NRX Pharmaceuticals Inc Earnings Call

Good morning, everyone and welcome to that and Rx Pharmaceuticals third quarter results and conference call. Currently all participants are in a listen only mode. Later, we will conduct a question and answer session.

As a reminder, this conference call is being recorded I will now turn the call over to Eric Goldstein, Managing director with let's say advisory. Please go ahead Sir.

Thank you operator before I proceed with the call we'd like to remind everyone that certain statements made during this call are forward looking statements under U S. Federal Securities 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 the SEC.

The forward looking statements made during this call speak only as of the date hereof and the company undertakes no obligation to update or revise the forward looking statements information presented on this call is contained in the press release issued yesterday after the market close.

And in the company's Form 10-Q, which may be accessed from the investors page of <unk> website.

Joining me today on today's call from <unk> Pharmaceuticals, Our Johnson, Java, Chairman and CEO, Randy Guggenheim <unk>, Chief business Officer for an Rx.

Jonathan will provide a summary of the company's progress during the quarter and recent weeks before turning you over to Randy for a review of the Companys financial results. Following their prepared remarks, the management team will address investor questions I will now turn the call over to Jonathan.

Thank you Eric.

Good morning, everyone and thank you for joining us today.

We appreciate your attendance and we look forward to answering your questions.

This morning, we issued a press release outlining the progress, we're making advancing our pipeline of three late stage programs with significant potential and COVID-19 and other respiratory illnesses. So put back the nation and bipolar suicidal depression as well as in our preparations for translation.

Commercial operation.

I'll spend just a few moments summarizing the major developments in these areas over the quarter and in recent weeks and then I'll turn the call over to Randy for a review of our third quarter financial results.

Then we'll be happy to answer the questions. Some of you submit it I'll start with an update on our lead programs I Sammy or a book to bill for the treatment of patients with acute respiratory failure critical COVID-19.

Ensley other respiratory condition.

When we began this project in March 2020, a bit to deal with member formulated commercial growth for intravenous use and we discovered that none of the analytic methods or acquired manufacturing processes has been developed.

When our partner stopped funding Sami's development in January 2021, we continued at full speed and at this point you have invested the majority of the R&D expenses associated with bringing this potentially lifesaving growth from dorm style to the patient's bedside or financial statements speak for themselves.

Eric shareholders have supported us in continuing to progress and 18 months from a cold start with Goldman files, we have data that we believe will ultimately support our growth full approval pending a second confirmatory trial and May support earlier avenues for Roxanne this drug to patients.

Yeah.

As we announced on November 4th the SBA declined to issue an emergency use authorization towards they've Sammy for the treatment of critical COVID-19 with respiratory failure.

Appointing decision in our view, but one that does not alter our plans for our confidence in the potential dates that need for treating COVID-19 and numerous other diseases that damage the lining of the law.

Now that the President has nominated in FDA Commissioner, we look forward to providing the FCA with the additional data that they require to let us get patients one last chance to make it home to their loved ones well.

While we hope to secure an earlier path to treating critically ill COVID-19 patients, we anticipate that the NIH active three D trial will provide clear proof of <unk> efficacy and safety.

Active three D has now enrolled more than half of its targeted 660 patients and as I. Sammy has had multiple safety and futility assessment by the independent data safety monitoring Committee. Dr. Gauci has breached the white house and Congress about NIH his decision.

To say Sami and unproven medicine from a small and then private company and a global phase III trial on September 21st Dr. Francis Collins director of the NIH gave a public presentation in which identified Sami.

As one of only a dozen candidates in hospital therapeutics in the NIH active program that have survived to phase three from a starting cohort of more than 600 candidate drugs.

Intravenous iron Fannie may be unique and targeting patients who have run out of other options and you can find the number of first person accounts and the media Ah patients who've made their home to their families when all otherwise sandblast.

Today with our partners in the NIH active <unk> program, we continue to engage with regulators and potential partners on multiple constant two advanced ice tammy toward worldwide regulatory approval.

NIH recently opened regulatory files precise time, it with the European Medicines agency, the United Kingdom Medicines regulatory agency and the Brazilian Health regulatory agency now that we have the FDA review of our manufacturing module and have passed a European qualified person or <unk>.

P inspection NIH plans to take the active <unk> crowd to Europe, the United Kingdom in Brazil, using our commercial scale medicine.

The use of commercial scale product and the anchor three b trial potentially supports new drug approval for XI Sammy without future additional bridging studies.

The regulatory files open by NIH on her behalf will help provide the foundation for worldwide development of say Sami both to treat Covid and also to treat a myriad of other leasehold conditions that attack the law.

Because of our fast track designation precise them.

The FDA agreed to allow rolling review of our new drug application, therefore elements, such as CMC manufacturing and non clinical safety and toxicology will be reviewed in advance of reviewing efficacy data.

We continue to believe that family offers a chance of life to those with COVID-19, respiratory failure, who have been so often all currently approved therapies, while we await approval. So they sadly rebate remains available to patients upon a physicians request under federal and.

<unk> right to try laws for those patients who meet the legal criteria.

In their letter advising us if they're EUA decision. The FDA stated that the decision with imports based on their review of safety data from only 131 randomized patients treated wounds I Sammy and asked us to present additional data we were surprised that the FDA did not consider.

The 150 or more additional patients already treated with the semi and the NIH anchor trial with no serious adverse events.

And we are continuing to coordinate that review and bring those patients into the review as well as a review of more than 300 patients treated would say Sami under our expanded access programs.

On November 2nd the NIH data safety monitoring board or D. SMB concluded its third scheduled analysis and again found no new safety issues. After reviewing a total of more than 300 patients, which is nearly half of the participants expected to participate in the trial.

In August we announced new findings from our phase <unk> three IV trial, demonstrating clinically significant improvements on two intermediate endpoints relief from respiratory distress and prevention of cytokine storm and critical COVID-19.

Patients in this trial created with say Sami demonstrated improvement in blood oxygen within a day of initiation of therapy, which is indicative of improve lung function.

Patients treated with say Sami Similarly showed far lower levels of cytokine IL six than those treated with placebo.

People are well aware of the role of cytokine storm.

In the lethal effect of COVID-19, both findings are highly and statistically significantly correlated with improved survival and recovery from COVID-19 in this clinical trial. This is our basis.

Or applying for new drug approval under Fda's accelerated approval pathway.

In October we announced the publication of peer reviewed results from a prospective open label administratively controlled trial of a book to bill for the treatment of respiratory failure in patients with critical COVID-19. This.

This study reported 60 day survival in 81% of those treated with Avista bill compared to 21% survival. Among those who received standard of care treatment at Houston Methodist Hospital.

A similar nine fold advantage was seen in the cumulative probability of recovery from respiratory failure.

It should be noted that these patients were to acutely ill and had morbidities that disqualify them from being enrolled in our randomized trial.

These results were published in the journal of infectious diseases, increasing.

In addition.

<unk> to these trials of IMD side, we also anticipate data from our ongoing trials of the inhaled formulation.

Abbvie Covid two trial of inhaled by expanding versus placebos sponsored by in Iraq.

And we currently expect of first data monitoring committee reviewed for the inpatient component of this trial by the end of this year.

<unk> has asked us for more data in support of future regulatory filings large federally supported trials are.

Are underway to generate those data and we are committed to delivering those data and other information that may emerge to the FDA as quickly as we can.

The FDA has expressed a commitment to working with us and to reviewing additional data as.

Presented.

Now, let me turn to the where we are on commercial preparation I'm, sorry, Sam because we believe there'll be an ongoing need for improved therapies to treat severe COVID-19 for some time and accordingly, we are moving forward with our commercial preparations for this trial.

We've contracted with Cardinal Health for third party logistics and commercial services. We've also contracted with <unk> for pharmacovigilance upon any potential approval or authorization.

We're pleased to announce that during this quarter. So Sami is finally, a fall from an early clinical stage medicines for a medicine that is ready for widespread use in clinical trials, and ultimately commercialization and delivery to the patient's bedside.

When we began this project in March 2020.

Our book to Bill has never been formulated as a commercial drug for intravenous use and we discovered that none of the analytical method. So required manufacturing processes have been developed because of the public health emergency. The SBA took the unusual step of allowing us to formulate the original clinical trial.

Medicine, and an FDA inspected <unk> pharmacy, and handmade batches of 300 doses per batch with a shelf life of only 62 days.

And that means that we were actually making drug every week, sometimes twice or three times a week in order to keep up with the clinical trial demand.

In September 2020, we initiated a manufacturing partnership with Nephron Pharmaceuticals, West Columbia, South Carolina.

One year later, we in that front has developed with the support of our investors proprietary and validated methods for manufacturing at scale.

And for proving manufacturing quality and stability. We are now able to release batches of up to 100000 doses with a shelf life of 150 days, which we continue to work to extend.

Thus for the first time in its history.

Vista del <unk>.

<unk> is a commercial ready drug.

When we initiated this project neither we nor our partner possess the single Gram of a book to Bill ingredient that is the drug substance with which to begin development.

Our book to Bill had never been manufactured at commercial scale suitable for inclusion in the national stockpile.

We were able to restart an old manufacturing process to get us into clinical trials, but even that process was capable of making only 100000 doses if it fits the bill every two months.

And the manufacturing process itself is no longer feasible because of new EPA guidelines.

With the assistance of the U S government, we partnered with the polypeptide Torrance, California to design and implement a proprietary modern high capacity manufacturing process for <unk>.

Really our process capable of delivering 5 million doses of GMP grade drug substance for batch we're about to receive our second manufacturing run above Vista del drug substance from this process.

Although a book to Bill is the natural peptide that is vasoactive intestinal peptide and not protected by patents. We have now built a body of proprietary processes. Some of which we are likely to patents that we believe will afford us valuable and protect the bowl intellectual property.

Over and above the data exclusivity that we expect to obtain from the FDA and other regulators.

Other natural peptide such as insulin and human growth hormone had benefited from similar forms of intellectual property protection.

In October we submitted a revised investigational new drug module on the manufacturing and thanks, Tami, which confirms that nephron is prepared to supply side semi on a commercial scale and includes all of our manufacturing methods and analytic methods. This module being.

Corporation and the FTE is rolling review process supporting the NDA precise that.

We have received multiple inquiries from investors and the public about introducing to extend it to Europe and the U K, where the public health emergency.

Continues to claim lives on a daily basis. Unfortunately until last month, there was simply nosedive Sami in existence that was manufactured to EU or U K standards for introduction into those territories. The handmade clinical trial supplies were adequate.

For ongoing trials and to meet right to try requests in the United States.

Without those semi manufacturer to UK standard neither we nor any partner.

Legally in a position to submit for or obtain emergency use in Europe or the United Kingdom.

Our regulatory application requires both evidence of safety and efficacy.

And evidence that medicine has been manufactured and will be supplied in a manner that meets local GMP or good manufacturing practice regulations clinical data that supports the safety and efficacy alone is not sufficient our application to the FDA for emergency use authorization was supported by the <unk>.

These tax sharing data from nephron NIH requested a waiver from EUR <unk> to accept semi manufactured to the GMP standards that are accepted in the U S and implemented in our FDA inspected facility.

However, this request was not granted.

Sami the sterile liquid product intended for intravenous injection and therefore subject to a particularly high level of manufacturing rigor.

The technical difference between U S and EU requirements. In this case is that the EU requires plant operators to change their protective clothing twice and pass through.

Second airlock as they enter the sterile Corp, a plant.

Although we demonstrated a perfect record on sterility, and our FDA inspected facility and despite the requested waiver from the second the airlock requirements on our behalf.

<unk> required full compliance with their more stringent manufacturing regulation.

To make <unk> available to residents of Europe in the UK. During Q3, we established a separate manufacturing capability that meets EU standards in conjunction with alchemy incorporated.

Last month, a European qualified person or two P. Auditor completed an inspection at the alchemy manufacturing facility with no adverse findings.

Our Q P. Auditor is responsible for certifying that each batch for medicinal product meets all required provisions when released from our manufacturing facility within the EU or imported into the EU and the declaration as required by the EU regulatory authorities for the release of <unk> Sami.

And its introduction into the EU now.

Now that we've met the EU and UK sterile products manufacturing requirements. The NIH is deploying them in Europe, the United Kingdom, and Brazil as part of the anchor <unk> trial.

We anticipate that the EU UK and Brazil phases of active three be led by NIH will support the efficacy and safety insight Sadly for people who live in these territories and will ultimately support our application for drug approval in these territories.

The EU UK manufacturing standards and passing the QP audit now enables us to immediately apply to you.

EU U K and Brazilian regulators for emergency use of say semi while active <unk> completes its enrollment we've retained expert regulatory counsel in the EU for that purpose.

To the best of our knowledge, we're the only company with the manufactured stable formulation of intravenous and inhaled a bit still inspected to international standards.

Without manufacturer drug there was no regulatory filing to be made.

Now there is and we've moved forward to register our drug worldwide in the face of a rapidly resurgent pandemic that is claiming more lives every day to do otherwise would be unconscionable at the same time, we remain committed to mediating our collaboration agreement with relief therapeutics in a manner.

That respects the risks taken and contributions made by the shareholders of both companies and bringing this life saving drug to patients.

As we previously announced the nation of Georgia Ministry of Health ranked US emergency use authorization based on examination of our data by Georges National Society of physicians.

We continue to anticipate first revenues by year end pending the formation of Georgia as new government.

In active conversation with several other health authorities in the caucuses region and neighboring countries and look forward to updating shareholders in the future.

We're continuing to invest in <unk> to bring this medicine to patients.

In 2022, we plan to launch our clinical trial led by Sami to treat acute respiratory distress syndrome caused by sepsis, which was the original.

Original dream of professor semi side and his research team.

In the future, we aim to launch crowd subs I Sami to treat sarcoidosis checkpoint inhibitor pneumonitis acute smoke inhalation and a variety of other lethal pulmonary conditions. <unk> has also been used off label by more than 10000 Americans for the treatment of allergy relate.

Did conditions according to FDA testimony, and we anticipate learning more about the role that <unk> might play in this setting.

We're working with several partners both to design digital health solutions that will make our medicine more convenient and impactful for patients and new dosage forms that will make our medicine, both more convenient for patients and longer lived especially at room temperature.

During the quarter, we advanced the engineering for our digital health solutions for inhaled side Sami in partnership with PIL tracker limit. This enterprise was originally funded by the Israel Innovation Authority. The Bird Foundation of the U S State Department, Merck kg ventures, and private investors to track from <unk>.

Lions with and medical results of medicines used in clinical trials.

Although pill tracker was originally envisioned around solid dose medicines I E pills and capsules killed trackers technology was selected by the boards of <unk> and released therapeutics at the time, we filed our inhaled <unk> signed me with SBA, because we mutually recognize the need for technology.

That would track adherence to our inhaled form of size Sammy and simultaneously measure the clinical benefits such as improved blood oxygen and ambulatory capacity.

We anticipate that filled trackers technology will be deployed in our inhaled use trial by year end.

Although we are encouraged by the progress we have made in formulating his eyes Sammy for intravenous use we continue to believe that patients will ultimately need a convenient means of administration that is stable at room temperature.

Accordingly in August we partnership we partnered with Mannkind Corporation to explore the use of Mannkind technosphere delivery system. The system that supports their inhaled insulin product as a means of enabling patients to carry and use a sammy.

And a compact simple debates.

Now that many kind of device also contains a bluetooth chip that is designed to be able to integrate with digital health solutions, such as pill tracker.

We're also exploring the option of using thin film, creating a proprietary system developed by <unk> pharmaceuticals, as a means of achieving a long term stable versions ice stemming suitable for stockpiling.

Let's turn to <unk>.

In July we added a third phase III program to our company when we signed a memorandum of understanding with Israel Institute for biological research or IPR to complete development and commercialization of their innovative experiment and possibly <unk>.

<unk>, a COVID-19 vaccine known as <unk>.

In this collaboration the IPR provides technical assistance and will receive customary royalty and milestone payments for intellectual property in exchange for worldwide exclusive rights on the part of an Rx to develop and market <unk>.

As the self propagating live virus vaccine realized differs from other COVID-19 vaccines.

It presents the entire spike protein of the Sars cov, two virus to the body's immune system rather than merely a small segment of that spike protein.

Moreover, the vaccine itself continues to evolve and develop its own variance of the Covid spike protein.

We like to think of.

<unk> is a sheep and wolf clothing in other words, it's a benign virus, but it looks to the body as if it was a corona virus and generates that immune response.

We believe this may be the reason that the realized vaccine shows encouraging protection against Delta and other variants of concern.

In preclinical studies.

And just this week.

Information was released suggesting that that same protection against Delta has been seen in early human studies with the realized vaccine. Additionally, as new variants are discovered despite protein complex of those new variance maybe rapidly.

Added to the free life vaccine, thereby expanding the spectrum coverage and adaptability to future variants.

In October we concluded the business mission to Luxembourg at the invitation of the Luxembourg Ministry of the economy for the establishment of vaccine manufacturing capability for realized to serve European and adjacent markets.

We've been granted an operating company business licensed by the Luxembourg government and established a commercial banking relationship with BNP powered bus Luxembourg. We're currently negotiating a comprehensive banking and supply chain commence solution and preparation for tech transfer and scale up.

And manufacturer realized.

And we are working to put in place the manufacturing backbone that will enable us to begin building a large scale capability to deliver commercial quantities of the vaccine.

We've signed an agreement with <unk>, a highly respected CMO close to Luxembourg to begin technology transfer and scale up with realized.

<unk> seen is manufactured by a newly developed bioreactor technology previously developed for gene therapy. We're fortunate that Luxembourg has shown us a confluence of unique technological capability and enthusiastic financing environment and instead of government priorities that include the type.

Of environmentally friendly high technology high Tech manufacturing, we require to advanced realized to the next level.

We hope to initiate GMP vaccine manufacturer in the first half of 2022 and to have results to share with you by the time of our first quarter 2022 conference call.

In August we announced the initiation of a phase <unk> trial of <unk> seen to be conducted in the nation of Georgia.

Rogers are particularly promising location for clinical development because of the Senator Richard Lugar Center Public Health research built by the U S government and operated by leading scientists in Georgia.

Those plans to conduct a placebo controlled study were interrupted by media reports that realized had unexpectedly demonstrated early signs of efficacy.

Particularly against the Delta bearings and the patients vaccinated with realized were given green passports as if they were vaccinated within mrna vaccine.

Based on this surprising and encouraging news, we and our CIO of partners.

Posted with the World Health organization, and the Europeans Medicine European Medicines agency.

And decided to move directly to a phase <unk> registration trial.

This study will compare <unk> ability to generate an immune response compared to an already licensed vaccine the.

The phase <unk> trial will be conducted in multiple nations supported by national governments and their health ministries together with our CIO partnered promos LLC.

Although the planned trial is technically a non inferiority trial. We believe it is possible that free life will demonstrate a better immune response to several variants of concern.

<unk> vaccine.

Indeed, we've already seen that early data from <unk> they are.

<unk> neutralizing antibody levels against the Delta variant in vaccinated patients that are as high as our as potent as the neutralizing antibody levels seen.

In those same patients against the original wild type Corona virus.

We aim to enroll sufficient patients to prove efficacy if realized against the original COVID-19 virus and its variants of concern by mid 2022.

We believe that the emergence of the Covid Delta vary during this past summer.

And the rapidity with which this and other variants have eroded the immunity generated by first generation vaccines highlight the unmet need for Covid vaccine that provides long lasting and safe immunity.

Resistant new variance of the virus as they emerge.

The significant research investments already made by the IAA VR has enabled a rapid path to registration studies.

We had an Rx are honored to have been selected for this project and grateful for the trust placed in us by the government of Israel, the people of Georgia and its neighboring countries as the Delta and subsequent very continued to threaten the immunity generated by first generation vaccines.

We hope that this new vector based approach.

They offer enhanced immunity.

So finally, let me turn to where we are and our ongoing developments within our X 101.

As you know in our X 101, with our foundation program for the treatment of suicidal bipolar depression.

The clinical trial was interrupted by the surge the initial surge of the Corona virus pandemic when multiple psychiatric facilities were shut down beds were converted to COVID-19 beds and were announced preparing to restart our phase III trial and currently expect.

The enrollment to resume in early 2022.

Suicidal depression is a condition that accounts for approximately 50000 deaths annually in the U S. According to the U S centers for disease control.

Suicide, a bipolar depression represents a unique unmet medical need, especially since the only currently approved treatment for people who have this condition is.

<unk> electric shock therapy.

We've been awarded breakthrough therapy designation by the FDA for <unk> hundred one in this indication.

And our X 101 is a patented fixed dose combination of <unk> and Loran.

Which has a dual targeted mechanism of action designed to achieve a clinically meaningful level of NMDA blockade without the side effects associated with other well known NMDA antagonist such as Kevin.

<unk> human studies have shown a positive effect on depression, <unk> suicidal ideation associated with these sites with Sara.

There is a compelling unmet need for an orally available non addictive non neurotoxic NMDA targeted drug to treat depression.

Cogs hallucinations.

And as tolerable and safe for patients.

The development of <unk> hundred one is based by Dr. Based on Dr. Daniel Javits early discovery of the role of the brain NMDA receptor in psychiatric disease, and his lifetime of research and neurochemistry.

Led to the award of a composition of matter patent in 2020.

The composition of matter patents awarded for this dual targeted mechanism within our X 101 is extensible to other dual targeted drugs for major depression and other conditions.

We have a special protocol agreement in place with the FDA for <unk> hundred one pivotal trial and <unk> hundred one has been granted breakthrough therapy designation fast track designation and has received a biomarker letter of support from the FDA.

We believe that if our phase III pivotal trial results.

Our results replicate those observed in our phase II study, we will meet FDA criteria for approval and will have a clear path for NDA submission to the FDA in 2022.

With that I'll turn it over to Randy for an overview of our financial results.

Thank you Jonathan I'll begin with the $30 million private placement, we completed in August and which we sold approximately two 7 million shares of common stock and preferred investment options with this.

Transaction, our cash position was $38 $9 million as of September 32021, compared to $1 9 million as of December 31, 2020.

We believe we have sufficient cash to support operations through the next 12 months note that our clinical trial operations for active <unk> and Eisai are primarily funded by the U S government.

Net loss for our third quarter was $20 8 million compared with a net loss of $5 2 million for the three months ended September 32020.

This was primarily due to noncash expenses associated with the establishment of key partnerships and an increase in clinical trials and development expenses related to best to Zeiss Sammy.

Reimbursements from relief Therapeutics were zero for the third quarter of 2021 compared to $2 9 million for the third quarter of 2020.

Research and development expenses for the third quarter were $6 3 million compared to $4 3 million for the prior year period.

The increase was primarily driven by an increase in clinical trials and development expenses related to its eye Sammy Jenny.

General and administrative expenses for the quarter were $13 8 million of which $9 3 million were noncash stock based compensation and consulting fees for the prior year quarter G&A expenses were $3 8 million of which $2 8 million was noncash stock based compensation consulting.

Fees and warrant expense the.

The increase was primarily due to the increase in the noncash stock based expenses as well as an increase in insurance expenses.

Other expenses for the three months ended September 32021.

Zero point $7 million compared to zero for the three months ended September 32020.

The increase was primarily due to increases in earn out cash liability and warrant liability.

With that I will turn it back to Jonathan for closing remarks.

Thank you Randy before taking questions I, just want to emphasize our commitment to efficient drug development.

And ask you to focus on.

<unk> belief that not only do we need to focus on clinical safety and efficacy, but on the manufacturer ability of our lead programs. We've made tremendous progress in our three lead programs in an incredibly short period of time.

And have efficiently utilize our resources and energies in areas of critical need where we can have the most impact.

We realize that it is a bit unusual for small cap biotechnology companies to focus on manufacturer ability of new medicines to the extent that we have.

However, we believe the early focus on CMC that chemical manufacturing and control analytics and manufacturing is critical if there's to be a smooth transaction from proving safe smooth transition improving safety and efficacy to being able to ship a new medicine.

Or vaccine to patients immediately upon approval, we look forward to working with FCA and regulators around the world on an ongoing basis for a review of our news ice family data becomes available.

Moving forward with our accelerated new drug application.

And we look forward to Fda's response to our application for breakthrough therapy designation by the end of the year and currently we're putting in place the infrastructure to support our transition to commercial operations to support both say Sami in real life, and we're planning to resume enrollment.

<unk> hundred one phase III trial in 2022, we can look ahead to multiple data readouts and other catalysts and remain confident in the opportunities before us. We appreciate the continued trust that you our shareholders have placed in us and we are reaffirmed.

Our commitment to bringing life saving treatments to patients with lethal conditions that are not addressed by current therapies, Eric we are ready to take questions.

Thank you.

Question on the held phase two three trial.

How many patients have been enrolled to date.

And when do you expect completion.

Well as we've said we're expecting completion in the first half of 2022 as the pandemic gains speed.

And Unfortunately, we are in the middle of an uptake in uptick in cases.

Roland has become more rapid.

So we may be able to pull that completion date further forward.

Okay.

On the pre life vaccine can you provide more detail on when you may seek regulatory approval or authorization from a health regulatory authority.

We're expecting to see phase two placebo controlled results.

Coming out of Israel by the end of this year.

And that's based on the reports that have already surfaced in the press.

<unk>.

That efficacy.

We're seeing that vaccine.

Effectiveness was seen by health authorities in patients who are vaccinated.

Is there are people walking around with with Green passports, who got that realized vaccine and we're not required to be vaccinated with mrna.

We're going to be starting a non inferiority registration trial comparing relate to a known vaccine.

And depending on.

How quickly that trial enrolls and what happens with the pandemic really depending on whether we're able to see the same kind of effect against the Delta and other variants concern in this next trial that's already been seen.

The patients vaccinated in Israel.

We could be talking about applying for.

Some form of regulatory approval.

Towards the midpoint of 2022.

Of course.

If we're talking about going all the way to new drug approval for a vaccine then you'd be expecting a more traditional year to 18 month time point.

But if these variants continue to come at us the way they have.

And if the vaccine lives up to some of the hopes.

We'd be looking at a shorter timeframe.

Okay. Thank you.

Yes.

Asking about further detailed breakthrough designation for XI Sammy.

And the chances of breakthrough designation when you might get an answer from the FDA any any more updates on timing.

We're expecting Fda's response to our breakthrough therapy designation towards at the end of the month.

And we've taken the steps that we think is a bit unusual we've posted the contents of our breakthrough therapy designation request on our website.

So that shareholders and members of the public can understand exactly why we believe this is a breakthrough drug and why we believe it demonstrates.

Preliminary evidence of efficacy, which is the regulatory requirements for breakthrough therapy designation.

People are free to read what we've submitted.

And we look forward to the Fda's response.

Okay.

Okay. Thank you.

We have a general question about Covid what are your thoughts on Covid, we will continue to remain present.

We will get worse as we get further into the colder months.

Well I think the most important thing plus we're now.

<unk>.

Two years.

The original recognition of Covid outbreak.

In Wuhan China.

And we're about 20 years from humanity's first known and counter with lethal Corona viruses the original Sars epidemic.

And of course, it's possible that Corona viruses.

Attacked humans in the past.

But we're so lethal that goes epidermis burn themselves out and certainly the same thing happened with Sars, some such a lethal virus.

That the Sars epidemic.

<unk> was pretty much contained simply because the people who were exposed to that virus.

The spread was contained but here we are two years into this pandemic, where the Corona virus has learned how to.

Live in people.

To not kill too many of them you should pardon the expression and therefore to be able to spread from person to person and a pandemic way and as somebody who spent his his license public health professional I think that.

Humanities and counter with the Corona virus.

Is going to be a long list one the same way that humanities encounter with influenza viruses.

Is here to stay.

This pandemic has a ways to go we don't yet have drugs that can stop.

Although we do have drugs that are at least showing promises for reducing the virulence.

Of the Corona virus.

And we're seeing the virus is ability to present itself in new variants of new mutations that are able to circumvent some of the original vaccines.

So.

Unfortunately.

For humanity.

Probably the benefits that we're talking about with <unk>, xiaomi and with the <unk> vaccine or benefits that humanity is going to need.

But at the same time, we hope that people will realize that a vista del that Sami is not just a corona virus drug. This is a drug that protects the lining of the law.

And a very profound way and protects the alveolar type to sell which makes the surfactants that the lung depends upon in order to transmit oxygen from the lungs from the air into the bloodstream.

And that's why we've focused on.

The original intent of size Xiaomi, which was for acute respiratory distress syndrome, and now that we finally have a manufactured performance ive family that can be mass produced and introduced into clinical trials the opportunity to test site, Sammy and a whole variety of lethal lung conditions.

Thank you Mark.

Because that is all questions. We have thank you everyone for joining us. This morning. This concludes the end Rx Pharmaceuticals third quarter results conference call. Thank you all for participating.

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