NRx Pharmaceuticals Inc. Q1 2023 Earnings Call
Speaker 1: You seven 9, seven
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Good day everyone and welcome to the NRX Pharmaceuticals first quarter 2023 earnings conference call. All participants will be in a listen on emotes. Should you need assistance? Please signal a conference specialist by pressing star than zero.
After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on a touch-tone phone. To withdraw your question, please press star then two. Please note, this event has been recorded. I would now like to turn the conference over to...
Suzanne Maveri, what's darned and resturrelations? Please go ahead.
Thank you, Vashnavi. Before we proceed with the call, I would like to remind everyone that certain statements made during this call are forward the King's 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 differ from statements made on this call is contained in our periodic reports filed with ESEC.
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 statement.
Information presented on this call is contained in the press release issued earlier today, and in the company's Form 10K, which was refiled, on May 1st, which may be accessed from the investors page of the NRX Pharmaceuticals Inc. website.
The donation presented on this call is contained in the press release issued earlier today, and in the company's Form 10K, which was refiled on May 1st, which may be accessed from the investors page of the NRX Pharmaceuticals Inc. website. Today suffering from Frughl in the progressed sales of research in Mexico for one of the seven
From NRX Pharmaceuticals, our Stephen Willard, Chief Executive Officer, and Seth Van Borghees, Chief Financial Officer and Treasurer.
Stephen will provide a summary of the company's progress. Seth will review the company's financial results, and then Stephen will review upcoming milestone before making closing comments.
Following their prepared remarks, Steven and staff will be joined by Jonathan Javitt, the company's chief scientist, and Matthew Duffy, the company's chief business officer to address investor questions. I will now turn the call over to Steven.
Thank you, Suzanne. Good morning, everyone. And thank you for joining us to discuss our continued success as we advance our pipeline of innovative therapeutics for patients facing psychiatric disorders with great unmet need, including treatment, resistance, suicidal, bipolar depression.
post-traumatic stress disorder, and potentially chronic pain related to depression.
Today, we will discuss first quarter 2023 results and provide a business update.
2023 is off to a great start as we continue to build our leading brain health franchise, advancing our compelling science, and building long-term value for our shareholders.
In recent months, we've made great strides in our clinical trials for our lead product candidate NRX 101 while continuing to execute on our corporate strategy.
And summarize, we aligned with the FDA on the chemistry, manufacturing, and controls of NRX 101, as well as a path to commercial stage product.
and continue to align with the FDA on a potential path for approval of NRX-101 in a Type B meeting.
We announced encouraging findings of our Independent Data Safety and Monitoring Board, or DSMB.
whose first evaluation of unblinded data identified no safety concerns and subsequent evaluation indicated that no safety or futility signals were reported in the first 50 patients treated and provided a positive recommendation to continue enrollment.
And based on FDA interactions and DSMB findings, we are consolidating our two clinical trials of NRX 101 in suicidal bipolar depression into one study for patients with suicidal treatment or resistance bipolar depression. Thank you.
I'll begin by reviewing recent progress made for NRX 101 in suicidal treatment resistance by COVID depression, PTSD, and chronic pain.
NRX 101 is a fixed dose combination of B cyclocerying, an NMDA receptor regulator, and lerazodone, a standard of care medicine for use in treatment resistant bipolar depression. There are approximately seven million people living with bipolar depression in the US, and the risk of suicide is very high with this population.
Data indicates that 50% or more of these patients will attempt suicide in their lifetime. However, there are currently no approved medicines for people with suicidal bipolar depression.
To our knowledge, NRX's first company to attempt to bring a medicine to people whose only FDA-approved treatment alternative is a lecture shot therapy.
This is a potentially life-saving advance because antidepressants carry black box warning labels regarding the potential for increased risk of suicide in vulnerable populations.
Based on the NRX's differentiated therapeutic profile, we believe that we have the potential to address a significant unmet need for patients who are currently underserved by available treatment options. On the other hand, we believe that we have a potential to address a significant unmet need for patients who are currently underserved by available treatment options.
Turning to the science behind the NRX 101, NMDA and Teginus drugs have been shown to reduce symptoms of depression and suicide liation. And neither decyclocerein or the residue have shown potential for abuse, which is an important consideration.
when treating psychiatric disorders with suicidal thoughts.
At NRX, we discovered the unique synergy between M-D- at M-M-D-A and 5-H-T-2-A targeted drugs, as well as the critical dosages at which decyclic hearing may be effective in these conditions.
These discoveries resulted in a portfolio of 90 patents around the world, 48 of which have now been issued.
relating to the treatment of bipolar depression, major depressive disorder, PTSD, and other central nervous system conditions.
We initially introduced NRX 101 as it drove.
matured benefiting conjunction with ketamine in acute care patients. Proof of concept data from the phase to stable B clinical trial, which administered NRX 101 following stabilization of a hospitalized bipolar patients with acute suicidal ideation after treatment with ketamine. Demonstrated a highly differentiated therapeutic profile in a patient population.
with no drug therapy options. Based on this data, the FDA granted breakthrough therapy designation as special protocol agreement.
or SPA for NRX 101 in bipolar depression with acute suicidality.
In January , 2023, the company initiated the phase three registration of clinical trial of NRX 101 for the treatment of severe bipolar depression with acute suicidal ideation and behavior.
Based on recent comments from the FDA at a Type B meeting of NRX-101 for hospitalized patients with acute suicidality, this study has been converged with our Phase II clinical trial of NRX-101 in bipolar depression with subacute suicidal ideation.
a study initiated in 2022 for a much broader potential patient population.
This decision was made in March of this year when we announced encouraging findings from our outpatient trial of NRX 101 in this subacute population versus the resinous.
Our independent DSMV examined unblinded data from the first 50 patients and found no futility signal at this time in the trial. Similarly, no safety signals were identified in association with NRX-101, and the DSMV did good enrollment in the trial continuous plan.
According to the study's statistical analysis plan, a failure to identify futility requires that an advantage, though not yet a statistically significant advantage.
of the investigational drug relative to the comparative treatment must be observed by the DSMB.
The newly converged and upgraded phase 2B slash 3 clinical trial includes patients with suicidal bipolar depression.
suicidal bipolar to patient populations, which represents a broader indication. We believe the results of this study could be used in a future registrational filing should the trial prove successful. In this trial, we have focused our outpatient clinical trial first on those who have been
of greatest unmet medical need, specifically those patients who are under care of the physician for bipolar depression and who have ongoing depressive symptoms and active thoughts of self-harm despite treatment of available medicines.
The objective of this multi-center randomized double-blind controlled
potentially a registration study is to demonstrate an our access ability to significantly improve symptoms of depression and suicidal. Over six weeks when taken twice a day on a home-eased basis.
The study has the potential to expand the use of our medicine to the nearly 1 million people who currently suffer from severe depression and suicidal ideation despite expert medical care with currently available medicines.
We anticipate that this is a market of approximately $2.2 billion a year.
The company believes that the strategy to converge the ongoing clinical trials and broaden the indication could enable more patients with suicidal bipolar depression the option of an outpatient therapy in the coming years.
Data from the ongoing phase 2b-3 clinical trials are expected in the fourth quarter of 2023. This broader indication may also offer significant advantages in commercialization and a matter of consistent with the FDA's recommendations.
Importantly, in January 2023, we also reached alignment with the FDA on our proposed manufacturing plan based on a Type C meeting to review our chemistry, manufacturing, and controls.
As a result, NRX is now positioned to conduct registration trials of NRX 101, and able to make NRX 101 available through expanded access and right to tribe programs for patients who have exhausted approved treatment options.
We are excited about this milestone. In particular, as we believe that adopting a commercial ready manufacturing process at this stage of our development can lead to a more seamless NDA submission, review, and approval process under the potential breakthrough therapy designation.
without the need for bridging studies. During first quarter of 2023, the company refined its ability to validate the psychometric ratings that are used to assess the efficacy endpoints for the clinical trial. The company relies upon a team of veteran Raiders who both train independent side Raiders and monitor the technical quality of each rating.
A standard was set of 90% of better concordance between the company's veteran rating team and site raters. This standard was met for all study participants, whose ratings were obtained in their primary language, and management believes that the standard can be maintained for the duration of the trial. The standard was set of 90% of better concordance between the company's veteran rating team and site raters.
In April 2023, the company contracted with one in health to initiate a recruitment campaign that may cover up to 45 states in the US to recruit sufficient participants for this enlarge trial. The company has similarly broadened its previously disclosed relationship with Science 37.
contract research organization that conducts decentralized clinical trials to enroll patients identified by the one-in-house recruitment initiative and to randomize them to be treated within the broad
Clinical trial. When in health has additionally engaged, almighty, a voice of the patient organization with national reach to publicize the clinical trial to the 800 plus thousand subscribers who have initiated and indicated.
focused on bipolar depression and civil sedality.
Additionally, last quarter we continued to work to advance our development plans for NRX 101 in post-traumatic stress disorder or PTSD. Another area of high unmet medical aid, which is also associated with suicidality.
Approximately 9 million individuals in our country experience PTSD and one third have severe PTSD with 10% experiencing civisiveality between 17 and 22 members of our armed forces or veterans have lost every day to suicide.
Depression and PTSD may be driven by pathways that are similar to those good drive depression and other conditions.
However, NMDA antagonists as a class and decyclercine in particular, may have a more specific effect in treatment of PTSD. And a preclinical PTSD study, decyclercine demonstrated the ability to extinguish, reoccurring images of traumatic events, also known as spear memory.
in the validated WKY model of PTSD.
This model has been similar to years by others to document a PTSD specific effective ketamine.
repeated IV ketamine.
has also been demonstrated to improve PTSD scores in a randomized controlled trial. Unlike ketamine, however, NRX 101 is not neurotoxic, is not addictive, and has not caused psychedelic side effects in clinical trials.
We anticipate that our investigational drug will show and by depressing effects in PTSD compared to placebo. And we hope that it will demonstrate specific effects on the clear memory components of PTSD and directly reduce symptoms of PTSD itself.
Today, there is no approved medicine for the specific PTSD symptoms.
We are on track to initiate a study of NRX 101 at PTSD in 2023.
We are incredibly excited about the potential life-saving effect of NRX 101. And in order to support the continued clinical development of these programs, we announced the close of a $2.9 million registered direct offering to support our pipeline efforts and more specifically the initiation of a deal.
expanded access protocol and safety database for NIRX 101 study improvement resistant by pollords depression with risk of cell crime. This database allows us to investigate the expanded indication put forward by the FDA psychiatric division and our type B meeting for our registration trial. And we look forward to providing you all with an update of our clinical activity in the months to come.
The continued financial support from our existing shareholders, based on our existing data and ongoing trials, demonstrates their commitment to people living with serious...
CNS disorders and the potential of NRX 101 to become commercially successful.
We have achieved the number of significant corporate milestones in recent months. In February , we received notice of the issuance of the US patent for NRX 101, which covers the use of NRX 101 to treat patients suffering from depression, including bipolar depression or major depression with or without suicidality.
This pattern strengthens the company's intellectual property position until at least 2033. We also strengthened our deep venture healthcare executives in world-class psychiatrists in recent months. We announced the appointment of Professor Andrew Nuremberg and Professor Mario LeBlaie.
to our advisory board in March.
Professor Nirenberg is a chair of professor of psychiatry of Harvard Medical School, and is the director of the Doughton Family Center for Bi-Polar Research at Massachusetts General Hospital. He is one of the world's most public scientists in the area of psychiatric research, particularly as a related biopolar disease. We are honored to have him as principal investigator of our ongoing clinical trial.
gebracht
Professor Liboyay is one of France's leading psychiatrists and extensively published researcher in the field of neuropsychiatry, particularly as it relates to bipolar disease and autism. In addition to her academic achievements, Professor Liboyay chairs the Phonestino Fundamentale and has facilitated this important collaboration between NIRX and NIRX.
and print psychiatric researchers. Study and Academy and for the treatment of acute suicidality among hospitalized patients, particularly patients with bipolar depression. Please see their biographies on our website.
Also, the company has continued to engage in a strategic conversation focused on funding the drug approval and commercialization of a product. In parallel, the company has established an ongoing dialogue with street-of-the-capital LLC, the current company's current debt lending.
to address the company's current debt facility to best support the ongoing needs of the clinical trial. We are confident that we have achieved a strong foundation for NRX that enables us to efficiently advance our clinical trial and make a difference in the lives of patients with life-threatening psychiatric disorders.
I would like to express my gratitude to the patients, the NRX team, clinical trial investigators, and shareholders for their continued support.
With that, I'll turn it over to Seth for a brief overview of our financial results.
Good morning, everyone. Thank you, students.
I will now review the highlights for first quarter 2023 financial results.
For the three months ended March 31, 2023, NRX Pharmaceuticals recorded 3.7 million of R&D expenses compared to 5.5 million for the quarter ended March 31, 2022.
The decrease of 1.8 million is related primarily to a reduction in clinical trials and development expense related to our discontinued activities related to Zatzami.
For the three months ended March 31, 2023, NRX Pharmaceuticals recorded 5.8 million of GNA expenses, compared to 10.2 million for the three months ended March 31, 2022. The decrease of 4.4 million was primarily related to a decrease in legal, professional, and accounting fees.
Our net loss for the quarter was $11 million, an improvement of 2.4 million, compared to the net loss of 13.4 million, for the comparable quarter in 2022.
On the financial side, our cash research were enhanced in March when we entered into a securities purchase agreement with accredited investors who had previously established positions in the company. This transaction involved the sale of approximately 3.9 million shares of the company's common stock and a five year warrant in a registered direct offering.
priced slightly above the market at 75 cents per unit for the securities. The investors agreed not to sell these shares of common stock or exercise the warrants for six months following the issuance date.
The aggregate gross proceeds to the company for the offering was approximately $2.9 million.
As of March 31, 2023, we had approximately 16.5 million in cash.
Assuming future debt payments can continue to be made and stock, the 16.5 million of cash and cash equivalents at the end of the first quarter of 2023 is expected to fund the company's operations through the expected delivery of data in the fourth quarter of this year from our Phase 2B3 trial.
Additionally, we are evaluating operation efficiencies associated with the completion of our manufacturing activities, as well as considering capital raising activities to extend this runway.
With that, I'll turn it back to Steve for closing remarks. Steve? Thanks, sir.
The past quarter has been incredibly productive, and we look forward to advancing our NRX 101 program in suicidal by pro-ordid pressure, PTSD, and chronic pain in the months to come.
Based on the experience we have is a clinical trial company working in CNS.
NRX is uniquely positioned for success and future growth.
We plan to build on a momentum in the remainder of 2023 as we continue to execute on multiple regulatory and clinical catalysts.
We believe that NRX 101 is a potentially life-saving medicine that could change the treatment paradigm for life-threatening psychiatric conditions, which is the driving force behind our mission to meeting the needs of underserved patients with serious CNS disorders. We believe that NRX 101 is a potentially life-threatening psychiatric conditions, which is the driving force behind our mission to meet the needs of underserved patients with serious CNS disorders.
We look forward to updating you on the near term milestones, which are on track for the coming year, including the initiation of our study of NRX 101 and DTSD, the advancement of NRX 101 and Chronic Pain associated with depression, as well as future updates on breakthrough therapy designation meeting.
for NRX 101 in treatment, resistance, suicidal bipolar depression, as well as data from our phase 2B slash 3 study in the fourth quarter.
With the shared commitment of our investors, our team and our researchers, we aim to bring hope to the millions of patients with suicidal bipolar depression and PTSD who have been systematically excluded from trials of previous antidepressants. Operator, we are ready to take questions. We are ready to take questions.
investors, our team and our researchers, we aim to bring hope to the millions of patients with suicidal bipolar depression and PTSD who have been systematically excluded from trials of previous antidepressants. Operator, we are ready to take questions from the call.
All right, then we will begin the question and answer session. To ask a question, you may press star, then one on your touch zone phone. If you're using the speaker phone, please pick up your hands before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star, then two.
At this time, we will pause momentarily to assemble a roster.
will pause momentarily to assemble a roster.
Our first question comes from Ed Wu with the Send-DM capital. Please go ahead. Yeah, thank you for taking my question. My question is on PSSD, additional indication. Do you anticipate starting following the IND?
this quarter or the next quarter in order to start it, the trial by the fourth quarter. Thank you, Ed. This is Jonathan Javid. Yes, we do anticipate filing that I and V. Great. And then in terms of how large the possible trial can be do you have any indications of how big it may be?
Well, I think from a registration perspective, there are some precedents from the NTI-depressant recent approvals.
But until there's a formal meeting with FDA, it's not possible to know exactly what the sample size would be. But I think there's some good precedents in recent approvals of antidepressants.
Great, and then my last question is in terms of what you guys have learned with your current study, do you think that you will be able to use any of that data to in order to facilitate the trial possibly, you know, being easier or being able to go faster?
Well, certainly a trial for any indication adds to the safety database.
for all indications. And clinical experience with a drug is always helpful. But the endpoints in PTSD are a little different than the endpoints in depression because in PTSD,
You're primarily relying on the CAHPS 5 scale, looking at symptoms of flashbacks and recurring memory, sorry, recurring fear of memory.
Some of that's been demonstrated with ketamine, which, as you know, is a very potent DMDA antagonist.
So this reason to be optimistic that a more controllable and MDA antagonist might also relieve symptoms of PTSD.
Great, well thanks for giving me that answer and I wish you guys good luck. Thank you. Thank you very much for your time.
Again, if you have a question, please press star then want to be joined into the queue. The next question comes from Jason Colbert with Dawson James. Please go ahead.
Hi guys, congratulations for having the progress.
Good morning. Can you talk a little bit about the dynamics of actually enrolling these bipolar depressed patients with suicide ideology? How do they come to you? How do they end up being referred into the trial? What's the entry criteria on these patients? And then I wanna talk a little bit about...
have severe depression as measured by a score of 30 or higher on the MADRIS scale and also have suicidal ideation to the extent that they have a score of three or higher on the Columbia Suicide Severity Rating Scale.
So historically, we've relied on traditional study sites to recruit these patients, either from the patients that they already know in their clinical treatment programs or patients that they're able to reach out to in the community.
And Steve discussed earlier in the call, we've decided to go broader than that.
and we've engaged one in health really to,
to stand up a recruitment effort that's licensed.
in 45 states so far.
18 Junction with the decentralized clinical trials organization, CulpScius 37.
Such that we're we're able to recruit patients in most of the country.
were able to recruit patients in most of the country. on.
and we're in the process of reaching out to a very large pool of people who've identified themselves as having bipolar depression.
And rather than the man that those patients come to a study site that could be some distance away from them.
But.
We have teams of nurses who are able to go do the initial screening at a location convenient to the potential participants, including your home.
to draw blood as needed by the protocol, again, at their location. And then we have psychometric graders who are able to do the assessments associated with the primary and secondary endpoints for the study.
on a remote basis. And we anticipate that by opening up our recruitment in that manner, we can much more efficiently recruit patients into the study, make it easier for them to stay in the study.
and at the same time be able to control the quality of the data through a very small pool of very highly experienced raders. Yeah, I mean I can appreciate the infrastructure required to accomplish all of that.
Well, prediction is challenging, especially as Yogi Berra once said, when you're talking about the future.
What we can tell you is that in the first week of the One in Health initiative, there were 150 inbound inquiries of which 75 were patients who were deemed to potentially meet the study criteria.
So the interest in this study is very palpable.
And by the time we speak again, I think we'll have a very good handle on the velocity with which enrollment can be achieved.
Okay, thank you. And can you break down for me, just review with me the primary endpoint and what exactly the components that are measured?
So the primary endpoint is very clear cut. It's the same primary endpoint that was used to approve lorazadone. It's the same primary endpoint that was used to approve abelity, which is.
change in the Magriss 10 depression score the Montgomery Asperg Depression rating scale over 42 days using what's called a mixed model repeated measures regression, all events.
described in detail in our protocol, which people are free to read. On the secondary endpoint, the key secondaries are...
detail in our protocol, which people are free to read. The secondary end point, the key secondaries are measurement.
Well, time to treatment failure, in other words, how long is it between the time you start the study and the time that the treating physician has determined that the medicine you were randomized to isn't working?
That's one secondary endpoint. And the other secondary endpoint is change on the Clinical Global Impression Suicide Severity Scale, which is a scale that we saw significant change on in the Stable B Study in the Phase II studies that are in this breakthrough therapy test.
So the endpoints are quite transparent in that regard. Really appreciate the update. Thank you. Great work on that.
Thank you. We have no further questions. This concludes our question and answer session. I would like to turn the conference back over to Suzanne for any closing remarks.
Thank you, everyone. That is all the time we have for questions. Thank you for joining us this morning. This concludes the NREX Pharmaceuticals First Quarter 2023 Financial Results Conference call. Have a great day.
The conference is now closed. The conference is now closed.