NRX Pharmaceuticals, Inc. Common Stock Status update

Before we begin, I'd like to remind everyone that certain statements made during today's call may be considered forward-looking statements within the meaning of applicable securities laws. These statements are based on management's current expectations and assumptions that are subject to risks, uncertainties, and other factors that could cause actual results to differ materially from these expressed or implied. Please refer to the company's SEC filings and today's press release for a discussion of these risks. NRx Pharmaceuticals undertakes no obligation to update any forward-looking statements except as required by law. Joining us today are Dr. Jonathan Javitt, founder, chairman, and chief executive officer of NRx Pharmaceuticals, and Glenn Tyson, chief commercial officer. Dr. Javitt will provide an overview of the company's recent developments and strategic priorities, followed by remarks from Glenn on commercialization activities and market readiness initiatives.

Following their prepared remarks, we'll open the call for questions. With that, it is my pleasure to turn the call over to Dr. Jonathan Javitt. Jonathan, please go ahead. Thank you, Brian.

Good morning, everyone. It's a privilege to meet with you and update you on the progress of our abbreviated new drug application, otherwise known as an ANDA, for preservative-free ketamine. As you know from our press release, we've completed our first cycle review with FDA, and we're delighted to share with you that, to the best of our knowledge, we have only one matter to clarify with FDA prior to approval. The agency has advised us that there are no major deficiencies related to our drug, to its ingredients, to its manufacture, to chemical manufacturing controls, to labeling, or any related matter connected to the drug itself. The sole remaining item is a concern raised by a reviewer that the Luer lock tip might deform in use and might not mate properly to the syringe.

Our vial is different from the glass vials that people are used to in that you do not have to open the top, put a syringe on a needle, push the needle through the stopper, draw up the medicine, remove the needle from the syringe, dispose of the needle, and finally administer the medicine to a patient. Instead, all you have to do is twist off the plastic cap of the vial, connect the Luer lock syringe to the neck of the vial, draw up the medicine, and administer it with no chance of a needlestick injury or sharps waste along the way. The ANDA contains documentation that this vial has now been used in three currently FDA-approved products that have collectively shipped about 11.9 million doses in the last 12 months with no complaints, no returns, no adverse events, and no recalls.

Moreover, the ANDA contained testing data documenting in-process testing of 500 vials per manufacturing lot for each of our seven lots, with no malfunctions observed in any of the 3,500 articles that were tested. The vial is manufactured under full design controls as specified in Code of Federal Regulations Part 820.3, which includes strict adherence to the ANSI standards underlying Luer locks and precise testing procedures for the twist-off force that is required to open our vial. We actually measure it down to newton centimeters. We have a special testing rig that does this precisely and mechanically. FDA has inspected this vial component on multiple occasions during its plant inspections at our manufacturer for the other products.

In a meeting on Thursday, the FDA recognized the extensive measures we took to comply with medical device law related to the Luer lock tip and the documentation of this both in the ANDA and on file at our manufacturer, where it was already inspected. Accordingly, FDA asked us simply to submit an attestation from the manufacturer that our vial is manufactured on the same manufacturing lines using the same materials and methods of the three currently approved products. This attestation is being submitted today. We believe the request we received is consistent with a final verification step rather than a request to generate new technical data. Because the requested information was already available from our manufacturing partner, we are able to respond immediately. We are delighted by this outcome, and we believe it significantly de-risks the likelihood of a near-term approval of our ANDA.

As a result, we are planning to increase our manufacturing orders substantially beyond the first 1 million units that we already announced to 5 million units of launch stock. In today's regulatory environment, only 14%-18% of ANDA products receive a clean approval in the first review cycle. To have emerged with only one item that was classified as major, where we believe we have arrived at a rapid path to resolution with FDA, is way ahead of the curve from our perspective. Importantly, this was not a review cycle that identified new studies, additional manufacturing work, labeling revisions, or changes to our commercial plans. Based on the feedback received, we continue to move forward with launch preparation supply chain expansion, distributor onboarding, and the commercial infrastructure necessary to support market entry once the review process is complete. As you know, ketamine is on the FDA drug shortage list.

It's been identified as a strategic drug product by the military and the VA. Hence, approving a U.S. manufactured source of ketamine at a time when hospitals and clinics are forced to buy non-FDA approved compounded ketamine from local pharmacies is a priority that goes all the way to senior levels of government. Our focus now is straightforward. We aim to complete the regulatory process, continue scaling inventory, and to be prepared to launch into a market where reliable domestic supply remains critically important. With the regulatory review substantially advanced and our commercial preparations accelerating, we believe NRx is well positioned to create meaningful shareholder value through disciplined execution and a clear path toward commercialization.

Last quarter, we told you that we had recruited Glenn Tyson to serve as our Chief Commercial Officer. I've asked Glenn to offer some thoughts on our commercialization plans, and then we'll take your questions.

Glenn? Thank you, Jonathan, and good morning to you all.

Happy to have this opportunity to meet you and give you an overview of our commercialization plans underway. As you're aware, this ANDA is the first key step in our progress toward commercialization of a portfolio of assets that we believe will provide new hope for people suffering with serious mental illness. NRx is not relying on a single product strategy to carry the story. Instead, we are deploying a staged commercialization model that starts with the ANDA and builds towards the launches of premium reimbursed branded therapies, NRX-100 and NRX-101. If approved, these two products could provide much needed options for people suffering with severe depression and suicidality. The interventional psychiatry market for ketamine, esketamine combined is growing rapidly and will likely exceed $3 billion in 2027.

We're already in the planning stages of a commercial model for NRX-100 that we believe will achieve broad market access, significant penetration in the growing interventional psychiatry space, and substantial revenue. What we can see is that the insurance reimbursed market is what's driving the profitability in this sector, and NRx looks to benefit from this with our portfolio of strategic assets. This launch sequencing allows NRx to generate potentially significant early cash flow from the ANDA while constructing a much more robust long-term market position with multiple proprietary assets. This first launch gives us the opportunity to set up a seamless distribution network that will both ensure we can meet market demand for ketamine and help solve the problem of the ketamine drug shortage in the U.S.

The ANDA, while launching into a generic market, has differentiating characteristics that when paired with an optimal distribution plan, we believe will lead to substantial market penetration. As a reminder, our ANDA product comes in a Luer lock vial, as Jonathan just outlined, and this allows for needleless draws. It is free of all preservatives, including benzethonium chloride, which is found in all other ketamine products currently on the market. Perhaps most importantly, we have consistent, reliable supply that is made in the U.S. Taken as a whole, this opportunity can expand access to ketamine in the U.S. for patients in need. Today, ketamine remains an important tool as a non-opioid anesthetic for many common surgical procedures, as well as having a place in emergency medicine, pain management, and within interventional psychiatry.