valuable than the older pediatric voucher. Is it clear it can be sold the way the other vouchers were? Has that been defined yet? Thank you.

Let me start with the second question first.

Speaker #6: Seems like you have very conventional clinical endpoints that you can argue you've hit. And I think of accelerated approval for more biomarker-type trials and a quick one on the new voucher.

I think the agency has been clear that the <unk> Tvs are not to be sold.

Certainly we would have no interest in.

In selling a.

Commissioner International priority voucher, where we to be awarded one our sole objective is to get this drug to patients.

Speaker #6: It looks like it's even more valuable than the older pediatric voucher. Is it clear it can be sold the way the other vouchers were?

Speaker #6: Has that been defined yet? Thank you.

As a life saving drug for a critical unmet medical need as quickly as humanly possible.

Speaker #4: Well, let me start with the second question first. I think the agency has been clear that the CMPVs are not to be sold. And certainly, we would have no interest in selling a Commissioner’s National Priority Voucher were we to be awarded one.

Jonathan Javitt: Let me start with the second question first. I think the agency has been clear that the CNPVs are not to be sold. Certainly, we would have no interest in selling a Commissioner's National Priority Voucher were we to be awarded one. Our sole objective is to get this drug to patients as a lifesaving drug for a critical unmet medical need as quickly as humanly possible. That is the objective of the Commissioner's Program, and that is the objective of NRx Pharmaceuticals. As far as accelerated approval for NRX-101, as you recall, the primary endpoint of the clinical trial that we conducted was reduction in depression compared to lurasidone alone. The secondary endpoint was reduction in suicidality and akathisia as your separate named endpoints.

That's the objective of the Commissioners program and that's the objective of an Rx.

As far as accelerated approval for <unk> hundred one.

Yes, as you recall the primary endpoint of the clinical trial that we conducted.

Speaker #4: Our sole objective is to get this drug to patients as a lifesaving drug for a critical unmet medical need as quickly as humanly possible.

Was reduction in depression compared to Lurasidone alone.

And.

Secondary end point was reduction in suicide <unk>.

Speaker #4: That's the objective of the Commissioner's program, and that's the objective of NRX. As far as accelerated approval for NRX 101, you know, as you recall, the primary endpoint of the clinical trial that we conducted was reduction in depression compared to lurasidone alone.

And <unk> as <unk>.

Named endpoints.

The clinical trial did not demonstrate.

Debt in our X 101 is a superior anti depressant.

Two a.

Very well established anti depressant, namely Lurasidone, but did demonstrate.

Reductions in <unk>.

Speaker #4: The secondary endpoint was a reduction in suicidality and akathisia, as your separate named endpoints. The clinical trial did not demonstrate that NRX-101 is a superior antidepressant to a very well-established antidepressant, namely lurasidone.

And suicide Ality.

And we believe that those are intermediate endpoints.

In that they haven't necessarily.

Jonathan Javitt: The clinical trial did not demonstrate that NRX-101 is a superior antidepressant to a very well-established antidepressant, namely lurasidone, but did demonstrate reductions in akathisia and suicidality. We believe that those are intermediate endpoints and that they have not necessarily been demonstrated to be associated with long-term health benefits. For that reason, we think the appropriate thing to do is ask for accelerated approval only for use in those patients who have demonstrated akathisia and suicidality despite best available medicine. In other words, for patients where there is truly an unmet medical need and an immediate risk of harm to the patient in the absence of treatment for those conditions, and to ask FDA to give us five years in which to demonstrate that NRX-101 has a conventional long-term benefit compared to placebo.

<unk> been demonstrated to be associated with long term health benefits.

So for that reason, we think the appropriate thing to do is ask for.

Accelerated approval only for use in those patients who have demonstrated a seizure and suicide reality, despite best available medicine.

Speaker #4: But it did demonstrate reductions in akathisia and suicidality. We believe that those are intermediate endpoints in that they haven't necessarily been demonstrated to be associated with long-term health benefits.

In other words for patients, where there's there is truly an unmet medical need and an immediate risk of harm to the patient and the absence of.

Of treatment for those conditions.

Speaker #4: So, for that reason, we think the appropriate thing to do is ask for accelerated approval only for use in those patients who have demonstrated akathisia and suicidality despite the best available medicine.

And to ask FDA to give us five years in which to demonstrate.

That in our X 101 has been still long term benefit compared to placebo.

Just a follow up what would the what was the <unk>.

Speaker #4: In other words, for patients where there's truly an unmet medical need and an immediate risk of harm to the patient in the absence of treatment for those conditions.

Second trial is a follow up trial confirmatory trial look like do you have any sense.

Yes, the confirmatory trial.

If you look at the.

Speaker #4: And to ask FDA to give us five years in which to demonstrate that NRX 101 has, you know, a conventional long-term benefit compared to placebo.

The approval path of ability for instance that confirmatory trial would be a very conventional.

Randomized controlled trial of <unk> hundred one versus placebo.

With depression on the mattress as primary endpoint because that's the endpoint that FDA has really set as the bar for all anti depressant drugs.

Jason Colbert: What would the second trial or the follow-up trial, confirmatory trial, look like? Do you have any sense?

Speaker #6: Just to follow up, what would the second trial or the follow-up trial, confirmatory trial, look like? Do you have any sense?

Speaker #4: Yeah. The confirmatory trial, if you look at the approval path of validity, for instance, the confirmatory trial would be a very conventional randomized controlled trial of NRX-101 versus placebo.

Jonathan Javitt: Yeah. The confirmatory trial, if you look at the approval path of Avelity, for instance, the confirmatory trial would be a very conventional randomized control trial of NRX-101 versus placebo with depression on the mattress as primary endpoint because that's the endpoint that FDA has really set as the bar for all antidepressant drugs.

Alright. Thanks.

Thanks for all the detail.

Alright. Thank you and your next question comes from the line of Jason Kolbert deeper a Catholic health East.

Good morning again, congratulations on all the progress can we talk a little bit about some expense guidance and I'm, not really talking about third quarter or fourth quarter, but just from a big picture point of view.

Speaker #4: With depression on the madras as primary endpoint because that's the endpoint that FDA has really set as the bar for all antidepressant drugs.

R&D.

Speaker #6: All right. Got it. Thanks for all the detail.

Jason Colbert: All right. Got it. Thanks for all the detail.

Is that likely to ramp up in the future should we see it at about the same level and G&A as you become a commercial entity, how do you envision G&A expanding and I also have some questions about the acquisition pipeline associated with the clinics.

Speaker #2: All right. Thank you. And your next question comes from the line of Jason Colbert with Dboral Capital. Please go ahead.

Operator: Thank you. Your next question comes from the line of Jason Colbert with B Group Capital. Please go ahead.

Speaker #7: Good morning. Again, yeah, congratulations on all the progress. Can we talk a little bit about some expense guidance? And I'm not really talking about the third quarter or fourth quarter, but just from a big-picture point of view, R&D; you know, is that likely to ramp up in the future?

Jason Colbert: Good morning again. Congratulations on all the progress. Can we talk a little bit about some expense guidance? I am not really talking about Q3 or Q4, but just from a big-picture point of view, R&D, is that likely to ramp up in the future? Should we see it at about the same level? G&A, as you become a commercial entity, how do you envision G&A expanding? I also have some questions about the acquisition pipeline associated with the clinics. Thanks.

So why do I care to clinic.

Oh.

<unk>. Please go ahead Sir.

Alright.

So all of that from a financial perspective, Jason. Thank you for your question.

Speaker #7: Should we see it at about the same level? And GNA, as you become a commercial entity, how do you envision GNA expanding? And I also have some questions about the acquisition pipeline associated with the clinics, thanks.

As you know, we don't give guidance.

So I think the best proxy for.

Our financial statements that our trends and the expectations is what's reported in the 10-Q.

And this is where it's very notable we talked about we had.

Absolutely, 50% reduction from 47% almost 50% reduction.

Speaker #5: So why don't we get into clinics?

Michael Abrams: So, if you look at the clinics.

Speaker #6: Oh, Jonathan, you want to answer the clinics first?

Jason Colbert: One more question.

Michael Abrams: Oh, Jonathan, you want to ask the clients first?

Our loss from operations.

Speaker #5: Please go ahead.

Jonathan Javitt: Please go ahead.

Speaker #6: Yep. Okay. Sorry. So I’ll answer from a financial perspective. Jason, thank you for your question. Obviously, as you know, we don’t give guidance. So I think the best proxy for our financial statements and our trends and the expectations is what’s reported in the 10-Q.

And so as a pre revenue company.

Michael Abrams: Yep. Okay. Sorry. I will add from a financial perspective, Jason, thank you for your question. Obviously, as you know, we do not give guidance. I think the best proxy for our financial statements and our trends and the expectations is what is reported in the 10-Q. This is where it is very notable. We talked about we had an approximately 50% reduction, 47%, almost 50% reduction in our loss from operations. As a pre-revenue company, that is entirely made up of G&A expense and R&D expense. The decline from $7 million to $3 million and change is a direct result of internal budgeting and cost-saving measures that we continue to execute on.

That isn't that is entirely made up of G&A.

G&A expense and R&D expense and so the decline from 7 million to three.

$3 million in change is as a direct result of internal.

Speaker #6: And this is where it's very notable. We talked about having approximately a 50 percent reduction—47 percent, almost a 50 percent reduction—in our loss from operations.

Budgeting and cost saving measures that we continue to.

To execute on it.

Okay.

Got to get clouded with.

The net loss that was reported because that involves fair value accounting, which some people call derivative liability accounting, which can be quite counterintuitive and its impact on the income statement the balance sheet.

Speaker #6: And so as a pre-revenue company, that is entirely made up of GNA expense and R&D expense. And so the decline from 7 million to 3 million or change is, you know, as a direct result of internal budgeting and cost-saving measures that we continue to execute on.

Goodbye.

An increase in our stock price. It makes it look like an increase liability increased expense.

Those are all noncash so really looking at.

Loss from operations of <unk>.

Speaker #6: And again, not to get clouded with the net loss that was reported, because that involves, you know, fair value accounting, which some people call derivative liability accounting, which can be quite counterintuitive, and its impact on the income statement and the balance sheet. An increase in our stock price makes it look like an increased liability and increased expense, but those are all non-cash.

Michael Abrams: Again, not to get clouded with the net loss that was reported because that involves fair value accounting, which some people call derivative liability accounting, which can be quite counterintuitive in its impact on the income statement, the balance sheet, whereby an increase in our stock price makes it look like an increased liability, increased expense, but those are all non-cash. Really looking at loss from operations, I think, is the cleaner view into our financial picture. The trends of reducing our overall operating costs comprised of G&A and R&D are evident and we believe to be continued. Again, not prepared to give guidance on where that may go in the future, but we announced it and discussed it because we think it is a worthy note of our financial statements that investors should take note of. With that, I will turn it back over to Jonathan.

Cleaner view into our financial picture and the trends of reducing our overall operating costs comprised of DNA in our D. R.

Our evidence and we believe to be continued.

Again, not prepared to give guidance on where that may go in the future, but we announced it and discussed it because we think it's a worthy.

No.

Statements that investors come in.

Chip that you take note of.

Speaker #6: So really looking at loss from operations, I think, is the cleaner view into our financial picture. The trends of reducing our overall operating costs, comprised of G&A and R&D, are evident, and we believe they will continue.

With that I'll turn it back over.

I can appreciate your comments, but you know.

The expectation is that we would see G&A ramping up as you become a commercial entity, but.

I think what you're saying is tempur.

Speaker #6: Again, we are not prepared to give guidance on where that may go in the future, but, you know, we announced it and discussed it because we think it's a worthy note of our financial statements that investors should take note of.

<unk> ramp up with the strength of the balance sheet. So thats kind of comes together and think that's how I interpret what you're saying well yeah just to follow up on the.

The increase any increase in G&A that is sometimes seen in these situations.

Speaker #6: With that, I'll turn it back over to Jonathan.

Speaker #4: I can appreciate your comments, but, you know, the expectation is that we would see GNA ramping up as you become a commercial entity.

Jonathan Javitt: I can appreciate your comments, but the expectation is that we would see G&A ramping up as you become a commercial entity. We'll, I think what you're saying is, temper expense ramp up with the strength of the balance sheet so that it kind of comes together in sync. That's how I interpret what you're saying.

As commercially comes also comes in line with revenue.

So we are we've been managing the business for what it is now as Jonathan mentioned in his comments.

Speaker #4: But, well, I think what you're saying is to temper the expense ramp-up with the strength of the balance sheet so that it kind of comes together and syncs.

During the call.

We believe we are.

Relatively near term commercialization.

Speaker #4: That's how I interpret what you're saying.

Speaker #5: Well, yeah, just to follow up on that. The any increase in GNA that is sometimes seen in these situations as commercialization comes also comes in line with revenue.

Advanced all of our drug programs as well as have opportunities with hopes therapeutics. So as revenue comes on we imagine will continue to assess those who make decisions but.

Michael Abrams: To follow up on that, any increase in G&A that is sometimes seen in these situations as commercialization comes also comes in line with revenue. We have been managing the business for what it is now. As Jonathan Javitt mentioned in his comments during the call, we believe we are with a relatively near-term commercialization and an advanced, all of our drug programs as well as have opportunities with Hope Therapeutics. As revenue comes on, management will continue to assess those and make decisions. The timing in which I am not going to want to provide forward-looking statements on or provide projections on what that revenue flow will look like. Any increase in expense related to commercialization will be taken part and parcel simultaneous with the revenue itself. Your point is noted.

The timing of which I'm not I don't want it.

Provide forward looking statements on or provide projections on what that revenue flow will look like but any increase in expense related to <unk>.

Speaker #5: And so we have imagined the business for what it is now, as Jonathan mentioned, it is his comments during the call. We believe we're, you know, relatively near-term commercialization and an advanced, you know, all of our drug programs as well as have opportunities with hope therapeutics.

Commercialization will be taken part and parcel to simultaneous with the.

The revenue itself so.

But youre right.

Yes.

And it's likely Jason a question.

Speaker #5: So, as revenue comes in, we imagine it will continue to assess those and make decisions. However, the timing of which I don't want to provide forward-looking statements on or provide projections on what that revenue flow will look like.

<unk>.

Can you get plugged into our model.

That ultimately projects a price per share for companies such as ours.

And you're asking a very legitimate way do we think our G&A may increase as we get forward to actually.

Speaker #5: But any increase in expense related to commercialization will be taken part and parcel simultaneous with, you know, the revenue itself. So your point is noted.

As we get closer to selling the drug.

And although that answer might will be yes by the time, we do that.

Speaker #6: Yeah, fair enough. Thank you, and.

Jonathan Javitt: Yeah. Fair enough. Thank you.

Speaker #4: Typically, Jason, a question, you know, like that, you know, is going to get plugged into a model that ultimately projects a price per share for a company such as ours.

Unknown: Typically, Jason, a question like that is going to get plugged into a model that ultimately projects a price per share for a company such as ours. You are asking in a very legitimate way, do we think our G&A may increase as we get closer to selling a drug? Although that answer might well be yes, by the time we do that, our probability of success in any such model will have substantially increased. The projected increased costs of G&A will be closely tied to an increased probability of corporate success.

Our probability of success.

In any such model will have substantially increased.

So yes.

Speaker #4: And you're asking in a very legitimate way, do we think our GNA may increase as we get forward to actually as we get closer to selling a drug?

Yes.

The projected increase cost of G&A.

We will be closely tied to an increased probability of corporate success.

Speaker #4: And although, you know, that answer might well be yes, by the time we do that, our probability of success in any such model will have substantially increased so that, you know, the projected increased costs of GNA will be closely tied to an increased probability of corporate success.

Of course, very reasonable and Jonathan how about the acquisition pipeline in terms of clinics and can you give any kind of idea of what you might look like I.

I mean from a big picture point of view five years from now.

What do you think your footprint looks like.

Well.

Five years from now.

If we're successful in what we aim to do with hope Therapeutics first of all it will almost certainly be.

Speaker #4: Of course. Very reasonable. And Jonathan, how about the acquisition pipeline in terms of clinics, and can you give any kind of idea of what you might look like?

Jonathan Javitt: Of course. Very reasonable. Jonathan, how about the acquisition pipeline in terms of clinics? Can you give any kind of idea of what you might look like? From a big-picture point of view, five years from now, what do you think your footprint looks like?

An independent company from an Rx pharmaceuticals.

And the companies that we would hope people would look at are companies like Davita and Fresenius that transformed the dialysis industry from.

Speaker #4: I mean, from a big-picture point of view, five years from now, what do you think your footprint looks like?

Disparate clinics, where it was almost impossible for a consumer to know what kind of quality to expect.

Speaker #6: Well, you know, five years from now,

Unknown: Well, five years from now, if we are successful in what we aim to do with Hope Therapeutics, first of all, it will almost certainly be an independent company from NRx Pharmaceuticals. The companies that we would hope people would look at are companies like DaVita and Fresenius that transformed the dialysis industry from disparate clinics, where it was almost impossible for a consumer to know what kind of quality to expect, to coherent networks of care delivery organizations where consumers had a reasonable expectation of consistent quality, consistent outcomes across the network, and investors enjoyed extraordinary financial success in the process. Our challenge is finding best-of-breed clinics that have really integrated the use of neuroplastic drugs. This is a word you will hear us using more and more. People talk about psychedelic therapy as if the hallucinations that are induced have something to do with the medical benefit.

Speaker #1: If we're successful in what we aim to do with Hope Therapeutics, first of all, it will almost certainly be an independent company from NRX Pharmaceuticals.

Two coherent networks of care delivery organizations.

Where consumers had a reasonable expectation of consistent quality consistent outcomes.

Speaker #1: And the companies that we would hope people would look at are companies like DaVita and Fresenius that transformed the dialysis industry from, you know, disparate clinics where it was almost impossible for a consumer to know what kind of quality to expect, to coherent networks of care delivery organizations where consumers had a reasonable expectation of consistent quality and consistent outcomes across the network.

Across the network.

Investors enjoyed extraordinary financial success.

In the process.

So our challenge is finding best of breed clinics.

That have really integrated.

The use of neural plastic drugs and this is a word you'll hear us using more and more.

People talk about psychedelic therapy.

As if the hallucinations that are induced has something to do with the medical benefit.

Speaker #1: And investors enjoyed extraordinary financial success in the process. Our challenge is finding best-of-breed clinics that have really integrated the use of neuroplastic drugs. This is a word you'll hear us using more and more; you know, people talk about psychedelic therapy.

But in our view, what's really going on.

Is that this class of drugs causes the brain cells to form new connections to other brain cells, that's a process called neuroplasticity.

If you if you want to make a computer chip you take a piece of silicon you exit with a laser.

Speaker #1: As if the hallucinations that are induced have something to do with the medical benefit. And they may. But in our view, what's really going on is that this class of drugs causes the brain cells to form new connections to other brain cells.

You may use programming to turn circuits on and off but the circuits on the chip will be there for.

Unknown: They may. But in our view, what is really going on is that this class of drugs causes the brain cells to form new connections to other brain cells. That is a process called neuroplasticity. If you want to make a computer chip, you take a piece of silicon, you etch it with a laser. You may use programming to turn circuits on and off, but the circuits on the chip will be there for the end of time. The brain works completely differently. Brain cells are constantly branching, making new connections to other brain cells, pruning those connections. The evidence is that when that process of neuroplasticity stops, that is when you have severe depression, you have suicidality.

For the end of time.

The brain works completely differently brain cells are constantly branching, making new connections to other brain cells pruning those connections.

And the evidence is that when that process of neuroplasticity stops. That's when you have severe depression, you have suicide ality.

Speaker #1: That's a process called neuroplasticity. If you want to make a computer chip, you take a piece of silicon, you etch it with a laser, you may use programming to turn circuits on and off, but the circuits on the chip will be there for the end of time.

And all of these drugs that are showing benefit.

Are doing so in our view and in the evolving view of many of the scientists we talk to because they're causing neuroplasticity.

Speaker #1: The brain works completely differently. Brain cells are constantly branching, making new connections to other brain cells, pruning those connections, and the evidence is that when that process of neuroplasticity stops, that's when you have severe depression, you have suicidality, and all of these drugs that are showing benefit are doing so in our view—and in the evolving view of many of the scientists we talk to—because they're causing neuroplasticity.

So how do you do that you can do it with ketamine and related drugs.

There's evidence you can do it with the psilocybin class of drugs, what people call the psychedelics.

There are drugs over the horizon that achieved neuroplasticity without the hallucinations.

Unknown: All of these drugs that are showing benefit are doing so, in our view and in the evolving view of many of the scientists we talk to, because they are causing neuroplasticity. So how do you do that? You can do it with ketamine and related drugs. There is evidence you can do it with the psilocybin class of drugs, what people call the psychedelics. There are drugs over the horizon that achieve neuroplasticity without the hallucinations. You can achieve it with a treatment called transcranial magnetic stimulation, which is FDA-approved. You put powerful electromagnets outside the head and achieve profound changes on depression, on suicidality. There is emerging evidence that may work for autism, for PTSD. People are seeing benefits with hyperbaric oxygen therapy. I am sure there will be other neuroplastic therapies coming down the pike.

You can achieve it with a treatment called transcranial magnetic stimulation, which is FDA approved you put powerful electromagnets outside the head.

And achieve profound changes on depression on suicide Ality.

Speaker #1: So, how do you do that? You can do it with ketamine and related drugs. There's evidence you can do it with a psilocybin class of drugs—what people call the psychedelics.

There is emerging evidence that may work for autism for PTSD.

And people are seeing benefits with hyperbaric oxygen therapy I'm sure there will be other neuroplasticity piece coming down the Pike. Our objective with hope therapeutics is to identify best in class claims that are already combining those treatments.

Speaker #1: There are drugs over the horizon that achieve neuroplasticity without the hallucinations. You can achieve it with a treatment called transcranial magnetic stimulation. Which is FDA approved, you put powerful electromagnetes outside the head and achieve profound changes on depression, on suicidality, these emerging evidence that may work for autism, for PTSD, and people are seeing benefits with hyperbaric oxygen therapy.

The notion of Ketamine clinic, where you can get IV ketamine on Mondays and.

Peptides on Tuesdays and vitamins on Wednesdays that's the opposite of what we think patients need.

So.

We may be able to identify a $100 million of.

Speaker #1: I'm sure there will be other neuroplastic therapies coming down the pike. Our objective with hope therapeutics is to identify best-in-class clinics that are already combining those treatments.

Acquisition.

Unknown: Our objective with Hope Therapeutics is to identify best-in-class clinics that are already combining those treatments. You know, the notion of a ketamine clinic where you can get IV ketamine on Mondays and peptides on Tuesdays and vitamins on Wednesdays, that is the opposite of what we think patients need. We may be able to identify $100 million of acquisition of that kind of best-in-breed clinic, but very quickly, you will see Hope Therapeutics shifting to a model of building clinics from the ground up to extend those flagship clinics that we acquire on day one because we do not think we can grow beyond $100 million or so just by acquiring clinics that already exist. You know, it is hard enough to talk about what we will do next year versus five years from now.

That kind of best in breed clinic, but very quickly youll see hope shifting to a model of building clinics from the ground up.

Speaker #1: You know, the notion of a ketamine clinic where you can get, you know, IV ketamine on Mondays and peptides on Tuesdays and vitamins on Wednesdays that's the opposite of what we think patients need.

To extend those flagship clinics that we acquire on day one.

Because we don't think we can grow.

Beyond the 100 million or so.

Speaker #1: So we may be able to identify $100 million of acquisition of that kind of best-in-breed clinic, but very quickly you'll see hope shifting to a model of building clinics from the ground up to extend those flagship clinics that we acquire on day one.

By acquiring clinics that already exist.

So it's.

It's hard enough to talk about what we'll do next year versus five years from now.

But I think five years from now Youre going to see a national network in place such that patients and families who are suffering from these conditions.

No to pick up the phone call hope therapeutics.

Speaker #1: Because we don't think we can grow beyond 100 million or so just by acquiring clinics that already exist. So it's hard enough to talk about what we'll do next year versus five years from now.

And expect to have a life changing.

Opportunity to get better.

That's amazing Thank you share your vision.

Speaker #1: But I think, five years from now, you’re going to see a national network in place such that patients and families who are suffering from these conditions know to pick up the phone, call Hope Therapeutics, and expect to have a life-changing opportunity to get better.

Unknown: But I think five years from now, you are going to see a national network in place such that patients and families who are suffering from these conditions know to pick up the phone, call Hope Therapeutics, and expect to have a life-changing opportunity to get better.

Alright. Thank you and your next question comes from the line of Patrick to Appeals in H C. Wainwright. Please go ahead.

Thanks, Good morning, and congrats on all the progress advancing on our X 100, and our X 101 in the whole platform. It's clear the team has made meaningful strides on both clinical and regulatory fronts and we have a few follow up questions. So the first is just on the citizen petition impact you've explained the scientific basis for the citizen petition on.

Speaker #6: It's amazing. Thank you. I share your vision.

Jonathan Javitt: is amazing. Thank you. I share your vision.

Thank you Tony and chloride I'm wondering if you can give us a sense of when you might expect an FDA response and from a commercial perspective, if the FDA were to mandate preservative free formulation of cross ketamine, how meaningful could that revenue uplift for <unk> 100, and how challenging might be for existing suppliers to adjust.

Speaker #2: All All right. Thank you. And your next question comes from the line of Patrick Trujillo with HTC Wainwright, please go ahead.

Operator: All right. Thank you. Your next question comes from the line of Patrick Tookio with HBC Wainwright. Please go ahead.

Speaker #7: Thanks. Good morning and congrats on all the progress advancing NRX 100, NRX 101, and the hope platform. It's clear the team's made meaningful strides on both clinical and regulatory fronts.

Michael Abrams: Thanks. Good morning, and congrats on all the progress advancing NRX-100, NRX-101, and the Hope platform. It is clear the team has made meaningful strides on both clinical and regulatory fronts. We have a few follow-up questions. The first is just on the citizen petition impact. You have explained the scientific basis for the citizen petition on benzalkonium chloride. I am wondering if you can give us a sense of when you may expect an FDA response. From a commercial perspective, if the FDA were to mandate preservative-free formulation across ketamine, how meaningful could that revenue uplift be for NRX-100, and how challenging might it be for existing suppliers to adjust?

Speaker #7: And we have a few follow-up questions. The first is just on the citizen petition impact. You've explained the scientific basis for the citizen petition on benzathonium chloride.

Yeah.

Well the.

The FCA requirement is to respond to a citizen's petition within six months of filing.

Speaker #7: I'm wondering if you can give us a sense of when you may expect an FDA response. And from a commercial perspective, if the FDA were to mandate preservative-free formulation across ketamine, how meaningful could that revenue uplift be for NRX 100 and how challenging might it be for existing suppliers to adjust?

And we hope that FDA will we'll beat that requirement.

Certainly we have a secretary of health and human services.

Mr. Kennedy, who has demonstrated.

A profound dislike.

Sure.

Both artificial colors.

Speaker #4: Well, the FDA's requirement is to respond to a citizen's petition within six months of filing. And, you know, we hope that FDA will beat that requirement.

Jonathan Javitt: The FDA's requirement is to respond to a citizen petition within six months of filing. We hope that FDA will beat that requirement. Certainly, we have a Secretary of Health and Human Services, Mr. Kennedy, who has demonstrated a profound dislike for both artificial colors and preservatives in foods, in drugs, who clearly recognizes that many of the things we've assumed to be safe, unless proven safe, may not be safe. In this particular case, we're talking about a preservative that's toxic to the point where FDA won't even allow you to put it into a hand cleaner or topical antiseptic. They know a lot about benzalkonium chloride, maybe even more than we do. In terms of impact, right now, the generic ketamine market is $750 million a year. It's mostly foreign-sourced goods.

And and preservatives.

In foods in drugs.

Who clearly recognizes that many of the things we've assumed to be safe.

Speaker #4: Certainly, we have a secretary of health and human services Mr. Kennedy who has demonstrated a profound dislike for both artificial colors and preservatives in foods, in drugs, you know, who clearly recognizes that many of the things we've, you know, assumed to be safe unless proven safe may not be safe.

Unless proven safe may not be safe.

And in this particular case, we're talking about a preservative that's toxic to the point, where FDA won't even allow you to put it into our hand cleaner or topical antiseptic. So they know a lot about ventral sodium chloride may be even more than we do.

In terms of impact right now the generic ketamine market is $750 million a year, it's mostly foreign sourced goods.

From what we've seen and we haven't gotten other peoples products into the laboratory measured ourselves.

Speaker #4: And in this particular case, we're talking about a preservative that's toxic to the point where the FDA won't even allow you to put it into a hand cleaner or topical antiseptic.

Level of BZ T may not be entirely consistent from product to product.

And if you read the toxicology paper that we posted last week for for the public to read.

Speaker #4: So they know a lot about benzathonium chloride, maybe even more than we do. In terms of impact, right now the generic ketamine market is 750 million dollars a year.

As you have repeated doses of ketamine.

Speaker #4: It's mostly foreign-sourced goods. From what we've seen—and we haven't gotten other people's products into the laboratory measured ourselves—that level of BZT may not be entirely consistent from product to product.

You start to get a cumulative.

Jonathan Javitt: From what we've seen, and we haven't gotten other people's products into the laboratory and measured ourselves, that level of BZT may not be entirely consistent from product to product. If you read the toxicology paper that we posted last week for the public to read, as you have repeated doses of ketamine, you start to get a cumulative impact of this what's called a quaternary amine preservative. In fact, one thing you'll see if you poke around is that there's a known incidence of ulcerative cystitis, that is an inflammatory and serious condition of the lining of the urinary bladder associated with repeated use of ketamine that's never been seen with repeated use of the J&J Spravato product, which is a nasal form of S-ketamine. If you ask what's different between the two products, certainly, intravenous ketamine is racemic, whereas the J&J product is the S enantiomer.

Impact of this.

What's called a cluttered nary a mean preservative.

In fact, one thing you'll you'll see if you poke around.

Speaker #4: And if you read the toxicology paper that we posted last week for the public to read, as you have repeated doses of ketamine, you start to get a cumulative impact of this what's called a cutiary amine preservative.

Is that there is a known incidents of ulcerative society that is.

And inflammatory and serious condition of the lining of the urinary bladder associated with repeated use academy.

That's never been seen with repeated use of the J&J rabato product, which is a nasal form of S ketamine well.

Speaker #4: In fact, one thing you'll see if you poke around is that there's a known incidence of ulcerative cystitis, which is an inflammatory and serious condition of the lining of the urinary bladder.

If you ask what's different between the two products.

Intravenous ketamine as with CMA, whereas the J&J product is the Essent antitumor.

And clearly in one case, it's given by nasal administration versus IV administration, but either way it once it's in the bloodstream.

Speaker #4: Associated with repeated use of ketamine, that's never been seen with repeated use of the J&J Spravato product, which is a nasal form of eschedamine.

The residual product winds up being metabolized by the liver screening in the bladder.

Speaker #4: Well, if you ask what's different between the two products, you know, certainly intravenous ketamine is racemic, whereas the J&J product is the S(+)N antimer.

And.

The main difference or eight main difference is that there is no bensel toneme chloride in the J&J product.

So it may be that we're already seeing.

Speaker #4: And, you know, clearly in one case it's given by nasal administration versus IV administration. But either way, once it's in the bloodstream, the residual product winds up being metabolized by the liver and excreted in the bladder.

Jonathan Javitt: Clearly, in one case, it's given by nasal administration versus IV administration. Either way, once it's in the bloodstream, the residual product winds up being metabolized by the liver, excreted in the bladder. The main difference, or a main difference, is that there's no benzalkonium chloride in the J&J product. It may be that we're already seeing an impact of repeated use of a BZT-containing ketamine in real life without having to look too hard for other examples. Now, in terms of what would be the impact of removing this toxic preservative from generic ketamine, it would, first of all, we think, benefit patients substantially because the only reason it is in the bottle is so that a doctor can stick a needle into the same bottle more than once and administer drugs from that bottle either to the same patients or to multiple patients.

An impact of repeated use of a DCT containing ketamine.

In real life.

Without having to look too hard for four other examples.

Speaker #4: And the main difference, or a main difference, is that there's no benzethonium chloride in the J&J product. So it may be that we're already seeing an impact of repeated use of a BZT-containing ketamine in real life.

Terms of what would be the impact of removing this toxic preservative from generic ketamine.

It would.

First of all we think benefit patients substantially because the only reason it's in the bottle is so that a doctor can stick a needle into the same bottle more than once.

And administer drugs from that Bob alluded to the same patients or to multiple patients.

Speaker #4: Without having to look too hard for other examples, now, in terms of what would be the impact of removing this toxic preservative from generic ketamine, it would, first of all, we think benefit patients substantially.

So theres no real benefit to the patient associated with injecting BZ T into the patient.

What would be the impact the impact could well be that rather than a.

Normal share of the generic market that we would associate with <unk> for a U S manufactured.

Speaker #4: Because the only reason it's in the bottle is so that a doctor can stick a needle into the same bottle more than once and administer drugs from that bottle either to the same patients or to multiple patients.

Safe and reliable form of ketamine.

We might have a substantially larger share of that generic market.

Speaker #4: So there's no real benefit to the patient associated with injecting BZT into the patient. What would be the impact? The impact could well be that rather than a normal share of the generic market that we would associate with an ANDA for a US manufactured safe and reliable form of ketamine, we might have a substantially larger share of that generic market while other suppliers readjust their formulations to take the toxic preservative out of those formulations.

Jonathan Javitt: So there is no real benefit to the patient associated with injecting BZT into the patient. What would be the impact? The impact could well be that rather than a normal share of the generic market that we would associate with an Abbreviated New Drug Application for a U.S.-manufactured, safe, and reliable form of ketamine, we might have a substantially larger share of that generic market while other suppliers readjust their formulations to take the toxic preservative out of those formulations. Since some of those current generic suppliers have pretty much left this product on the shelf, it is not even clear how many of them would readjust their formulations and reenter the marketplace versus simply go on to other things. So granted, the citizen petition could really help us exceed people's financial expectations for us.

While other suppliers readjust their formulations to take the toxic preservative out of those formulations.

And since some of those current genetic suppliers of.

Pretty much.

Left this product on the shelf it's.

It's not even clear how many of them would readjust their formulations and reenter the marketplace versus simply go on to other things.

So granted the citizen's petition could.

Really help us exceed people's financial expectations for us.

Yeah.

Alright.

Speaker #4: And since some of those current genetic suppliers have pretty much left this product on the shelf, it's not even clear how many of them would readjust their formulations and re-enter the marketplace versus simply go on to other things.

That's really helpful and just another follow up on our X 100, I think you mentioned plans to submit real world data from nearly 180000 patients treated with ketamine and <unk> I'm wondering how you expect the FDA to weigh this data set alongside the randomized controlled trials and do you believe it can further strengthen the case for an accelerated approval.

Speaker #4: So granted, the citizen's petition could really help us exceed people's financial expectations for us.

Yeah.

Well, we think real world data and in that quantity of patients certainly should.

Speaker #6: Right. That's really helpful. And just another follow-up on NRX-100. I think you mentioned plans to submit real-world data from nearly 180,000 patients treated with ketamine and Spravato.

Michael Abrams: Right. That is really helpful. Just another follow-up on NRX-100. I think you mentioned plans to submit real-world data from nearly 180,000 patients treated with ketamine and Spravato. I am wondering how you expect the FDA to weigh this data set alongside the randomized control trials. Do you believe it could further strengthen the case for an accelerated approval?

Motivate FCA.

To see the cases is substantially strengthened.

The FDA guidance is that the agency really needs to pay attention to real world data and Commissioner Mccarty has has said.

Speaker #6: I'm wondering how you expect the FDA to weigh this data set alongside the randomized controlled trials and do you believe it could further strengthen the case for an accelerated approval?

Very clearly.

<unk>.

Speaker #4: Well, we think real-world data in that quantity of patients certainly should motivate the FDA to see the cases as substantially strengthened. You know, the FDA guidance is that the agency really needs to pay attention to real-world data.

Debt.

Jonathan Javitt: We think real-world data in that quantity of patients certainly should motivate FDA to see the cases as substantially strengthened. You know, the FDA guidance is that the agency really needs to pay attention to real-world data. Commissioner McCarry has said very clearly that he wants to move the agency, you know, solidly into the 21st century in terms of using real-world data. We hope this will be one of the first examples where real-world data supports an approval. It's very rare to have a drug approval coming down the pike where, you know, more than 200,000 people have already gotten the drug for this purpose. It just doesn't happen to be approved for this purpose yet. That's a unique circumstance.

He wants to move the agency, yes solidly into the 21st century.

In terms of using real world data. So we hope this will be one of the first examples.

Real World data supports and approval.

It's very rare to have a drug approval coming down the pike, where.

Speaker #4: And Commissioner McCarry has said very clearly that he wants to move the agency solidly into the 21st century in terms of using real-world data.

More than.

More than 200000 people, who have already gotten the drug for this purpose. It just doesn't have happened to be approved for this purpose yet.

Hey, Brian each circumstance.

Speaker #4: So, we hope this will be one of the first examples where real-world data supports an approval. It's very rare to have a drug approval coming down the pike where more than 200,000 people have already gotten the drug for this purpose.

Yes, that's interesting and then just on <unk> hundred one.

It's sort of interesting highlight the potential synergy between <unk> 101, and Tms and I'm wondering if this combination could it accelerate adoption either within the whole clinics or across interventional psychiatry and more broadly and is this something that you may see.

Speaker #4: It just doesn't happen to be approved for this purpose yet. That's a unique circumstance.

A label expansion to more formally capture this potential.

Speaker #6: Yes, that's interesting. And then just on NRX 101, you know, but an interesting highlight of the potential synergy between NRX 101 and TMS. And I'm wondering if this combination could it accelerate adoption either within the hope clinics or across interventional psychiatry more broadly?

Thank you you're asking a fascinating question and.

Michael Abrams: Yes, that's interesting. Then just on NRX-101, it's an interesting highlight of the potential synergy between NRX-101 and TMS. I am wondering if this combination could accelerate adoption either within the Hope Therapeutics clinics or across interventional psychiatry more broadly. Is this something that you may seek a label expansion to more formally capture this potential?

We've identified a very provocative and a good way provocative scientific study that was performed out of Canada, where investigators showed.

And our X 101, well they specifically showed that the cyclists series the main active ingredient in <unk> hundred one.

Speaker #6: And is this something that you may seek a, you know, a label expansion to more formally capture this potential?

Compared to placebo.

Speaker #4: Thank you. You're asking a fascinating question. And, you know, we've identified a very provocative, in a good way, scientific study that was performed out of Canada, where investigators showed that NRX-101, while they specifically showed that B-cycloserine, the main active ingredient in NRX-101, compared to placebo, enhanced the effect of transcranial magnetic stimulation, or TMS, in treating depression.

Jonathan Javitt: Thank you. You are asking a fascinating question. We have identified a very provocative, in a good way, provocative scientific study that was performed out of Canada, where investigators showed that NRX-101, well, they specifically showed that D-cycloserine, the main active ingredient in NRX-101, compared to placebo, enhanced the effect of transcranial magnetic stimulation, or TMS, in treating depression. They did not really give an antidepressant dose of D-cycloserine. They gave about 100 milligrams per patient per day, which was a lower dose than would be needed to block the NMDA receptor. As you recall, my brother, Dan Javitt, has done most of the work, as supported by patents all over the world, in demonstrating that you have to get to about 400 to 500 milligrams a day of D-cycloserine before the drug becomes a potent NMDA antagonist. They used a much lower dose of D-cycloserine.

Enhanced the effect of transcranial magnetic stimulation or Tms.

In treating depression.

And.

They didn't really give an anti depressant dose.

And of the cyclists series and they gave about 100 milligrams.

Our per patient per day.

Which was a lower dose than would be needed to.

And to block the NMDA receptor as Youll recall my brother, Dan Cabot has done most of the work.

Speaker #4: And they didn't really give an antidepressant dose of B cycloserin. They gave about 100 milligrams per patient per day. Which was a lower dose than would be needed to block the NMDA receptor.

As supported by patents all over the world in demonstrating that you have to get to about.

Four to 500 milligrams, a day of the cyclic Sarah and before the drug becomes a potent NMDA antagonist.

So they used a much lower dose of the cycles here in the east 100 milligrams, a day, which is believed to be neuro plastic.

Speaker #4: As you recall, my brother, Dan Javitt, has done most of the work, as supported by patents all over the world, in demonstrating that you have to get to about 400 to 500 milligrams a day of B-cycloserine before the drug becomes a potent NMDA antagonist.

Even if it's not a potent NMDA antagonist that those doses.

And Lo and Behold showed a very potent.

Improvement in the results achieved with transcranial magnetic stimulation.

So we're in active discussion.

Speaker #4: So, they used a much lower dose of B-cycloserine. They used 100 milligrams a day, which is believed to be neuroplastic, even if it's not a potent NMDA antagonist at those doses.

With the U S academic medical centers about mounting a confirmatory clinical trial in that area.

Jonathan Javitt: They used 100 milligrams a day, which is believed to be neuroplastic, even if it is not a potent NMDA antagonist at those doses. Lo and behold, they showed a very potent improvement in the results achieved with transcranial magnetic stimulation. We are in active discussion with U.S. academic medical centers about mounting a confirmatory clinical trial in that area. It would be a very interesting label expansion for NRX-101. More importantly, if that drug is able to potentiate the effect of TMS, it will bring TMS, in our estimate, much more into the mainstream as, you know, maybe even a first-line treatment for depression rather than starting out with these old generic serotonin drugs that may or may not work depending on, you know, who you read.

It would be a.

A very interesting label expansion.

Speaker #4: And lo and behold, we showed a very potent improvement in the results achieved with transcranial magnetic stimulation. So we're in active discussion with U.S. academic medical centers about mounting a confirmatory clinical trial in that area.

For <unk> hundred one but more importantly.

If that drug is able to potentiate the effect of Tms.

It will bring Tms in our estimate for much more into the mainstream.

As you may be even a first line treatment for depression.

Whether then starting out with these old generic serotonin drugs that.

Speaker #4: It would be a very interesting label expansion for NRX-101, but more importantly, if that drug is able to potentiate the effect of TMS, it will bring TMS, in our estimate, much more into the mainstream as maybe even a first-line treatment for depression rather than starting out with these old generic serotonin drugs that may or may not work depending on, you know, who you read.

May or may not work, depending on who you read.

And certainly every one of them has a label that says pushing this drug may be associated with increased levels of suicidal ideation.

So anything that leads to better outcomes from Tms anything that makes that treatment.

More accessible and more potent for patients.

Has the potential to really shift the whole paradigm of how we treat suicidal depression, even ordinary depression.

Speaker #4: And certainly, every one of them has a label that says caution this drug may be associated with increased levels of suicidal ideation. So anything that leads to better outcomes from TMS, anything that makes that treatment more accessible and more potent for patients has the potential to really shift the whole paradigm of how we treat suicidal depression even ordinary depression and PTSD.

Jonathan Javitt: Certainly, every one of them has a label that says, "Gosh, and this drug may be associated with increased levels of suicidal ideation." Anything that leads to better outcomes from TMS, anything that makes that treatment more accessible and more potent for patients has the potential to really shift the whole paradigm of how we treat suicidal depression, even ordinary depression, and PTSD.

And P T S D.

Right.

That's really helpful. Thank you so much.

Alright. Thank you and your next question comes from the line of Edward <unk> from BMO Capital. Please go ahead.

Yes, congratulations on all the progress what is your commercial strategy with <unk> 100, and a 101 or are you going to wait until closer to approval to actually expand potentially got a sales force.

Speaker #6: Right. That's really helpful. Thank you so much.

Michael Abrams: Right. That's really helpful. Thank you so much.

Yes, it's a wonderful question and.

Matt Matt Duffy is on the phone with US a lot of people know Matt.

Speaker #2: All right. Thank you. And your next question comes from the line of Ed Wu with Ascendant Capital. Please go ahead.

Operator: Thank you. Your next question comes from the line of Ed Wu with Ascendant Capital. Please go ahead.

In his role within our company as our Chief business Officer.

Speaker #7: Yeah. Congratulations on all the progress. What is your commercial strategy with NRX-100 and NRX-101? Are you going to wait until closer to approval to, you know, actually expand and potentially get a sales force?

Jason Colbert: Yeah. Congratulations on all the progress. What is your commercial strategy with NRX-100 and NRX-101? Are you going to wait until closer to approval to, you know, actually, you know, expand and potentially get a sales force?

People have known Matt and his role.

At.

On Wall Street as a highly respected research analyst with fewer people know is that met got out of college joined Pfizer.

Speaker #6: Yeah. It's a wonderful question. And you know, Matt Duffy is on the phone with us. A lot of people know Matt. In his role within our companies, our chief business officer, people have known Matt.

Jonathan Javitt: Yeah, it is a wonderful question. Matt Duffy is on the phone with us. A lot of people know Matt in his role within our company as our Chief Business Officer. People have known Matt in his role on Wall Street as a highly respected research analyst. What fewer people know is that Matt got out of college, joined Pfizer, succeeded in a commercial role to the point where he actually wound up as the product manager for Viagra and went on to launch highly successful biologics at other companies. Matt, why don't you walk Ed through what you would be likely to do if we dropped a drug approval in your lap?

<unk> succeeded in a commercial role to the point, where he actually wind up as the product manager for Viagra and went on to launch.

Highly successful biologics at other companies.

Speaker #6: In his role on Wall Street as a highly respected research analyst, what fewer people know is that Matt got out of college, joined Pfizer, and succeeded in a commercial role to the point where he actually wound up as the product manager for Viagra. He went on to launch highly successful biologics at other companies.

Matt why don't you walk it through.

What.

What you would be likely to do if we dropped to drug approval in your lap.

Sure. Thanks for the question Ed good to hear from you.

So we've done launches like this have done a few of them.

Medimmune is probably the most notable but also at less pharma, where it's a pretty pretty focused launch but for both of these drugs. It would be different with different targets. If you think of <unk> 100 U.

Speaker #6: So, Matt, why don't you walk Ed through what you'd be likely to do if we dropped a drug approval in your lab?

You think of the clinics like we have with hope and other and other.

Mental health.

Facilities.

There's probably 600 to 1000 that are really solid.

Speaker #4: Sure. Thanks for the question, Ed. Good to hear from you. So we've done launches like this. I've done a few of them; the Metamine is probably the most notable, but also Levpharma.

Jason Colbert: Sure. Thanks for the question, Ed. Good to hear from you. We've done launches like this. I've done a few of them. The Metamine is probably the most notable, but also at Lev Pharma, where it's a pretty focused launch for both of these drugs. It'd be different.

Places that they'll administer these medications at this point that will grow once you have a reimbursed.

<unk>.

But.

Speaker #4: It's a pretty, pretty focused launch. But for both of these drugs, it'll be different, with different targets. If you think of NRX-100, you think of clinics like we have with Hope and other mental health facilities.

When you start looking at those numbers and thinking about what a rep or an MSL.

Matthew Duffy: different targets. If you think of NRX-100, you think of the clinics like we have with Hope Therapeutics and other mental health facilities. There are probably 600 to 1,000 that are really solid places that will administer these medications at this point that will grow once you have a reimbursed product. When you start looking at those numbers and thinking about what a rep, or an MSL, or a business person, an administrative person might be able to do, you probably can get away with that and really be successful with a small commercial force. I think at MedImmune our initial group of reps and MSLs was about 20 people. That was a very focused group of folks in about 500 hospitals. At Lev, it was a similar situation with individual rheumatologists that we were targeting.

Or a business a business person.

Administrative person might be able to do you probably can get away with not had been really be successful with.

Speaker #4: There are probably 600 to 1,000 really solid places that will administer these medications at this point, and that number will grow once you have a reimbursed product.

Our small commercial force I think at Medimmune, our initial group.

Of reps and Msl's was about 20 people.

And that was that was a very focused group of focusing on about 500 hospitals.

Speaker #4: But you know, when you start looking at those numbers and thinking about what a rep, an MSL, or a business person—an administrative person—might be able to do, you probably can get away and really be successful with a small commercial force.

And then and then it love it was a similar situation with with individual rheumatologists that we're targeting and so the so for 400, you're probably you're probably launch with around 20 people and you can do the math on what the Msos and reps costs. These days.

And really do a good job really covering the key players in the market and.

And really really getting good coverage over a huge proportion of what we really think is the opportunity in the mental health side for Academy.

<unk> hundred <unk>.

Gonna be kind of similar with <unk> hundred one but look different.

There is a very focused number of perhaps I think the number is about 15 or 1600 maximum.

Matthew Duffy: So for NRX-100, you probably launch with around 20 people, and you can do the math on what the MSLs and reps cost these days. You can really do a good job covering the key players in the market and really getting good coverage over a huge proportion of what we really think is the opportunity in the mental health side for ketamine and NRX-100. It is going to be kind of similar with NRX-101, but look different. There is a very focused number of perhaps, I think the number is about 1,500 or 1,600 maximum, psychiatrists who treat bipolar patients. Those numbers are a little dated from market research we did a few years ago. If you do the math backwards in terms of rep coverage and MSL coverage for that, it is a similar number of patients, or I am sorry, field personnel.

Psychiatrists, who treat bipolar patients.

These numbers are a little data from market research, we did a few years ago, but if you do the math backwards in terms of rep coverage and MSL covered for that it's a similar number of patients.

Eric I'm sorry.

Personnel.

Those folks may be a little bit more expensive because you may have a little better bigger tilt towards that ourselves, but she didn't cover 500 high prescribing bipolar psychiatrists.

But not that many reps and so those are those are pretty focused efforts and then the marketing behind it. Therefore is more focused as well. So I think these are two really focused watches it can be synergistic because of the knowledge base.

Bipolar depression, and major depression and suicide Ality for both will have a lot of overlap, but as you look at those.

Matthew Duffy: Those folks may be a little bit more expensive because you may have a little better, bigger tilt towards MSLs. You can cover 1,500 high prescribing bipolar psychiatrists with not that many reps. So those are pretty focused efforts. The marketing behind it, therefore, is more focused as well. I think if these are two really focused launches, they can be synergistic because of the knowledge base of bipolar depression and major depression and suicidality for both will have a lot of overlap. As you look at those, the company will obviously get smarter and smarter on the commercial side, as we are getting closer and as we are launching the products. You are probably talking about 20 to 25-person commercial organizations with the supporting infrastructure. It is really focused. We did it with not a lot of money at MedImmune.

The company will obviously get smarter and smarter on the commercial side as we're getting closer to as we're launching the products, but you're probably talking about $2 2025 person commercial organizations with the supporting infrastructure. Its really focused weekend, we did it with not a lot of money at medimmune needed it with not a lot of money at 11, then when when Bureau pharma.

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Shortly thereafter.

Because you're really focused and it can be a very efficient launch and the nice thing about that is you get profitability much much much more quickly than if you have a 500 person primary care sales force like you know Pfizer with what we want to watch with adviser.

Yeah.

Great. Thanks for answering my questions and I wish you guys. Good luck. Thank you.

Thanks, Ed.

Matthew Duffy: They did it with not a lot of money at Lev, and then when Vero Pharma bought us shortly thereafter. It can be really focused. It can be a very efficient launch. The nice thing about that is you hit profitability much, much, much more quickly than if you have a 500-person primary care sales force like Pfizer would launch with at Pfizer.

And we have no further questions over the phone lines I would like to strike back to Matthew Duffy for his closing remarks.

Well. Thank you everyone for joining us. This morning, we're extremely excited about the path ahead with three potential approvals and the and our hope subsidiary targeting multiple profitable mental health clinics and interventional psychiatry centers.

This concludes the <unk> Pharmaceuticals second quarter 2025 results conference call. Thank you all for participating you may disconnect.

Rachel Smith: Great. Thanks for answering my questions. I wish you guys good luck. Thank you.

Matthew Duffy: Thanks, Ed.

Operator: We have no further questions over the phone line. I would like to turn it back to Matthew Duffy for closing remarks.

Matthew Duffy: Thank you, everyone, for joining us this morning. We are extremely excited about the path ahead with three potential approvals and our Hope Therapeutics subsidiary targeting multiple profitable mental health clinics and interventional psychiatry centers. This concludes the NRx Pharmaceuticals Q2 2025 results conference call. Thank you all for participating. You may disconnect.