Q2 2024 PAVmed Inc Earnings Call
Speaker Change: Good morning, and welcome to PADMED's second quarter 2024 business update conference call. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press star zero for the operator.
Operator: Conference call. At this time, all lines are in on listen-only mode. Following the presentation, we welcome back a question in the answer session.
Operator: At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star 0 for the operator. Please note this event is being recorded. I would now like to turn the conference over to Matt Riley, PubMed's Director of Investor Relations.
Operator: At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. Please note, this event is being recorded. I would now like to turn the conference over to Matt Riley, PAVmed's Director of Investor Relations.
Operator: If at any time during this call you require immediate assistance, please press the star zero for the operator.
Operator: Please note this event is being recorded.
Matt Riley: I would now like to turn the conference over to Matt Riley, have met director of investor relations, please go ahead.
Speaker Change: Please note this event is being recorded. I would now like to turn the conference over to Matt Riley, PubMed Director of Investor Relations. Please go ahead.
Matt Riley: Thank you, operator, and good morning, everyone. Thank you for participating in today's business update call. Joining me today on the caller, Dr. Lishan Aklog, Chairman and Chief Executive Officer of PAVmed, along with Dennis McGrath, Chief Financial Officer of PAVmed.
Matt Riley: Thank you, operator. And good morning, everyone.
Matt Riley: Thank you, Operator, and good morning, everyone. Thank you for participating in today's business update call. Joining me today on the call are Dr. Lishan Aklog, Chairman and Chief Executive Officer of PAVMed, along with Dennis McGrath, Chief Financial Officer of PAVMed. The press release announcing our business update and financial results is available on PAVMed's website. Please take a moment to read the disclaimers about forward-looking statements in the press release. The business update, the press release, and the conference call all include forward-looking statements, and these forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from the statements made. Factors that could cause actual results to differ are described in the disclaimer and in our filings with the Securities and Exchange Commission.
Matt Riley: Thank you, Operator, and good morning, everyone. Thank you for participating in today's business update call. Joining me today on the caller, Dr. Lishan Aklog, Chairman and Chief Executive Officer of PavMed, along with Dennis McGrath, Chief Financial Officer of PavMed.
Matt Riley: Thank you for participating in today's business update call. Joining me today on the call are Dr. Lishan Aklog, Chairman and Chief Executive Officer of PAVmed, along with Dennis McGrath, Chief Financial Officer of PAVmed. The press release announcing our business update and financial results is available on PAVmed's website. Please take a moment to read the disclaimers about forward-looking statements in the press release. The business update, the press release, and the conference call all include forward-looking statements, and these forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from the statements made.
Matt Riley: The press release announcing our business update and financial results is available on PAVmed's website. Please take a moment to read the disclaimers about four looking statements in the press release. The business update, press release, and the conference call all include four looking statements, and these four looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from the statements made. Factors that could cause actual results to differ are described in a disclaimer and in our filings of the Securities and Exchange Commission. For a list and a description of these and other important risks and uncertainties that may affect future operations, the Part One, Item One A entitled Risk Factors and PAVmed's most recent annual report on forms 10-K filed with SEC and any subsequent updates filed in the quarterly reports on forms 10-Q and subsequent forms 8-K.
Speaker Change: The press release announcing our business update and financial results is available on PadMed's website. Please take a moment to read the disclaimers about forward-looking statements in the press release.
Speaker Change: The business update, press release, and the conference call all include forward-looking statements, and these forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from the statements made.
Speaker Change: Factors that could cause actual results to differ are described in the disclaimer and in our filings of the Securities and Exchange Commission.
PAVMED: For a list and a description of these and other important risks and uncertainties that may affect future operations, see Part 1, Item 1A, entitled Risk Factors in PAVMED's most recent annual report on Forms 10-K filed with SEC.
PAVMED: and any subsequent updates filed in the quarterly reports on Forms 10-Q and subsequent Forms 8-K.
Matt Riley: Accept is required by law of PAVmed, disclaims any intentions or obligations to publicly update or revise any four looking statements, to reflect changes in expectations or in events, conditions or circumstances on which expectations may be based or that may affect the likelihood that actual results will differ from those contained in the four looking statements.
PAVMED: Accept as required by law if PASMED disclaims any intentions or obligations to publicly update or revise any forward-looking statements to reflect changes in expectations or in events, conditions, or circumstances on which expectations may be based or that may affect the likelihood that actual results
Lishan Aklog: I would now like to turn the call over to Dr. Lee Chan-Aklad, Chairman and CEO of PAVmed.
Matt Riley: Factors that could cause actual results to differ are described in the disclaimer and in our filings with the Securities and Exchange Commission. For a list and a description of these and other important risks and uncertainties that may affect future operations, see Part 1, Item 1A, entitled Risk Factors, and PAVmed's most recent annual report on Forms 10-K filed with the SEC, and any subsequent updates filed in the quarterly reports on Forms 10-Q and subsequent Forms 8-K.
Matt Riley: For a list and a description of these and other important risks and uncertainties that may affect future operations, see Part 1, Item 1A, entitled Risk Factors, and PAVmed's most recent annual report on Forms 10-K filed with the SEC, and any subsequent updates filed in the quarterly reports on Forms 10-Q and subsequent Forms 8-K. Acceptance by law of PAVmed disclaims any intentions or obligations to publicly update or revise any forward-looking statements to reflect changes in expectations or in events, conditions, or circumstances on which the expectations may be based or that may affect the likelihood that actual results will differ from those contained in the forward-looking statement. I would now like to turn the call over to Dr. Lishan Aklog, Chairman and CEO of PAVmed. Take it away, Lishan.
Lishan Aklog: will differ from those contained in the foregoing statements. I would now like to turn the call over to Dr. Lishan Aklog, Chairman and CEO of PavMed. Take it away, Lishan. Thank you, Matt, and good morning, everyone. Thank you for joining our quarterly update call. Before proceeding, I'd like to thank our long-term shareholders for your ongoing support and commitment.
Lishan Aklog: Take it away, Lee Chan. Thank you, Matt, and good morning, everyone. Thank you for joining our quarterly update call before proceeding.
Matt Riley: The acceptance required by law of PAVmed disclaims any intentions or obligations to publicly update or revise any forward-looking statements to reflect changes in expectations or in events, conditions, or circumstances on which the expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statement. I would now like to turn the call over to Dr. Lishan Aklog, Chairman and CEO of PAVmed. Take it away, Lishan. Thank you.
Lishan Aklog: Thank you, Matt. And good morning, everyone. Thank you for joining our quarterly update call. Before proceeding, I'd like to thank our long-term shareholders for your ongoing support and, as we discussed in recent calls, our updated strategy for PAVmed has been to strengthen its finances and long-term stability by seeking to have each of its subsidiaries be independently financeable and well-positioned to leverage PAVmed's shared infrastructure. I'm pleased at the progress we've made on this.
Lishan Aklog: Thank you, Matt, and good morning, everyone. Thank you for joining our quarterly update call. Before proceeding, I'd like to thank our long-term shareholders for your ongoing support and continued support. As we discussed in recent calls, our updated strategy for PAVmed has been to strengthen its finances and long-term stability by seeking to have each of its subsidiaries be independently financeable and well-positioned to leverage PAVmed's shared infrastructure. I'm pleased at the progress we've made on this.
Lishan Aklog: I'd like to thank our long-term shareholders for your ongoing support and commitment. As we discuss in recent calls, our updated strategy for PAVmed has been to strengthen its finances and long-term stability by seeking to have each of its subsidiaries be independently financeable and while positioned to leverage PAVmed's shared infrastructure. I'm pleased at the progress we've made on this front. Lucid remains PAVmed's strongest asset. It has been able to independently finance its operations. And, as we discussed in yesterday's Lucid earnings call, is making solid progress over multiple fronts towards fulfilling its large commercial potential. PAVmed's two other subsidiaries are also headed in a positive direction, consistent with the strategies.
Lishan Aklog: As we discussed in recent calls, our updated strategy for PADMET has been to strengthen its finances and long-term stability by seeking to have each of its subsidiaries be independently financeable and well-positioned to leverage PADMET's shared infrastructure. I'm pleased at the progress we've made on this front.
Lishan Aklog: Lucid remains PAVmed's strongest asset and has been able to independently finance its operations. And, as we discussed in yesterday's earnings call, Lucid is making solid progress on multiple fronts towards fulfilling its large commercial potential. Two other subsidiaries are also headed in a positive direction consistent with this strategy. As we'll discuss later, Veris Health is close to securing an independent financing round, and the PMX Incubator is deep in the process of securing financing for Port IO. Both of these add attractive value. Let's start with some highlights from the second quarter and... Again, starting with lucid diagnostics, just briefly. In the second quarter, Eastern Guard revenue was flat.
Lishan Aklog: Lucid remains PAVmed's strongest asset; it has been able to independently finance its operations, and, as we discussed in yesterday's earnings call, is making solid progress on multiple fronts towards fulfilling its large commercial potential. PAVmed's two other subsidiaries are also headed in a positive direction consistent with this strategy. As we'll discuss later, Veris Health is close to securing an independent financing round, and the PMX Incubator is deep in the process of securing financing for PortIO, both of these at attractive values. Let's start with some highlights from the second quarter and research. Again, starting with Lucid Diagnostics, just briefly. In the second quarter, Easter Guard revenue was flat.
Lishan Aklog: Lucid remains Padmet's strongest asset, has been able to independently finance its operations, and as we discussed in yesterday's Lucid earnings call, is making solid progress over multiple fronts towards fulfilling its large commercial potential.
Lishan Aklog: Padme's two other subsidiaries are also headed in a positive direction, consistent with this strategy. As we'll discuss later, Veris Health is close to securing an independent financing round, and the PMX Incubator is deep in the process of securing financing for Port IO. Both of these add attractive valuations.
Lishan Aklog: As we will discuss later, Varys helped as close as securing an independent financing round. And the PMX incubator is deep in the process of securing financing for Port IO. Both of these add attractive valuations.
Lishan Aklog: Let's start with some highlights from the second quarter and recent weeks. Again, starting with Lucid Diagnostics, just briefly, and second quarter, ESA Guard revenue was flat. The test volume increased to approximately 31% quarter on quarter and 44% year on year, and it was a record quarter for us. An important highlight is that we had a productive meeting with the CNS Medicare Contractor Multi-X program and look forward to being able to follow up on that meeting with the submission of our Nathan. We held our first large Check Your Food to Prevent with upfront contracted payments and important milestone with regard to us being able to translate test flying growth and check your food to prevent with revenue and revenue growth.
Lishan Aklog: The test volume increased approximately 31% quarter-on-quarter and 44% year-on-year. It was a record quarter. An important highlight is that we had a productive meeting with the CMS Medicare Contractor, Moldy X program, and look forward to being able to follow up on that meeting with the submission of our data. We held our first large Check Your Food Tube event with upfront contracted payments, an important Milestone with regard to us being able to translate test volume growth and check your food type events. Revenue on revenue.
Lishan Aklog: Let's start with some highlights from the second quarter and recent weeks.
Lishan Aklog: Again, starting with Lucid Diagnostics just briefly, second quarter Easter Guard revenue was flat.
Lishan Aklog: The test volume increased approximately 31% quarter-on-quarter and 44% year-on-year. It was a record quarter. An important highlight is that we had a productive meeting with the CMS-Medicare Contractor MOLDI-X program and look forward to being able to follow up on that meeting with the submission of our data. We held our first large Check Your Food Tube event with upfront contracted payments, an important Milestone with regard to us being able to translate test volume growth and check your food to prevent with revenue on revenue.
Lishan Aklog: The test volume increased approximately 31% quarter-on-quarter and 44% year-on-year. It was a record quarter for us.
Lishan Aklog: An important highlight is that we had a productive meeting with the CMS Medicare Contractor Multi-X Program and look forward to being able to follow up on that meeting with the submission of our data.
Lishan Aklog: We held our first large Check Your Food Tube event with upfront contracted payments, an important milestone with regard to us being able to translate test volume growth and Check Your Food Tube events with
Lishan Aklog: And for our health, our focus has been on our pilot program with the Ohio State James Cancer Center, and we, as we'll discuss later, our first patients onto the platform. As I mentioned, we are in the process of raising capital in Severus, and we expect the first punch to close very soon. Concurrent with that, we're preparing to remanche the development of our implantable monitoring, which we will begin once we have secured that financing. And, as I mentioned for under the PMX incubator, we're focused on raising capital for Port Ion.
Lishan Aklog: And Ferris Health, our focus has been on our pilot program with the Ohio State James Cancer Center, and we have, as we'll discuss later, our first patients on the pilot. As I mentioned, we are in the process of raising capital into Veris, and we expect the first tranche to close very soon.
Lishan Aklog: And Ferris Health, our focus has been on our pilot program with the Ohio State James Cancer Center, and we have, as we'll discuss later, our first patients on the platform. As I mentioned, we are in the process of raising capital into Veris, and we expect the first tranche to close very soon.
Lishan Aklog: at Revenue on Revenue Growth.
Speaker Change: At Ferris Health, our focus has been on our pilot program with the Ohio State James Cancer Center and we have, as we'll discuss later, our first patients onto the platform.
Speaker Change: As I mentioned, we are in the process of raising capital in Tavares and we expect the first tranche to close very soon.
Lishan Aklog: Concurrent with that, we're preparing to relaunch the development of our implantable monitoring, which we will begin once we have secured that. And as I mentioned, under the PMX incubator, we're focused on raising capital for Port Island. Just a quick overview for those of you who might be new to the PAVmed story, here's our corporate structure. PAVmed operates by offering shared services. The entire infrastructure of Sheriff Services on behalf of its subsidiaries.
Lishan Aklog: Concurrent with that, we're preparing to relaunch the development of our implantable monitoring, which we will begin once we have secured that funding. And as I mentioned, under the PMX Incubator, we're focused on raising capital for Port Island. Just a quick overview for those of you who might be new to the PAVmed story. Here's our corporate structure. PAVmed operates by offering shared services. In particular, the entire infrastructure of Sheriff Services on behalf of its subsidiaries.
Speaker Change: Concurrent with that, we're preparing to relaunch the development of our implantable monitoring, which we will begin once we have secured that site stance.
Speaker Change: And as I mentioned for under the PMX incubator, we're focused on raising capital for Port Ion.
Lishan Aklog: Just a quick overview for those of you who might be new to the Padman story. Here's our corporate structure. Padman operates by offering shared services. An entire infrastructure of shared services on behalf of the subsidiaries. The subsidiaries include, as I mentioned, Elusive Diagnostics, a publicly traded diagnostic company; Very Health, a privately held digital health company; and our incubator PMX, which was recently launched, focusing on one of the products in our portfolio, Port Ion. And this structure is designed to allow us to bring in other assets, other technologies under this umbrella and shared services model.
Speaker Change: Just a quick overview for those of you who might be new to the Padme story. Here's our corporate structure. Padme operates by offering shared services.
Lishan Aklog: The subsidiaries include, as I mentioned, Lucid Diagnostics, our publicly-traded diagnostic company; Veris Health, a privately-held digital health company; our incubator, PMX, which was recently launched, which is focusing on one of the products in our portfolio, PortIO. And this structure is designed to allow us to bring in other assets, other technologies, under this umbrella at Sheriff Services. So let's start with Lucid. Again, I'll be brief here.
Lishan Aklog: The subsidiaries include, as I mentioned, Lucid Diagnostics, our publicly-traded diagnostic company; Veris Health, a privately-held digital health company; our incubator, PMX, which was recently launched, which is focusing on one of the products in our portfolio, PortIO. And this structure is designed to allow us to bring in other assets, other technologies, under this umbrella at Sheriff Services. So let's start with Lucid.
Speaker Change: entire infrastructure of Sheriff's Services on behalf of its subsidiaries.
Speaker Change: Other subsidiaries include, as I mentioned, Lucid Diagnostics, our publicly traded diagnostic company. Veris Health, a privately held digital health company. Our incubator, PMX, which was recently launched.
Speaker Change: which is focusing on one of the products in our portfolio, Port.io, and this structure is designed to allow us to bring in other assets, other technologies under this umbrella and in a shared services model.
Lishan Aklog: So let's start with Lucid. Again, I'll be brief here. I would really encourage you to refer to the webinar from yesterday, as well as a press release for further details. As you can see here, Lucid's test volume grew to a record level in the last quarter, and our revenues have held up and have remained flat quarter on quarter. The numbers are shown here. Revenue flat quarter on quarter, up 500 percent annually; test volume up 31 percent on quarter on quarter on a record quarter, and up 44 percent annually. As we mentioned yesterday, we held over 50 high volume health fair events that we refer to as Check Your Food to PreCancer testing events.
Lishan Aklog: I would really encourage you to refer to the webinar from yesterday, as well as the press release, for further information. As you can see here, Lucid's test volume grew to a record level in the last quarter, and our revenues have held up and have remained flat quarter on quarter. The numbers are shown here. Revenue flat quarter on quarter, up 500% annually.
Lishan Aklog: Again, I'll be brief here. I would really encourage you to refer to the webinar from yesterday as well as the press release for further information. As you can see here, Lucid's test volume grew to a record level in the last quarter, and our revenues have held up and have remained flat. The numbers are shown here, revenue flat quarter-on-quarter, up 500% annually, test volume up 31% quarter-on-quarter and a record quarter, and up 44% annually. As we mentioned yesterday, we held over 50 high-volume health fair events that we refer to as Check Your Food Tube pre-cancer testing events.
Speaker Change: So, let's start with Lucid. Again, I'll be brief here. I would really encourage you to refer to the webinar from yesterday, as well as the press release for further details.
Speaker Change: As you can see here Lucid's test volume grew to a record level in the last quarter and our revenues have held up and have remained flat quarter on quarter.
Speaker Change: The numbers are shown here. Revenue flat quarter-on-quarter, up 500% annually. Test volume up 31% quarter-on-quarter and a record quarter, and up 44% annually.
Lishan Aklog: Test volume was up 31% quarter on quarter and a record quarter and up 44% annually. As we mentioned yesterday, we held over 50 high-volume health fair events that we refer to as Check Your Food Tube pre-cancer testing events. And we had the first one of those, which allowed us to get upfront contracted payment. The key strategic accomplishments, as I emphasized later, really relate to our clinical evidence base. Two studies, the NVET-BE Clinical Utility Study and the E-Sugar BE-1 Clinical Validation Study, had new data released and are pending peer review publication.
Speaker Change: As we mentioned yesterday, we held over 50 high-volume health fair events that we refer to as Check Your Food Tube pre-cancer testing events, and we had the first one of those which allowed us to get upfront contracted payment.
Lishan Aklog: And we had the first one of those, which allowed us to get up-front contracted payment. The key strategic accomplishments, as I emphasized later, really relate to our clinical evidence base. Two studies, the NVET-BE Clinical Utility Study and the E-Sugar BE-1 Clinical Validation Study, had new data released and are pending peer-review publication. And another critical study, the Cleveland VA Clinical Validation Study, was the NVET-BE Clinical Validation Study.
Lishan Aklog: And we had the first one of those, which allowed us to get upfront contracted payment. The key strategic accomplishment was, as I emphasized, the later, really relate to our clinical evidence space, two studies, the NZBE clinical utility study, and the ESA grant, the E1 clinical validation study, had the new data released, interpending peer review publication, and another critical study, the Cleveland VA clinical validation study, a completed peer review publication. Our meeting with the MDX program was very productive until last month, and we look forward to submitting our data and working with the MDX team to secure Medicare coverage for ESA grant.
Speaker Change: The key strategic accomplishments, as I emphasized later, really relate to our clinical evidence base. Two studies, the NZBE Clinical Utility Study and the Eastern Grid BE-1 Clinical Validation Study had new data released.
Lishan Aklog: And another critical study, the Cleveland VA Clinical Validation Study, has completed peer-reviewed publication. Our meeting with the MoldeX program was very productive until last month, and we look forward to submitting our data and working with the MoldeX team to secure Medicare coverage for you. I'll transition now to a bit of an overview of health. So, Varis Health is a commercial-stage digital health company that we seek to enhance personalized cancer care. It consists of two components.
Speaker Change: peer review publication, and another critical study, the Cleveland VA Clinical Validation Study.
Lishan Aklog: Completed peer-reviewed publication. Our meeting with the MoldeX program was very productive last month, and we look forward to submitting our data and working with the Moldy X team to secure Medicare coverage for. Now, I'll transition now to a bit of an overview of health. So Varus Health is a commercial-stage digital health company that we seek to enhance personalized cancer care. It consists of two components.
Speaker Change: completed peer-reviewed publication.
Speaker Change: Our meeting with the MoldeX program was very productive, until last month, and we look forward to submitting our data and working with the MoldeX team to secure Medicare coverage for e-cigar.
Lishan Aklog: Now, I'll transition now to a bit of an overview on address health. So, various health at the commercial stage, digital health company that seek to enhance personalized cancer care consists of two components. One is the various cancer care platform. This is a software platform, which includes a patient care module and a positional or caretaker module, and they interface with a box of connected devices, Bluetooth connected devices, that provides physiological information for the clinicians to improve the care that patients. We have an implantable monitor that's under development that will seek to provide continuous data for the patient and interface with the platform.
Speaker Change: I'll transition now to a bit of an overview on Veris Health.
Speaker Change: So Varis Health is a commercial stage digital health company that we seek to enhance personalized cancer care. It consists of two components. One is the Varis Cancer Care Platform. This is a software platform which includes a patient care module and a...
Lishan Aklog: One is the Varus Cancer Care Platform. This is a software platform that includes a patient care module and a physician or caretaker module, and they interface with a box of connected devices, Bluetooth-connected devices that provide physiologic information for the clinicians to improve the care of the patient. We have an implantable monitor that's under development that will seek to provide continuous data for the patient and interface with the platform. The mission of the company is to utilize modern remote patient monitoring tools to improve care through early detection of complications.
Lishan Aklog: One is the Varis Cancer Care platform. This is a software platform that includes a patient care module and a physician or caretaker module, and they interface with a box of connected devices, Bluetooth-connected devices that provide physiologic information for the clinicians to improve the care of the patient. We have an implantable monitor that is under development that will seek to provide... Continuous data for the patient and interface with the platform.
Speaker Change: physician or caretaker module and they interface with a box of connected devices, Bluetooth connected devices that provide physiologic information for the clinicians to improve the care of the patient.
Speaker Change: We have an implantable monitor that's under development that will seek to provide
Speaker Change: continuous data for the patient and interface with the platform.
Lishan Aklog: The mission of the company is to utilize modern remote patient monitoring tools to improve care through early detection of complications. Established Longitudinal Trends and The Implantable was on hold pending financing, and as I mentioned, we're close to securing financing and look forward to restarting the Implantable monitoring. As we discussed on previous calls, our focus has been on large academic centers and strategic accounts. We have been engaged with Ohio State University under a memorandum of understanding.
Lishan Aklog: The vision of the companies to utilize modern remote patient monitoring tools to improve care through early detection of complications, established longitudinal trends in risk management. The implantable was on hold, Paddick financing. As I mentioned, we're close to securing financing and look forward to restarting the implantable monitor projects. As we discussed on the previous call, our focus has been on large academic centers for teaching accounts. We have been engaged with the Ohio State University under a memorandum of understanding, and this past June, we launched our pilot program consistent with that MOU, was launched in the bone marrow transplant and gynecology, oncology units. 20 approximately 26 patients that have been onboarded to date.
Speaker Change: The mission of the company is to utilize modern remote patient monitoring tools to improve care through early detection of complications, establish longitudinal trends and risk management.
Lishan Aklog: Establish Longitudinal Trends and The Implantable was on hold, pending financing, and as I mentioned, we're close to securing financing and look forward to restarting the Implantable monitoring. As we discussed on previous calls, our focus has been on large academic centers and strategic accounts. We have been engaged with Ohio State University under a memorandum of understanding.
Speaker Change: The implantable was on hold pending financing and as I mentioned, we're close to securing financing and look forward to restarting the implantable monitor project
Speaker Change: As we discussed on previous calls, our focus has been on large academic center strategic accounts. We have been engaged with the Ohio State University under a memorandum of understanding. And this past June, we launched our pilot program consistent with that MOU.
Lishan Aklog: And this past June, we launched our pilot program consistent with that MOU, was launched in the bone marrow transplant and gynecology oncology unit. Approximately 26 patients have been onboarded to date. And we had our first patient success story in mid-July that demonstrated that our platform's ability to pick up signs of clinical deterioration resulted in a patient returning to the hospital and getting care and avoiding complications. Our plan is, upon completion of this pilot study, to transition to a full commercial engagement and seek other potential strategic partnerships with the university.
Lishan Aklog: And this past June, we launched our pilot program consistent with that MOU, was launched in the bone marrow transplant and gynecology oncology units. Approximately 26 patients have been onboarded to date. And we had our first patient success story in mid-July; signs of clinical deterioration resulted in a patient returning to the hospital and getting care and avoiding complications. Our plan is, upon completion of this pilot study, to transition to a full commercial engagement and seek other potential strategic partnerships with the university.
Speaker Change: was launched in the bone marrow transplant and gynecology oncology units. Approximately 26 patients have been on boarded to date.
Lishan Aklog: And we've had our first patient success story in mid July that demonstrated that our platform's ability to pick up signs of clinical deterioration resulted in a patient returning to the hospital and getting care and avoiding complications. Our plan is, upon completion of this pilot study, to transition to a full commercial engagement and seek other potential strategic partnerships with university, and based on the success of this pilot and this engagement, we look to continue our strategy to identify other large academic cancer centers to partner with in a similar fashion.
Speaker Change: And we've had our first patient success story in mid-July that demonstrated that our platform's ability to pick up
Speaker Change: Signs of clinical deterioration resulted in a patient returning to the hospital and getting care and avoiding complications.
Speaker Change: Our plan is upon completion of this pilot study to transition to a full commercial engagement and seek other potential strategic partnerships with with the university and based on the success of this pilot
Lishan Aklog: And based on the success of this pilot, on this engagement, we look to continue our strategy to identify other large academic cancer centers to partner with in a similar fashion. So I briefly mentioned the Varus implantable monitor, but here's some further details. The goal here is to have a monitor that can be implanted in conjunction with a vascular access port. You can see on the right there, the purple structure is a typical vascular access port, and our implantable monitor is designed to be implanted in conjunction with that.
Lishan Aklog: And based on the success of this pilot, in this engagement, we look to continue our strategy to identify other large academic cancer centers to partner with in a similar fashion. So I briefly mentioned the Verisim plantable monitor, but here's some further details.
Speaker Change: On this engagement, we look to continue our strategy to identify other large academic cancer centers to partner with in a similar fashion.
Lishan Aklog: So briefly mentioned the various implantable monitor, but here's some further details. The goal here is to have a monitor that can be implanted in conjunction with a vast of access port. You can see on the right there the purple structure is a typical vast of access port, and our plantable monitor is designed to be implanted in conjunction with that. There's a variety of key features that can detect continuous cardiac monitoring, activity, has a patient triggered event monitor, can track temperature or respiratory rate, and has Bluetooth connectivity so we can deliver that information without any involvement of the patient.
Lishan Aklog: The goal here is to have a... A monitor that can be implanted in conjunction with a vascular access port. You can see on the right there, the purple structure is a typical vascular access port, and our plantable monitor is designed to be implanted in conjunction with that. It has a variety of key features and can detect continuous cardiac monitoring activity, has a patient-triggered event monitor, can track temperature, respiratory rate, and has Bluetooth connectivity, so it can deliver that information without any involvement of the patient.
Speaker Change: So I briefly mentioned the Verisim plantable monitor, but here's some further details. The goal here is to have a...
Speaker Change: A monitor that can be implanted in conjunction with a vascular access port. You can see on the right there, the purple structure is a typical vascular access port, and our implantable monitor is designed for that.
Lishan Aklog: It has a variety of key features and can detect continuous cardiac monitoring activity, has a patient-triggered event monitor, can track temperature, respiratory rate, and it has Bluetooth connectivity, so it can deliver that information without any involvement of the patient.
Speaker Change: to be implanted in conjunction with that. It has a variety of key features and can detect continuous cardiac monitoring activity, has a patient-triggered event monitor, can track temperature, respiratory rate, and has Bluetooth connectivity, so it can deliver that information without any
Lishan Aklog: It assures 100% compliance with the requirements for billing under a remote patient monitor, so we've had a clear path to FDA clearance at commercial launch. We've completed multiple meetings with the FDA, and we have been poised to relaunch this development and pursue FDA clearance, and we expect to do so shortly once this upcoming financing is closed. We did have some final pre-submission meetings with the FDA that went well, and we're already starting the process of reengaging with vendors to plan the relaunch upon completion.
Lishan Aklog: It assures 100% compliance with the requirements for billing under a remote patient monitor, so we've had a clear path to FDA clearance at commercial launch. We've completed multiple meetings with the FDA and are poised to relaunch this development and pursue FDA clearance, and we expect to do so shortly once this upcoming financing is closed. We did have some final pre-submission meetings with the FDA that went well, and we're already starting the process of re-engaging with vendors to plan the relaunch upon completion.
Lishan Aklog: And as sure as 100% compliance with the requirements for billing under remote patient monitoring. So we've had a clear path to FDA clearance that commercial launch. We've completed multiple meetings with the FDA, and we've been poised to relaunch this development and pursue FDA clearance, and we expect to do so shortly once this upcoming financing is closed. We did have some final pre-submission meetings with the FDA that went well, and we were already starting the process of re-engaging with vendors to plan the relaunch upon the completion of this cancer.
Speaker Change: involvement of the patient and assures 100% compliance with the requirements for billing under a remote patient monitoring.
Speaker Change: So, we've had a clear path to FDA clearance and commercial launch. We've completed multiple meetings with the FDA, and we have been poised to relaunch this development and pursue FDA clearance, and we expect to do so shortly once this upcoming financing is closed.
Speaker Change: We did have some final pre-submission meetings with the FDA that went well and we were already starting the process of re-engaging with vendors to plan the relaunch upon the completion of this year.
Lishan Aklog: Moving on to our incubator, we talked about this briefly over the last call. Well, the incubator is a partnership between PadMed and an experienced group in the MedTech space called Hatch Medical. We've decided within this incubator to focus on one product that we had been developing but put on pause a couple of years ago. That's port I.O. Port I.O. is a direct long-term access to the bone marrow. That can reduce complications and infection rates as an alternative for VS access. Address is a very large unmet need on a very diverse target population, including patients with proven venous access and renal failure.
Lishan Aklog: Moving on to our incubator, we talked about this briefly on the last call. The incubator is a partnership between PAVmed and an experienced group in the medtech space called Hatch Medical. We've decided within this incubator to focus on one product that we had been developing but put on pause a couple years ago. That's PortIO.
Lishan Aklog: Moving on to our incubator, we talked about this briefly on the last call. The incubator is a partnership between PAVmed and an experienced group in the medtech space called Hatch Medical. We've decided within this incubator to focus on one product that we had been developing but put on pause a couple years ago. That's PortIO. PortIO is a direct, long-term access to the bone marrow that can reduce complications and infection rates as an alternative to venous access.
Speaker Change: Moving on to our incubator, we talked about this briefly over the last call.
Speaker Change: Well, the incubator is the partnership between Padmed and a experienced group in the med tech space called Hatch Medical. We've decided within this incubator to focus on one product that we have had been developing but put on pause.
Lishan Aklog: PortIO is a direct long-term access to the bone marrow that can reduce complications and infection rates as an alternative to venous access. It addresses a very large unmet need and a very diverse target population, including patients with poor venous access and renal failure. It has a large total addressable market, really solid IP protection, and it's been used in humans. We successfully completed our first in-human study, and we have a clear path to FDA clearance.
Speaker Change: a couple of years ago, that's Port IO.
Lishan Aklog: It addresses a very large unmet need and a very diverse target population, including patients with poor venous access and renal failure. It has a large total addressable market, really solid IP protection, and it's been used in humans.
Speaker Change: that can reduce complications and infection rates.
Speaker Change: as an alternative for venous access. It addresses a very large unmet need and a very diverse target population, including patients with poor venous access and renal failure. A large total addressable market, really solid IP protection, and it's been used in humans. We successfully completed our first in-human study.
Lishan Aklog: Large, a large total address will market, really solid IP protection. And it's been used in humans; we have successfully completed our first in human study. And we have a clear path to FDA clearance. So we are now actively raising capital to fund a board IO and fund the completion of the ID study. As well as completion of the second generation version, we're looking forward to carrying that financing and getting this project off the ground again.
Lishan Aklog: We successfully completed our first in-human study, and we have a clear path to FDA clearance. So we are now actively raising capital to fund Port IO and fund the completion of the IDE study, as well as the completion of the second generation version. With that, I'll pass the baton over to Dennis to give us our...
Lishan Aklog: So we are now actively raising capital to fund Port IO and fund the completion of the IDE study, as well as the completion of the second generation version. We're looking forward to securing that financing and getting this project off the ground. With that, I'll pass the baton over to Dennis to give us our. Thanks, Lishan, and good morning, everyone.
Speaker Change: And we have a clear path to FDA clearance. So we are now actively raising capital to fund Port IO and fund the completion of the IDE study, as well as completion of the second-generation version. We're looking forward to securing that financing and getting this project off the ground again.
Dennis McGrath: With that, I'll pass the baton over to Dennis to give us our financial updates.
Speaker Change: With that, I'll pass the baton over to Dennis to give us our financial aid.
Dennis McGrath: Thanks, Lee Channing.
Dennis McGrath: Thanks Lishan and good morning everyone. Our summary financial results for the second quarter were reported in our press release and published last week. On the next three slides, I'll emphasize a few key highlights from the quarter, but I encourage you to consider those remarks in the context of the full disclosures covered in our quarterly report on Form 10-Q. With regard to the balance sheet. Cash at quarter end June 30th was $25.5 million.
Dennis McGrath: Good morning, everyone. Our summary financial results for the second quarter reported our press release was published last night.
Dennis McGrath: Our summary financial results for the second quarter were reported in our press release and published last. On the next three slides, I'll emphasize a few key highlights from the quarter, but I encourage you to consider those remarks in the context of the full disclosures covered in our quarterly report on Form 10-Q. With regard to the balance sheet, cash at quarter end June 30th was $25.5 million.
Dennis: Thanks, Lishan, and good morning, everyone. Our summary financial results for the second quarter were reported in our press release and was published last night.
Dennis McGrath: On the next three slides, I'll emphasize a few key highlights from the quarter, but I encourage you to consider those remarks in the context of the full disclosures covered in our quarterly report on Form 10-Q. With regards to the balance sheet, ash at quarter end June 30th was 25.5 million. During the quarter, we added 11.6 million to that amount with elusive financing previously announced. The average quarterly burn rate for the trailing four quarters is 11.6 million dollars per quarter.
Dennis: On the next three slides, I'll emphasize a few key highlights from the quarter, but I encourage you to consider those remarks and the context of the full disclosures covered in our quarterly report on Form 10Q.
Ash: With regards to the balance sheet, Ash at quarter-end June 30th was 25.5 million.
Dennis McGrath: During the quarter, we added $11.6 million to that amount with elusive financing previously. The average quarterly burn rate for the trailing four quarters is $11.6 million per quarter. We disclosed in the 10-Q that our ability to fund operations beyond one year from today is largely dependent on how revenues ramp over the next four quarters, which is dependent on how the reimbursement landscape for both government and private health insurers continues to improve for ESA Guard. Additionally, our direct contracting efforts with self-insured employers and our corporate finance activities, including refinancing. Refinancing any outstanding debt at the time can also work to exceed that threshold.
Dennis McGrath: During the quarter, we added $11.6 million to that amount with elusive financing previously. The average quarterly burn rate for the trailing four quarters is $11.6 million per quarter. We disclosed in the 10-Q that our ability to fund operations beyond one year from today is largely dependent on how revenues ramp over the next four quarters, which is dependent on how the reimbursement landscape for both government and private health insurers continues to improve for ESA Guard. Additionally, our direct contracting efforts with self-insured employers and our corporate finance activities, including refinancing. Refinancing any outstanding debt at the time can also work to exceed that threshold.
Dennis: During the quarter, we added $11.6 million to that amount with the lucid financing previously announced.
Dennis: The average quarterly burn rate for the trailing four quarters is $11.6 million per quarter.
Dennis McGrath: We disclosed in the 10-Q that our ability to fund operations beyond one year from today is largely dependent on how revenues ramp over the next four quarters, which is dependent on how the reimbursement landscape for both government and private health insurance continues to improve for ESA Guard. Additionally, our direct contracting efforts with self-insured employers and our corporate finance activities, including refinancing any outstanding debt at the time, can also work to exceed that threshold. Furthermore, as we advance the initiatives, both with PMX Incubator and Nurse Health, particularly in connection with the High State University Cancer Care Center, any direct financing into either of these subsidiaries will further satisfy that threshold.
Dennis: We disclosed in the 10-Q that our ability to fund operations beyond one year from today is largely dependent on how revenues ramp over the next four quarters, which is dependent on how the reimbursement landscape for both government and private health insurers continues to improve for ESA Guard.
Dennis: Additionally, our direct contracting efforts with self-insured employers and our corporate finance activities, including refinancing any outstanding data time, can also work to exceed that threshold.
Dennis McGrath: Furthermore, as we advance the initiatives, both with PMX Incubator and Nurse Health, particularly in connection with the High State University Cancer Care Center, any direct financing into either of these subsidiaries will further satisfy that threshold. The change in other assets is largely related to the three-year lease renewal for Lucid's Lab in California, which is accompanied by a similar increase in other current and long-term liabilities. The sequential decrease in the fair value of the convertible notes is largely related to principal reductions in the Lucid convertible note through conversion notices and issuances of Lucid shares and satisfaction of that note.
Dennis McGrath: Furthermore, as we advance the initiatives, both with PMX Incubator and NurseHealth, particularly in connection with the High State University Cancer Care Center, any direct financing into either of these subsidiaries will further satisfy that threshold. The change in other assets is largely related to the three-year lease renewal for Lucid's Lab in California, which is accompanied by a similar increase in other current and long-term liabilities. The sequential decrease in the fair value of the convertible notes is largely related to principal reductions in the Luced convertible note through conversion notices and issuances of Luced shares and satisfaction of that note.
Dennis: Furthermore, as we advance the initiatives both with PMX Incubator and Nurse Health, particularly in connection with the High State University Cancer Care Center, any direct financing into either of these subsidiaries will further satisfy that threshold.
Dennis McGrath: The change in other assets is largely related to the three-year lease renewal for loses lab in California, which is accompanied by a similar increase in other current and long-term viabilities. The sequential decrease in the fair value of the convertible notes is largely related to principal reductions in elusive convertible note through conversion notices and issuances of lucid shares and satisfaction of that note. As mentioned on our lucid call yesterday, during the quarter, Lucid issued 2.1 million shares in satisfaction of conversion notices during the quarter. Shares outstanding included, including invested restrict stock awards as of last week are 10.3 million shares outstanding.
Speaker Change: The change in other assets is largely related to the three-year lease renewal for Lucid's Lab in California, which is accompanied by a similar increase in other current and long-term liabilities.
Dennis: The sequential decrease in the fair value of the convertible notes is largely related to principle reductions in elusive convertible notes through conversion notices and issuances of Lucy chairs and satisfaction of that note.
Dennis McGrath: As mentioned on our LUCID call yesterday, during the quarter, LUCID issued 2.1 million shares in satisfaction of conversion notices. Shares Outstanding, including Unvested Restricted Stock Awards, as of last week, are 10.3 million shares outstanding. The GAAP outstanding shares of 9.6 million are reflected on the slide as well as the face of the balance sheet in the 10-Q. Gap shares do not reflect unvested restricted stock, with regard to the
Dennis McGrath: As mentioned on our LUCID call yesterday, during the quarter, LUCID issued 2.1 million shares in satisfaction of conversion notices. Total shares outstanding, including unvested restricted stock awards, as of last week, are 10.3 million shares outstanding. The GAAP outstanding shares of 9.6 million are reflected on the slide as well as the face of the balance sheet in the 10-Q. Gap shares do not reflect unvested restricted stock, with regard to the P&
Speaker Change: As mentioned on our LUCID call yesterday, during the quarter, LUCID issued 2.1 million shares in satisfaction of conversion notices during the quarter.
Speaker Change: Shares outstanding, including unvested.
Speaker Change: Restricted Stock Awards, as of last week, are 10.3 million shares outstanding. The GAAP outstanding shares of 9.6 million are reflected on the slide as well as the face of the balance sheet in the 10-Q. GAAP shares do not reflect unvested restricted stock awards.
Dennis McGrath: The gap outstanding shares of 9.6 million are reflected on the slide as well as the face of the balance sheet and 10-Q. Gap shares do not reflect unvested restricted stock awards.
Dennis McGrath: With regard to the P&L, this slide compares this year's second quarter to last year's second quarter on certain key items. Trust you'll review the information in my comments in the light of the cautionary disclosure on the bottom of the slide about supplemental information, particularly non-GAAP. Revenue of approximately one million for the second quarter is about even with the previous two quarters and reflects a six-fold increase over the prior year's second quarter. As detailed on our Lucid quarterly call yesterday, Lucid performed nearly 3,200 tests in the quarter, representing approximately $8 million in billable claims submitted for insurance reimbursement.
Dennis McGrath: This slide compares this year's second quarter to last year's second quarter on certain key items. I trust you'll review the information and my comments in light of the cautionary disclosure at the bottom of the slide about supplemental information, particularly non-GAAP information. Revenue of approximately $1 million for the second quarter was about even with the previous two quarters and reflects a six-fold increase over the prior year's second quarter. As detailed on our LUCID quarterly call yesterday, LUCID performed nearly 3,200 tests in the quarter, representing approximately $8 million in billable claims submitted for insurance reentry. However, lucid cash collections generally limit the amount of recognized revenue from the amounts billed to insurance companies.
Dennis McGrath: This slide compares this year's second quarter to last year's second quarter on certain key items. I trust you'll review the information in my comments in light of the cautionary disclosure at the bottom of the slide about supplemental information, particularly non-GAAP information. Revenue of approximately $1 million for the second quarter is about even with the previous two quarters and reflects a six-fold increase over the prior year. As detailed on our LUCID quarterly call yesterday, LUCID performed nearly 3,200 tests in the quarter, representing approximately $8 million in billable claims submitted for insurance reimbursement. However, lucid cash collections generally limit the amount of recognized revenue from the amounts billed to insurance.
Speaker Change: With regard to the P&L, this slide compares this year's second quarter to last year's second quarter on certain key items.
Speaker Change: Trust you'll review the information and my comments in light of the cautionary disclosure on the bottom of the slide about supplemental information, particularly non-GAAP information.
Speaker Change: Revenue of approximately $1 million for the second quarter is about even with the previous two quarters and reflects a six-fold increase over the prior year's second quarter.
Speaker Change: As detailed on our LUCID quarterly call yesterday, LUCID performed nearly 3,200 tests in the quarter, representing approximately $8 million in billable claims submitted for insurance reimbursement.
Dennis McGrath: However, Lucid Cash Collections generally limit the amount of recognized revenue from the amounts billed to insurance companies. Consequently, Lucid's portion of PAVmed's consolidated revenue is approximately $965,000 after elimination of any company transactions.
Speaker Change: However, lucid cash collections generally limit the amount of recognized revenue from the amounts billed to insurance companies.
Dennis McGrath: Consequently, Lucid's portion of PAVMed's consolidated revenue is approximately $965,000 after the elimination of intercompany transactions. For those of you that are new to our PAVmed earnings poll, a comment on Lucid revenue recognition is worth repeating. A key determinant in the amount of billable revenue that can be recognized is the probability of customer payment. Therefore, due to the fact that we are in the early stages of the reimbursement process means revenue recognition claims submitted through traditional government or private health insurers will be recognized when the claim is actually collected, versus when the patient report is delivered, invoiced, and submitted for reimbursement.
Dennis McGrath: Consequently, LUCID's portion of PAVMed's consolidated revenue is approximately $965,000. After Elimination in Your Company Transcript. For those of you that are new to our PAVmed earnings poll, a comment on lucid revenue recognition is worth repeating. A key determinant in the amount of billable revenue that can be recognized is the probability of customer payment.
Speaker Change: Consequently, Lucid's portion of Pavans Consolidated Revenue is approximately 965,000 after elimination of inner company transactions.
Dennis McGrath: For those of you that are new to our PAVmed earnings poll, comment on Lucid revenue recognition is worth repeating. A key determinant in the amount of billable revenue that can be recognized is the probability of customer payment. And therefore, do the fact that we are in the early stages of the reimbursement process means revenue recognition claims submitted through traditional government or private health insurance will be recognized when the claim is actually collected. Versus when the patient report is delivered, invoiced, and submitted for reimbursement. As you'll see in our 10-Q, this is called variable consideration in the normal jargon of GAAP's ASC 606 revenue recognition guidelines.
Speaker Change: For those of you that are new to our Padlet earnings poll, a comment on lucid revenue recognition is worth repeating.
Speaker Change: A key determinant in the amount of billable revenue that can be recognized is the probability of customer payment.
Dennis McGrath: Therefore, due to the fact that we are in the early stages of the reimbursement process, revenue recognition claims submitted to traditional government or private health insurers will be recognized when the claim is actually collected, versus when the patient report is delivered, invoiced, and submitted for reimbursement. As you'll see in our 10-Q, this is called variable consideration in the normal jargon of GAAP's ASC-606 Revenue Recognition Guidelines. And presently, there is insufficient predictive data to reflect revenue when the test report is delivered to the referring firm.
Speaker Change: Therefore, due to the fact that we are in the early stages of the reimbursement process means revenue recognition claims submitted to traditional government or private health insurers will be recognized when the claim is actually collected versus when the patient report is delivered, invoiced, and submitted for reimbursement.
Dennis McGrath: As you'll see in our 10-Q, this is called Variable Consideration in the normal jargon of GAAP's ASC-606 Revenue Recognition Guidelines. And presently, there is insufficient predictive data to reflect revenue when the test report is delivered to the referring facility. For billable amounts contracted directly with employers and are fixed and determinable will be recognized as revenue when our contracted service is delivered. Generally, that means when the report is delivered to the
Speaker Change: As you'll see in our 10-Q, this is called variable consideration in the normal jargon of GAAP's ASC 606 Revenue Recognition Guidelines. And presently, there is insufficient predictive data to reflect revenue when the test report is delivered to the referring physician.
Dennis McGrath: And presently, there is insufficient predictive data to reflect revenue when the test report is delivered to the referring physician. For billable amounts contracted directly with employers and are fixed and determinable, we'll be recognized as revenue when our contract and service is delivered. Generally, it means when the report is delivered to the referring physician.
Dennis McGrath: For billable amounts contracted directly with employers and that are fixed and determinable will be recognized as revenue when our contracted service is delivered. Generally, that means when the report is delivered to the referring party. The second quarter year-over-year reduction in operating expenses of about $2 million is primarily related to non-cash charges in the prior year flowing through OPEX, including stock-based compensation expenses.
Speaker Change: For billable amounts contracted directly with employers and are fixed and determinable, will be recognized as revenue when our contracted service is delivered. Generally that means when the report is delivered to the referring position.
Dennis McGrath: The second quarter year-over-year reduction in operating expenses of about $2 million is primarily related to non-cash charges in the prior year, flowing through OPEX, including stock-based compensation expense, and about 650,000 of R&D expenses paid in stock. Our non-GAPS loss for the second quarter of $7.7 million reflects about $1 million sequential improvement compared to the first quarter loss, and about a $2.5 million improvement year-over-year from the prior year quarter. The non-GAAP loss for share for the second quarter was 84 cents per share. On a GAPEPS basis, out of the $19 loss for share, non-cast charges account for approximately 35 cents per share in the second quarter, and that's largely related to the convertible debt charges and the stock compensation expense.
Dennis McGrath: The second quarter year-over-year reduction in operating expenses of about $2 million is primarily related to non-cash charges in the prior year flowing through OPEX, including stock-based compensation expenses and about $650,000 of R&D expenses paid in stock. Our non-GAAP loss for the second quarter of $7.7 million reflects about a $1 million sequential improvement compared to the first quarter loss and about a $2.5 million improvement year-over-year from the prior year. The non-GAAP loss per share for the second quarter was $0.84 per share.
Speaker Change: The second quarter year over year reduction of operating expenses of about $2 million is primarily related to non-cast charges in a prior year. Lowing through objects, including stock-based compensation expense.
Dennis McGrath: About $650,000 of R&D expenses were paid in stock. Our non-GAAP loss for the second quarter of $7.7 million reflects about $1 million sequential improvement compared to the first quarter loss and about a $2.5 million improvement year-over-year from the prior year. The non-GAAP loss per share for the second quarter was $0.84 per share.
Speaker Change: and about $650,000 of R&D expenses paid in stock.
Speaker Change: Our non-GAAP loss for the second quarter of $7.7 million reflects about $1 million sequential improvement compared to the first quarter loss and about a $2.5 million improvement year-over-year from the prior year quarter.
Speaker Change: The non-GAAP loss per share for the second quarter was $0.84 per share.
Dennis McGrath: On a GAAP EPS basis, out of the $1.19 loss per share, non-cash charges accounted for approximately $0.35 per share in the second quarter, and that was largely related to the convertible debt charges and the stock market. With regard to non-GAAP operating expenses, on this slide, you'll see a graphic illustration of our operating expenses over time, which is also presented in detail in our press release. Total non-GAAP operating expenses were $12.3 million for the second quarter of 2024, and as you can see, is in line with the first quarter levels and the year-over-year amount. Also worthy of repeating are some reimbursement stats related to the first six months of 2024, as mentioned on our elusive call yesterday. In the second quarter of this year, we build.
Dennis McGrath: On a GAAP EPS basis, out of the $1.19 loss per share, non-cash charges accounted for approximately $0.35 per share in the second quarter, and that was largely related to the convertible debt charges in the stock. With regard to non-GAAP operating expenses, on this slide, you'll see a graphic illustration of our operating expenses over time, which is also presented in detail in our press release. Total non-GAAP operating expense is $12.3 million for the second quarter of 2024, and as you can see, it is in line with the first quarter levels and the year-over-year. Also worthy of repeating are some reimbursement stats related to the first six months of 20 In the second quarter of this year, we built 3,174 tests, reflecting just under $8 million in pro forma. During the second quarter, we collected $976,000.
Speaker Change: On a GAAP EPS basis, out of the $1.19 loss per share, non-cash charges accounted for approximately $0.35 per share in the second quarter, and that's largely related to the convertible debt charges and the stock market compensation expense.
Dennis McGrath: With regard to non-GAAP operating expenses on the slide, you'll see a graphic illustration of our operating expenses over time, and which are also presented in detail in our press release. Total non-GAP operating expense is $12.3 million for the second quarter, $2,024, and as you can see, is in line with the first quarter levels and the year-over-year amounts.
Speaker Change: and others. And that's
Speaker Change: With regard to non-GAAP operating expenses, on this slide you'll see a graphic illustration of our operating expenses over time, of which are also presented in detail in our press release.
Speaker Change: Total non-GAAP operating expense is $12.3 million for the second quarter, 2024, and as you can see is in line with the first quarter levels and the year-over-year amounts.
Dennis McGrath: Also worthy of repeating or some reimbursement stats related to the first six months of 2024, as mentioned on our loses call yesterday. In the second quarter of this year, we build 3,174 tests reflecting just on their $8 million in pro-former revenue. During the second quarter, we collect at $976,000.
Speaker Change: Also worthy of repeating are some reimbursement stats related to the first six months of 2024 as mentioned on our lucid call yesterday.
Dennis McGrath: 3,174 tests, reflecting just under $8 million in Proforma Red. During the second quarter, we collected $976,000. Of that amount collected, about 35% of the $976,000 claims paid were from those submitted in the current quarter, and about 45% were from those submitted in the first. And the balance of the claims were submitted last year with the longest-dated item being about 12 months. Our Revenue Cycle Manager is reporting that turnaround times have been increasing for the largest payers, but we've seen an increase in claims being designated medically non-payable. The Revenue Cycle Manager is a mitigation plan for both issues, including increasing the speed of follow-up with late payers and proactively soliciting medical records for use in appeals at an earlier stage in the process.
Speaker Change: In the second quarter of this year, we build
Speaker Change: 3,174 tests reflecting just under eight million dollars in pro forma revenue.
Dennis McGrath: Of that amount collected, about 35% of the $976,000 claims paid were from those submitted in the current quarter, about 45% from claims submitted in the first, and the balance of the claims were submitted last year with the longest-dated item being about 12 months. Our Revenue Cycle Manager is reporting that turnaround times have been increasing for the largest payers. We've seen an increase in claims being designated medically non-committal. The Revenue Cycle Manager is a mitigation plan for both issues, including increasing the speed of follow-up with late payers and proactively soliciting medical records for use in appeals at an earlier stage in the process.
Dennis McGrath: Parks. A VAT amount collected about 35% of the 976,000 claims paid were from those submitted in the current quarter. About 45% from claims submitted in the first quarter. And the balance of the claims were submitted last year with the longest data item from about 12 months ago.
Speaker Change: During the second quarter, we collected $976,000.
Speaker Change: Of that amount collected, about 35% of the $976,000 claims paid were from those submitted in the current quarter.
Speaker Change: About 45% from claims submitted in the first quarter.
Speaker Change: And the balance of the claims were submitted last year, with the longest dated item from about 12 months ago.
Dennis McGrath: A Revenue Cycle Manager is reporting that turnaround times have been increasing for the largest payers. But we've seen an increase in claims being designated medically not necessary. The Revenue Cycle Manager is a mitigation plan for both issues, including increasing the speed to follow up with late payers and proactively soliciting medical records for use and appeals at an earlier stage in the process.
Speaker Change: Our Revenue Cycle Manager is reporting that turnaround times have been increasing for the largest payers, but we've seen an increase in claims being designated medically not necessary.
Speaker Change: The Revenue Cycle Manager is a mitigation plan for both issues, including increasing the speed of follow-up with late payers and proactively soliciting medical records for use in appeals at an earlier stage in the process.
Dennis McGrath: We submit reimbursement claims for nearly 55,600 claims during the first half of this year, representing just under 14 million dollars in pro forma revenue. About 77% have been adjudicated, and 23% are pending. Out of the 77% that have been adjudicated, about 25% resulted in an allowable amount by the insurance company with a weighted average of about $1,540 per test. Although tonight, about 43% are deemed not medically necessary or require a prior authorization. Additionally, about 26% were deemed to be non-covered.
Dennis McGrath: We submitted reimbursement claims for nearly 5,600 claims during the first half of this year, representing just under $14 million in pro forma revenue. About 77% have been adjudicated, and 23% have been acquitted. Out of the 77% that have been adjudicated, About 25% resulted in an allowable amount by the insurance company with a weighted average of about $1,540. Of those denied, about 43% are deemed not medically necessary or require prior authorization. Additionally, about 26% were deemed to be non-COVID. With that, Operator, let's open it up for questions.
Dennis McGrath: We submitted reimbursement claims for nearly 5,600 claims during the first half of this year, representing just under $14 million in pro forma revenue. About 77% have been adjudicated, and 23% are free. Out of the 77% that have been adjudicated, about 25% resulted in an allowable amount by the insurance company with a weighted average of about $1,540. Of those denied, about 43% are deemed not medically necessary or require prior authorization.
Speaker Change: We submitted reimbursement claims for nearly 5,600 claims during the first half of this year, representing just under $14 million in pro forma revenue.
Speaker Change: About 77% have been adjudicated and 23% are pending.
Speaker Change: Out of the 77% that have been adjudicated,
Speaker Change: About 25% resulted in an allowable amount by the insurance company with a weighted average of about $1,540 per test.
Speaker Change: Of those denied, about 43% are deemed not medically necessary or require a prior authorization.
Operator: With that operator, let's open it up for questions. Thank you.
Speaker Change: Additionally, about 26% were deemed to be non-covered.
Operator: Additionally, about 26% were deemed to be non-committal. With that, Operator, let's open it up for questions. Thank you. And, ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the number one on your telephone keypad. You will hear a prompt that your hand has been raised. Should you wish to decline the calling process, please press the star followed by the number 2. If you are using a speakerphone, please pick up your handset before pressing any keys.
Speaker Change: With that, operator, let's open it up for questions.
Operator: Thank you. And, ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the number one on your telephone keypad. You will hear a prompt that your hand has been raised. Should you wish to decline the calling process, please press the star followed by the number 2. If you are using a speakerphone, please pick up your handset before pressing any keys. One moment, please, for your first question.
Operator: And ladies and gentlemen, we will now begin the question-and-answer session. Should you have a question, please press the star followed by the number one on your telephone keypad. You will hear a prompt that your hand has been raised. Should you wish to decline from the calling process, please press the star, followed by the number two. If you're using a speaker phone, please speak of your handset before pressing any keys. One moment, please, for your first question.
Speaker Change: Thank you. And ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the number one on your telephone keypad. You will hear a prompt that your hand has been raised.
Operator: Conference Call. At this time, all lines are in on listen only mode. Following the presentation, we welcome back a question in the answer session.
Speaker Change: Should you wish to decline from the calling process, please press the star followed by the number 2. If you are using a speakerphone, please pick up your handset before pressing any keys. One moment please for your first question.
Operator: If at any time during this call you require immediate assistance, please press the star zero for the operator. Please note this event is being recorded.
Operator: One moment, please, for your first question. And your first question comes from the line of Ross Osborn with Contra Pittsburgh. Please go ahead. Good morning, Ross. Good morning, Lishan, and Dennis. This is Matthew Park on for Ross today.
Ross Osborn: And your first question comes from the line up, Ross Aspern, with Contra Vittural. Please go ahead.
Matt Riley: I would now like to turn the conference over to Matt Riley, have met director of investor relations, please go ahead. Thank you operator and good morning everyone. Thank you for participating in today's business update call. Joining me today on the caller, Dr. Lishan Aklog, Chairman and Chief Executive Officer of PAVmed, along with Dennis McGrath, Chief Financial Officer of PAVmed. The press release announcing our business update and financial results is available on PAVmed's website.
Speaker Change: And your first question comes from the line of Ross Osborne with Contra Pittsburgh. Please go ahead.
Matt Riley: More to Ross.
Matthew Park: Good morning, Lishan and Dennis. This is Matthew Park on for Ross today. Thanks for taking the questions.
Matt Riley: Good morning, we shall meet Dennis. This is Matt and Park on for Ross today. Thanks for taking the question. I was just hoping to provide more color in terms of the scale of the pilot launch and I guess your timeline for full launch and when we should start to see revenue coming up. Yeah, so the pilots going on pace, since we're about a third of the way through. It's designed to follow, to have 100 patients enrolled in the platform. And it's going well, you know, the purpose of the pilot was, so this is a large medical center.
Matthew Park: Thanks for taking the question. Hey, Matthew. I was just hoping you could provide more color in terms of the scale of the pilot launch and, I guess, your timeline for full launch and when we should start to see revenue coming. Yeah, so, the, uh, the pilot's going on pace. We've, um, um, since, um, um, we're about a third of the way through.
Speaker Change: Good morning Ross.
Speaker Change: Good morning, Lishan and Dennis. This is Matthew Park on for us today. Thanks for taking the questions.
Lishan Aklog: It's designed to have 100 patients enrolled on the platform, and it's going well. You know, the purpose of the pilot was to show this is a large medical center. They're the third largest cancer center in the country, and it was really about making sure that we're aligned with logistics with regard to how they handle calls and incoming notifications, and all of that is going really well. So... We expect the pilot to wrap up in several months, and then, based on the success of that transition, to not just a full commercial engagement, but we're really looking forward to finding ways to engage strategically with the institution on a whole variety of fronts, consistent with what we described in the Memorandum of Understanding and, of course, using this as a prototype to engage with other large academic cancer centers. I got it.
Matthew Park: I was just hoping you could provide more color in terms of the scale of the pilot launch and I guess your timeline for full launch and when we should start to see revenue coming into the fold.
Lishan Aklog: Yeah, so, the, uh, pilot's going on pace. We've, um, um, since, um, um, we're about a third of the way through.
Matt Riley: Please take a moment to read the disclaimers about four looking statements in the press release. The business update, press release and the conference call all include four looking statements and these four looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from the statements made. Factors that could cause actual results to differ are described in a disclaimer and in our filings of the Securities and Exchange Commission.
Speaker Change: Yeah, so the pilot's going on pace, we've since...
Lishan Aklog: It's designed to have 100 patients enrolled on the platform, and it's going well. You know, the purpose of the pilot was to show this is a large medical center. They're the third largest cancer center in the country, and it was really about making sure that we're aligned with logistics with regard to how they handle calls and incoming notifications, and all of that is going really well. So... We expect the pilot to wrap up in several months, and then, based on the success of that transition, to not just a full commercial engagement, but we're really looking forward to finding ways to engage strategically with the institution on a whole variety of fronts, consistent with what we described in the memorandum of understanding, and then, of course, to use this as a prototype to engage with other large academic cancer centers.
Speaker Change: We're about a third of the way through. It's designed to follow.
Matthew Park: to have 100 patients enrolled on the platform and it's going well. You know, the purpose of the pilot was, so this is a large...
Lishan Aklog: They're the third is really about making sure that we're aligned with logistics with regard to how they handle calls and incoming notifications, and all of that is really going really well. So we expect the pilot to wrap up in several months, and then we'll look to get, based on the success of that transition, to not just a full commercial engagement, but we're really looking forward to finding ways to engage strategically with the institution on a whole variety of fronts, consistent with what we described in the memorandum of understanding. And then, of course, using this as a prototype to engage with other large academic cancer centers.
Matthew Park: Medical Center. They're the third largest cancer center in the country and it was really about making sure that we're aligned with logistics with regard to how they handle calls and incoming notifications and all of that is really going really well so
Matt Riley: For a list and a description of these and other important risks and uncertainties that may affect future operations, the part one, item one A entitled risk factors and PAVmed's most recent annual report on forms 10K filed with SEC and any subsequent updates filed in the quarterly reports on forms 10Q and subsequent forms 8K. Accept is required by law of PAVmed, disclaims any intentions or obligations to publicly update or revise any four looking statements, to reflect changes in expectations or in events, conditions or circumstances on which expectations may be based or that may affect the likelihood that actual results will differ from those contained in the four looking statements.
Matthew Park: We expect the
Matthew Park: The pilot to wrap up in several months and then we'll look to
Matthew Park: Again, based on the success of that transition to not just a full commercial engagement, but we're really looking forward to finding ways to engage strategically with.
Matthew Park: the institution on a whole variety of fronts consistent with what we described in the Memorandum of Understanding. And then, of course, using this as a prototype to engage with other large academic cancer centers along the way.
Matt Riley: on the way. Got it. That's helpful.
Lishan Aklog: I would now like to turn the call over to Dr. Lee Chan-Aklad, Chairman and CEO of PAVmed. Take it away, Lee Chan. Thank you, Matt, and good morning, everyone. Thank you for joining our quarterly update call before proceeding. I'd like to thank our long-term shareholders for your ongoing support and commitment. As we discuss in recent calls, our updated strategy for PAVmed has been to strengthen its finances and long-term stability by seeking to have each of its subsidiaries be independently financeable and while positioned to leverage PAVmed's shared infrastructure.
Matthew Park: That's helpful. And then, I guess, following up on that, would you walk us through your pipeline of additional contracts and any conversations you guys are having right now with large centers? Yeah, we do have a pipeline of about a dozen or so large centers and have active conversations with several of them. We expect those to move forward and accelerate really upon completion of this pilot. You know, Pat, Luz, sorry, Veris has been, you know, we've been careful with our expenditures and our operating expenses to focus on this particular account as a driver to be able to secure financing to restart the development of the implantable monitor and so forth.
Lishan Aklog: Got it. That's helpful. And then, I guess, following up on that, would you walk us through your pipeline of additional contracts and any conversations you guys are having right now with large centers?
Lishan Aklog: And then I guess, following up on that, would you walk us through your pipeline of additional contracts and any conversations you guys are having right now with large centers? Yeah, we do have a pipeline of about a dozen or so large centers and have active conversations with several of them. We expect, we expect those to move forward and accelerate really upon completion of this pilot. You know, Luis, sorry, Varys has been, you know, we've been careful with our expenditures and our operating expenses to focus on this particular account as a driver to be able to secure financing, to drive, to restart the develops of the implantable monitoring and so forth.
Speaker Change: Got it. That's helpful. And then I guess following up on that, would you walk us through your pipeline of additional contracts and any conversations you guys are having right now with large centers?
Lishan Aklog: Yeah, we do have a pipeline of about a dozen or so large centers and have active conversations with several of them. We expect we expect those to move forward and accelerate really upon completion of this pilot, you know, Pat loose, sorry, various has been, you know, we've been careful with our expenditures and our operating expenses to focus on this particular account as a driver to be able to secure financing to restart the development of the implantable monitor and so forth. And, as I've mentioned, that strategy is working, and we're close to securing some additional financing. I believe once we do, and once we complete this pilot, we'll be able to start securing additional accounts.
Matthew Park: Got it. That's helpful. And then, I guess, just one more on my end.
Speaker Change: Yeah, we do have a pipeline of about a dozen or so large centers and have active conversations with several of them.
Speaker Change: We expect, we expect those two.
Speaker Change: move forward and accelerate really upon completion of this pilot. You know, Veris has been, you know, we've been careful with our expenditures and our operating expenses to focus on this particular account as a driver to be able to secure financing to drive
Lishan Aklog: I'm pleased at the progress we've made on this front. Lucid remains PAVmed's strongest asset. It has been able to independently finance its operations. And as we discussed in yesterday's Lucid earnings call is making solid progress over multiple fronts towards fulfilling its large commercial potential. PAVmed's two other subsidiaries are also headed in a positive direction, consistent with the strategies. As we will discuss later, Varys helped as close as securing an independent financing round. And the PMX incubator is deep in the process of securing financing for Port IO. Both of these add attractive valuations.
Lishan Aklog: And as I've mentioned, that strategy is working and we're close to securing some additional financing. I believe once we do, and once we complete this pilot, that will be able to start securing additional accounts. Got it. That's helpful.
Matthew Park: And as I've mentioned, that strategy is working, and we're close to securing some additional financing. And I believe once we do, and once we complete this pilot, we'll be able to start securing additional accounts. Got it. That's helpful. And then, I guess, just one more on my end. Turning to the Inflatable Monitor, pending additional financing, have you guys provided longer-term guidance on when you expect to submit the monitor for approval? And I guess the steps that you guys need to take to get there.
Speaker Change: to restart the development of the implantable monitor and so forth. And as I've mentioned, that strategy is working and we're close to securing some additional financing. And I believe once we do and once we complete this pilot, we'll be able to start securing additional accounts.
Lishan Aklog: Turning to the Influenceable Monitor, pending additional financing, have you guys provided longer-term guidance on when you expect to submit the monitor for approval? And, I guess, the steps that you guys need to take to get there? Thank you.
Lishan Aklog: And then I guess just one more on my end. Turning to the implantable monitor, pending additional financing. Have you guys provided longer-term guidance on when you expect the monitor approval? I guess the steps that you guys said together. Thank you. Yeah, the timeline for the mission, the pathway to clearance, has all been pretty well worked out. We've had, you know, multiple, as I've said before, we've had multiple meetings with the FDA. We've done a variety of preclinical studies that, at their request. And so we feel like we're in pretty good shape. I have a pretty, pretty predictable path.
Lishan Aklog: Let's start with some highlights from the second quarter and recent weeks. Again, starting with Lucid diagnostics, just briefly, and second quarter, ESA Guard revenue was flat. The test volume increased to approximately 31% quarter on quarter and 44% year on year, and it was a record quarter for us. An important highlight is that we had a productive meeting with the CNS Medicare Contractor Multi-X program and look forward to being able to follow up on that meeting with the submission of our Nathan.
Speaker Change: Got it. That's helpful. And then I guess just one more on my end. Turning to the Inflatable Monitor, pending additional financing, have you guys provided longer term guidance on when you expect to submit the monitor for approval? And I guess the steps that you guys need to take to get there. Thank you.
Lishan Aklog: The timeline for submission, the pathway to clearance has all been pretty well worked out. We've had, as I've said before, we've had multiple meetings with FDA. We've done a variety of preclinical studies at their request.
Lishan Aklog: Thank you. Yeah. The timeline for submission, the pathway to clearance has all been pretty well worked out. We've had, as I've said before, we've had multiple meetings with FDA. We've done a variety of preclinical studies at their request.
Lishan Aklog: And so we feel like we're in pretty good shape, have a pretty predictable path. And if we are able to secure that financing soon and be able to relaunch the development of the product, that'll take some time. It takes some time to bring vendors back online and to get back to where we left off. But, you know, we're looking at sometime in mid-next year 2025 as a reasonable target for FDA submission. And once we're submitted, we believe the clearance path is pretty straightforward.
Lishan Aklog: And so we feel like we're in pretty good shape, have a pretty predictable path. And if we are able to secure that financing soon and be able to relaunch the development of the product, that'll take some time. It takes some time to bring vendors back online and to get back to where we left off. But, you know, we're looking at sometime in mid-next year 2025 as a reasonable target for FDA submission. And once we're submitted, we believe the clearance path is pretty straightforward. Great. Thanks for taking the questions.
Matthew Park: Great. Thanks a lot.
Lishan Aklog: We held our first large Check Your Food to Prevent with upfront contracted payments and important milestone with regard to us being able to translate test flying growth and check your food to prevent with revenue and revenue growth. And for our health, our focus has been on our pilot program with the Ohio State James Cancer Center and we as we'll discuss later, our first patients onto the platform. As I mentioned, we are in the process of raising capital in Severus and we expect the first punch to close very soon.
Speaker Change: Preclinical Studies that at their request and so we feel like we're in pretty good shape have a pretty pretty predictable path and if
Lishan Aklog: And if we are able to secure that financing soon and be able to relaunch the development of the product, that'll take some time. It takes some time to bring vendors back online and to get back to where we left off. But, you know, we're looking at some time in mid-next year, 2025, as a reasonable target for FDA submission. Once we're submitted, we believe the clearance path is pretty straightforward.
Speaker Change: Um.
Speaker Change: If we are able to secure that financing soon and to be able to relaunch the development of the product.
Speaker Change: That will take some time. It takes some time to bring vendors back online and to get back to where we left off. But we're looking at sometime mid-next year, 2025, as a reasonable target for an FDA submission. And once we're submitted, we believe the clearance path is pretty straightforward.
Matt Riley: Great.
Matthew Park: Great. Thanks for taking the questions. Thanks a lot.
Matt Riley: Thanks for taking the questions. Great. Thanks a lot. Appreciate it. Thank you.
Lishan Aklog: Concurrent with that, we're preparing to remanche the development of our implantable monitoring, which we will begin once we have secured that financing. And as I mentioned for under the PMX incubator, we're focused on raising capital for Port Ion.
Speaker Change: Great. Thanks for taking the questions.
Operator: Thank you. And once again, if you'd like to ask a question, please press the star followed by the number one on your telephone keypad. Your next question comes from the line of Anthony Vendetti with Maxim Group. Please go ahead. Thank you. Good morning, Anthony. Good morning, Lishan.
Operator: Thank you. And once again, if you'd like to ask a question, please press the star followed by the number one on your telephone keypad. Your next question comes from the line of Anthony Vendetti with Maxim Group. Please go ahead.
Operator: And once again, if you would like to ask a question, please press a star followed by the number one on your telephone keypad.
Speaker Change: Great. Thanks a lot. Appreciate it.
Speaker Change: Thank you. And once again, if you would like to ask a question, please press the star followed by the number one on your telephone keypad.
Anthony Vendetti: Your next question comes from the line of Anthony Vendetti, with Maxine Group. Please do head. Thank you. Good morning, Anthony. Thank you. Good morning, Lee Chong. Good morning, Dennis. I think you may have answered the question, but I just want to clarify. So when you were talking about the financing, you were talking about that you were talking about for Varys, not for the incubator, correct?
Lishan Aklog: Just a quick overview for those of you who might be new to the Padman story. Here's our corporate structure. Padman operates by offering shared services. An entire infrastructure of shared services on behalf of the subsidiaries. The subsidiaries include, as I mentioned, elusive diagnostics are publicly traded on a diagnostic company, very health, privately held, digital health company, our incubator PMX, which was recently launched, which is focusing on one of the products in our portfolio, Port Ion. And this structure is designed to allow us to bring in other assets, other technologies under this umbrella and shared services model.
Speaker Change: Your next question comes from the line of Anthony Vendetti with Maxim Group. Please go ahead.
Anthony Vendetti: Thank you. Good morning, Anthony. Good morning, Lishan. Good morning, Dennis. I think you may have answered the question, but I just want to, I just want to clarify. So when you were talking about the financing, you were talking about it for Veris, not for the incubator, correct?
Lishan Aklog: Well, for both. Yeah, we mentioned that for both, but the various ones furthest along. Again, just to maybe use this as an opportunity to reiterate, that's PAVmed's new model, right?
Anthony Vendetti: Good morning, Dennis. I think you may have answered the question, but I just want to clarify. So when you were talking about the financing, you were talking about Veris, not the incubator, correct? Well, for both. Yeah, we mentioned that for both. But the Varus one is the furthest along.
Speaker Change: Thank you. Good morning, Anthony.
Anthony Vendetti: Good morning Lishan, good morning Dennis. I think you may have answered the question but I just want to I just want to clarify so when you're talking about the financing you were talking about you were talking about for Veris not for the incubator, correct?
Lishan Aklog: Well, for both. Yeah, we mentioned that for both. But the Varys, the Varys wants further, further along.
Speaker Change: Well, for both, yeah, we mentioned that for both, but the various, the various ones further furthest along and
Lishan Aklog: And again, just to maybe use this as an opportunity to reiterate, that's had met new model, right? We have a shared services model. We have subsidiaries, and we're seeking to raise capital into each of the subsidiaries. Obviously, Elucid has done that well over the past couple of years. And we're looking for the first time, really, to raise capital directly into Varys.
Lishan Aklog: Again, just to maybe use this as an opportunity to reiterate, that's PAVmed's new model, right? We have a shared services model, we have subsidiaries, and we're seeking to raise capital for each of the subsidiaries. Obviously, Ellucid has done that well over the past couple of years, and we're looking for the first time, really, to raise capital directly into Veris. And the incubator that we launched a couple quarters ago is designed also to raise capital, not just into the incubator itself but into individual corporate entities that hold individual assets, such as Fortnite.
Lishan Aklog: We have a shared services model, we have subsidiaries, and we're seeking to raise capital into each of the subsidiaries. Obviously, Ellucid has done that well over the past couple of years, and we're looking for the first time, really, to raise capital directly into Veris. And the incubator that we launched a couple quarters ago is designed also to raise capital, not just into the incubator itself but into individual corporate entities that hold individual assets, such as Port IO.
Speaker Change: Again, just to maybe use this as an opportunity to reiterate, that's PadMED's new model, right? We have... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ...
Lishan Aklog: So let's start with Lucid. Again, I'll be brief here. I would really encourage you to refer to the webinar from yesterday, as well as a press release for further details. As you can see here, Lucid's test volume grew to a record level in the last quarter, and our revenues have held up and have remained flat quarter on quarter. The numbers are shown here. Revenue flat quarter on quarter, up 500 percent annually, test volume up, 31 percent on quarter on quarter on a record quarter, and up 44 percent annually.
Speaker Change: a shared services model. We have subsidiaries and we're seeking to raise capital into each of the subsidiaries. Obviously, Lucid has done that well over the past
Speaker Change: A couple of years.
Lishan Aklog: And the incubator that we launched a couple of quarters ago is designed also to raise capital not just into the incubator itself, but into individual corporate entities that hold individual assets, which is a point I'm thank you. Okay, great.
Speaker Change: And we're looking for the first time really to raise capital directly into Veris and the incubator that we launched a couple of quarters ago is designed also to raise capital, not just into the incubator itself, but into individual corporate entities that hold individual assets such as PortIO.
Anthony Vendetti: Okay, great. And at this point, though, it's not a spinoff into an IPO like Lucid, correct?
Lishan Aklog: Okay, great. And at this point, though, it's not a spin-off into an IPO like Lucid, correct? No, no, we don't think that the markets are really amenable to that right now. This is just simply, where do we raise the capital to advance these technologies?
Lishan Aklog: And at this point, though, it's not a spin-off into an IPO like, like, Lucid, correct? No, no, we don't think that the market zone are really minimal to that right now. This is just simply, where do we rate the capital to advance these technologies? And our conclusion earlier this year was that to take advantage of Padman Shared Services Model and the infrastructure that we've created and to advance other assets beyond Lucid, that each of those assets would have to raise its own capital privately, but not in the public markets really or not the place right now for these early-stage assets.
Lishan Aklog: As we mentioned yesterday, we held over 50 high volume health fair events that we refer to as check your food to precancer testing events. And we had the first one of those, which allowed us to get upfront contracted payment. The key strategic accomplishment was, as I emphasized, the later, really relate to our clinical evidence space, two studies, the NZBE clinical utility study, and the ESA grant, the E1 clinical validation study, had the new data released, interpending peer review publication, and another critical study, the Cleveland VA clinical validation study, a completed peer review publication. Our meeting with the MDX program was very productive until last month, and we look forward to submitting our data and working with the MDX team to secure Medicare coverage for ESA grant.
Speaker Change: Okay, great. And at this point, though, it's not a spin-off.
Lishan Aklog: No, no, we don't think that the markets are really amenable to that right now. This is just simply, where do we raise the capital to advance these technologies? And our conclusion earlier this year was that to take advantage of PAVmed's shared services model and the infrastructure that we've created and to advance other assets beyond Lucid, each of those assets would have to raise its own capital privately, but not in the public markets, really, or not the place right now for these early stage companies.
Speaker Change: into an IPO like Lucid, correct?
Speaker Change: No, no, we don't think that that's the market.
Speaker Change: are really amenable to that right now. This is just simply where do we raise the capital to advance these technologies and
Lishan Aklog: And our conclusion earlier this year was that to take advantage of PAVmed's shared services model and the infrastructure that we've created, and to advance other assets beyond Lucid, each of those assets would have to raise its own capital privately, but not in the public markets, which are not the place right now for these early-stage technologies. Agreed. Yeah. No, that makes sense.
Speaker Change: Our conclusion earlier this year was that to take advantage of Padmet's shared services model and the infrastructure that we've created and to advance other assets beyond Lucid, that each of those assets would have to
Speaker Change: raise its own capital privately, but not in the public markets, really, are not the place right now for these early-stage
Anthony Vendetti: Assets. Agreed. Yeah, no, that makes sense. So, based on your best estimate, you expect VAERS to have funding for VAERS in place before the end of the year and then submit it to the FDA by mid-25, is that correct?
Lishan Aklog: Agreed. Yeah, no, that makes sense.
Lishan Aklog: So, based on your best estimates, you expect to have funding for various in place before the end of the year, and then submit to the FDA by mid-25, is that correct? Yeah, that sounds about right. I think, as I said, I think the financing is that effort is going well. We're hopeful to close on an additional charge that will allow us to get things off the ground actually pretty soon. So that those broad estimates would regard to timeline are reasonable.
Anthony Vendetti: So, based on your best estimate, you expect VAERS to have funding for VAERS in place before the end of the year and then submit it to the FDA by mid-25, is that correct? Yeah, that sounds about right. I think, as I said, the financing effort is going well. We're hopeful to close on an initial tranche that will allow us to get things off the ground actually pretty soon. So those broad estimates with regard to the timeline are reasonable.
Speaker Change: Agreed. Yeah. No, that makes sense. So, based on your best estimate, you expect to have funding for VAERS in place before the end of the year and then submit to the FDA by mid-25, is that correct?
Lishan Aklog: Now, I'll transition now to a bit of an overview on address health. So, various health at the commercial stage, digital health company that seek to enhance personalized cancer care consists of two components. One is the various cancer care platform. This is a software platform, which includes a patient care module and a positional or caretaker module, and they interface with a box of connected devices, Bluetooth connected devices, that provides physiological information for the clinicians to improve the care that patients.
Lishan Aklog: Yeah, that sounds about right. I think, as I said, the financing is going well. We're hopeful to close on an initial tranche that will allow us to get things off the ground actually pretty soon. So those broad estimates with regard to the timeline are reasonable.
Speaker Change: Yeah, that sounds about right. I think, as I said, I think the financing is...
Speaker Change: That effort is going well. We're hopeful to close on an initial tranche that will allow us to get things off the ground actually pretty soon. So, those broad estimates with regard to timeline are reasonable.
Lishan Aklog: Okay, great. Thank you very much. I'll hop back in the queue.
Anthony Vendetti: Okay, great. Thank you very much. I'll hop back in the queue. Appreciate it.
Anthony Vendetti: Okay, great. Thank you very much. I'll hop back in the queue. Appreciate it. Great. Thanks, everybody.
Lishan Aklog: We have an implantable monitor that's under development that will seek to provide continuous data for the patient and interface with the platform. The vision of the companies to utilize modern remote patient monitoring tools to improve care through early detection of complications, established longitudinal trends in risk management. The implantable was on hold, Paddick Financing. As I mentioned, we're close to securing financing and look forward to restarting the implantable monitor projects. As we discussed on previous call, our focus has been on large academic centers for teaching accounts.
Speaker Change: Okay, great. Thank you very much. I'll hop back in the queue. Appreciate it. Thanks for everything. Appreciate it.
Ed Wu: And your next question comes from the line of Ed Wu with Ascendient Capital. Please go ahead. Yeah, thank you very much. I had a I had a very general question about valuations. Have you seen valuations change significantly in terms of when you're going out trying to, you know, raise funding for the incubator as well as for Barris? Yeah, I mean I think obviously it depends on the individual asset. You know, Barris is further along. Although Portio has actually been advanced, been advanced quite far and was just waiting the launch of the clinical study ID study.
Operator: And your next question comes from the line of Ed Woo with Ascendian Capital. Please go ahead.
Anthony Vendetti: I appreciate it. Thanks, everybody. I appreciate it. And your next question comes from the line of Ed Woo with Ascendian Capital. Please go ahead. Yeah, thank you very much. I had a very general question about valuations. Have you seen valuations change significantly in terms of when you go out trying to, you know, raise funding for the incubator as well as for Veris? Yeah, I mean, obviously, it depends on the individual asset. Veris is further along, although PortIO has actually been advanced quite far and was just awaiting the launch of the clinical study, the IDE study.
Speaker Change: And your next question comes from the line of Ed Wu with Ascendian Capital. Please go ahead.
Ed Woo: Yeah, thank you very much. I had a very general question about valuations. Have you seen valuations change significantly in terms of when you're going out trying to, you know, raise funding for the incubator as well as for varus?
Ed Woo: So, we've been, you know, again, these are not closed yet, so I don't want to speak prematurely, but we, you know, they're both strong assets, and we've been pleasantly surprised at the interest and valuations that we believe we can close these transactions on. Great. Well, thanks for answering my questions, and I wish you guys good luck. Thank you. Yeah, thanks, Ed. And I'm showing no further questions at this time. I would like to turn it back to Dr. Lishan Aklog for his closing remarks.
Ed Wu: Yeah, thank you very much. I had a I had a very general question about valuations. Have you seen valuations change significantly in terms of when you're going out trying to, you know, raise funding for the incubator as well as for Veris?
Lishan Aklog: Yeah, I mean, obviously, it depends on the individual asset. You know, Veris is further along, although PortIO has actually been advanced quite far and was just awaiting the launch of the clinical study, the IDE study. So, we've been, you know, again, these are not closed yet, so I don't want to speak prematurely, but they're both strong assets, and we've been pleasantly surprised at the interest and valuations we believe we can close these transactions at.
Speaker Change: Yeah, I mean, I think, obviously, it depends.
Speaker Change: on
Speaker Change: The individual asset, you know, VARIS is further along, although Port IO has actually been advanced quite far and was just awaiting the launch of the clinical study.
Lishan Aklog: We have been engaged with the Ohio State University under a memorandum of understanding and this past June, we launched our pilot program consistent with that MOU, was launched in the bone marrow transplant and gynecology, oncology units, 20 approximately 26 patients that have been onboarded to date. And we've had our first patient success story in mid July that demonstrated that our platform's ability to pick up signs of clinical deterioration resulted in a patient returning to the hospital and getting care and avoiding complications.
Lishan Aklog: So we've been there again. These are not closed yet. So I don't I don't want to speak prematurely, but we the other both strong assets and we've been pleasantly surprised at the interest and valuations that we believe we can close these transactions.
Speaker Change: IDE study. So we've been, you know again, these are not closed yet so I don't I don't want to speak prematurely, but we, you know, they're both strong assets and we've been pleasantly surprised at
Speaker Change: at the interest and valuations that we believe we can close these transactions at.
Lishan Aklog: Great. Well, thanks for answering my questions, and I wish you good luck. Thank you. Yeah, thanks, Ed.
Ed Woo: Great. Well, thanks for answering my questions, and I wish you guys good luck. Yeah, thanks.
Speaker Change: Great. Well, thanks for answering my questions and I wish you guys good luck. Thank you. Thanks, Ed.
Operator: And I'm showing no further questions at this time.
Lishan Aklog: Our plan is upon completion of this pilot study to transition to a full commercial engagement and seek other potential strategic partnerships with university and based on the success of this pilot and this engagement, we look to continue our strategy to identify other large academic cancer centers to partner with in a similar fashion. So briefly mentioned the various implantable monitor but here's some further details. The goal here is to have a monitor that can be implanted in conjunction with a vast of access port.
Operator: And I'm showing no further questions at this time. I would like to turn it back to Dr. Lishan Aklog for closing remarks.
Lishan Aklog: I would like to try to back to Dr. Luciano Club for closing your marks. Great. Thank you very much, operator, and I'd like to thank our colleagues for their excellent questions. I'm getting really, really excited about this important transition point for PadMed and for its subsidiaries and Barris and incubator in particular. And we look forward to keeping you abreast of our progress via news releases, our peer-on calls such as this one, and encourage you to keep up with our news updates and events by signing up for email alerts on our PadMed investor relations website and to follow us on social media on Twitter and LinkedIn.
Speaker Change: And I'm showing no further questions at this time. I would like to turn it back to Dr. Lishan Aklog for closing remarks.
Ed Woo: Great. Thank you very much, Operator, and I'd like to thank our colleagues for their excellent questions, and we're really, really excited about this important transition point for PAVmed and for its subsidiaries, Veris, and the Incubator in particular. And we look forward to keeping you abreast of our progress via news releases or periodic calls such as this one, and encourage you to keep up with our news updates and events by signing up for email alerts on our PAVmed Investor Relations website and following us on social media on Twitter and LinkedIn.
Lishan Aklog: Great. Thank you very much, Operator, and I'd like to thank our colleagues for their excellent questions, and we're really, really excited about this important transition point for PAVmed and for its subsidiaries, Veris and the Incubator in particular. And we look forward to keeping you abreast of our progress via news releases or periodic calls such as this one, and encourage you to keep up with our news updates and events by signing up for email alerts on our PAVmed Investor Relations website and following us on social media on Twitter and LinkedIn. So, thank you, everybody, and have a great day.
Lishan Aklog: Great. Thank you very much, Operator. And I'd like to thank...
Lishan Aklog: Our colleagues for their excellent questions. Again, we're really, really excited about this important transition point for
Lishan Aklog: for Padmet and for its subsidiaries, Veris and the Incubator in particular.
Lishan Aklog: and we look forward to keeping you abreast of our progress via news releases or periodic calls such as this one and encourage you to keep up with our news updates and events by signing up for email alerts on our PadMet Investor Relations website and to follow us on social media on Twitter and LinkedIn. So thank you everybody and have a great day.
Lishan Aklog: You can see on the right there the purple structure is a typical vast of access port and our plantable monitor is designed to be implanted in conjunction with that. There's a variety of key features that can detect continuous cardiac monitoring, activity, has a patient triggered event monitor, can track temperature or respiratory rate and has Bluetooth connectivity so we can deliver that information without any involvement of the patient. And as sure as 100% compliance with the requirements for billing under remote patient monitoring.
Lishan Aklog: So, thank you everybody, and have a great day. Thank you, presenters. And ladies and gentlemen, this concludes today's conference call. Thank you all for participating.
Operator: So thank you, everybody, and have a great day. Thank you, presenters, and ladies and gentlemen.
Operator: Thank you, presenters, and ladies and gentlemen, this concludes today's conference call. Thank you all for participating. You may now disconnect.
Operator: This concludes today's conference call. Thank you all for participating. You may now disconnect.
Speaker Change: Thank you, presenters and ladies and gentlemen. This concludes today's conference call. Thank you all for participating. You may now disconnect.
Lishan Aklog: So we've had a clear path to FDA clearance that commercial launch. We've completed multiple meetings with the FDA and we've been poised to relaunch this development and pursue FDA clearance and we expect to do so shortly once this upcoming financing is closed. We did have some final pre-submission meetings with the FDA that went well and we were already starting the process of re-engaging with vendors to plan the relaunch upon the completion of this cancer.
Lishan Aklog: Moving on to our incubator, we talked about this briefly over the last call. Well, the incubator is a partnership between PadMed and a experienced group in the MedTech Space called Hatch Medical.
Lishan Aklog: We've decided within this incubator to focus on one product that we had been developing but put on pause a couple of years ago. That's Port I.O. Port I.O, is a direct long-term access to the bone marrow. That can reduce complications and infection rates as an alternative for VS access. Address is a very large unmet need on a very diverse target population, including patients with porvenous access and renal failure. Large, a large total address will market, really solid IP protection. And it's been used in humans, we have successfully completed our first in human study. And we have a clear path to FDA clearance.
Lishan Aklog: So we are now actively raising capital to fund a board IO and fund the completion of the ID study. As well as completion of the second generation version, we're looking forward to carrying that financing and getting this project off the ground again.
Dennis McGrath: With that, I'll pass the baton over to Dennis to give us our financial updates. Thanks, Lee Channing.
Dennis McGrath: Good morning, everyone. Our summary financial results for the second quarter reported our press release was published last night. On the next three slides, I'll emphasize a few key highlights from the quarter, but I encourage you to consider those remarks in the context of the full disclosures covered in our quarterly report on form 10Q. With regards to the balance sheet, ash at quarter end June 30th was 25.5 million. During the quarter, we added 11.6 million to that amount with elusive financing previously announced.
Dennis McGrath: The average quarterly burn rate for the trailing four quarters is 11.6 million dollars per quarter. We disclosed in the 10Q that our ability to fund operations beyond one year from today is largely dependent on how revenues ramp over the next four quarters, which is dependent on how the reimbursement landscape for both government and private health insurance continues to improve for ESA guard. Additionally, our direct contracting efforts with self-insured employers and our corporate finance activities, including refinancing any outstanding debt at the time can also work to exceed that threshold.
Dennis McGrath: Furthermore, as we advance the initiatives, both with PMX incubator and nurse health, particularly in connection with the High State University Cancer Care Center, any direct financing into either of these subsidiaries will further satisfy that threshold. The change in other assets is largely related to the three-year lease renewal for loses lab in California, which is accompanied by a similar increase in other current and long-term viabilities. The sequential decrease in the fair value of the convertible notes is largely related to principal reductions in elusive convertible note through conversion notices and issuances of lucid shares and satisfaction of that note.
Dennis McGrath: As mentioned on our lucid call yesterday, during the quarter, lucid issued 2.1 million shares and satisfaction of conversion notices during the quarter. Shares outstanding included, including invested restrict stock awards as of last week are 10.3 million shares outstanding. The gap outstanding shares of 9.6 million are reflected on the slide as well as the face of the balance sheet and 10Q. Gap shares do not reflect unvested restricted stock awards.
Dennis McGrath: With regard to the P&L, this slide compares this year's second quarter to last year's second quarter on certain key items. Trust you'll review the information in my comments in the light of the cautionary disclosure on the bottom of the slide about supplemental information particularly non-gap. Revenue of approximately one million for the second quarter is about even with the previous two quarters and reflects a six-fold increase over the prior year's second quarter.
Dennis McGrath: As detailed on our Lucid Quarterly call yesterday, Lucid performed nearly 3,200 tests in the quarter, representing approximately $8 million in billable claims submitted for insurance reimbursement. However, Lucid Cash Collections generally limit the amount of recognized revenue from the amounts billed to insurance companies. Consequently, Lucid's portion of PAVmed's consolidated revenue is approximately $965,000 after elimination of any company transactions.
Dennis McGrath: For those of you that are new to our PAVmed earnings poll, comment on Lucid revenue recognition is worth repeating. A key determinant in the amount of billable revenue that can be recognized is the probability of customer payment. And therefore, do the fact that we are in the early stages of the reimbursement process means revenue recognition claims submitted through traditional government or private health insurance will be recognized when the claim is actually collected.
Dennis McGrath: Versus when the patient report is delivered, invoiced and submitted for reimbursement. As you'll see in our 10Q, this is called variable consideration in the normal jargon of GAPS ASC 606 revenue recognition guidelines. And presently, there is insufficient predictive data to reflect revenue when the test report is delivered to the referring physician. For billable amounts contracted directly with employers and are fixed and determinedable, we'll be recognized as revenue when our contract and service is delivered.
Dennis McGrath: Generally, it means when the report is delivered to the referring physician. The second quarter year-over-year reduction in operating expenses of about $2 million is primarily related to non-cast charges in the prior year, flowing through OPEX, including stock-based compensation expense, and about 650,000 of R&D expenses paid in stock. Our non-GAPS loss for the second quarter of $7.7 million reflects about $1 million sequential improvement compared to the first quarter loss, and about a $2.5 million improvement year-over-year from the prior year quarter.
Dennis McGrath: The non-GAPS loss for share for the second quarter was 84 cents per share. On a GAPEPS basis out of the $19 loss for share, non-cast charges account for approximately 35 cents per share in the second quarter, and that's largely related to the convertible debt charges and the stock compensation expense. With regard to non-GAP operating expenses on the slide, you'll see a graphic illustration of our operating expenses over time, and which are also presented in detail in our press release. Total non-GAP operating expense is $12.3 million for the second quarter, $2,024, and as you can see is in line with the first quarter levels and the year-over-year amounts.
Dennis McGrath: Also worthy of repeating or some reimbursement stats related to the first six months of 2024, as mentioned on our loses call yesterday. In the second quarter of this year, we build 3,174 tests reflecting just on their $8 million in pro-former revenue. During the second quarter, we collect at $976,000. Parks. A VAT amount collected about 35% of the 976,000 claims paid were from those submitted in the current quarter. About 45% from claims submitted in the first quarter.
Dennis McGrath: And the balance of the claims were submitted last year with the longest data item from about 12 months ago. A Revenue Cycle Manager is reporting that turnaround times have been increasing for the largest payers. But we've seen an increase in claims being designated medically not necessary. The Revenue Cycle Manager is a mitigation plan for both issues, including increasing the speed to follow up with late payers and proactively soliciting medical records for use and appeals at an earlier stage in the process.
Dennis McGrath: We submit reimbursement claims for nearly 55, 5600 claims during the first half of this year, representing just under 14 million dollars in pro forma revenue. About 77% have been adjudicated and 23% are pending. Out of the 77% that have been adjudicated, about 25% resulted in an allowable amount by the insurance company with a weighted average of about $1,540 per test. Although tonight, about 43% are deemed not medically necessary or require a prior authorization. Additionally, about 26% were deemed to be non-covered.
Operator: With that operator, let's open it up for questions. Thank you.
Operator: And ladies and gentlemen, we will not begin the question-and-answer session. Should you have a question, please press the star, followed by the number one on your telephone keypad. You will hear a prompt that your hand has been raised. Should you wish to decline from the calling process, please press the star, followed by the number two. If you're using a speaker phone, please speak of your handset before pressing any keys. One moment, please for your first question.
Michael Parks: And your first question comes from the line up, Ross Aspern, with Contra Vittural, please go ahead. More to Ross. Good morning, we shall meet Dennis. This is Matt and Park on for Ross today. Thanks for taking the question. I was just hoping to provide more color in terms of the scale of the pilot launch and I guess your timeline for full launch and when we should start to see revenue coming up.
Michael Parks: Yeah, so the pilots going on pace, since we're about a third of the way through, it's designed to follow, to have 100 patients enrolled in the platform. And it's going well, you know, the purpose of the pilot was, so this is a large medical center. They're the third is really about making sure that we're aligned with logistics with regard to how they handle calls and incoming notifications and all of that is really going really well.
Michael Parks: So we expect the pilot to wrap up in several months and then we'll look to get based on the success of that transition to not just a full commercial engagement, but we're really looking forward to finding ways to engage strategically with the institution on a whole variety of fronts consistent with what we described in the memorandum of understanding. And then of course, using this as a prototype to engage with other large academic cancer centers, on the way.
Michael Parks: Got it. That's helpful. And then I guess following up on that, would you walk us through your pipeline of additional contracts and any conversations you guys are having right now with large centers? Yeah, we do have a pipeline of about a dozen or so large centers and have active conversations with several of them. We expect, we expect those to move forward and accelerate really upon completion of this pilot. You know, Luis, sorry, Varys has been, you know, we've been careful with our expenditures and our operating expenses to focus on this particular account as a driver to be able to secure financing, to drive, to restart the develops of the implantable monitoring and so forth.
Michael Parks: And as I've mentioned, that that strategy is working and we're close to securing some additional financing. I believe once we do, and once we complete this pilot, that will be able to start securing additional accounts. Got it. That's helpful. And then I guess just one more on my end. Turning to the implantable monitor, pending additional financing. Have you guys provided longer term guidance on when you expect the monitor approval? I guess the steps that you guys said together.
Michael Parks: Thank you. Yeah, the timeline for the mission, the pathway to clearance has all been pretty well worked out. We've had, you know, multiple, as I've said before, we've had multiple meetings with FDA. We've done a variety of preclinical studies that at their request. And so we feel like we're in pretty good shape. I have a pretty, pretty predictable path. And if we are able to secure that financing soon and be able to relaunch the development of the product, that'll take some time.
Michael Parks: It takes some time to bring vendors back online and to get back to where we left off. But, you know, we're looking at some time in mid-next year, 2025, as a reasonable target for FDA submission. Once we're submitted, we believe the clearance path is pretty straightforward. Great. Thanks for taking the questions. Great. Thanks a lot. Appreciate it. Thank you.
Operator: And once again, if you would like to ask a question, please press a star followed by the number one on your telephone keypad.
Anthony Vendetti: Your next question comes from the line of Anthony Vendetti, with Maxine Group, please do head. Thank you, good morning, Anthony. Thank you. Good morning, Lee Chong. Good morning, Dennis. I think you may have answered the question, but I just want to clarify. So when you were talking about the financing, you were talking about that you were talking about for Varys, not for the incubator, correct? Well, for both. Yeah, we mentioned that for both.
Anthony Vendetti: But the Varys, the Varys wants further further along. And again, just to maybe use this as an opportunity to reiterate, that's had met new model, right? We have a shared services model. We have subsidiaries and we're seeking to raise capital into each of the subsidiaries. Obviously, elucid has done that well over the past couple of years. And we're looking for the first time, really, to raise capital directly into Varys. And the incubator that we launched a couple of quarters ago is designed also to raise capital not just into the incubator itself, but into individual corporate entities that hold individual assets, which is a point I'm Thank you.
Anthony Vendetti: Okay, great. And at this point though, it's not a spin-off into an IPO like, like, Lucid, correct? No, no, we don't think that the market zone are really minimal to that right now. This is just simply, where do we rate the capital to advance these technologies? And our conclusion earlier this year was that to take advantage of Padman Shared Services Model and the infrastructure that we've created and to advance other assets beyond Lucid, that each of those assets would have to raise its own capital privately, but not in the public markets really or not the place right now for these early-stage assets.
Anthony Vendetti: Agreed. Yeah, no, that makes sense. So based on your best estimates, you expect to have funding for various in place before the end of the year, and then submit to the FDA by mid-25, is that correct? Yeah, that sounds about right. I think, as I said, I think the financing is that effort is going well, we're hopeful to close on an additional charge that will allow us to get things off the ground actually pretty soon. So that those broad estimates would regard to timeline are reasonable. Okay, great. Thank you very much. I'll hop back in the queue. Appreciate it.
Ed Wu: And your next question comes from the line of Ed Wu with Ascendient Capital.
Ed Wu: Please go ahead. Yeah, thank you very much. I had a I had a very general question about valuations. Have you seen valuations change significantly in terms of when you're going out trying to you know raise funding for the incubator as well as for Barris? Yeah, I mean I think obviously it depends on the individual asset. You know, Barris is further along. Although Portio has actually been advanced, been advanced quite far and was just waiting the launch of the clinical study ID study.
Ed Wu: So we've been there again. These are not closed yet. So I don't I don't want to speak prematurely but we the other both strong assets and we've been pleasantly surprised at at the interest and valuations that we believe we can close these transactions.
Ed Wu: Great. Well, thanks for answering my questions and I wish you a good luck. Thank you. Yeah, thanks Ed.
Operator: And I'm showing no further questions at this time.
Lishan Aklog: I would like to try to back to Dr. Luciano Club for closing your marks. Great. Thank you very much operator and I'd like to thank our colleagues for their excellent questions.
Lishan Aklog: I'm getting really really excited about this important transition point for for for PadMed and for its subsidiaries and Barris and incubator in particular. And we look forward to keeping your abreast of our progress via news releases, our peer-on to call such as this one and encourage you to keep up with our news updates and events by signing up for email alerts on our PadMed investor relations website and to follow some social media on Twitter and LinkedIn.
Operator: So thank you everybody and have a great day. Thank you, presenters and ladies and gentlemen. This concludes today's conference call. Thank you all for participating. You may now disconnect.