Q3 2022 Beyond Air Inc Earnings Call

Speaker 1: Greetings and welcome to the Beyond Air third quarter 2022 earnings call. At this time, all participants are in a listen only mode. A question and answer session will follow the form of reason to...

Greetings and welcome to the beyond Air third quarter 2022 earnings call. At this time, all participants are in a listen only mode.

And answer session will follow the formal presentation.

Speaker 1: If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note, this conference is being recorded.

If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.

Please note. This conference is being recorded I will now turn the conference over to your host.

Speaker 1: Maria Jantowski, Head of Investor Relations. You may be here.

Koski head of Investor Relations you may begin.

Speaker 2: Thank you, operator. Good afternoon, everyone, and thank you for joining us. Today, after market closed, we issued a press release announcing the third fiscal quarter of 2022 operational highlights and financial results. A copy of this press release can be found on the Investor Relations page of our website.

Thank you operator, good afternoon, everyone and thank you for joining us today after market close we issued a press release announcing the third fiscal quarter of 2022 operational highlights and financial results. A copy of this press release can be found on the Investor Relations page of our website.

Speaker 2: Before we begin, I would like to remind everyone that we will be making comments and various remarks about future expectations, plans, and prospects which constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995.

Before we begin I would like to remind everyone that we will be making comments and various remarks about future expectations plans and prospects, which constitute forward looking statements for the purposes of the safe Harbor provisions under the private Securities Litigation Reform Act of 1995 beyond.

Speaker 2: Beyond air cautions that these forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated.

<unk> cautions that these forward looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated we encourage everyone to review the company's filings with the Securities and Exchange Commission, including without limitation, the company's Form 10-K , which identifies specific.

Speaker 2: We encourage everyone to review the company's filings with the Securities and Exchange Commission, including without limitation the company's Form 10-K , which identifies specific factors that may cause actual results or events to differ materially from those described in the forward-looking state.

Factors that may cause actual results or events to differ materially from those described in the forward looking statements.

Speaker 2: Additionally, this conference call is being recorded and will be available for audio rebroadcast on our website, www.beyondair.com.

Additionally, this conference call is being recorded and will be available for audio rebroadcast on our web site www dot beyond their dot net.

Speaker 2: Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, February 10, 2022. Beyond Air undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this call.

Or more of the content of this conference call contains time sensitive information that is accurate only as of the date of the live broadcast February 10th 2020 to be.

<unk> undertakes no obligation to revise or update any statements to reflect events or circumstances. After the date of this call.

Speaker 2: Joining me on today's call are Steve Leacy, our Chairman and Chief Executive Officer, Duncan Sattkin, our Chief Commercial Officer, and Douglas Larson, our Chief Financial Officer. With that, I will turn the call over to Steve Leacy, our CEO . Steve.

Joining me on today's call are Steve Lisi, our chairman and Chief Executive Officer, Duncan Satkin, our Chief commercial Officer, and Douglas Larson, Our Chief Financial Officer with that I will turn the call over to Steve Lisi, Our CEO Steve.

Thanks, Maria and good afternoon to everyone joining us on today's call.

Speaker 3: Thanks, Maria, and good afternoon to everyone joining us on today's call. As always, I would like to start by thanking the Beyond Air team as they continue to embody the mission of our organization and move us forward towards regulatory approvals and R&D pipeline progression and expansion.

As always I would like to start by thanking the beyond air team as they continue to embody the mission of our organization and move us forward towards regulatory approvals and R&D pipeline progression and expansion.

Speaker 3: We continue to believe in the potential of LungFitPH to revolutionize the treatment of persistent pulmonary hypertension of the newborn, or PPHN, in the United States and cardiac surgeries around the world.

We continue to believe in the potential of longs with ph to revolutionize the treatment of persistent pulmonary hypertension of the newborn or P. P. H N in the United States and cardiac surgeries around the world.

Today, our commercial team continues to prepare for a U S. Commercial launch of lung fifth ph in anticipation of a regulatory decision in the first half of this calendar year.

Speaker 3: Today, our commercial team continues to prepare for a U.S. commercial launch of LungFit pH in anticipation of a regulatory decision in the first half of this calendar year.

Speaker 3: I will have our Chief Commercial Officer Duncan Fakin discuss this preparation in much greater detail shortly.

I'll have our chief commercial officer, Duncan Fac and discuss this preparation in much greater detail shortly.

Speaker 3: Beyond Air continues to work collaboratively with the FDA to bring our device to the market as quickly as possible.

Beyond Air continues to work collaboratively with the FDA to bring our device to the market as quickly as possible.

I won't be able to comment further on our ongoing interactions with the FDA.

Speaker 3: I won't be able to comment further on our ongoing interactions with the FDA.

Speaker 3: except to assure everyone that the dialogue is productive and we have provided the agency with all information and support we believe they need to grant approval for lung 58.

Except to assure everyone that the dialogue is productive and we have provided the agency with all information and support we believe they need to grant approval for lung for ph.

Speaker 3: Additionally, we remain on track to receive CE mark in Europe in the first half of this calendar year.

Additionally, we remain on track to receive CE Mark in Europe in the first half of this calendar year.

Speaker 3: We expect to secure an international commercial partnership for LungFit pH for ex-US markets following CE mark, and will provide more information on our global strategy at a later time.

We expect to secure an international commercial partnership for lunch at ph for ex U S markets. Following CE, Mark and we'll provide more information on our global strategy at a later time.

Speaker 3: Turning now to recent operational highlights. In December of last year, we expanded our leadership team and welcomed Dr. Andrew Cohen as our new chief medical officer.

Turning now to recent operational highlights in December of last year, we expanded our leadership team and welcome Dr. Andrew Cohen, as our new Chief Medical Officer.

Speaker 3: Dr. Colin has been a valuable contributor to our scientific advisory board.

Colin has been a valuable contributor to our scientific Advisory Board since 2013, and his advice has been instrumental to the progress of our ongoing clinical programs to date.

Speaker 3: 2013 and his advice has been instrumental to the progress of our ongoing clinical programs to date.

Speaker 3: He has been tasked with leading our late stage development efforts of both LungFit Pro and LungFit Go systems given his medical background as a board certified pediatric pulmonologist with more than four decades of clinical experience in respiratory physiology, cystic fibrosis, and lung infection.

He's been tasked with leading our late stage development efforts of both lumpy pro in lungs did go systems given his medical background as a board certified pediatric pulmonologist with more than four decades of clinical experience in respiratory physiology, cystic fibrosis and lung infections.

With regards to scientific updates and our presence at upcoming medical conferences I am happy to report that we have been accepted to present, new data from our pipeline programs at three leading scientific conferences all within the next four months.

Speaker 3: With regards to scientific updates and our presence at upcoming medical conferences, I am happy to report that we have been accepted to present new data from our pipeline programs at three leading scientific conferences all within the next four months.

Speaker 3: I will start off our pipeline commentary with our LungFitGo NTM lung infection pilot study.

I'll start off.

Our pipeline commentary without lungs could go N T M lung infection pilot study.

As you May recall in December 2020, we began screening for refractory MTM patients, but this pilot trial in Australia.

Speaker 3: As you may recall, in December 2020, we began screening for refractory NTM patients for this pilot trial in Australia.

Speaker 3: In October , we released interim data where a total of eight refractory NTM patients had been titrated up to the maximum dose of 250 parts per million nitric oxide in the hospital over several days and then sent home to self-administer therapy.

October we released interim data, where a total of eight refractory MTM patients had been titrated up to a maximum dose of 250 parts per million nitric oxide in the hospital over several days and then sent home to self administer therapy.

There were no dose reductions no study discontinuation and no treatment related serious adverse events reported.

Speaker 3: There were no dose reductions, no study discontinuations, and no treatment-related serious adverse events reported. Our team was very encouraged by this initial safety profile. We have now been accepted to present additional results from this pilot study at the American Thoracic Society International Conference being held from May 13 to May 18 in San Francisco.

Our team was very encouraged by this initial safety profile. We have now been accepted to present additional results from this pilot study at the American Thoracic Society International Conference being held from May 13th to May 18th in San Francisco.

Beyond the safety profile. The study aims to evaluate efficacy parameters such as quality of life physical function and bacteria load among other metrics.

Speaker 3: Beyond the safety profile, this study aims to evaluate efficacy parameters such as quality of life, physical function, and bacterial load, among other metrics.

Speaker 3: Remember, this is a pilot study designed as a single arm 12 week at home trial aiming to enroll up to 20 cystic fibrosis or non CF bronchiectasis patients with a refractory NTM lung infection.

Remember this is a pilot study designed as a single arm 12 week at home trial aims to enroll up to 20, cystic fibrosis or non CF bronchiectasis patients with refractory N T M lung infection.

Either mycobacterium avium complex or Mycobacterium abscesses.

Speaker 3: either Mycobacterium avium complex or Mycobacterium accessor.

Speaker 3: It is important to note that NTM is a disease area of focus for FDA. In fact, 50% of patients will die in less than five years from the initial diagnosis of mycobacterium abscessus lung infection.

It is important to note that N T M. As a disease area of focus for F. D. A.

In fact, 50% of patients will die in less than five years from the initial diagnosis of Mycobacterium abscesses lung infection.

As such the success of this trial could signal that long ago has the potential to be a game changer for this patient population.

Speaker 3: As such, the success of this trial could signal that LungFitGo has the potential to be a game changer for this patient population and start to open up the enormous potential of the home market for us.

And start to open up the enormous potential of the whole market for our system.

Speaker 3: We have always had an interest in investing in other indications with our LungFitGo system and have announced our intention of beginning a pilot study to treat severe COPD exacerbations due to lung infections over the next 12 to 24 months.

We have always had an interest in investing in other indications without once it goes system and have been.

Our intention of beginning a pilot study to treat severe COPD exacerbations due to lung infections over the next 12 to 24 months.

Moving onto our viral lung infection program with.

Speaker 3: Moving on to our viral lung infection program, which uses the LungFit Pro system at 150 parts per million nitric oxide to treat community acquired viral pneumonia in adults and bronchiolitis in children under two years of age.

It uses the lungs at pro system at 150 parts per million nitric oxide too.

Treat community acquired viral pneumonia in adults and bronchiolitis in children under two years of age.

As many of you may recall, we presented interim data from our adult cohort of hospitalized pneumonia patients last may at the American Thoracic Society International Conference.

Speaker 3: As many of you may recall, we presented interim data from our adult cohort of hospitalized pneumonia patients last May at the American Thoracic Society International Conference

Speaker 3: In the time of the cutoff period for these data, we analyzed a total of 19 patients on an intent to treat base.

At the time of the cutoff period for these data we analyze a total of 19 patients on an intent to treat basis.

Speaker 3: nine of the patients in the NO treatment arm, and ten in the control arm, all of which will...

None of the patients in the treatment arm and 10 in the control arm.

All of which were COVID-19 patients.

Speaker 3: These data show that 150 parts per million NO administered by a lung fit pro was deemed to be safe and well tolerated with no treatment related or possibly related adverse events or serious adverse events.

These data show that 150 parts per million N O administered by a luxury pro was deemed to be safe and well tolerated with no treatment related or possibly related adverse events or serious adverse events.

Additionally, 22% of subjects and the N O treated group required oxygen support beyond their hospital stay.

Speaker 3: Additionally, 22% of subjects in the NO Treaty group required oxygen support beyond their hospital stay. To begin, Dr.

3rd% to 40% of control subjects.

Speaker 3: respect to duration of oxygen support, NO-treated patients average two days less than control.

Specter duration of action support N O treated patients averaged two days less in control.

26 hour reduction in mean duration of hospital stay between the treatment group and control was observed when adjusting for extreme outliers.

Speaker 3: A 26-hour reduction in mean duration of hospital stay between the NO treatment group and control was observed when adjusting for extreme outlook.

Speaker 3: Since presenting these data, we have kept the study active with trial sites open for enrollment.

Just presenting these data we have kept the study active with trial sites open for enrollment.

Speaker 3: I'm happy to report that we have been accepted to present new data at the 32nd European Congress of Clinical Microbiology and Infectious Disease being held April 23rd through 26th in Lisbon.

I'm happy to report that we have been accepted to present, new data at the 32nd European Congress of clinical microbiology and infectious disease being held April 23rd through 26th in Lisbon.

Speaker 3: Our team is excited to have the opportunity to share these additional data with the scientific and medical community.

Our team is excited to have the opportunity to share. These additional data with the scientific and medical communities.

Speaker 3: Finally, I would like to provide updates on our private affiliate Beyond Cancer.

Finally, I would like to provide updates on our private affiliate beyond cancer.

Speaker 3: Late last year, we successfully raised 30 million in a private placement of common shares to spin out our oncology program, developing ultrahigh concentration nitric oxide, or Unotherapy, for the treatment of solid-

Late last year, we successfully raised 30 million in a private placement of common shares to spin out our oncology program developing ultra high concentration nitric oxide or no therapy for the treatment of solid tumors.

Speaker 3: We believe Unotherapy may not only partially ablate or shrink the primary tumor, but also can arm the immune system to recognize and attack same tumor cells if they metastasize to other regions in the body.

We believe it when a therapy may not only partially a bleed or shrink the primary tumor, but also can arm the immune system to recognize and attack seen tumor cells, if they metastasize to other regions in the body.

Our preclinical data show that treating a tumor immunotherapy will cause local cell death, exposing the immune system to tumor antigens, thereby creating a memory immune response.

Speaker 3: Our preclinical data show that treating a tumor with oome therapy will cause local cell death, exposing the immune system to tumor antigens, thereby creating a memory immune response. For patients, this could mean preventing recurrence or metastases.

For patients this could mean, preventing recurrence or metastases.

Under the leadership of CEO , Dr Slim as Shashank.

Speaker 3: Beyond Cancer has established its six-member board with the recruitments of Mr. David Dvorak, previously the CEO of Zimmer Biomint, and Dr. Gregory Burke, a clinically trained physician who is currently serving as a chief medical officer and interim CEO of GT Biopharma, a clinical stage immuno-oncology company.

Cancer has established six member board with the recruitment of Mr. David Dvorak previously the CEO of Zimmer Biomet and Dr. Gregory Burke, a clinically trained physician who is currently serving as the Chief Medical officer, and interim CEO of G. T Biopharma clinical stage immuno oncology company.

Additionally, beyond cancer present, two datasets at the American Association for Cancer Research annual meeting.

Speaker 3: Additionally, Beyond Cancer will present two data sets at the American Association for Cancer Research Annual Meeting, which is being held from April 8th through.

Which is being held from April eight through 13th in New Orleans recall, we previously presented in vitro and in vivo preclinical data for ultra high concentration gaseous nitric oxide at several conferences in 2020, which suggested that direct administration of immunotherapy to solid tumors triggers a systemic anti tumor immune response, which could serve as.

Speaker 3: Recall, we previously presented in vitro and in vivo preclinical data for ultra-high concentration gaseous nitric oxide at several conferences in 2020, which suggested that direct administration of immunotherapy to solid tumors triggers a systemic antitumor immune response, which could serve as the basis for an effective immunotherapy.

The basis for an effective immunotherapy.

Speaker 3: These new preclinical data being presented in April will continue to build upon this growing body of evidence, and we are excited to support the progress as a partner beyond.

These new preclinical data being presented in April we'll continue to build upon this growing body of evidence and we are excited to support progress as a partner beyond cancer.

Speaker 3: I will now turn the call over to Duncan Facken, the Chief Commercial Officer of Beyond Air, to provide additional details on the U.S. commercial launch for Lung Fit pH.

I will now turn the call over to Duncan Fac and Chief commercial officer of beyond air to provide additional details.

On the U S commercial launch for lung fifth ph.

Thanks, Steve and good afternoon to our investors.

As I highlighted last year, the commercial organization is ready to launch lung fit ph domestically as soon as we receive FDA approval.

Speaker 4: As I highlighted last year, the commercial organization is ready to launch lung fit pH domestically. As soon as we receive FDA approval.

Our strategy has not changed.

Speaker 4: as we aim to focus on a limited release for the first six to nine months post launch and target a select number of hospitals that have level three or level four NICUs and staff experienced with inhaled nitric oxide.

We aim to focus on a limited release for the first six to nine months post launch.

It's a select number of hospitals that have level, three or level, four knickers and stuff experienced with inhaled nitric oxide.

Speaker 4: We continuously refine our marketing plan and work to optimize our customer service model as we draw closer to a decision date from the FDA.

We continuously refine our marketing plan and work to optimize our customer service model as we draw closer to a decision dates from the FDA.

Our launch team is securely in place and consists of highly experienced individuals with decades of nitric oxide experience.

Speaker 4: Our launch team is securely in place and consists of highly experienced individuals with decades of nitric oxide experience.

Speaker 4: who will work closely with our target hospitals to ensure that we provide the best possible logistics support, customer service and product performance.

Work closely with our target hospitals to ensure that we provide the best possible logistics support customer service and product performance.

As I've said before since many of our target hospitals are currently in multiyear contracts with cylinder based nitric oxide suppliers will be targets in hospitals with fewer than 12 months left on their existing contracts.

Speaker 4: As I have said before, since many of our target hospitals are currently in multi-year contracts with cylinder-based nitric oxide suppliers, we'll be targeting hospitals with fewer than 12 months left on their existing contracts.

Speaker 4: And we anticipate it taking approximately four years to have an opportunity to convert every hospital that uses nitric oxide in the United States.

And we anticipate it taken approximately four years to have an opportunity to convert every hospital that uses nitric oxide in the United States.

Speaker 4: As a reminder, here are the main areas of immediate focus for the commercial team. First...

As a reminder, here are the main areas of immediate focus for the commercial team.

First building and developing the team.

A preapproval launch team is ready to be deployed immediately following approval.

Speaker 4: Our pre-approval launch team is ready to be deployed immediately following approval.

We continue to build on the nitric oxide experience that our team has brought to beyond the tour intensive internal training program.

Speaker 4: We continue to build on the nitric oxide experience that our team has brought to Beyond Air through our intensive internal training program.

Speaker 4: As I previously mentioned, we have numerous respiratory therapists on staff and experienced leaders to run our sales and marketing efforts.

As I've previously mentioned, we have numerous respiratory therapists on staff and experienced leaders to run a sales and marketing efforts.

Speaker 4: Our launch team is also preparing for the execution of our ex-US partnership plans following CE mark. Anticipated in the first half of the presentation.

Our launch team is also preparing for the execution of our ex U S partnership plans following CE Mark.

Anticipated in the first half of 2022.

Second we are refining our logistics plan to ensure that the first phase of beyond their customers of an optimized customer experience.

Speaker 4: Second, we are refining our logistics plan to ensure that the first phase of beyond their customers have an optimized customer experience.

Speaker 4: We're especially excited to launch our customer service and support program upon approval with a focus on flexibility and transparency with all of our customer stakeholders.

We're especially excited to launch our customer service and support program upon approval with a focus on flexibility and transparency with all of our customers stakeholders.

Speaker 4: Last, we are confident that customers will see significant value compared to cylinder-based systems, as LongFit PH would be the first and only FDA-approved system that generates nitric oxide from room F.

Last we are confident that customers will see significant value compared to cylinder based systems.

Long fit pay I guess would be the first and only FDA approved system that generates nitric oxide from room.

We look forward to sharing the logistical patient workflow and healthcare economic benefits with you in more detail upon approval.

Speaker 4: We look forward to sharing the logistical patient workflow and healthcare economic benefits with you in more detail upon approval.

These messages with will also be highlighted on the lung fifth ph websites lung fifth P. H dot com.

Speaker 4: These messages will also be highlighted on the LungFitPH website, LungFitPH.com.

Speaker 4: which will be made publicly available on day one of our law.

Which will be made publicly available on day, one of a launch.

We are planning to attend all the major neonatal respiratory conferences throughout 2022, and look forward to engaging with potential customers when appropriate.

Speaker 4: We are planning to attend all the major neonatal and respiratory conferences throughout 2022 and look forward to engaging with potential customers when appropriate.

We will continue to maintain a highly visible presence at these conferences to showcase lung fifth P H and the benefits of our innovative system.

Speaker 4: We will continue to maintain a highly visible presence at these conferences to showcase BlankfitPH and the benefits of our innovative system.

Speaker 4: Our vision is to harness the power of nitric oxide to unlock access, empower healthcare providers, and transform more lives in more ways.

Our vision is to harness the power of nitric oxide.

Unlocked access empower health care providers and transform more lives in more ways.

Speaker 4: LungFit pH is a groundbreaking all-in-one nitric oxide generator, monitoring and delivery system and we're extremely excited to share our story with potential customers in the US and beyond.

Lung fit ph is a ground breaking all in one nitric oxide generates a monitoring and delivery system.

We're extremely excited to share our story with potential customers in the U S and beyond.

Speaker 4: Thank you, and I will now turn the call over to Doug for the full financial review. Thanks Duncan.

Thank you and I'll now turn the call over to Doug for the full financial review.

Thanks, Duncan and good afternoon to our investors.

Speaker 5: Before I jump into the financials for the past quarter, I'd like to address a couple of housekeeping...

Before I jump into the financials for the past quarter I'd like to address a couple of housekeeping items.

Speaker 5: First of all, it's important to note that our balance sheet, P&L, and cash flows now include beyond cancer, our private oncology of...

First of all it's important to note that our balance sheet P&L and cash flows now include beyond cancer or private oncology affiliate.

Due to our majority ownership position their financial statements are fully consolidated with those of beyond air.

Speaker 5: Due to our majority ownership position, their financial statements are fully consolidated with those of beyond

Speaker 5: The P&L and equity sections in our 10Q break out the amounts attributable to the non-controlling interests that own 20% of the common stock in Beyond.

The P&L and equity sections in our 10-Q breakout the amounts attributable to the noncontrolling interests that own 20% of the common stock and beyond cancer.

Speaker 5: Second, we had a large number of warrants exercised for common stock in fiscal...

Second we had a large number of warrants exercised for common stock in fiscal Q3.

Speaker 5: especially our warrants issued in January of 2017, which expired in January of 2017.

Especially our warrants issued in January of 2017, which expired in January of 2022.

We issued just over 748000 shares of common stock upon exercise of warrants in Q3 and brought in almost $1.4 million from those transactions.

Speaker 5: We issued just over 748,000 shares of common stock upon exercise of warrants in Q3 and brought in almost $1.4 million from those transfers.

Balance of the warrants from January of 2017 were exercised in January of 2022, bringing in almost $4 $6 billion of additional cash, which we called out in our note on subsequent subsequent events in our 10-Q.

Speaker 5: Balance of the warrants from January of 2017 were exercised in January of 2022, bringing in almost $4.6 million of additional cash, which we call out in our note on subsequent events in our 10 years.

With that I will now turn to the brief review of our financial results for our third fiscal quarter of 2022, which ended on December 31 2021.

Speaker 5: With that, I will now turn to the brief review of our financial results for our third fiscal quarter of 2022, which ended on December 31, 2020.

Speaker 5: Revenue for the fiscal quarter ended December 31st, 2021 was zero as compared to $0.1 million for the fiscal quarter ended December 31st, 2020 all of which was licensing revenue.

Revenue for the fiscal quarter ended December 31, 2021 was zero as compared to zero point $1 million for the fiscal quarter ended December 31, 2020, all of which was licensing revenue.

Speaker 5: Research and development expenses for the fiscal quarter ended December 31st, 2021, where $2.5 million compared to $3.4 million for the fiscal quarter ended December 31st, 2020.

Research and development expenses for the fiscal quarter ended December 31, 2021 were $2 $5 million compared to $3 $4 million for the fiscal quarter ended December 31 2020.

General and administrative expenses for the fiscal quarter ended December 31, 2021 were $4 $9 million compared to $2 $5 million for the fiscal quarter ended December 31 2020.

Speaker 5: General and administrative expenses for the fiscal quarter ended December 31, 2021, or $4.9 million compared to $2.5 million for the fiscal quarter ended December 31, 2020.

Speaker 5: Other income and expense for the fiscal quarter ended December 31st, 2021 was a loss of $0.5 million.

Other income and expense for the fiscal quarter ended December 31st 2021 was a loss of zero point $5 million.

Speaker 5: For the fiscal quarter ended December 31st, 2021, the company had a net loss of $8 million, of which $7.7 million, or $0.29 per share, was attributable to the shareholders of Beyond Air Inc., compared to a net loss of $5.8 million, or $0.33 per share, for the fiscal quarter ended December 31st, 2021.

For the fiscal quarter ended December 31, 2021 the company had a net loss of $8 million of which $7 7 million or <unk> 29 per share was attributable to the shareholders of beyond Air Inc. Compared to a net loss of $5 $8 million or <unk> 33 per share for the fiscal quarter ended December 31 2012.

Yeah.

For the fiscal quarter ended December 31, 2021, the company used $6 $3 million of cash for operating activities.

Speaker 5: For the fiscal quarter ended December 31st, 2021, the company used $6.3 million of cash for operating activities.

Speaker 5: As of December 31, 2021, the company had cash and cash equivalents of $83.5 million, of which $54.5 million is in Beyond Air and $29 million is in Beyond Cancer.

As of December 31, 2021, the company had cash and cash equivalents of $83 5 million of which $54 $5 million in beyond air and $29 million isn't beyond cancer.

Speaker 5: keep in mind this does not include the additional 4.6 million dollars we brought in in January that I mentioned earlier.

And keep in mind. This does not include the additional $4 $6 million. We brought in in January that I mentioned earlier.

Speaker 5: We believe that our cash on hand is sufficient to fund operations well beyond the next 12 months, including through the commercial launch phase of Lung Fit pH in the US. And with that, I'll hand the call back to Steve. Thanks Doug. Operator, we're ready for Q&A now. Thank you at this time.

We believe that our cash on hand is sufficient to fund operations well beyond the next 12 months, including through the commercial launch phase of lung fit ph in the U S.

And with that I'll hand, the call back to Steve.

Thanks, Todd operator, we're ready for Q&A now.

Thank you and at this time, we will be conducting a question and answer session. If he would like to ask a question. Please press star one on your telephone keypad.

Speaker 1: The confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the chat.

Information tone will indicate your line is in the question queue. You May Press Star two if you would like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys.

Speaker 1: participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

One moment, please while we poll for questions.

Yeah.

Speaker 1: And our first question comes from the line of Greg Fraser with DREWS. Please proceed with your questioning.

And our first question comes from the line of Greg Fraser with Jewish. Please proceed with your question.

Thank you Doug.

Yes.

Speaker 6: Among the PH, I appreciate the color on your interactions with the agency. It sounds like there's nothing outstanding from your end. Is there anything specific that you're aware of that's gaining approval at this point, or do you just have to wait to see what the agency comes back with next?

Hum along fifth P. H I appreciate the color on your interactions with the agency it sounds like there's nothing outstanding from your end is there anything specific that youre aware of is gaining approval at this point or you just have to wait to see what the agency comes back with next.

Speaker 3: Yeah, Greg, I wish I could give you something more specific, but we're just kind of waiting to see what they come back with at this point.

Yeah, Greg I wish I could give you something more specific but we're just we just are kind of waiting to see what they come back with at this point.

Okay.

Speaker 6: Got it. Okay. How important will the transport system be to the broader launch strategy when you expand to more hospitals? Can you speak to the timing of approval for a transport system?

Got it okay.

How important will the transport system be it the broader launch strategy would you be stand to more hospitals and can you speak to the timing.

Approval for a transport system.

Speaker 3: I'll speak to the timing and I'll let Duncan tell you how important it is. You know, the timing will be, you know, I would say within the first two years after we launched the product. So, maybe sometime in the 15 to 18 month time period or so to speak after we get the approval is probably when you'll see the transport.

I'll speak to the timing and I'll, let Don can tell you how important. It is you know the timing will be you know I would say within our within the first two years. After we launched the product so.

Maybe some time in the 15 to 18 month time period or so to speak after we get the approval is probably when youll see.

The transport unit.

Yeah, Greg Thanks for the question. So the transfer system. It's important that the there is a transfer system that the hospital has access to the good news for US is that we have made the decision to have a controlled phase launch in that first period, where in the first six to nine months. We go to the 10 to 12 hospitals we've.

Speaker 4: Yeah, Greg, thanks for the question. So the transport system. It's important that the there is a transport system that the hospital has access to the good news for us.

Speaker 4: is that we have made the decision to have a controlled phased launch and in that first period where in the first six to nine months we go to the 10 to 12 hospitals we've previously talked about, we don't anticipate there to be any resistance to there not being a transport system available. And in fact, based on the feedback we've had from many of the customers that have approached us,

<unk> previously talked about we don't anticipate that to be any resistance to not be in our transport system available and in fact based on the feedback we've had from many of the customers that have approached us.

Speaker 4: They can definitely use our system without a transport system being available for a significant period of time, by which time we will have a transport solution and we believe it'll have some significant differentiation that will be welcomed by our customers.

They can definitely use our system without a transport system being available for a significant period of time by which time, we will have a transport solution and we believe it will have some significant differentiation.

We will be welcomed by our customers.

Speaker 6: Got it. Thanks. That's very helpful. And then on LungFit Pro, will the additional data from the study that you'll be presenting be for the same group of patients, or will you have data for additional patients, including non-COVID folks? Yeah, there'll be more patients for sure.

Got it thanks, that's very helpful and then.

I loved it pro will be additional data from the study that you'll be presenting piece of the same group of patients or what do you have data for additional patients, including non COVID-19 folks.

Yeah, there'll be more patients for sure.

Got it. Thank you thanks for taking the questions.

Thanks, Greg.

Speaker 1: And our next question comes from the line of Siraj Cali with Oppenheimer & Company. Please proceed with your question. Good afternoon, everyone. Steve, couple of questions for you and one for Duncan. Specifically, Stephen, I appreciate you being here today.

And our next question comes from the line of Suraj Kalia with Oppenheimer and company. Please proceed with your question.

Good afternoon, everyone. Steve couple of questions for you and one for Duncan.

Specifically Stephen I appreciate.

Your commentary about not giving.

Giving specifics on the F D. A process for PPA Chen I was wondering if you all could give us a flavor.

New data provided since the last conference call.

So Steve the Subpart for you is any color you can provide with the ongoing bankruptcy, if mallinckrodt and I don't see any structural changes in the marketplace.

Is it going to prepare for commercial launch I'll throw in the question for Dunkin' also Duncan Fort beyond cancer.

And I'm drawing a blank here in terms of your previous commentary, maybe you could just kind of a highlight for us how from a modeling perspective, we should think about opex for beyond cancer flowing through beyond there gentlemen, thank you for taking my questions Alright.

Speaker 3: All right, Suraj, I'm going to give that last one to Doug on the Beyond Cancer side. That's a finance question there. So let's take them kind of

Alright suraj.

And I give that last one that Doug on the beyond cancer side.

That's finance question there so.

Let's let's take them take them kind of.

Speaker 3: in order. So why don't you just do me a favor because like we were a little bit shocked you said question for Duncan and it came out as a cancer question. So just kind of recap your questions so we could take them in order please. I apologize.

In order. So why don't you just do me a favor because like we were a little bit shocked question with Duncan and it came out as.

Cancer question. So just just kind of recap your question. So we can take them in order to please I apologize.

Real quickly you don't don't say the whole question again.

Suraj.

Hi, Suraj is your phone on mute if Kenny can you hear me now sorry.

Speaker 1: I saw your phone you can you can you hear me now sorry now I can yeah okay

Yeah, Okay apologies so.

Speaker 1: So very briefly, any new info provided on PPHN? Okay. Yeah, the answer to that is no new information has been provided. Okay. Any structural changes in the marketplace?

Very briefly.

Full provided on P. P S. Okay.

Yeah. The answer to that is there's no new information has been provided.

Okay.

Any structural changes in the marketplace.

The ongoing <unk> Mellon crop bankruptcy.

Speaker 3: as you'll hear from Marshall Launch. Yeah, I mean, I don't want, you know, whatever is in the public domain about their bankruptcy is in the public domain, but with respect to the market, I don't think we've seen much change over the past, you know, two years, you know, from just prior to their bankruptcy up until now.

Yeah.

Marshall launch Yeah, Yeah, I mean, I don't want you know whatever is in the public domain about their bankruptcies in the public domain, but with respect to the market I don't think we've seen much change over the past.

Two years.

From just prior to their bankruptcy and up until now.

Speaker 3: It's been the competition from Praxair and Vero has been there. And I don't think the bankruptcy has really impacted much. And now that they're coming out, we don't really see much difference on us.

It's been you know the competition from from Praxair and Bureau has been there and I don't think the bankruptcy was really impacted much and now that theyre coming out we don't really see much difference honestly.

Speaker 4: Duncan if you have anything else that no, I think Steve's captured it. It's certainly nothing that changes our strategy Okay, just uh

Duncan do you have anything else that no I think steves captured it certainly nothing that changes our strategy.

Okay, just maybe.

And Steve maybe I eh.

For Dunkin' know from me or just the the beyond cancer Opex flow, how should we think about it from a housekeeping perspective gentlemen, thank you.

Speaker 1: or Junkanoframy, or just the beyond-cancer, OpEx flow, how should we think of it?

So.

Speaker 3: So the expenses for Beyond Cancer, they'll be consolidated to Beyond Air. We own 80%, so we'll consolidate all those expenses and you'll be able to see that broken out as 20% that's not owned by Beyond Air will have to be broken out in our financials. And I think Doug, you may wanna just comment on how it's shown in the 10-Q.

So the expenses for beyond cancer.

There'll be consolidated to beyond air where we own 80%. So we'll consolidate all those expenses.

You'll be able to see that broken out.

20%, that's that's not owned by beyond there will have to be broken out in our financials and then I think Doug you may want to just comment on how it's shown in the 10-Q.

Okay.

So right now, we're consolidating 100% of beyond cancer into beyond air.

Speaker 5: So right now, we're consolidating 100% of Beyond Cancer into Beyond Air.

So when we had the $30 million investment that 20% or $6 million of flows into Noncontrolling interest.

Speaker 5: So when we had the $30 million investment, $20% or $6 million flows into non-controlling interest.

Speaker 5: And then as we generate, in this case, losses through the quarter, 20% of the losses also flow into non-controlling interest. And in future Qs and Ks, we're going to be breaking that out so that you can see the equity bridge from the $6 million in non-controlling interest to the ending position for the quarter.

And then as we generate.

This case losses through the quarter, 20% of the losses also flow into Noncontrolling interest and in future queues and case, we're gonna be breaking that out. So that you can see the equity bridge from the $30 million original two two or sorry from the $6 million noncontrolling interests to the ending position for.

For the quarter.

Thank you.

Speaker 1: And our next question comes from the line of Matt Kaplan with Lattenberg-Dalman. Please proceed with your...

And our next question comes from the line of Matt Kaplan with Ladenburg Thalmann. Please proceed with your question.

Speaker 1: Hey, thanks for taking the question and congrats to the progress. Just wanted to focus a little bit more on the PMA process ongoing. Can you give us any sense, it seems like you're basically ready to launch any day now. Can you give us a sense in terms of what the next steps are with FDA? Is it just waiting for approval? You're expecting another turn and more questions from them.

Hey, Thanks for taking my question and congrats on the progress.

Just wanted to focus a little bit more on the PMA process ongoing can you give us any sense. It seems like you're basically ready to launch any day now can you give us a sense in terms of.

Well, what what the what the next steps are with with F. D. A is it is it just waiting for approval all you're expecting another turn and more questions from them.

Speaker 3: So Matt, it's an ongoing process. So we continue to work with FDA to get to this end game of approval. So, I mean, I'm not gonna say much more than that.

So Matt it's it's it's an ongoing process. So we continue to work with F. D. A to to get to this end game of approval. So I mean, I'm not going to say much more than that.

Or no more than that let's say and.

Speaker 3: or no more than that let's say and you know as for the commercial team they're ready to go I mean if FDA were were to give us a call tonight and say uh you know you're approved on Monday Duncan's team be ready to launch it on Tuesday no problem that's not going to happen I'm just giving you an example okay yep okay uh fair enough fair enough um

You know as for the commercial team, they're ready to go I mean, if FDA where were to give US a call Tonight and say you know you're approved on Monday Duncan and his team will be ready to launch it on Tuesday, no problem, that's not going to happen I'm, just giving you an example.

Yep.

Okay Fair enough fair enough and then maybe just switching.

Speaker 1: switching to some of your programs that you have in pilot.

Switching to some of your programs that you haven't been in pilot.

Speaker 1: Once it goes, can you give us a sense in terms of the ongoing pilot study in the at-home shedding.

Stage of development long think Oh can you give us a sense in terms of the ongoing pilot study at home and in the at home setting.

Speaker 1: When do you think that study could complete and then what the next steps are for developing an NTM and kind of map that out for us a little bit? I guess you did did did announce you plan to launch additional work in COPD in the next 12 to 24 months, but we're focusing on NTM. What are the next steps?

When do you think that study could complete and then what the next steps are for developing an MTM and kind of map that out for us a little bit I guess you did did did announce you plan to.

Additional work in C O P D. In the next 12 to 24 months, but.

We're focusing on MTR, but what are the next steps there.

So what well we're going to have some data that are at a T. S and study since it is a 12 week follow up.

Speaker 3: So, you know, we're going to have some data at ATS and the study, you know, since it is a 12-week follow-up.

That will complete over the summer the last patient follow up and then it'll be a several month process to take.

Speaker 3: That'll complete over the summer, the last patient followed up, and then it'll be a several month process to take all the data and put it into a pre submission to give to FDA. We also have some some work being done in the lab. So, once we get the final.

Take all the data and put it into a pre submission to give to F. D. A.

We also have some some work being done in the lab. So once we get the final speed.

Speaker 3: sputum samples from the last patients, we'll be sending it out to a lab for further analysis, which I think is important for everyone to understand, and we wanna present that to FDA. We're gonna wait for all that data to come in.

Sputum samples from the last patient will be singing out to a lab for further analysis, which I think is important.

For everyone to understand you know and we want to present that to FDA, So you're going to wait for that data to come in go to them and run through the process and see how that will work out.

Speaker 3: go to them and run through the process and see how that'll work out. And I think sometime, you know, probably in the middle of 23 or back half of 23, we'll embark upon starting a study. And what I mean by that is, you know, we'll embark upon, you know, identifying sites and speaking with them and trying to get them up and running with

And I think some time you know probably in the middle of 'twenty, three or back half of 'twenty three will will will embark upon starting a study and what I mean by that is you know we'll embark upon you know identifying sites and speaking with them and trying to get them up and running with all the process that takes and as you know this process can take six to nine months to get to <unk>.

Speaker 3: with all the process that takes. And as you know, this process can take, you know, six to nine months to get sites up and running.

It's up and running so you know.

Speaker 3: I would look at that kind of a timeline. Could it be faster? Sure, but I really want to be cautious on this because these things do take time and it's a new...

I would look at that.

That kind of a timeline could it be faster sure, but I really want to be cautious on this because you know these things do take time.

And you know it's a new.

It's new ground for for everyone for F D. A for the physicians for their patients.

Speaker 3: It's new ground for everyone, for FDA, for the physicians, for the patients of what we're doing here. And hopefully the data will work out to be very strong and people will catch on quickly. But until that happens, I'm gonna keep that kind of a rough timeline. And you know, long fit go, as you mentioned COPD, yeah.

What we're doing here.

And hopefully the data will work out to be very strong and now people will catch on quickly, but until that happens I'm going to keep that kind of a rough timeline.

Lungs could go as.

As you mentioned COPD, Yeah, I mean.

Speaker 3: We want to do COPD as well, because this is also targeting mostly for patients at home. And obviously, we feel confident that our LungFit Pro system, which was used in this pilot study,

We want I do COPD as well because this is also.

Targeting mostly for patients at home.

And.

Obviously, we feel confident that our long fit pro system, which was used in this pilot study.

Speaker 3: will become our Lung Fit Go system is ready for prime time in the home market or we wouldn't be embarking into COPD. So we're very excited about how the machine, the system performed, how it held up, how simple it was to use, and the feedback we got from the participants.

Will become our lungs that go system.

Is ready for prime time, and the whole market or we wouldn't be embarking into COPD. So we're very excited about how the machine the system performed how it held up.

Simple it was to us.

The feedback we got from from the participants.

Speaker 3: not just the patients but also the engineers and physicians and medical staff, you know, halfway around the world from us and we were obviously managing this.

Not just the patients, but also the engineers and physicians and medical staff and all halfway around the world from US and we were obviously managing this remotely. The study. So the feedback was fantastic and this is why we're where we're now trying to push for COPD and we can get something started up this year fantastic, we'll do everything we can but it may be in 'twenty three again.

Speaker 3: remotely this study so the feedback was fantastic and this is why we're now trying to push for COPD and we can get something started up this year fantastic. We'll do everything we can but it may be in 23.

Speaker 3: Sometimes it's tough to push things really fast when it's so new for the people that you're talking to.

Sometimes it's tough to push things really fast when its so new for the people that youre talking to.

Speaker 1: Right, right. Okay, fair enough. And just to be clear, so final data from the pilot study late this year and then embark on potentially a pivotal study starting mid to second half of next year.

Alright, Okay fair enough and just to be clear so final data from the pilot study.

Late this year and then embark on a potentially I E.

Little study starting mid to second half of next year.

That makes sense I think that yeah, I don't think there'll be any patients enrolled in twenty-three, Matt I think that.

Speaker 3: I think that yeah, I don't think there'll be any patients enrolled in 23 Matt. I think that

Speaker 3: that would probably be later on because, again, it does take time to get sites moving, getting them set up, getting through IRB process and so forth. So I would look more towards maybe, you know, best case end of 23, more likely a first half of 24 type of, you know, getting paid in to a study. I think, and again, I hope it's faster than that, but, you know, these things.

That would probably be later on because again it does take time to get sites moving.

Getting them set up getting through IRB process, and so forth. So I would I would look more.

Towards maybe best case end of 'twenty, three more likely first half of 'twenty four type of you know.

Getting paid in two a study I think I and again I hope, it's faster than that but as you know these things.

Speaker 3: You know, they take time. We've surprised a few people with what we've tried to do. And, you know, we realize not everybody is up to speed on what nitric oxide is and does. But I think people are catching on based on the progress we've made over the past few years.

You know they they take time, where we've surprised a few people with what we've tried to do and.

We realize not everybody is as up to speed on what nitric oxide isn't does but I think people will get catching on based on the progress you've made over the past few years.

Speaker 1: Okay, okay, good. And then just similarly for LungFixPro, the pilot study that you have going there, help us understand kind of the next steps there in terms of, I guess you're going to have some additional data in April , but in terms of wrapping up that study and then moving to the next phase of development.

Okay. Okay. Good and then just just similarly.

One thing probably that the pilot study that you have going there.

Help us understand kind of the next steps are in terms of I guess, you can have some additional data and and and and April .

But in terms of wrapping up that study and then and are moving to the next phase of development.

And that study is.

Speaker 3: It's wrapping up now. I mean, this is the winter is.

It's wrapping up now I mean this this this is the winters.

Speaker 3: you know, we're in the, I guess the back half of the winter now. So we're wrapping this study up. And, you know, we're moving as fast as we can here. And the key for this is it's seasonal. We need to do a study that all the patients we're targeting are enrolled within the same winter season.

We're in the I guess the back half of the winter now so we're wrapping this study up.

And we're moving as fast as we can here.

And the key for this is that seasonal.

We need to do a study that is all the patients. We're targeting are enrolled within the same winter season. So we are we're fighting against the clock here to try to get things done and work with F. D. A to to get this oh.

Speaker 3: So we're fighting against the clock here to try to get things done and work with FDA to get this.

Speaker 3: Study off the ground so we can get going coming up this November So we're working on that stay tuned if we can get everything done and in time what we'll be doing a study this coming winter

Study off the ground. So we can get going coming up this November .

We're working on that stay tuned if we can get everything done in time, we'll be doing a study this coming winter.

Speaker 1: OK, great. All right, thanks for taking questions, Steve.

Okay, Great Alright.

Alright. Thanks.

For taking questions.

Thanks, Matt.

Our next question comes from the line of Ken would leave <unk> Company. Please proceed with your question.

Speaker 7: Our next question comes from the line of Yale Ken with Lake Law & Company. CONTINUE THE Pressure

Speaker 8: Good afternoon and thanks for taking the questions. I just want to follow up what the math has asked, maybe the last one, which is for the long-fit probe, the study you were talking about, would that be for pediatric or for adult, or you have not decided?

Good afternoon, and thanks for taking the questions.

I just want to follow up what the math as to maybe the last one which is therefore the lungs at probe. The study you are talking about would that be a pediatric or adult or are you all have not decided.

But I it would be for adult.

Speaker 8: Okay, and two quick questions here. First one is it's a little bit more fun, which is that have you guys give a formal name for the oncology treatment at this point?

Okay and two quick questions here.

First one is it's a little bit more fun, which is that Oh did you guys give a formal name for the oncology a freeman.

Freeman.

At this point.

So we're using Uno therapy right now.

Speaker 3: So, we're using UNO therapy right now for ultra-high nitric oxide. So, you know, we'll see how that goes, but we're calling it UNO therapy at the moment. Okay. So, not like the card game, but, you know, we'll see what we can do with it. But that's the name now, and we'll see how that progresses as we go forward.

Our ultra high nitric oxide.

So you know, we'll see how that goes but we're calling it no therapy at the moment.

Okay. So.

Not like the card game, but you know what.

We will see what we can do with it but that's the name now and we'll see how that progresses as we go forward.

Speaker 8: And last question here is just actually for Duncan. I'm just curious in terms of for the long-term care, as you promote that, do you potentially will go through some of the group purchasing organization or that's purely not relevant and just go to each hospital specifically?

And our last question here is just a caseload.

I'm just curious in terms of Oh, the philosophy P. H a few a promote debt do you potentially will go through some of the group purchasing organization or that's totally not irrelevant and it just go to each hospital specifically.

Yeah. Thanks for the question Yeah I'll just a reminder, we are definitely not promoting the product right now obviously, it's I understand.

Speaker 4: Yeah, thanks for the question, Yale. Just a reminder, we're definitely not promoting the product right now, obviously. I understand. After your lunch.

Yeah, I'll say along to that.

Speaker 4: But for the record, but certainly going forward, of course, we will engage with buying groups as appropriate because we have a phase launch, the initial phase, that group of hospitals I mentioned that there's certainly not going to be any of those kinds of arrangements in place.

For the record.

But certainly going forward of course, we will engage with.

Buying groups as appropriate because we have a phased launch the initial phase that group of hospitals I mentioned, they are certainly not going to be any of those kind of.

Arrangements in place, but definitely have been context from various groups and a lot of the key hospitals that you would know around the country has a lot of interest in our technology.

Speaker 4: But there definitely have been contacts from various groups and a lot of the key hospitals that you would know around the country. There's a lot of interest in our technology and we will negotiate and discuss that with them accordingly. But reinforcement that we don't expect to be competing on price, we're focused very much on the benefits.

And we will.

Negotiate and discuss that with them accordingly, but reinforcement, though we don't expect to be competing on price with focus very much on the benefits that we provide both potentially clinically logistically in terms of patient workplace.

Speaker 4: that we provide both potentially, clinically, logistically, and in terms of patient workflows. So, that's a long yes.

That's a that's a long, yes, but not now.

Speaker 8: I understand. And maybe just squeezing one more. In terms of long fit goal, in terms of the level of nitrox that is based on PPM, is that the same work for the NTM versus the COPD or they could be different?

And maybe just squeezing one more in terms of long fit our DAU in terms of the level that the P. P.

The level of I taught science based on P. P. M is that the same workflow the N T M versus the C O P D or they could be different.

<unk>.

Speaker 3: Thanks, Yael. So for NTM, we titrate up to 250 parts per million.

Thanks, Yeah. So for N P M. We titrate up to 250 parts per million.

Speaker 3: For patients with underlying COPD who have lung infections that cause severe exacerbations, again, we'd be treating.

For for patients with underlying COPD, who have lung infections that cause severe exacerbations again, we'd be treating.

Speaker 3: the exacerbation, not the underlying disease of COPD. We haven't decided on where that.

The exacerbation not the underlying disease of COPD we.

We haven't decided on where that.

Speaker 3: ultimate high end of the range will be for treatment but it obviously will be at at least 150 parts per million minimum so it could be 200 or 250 we're just not sure yet but I don't think we can go above 250 parts per million just yet so that'll probably be the highest we possibly would go at this moment in time.

Ultimate high end of the range will be for treatment, but it obviously it'll be at least 150 parts per million minimum.

So it could be 200, or 250 were just not sure yet but I.

And I don't think we can go above 250 parts per million just yet so that'll probably be the highest and possibly would go at this moment in time.

Speaker 3: It's not machine related, it's not a device related. It's more of a, you know, what we've learned so far that we're able to do with staying within safety parameters.

It's not machine related device related it's it's more of a you.

What what what we've learned so far that the.

We're able to do with staying within safety parameters.

Speaker 8: Okay, great. That's very helpful. Again, congrats on the progress and look forward to launch.

Okay, Great. That's very helpful again, congrats on the progress and look forward to lunch.

Thanks, Jeff.

Yes.

Speaker 7: Again, as a quick reminder, if you have any questions, you may press star 1 on your telephone.

And as a quick reminder, if you have any questions you May press star one on your telephone keypad.

Speaker 7: The next question comes from the line of Scott Henry with Rive Capital. Please proceed with your time.

Next question comes from the line of Scott Henry with Roth Capital. Please proceed with your team.

Yeah.

Speaker 8: Thank you, and good afternoon. Just a couple questions. Most of mine have been.

Thank you and good afternoon, just a couple questions most of mine have been.

Speaker 8: answered already uh... i guess uh... for doug a couple modeling questions uh... first gene a with certainly above trend in third quarter uh... he's there one-time events in there from the beyond cancer uh... transaction or you know perhaps maybe

Answered already I guess for Doug a couple of modeling questions.

First G&A was certainly above trend in third quarter.

Is there some one time events in there from the beyond cancer.

Transaction or perhaps maybe.

Speaker 8: it should take a step up as you have that entity as well, just trying to get a sense of how to think about the GNA going forward.

It should take a step up as as you have that entity as well just trying to get a sense of how to think of G&A going forward.

Speaker 5: Sure, yeah, no problem. Thanks for the question. So there were a couple things that happened in there. Certainly the setup of the cancer business did generate some legal fees, especially some one-time costs around that creation.

Sure no problem. Thanks for the question. So there were a couple of things that happened in there certainly the setup of the cancer business did generate some legal fees, especially you know some onetime costs.

Around that creation.

You may have noticed we didn't use a bank, but that didn't keep the keep the legal fees down.

So we did have those we also had a restricted share grants in the quarter.

Speaker 5: And the way we account for that, so this is a non-cash item obviously, but the way we account for that is we take each tranche

And the way we the way we account for that so this is a noncash item obviously, but the way we account for that is we take each tranche.

And spread it over the life of the tranche and so whenever we have a grants we have a pick up on it.

Through the P&L, that's that's a fairly significant so between those two items that explains the biggest chunk of the increase.

Okay, Great and you did mention the warrant transactions, particularly in January and.

I haven't seen the Q, yet, but could you give us a sense of where the real time shares are.

Today.

You mean, how many shares are out.

Standing in real life.

Speaker 3: Yeah, so we just put up the shelf registration. So the share count is in there. I believe it's actually the queue as well as 29.8 million. Yeah, there you go. Yeah. I think it's, it's almost the same as what we had in there. The shelf... rushlife. To principled 35.5 million.

Yeah. So we just put up a shelf registration so the share count is in there I believe it for space next year as well as $29 8 million yeah. They go Oh, Yeah, I think it's it's almost the same as what we had on the shelf, but yeah yeah. Okay.

Perfect. Thank you. Our final question I think you've talked about this in the past, Steve, but as we get closer to potential launch how.

Speaker 8: perfect thank you uh... final question uh... i think you've talked about this in the past eve but as we get closer to potential launch uh... how would you kind of categorize the manufacturing capacity capacity any supply issues or you feel pretty good about that for the

How would you kind of categorize the manufacturing capacity any capacity any supply issues or you feel pretty good about that for the considerable future.

Speaker 3: So I think for the first six to nine months of our focused launch, we're all set. I think

So I think for the first six to nine months of our of our focused launch where we're all set I think you know.

Speaker 3: There's nothing really that concerns us with respect to supply or manufacturing capacity for that timeframe. But as we go beyond that, we have to manage the supply chain. I don't think our capacity, our actual manufacturing capacity is fine. It's really supply chain. I mean, there are still things that are difficult to source out there. I'm sure we're not the only company to say that, nor is our industry the only one to have the problem. I think things are getting a little bit better. But even with the arrived demand in this next few months, I do think this is worth my time answer. That's the thing. Not this year, I believe, that live brands are going to have Hats off right now. It's been going on for billions of years. Ok, I'm going to keep watching lots of pings, and Santas is on a run, and we've got a lot of money in Aging. We'veously Almost got good surprises just met by ABC Greueler. Think of everything we've seen and seen.

Shouldn't there's nothing really arent that concerns us with respect to supplier manufacturing capacity for that timeframe, but as we go beyond that.

You know we have to manage the supply chain I don't think our capacity our actual manufacturing capacity is fine it's really supply chain I mean, there's still there are still things that are difficult to source out there I'm sure. We're not the only company to say that nor has our industry. The only one to have the problem.

Things are getting a little bit better and you know I hate to say it but I mean, I wish we had approval already but there's a little bit of a push out has helped us to be able to source. Some of these things. So that we do feel more comfortable going beyond that first six to nine months. So we do feel a little bit better about that but I don't want to say, it's it's something that isn't a concern it has to be.

Speaker 3: You know, I hate to say it, but I mean, I wish we had approval already. But, you know, this little bit of a pushout has helped us to be able to source some of these things so that we do feel more comfortable going beyond that first six to nine months. So we do feel a little bit better about that, but I don't want to say it's.

Speaker 3: it's something that isn't a concern. It has to be a concern given the environment, you know, in the world right now. So, but we're certainly comfortable to get through the first phase and enter the second phase of our launch, but I don't want to be too bold and say it's not an issue, but I'm very comfortable with the team and the,

Insert given the environment.

In the World right now so, but we're certainly comfortable to get through the first phase and into the second phase of our launch.

But I don't want to be too bold and say, it's not an issue, but I'm very comfortable with the team and the b.

Speaker 3: the things that they put in place to make sure that we're gonna do okay in the next, you know, two to three years with supply chain. I'm actually...

The things that they've put in place to make sure that we're going to we're going to do okay. In the next two to three years with supply chain I'm actually.

Speaker 8: quite impressed with the team. Glad I have them because they know more than me. So it's a good thing. Okay, great. Thank you for the color and thank you for taking the time.

Quite impressed with the team glad to have them because they know more than me.

Good thing.

Okay, great. Thank you for the color and thank you for taking the questions.

Thanks Scott.

Yeah.

And we have reached the end of the question and answer session I will now turn the call over to Steve Lisi for closing remarks.

Speaker 7: And we have reached the end of the question and answer session. I'll now turn the call over to Steve Leecy for a closed room.

Thanks, everyone for joining today much appreciated and we look forward to the next time, we speak.

Speaker 3: Thanks everyone for joining today. Much appreciated and we look forward to the next time we speak.

And this concludes today's conference and you may disconnect. Your lines at this time. Thank you for your participation.

Speaker 7: And this concludes today's conference and you may disconnect your lines at this time. Thank you for your participation.

Speaker 9: ?

[music].