Q2 2024 NRx Pharmaceuticals Inc Earnings Call

Good afternoon everyone and welcome to the NRX Pharmaceuticals, Incorporated.

Operator: Shooticles Incorporated, 2nd quarter of 2024 Results Conference Call. Currently, all participants are in a listen-only mode.

Second Quarter of 2024 Results Conference Call. Currently, all participants are in a listen-only mode.

Operator: As a reminder, this conference call is being recorded. I will now turn the call over to Matthew Duffy, the company's Chief Business Officer. Please go ahead.

As a reminder, this conference call is being recorded. I will now turn the call over to Matthew Duffy, the company's Chief Business Officer. Please go ahead.

Matthew Duffy: Thank you, Franzi, 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 which could cause actual results to differ materially from historical experience or present expectations. Additional information concerning factors that could cause actual results to differ from statements made on this call is contained in our periodic reports filed with the SEC.

Speaker Change: Thank you, Francie, and welcome, everyone.

Speaker Change: Corey proceed with the call. I would like to remind everyone that certain statements made during this call are forward-looking statements under US Federal Security. These statements are subject to risks and uncertainties, because actual results are different materially from historical experience or present expectations.

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

Matthew Duffy: 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 forward-looking statements. Information presented on this call is contained in the press release issued today and in the company's Form 10-Q, which may be accessed from the investors page of the NRX Pharmaceuticals website. Joining me today are Dr. Jonathan Javitt, our Founder, Chairman and Chief Scientist. Stephen Willard, Chief Executive Officer, Richard Narido, Chief Financial Officer and Treasurer.

Speaker Change: 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 forward-looking statements.

Speaker Change: Information presented on this call is contained in the press release issued today and in the company's Form 10-Q , which may be accessed from the investors page of the NRX Pharmaceuticals website. Joining me today are Dr. Jonathan Javitt, our founder

Speaker Change: and Chief Scientist, Stephen Willard, our Chief Executive Officer, and Richard Narido, Chief Financial Officer and Treasurer.

Richard Narido: Stephen and Jonathan will provide a summary of our company's progress. Richard will review the company's financial results, and then Jonathan will review upcoming milestones before making closing comments.

Matthew Duffy: Stephen and Jonathan will provide a summary of our company's progress, Richard will review the company's financial results, and then Jonathan will review upcoming milestones before making closing comments. Following the prepared remarks, we will address investor questions. I'll now turn the call over to Jonathan.

Richard Narido: Following the prepared remarks, we will address investor questions. I'll now turn the call over to Jonathan.

Jonathan Javitt: Thank you for joining us. Steve, Matt, Rich, the rest of the team have now reached a point where years of hard work are beginning to bear visible fruit. We've reached three key inflection points on scientific, business and financing fronts in advancing our business. First, on the scientific front, we're poised to file two NDAs for our product candidates in the coming months. NRX100 for clinic-based treatment of suicidal depression, that is intravenous ketamine, and NRX101 for home-based treatment of bipolar depression in patients with suicidality or akathisia, that's an oral combination of D-cycloserine and lorazodone.

Jonathan Javitt: Thank you, Matt.

Jonathan Javitt: Second, on the business front, we've laid the foundation for a roll-up of state-of-the-art ketamine and interventional psychiatry clinics that will advance the treatment of patients with suicidal depression. In the process, as Rich will tell you, we've substantially reduced operating costs and cut our loss per share by nearly 50% compared to the prior year.

Jonathan Javitt: Good afternoon everybody. Thank you for joining us. Steve, Matt, Rich, the rest of the team have now reached a point where years of hard work are beginning to bear visible fruit. We've reached three key inflection points on scientific, business, and financing fronts in advancing our business.

Jonathan Javitt: Third, on the corporate financing front, we fundamentally stabilized our business from an economic perspective, by attracting a fundamental investor with more than a billion dollars under management, while simultaneously eliminating toxic debt that was the subject of litigation, from Our Balance. That new investor and some partners committed between $10.5 and $16 million in new funding, as announced in last night's 8K filing. Investors have expressed a repeated concern as to whether we can fund the activities required to get our drugs approved.

Jonathan Javitt: First, I'm a scientific front, we're pleased to file two of the aids for our product candidates in the current coming months.

Speaker Change: NRX-100 for clinic-based treatment of suicidal depression that is intravenous catamine and NRX-101 for home-based treatment of bipolar depression in patients with suicide or death. That's an oral combination of the psychocyrin and the razzidone.

Speaker Change: Second, on the business front, we've laid the foundation for a roll-up of state-of-the-art ketamine and interventional psychiatry clinics that will advance the treatment of patients with suicidal depression.

Speaker Change: In the process, as Rich will tell you, we've substantially reduced operating costs and cut our loss per share by nearly 50% compared to the prior year.

Rich: Third, on the corporate financing front, we fundamentally stabilize our business from an economic perspective.

Speaker Change: by attracting a fundamental investor with more than a billion dollars under management. While simultaneously eliminating toxic debt, that was a subject of litigation from our balance sheet.

Speaker Change: That new investor and some partners committed between $10.5 and $16 million in new funding as announced in last night's 8K filing.

Speaker Change: Investors have expressed a repeated concern as to whether we can fund the activities required to get our drugs approved. As announced yesterday, this is no longer a concern.

Jonathan Javitt: As announced yesterday, this is no longer a concern. In announcing the funding transaction, the principal of Anson said, NRX Pharmaceuticals has a promising pipeline with potential to transform the lives of patients and their loved ones. We are pleased to be working with NRX pharmaceuticals team to support these drugs in their registration and hopefully their approval phase. We intend to live up to those wishes.

Speaker Change: In announcing the funding transaction, the principal of Anson said NRX Pharmaceuticals has a promising pipeline with potential to transform the lives of patients and their loved ones.

Speaker Change: We are pleased to be working with NRX Pharmaceuticals team to support these drugs in their registration and hopefully their approval phase.

Jonathan Javitt: The funds from the Anson investment will both pay for our FDA submissions and will retire debt from our balance sheet that has impeded our forward progress. The Anson funding brings us a substantially lower interest rate, a substantially lower conversion discount on our stock, and reduced expense in its other key features. It frees NRX from extraordinary conversion demands that in the past led to significant erosion in shareholder value. Much of the stock we allocated for this transaction is in the form of currently unregistered shares, demonstrating substantial faith on the part of the new investor that we can and will execute on our commitments to commercial success. These three inflections were, Scientific, business, and finance related are near-term in nature rather than ephemeral.

Speaker Change: We intend to live up to those wishes.

Speaker Change: The funds from the Anson investment will both pay for our FDA submissions and will retire debt from our balance sheet that has impeded our forward progress.

Speaker Change: The Anson funding brings us a substantially lower interest rate, a substantially lower conversion discount on our stock, and reduced expense in its other key features.

Speaker Change: It frees NRX from extraordinary conversion demands that in the past led to significant erosion in shareholder value.

Speaker Change: Much of the stock we allocated for this transaction is in the form of currently unregistered shares, demonstrating substantial faith on the part of the new investor that we can and will execute on our commitments to commercial success.

Speaker Change: These three inflection points.

Speaker Change: Scientific, business, and finance related are near-term in nature rather than ephemeral. We aim to receive drug approvals for NRX 101 and NRX 100 in 2025 and to make these drugs available to patients.

Jonathan Javitt: We aim to receive drug approvals for NRX 101 and NRX 100 in 2025 and to make these drugs available to patients. Until then, we will do so through compounding pharmacy relations. The First Hope Therapeutics Clinic, has been identified along with multiple follow-on acquisitions and the acquisition structure is currently in negotiation. One of the nation's leading psychiatrists who pioneered the use of ketamine more than 15 years ago, has agreed to serve as our Chief Medical Innovation Officer. These are critical steps in our quest to bring hope to life.

Speaker Change: Until then, we will do so through compounding pharmacy relationships.

Speaker Change: The first HOPE Therapeutics Clinic has been identified, along with multiple follow-on acquisitions, and the acquisition structure is currently in negotiation.

Speaker Change: One of the nation's leading psychiatrists who pioneered the use of ketamine more than 15 years ago has agreed to serve as our Chief Medical Innovation Officer.

Speaker Change: These are critical steps in our quest to bring hope to life. Thus, from a scientific and financial perspective, we have a company that's now poised to bring life-saving drugs to patients and financial returns to its investors.

Jonathan Javitt: Thus, from a scientific and financial perspective, We have a company that's now poised to bring life-saving drugs to patients, and Financial Returns to its Investors. On the scientific front, we believe that NRX 101 has demonstrated a paradigm-changing breakthrough, in the Care of Bipolar Depression. Unfortunately, that breakthrough may not be completely understood because advances in drugs are so often viewed as advances in efficacy rather than advances in safety. In our recently completed clinical trial, we did not demonstrate that NRX101 is more effective in reducing symptoms of depression than the market-leading drug lorazidone. It doesn't need to be in order to be an extremely effective drug.

Speaker Change: On the scientific front, we believe that NRX 101 has demonstrated a paradigm-changing breakthrough.

Speaker Change: in the Care of Bipolar Depression. Unfortunately, that breakthrough may not be completely understood because advances in drugs are so often viewed as advances in efficacy rather than advances in safety.

Speaker Change: In our recently completed clinical trial, we did not demonstrate that NRX 101 is more effective in reducing symptoms of depression.

Speaker Change: and the market-leading drug lorazidone.

Speaker Change: It doesn't need to be in order to be an extremely effective drug. What we did demonstrate is that NRX101 is the first oral antidepressant to reduce symptoms of suicidality.

Jonathan Javitt: What we did demonstrate is that NRX101 is the first oral antidepressant to reduce symptoms of suicidality and the first oral antidepressant to reduce symptoms of akathisia, a highly dangerous side effect of every known antidepressant. The NRX 101 data presented at the American Society of Clinical Psychopharmacology demonstrated a new paradigm for the treatment of bipolar depression. From the start, serotonin-targeted drugs for the treatment of depression, It was known that these drugs caused side effects such as acathesia that directly caused their propensity to trigger suicidality.

Speaker Change: and the first oral antidepressant to reduce symptoms of akathisia, a highly dangerous side effect of every known antidepressant.

Speaker Change: The NRX 101 data presented at the American Society of Clinical Psychopharmacology demonstrated a new paradigm for the treatment of bipolar depression.

Speaker Change: From the start, serotonin targeted drugs for the treatment of depression, it was known that these drugs caused side effects such as akathisia that directly caused their propensity to trigger suicidality.

Jonathan Javitt: Doctors and patients have lived with these side effects in order to achieve the critical antidepressant effects that are needed to control this life-threatening disease. The data we presented at ACSP, ASCP, confirms our earlier stable B trial, demonstrating that NRX 101 is the first oral antidepressant to have effective antidepressant properties, while simultaneously decreasing atyphesia and suicidality. The data we presented at ACSP is the first oral antidepressant to have effective antidepressant properties, while simultaneously decreasing atyphesia and suicidality.

Speaker Change: Doctors and patients have lived with these side effects in order to achieve the critical antidepressant effects that are needed to control this life-threatening disease.

Speaker Change: The data we presented at ASCP confirms our earlier STABLE-B trial demonstrating that NRX101 is the first oral antidepressant to have effective antidepressant properties.

Speaker Change: while simultaneously decreasing akathisia and suicidality.

Jonathan Javitt: On the NRX Pharma 100 or Catamene side, as our quarterly report was going to the printer, a major scientific breakthrough was published in the Journal of Translational Psychiatry. A retrospective cohort study that considered the electronic medical records data of more than 500,000 Americans with depression. Demonstrated that those treated with ketamine were substantially and significantly less likely to have suicidal ideation for up to nine months post-treatment, versus those not treated with ketamine. Although FBA traditionally considers data from randomized control trials as its primary base, for Determining Emphasis.

Speaker Change: On the NRX 100, the war-cadermine side, as our quarterly report was going to the printer, a major scientific breakthrough was published in the Journal of Translational Psychiatry.

Speaker Change: A retrospective cohort study that considered the electronic medical records data of more than 500,000 Americans with depression.

Speaker Change: demonstrated that those treated with ketamine were substantially and significantly less likely to have suicidal ideation for up to nine months post-treatment versus those not treated with ketamine.

Speaker Change: Although FBA traditionally considers data from randomized control trials as its primary basis

Jonathan Javitt: Real-world data such as this, when it mirrors the findings of already demonstrated and randomized controlled trials, as we have demonstrated, can be important and persuasive. As you know from our various scientific presentations, we aim to present the FDA with patient level data on nearly 1000 patients in which ketamine has been tested, in a prospective, randomized manner against placebo, active comparator, and electroshock therapy. We thank our investors for their patience, as our novel, preservative-free presentation of ketamine matures and becomes ready for FDA filing.

Speaker Change: For determining efficacy, real-world data such as this, when it mirrors the findings of already demonstrated and randomized controlled trials, as we have demonstrated, can be important and persuasive.

Speaker Change: As you know from our various scientific presentations, we aim to present the FDA with patient-level data on nearly 1,000 patients in which ketamine has been tested.

Speaker Change: in a prospective, randomized manner against placebo, active comparator, and electroshock therapy.

Speaker Change: We thank our investors for their patience.

Unknown Executive: Shooticles Incorporated, 2nd quarter of 2024 Results Conference Call. Currently, all participants are in a listen-only mode. As a reminder, this conference call is being recorded.

Speaker Change: As our novel, preservative-free presentation of ketamine matures and becomes ready for FDA filing.

Jonathan Javitt: Unfortunately, many in the public don't know that in order to seek approval of a drug, you must actually hold a fully manufactured drug in your hands that's been stable on the shelf for a year or more. Without that, the FDA will refuse to file a new drug application.

Speaker Change: Unfortunately, many in the public don't know that in order to seek approval of a drug, you must actually hold a fully manufactured drug in your hands that's been stable on the shelf for a year or more. Without that, the FDA will refuse to file the new drug application.

Matthew Duffy: I will now turn the call over to Matthew Duffy, the company's Chief Business Officer. Please go ahead. Thank you, Fronzy, and welcome everyone. For you proceed with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under US Federal Security. These statements are subject to risks and uncertainties, which could cause actual results to differ materially from historical experience or present expectations. Additional information concerning factors that could cause actual results differ from statements made on this call is contained in our periodic reports filed with the SEC. The forward-looking statements made during this call speak only as of the date hereof, and the company undertakes no obligation to update or revise forward-looking statements.

Jonathan Javitt: We anticipate reaching the critical point in our manufacturing stability program where FDA filing is possible for NRX 100 by the end of October. A second key requirement for FDA to file an NDA is alignment on a pediatric study plan as required by law. Several weeks ago, we announced that we achieved this critical alignment with FDA. The notion of a preservative-free ketamine has been surprising to some in the public. However, data have emerged from both primate and human studies, that repeated doses of the currently available commercial intravenous ketamine are toxic to the brain.

Speaker Change: We anticipate reaching the critical point in our manufacturing stability program where FDA filing is possible for NRX100 by the end of October .

Speaker Change: A second key requirement for FDA to file an NDA is alignment on a pediatric study plan as required by law. Several weeks ago, we announced that we achieved this critical alignment with FDA.

Speaker Change: The notion of a preservative-free ketamine has been surprising to some in the public. However, data have emerged from both primate and human studies that repeated doses of the currently available commercial intravenous ketamine are toxic to the brain.

Matthew Duffy: Information presented on this call is contained in the press release issue today, and the company's Form 10Q, which may be accessed from the investor's page of the NRX Pharma Shooticles website.

Jonathan Javitt: The commercial preparation was designed for anesthesia in a multi-dose vial where it was anticipated that doctors would draw from the same vial for multiple patients. That's no longer a loud in hospitals today, but that's how it was designed. Accordingly, commercial ketamine preparations are manufactured with a potentially toxic preservative, benzothonine chloride. While there is no evidence that densethonine fluoride is toxic at its current concentration for the intended use of anesthesia, Its safety has never been shown or even proposed for chronic use.

Speaker Change: The commercial preparation was designed for anesthesia in a multi-dose vial, where it was anticipated that doctors would draw from the same vial for multiple patients.

Matthew Duffy: Joining me today are Dr. Jonathan Javitt, our founder and chairman and chief scientist, Stephen Willard, our chief executive officer, Richard Narido, chief financial officer and treasurer. Stephen and Jonathan will provide a summary of our company's progress. Richard will review the company's financial results, and then Jonathan will review upcoming milestones before making closing comments. Following the prepared remarks, we will address investor questions.

Speaker Change: That's no longer allowed in hospitals today, but that's how it was designed. Accordingly, commercial ketamine preparations are manufactured with a potentially toxic preservative, benzothonine fluoride.

Speaker Change: Well, there's no evidence that Pennsylvania and Florida is toxic at its current concentration for the intended use of anesthesia.

Jonathan Javitt: I will now turn the call over to Jonathan. Thank you, Matt.

Speaker Change: Its safety has never been shown or even proposed for chronic use.

Jonathan Javitt: Hence, we believe we are poised to file the first new drug application, for a novel preparation of ketamine in unpreserved form that will bring substantial value to patients, and be reimbursable by payer, whereas the current off-label use of ketamine is available only to patients who can pay substantial amounts of money out of pocket. In introducing Steve, I'd like to thank him for his profound contribution to our company as its first non-founder CEO.

Speaker Change: Hence, we believe we are poised to file the first new drug application.

Jonathan Javitt: Good afternoon, everybody. Thank you for joining us. Steve, Matt, Rich, rest of the team have now reached a point where years of hard work are beginning to bear visible proof. We've reached three key inflection points on scientific business and financing fronts in advancing our business. First, on the scientific front, we're poised to file two of the aids for our product candidates in the current coming months. NRX 100 for clinic-based treatment of suicidal depression, that is intravenous ketamine, and NRX 101 for home-based treatment of bipolar depression in patients with suicidality or ecafesia.

Speaker Change: for a novel preparation of ketamine in unpreserved form that will bring substantial value to patients.

Jonathan Javitt: That's an oral combination of de-cyclocerying and lyracidone. Second, on the business front, we've laid the foundation for a roll-up of state-of-the-art ketamine and interventional psychiatry clinics. That will advance the treatment of patients with suicidal depression. In the process, as Rich will tell you, we've substantially reduced operating costs and cut our loss for share by nearly 50% compared to the prior year. Third, on the corporate financing front, we fundamentally stabilized our business from an economic perspective by attracting a fundamental investor with more than a billion dollars under management.

Speaker Change: and be reimbursable by payers, whereas the current off-label use of ketamine is available only to patients who can pay substantial amounts of money out of pocket.

Speaker Change: In introducing Steve, I'd like to thank him for his profound contribution to our company as its first non-founder CEO.

Jonathan Javitt: These joined our company on the tail of the COVID pandemic at a time when we were restarting our psychiatry program and recovering our equanimity in the wake of a world catastrophe, that cost the lives of one million Americans and many millions more around the globe. Steve brought a methodical wisdom to our team.

Speaker Change: These joined our company on the tail of the COVID pandemic at a time when we were restarting our psychiatry program and recovering our equanimity in the wake of a world catastrophe that cost the lives of one million Americans and many millions more around the globe.

Stephen Willard: Steve has advised me that as we prepare for 2025 as our first year of commercial operation. We should seek a CEO who has had commercial experience in marketing and successfully selling at least $1 billion in pharmaceutical products. We're starting that search today, and Steve will be a key part of that process. Through his poise and legal discipline, Steve has afforded me the opportunity to take bolder steps in advancing our scientific agenda and our commercial process, will continue to be a key member of our team and our family. Please.

Speaker Change: Steve brought a methodical wisdom to our team.

Speaker Change: Steve has advised me that as we prepare for 2025 as our first year of commercial operations.

Speaker Change: We should seek a CEO who has had commercial experience in marketing and successfully selling at least $1 billion in pharmaceutical products.

Speaker Change: We're starting that search today and Steve will be a key part of that process.

Jonathan Javitt: While simultaneously eliminating toxic debt, that was the subject of litigation from our balance sheet. That new investor, Anson Partners, committed between $10.5 and $16 million in new funding, has announced in last night's AK filing. Investors have expressed a repeated concern as to whether we can fund the activities required to get our drugs approved. As announced yesterday, this is no longer a concern. In announcing the Funding Transaction, the principal of Anson said, NRX Pharmaceuticals has a promising pipeline with potential to transform the lives of patients and their loved ones.

Stephen Willard: Jonathan, thank you for those very gracious comments. The chance to lead NRX has been one of the great joys of my life, and I look forward to helping guide NRX to its success as a commercial enterprise. I'm incredibly proud of the process and progress our team has made over the past months.

Speaker Change: Jonathan, thank you for those very gracious comments.

Jonathan Javitt: The chance to lead NRX has been one of the great joys of my life, and I look forward to helping guide NRX to its success as a commercial enterprise.

Speaker Change: I'm incredibly proud of the process and progress our team has made over the past months, and I'm grateful to our partners and investors, as well as to all of the patients who have participated in our clinical trials.

Stephen Willard: And I'm grateful to our partners and investors, as well as to all of the patients who have participated in our clinical trial. We look forward to continuing to build value for our shareholders and deliver life-saving treatments to patients. Most importantly, we continue to believe that these steps represent the beginning of our transition from a purely research and development company to a revenue generating pharmaceutical, We've made important progress with our clinical development pipeline in this year. Suicidality is a national epidemic. Approximately 3.8 million Americans make an active plan to commit suicide each year according to the CDC.

Speaker Change: We look forward to continuing to build value for our shareholders and deliver life-saving treatments to patients.

Jonathan Javitt: We are pleased to be working with NRX Pharmaceuticals team to support these drugs in their registration and hopefully their approval phase. We intend to live up to those wishes. The funds from the Anson Investment will both pay for our FDA submissions and will retire debt from our balance sheet that has impeded our forward progress. The Anson Funding brings us a substantially lower interest rate, a substantially lower conversion discount on our stock and reduced expense in its other key features.

Speaker Change: Most importantly, we continue to believe that these steps represent the beginning of our transition from a purely research and development company to a revenue generating pharmaceutical company.

Speaker Change: David Gingher, David Gingher

Speaker Change: We've made important progress with our clinical development pipeline this year.

Speaker Change: Suicidality is a national epidemic. Approximately 3.8 million Americans make an active plan to commit suicide each year according to the CDC.

Stephen Willard: We plan to bring NRX100, clearly a life-saving product, to market as soon as possible. The current market for intranasal ketamine is already $800 million, which is not demonstrated and by suicidal problems. We expect our market to be much lighter.

Speaker Change: We plan to bring NRX100, clearly a life-saving product, to market as soon as possible.

Jonathan Javitt: It frees NRX from extraordinary conversion demands that in the past led to significant erosion in shareholder value. Much of the stock we allocated for this transaction is in the form of currently unregistered shares demonstrating substantial faith on the part of the new investor that we can and will execute on our commitments to commercial success. These three inflection points, scientific, business, and finance related are near-term in nature rather than a femoral. We aim to receive drug approvals for NRX 101 and NRX 100 in 2025 and to make these drugs available to patients. Until then, we will do so through compounding pharmacy relationships. The first hope therapeutics clinic has been identified along with multiple follow-on acquisitions and the acquisition structure is currently in negotiation.

Speaker Change: The current market for intranasal ketamine is already $800 million, which has not demonstrated anti-suicidal properties.

Richard Narido: We continue work toward a distribution of shares in Hope Therapeutics to our existing shareholders. We plan to seek public listing for the company on a national exchange [inaudible] Hope is planned to be a care delivery company developing a best-in-class network of clinics that currently offer ketamine and other life-saving therapies to patients with suicidal depression and related disorders, together with digital therapies designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.

Speaker Change: We expect our market to be much larger.

Speaker Change: We continue work toward a distribution of shares in Hope Therapeutics to our existing shareholders. We plan to seek a public listing for the company on a national exchange.

Hope: Hope is planned to be a care delivery company developing a best-in-class network of clinics.

Hope: that currently offer ketamine and other life-saving therapies to patients with suicidal depression and related disorders, together with digital therapies designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.

Richard Narido: We expect funding for HOPE to be independent and less non-dilutive to NRX. At the same time, we believe this will continue to build value for NRX shareholders with this important asset on its balance sheet. I will now ask Richard Narido, our CFO, to review the first quarter financials. Rich?

Hope: We expect funding for HOPE to be independent and most non-dilutive to NRH.

Hope: At the same time, we believe this will continue to build value for NRX shareholders with this important asset on its balance sheet.

Jonathan Javitt: One of the nations leading psychiatrists who pioneered the use of ketamine more than 15 years ago has agreed to serve as our chief medical innovation officer. These are critical steps in our quest to bring hope to life, thus from a scientific and financial perspective. We have a company that's now poised to bring life-saving drugs to patients and financial returns to its investors. On the scientific front, we believe that NRX 101 has demonstrated a paradigm-changing breakthrough in the care of bipolar depression.

Richard Narido: I will now ask Richard Narido, our CFO, to review the first quarter financials. Rich?

Richard Narido: Thanks, Steve, for the three months ended June 30th, 2024, we at NRX Pharma Surgical reduced our net loss from $8.7 million in the second quarter of 2023 to $7.9 million in 2024, representing nearly a 10% improvement year-o-rear. For that same period, we reduced research and development expenses from $3.9 million in 2023 to $2.8 million in 2024. The $1.1 million decrease is related primarily to decrease of $2.4 million in clinical trial and development expenses offset by an increase of $1.3 million related to the Alvogen War.

Rich: Thanks, Steve.

Richard Narido: For the three months ended June 30, 2024, we at NRX Pharmaceuticals reduced our net loss from $8.7 million in the second quarter of 2023 to $7.9 million in 2024.

Speaker Change: representing nearly a 10% improvement year-over-year.

Speaker Change: For that same period, we reduced research and development expenses from $3.9 million in 2023 to $2.8 million in 2024.

Speaker Change: The $1.1 million decrease is related primarily to a decrease of $2.4 million in clinical trial and development expenses offset by an increase of $1.3 million related to the allergen warrants.

Jonathan Javitt: Unfortunately, that breakthrough may not be completely understood because advances in drugs are so often viewed as advances in efficacy rather than advances in safety. In our recently completed clinical trial, we did not demonstrate that NRX 101 is more effective in reducing symptoms of depression than the market leading drug lyridone. It does not need to be in order to be an extremely effective drug. What we did demonstrate is that NRX 101 is the first oral antidepressant to reduce symptoms of suicidality and the first oral antidepressant to reduce symptoms of acathesia, a highly dangerous side effect of every known antidepressant.

Richard Narido: Also, in the three months period, we recorded an increase in general administrative expenses from 4.1 million in 2023 to 4.2 million in 2024. The increase of 0.1 million is related primarily to an increase in consultants and legal fees, partially offset by lower insurance.

Speaker Change: Also, in the three-month period, we recorded an increase in general administrative expenses from $4.1 million in 2023 to $4.2 million in 2024. The increase of $0.1 million is related primarily to an increase in consultants and legal fees, partially offset by lower insurance expenses.

Richard Narido: For the six months ended June 30, 2024, NRX Pharmaceuticals reduced its net loss to $14.4 million compared to $19.8 million in the prior year. These sufficiencies represent an improvement in net loss of $5.4 million year over year, and a $1.32 or 47% improvement in net loss per share year over year. Over that six month period, we recorded 4.6 million of research and development expenses compared to 7.5 million for the same period in 2023, representing a 39% decrease year over year.

Richard Narido: The decrease of 2.9 million is related primarily to a decrease of 4.1 million in clinical trial and development expenses. $1.3 million related to fees paid to regulatory and process development consultants, while offset by $1.3 million related to the allergen warrants, and $0.4 million related to fees paid to regulatory development consultants.

Speaker Change: For the six months ended June 30, 2024, NRX Pharmaceuticals reduced

Speaker Change: It's net loss to $14.4 million compared to $19.8 million in the prior year. These sufficiencies represent an improvement in net loss of $5.4 million year over year and a $1.32 or 47% improvement in net loss per share year over year.

Jonathan Javitt: The NRX 101 data presented at the American Society of Clinical Psychopharmacology demonstrated a new paradigm for the treatment of bipolar depression. From the start, there were tone and targeted drugs for the treatment of depression. It was known that these drugs caused side effects such as acrophysia that directly caused their propensity to trigger suicidality. Doctors and patients have lived with these side effects in order to achieve the critical antidepressant effects that are needed to control this life-threatening disease.

Speaker Change: Over that six-month period, we recorded $4.6 million of research and development expenses compared to $7.5 million for the same period in 2023, representing a 39% decrease year-over-year.

Speaker Change: The decrease of $2.9 million is related primarily to a decrease of $4.1 million in clinical trial and development expenses.

Speaker Change: $0.3 million related to fees paid to regulatory and process development consultants while offset by $1.3 million related to the allergen warrants.

Jonathan Javitt: The data we presented at ACSP, ASCP, confirms our earlier stable B trial demonstrating that NRX 101 is the first oral antidepressant to have effective antidepressant properties while simultaneously decreasing acrophysia and suicidality. On the NRX100 or ketamine side, as our quarterly report was going to the printer, a major scientific breakthrough was published in the Journal of Translational Psychiatry, a retrospective cohort study that considered the electronic medical records data of more than 500,000 Americans with depression.

Speaker Change: and $0.4 million related to fees paid to regulatory development consultants.

Jonathan Javitt: Also in that six month period, we decreased GNA by 1.4 million from 9.9 million to 8.5 million in 2024, nearly a 15% decrease year [inaudible] As of June 30th, we had 1.9 million cash and cash equivalent equivalent. As previously stated, we recently announced that we secured up to $16 million of senior secured debt financing from Absent Funds. This financing is expected to support 2024 filing of new drug applications for NRX 100, and NRX 101, and to support the launch of Whole Therapeutics as well as retirees' historical debt with more favorable terms and a lower annual interest rate. NRX continues to implement operational efficiencies to extend cash runway and maintain focus on our path to generating revenue and value for our shareholders, With that, I will turn it back to Jonathan for closing remarks. Jonathan?

Speaker Change: Also, in that six-month period, we decreased GNA by 1.4 million from 9.9 million to 8.5 million in 2024, nearly a 15% decrease year over year.

Speaker Change: As of June 30th, we had $1.9 million in cash and cash equivalents.

Speaker Change: As previously stated, we recently announced that we secured up to $16 million of senior secured debt financing from Adsense Funds. This financing is expected to support 2024 filing of new drug applications for NRX 100.

Speaker Change: and NRX 101 and to support the launch of Whole Therapeutics as well as retirees' historical debt with more favorable terms and a lower annual interest rate.

Jonathan Javitt: Demonstrated that those treated with ketamine were substantially and significantly less likely that have suicidal ideation for up to nine months post-treatment versus those not treated with ketamine. Although FDA traditionally considers data from randomized control trials as its primary basis for determining efficacy, real world data such as this when it mirrors the findings of already demonstrated in randomized control trials as we demonstrated can be important and persuasive. As you know, from our various scientific presentations, we aim to present the FDA with patient-level data on nearly 1,000 patients in which ketamine has been tested in a prospective randomized manner against placebo, active comparative, and electro-shock therapy.

Speaker Change: NRX continues to implement operational efficiencies to extend cash runway and maintain focus on our path to generating revenue and value for our shareholders. With that, I will turn it back to Jonathan for closing remarks.

Jonathan Javitt: Thank you, Rich. With two MBAs planned for the current month, coming months, the initiation of Hope's clinic acquisition programs to be financed for a non-deludive mechanism, together with a stabilized cash position, we're in a solid position to build shareholder value. Most importantly, we're poised to address critical unmet medical needs for patient suffering from suicidal bipolar depression. We're in a solid position. We're in a solid position.

Speaker Change: David Gingher, David Gingher,

Jonathan Javitt: Thank you, Rich.

Jonathan Javitt: With two NDAs planned for the coming months, the initiation of HOPE's clinic acquisition program to be financed through a non-dilutive mechanism, together with a stabilized cash position, we're in a solid position to build shareholder value.

Speaker Change: Most importantly, we are poised to address critical unmet medical needs for patients suffering from suicidal bipolar depression, suicidal major depression, and those with limited access to advanced psychiatric care.

Operator: We're in a solid position, suicidal major depression, and those with limited access to advanced psychiatric care. In other words, we intend to deliver on our promise to bring hope to life. Operator, we're ready to take questions from the audience. Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the number one on your touchtone phone. You will hear a pop that your hand has been raised. Should you wish to decline from the polling process, please press the star, followed by the number it. If you are using a speakerphone, please lift the handset before pressing any keys.

Jonathan Javitt: We thank our investors for their patients as our novel preservative-free presentation of ketamine maturers and becomes ready for FDA filing. Unfortunately, many in the public don't know that in order to seek approval of a drug, you must actually hold a fully manufactured drug in your hands that's been stable on the shelf for a year or more. Without that, the FDA will refuse to file the new drug application. We anticipate reaching the critical point in our manufacturing stability program where FDA filing is possible for interacts 100 by the end of October.

Speaker Change: In other words, we intend to deliver on our promise to bring hope to life. Operator, we're ready to take questions from the audience.

Speaker Change: Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the number one on your touchtone phone. You will hear a pop that your hand has been raised.

Speaker Change: Should you wish to decline from the polling process, please press the star followed by the number 2.

Speaker Change: If you are using a speakerphone, please lift the handset before pressing any keys. Again, to ask a question, that star followed by the number 1. Your first question comes from the line of Ed Woo from Ascendia. Your line is now open.

Operator: Again, to ask a question, that star followed by the number one. Your first question comes from the line of Ed Woo from Ascendia. Your line is now open. Yeah, congratulations on all the progress. It seems like your initial focus will be on the U.S. market, but have you given thought about international opportunities for both NRX 100 and 101? Well, there's no question that the rest of the world is important to us, and we've consistently listed a large number of foreign patent approvals.

Jonathan Javitt: A second key requirement for FDA to file an NDA is alignment on a pediatric study plan as required by law. Several weeks ago, we announced that we achieved this critical alignment with FDA. The notion of a preservative-free ketamine has been surprising to some in the public. However, data have emerged from both primate and human studies that repeated doses of the currently available commercial and preventive ketamine are toxic to the brain. The commercial preparation was designed for anesthesia in a multi-dose file where it was anticipated that doctors would draw from the same file from multiple patients.

Speaker Change: Yeah, congratulations on all the progress. It seems like your initial focus will be on the U.S. market, but have you given thought about international opportunities for both, you know, NRX 100 and 101?

Speaker Change: Well, there's no question that the rest of the world is important to us, and we've consistently listed a large number of foreign patent approvals.

Jonathan Javitt: Yeah, as you know, we have composition of matter patent protection on NRX 101. And so far, it's been approved. Paul Mannheiter, Lekro measured porp... and rayson hydroxide (*).

Speaker Change: As you know, we have Composition of Matter Patent Protection on NRX 101, and so far it's been approved.

Jonathan Javitt: That's no longer allowed in hospitals today, but that's how it was designed. Accordingly, commercial ketamine preparations are manufactured with a potentially toxic preservative benzopenium chloride. While there's no evidence that benzopenium chloride is toxic at its current concentration for the intended use of anesthesia, its safety has never been shown or even proposed for chronic use. Hence, we believe we are poised to file the first new drug application for a novel preparation of ketamine in unpreserved form that will bring substantial value to patients and be reimbursable by payers, whereas the current off-label use of ketamine is available only to patients who can pay substantial amounts of money out of pocket.

Speaker Change: in just about every jurisdiction where we've applied.

unknown: Paul, at good age 20 Eth- I'm certainly glad to see you here. Hope to see you in the room tonight. Okay. Thank you for bringing him to this panel on the same subject. Uh, again, John, thank for. Uh, let's continue on, in just about every jurisdiction where we've applied. So that rest of the world opportunity is.

Speaker Change: So, that rest-of-the-world opportunity is...

Jonathan Javitt: It's something we're very much focused on. As you know, we've added Professor Mary Le Boier, who's one of the leading psychiatrists in France, and Professor of BioTreat Interest Sermon Parris, to our advisory board, and it's something we think about on a regular basis. That said, we do anticipate that the initial launch will be in the United States.

Speaker Change: It's something we're very much focused on. As you know, we've added Professor Marion Lavoie, who's one of the the leading psychiatrists in France, the professor of psychiatry at Inserm in Paris.

Speaker Change: to our advisory board and it's something we you know think about on a regular basis.

Speaker Change: That said, we do anticipate that the initial launch will be in the United States.

Speaker Change: Great. Thanks for answering my questions and I wish you guys good luck. Thank you.

Jonathan Javitt: Great, thanks for answering my questions and I wish you guys good luck. Thank you. Operator, we've received some electronic questions as well. I think this is for Dr. Javitt. Would you please tell us more about the whole business plan, how the funding is going to work and what the benefits to NRX shareholders may be? So one of the things we've realized is that, while there is some outstanding ketamine clinics run by dedicated psychiatrists in the U.S. Many of the initial attempts, to create ketamine-spinic networks across the country, have been private equity driven, focused on minimizing costs of care, but not necessarily maximizing.

Matthew Duffy: In introducing Steve, I'd like to thank him for his profound contribution to our company as its first non-founders CEO. These joined our company on the tail of the COVID pandemic at its time when we were restarting our psychiatry program and recovering our equanimity and the wake of the world catastrophe that cost the lives of 1 million Americans and many millions more around the globe. Steve brought a methodical wisdom to our team.

Speaker Change: Operator, we've received some electronic questions as well.

Dr. Javitt: I think this is for Dr. Javitt. Would you please tell us more about the whole business plan, how the funding is going to work, and what the benefits to the shareholders may be?

Dr. Javitt: So one of the things we've realized is that

Dr. Javitt: while there is some outstanding

Speaker Change: ketamine clinics run by dedicated psychiatrists in the U.S.

Matthew Duffy: Steve advised me that as we prepare for 2025 as our first year of commercial operations, we should seek a CEO who has had commercial experience in marketing and successfully selling at least $1 billion in pharmaceutical products. We're starting at Search Today and Steve will be a key part of that process through his poise and legal discipline. Steve has afforded me the opportunity to take bolder steps in advancing our scientific agenda and our commercial prospects, so it continues to be a key member of our team and our family.

Speaker Change: Many of the initial attempts

Speaker Change: to create ketamine clinic networks across the country.

Speaker Change: have been private equity driven, focused on minimizing costs of care, but not necessarily maximizing.

Jonathan Javitt: Quality and Innovation of Care, and what we in came to do through hope therapeutic, is to bring together Edward. Best of Breed Ketamine and Interventional Psychiatry Clinic, Together with networks of clinics that want to learn from them, want to bring their standards up to the best possible standards, and we've, We've seen a fair degree of an investor enthusiasm for that structure. We'll certainly have more to say in coming months. But I think you'll see hope as a living, breathing entity, in the coming quarter.

Speaker Change: Quality and Innovation of Care.

Speaker Change: and what we intend to do through Hope Therapeutics is to bring together a best-of-breed ketamine and interventional psychiatry clinics.

Speaker Change: together with networks of clinics that want to learn from them, want to bring their standards up to the best possible standards.

Stephen Willard: Steve? Jonathan, thank you for those very gracious comments. The chance to lead NRX has been the great choice of my life, and I look forward to helping guide NRX to its success as a commercial enterprise. I'm incredibly proud to process and progress our team has made over the past months and I'm grateful to our partners and investors as well as to all of the patients who have participated in our clinical trials. We look forward to continuing to build value for our shareholders and deliver life-saving treatments to patients.

Speaker Change: and we've

Speaker Change: We've seen a fair degree of investor enthusiasm for that structure.

Speaker Change: We'll certainly have more to say in the coming months.

Speaker Change: But I think you'll see hope as a living, breathing entity.

Speaker Change: in the coming quarter.

Jonathan Javitt: Another one came in, and the question is, how do you see NRX 101 fitting into the treatment paradigm for bipolar depression? I think if we're able to get accelerated approval for NRX 101 in patients who have a cathesia and or suicidal ideation on the current generation, of God, of 5-HT2A antagonist drugs.

Stephen Willard: Most importantly, we continue to believe that these steps represent the beginning of our transition from a purely research and development company to a revenue-generating pharmaceutical company. We have made important progress with our clinical development pipeline in this year. Suicidality is a national epidemic. Approximately 3.8 million Americans make an active plan to commit suicide each year according to the CDC. We plan to bring NRX 100 clearly a life-saving product to market as soon as possible. The current market for international ketamine is already $800 million, which has not demonstrated We expect our market to be much larger. We continue work toward a distribution of shares and hope therapeutics to our existing shareholders.

Speaker Change: Thanks. Another one came in and the question is how do you see NRX 101 fitting into the treatment paradigm for bipolar depression?

Speaker Change: I think if we're able to get accelerated approval,

Speaker Change: For NRX 101, in patients who have akathisia and or suicidal ideation on the current generation of 5-HT2A antagonist drugs, are you talking about

Jonathan Javitt: Larasidone, Lancetine, Perreprousine, that family of drugs. I think you'll see NRX 101 become a preferred drug in that category because acathesia is, The one leading psychiatrist put it to me, the worst side effect, of every antidepressant. It can have lethal consequences, and until now... People didn't talk about it too much because there wasn't much to do about it. All of a sudden there is something to do about it and we hope to be that solution. Okay, thank you. The last electronic question that we received is Steve mentioned that ketamine, sorry, inhaled ketamine, had not shown an improvement in suicide alley. Why would I be be better?

Speaker Change: Larasadona, Lancetine, Perreprousine, that family of drugs.

Speaker Change: I think you'll see NRX 101 become a preferred drug in that category because acathesia is, as one leading psychiatrist put it to me, the worst side effect of every antidepressant.

Stephen Willard: We plan to seek public listing for the company on a national exchange. Hope is planned to be a care delivery company developing a best in-class network of clinics that currently offer ketamine and other life-saving therapies to patients with suicidal depression and related disorders. Together with digital therapies designed to augment and preserve the clinical benefit of NMDA targeted drug therapy. We expect funding for hope to be independent and most non-deludive to NRX. At the same time, we believe this will continue to go value for NRX shareholders with this important asset on its balance sheet.

Speaker Change: It can have lethal consequences, and until now, people didn't talk about it too much because there wasn't much to do about it.

Speaker Change: All of a sudden there is something to do about it and we hope to be that solution.

Speaker Change: Okay. Thank you.

Speaker Change: The last electronic question that we received is Steve mentioned that ketamine, sorry, inhaled ketamine had not shown an improvement in suicidality. Why would IV be better than that?

Speaker Change: David Gingher, Richard Narido

Jonathan Javitt: Well, and it's certainly possible that at a future trial will show that intranasal ketamine has improved properties against suicidality compared to placebo. Although that wasn't the case, either with inhaled racemic ketamine, or so far hasn't been shown, with inhaled eskerimis. It's possible that the, And, you know, some doctors have hypothesized this, that the steady state nature of an intravenous administration is important compared to the more sort of wax and waning, the more of a cute blast of ketamine that you get when it's happening trinasally, rather than focus on, Yeah, other people's approach.

Speaker Change: Well, and it's certainly possible that, you know, a future trial will show that the

Richard Narido: I will now ask Rich Narito, RCFO, to review the first quarter financials. Rich? Thanks, Steve. For the three months ended June 30th, 2024, we at NRX pharmaceuticals reduced our net loss from 8.7 million in the second quarter of 2023 to 7.9 million in 2024, representing nearly a 10% improvement year over year. For that same period, we reduced research and development expenses from 3.9 million in 2023 to 2.8 million in 2024. The $1.1 million decreases related primarily to decrease of 2.4 million in clinical trial and development expenses offset by an increase of 1.3 million related to the Alvogen Awards.

Speaker Change: that intranasal ketamine has improved properties against suicidality compared to placebo.

Speaker Change: although that wasn't the case.

Speaker Change: either with inhaled racemic ketamine

Speaker Change: or so far hasn't been shown.

Speaker Change: with inhaled excatement.

Speaker Change: It's possible that the...

Speaker Change: And some doctors have hypothesized this, that the steady state nature of an intravenous administration is important.

Speaker Change: compared to the more sort of wax and wane, the more of a cute blast of ketamine that you get when it's given intranasally.

Richard Narido: Also in the three months period, we recorded an increase in general administrative expenses from 4.1 million in 2023 to 4.2 million in 2024. The increase of 0.1 million is related primarily to an increase in consultants and legal fees, partially offset by lower insurance expenses. For the six months ended June 30th, 2024, NRX pharmaceuticals reduced its net loss to 14.4 million compared to 19.8 million in the prior year. These deficiencies represent an improvement in net loss of 5.4 million year over year and a $1.32 or 47% improvement in net loss per share year over year.

Speaker Change: Alright.

Speaker Change: rather than focus on

Jonathan Javitt: I think if we just focus on ours and say we've seen an important decrease in suicidality in the clinical trials that we're presenting to the FDA. And that decrease has now been echoed, in a 500,000 person cohort study. That's really the important message. Okay, thank you. Those are all of our electronic questions. Ed Woo has, I believe, asked another one. Operator, would you please take his question? Thank you. We have a follow-up questions from Edward Woo, your light is now open.

Speaker Change: Yeah, other people's approaches.

Speaker Change: I think if we just focus on ours and say we've seen an important decrease in suicidality in the clinical trials that we're presenting to the FDA.

Speaker Change: and that decrease has now been echoed in a 500,000 person cohort study that's really the important message.

Speaker Change: Okay, thank you. Those are all of our electronic questions.

Richard Narido: Over that six month period, we recorded 4.6 million of research and development expenses compared to 7.5 million for the same period in 2023, representing a 39% decrease year over year. The decrease of 2.9 million is related primarily to a decrease of 4.1 million in clinical trial and development expenses, 0.3 million related to fees paid to regulatory and process of development consultants, while offset by 1.3 million related to the Alvogen Awards, and 0.4 million related to fees paid to regulatory development consultants.

Speaker Change: So Edward Woo has, I believe, asked another one of Operator Richard, please take his question.

Speaker Change: Thank you. We have a follow-up question from Ed Woo. Your line is now open.

Jonathan Javitt: Yeah, thanks for taking up my follow-up question. As you guys are planning on submitting MDAs this year and possible approval for next year, have you thought about your commercial strategies, whether you will develop your own commercial team or whether you'll look for commercial partners?

Ed Wu: Yeah, thanks for taking up my follow-up question. As you guys are planning on submitting NDAs this year and possible approval for next year, have you thought about your commercial strategies, whether you will develop your own commercial team or whether you'll look for commercial partners? Thank you.

Jonathan Javitt: Thank you. Well, in the case of NRX100, we already know who the customers are, because it's a clinic-based drug, and there's a limited number of clinics. So, you know, about 600, and it could grow to 1000 by next year, who are using the drug.

Speaker Change: Well, in the case of NRX-100...

Richard Narido: Also in that six month period, we decreased GNA by 1.4 million from 9.9 million in 2023 to 8.5 million in 2024, nearly a 15% decrease year over year. As of June 30th, we had 1.9 million cash and cash equivalents. As previously stated, we recently announced that we secured up to 16 million of senior secured debt financing from Madison funds. This financing is expected to support 2024 filing of new drug applications for NRI-100, and NRX 101, and to support the launch of author Felix as well, as retired as historical debt with more favorable terms and a lower annual interest rate. NRX continues to implement operational efficiencies to extend cash runway and maintain focus on our path to generating revenue and value for our shareholders.

Speaker Change: We already know who the customers are, because it's a clinic-based drug, and there's a limited number of clinics, you know, about 600, and it could grow to a thousand by next year.

Jonathan Javitt: And some of those clinics are going to be clinics that hold therapeutic zones. So. There's no need for the overhead of a large commercial partner to reach customers who already want to talk. In the case of NRX 101, It's also a fairly compact footprint. There are approximately 1,600 psychiatrists in the United States, who currently prescribed the lorazidone class of drugs, and.., you can reach that number of doctors, with a fairly compact sales force, of about 50 people.

Speaker Change: who are using the drug.

Speaker Change: And some of those clinics are going to be clinics at Hope Therapeutic Zones.

Speaker Change: So.

Speaker Change: There's no need for the overhead of a large commercial partner to reach customers who already want to talk to you.

Speaker Change: in the case of NRX 101.

Speaker Change: It's also a fairly compact footprint. There are approximately 1,600 psychiatrists in the United States who currently prescribe the lorazidone class of drugs.

Jonathan Javitt: With that, I will turn it back to Jonathan for closing remarks. Jonathan? Thank you, Rich. With two MBAs planned for the current month, coming months, the initiation of Hope's clinic acquisition program to be financed for a non-deludive mechanism, together with a stabilized cash position, we're in a solid position to build shareholder value.

Speaker Change: And.

Speaker Change: You can reach that number of doctors.

Speaker Change: with a fairly compact sales force.

Matthew Duffy: Now I'm possibly the least qualified person in the company to talk about that. Matt Duffy, started out doing that for a living and Matt, why don't you come? Thanks, Jonathan. Sure. You can look at a number of different parameters in terms of number of prescribers, in terms of geography, and access to representatives. There's a number of ways to approach it, but you can very effectively get out with reps, you know, reps in the, you know, the 20 to 30 rep range, or not necessarily reps, but field force, and really planket the key prescribers, actually, as Jonathan pointed out, both of these drugs.

Matt Duffy: of about 50 people. Now, I'm possibly the least qualified person in the company to talk about that. Matt Duffy started out doing that for a living, and Matt, why don't you comment?

Matt Duffy: Thanks, Jonathan. Sure.

Jonathan Javitt: Most importantly, we're poised to address critical, unmet medical needs for patient suffering from suicidal bipolar depression, suicidal major depression, and those with limited access to advanced psychiatric care. In other words, we intend to deliver on our promise to bring hope to life.

Matt Duffy: You can look at a number of different parameters in terms of...

Matt Duffy: A number of prescribers in terms of geography and access to representatives. There's a number of ways to approach it, but you can very effectively get out with reps.

Speaker Change: reps in the, you know, the 20 to 30 rep range, or not necessarily reps, but field force.

Unknown Executive: Operator, we're ready to take questions from the audience. Thank you.

Unknown Executive: Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the number one on your touch phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star followed by the number two. If you were using a speaker phone, please lift the hand set before pressing any keys. Again, to ask a question that star followed by the number one.

Speaker Change: and really planket the key prescribers in, actually, as Jonathan pointed out, both of these drugs.

Matthew Duffy: And as you do so, really target the highest prescribing folks out there. I've done this before at Lev and at MedImmune, and the targeted salesforce is a really good way to go. It's very efficient, and you can really get the word out there very quickly. And so those are, I think, the important parameters as we look into taking this really to the next level, because there's just a tremendous amount of opportunity. Great. Thank you. And again, I wish you guys good luck. Thanks Ed. And speakers, we don't have any questions over the phone.

Jonathan Javitt: And as you do so,

Jonathan Javitt: really target the highest prescribing folks out there.

Speaker Change: I've done this before at Lev and at MedImmune, and the targeted sales for it is a really good way to go. It's very efficient, and you can really get the word out there very quickly. And so those are, I think, the important parameters as we look into taking this really

Edward Woo: Your first question comes from the line of Ed Wu from Assyndia. Your line is now open. Yeah, congratulations on all the progress.

Speaker Change: to the next level, because there's just a tremendous amount of opportunity.

Speaker Change: Great. Thank you again. I wish you guys good luck.

Jonathan Javitt: It seems like your initial focus will be on the US market, but have you still given thought about international opportunities for both and RX100 and 101? Well, there's no question that the rest of the world is important to us, and we've consistently listed a large number of foreign patent approvals. As you know, we have composition of matter patent protection on RX101. And so far, it's been approved in just about every jurisdiction where we've applied. So, that rest of the world opportunity is something we're very much focused on.

Operator: Please continue. I'd like to hand a call over to Mr. Matthew Duffy. Thank you, Franzi, and thank you everyone. That's all the time we have for questions and our time for our call.

Speaker Change: Thanks, Ed.

Speaker Change: And speakers, we don't have any questions over the phone. Please continue. I'd like to hand the call over to Mr. Matthew Duffy.

Matthew Duffy: So thank you everyone for joining us this evening. And this concludes the NRX Pharmaceuticals second quarter 2024 results conference call. Thank you for participating. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect. Thank you, www.nrx.org.au

Matthew Duffy: Thank you, Franzi, and thank you, everyone. That's all the time we have for questions, and our time for our call. So thank you, everyone, for joining us this evening, and this concludes the NRX Pharmaceuticals second quarter 2024 results conference call.

Matthew Duffy: Thank you for participating.

Speaker Change: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect. Thank you.

Jonathan Javitt: As you know, we've added Professor Mary and LaVoyet, who's one of the leading psychiatrists in France, the professor of psychiatry, and the internment Harris toward advisory board. And it's something we think about on a regular basis. That said, we do anticipate that the initial launch will be in the United States.

Edward Woo: Great. Thanks for answering my questions, and I wish you guys good luck. Thank you.

Unknown Executive: Operator, we've received some electronic questions as well. I think this is for Dr. Javitt.

Jonathan Javitt: Would you please tell us more about the whole business plan, what how the funding is going to work and what the benefits of the shareholders may be? So one of the things we've realized is that while there are some outstanding ketamine clinics run by dedicated psychiatrists in the US, many of the initial attempts to create ketamine clinic networks across the country have been private equity driven, focused on minimizing costs of care, but not necessarily maximizing quality and innovation care.

Jonathan Javitt: And what we intend to do through hope therapeutics is to bring together best of breathe ketamine and interventional psychiatry clinics together with networks of clinics that want to bring their standards up to the best possible standards. And we've seen a fair degree of investor enthusiasm for that structure. We'll certainly have more to say in coming months, but I think you'll see hope as a living, breathing entity in the coming quarter. Thanks.

Jonathan Javitt: Another one came in and the question is how do you see NRX 101 fitting into the treatment paradigm for bipolar depression? I think if we're able to get accelerated approval for NRX 101 in patients who have a cathetia and or suicidal ideation on the current generation of 5-HT2A antagonist drugs, do you talk to me that lyrazodone, lansapine, prerprosine, that family of drugs? I think you'll see NRX 101 was come a preferred drug in that category because acatetia is one leading psychiatrist put it to me, the worst side effect of every antidepressant.

Jonathan Javitt: It can have lethal consequences and until now people didn't talk about it too much because there wasn't much to do about it. All of a sudden there is something to do about it and we hope to be that solution.

Unknown Executive: Okay, thank you.

Unknown Executive: The last electronic question that we received is Steve mentioned that ketamine, sorry, inhaled ketamine had not shown an improvement in suicidal ideation.

Jonathan Javitt: Why would IV be better than that? Well, and it's certainly possible that a future trial will show that intranasal ketamine has improved properties against suicidal ideation compared to placebo. Although that wasn't the case, either with inhaled recemic ketamine, or so far hasn't been shown with inhaled escadamine. It's possible that the, and some doctors have hypothesized this, that the steady state nature of an intravenous administration is important compared to the more sort of wax and wave, the more of a acute blast of ketamine that you get when it's given intranasally.

Jonathan Javitt: Rather than focus on other people's approaches, I think if we just focus on ours and say, we've seen an important decrease in suicidality in the clinical trials that we're presenting to the FDA. And that decrease has now been echoed in a 500,000 person cohort study. That's really the important message.

Unknown Executive: Okay, thank you. Those are all of our electronic questions.

Edward Woo: Edward Woo is, I believe, asked another way of operating. Would you please take his question. Thank you. We have a follow-up questions from Edward. Your slide is now open. Yeah, thanks for kicking out my follow-up question.

Jonathan Javitt: As you guys are planning on submitting MDAs this year on possible approval for next year, have you thought about your commercial strategies, whether you will develop your own commercial team or whether you'll look for commercial partners? Thank you. Well, in the case of NRX100, we already know who the customers are because the clinic's base drug. And there's a limited number of clinics. So, you know, about 600, and it could grow to a thousand by next year who are using the drug.

Jonathan Javitt: And some of those clinics are going to be clinics that hope therapeutic zones. So, there's no need for the overhead of a large commercial partner to reach customers who already want to talk to you. In the case of NRX101, it's also a fairly compact footprint. There are approximately 1,600 psychiatrists in the United States who currently prescribe the lyracidone class of drugs. And you can reach that number of doctors with a fairly compact sales force of about 50 people.

Matthew Duffy: Now, I'm possibly the least qualified person in the company to talk about that. Matt Duffy started out doing that for living. Matt, why don't you comment? Thanks, Jonathan. Sure. You can look at a number of different parameters in terms of number of prescribers in terms of geography and access to representatives. There's a number of ways to approach it, but you can very effectively get out with reps in the 20 to 30 rep range or some reps for field force, and really blanket the key prescribers in actually, as Jonathan pointed out both of those of these drugs, and as you do so, really target the highest prescribing folks out there.

Matthew Duffy: I've done this before at Love and at Metamune, and the target of Salesforce is a really good way to go. It's very efficient, and you can really get the word out there very quickly. And so those are I think the important parameters as we look as we look into taking this really to the next level, because there's just a tremendous amount of opportunity.

Edward Woo: Great, thank you again. I wish you guys good luck. Thanks Ed. And speakers, we don't have any questions over the phone. Please continue.

Matthew Duffy: I would like to hand over to Mr Matthew Duffy. Thank you, Fauzi, and thank you everyone.

Matthew Duffy: That's all the time we have for questions, and our time for our call.

Unknown Executive: So thank you everyone for joining us this evening, and this concludes the NRX pharmaceuticals second quarter, 2024 results conference call. Thank you for participating.

Unknown Executive: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation.

Unknown Executive: You may now disconnect. Thank you.

Unknown Executive: Music