Q1 2022 Titan Medical Inc Earnings Call

[music].

Good morning, ladies and gentlemen, and welcome to Titan Medical's cross-quarter 2022 earnings conference course. At this time, all participants are in mission only mode.

Good morning, ladies and gentlemen, and welcome to Titan Medical fourth quarter 2022 earnings Conference call.

At this time, all participants are in listen only mode.

After the presentation, there will be an opportunity for co-participants to ask questions.

After the presentation there'll be an opportunity for participants to ask questions.

If anyone should require operator assistance during the conference, please press star and then zero on your telephone keypad. As a reminder, today's conference...

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

As a reminder, today's conference is being recorded.

I will now turn the conference over to Kristin Galchetti, Python Medical Vice President of Industrial Relations and Corporate Communication.

I will now turn the conference over to Kristen Bell catchy hygiene medical Vice President Investor Relations and corporate Communications. Please proceed.

Thank you, Gennay. Good morning, everyone, and thank you for joining us for Titan Medical's First Quarter 2022 Earnings Conference Call. Early this morning, we issued a press release summarizing Titan's First Quarter 2022 financial results and business highlights. A copy of the release can be found in the Investor Relations section of our website at www.titanmedicalinc.com.

Thank you Denise good morning, everyone and thank you for joining us for Titan Medicals first quarter 2022 earnings conference call.

Early this morning, we issued a press release summarizing tightens first quarter 2022 financial results and business highlights a copy of the release can be found in the Investor Relations section of our website at Www tightened Medical Inc. Dot com.

As a reminder, certain statements made during this conference call constitute forward looking statements that reflect management's current expectations of the company's future growth results.

As a reminder, certain statements made during this conference call constitute forward-looking statements that reflect management's current expectations of the company's future growth, results of operations, performance and business prospects, and opportunities. Forward-looking statements involve significant risk, uncertainties, and assumptions.

Results of operations performance and business prospects and opportunities forward looking statements involve significant risks uncertainties and assumptions many factors could cause the company's actual results performance or achievements to be materially different from any future results performance or achievements that may be expressed or implied by such forward looking statements, including without.

Many factors could cause the company's actual results, performance, or achievements to be materials different from any future results, performance, or achievements that may be expressed or implied by such forward-looking statements, including, without limitation, those listed in the caution regarding forward-looking statements and risk factors section of the company's annual report on Form 20F for the fiscal year ended December 31, 2021, which may be viewed at cedar.com and at sec.gov.

Patients those listed in the caution regarding forward looking statements and risk factors section of the company's annual report on form 20-F.

So year ended December 31, 2021, which may be viewed at theater dot com and at SEC Gov.

Please read all formative statements and risk cautions in these sections, and in today's news release, announcing our financial and operating results, and be guided by their contents in making investment decisions or recommendations. The news release is available at www.titanmedicalinc.com.

Please read our forward looking statements and risk Washington infections and in today's news release announcing our financial and operating results and be guided by their contents in making investment decisions or recommendations. The news release is available at Www Dot tightened Medical Inc. Dot com.

With that, I'll turn the call over to Paul Taddeford, Titan's intern president and chief executive officer.

With that I'll turn the call over to Paul Patterson, Tightens interim President and Chief Executive Officer Paul.

Thank you, Kristin. Good morning, everyone, and welcome to Titan Medical's first quarter 2022 financial update call. Also joining me today on the call is Stephen Lemieux, our Chief Financial Officer.

Thank you Christian good morning, everyone and welcome to Titan Medical's first quarter 2022 financial update call also joining me today on the call are Steven Lemieux, our Chief Financial Officer.

Today, we'd like to share with you our recent accomplishments and discuss what we see on the horizon for tight medical. As many of you are familiar, we are a leading innovator at single access robotic assisted surgery, having designed our, you know, surgical system from the ground up utilizing proprietary technology that's protected by a broad patent portfolio trade secrets and know how.

Today, we'd like to share with you our recent accomplishments and discuss what we see on the horizon for Titan medical as many of you are familiar we are a leading innovator in single access robotic assisted surgery, having designer you know surgical system from the ground up utilizing proprietary technology that is protected by our broad patent portfolio trade secrets and know how.

Our Eno system has been designed to develop to make surgical procedures easier, more comfortable, and more effective for surgeons to improve outcomes for patients by reducing the number of incisions or access points, resulting in smaller and fewer scars, faster recovery, and less pain and trauma, and to drive adoption at hospitals by lowering costs, decreasing the size of the equipment, and increasing efficiency.

Our email system has been designed and developed to make surgical procedures easier more comfortable and more effective resurgence to improve outcomes for patients by reducing the number of incisions are access points, resulting in smaller and purer scars faster recovery and less pain and trauma and to drive adoption at hospitals by lowering costs decreasing the Si.

Of the equipment and increasing efficiency.

We have developed our surgeon workstation with ergonomics in mind. We have created a workstation which allows the surgeon to openly interact with operating room team members. The surgeon interface, foot pedals, hand controllers, and the 3D HD screen for displaying images of the surgical site and graphical overlays are easy to learn and master. A dexterous and extendable 3D HD camera and precision instruments convert easy-to-learn and natural hand gestures to accurate surgical movements.

We have developed our surgeon workstation with economics in mind, we have created a workstation, which allows the surgeon to openly interact with operating room team members. The surgeon interface like pedals hand controllers in that three D. H D screen for displaying images of the surgical site and graphic.

Graphical overlays are easy to learn and master or dexterous, and extendable three D HD camera and precision instruments convert easy to learn and natural hand gestures accurate surgical movements.

The instruments have been designed to allow surgeons to operate close to the abdominal wall or entry point in a tight surgical volume, but also extend to increase versatility when required without having to reposition the patient cart.

The instruments have been designed to allow surgeons to operate close to the abdominal wall. Our entry point in a tight surgical volume, but also extend to increased versatility when required without having to reposition the patient cart.

The EnoSystem patient card is designed to deliver an integrated 2D HD camera with illumination in addition to a steerable 3D HD endoscope camera with illumination and two multi-articulating instruments through a single 25mm incision. Additionally, the patient card is designed to offer a swift docking, multi-quadrant positioning, easy to load instruments, and easy draping. We believe these features will allow hospitals to turn over the surgical suites faster and more efficient.

System patient card is designed to deliver an integrated <unk> HD camera with elimination. In addition to our sterile <unk> HD endoscope camera with illumination and two multi articulating instruments through a single 25 millimeter incisions. Additionally, the patient card is designed to offer a swift docking multi quadrant.

<unk> east load instruments and easy draping. We believe these features will allow hospitals to turnover the surgical suites faster and more efficiently.

The market for robotic assistance and surgical systems is robust and continues to grow. And while the install base for single access, like the Eno system, is somewhat small in comparison to multi-port systems, we believe the opportunity for single access will eventually overtake the multi-port install.

Market for robotic assisted surgical systems is robust and continues to grow and while the installed base for single access like Dino system is somewhat small in comparison to multiport systems. We believe the opportunity for single access will eventually overtake the multiport install base, we're initially targeting gynecology indications where the benefits.

were initially targeting gynecology indications where the benefits for single access are likely most impactful. We intend to follow up with urology and other indications upon regulatory clearance and launch of the ENO.

For single access are likely most impactful, we intend to follow up with urology and other indications upon regulatory clearance and launch of the emails.

Based on a wide range of pre-clinical studies and discussions with leading surgeons, we are confident that the EnoSystem will eventually be used in a number of procedures. Our Surgeon Advisory Board, comprised of leading laparoscopic and robotic surgery surgeons, continues to provide feedback, insight, and direction on where the EnoSystem and underlying technology might be applied to address unmet needs and applications.

Based on a wide range of preclinical studies and discussions with leading surgeons. We are confident that the email system will eventually be used in a number of procedures are surgeon advisory board comprised of leading laparoscopic and robotic assisted surgery surgery surgeons continues to provide feedback insight and direction on where the <unk> system and <unk>.

Underlying technology might be applied to address unmet needs and applications. We are proud of our team here at Titan, who through tireless work creativity and commitment remain on track with our project plan and regulatory approval path. We're also grateful to our many partners and collaborators who are all assisting in our mission to bringing email system to market.

We are proud of our team here at Titan Zoo. Through tireless work, creativity, and commitment, we remain on track with our project plan and regulatory approval path. We are also grateful to our many partners and collaborators who are all assisting in our mission to bringing Eno's system to market.

During the first quarter of 2022, and the weeks leading up to today tightened has accomplished quite a bit we announced a purchase order with Medtronic that covers the purchase of instruments and cameras there'll be used in preclinical activities and the evaluation of Titan medical has it.

During the first quarter of 2022 and the weeks leading up to today, Titan has accomplished quite a bit. We announced a purchase order with Medtronic that covers the purchase of instruments and cameras that will be used in preclinical activities and the evaluation of Titan Medical has a potential manufacturing and supplying partner for Medtronic.

Manufacturing and supplying partner for Medtronic, we believe that this purchase is strategic benefits for our company highlighting the confidence of third parties in our technology and Knowhow and single asset surgery, and providing further reason to build and expand on our in house manufacturing capabilities.

We believe that this purchase has strategic benefits for our company, highlighting the confidence of third parties in our technology and know-how in single-axis surgery and providing further reason to build and expand on our in-house manufacturing capability.

We completed another preclinical lab study adding to the over 80 procedures already completed. These labs not only provide additional surgeon validation, but real-time feedback on some of the recent improvements we've made to the vision system and electrical energy instrumentation. In this most recent lab, new insights on how a traditional laparoscopic surgeon adapts to robotic surgery will be helpful as we develop training programs for our human clinical trials after our ID submission.

When complete we completed another preclinical lab study, adding to the over 80 procedures already completed these labs not only provide additional surgeon validation, but real time feedback on some of the recent improvements we've made to the vision system and electrical energy instrumentation. In this most recent lab new insights on how a traditional laparoscopic.

Opex surgeon adapts to robotic surgery will be helpful. As we develop training programs for our human clinical trials after our IDE submission.

Our interactions with the FDA continue to be productive and informative as we use the Q submission process. In the quarter, we completed another conference call with the FDA after submitting a Q submission at the end of last year. The company anticipates submitting another Q submission later this year.

Our interactions with the FDA continue to be productive and informative as we use the Q submission process in the quarter. We completed another conference call with the FDA after submitting a key submission at the end of last year. The company anticipates submitting another key submission later this year.

Transfer to manufacturing continues as we continue with our product development. The company completed the final design transfer to benchmark of capital equipment, a surgeon workstation and patient cart, and is working to finalize selection for contract manufacturers for draping and consumable.

Transfer to manufacturing continues as we continue with our product development. The company completed the final design transfer da benchmark of capital equipment, a surgeon workstation and patient card and is working to finalize selection for contract manufacturers for draping and consumables.

The permanent CEO search is progressing well. The board ad hoc CEO selection committee has now met with a number of qualified candidates with a few moving to a leadership assessment analysis.

The permanent CEO search is progressing well the boards AD hoc CEO selection Committee has now met with a number of qualified candidates with a few moving to a leadership assessment analysis, we continue to evaluate options to address the NASDAQ notification regarding minimum bid price deficiency.

continue to evaluate options to address the NASDAQ notification regarding minimum bid price deficiencies.

Finally, Steven and I participated in the Blume-Burton and Company Health Care Investor Conference in Toronto on May 2nd, 2022, where I had the opportunity to present, and we encourage you all to listen to the webcast, which is available on our website.

Finally, Stephen and I participated in the Bloom Burton <unk> company, a health care Investor Conference in Toronto on May 2nd 2022, where I had the opportunity to present and we encourage you all to listen to the webcast, which is available on our website.

Our timeline for commercialization remains unchanged and we continue to evaluate this timeline on a regular basis to mitigate against uncontrollable items. As previously outlined we are proceeding with plans for marketing authorization utilizing the novo classification request pathway.

Our timeline to commercialization remains unchanged, and we continue to evaluate this timeline on a regular basis to mitigate against uncontrollable items. As previously outlined, we are proceeding with plans for marketing authorization, utilizing the DeNovo classification request pathway.

communications with the FDA have been informative and productive. We currently plan to file the IDE application with the FDA in the first quarter of 2023 and anticipate receiving a response on the IDE from the FDA in the first half of 2023. Following IDE approval, we expect to start the IDE human clinical trial or human clinical study in the second half of 2022.

Our communications with the FDA have been informative and productive we currently plan to file the IDE application with the FDA in the first quarter of 2023 and anticipate receiving a response on the <unk> from the FDA in the first half of 2023.

Following <unk> approval, we expect to start the <unk> human clinical trial for human clinical study in the second half of 2023.

We anticipate, given what we know today, that our ID clinical study will include total laparoscopic hysterectomies performed on 30 to 40 patients at three to four clinical sites.

We anticipate given what we know today that our IDE clinical study will include total laparoscopic hysterectomies performed on 30 to 40 patients at three to four clinical sites. Upon completion of the clinical study we plan to submit the de Novo classification request with the FDA in 2020 for commercial launch of the email system is.

Upon completion of the clinical study, we plan to submit a de novo classification request with the FDA in 2024. Commercial launch of the E-NOS system is scheduled to begin upon receipt of marketing authorization from the FDA anticipated in early 2025. I've got to tell you, it's a privilege to work with such a committed and talented team.

Scheduled to begin upon receipt of marketing authorization from the FDA anticipated in early 2025 I've got to tell you. It's a privilege to work with such as committed and talented team.

Our capital equipment manufacturing partner Benchmark continues to perform. Our engineering, procurement, regulatory and quality management team are fully integrated with their team and working well with their Benchmark counterparts.

Our capital equipment manufacturing partner benchmark continues to perform our engineering procurement regulatory and quality management team are fully integrated with their team and working well with their benchmark counterparts. While we all remain concerned about the ongoing Ukraine, Russia conflict market instability, COVID-19 variance supply chain issues and a tightening labor.

While we all remain concerned about the ongoing Ukraine-Russia conflict, market instability, COVID variants, supply chain issues, and a tightening labor market, we continue to diligently monitor these factors, trying to mitigate risk and impact where we are able.

We continue to diligently monitor these factors trying to mitigate risk and impact where we are able.

We remain optimistic as we look at the long-term opportunity for our company and our shareholders. We believe that our innovative and differentiated single access, robotic assisted, you know, surgical platform once cleared by the FDA will be well received by surgeons and hospital.

We remain optimistic as we look at the long term opportunity for our company and our shareholders. We believe that our innovative and differentiated single access robotic assistance.

Surgical platform once cleared by the FDA will be well received by surgeons and hospitals.

Our intellectual property portfolio, our knowledge and experience, and our talented team all continue to grow. Partnerships with companies like Medtronic tell us we're on the right path, and our role and contribution to single-access robotic-assisted surgery technology industry is meaningful and needed. Steve and I look forward to participating in additional investor conferences and meeting with current and new institutional investors as market conditions improve and in-person meetings come back into favor.

Our intellectual property portfolio, our knowledge and experience and our talented team all continue to grow partnerships with companies like Medtronic tell us we're on the right path and our role and contribution to single axis robotic assisted surgery technology industry is meaningful and need it Steve and I look forward to participating in additional investor conferences.

Meeting with current and new institutional investors as market conditions improve and in person meetings come back into favor.

Our increased investor outreach activities and focus on developing Titan's narrative for the EnoSystem have resulted in increased coverage by health technology journalists. Our story on how the EnoSystem is positioned to positively impact patient outcomes provided performance benefits to surgeons and improve hospital economics is resonating.

Our increased investor outreach activities and focus on developing tightens narrative for the email system have resulted in increased coverage by health technology journalists. Our story on how the ecosystem is positioned to positively impact patient outcomes provide performance benefits to surgeons and improve hospital economics is resonating.

I'll now turn the call over to Steven Lemieux, our Chief Financial Officer, to review our financial results. Steven?

I will now turn the call over to Steven <unk>, Our Chief Financial Officer to review our financial results Steven.

Thank you, Paul. In the following discussion of results, please note that all numbers are in U.S. only.

Thank you Paul.

The following discussion of results. Please note that all numbers are in U S dollars.

As of March 31st, 2022, we had cash and cash equivalents of $30.1 million, a $2.2 million decrease from $32.3 million at December 31st, 2021.

As of March 31, 2022, we had cash and cash equivalents of $31 million or $2 2 million decrease from $32 3 million at December 31, 2021.

In the quarter, an operational cash burn of $10.2 million was partially offset by the $8.3 million received from Medtronic in January . We continue to anticipate that our cash on hand will fund operations into Q1 2022.

In the quarter and operational cash burn of $10 2 million was partially offset by the $8 3 million received from Medtronic in January .

We continue to anticipate that our cash on hand will fund operations into Q1 2023.

Total expenses were $12 1 million in the quarter, a slight increase from $11 8 million in Q1 2021.

Total expenses were $12.1 million in the quarter, a slight increase from $11.8 million in Q1 2021.

Research and development expenses were 78 percent of total operating expenses, compared to 65 percent in the comparative period. This shows an effort by the company to focus more resources on the development of the ENO system.

Research and development expenses were 78% of total operating expenses compared to 65% in the comparative period.

This shows an effort by the company to focus more resources on the development of the <unk> system.

R&D expenses were $9 4 million in the first quarter of 2022 compared to $7 6 million for the three months ended March 31, 2021 in the quarter. The company's R&D expenses, we're focused on finishing product development and transferring key components of the ecosystem to manufacturer.

R&D expenses were $9.4 million in the first quarter of 2022 compared to $7.6 million for the three months ended March 31st, 2021. In the quarter, the company's R&D expenses were focused on finishing product development and transferring key components of the ENO system to manufacturers.

In the comparative period, R&D expenses related to the development of the ENO system and the development work required to achieve the milestones under the development agreement with MENTRONIC.

In the comparative period R&D expenses related to the development of the <unk> system and the development work required to achieve the milestones under the development agreement with Medtronic.

GNA expenses decreased to $2.5 million for the first quarter of 2022 compared to $4.1 million for the comparative period. The decrease in GNA expenses in the quarter is related to a decrease in professional and consulting fees of $0.9 million and a decrease in stock-based compensation of $0.2 million.

G&A expenses decreased to $2 5 million.

For the first quarter of 2022 compared to $4 1 million for the comparative period.

The decrease in G&A expenses in the quarter is related to a decrease in professional and consulting fees of <unk> 9 million and a decrease in stock based compensation of $1 2 million.

Our team has been diligently improving and streamlining our processes that have resulted in efficiencies and savings across the company, as evident in our financial statements this quarter. We have and will continue to resource programs that support reaching our corporate goals.

Our team has been diligently improving and streamlining our processes that have resulted in efficiencies and savings across the company.

As evident in our financial statements this quarter.

And we will continue to resorts programs that support reaching our corporate goals.

We also continue to investigate capital market options that will support financing the ENO system through the de novo regulatory pathway. We plan to share the results of this work

We also continue to investigate capital market options that will support financing system through the de Novo regulatory pathways.

We plan to share the results of this work in the coming quarters.

Tightens accomplishments are significant and support our continued shift from product development working with manufacturing partners and in house talent to build the ecosystem for planned use of IV clinical trials and ultimately commercialization with that I will turn the call back over to Paul.

Titans accomplishments are significant and support our continued shift from product development to working with manufacturing partners and in-house talent to build the ENO system for planned use in IDE clinical trials and ultimately commercialization. With that, I will turn the call back over to Paul.

Thank you, Stephen. In summary, we remain on track with our timeline tomorrow.

Thank you Steven.

In summary, we remain on track with our timeline to market. Our team is engaged committed and performing our product is designed to address clearly understood market needs and requirements and will provide the economic benefits hospitals demand are.

team is engaged, committed and performing. Our product is designed to address clearly understood market needs and requirements and will provide the economic benefits hospitals demand. Our single-axis surgical technology is innovative and protected by a broad portfolio of patents.

Our single Axis surgical technologies innovative and protected by a broad portfolio of patents we'd.

We'd like to thank our board, our partners, our employees, and most importantly, our patient shareholders. We will continue on our mission to get the email system to market as safely and as soon as possible. We'll now open the line for questions.

We'd like to thank our board our partners our employees and most importantly, our patient shareholders. We will continue on our mission to get the email system to market as safely and as soon as possible.

I'll now open the line for questions operator.

Inclusive. At this stage, we will be conducting a question and answer session. If you would like to ask a question, please press star and then one on your telephone keypad for confirmation tone or indicate your line is in the question.

Thank you Sir.

At this stage, we will be conducting a question and answer session.

I would like to ask a question. Please press star and then one on your telephone keypad unconfirmed.

A confirmation tone will indicate your line is in the question queue.

We will press star and then two if you would like to remove your question from the chat.

You May press Star and then two if you would like to move your question from the queue.

for participants using speaker equipment, it may be necessary to pick up your handset before pressing the stop.

For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star.

The first question we have is from Siraj Kalyar from Oppenheimer and Co. Please go ahead. Morning, everyone.

The first question you had.

It's from Suraj Kalia from Oppenheimer <unk> co. Please go ahead.

Good morning, everyone. Paul can you hear me all right.

I can hear you great. Thanks.

Perfect. Hey, Paul Sue, the Q sub, right? If I got your comments right,

Perfect Hey, Paul So the Q sub right. It's if I got your comments right.

There was another Q sub file and I'm curious to know more about that. Our understanding is if let's say you know the Q sub lasts 75 days at least when the FDA has to you know give you some response as to the next step.

There was another CUSIP by CUSIP filed.

And I'm curious to know more about that our understanding is that if let's say.

Q sub last 75 days at least been the FTE of Caf II.

Give you some responds as it did in the next steps. So I'm curious what happened in the first Q. So why is the second Q sub needed, especially if you're going down the de Novo five 10-K, Rob.

So I'm curious, what happened in the first Q-sub? Why is the second Q-sub needed, especially if you're going down a DeNovo 510K route?

Yeah, no, thanks for the questions rush. It's what we're doing is the last Q sub was filed in December and then and then as you point out they have a time limit when they need to respond and then they set up a one hour conference call with what we typically do with these Q submission.

Yeah no. Thanks for the question Suraj.

What we're doing as a last kiss up was filed in December and then and then as you point out they have the time limit when they need to respond and then they set up a one hour conference call.

We typically do with these Q submissions is we posed a number of questions and we put together some some responses and we look for reassurance, our comfort from the FDA or an answer to the question. The questions that we targeted at in December were related to the clinical trial protocol.

We pose a number of questions and we put together, you know, some responses and we look for reassurance or comfort from the FDA or, you know, an answer to the question.

The questions that we targeted in December were related to the clinical trial protocol and a few other issues as it relates to new usage for the human clinical trials. The next set of Q-subs, and by the way, you're allowed to do as many Q-subs as you like. It's the mechanism that the FDA uses.

And a few other issues as it relates to.

Usage for the human clinical trials.

A set of Q subs and by the way Youre allowed to do as many Q subs as you like it.

It's the mechanism that the FDA uses to encourage questions and clarifications. The next set of Q subs relates to some of our validation verification testing, which will begin after receipt of the capital equipment at the end of July early August and so we've posed a number of questions, making sure that our verification valid.

to encourage questions and clarification.

The next set of Q-subs relates to some of our validation verification testing, which we'll begin after receipt of the capital equipment at the end of July , early August . And so we've posed a number of questions, making sure that our verification validation techniques are valid, and so we'll be using that Q-submission process.

Validation techniques are are valid and and so we'll be using that Q submission process again.

Got it.

about one additional question in terms of being a potential manufacturing and supply partner for Metronix. I'd love to get some perspective. Is this for a separate Metronix platform? Is this for the Hugo or any addition color would be greatly appreciated? Thank you for taking my question.

One additional question in terms of being a potential manufacturing and supply partner for Medtronic.

I'd love to get some perspective is this for a separate medtronic platform.

Is this for the Hugo or any additional color would be greatly appreciated. Thank you for taking my questions.

Yeah, no, thanks again for the follow-up question. Yeah, I mean, we don't know because the Metronica have given us what platform or what their commercialization strategy is.

Thanks again for the follow up question.

I mean, we don't know because the medtronic have been given us.

What platform are what their commercialization strategy is.

but really the supply of instruments and cameras and the evaluation of this instrument and cameras really is a follow on from the,

But really the supply of instruments and cameras and the evaluation of this instrument and cameras.

Really as a follow on from from the from.

The last engagement, we have with milestone running through most of 2021.

last engagement we had with Milestone running through most of 2021. So yeah, the short answer is we don't know what platform they intend to commercialize on, but it's just the evaluation of those instruments and cameras.

So, yes, I mean.

Short answer is we don't know what platform the intend to commercialize on but it's just the evaluation of those instruments and cameras.

Thank you.

Thank you Sir.

Ladies and gentlemen, please do remind us if you would like to ask a question, please press star and then one.

Ladies and gentlemen, just a reminder, if you would like to ask a question. Please press Star then one.

We'll pause the moment to see if we have any further questions from the conference.

We'll pause a moment to see if we have any further questions from the conference.

We have a couple questions from the webcast that I can share.

We have a couple questions from the webcast and I can share.

Please go ahead ma'am.

The first question is, with the rebooting of Titan Medical's Regulatory Division, do you feel confident that everything is in place to ensure a smooth pathway to IDE application for the Eno system? Yeah, I don't know.

So the first question is with the rebuilding of tightened medical and regulatory Division do you feel confident that everything is in place to ensure a smooth pathway to IV application for the <unk> system.

Yes, thanks for the question Kristen.

I mean, it's never a smooth pathway, I'll be honest, but the team is in place anticipating questions from the FDA.

Yes.

It's never a smooth pathway I'll be honest.

But the team is in place anticipating questions from the FDA.

You're putting all the infrastructure that's required for our quality management system and putting together the innovation innovation device exemption application. So the team is its a significant team now and.

So the team is, it's a significant team now and I think it's seven or eight people run by Tammy and, you know, they are, they're anticipating questions in advance. I've talked earlier about the Q submission process and taking full, full advantage of that to engage the FDA and get clarification. So, I think it's as smooth as it could possibly go. And the next question is, perhaps for Stephen, could you comment on the monthly burn rate and describe what we might be able to do in the future?

They get seven or eight people run by Tammy.

They are they are anticipating questions in advance I talked earlier about the Q submission processes and taking full advantage of that to engage the FDA and get clarification. So I think it is as smooth as it can possibly go.

And the next question is perhaps for Stephen, could you comment on the monthly burn rate and describe what we might be expecting there in the future?

And the next question is perhaps for Steven could you comment on the monthly burn rate and describe what we might be expecting there in the future.

Sure. Thanks, Kristen. Yeah. So in this quarter, we burn just over 10 million. We expect the burn to be lumpy over the next few quarters because in Q2, Q3, we'll start

Sure. Thanks Christian yes, so in this quarter, we burn.

Just over $10 million, we expect the burn to be lumpy over the next few quarters because in Q2 Q3, we'll start.

receiving capital equipment, but then our internal burn to transfer to capital will decrease so we

Receiving capital equipment, but then our internal burn to transfer to capital will decrease so we.

We had $30 million to cash it the end of the quarter we expect that cash is going to last us into the first quarter of next year and then our burn on average somewhere in the eight to 10 million range of quarter.

We had $30 million of cash at the end of the quarter. We expect that cash is going to last us into the first quarter of next year and then our burn on average somewhere in the $8 million to $10 million in each quarter.

And Paul touched on this a little bit, perhaps give an update on where we are with the new CEO search.

And Paul touched on this a little bit perhaps give an update on where we are with the new CEO .

Search.

Yeah, no, I've already covered that off on the call, Kristen, and thanks for the call. But the ad hoc committee has been evaluating candidates using a top tier recruiting organization. And we've moved a few of the candidates into a leadership assessment process. And just making sure that we have, you know, a good fit with a number of candidates with our company culture and where we're going as an organization.

Yes no.

I've already covered that off on the on the call Christian and thanks for the call, but the AD hoc committee has been.

In evaluating candidates using our top tier recruiting organization and we've moved a few of the candidates into a leadership assessment process.

And just making sure that we have a good fit with a number of candidates with our company culture, and where we're going as an organization.

Super. And maybe this is for Stephen. Could you elaborate on the shareholder purchase program and maybe your efforts to increase insider holdings?

Super and then maybe this is for Stephen could you elaborate on the shareholder purchase.

Purchase program.

And.

Maybe your efforts to increase insider holdings.

Sure. Thanks, Kristen. Yeah, so we were heading into our annual shareholders meeting in June . One of the items that are being voted on is an employee share purchase plan. So this will allow employees and management in the board to purchase shares.

Sure. Thanks, Chris Yeah. So we were heading into our annual shareholders meeting in June one of the.

Items that are being voted on is the employee share purchase plan. So this will allow employees.

Management and the board to purchase shares.

in the company, and it allows us to do that through blackout periods. So right now the challenge is there's a small company, it gets tough to accumulate stocks, so this is a tool we can use. The other tool that we have is the restricted share unit program, so we do have some members of our board and executives like Paul are taking a portion of their compensation and stock as well. So we're starting to leverage these tools to give employees in management the opportunity to start buying more shares in Titan Medical.

In the company and it allows us to do that through blackout periods. So right now the challenges.

It's a small company it gets tough to accumulate stock. So this is a tool we can use the other tools. We have is the restricted share unit program. So we do have some members of our board and the executive like Paul or taking a portion of their compensation in stock as well. So we're starting to leverage these tools to give employees in management the opportunity to start.

Buying more shares important medical.

Yeah.

Okay.

And when do we expect the first system to be delivered by benchmark to tighten medical?

And when we expect the first system to be delivered by benchmark too tight.

<unk> medical.

Yes, I think the current project plan it looks like it's coming in the end of July and then we I think we will be taking delivery of of six units. The first unit is going to be called with an engineering confidence build just making sure all the all the setups right and all these sorts of things.

Yeah, I think the current project plan looks like it's coming in the end of July and then we I think we'll be taking delivery of.

of six units. The first unit is going to be called with an engineering confidence build, just making sure all the setups right and all these sorts of things, including creating and shipping to our device and some real detail. And then the other subsequent five units will be coming in after that.

Creating and shipping to our device.

Some real detail and then the subsequent five units will be coming in after that.

But yeah, we're looking at delivery, I think the first delivery is the end of July , and then the rest of the unions should be shipped out sometime during the beginning of August .

But yes, we're looking at delivery I think the first deliveries in July and then the rest of the year should be shipped out sometime during the beginning of August .

Perfect.

And then perhaps even you could talk about the notification that we received from NASDAQ and our efforts to to meet their requirements.

And then perhaps even you could talk about the notification that we received from NASDAQ and our efforts to.

To meet their requirements.

Sure. Yeah, thanks, Kristen. Yeah, we, as we know, we received a Nasdaq deficiency notice that we press release in December .

Sure Yeah.

Thanks Christian.

We received a NASDAQ deficiency notice that we press released in December .

As part of the first six six months period ends June so we're working with the people of advisors to look at all the options we have.

as part of the first six months with that period ends June . So we're working with the group of advisors to look at all the options we have to satisfy the NASDAQ listing requirements. So we'll have further updates on that in the future. But the one, like, we did release all of our proxy stuff, so a reverse box was not one of the tools that we were gonna use at this AGM. So we're gonna look at some of the other options that are available to us, and we'll provide further updates as we get closer to that tube date.

To.

Satisfied the NASDAQ listing requirements and we'll have further updates on that in the future.

One.

We did release all of our proxy stuff so.

A reverse stock split was not one of the tools that we were going to use the CGM. So we're going to look at some of the other options that are available to us and we'll provide further updates as we get closer to that date.

Yeah.

Perfect. And then just regarding the IDE application next year, how long do you anticipate the human clinical studies to take three to four months question mark?

Perfect and then just regarding the IV application next year, how long do you anticipate the human clinical studies to take.

Three to four months question Mark.

Yeah, I think I think I'm a current project plan. It's anticipated to be three to four months. We're targeting.

Yes, I think I think on the current project plan, it's anticipated to be three to four months, we're targeting three to four sites.

3 to 4 sites, more likely 4 sites. Part of that is to mitigate the risk of a hospital gets closed down for COVID related issues or something on those lines. So, the inclusion criteria is quite broad for the, for the, for the number of patients that's required for our clinical studies. So, we think that we should be able to get.

Before sites part of that is to mitigate the risk of a hospital gets closed down for COVID-19 related issues or something on those lines. So.

The inclusion Criterias is quite broad for the for the for the number of patients that is required for a clinical study. So we think that we should be able to get.

I don't think that'll be a constraint. Yeah, so I think three or four months probably makes the most sense. And then we have to then take those clinical findings, wrap them all up, and then along with some additional validation verification testing, then complete the de novo application. So, I mean, that process requires a lot of work, a lot of time, but yeah, the human clinical trial should be three to four months.

I don't think that'll be that'll be constraint yes.

So I think three or four months, probably is makes it makes the most sense.

And then and then we have to.

Take those critical findings wrapped them all up and then.

Along with some additional <unk>.

Validation verification testing then complete that de novo applications. So I mean that processes as you know requires.

Requires a lot of work a lot of time, so but yes.

The human clinical trials should be three to four months.

Perfect.

And then maybe one final question. We know it's hard to comment a lot on this, but can you share how Titan looks at its timelines when we look at compared to vicarious? It seems as if we could be ahead and have a clear time table that puts us as the one to watch first.

And then maybe one final question.

We know it's hard to comment a lot on this but can you share how tightened looks.

At its timeline when we look at comparative vicarious. It seems as if we could be ahead and have a clear timetable that puts us as the one to watch first.

Yeah, I mean, it's there's a lot of work to do between now and when we receive final FDA clearance, I had a chance to review the vicarious documents in too, too much detail. But at this point in time, it looks like we will be ahead of the carriers by at least six to 12 months on our on our FDA application and subsequent approval. But, I mean, like I said, there's a lot of uncertainty on that and.

Yes, I mean, it's.

Is there a lot of work to do between now and when we receive final FDA clearance.

I had a chance to review the vicarious documents into too much detail, but at this point in time. It looks like we will be ahead of it curious by at least six months to 12 months on our FDA application and subsequent approval, but I mean, like I said theres a lot of uncertainty on that.

And right.

You know, right now it looks like there's an advantage, but hopefully that'll play out in the next four to six quarters.

Right now it looks like there is an advantage, but hopefully that will play out over the next over the next four to six quarters.

And then final question, are you still looking at outside partnership?

And then final question are you still looking at outside partnership.

Yeah, absolutely. It's one of our quality, it's one of our company objectives for this year to look at.

Yes, absolutely.

One of our quality, it's one of our.

Company objectives for this year to look at potential.

potential licensing partners to license part or portion of our intellectual property, and we'll always be looking for partners as it relates to vendors for our supply chain, these sorts of things, as well as ongoing features and functionality for the e-mail's platform. So we're open, we're collaborative, and we're looking to increase

Licensing partners to licensed partner portion of our our intellectual property.

And well always be looking for.

Partners as it relates to.

Vendors for our supply chain the sorts of things.

As well as ongoing features and functionality for the platform. So.

We're open we're collaborative and we're looking to.

Kris.

the number of partners that we work with over the next six to 12 months.

The number of partners that we've worked with over the next six months six to 12 months.

Thank you.

Ladies and gentlemen.

Okay.

Apologies.

Ladies and gentlemen, you have reached the end of our question and answer session. Now I would like to turn the call back for Paul for closing them off.

Ladies and gentlemen reached the end of our question and answer session and I would like to turn the call back to Paul for closing remarks.

Well thank you operator. I want to thank everyone for joining us on the call this morning. We're very excited about the opportunity that lies ahead for Titan and remain focused on bringing our single access robotic-assisted surgical system to market for the benefits of patients, surgeons, and hospitals. We appreciate your support and look forward to sharing future updates on our progress over the next several months. Thank you again and have a great day.

Well. Thank you operator, I want to thank everyone for joining us on our call. This morning, we're very excited about the opportunity that lies ahead for Titan and remain focused on bringing our single access robotic assisted surgical system to market for the benefit of patients surgeons and hospitals. We appreciate your support and look forward to sharing future updates on our progress.

Over the next several months. Thank you again and have a great day.

Thank you, Sir ladies and gentlemen that can compete based country.

Thank you, sir. Ladies and gentlemen, that then concludes today's conference. Thank you for joining us, and we now disconnect your lines.

Thank you for joining US you may now disconnect your lines.

Yeah.

Okay.

I I I

[music].

Sure.

Yes.

[music].

Yes.

[music].