Q2 2024 Perimeter Medical Imaging AI Inc Earnings Call

Speaker Change: Good afternoon, ladies and gentlemen, and welcome to the Perimeter Medical Q2 2024 conference call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question-and-answer session.

Operator: Q2 2024 conference call. At this time, all lines are in listen-only mode.

Operator: Q2 2024 conference call. At this time, all lines are in 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: 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. This call is being recorded on Wednesday, August 13, 2024. I would now like to turn the conference over to Stephen Kilmer, Investor Relations. Please go ahead.

Speaker Change: If at any time during this call you require immediate assistance, please press star zero for the operator.

Operator: This call is being recorded on Wednesday, August 13, 2024.

Speaker Change: This call is being recorded on Wednesday, August 13, 2024. I would now like to turn the conference over to Stephen Kilmer, Investor Relations. Please go ahead.

Stephen Kilmer: I would now like to turn the conference over to Stephen Kilmer, Investor Relations. Please go ahead.

Stephen Kilmer: Thank you.

Stephen Kilmer: Thank you. Good afternoon, everyone. Let me start out by pointing out that this conference call will include forward-looking statements within the meaning of applicable securities law. These may include statements regarding the future financial position, business strategy, and strategic goals, commercial activities and timing, competitive conditions, research and development activities, projected costs and capital expenditures, research and clinical testing outcomes, the potential benefits of our products, including Perimeter S-Series OCT, Perimeter B-Series OCT, and Perimeter Image Assist, Perimeter's ability to broaden its user base and the expected approval of its proprietary AI, expectations regarding new products and the timing thereof, and expectations regarding opportunities for market.

Stephen Kilmer: Good afternoon, everyone.

Stephen Kilmer: Let me start out by pointing out that this conference call will include four looking statements within the meaning of applicable security flaws. These may include statements regarding the future financial position, business strategy and strategic goals, commercial activities and timing, competitive conditions, research and development activities, projected costs and capital expenditures, research and clinical testing outcomes, the potential benefits of our products, including Perimeter S-series OCT, Perimeter B-series OCT and Perimeter Image Assist, Perimeter's ability to broaden its user base and the expected approval of its proprietary AI, AI, expectations regarding new products and the timing thereof, and expectations regarding opportunities for market expansion.

Stephen Kilmer: Thank you. Good afternoon, everyone. Let me start out by pointing out that this conference call will include forward-looking statements within the meaning of applicable security flaws.

Stephen Kilmer: These may include statements regarding the future financial position, business strategy and strategic goals.

Speaker Change: Commercial Activities and Timing, Competitive Conditions, Research and Development Activities, Projected Costs and Capital Expenditures, Research and Clinical Testing Outcomes, the Potential Benefits of our Products, including Perimeter S-Series OCT, Perimeter B-Series OCT, and Perimeter Image Assist.

Speaker Change: Perimeter's ability to broaden its user base and the expected approval of its proprietary AI, expectations regarding new products and the timing thereof, and expectations regarding opportunities for market expansion.

Stephen Kilmer: Four of the statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time to time in our public filings and press releases, which are posted on cedar.ca. Our results made different materially from those projected on today's call. No four-looking statement can be guaranteed. Primary rider takes no obligation to us publicly update or revise any four-looking statement, whether it's results of new information, future events or otherwise, other than it is required by law.

Stephen Kilmer: All of the statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time to time in our public filings and press releases, which are posted on cedar.ca Our results may materially differ from those projected on today's call. No forward-looking statement can be guaranteed.

Speaker Change: Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time to time in our public filings and press releases, which are posted on cedar.ca, cedarplus.ca, sorry.

Firmary Rodriguez: Our results may differ materially from those projected on today's call. No forward-looking statement can be guaranteed. Perimeter ID retakes no opposition to us, publicly updated or revised any forward-looking statement, whether it's results of new information, future events or otherwise, other than this required by law.

Stephen Kilmer: Perimeter Rider takes no obligation to publicly update or revise any foreign linkage statement, whether as a result of new information, future events, or otherwise, other than as required by law. For the benefit of those who are new to the Perimeter story, I would also like to take a moment to summarize our business. We are a medical technology company working to transform cancer surgery with ultra-high-resolution, real-time, advanced imaging tools to address areas of high unmet medical need.

Stephen Kilmer: For the benefit of those who are new to the perimeter story, I would also like to take a moment to summarize our business. We are a medical technology company working to transform cancer surgery with ultra-high resolution real-time advanced imaging tools to address areas of high unmet medical needs. Our FDA-cleared perimeter S-series OCT system provides real-time cross-sexual visualization at that size tissues at the cellular level. Our breakthrough device designated investigational perimeter B-series OCT with image assist AI represents our next generation artificial intelligence technology. B-series OCT with image assist AI is currently being evaluated in an ongoing pivotal clinical trial in breast-conserving cancer surgeries.

Speaker Change: For the benefit of those who are new to the Perimeter story, I would also like to take a moment to summarize our business.

Speaker Change: We are a medical technology company working to transform cancer surgery with ultra-high resolution, real-time, advanced imaging tools to address areas of high unmet medical needs.

Stephen Kilmer: Our FDA-Cleared Perimeter S-Series OCT system provides real-time, cross-sexual visualization at that size of tissues at the cellular level. Our breakthrough device designated investigational, Perimeter Big Series OCT, with Image Assist AI, represents our next generation Artificial Intelligence Technology. B-series OCT with ImageAssist AI is currently being evaluated in an ongoing pivotal clinical trial in breast conserving cancer surgery. On the call representing the company are Adrian Mendes, Perimeter's Chief Executive Officer, Andrew Berkeley, Perimeter's Chief Innovation Officer, and Sara Brien, the Company's Chief Financial Officer. With that said, I'll now turn the call over to Thank you, Steve.

Speaker Change: Our FDA-Cleared Perimeter S-Series OCT system provides real-time cross-sectional visualization of excise tissues at the cellular level.

Speaker Change: Our breakthrough device designated Investigational Perimeter B Series OCT with ImageAssist AI represents our next generation artificial intelligence technology.

Speaker Change: B-Series OCT with Image Assist AI is currently being evaluated in an ongoing pivotal clinical trial in breast-concerting cancer surgeries.

Stephen Kilmer: On the call representing the company are Adrian Mendez, Perimeter Chief Executive Officer, Andrew Berkeley, Perimeter Chief Innovation Officer, and Sarah, bringing the company's Chief Financial Officer.

Speaker Change: On the call representing the company are Adrian Mendes, Perimeter's Chief Executive Officer, Andrew Berkley, Perimeter's Chief Innovation Officer, and Sara Brien, the company's Chief Financial Officer. With that said, I'll now turn the call over to Sara.

Sarah: With that said, I'll now turn the call over to Sarah. Thank you, Steve. Good afternoon, everyone, and welcome to our second quarter 2024 conference call. On behalf of the management team and everyone at Perimeter, I would like to thank you for your ongoing interest in our company. For those of you who are shareholders, we appreciate your continued interest and support.

Unknown Executive: Good afternoon, everyone, and welcome to our second quarter 2024 conference call on behalf of the management team and everyone at Perimeter. I would like to thank you for your ongoing interest in our company. For those of you who are shareholders, we appreciate your continued interest and support.

Sara Brien: Thank you, Steve. Good afternoon, everyone, and welcome to our second quarter 2024 conference call. On behalf of the management team and everyone at Perimeter, I would like to thank you for your ongoing interest in our company. For those of you who are shareholders, we appreciate your continued interest and support.

Sarah: I will turn the call over to Adrian in a moment after an update, for an update on our strategic plans and commercial activities. However, before I do, I'd like to provide a brief update on our Q2 2024 financial results. To streamline things, all of our numbers we refer to today have been rounded, so they are approximate. We also report in US dollars. For the three-month period ending June 30th, 2024, the company recorded revenue of $246,000. That consistent of the sale of consumables and system leases. For the first time, we entered into an equipment service plan, warranty program with two customers, which includes annual preventive maintenance for the ocean.

Unknown Executive: I will turn the call over to Adrian in a moment for an update on our strategic plans and commercial activities. However, before I do, I'd like to provide a brief update on our Q2 2024 financial results. To streamline things, all of the numbers we refer to today have been rounded, so they are approximate.

Speaker Change: I will turn the call over to Adrian in a moment for an update on our strategic plans and commercial activities. However, before I do, I'd like to provide a brief update on our Q2 2024 financial results.

Sara Brien: We also report in U.S. dollars. For the three-month period ending June 30, 2024, the company recorded revenue of $246,000. That consisted of the sale of consumables and system leases. For the first time, we entered into an equipment service plan warranty program with two customers, which includes annual preventive maintenance for the OCT equipment. The total contract value was approximately $139,000 and will be recognized over the three-year term of the contract as services are rendered starting next quarter.

Speaker Change: To streamline things, all of our numbers we refer to today have been rounded, so they are approximate. We also report in U.S. dollars.

Adrian Mendes: For the three-month period ending June 30, 2024, the company recorded revenue of $246,000.

Adrian Mendes: That consisted of the sale of consumables and system leases. For the first time, we entered into an equipment service plan warranty program with two customers, which includes annual preventive maintenance for the OCT equipment.

Sarah: The total contract value was approximately $139,000 and will be recognized over the three-year term of the contract as services are rendered starting next quarter. Operating expenses for the second quarter were approximately $5.5 million compared to approximately $3.4 million for the same period in 2023. Second quarter, 2024 net loss improved 35% to approximately $3.2 million or $5 per common share compared to $4.9 million or $8 per common share in the three months ended June 30th, 2023. Cash used in operating activities in the three months ended June 30th, 2024 was approximately $7.5 million, relatively flat compared to approximately $7.2 million in Q2 2023.

Adrian Mendes: The total contract value is approximately $139,000 and will be recognized over the three-year term of the contract as services are rendered, starting next quarter.

Sara Brien: Operating expenses for the second quarter were approximately $5.5 million compared to approximately $3.4 million for the same period in 2023. Second quarter 2024 net loss improved 35% to approximately 3.2 million or $0.05 per common share compared to $4.9 million or $0.08 per common share and the three months ended June 30, 2023.

Adrian Mendes: Operating expenses for the second quarter were approximately $5.5 million compared to approximately $3.4 million for the same period in 2023.

Adrian Mendes: Second quarter 2024 net loss improved 35% to approximately $3.2 million, or $0.05 per common share, compared to $4.9 million, or $0.08 per common share, and the three months ended June 30, 2023.

Adrian Mendes: Cash used in operating activities in the three months ended June 30, 2024, was approximately $7.5 million, relatively flat compared to approximately $7.2 million in Q2 2023.

Sara Brien: Cash used in operating activities in the three months and June 30, 2024 was approximately $7.5 million, relatively flat compared to approximately $7.2 million in Q2 2023. As of June 30, 2024, cash and cash equivalents were approximately 6.5 million. This amount does not include a super grant receivable of approximately 1.8 million as of the end of the quarter 2024.

Sarah: As of June 30th, 2024, cash and cash equivalents for approximately $6.5 million.

Adrian Mendes: As of June 30, 2024, cash and cash equivalents were approximately $6.5 million. This amount does not include a CPER grant receivable of approximately $1.8 million as of the end of the quarter 2024.

Sarah: This amount does not include a super grant receivable of approximately $1.8 million as of the end of the quarter 2024.

Adrian Mendes: With that, I'll now turn over the call to Adrian. Adrian?

Adrian Mendes: With that, I'll now turn over the call to Adrian. Thanks, Sara. And thanks again, everyone, for your time and attention today. As Steve mentioned at the start of the call, we are committed to making a real difference in the lives of patients by creating and commercializing innovative interoperative imaging technology. The fact is, surgeons have worked for years to innovate every step of the diagnosis and treatment plan for their cancer patients with the ultimate goal of improving survivability and quality of life. Yes, interoperative margin assessment remains one of their most pressing problems.

Adrian Mendes: With that, I'll now turn over the call to Adrian. Adrian?

Adrian Mendes: Thanks, Sarah, and thanks again, everyone, for your time and attention today. As Steve mentioned at the start of the call, we are committed to making a real difference in the lives of patients by creating and commercializing innovative interoperative imaging technologies. The fact is, surgeons have worked for years to innovate every step of the diagnosis and treatment plan for their cancer patients, with the ultimate goal of improving survivability and quality of life. Yes, interoperative margin assessment remains one of their most pressing problems. We're working hard to change that. Permiters S-Series OCT technology gives surgeons the most advanced interoperative margin visualization available as they strive to reduce re-excisions, clarity on margin status, and the OR versus waiting days for pathology results to confirm, and actionable real-time insights to tailor clinical decisions to each patient.

Adrian Mendes: Thanks, Sara, and thanks again everyone for your time and attention today. As Steve mentioned at the start of the call, we are committed to making a real difference in the lives of patients by creating and commercializing innovative interoperative imaging technologies.

Adrian Mendes: The fact is, surgeons have worked for years to innovate every step of the diagnosis and treatment plan for their cancer patients with the ultimate goal of improving survivability and quality of life. Yet, interoperative margin assessment remains one of their most pressing problems.

Adrian Mendes: We're working hard to change that. Perimeter's S-Series OCT technology gives surgeons the most advanced interoperative margin visualization available as they strive to reduce re-excisions, clarity on margin status in the OR versus waiting days for pathology results to confirm, and actionable real-time insights to tailor clinical decisions to each patient. In a way, our product promise is greater peace of mind, both to the surgeon who, no matter how skilled, currently faces nearly one in five odds of needing to perform repeat surgery due to positive margins, and also to their patients who under the current treatment pathway typically need to wait and worry for two to seven days for their surgeon to receive a post-opthology report, which will determine whether they will have to go through the emotional and physical trauma of a second surgery due to cancer left behind.

Adrian Mendes: We're working hard to change that. Perimeter's S-Series OCT technology gives surgeons the most advanced interoperative margin visualization available as they strive to reduce re-excisions.

Adrian Mendes: clarity on margin status in the OR versus waiting days for pathology results to confirm, and actionable real-time insights to tailor clinical decisions to each patient.

Adrian Mendes: In a way, our product promise is greater peace of mind. Both to the surgeon who, no matter how skilled, currently faces nearly one in five odds that means perform repeat surgery due to positive margins. And also to their patients who, under the current treatment pathway, typically need to wait and worry for two to seven days for their surgeon to receive a post-op pathology report, which will determine whether they will have to go through the emotional and fiscal trauma of a second surgery due to cancer left behind.

Adrian Mendes: In a way, our product promise is greater peace of mind, both to the surgeon who, no matter how skilled, currently faces nearly one in five odds of needing to perform repeat surgery due to positive margins,

Adrian Mendes: and also to their patient who under the current treatment pathway typically need to wait and worry for two to seven days for their surgeon to receive a post-op pathology report.

Adrian Mendes: which will determine whether they will have to go through the emotional and physical trauma of a second surgery due to cancer left behind.

Adrian Mendes: But as compelling a clinical value proposition that the S-Series OCT represents, it will be our execution of a well thought out and carefully planned market entry strategy that will drive Perimeter's ultimate commercials. To that end, ever since the company completed the leadership transition in mid-2023, we've been laying down a number of foundational things. And I'm pleased to report that each of the pillars of our strategy are starting to bear fruit. We're currently commercializing our first FDA-cleared interoperative imaging technology, the S series OCT, which provides surgeons with image resolutions capable of visualizing tissue structures at the federal level down to the critical two millimeter depth when assessing margins real time in the operating room.

Adrian Mendes: But as compelling a clinical value proposition that our S-series OCT represents, it will be our execution of a well-thought-out and carefully planned market entry strategy that will drive Perimeter's ultimate commercial success. To that end, ever since the company completed a leadership transition in mid-2023, we've been laying down a number of foundational things, and I'm pleased to report that each of the pillars of our strategy Before elaborating on some of the tangible results we have already seen from the foundational things we've been laying down since Perimeter completed a leadership transition, I would like to take a moment to set the stage for our commercial rollout.

Speaker Change: But, as compelling a clinical value proposition that our S-series OCT represents, it will be our execution of a well thought out and carefully planned market entry strategy that will drive Perimeter's ultimate commercial success.

Speaker Change: To that end, ever since the company completed a leadership transition in mid 2023, we've been laying down a number of foundational things, and I'm pleased to report that each of the pillars for strategy are starting to bear fruit.

Speaker Change: Before elaborating on some of the tangible results we have already seen from the foundational things we've been laying down since Perimeter completed a leadership transition, I would like to take a moment to set the stage of our commercial rollout.

Adrian Mendes: As many of you know, we are currently commercializing our first FDA-cleared intraoperative imaging technology, the S-Series OCT, which provides surgeons with image resolutions capable of visualizing tissue structures at the cellular level down to the critical 2-millimeter depth when assessing margins real-time in the operating room. It is cleared under a general indication and has not been evaluated by the FDA specifically for use in breast tissue, breast cancer, or other types of cancer margin evaluation and reduced reexcision rate.

Speaker Change: As many of you know, we are currently commercializing our first FDA cleared interoperative imaging technology, the S-series OCT.

Speaker Change: which provides surgeons with image resolutions capable of visualizing tissue structures at the cellular level down to the critical 2mm depth when assessing margins real-time in the operating room.

Adrian Mendes: It is clear; it is cleared under a general indication, and it's not been evaluated by the FDA specifically for use of breast tissue, breast cancer, or other types of cancer, margin evaluation, and reduce for excision rates. Our goal has been to seed the market with S series OCT in order to create a strong network of early adopters in preparation for a potential FDA clearance of our next generation system, B Series OCT with Image Assist AI. Led by principal investigator, Dr. Alistair Thompson, at Baylor College of Medicine, Perimeter is conducting a multi-center, randomized, two-armed clinical trial to measure the effectiveness of this AI-enabled OCT technology in reducing the number of unaddressed pods of margins and breast lumpectomy procedures when used in addition to standard interoperative margin assessment.

Speaker Change: It is clear, it is cleared under a general indication and it's not been evaluated by the FDA specifically for use in breast tissue, breast cancer or other types of cancer margin evaluation and reduced excision rates.

Adrian Mendes: Our goal has been to seed the market with S-Series OCT in order to create a strong network of early adopters in preparation for a potential FDA clearance of our next generation system, B-Series OCT with ImageAssist AI. Led by Principal Investigator Dr. Alastair Thompson at Baylor College of Medicine, Perimeter is conducting a multi-center, randomized, two-arm clinical trial to measure the effectiveness of this AI-enabled OCT technology in reducing the number of unaddressed positive margins in breast lumpectomy procedures when used in addition to standard interoperative margin assessment.

Speaker Change: Our goal has been to seed the market with S-Series OCT in order to create a strong network of early adopters in preparation for a potential FDA clearance of our next generation system, B-Series OCT with ImageAssist AI.

Speaker Change: Led by Principal Investigator Dr. Alistair Thompson at Baylor College of Medicine

Adrian Mendes: Our focus on improving the level and pace of execution across all aspects of Perimeter's business has contributed to, among other things, the acceleration of patient enrollment in the PIVOT trial, resulting in it tracking well ahead of schedule. We announced today that we now anticipate patient enrollment to be completed in Q3, a quarter ahead of previous expectations. Moving forward from there, since we have already received FDA breakthrough device designation for a B-Series system.

Speaker Change: Perimeter is conducting a multi-center, randomized, two-arm clinical trial to measure the effectiveness of this AI-enabled OCT technology in reducing the number of unaddressed positive margins in breast lumpectomy procedures when used in addition to standard interoperative margin assessment.

Adrian Mendes: Our focus on improving the level and pace of execution across all aspects of printer's business has contributed to, among other things, the acceleration of patient enrollment in the pivot trial, resulting in it tracking well ahead of schedule. We announced today that we now anticipate patient enrollment to be completed in Q3, a quarter ahead of previous expectations. Moving forward from there, since we have already received FDA Breakthrough Device designation for a B Series system, we anticipate the readout from this study will be a significant catalyst for our business. If positive, these data will support the full commercial launch of Series B OCT technology, representing the next major step in our go-to-market strategy, and an opportunity to significantly broaden our user base across the US.

Speaker Change: Our focus on improving the level and pace of execution across all aspects of printer's business has contributed to, among other things, the acceleration of patient enrollment in the pivot trial, resulting in it tracking well ahead of schedule.

Speaker Change: We announce today that we now anticipate patient enrollment to be completed in Q3, a quarter ahead of previous expectations.

Speaker Change: Moving forward from there, since we have already received FDA breakthrough device designation for a B-series system, we anticipate the readout from this study will be a significant catalyst for our business.

Adrian Mendes: We anticipate the readout from this study will be a significant catalyst for our business. If positive, these data will support the full commercial launch of Series V OCT technology, representing the next major step in our go-to-market strategy and an opportunity to significantly broaden our user base across the U.S. In the meantime, as you can see from today's press release, the growth pillars we've been laying down are starting to produce tangible results.

Speaker Change: If positive, these data will support the full commercial launch of Series V OCT technology, representing the next major step in our go-to-market strategy, and an opportunity to significantly broaden our user base across the U.S.

Adrian Mendes: In the meantime, as you can see from today's press release, the growth pillars we've been laying down are starting to produce tangible results. For example, restructuring our sales organization, which also, while also implementing some key process of improvement, have helped drive increased commercial adoption of perimeter S Series OCT both in terms of installed base growth and existing system utilization. To put that in perspective, we've already closed six S Series OCT placements so far this year compared to three in all of 2023. Also in Q2, also Q2 revenues, which are recurring since their derived from sales consumables and system leases, grew 83% year over year, and 150% sequentially from the first quarter of 2024.

Speaker Change: In the meantime, as you can see from today's press release, the growth pillars we've been laying down are starting to produce tangible results.

Adrian Mendes: For example, restructuring our sales organization, which also, while also implementing some key process improvements, has helped drive increased commercial adoption of Perimeter S-Series OCT, both in terms of installed-based growth and existing system utilization. To put that in perspective, we've already closed six S-series OCT placements so far this year, compared to three in all of 2023. Also in Q2, Q2 revenues, which are recurring since they're derived from sales of consumables and system leases, grew 83% year over year and 150% sequentially from the first quarter of 2024.

Speaker Change: For example, restructuring our sales organization, which also while also implementing some key process and improvements, have helped drive increased commercial adoption of Perimeter as Series OCT, both in terms of installed base growth and existing system utilization.

Speaker Change: To put that in perspective, we've already closed six S series OCT placement so far this year compared to three in all of 2023.

Speaker Change: Also in Q2, also Q2 revenues, which are recurring since they're derived from sales of consumables and system leases, grew 83% year over year and 150% sequentially from the first quarter 2024.

Adrian Mendes: Finally, just after the end of the quarter, the 1,000 paid perimeter series OCT patient scan was performed, marking an important clinical and commercial milestone.

Adrian Mendes: Finally, just after the end of the quarter, the 1000th paid Perimeter Series OCT patient scan was performed, marking an important clinical and commercial milestone. In addition, our strengthened commitment to methodical data collection helped facilitate Dr. Amelia Gunter authoring an exciting white paper in June. It reported reoperation rates among 72 patients in her practice who underwent OCT imaging during breast conserving surgery. The research demonstrated that OCT helped achieve a reoperation rate of 5.6 percent as compared to the national average of 19.9 percent.

Speaker Change: Finally, just after the end of the quarter, the 1,000th paid Perimeter Series OCT patient scan was performed, marking an important clinical and commercial milestone for us.

Adrian Mendes: for us. In addition, our strengthens commitment to methodical data collection help facilitate Dr. Amelia Gunter, authoring an exciting white paper in June. It reported re-operation rates among 72 patients in practice who underwent OCT imaging during breast conserving surgery. The research demonstrated that OCT helped achieve a re-operation rate of 5.6 percent as compared to the national average of 19.9 percent. Also, while the national re-operation rate in patients with a certain type of breast cancer called ductal carcinoma in situ, DCIS, was 30.8 percent versus 13.3 percent in patients where OCT was used. And in patients with invasive ductal carcinoma (IDC), the national rate re-operation was shown to be 18 percent, while our S-series OCT operation rate was 0 percent.

Speaker Change: In addition, our strengthens commitment to methodical data collection help facilitate Dr. Amelia Gunter, authoring an exciting white paper in June .

Speaker Change: It reported reoperation rates among 72 patients in our practice who underwent OCT imaging during breast conserving surgery.

Speaker Change: The research demonstrated that OCT helped achieve a re-operation rate of 5.6% as compared to the national average of 19.9%.

Adrian Mendes: Also, while the National Reoperation Rate in Patients with a certain type of breast cancer called ductile carcinoma in situ, DCIS, was 30.8%, versus 13.3% in patients where a OCT was used, and in patients with invasive ductal carcinoma, IDC, the national rate of reoperation was shown to be 18%, while our S-series OCT operation rate was 0%.

Speaker Change: Also, while the national reoperation rate in patients with a certain type of breast cancer called ductal carcinoma in situ, DCIS, was 30.8% versus 13.3% in patients where OCT was used.

Speaker Change: And in patients with invasive ductile carcinoma, IDC, the national rate of re-operation was shown to be 18%.

Speaker Change: while our S-Series OCT operation rate was 0%.

Adrian Mendes: Dr. Gunter's white paper is available on our website, and I encourage you to review it there if you haven't already had a chance to do that. Finally, our additional focus on gathering user feedback in order to apply an agile approach to continuously improve our product offering resulted in the first of its kind installation of our new image clear AI image enhancement algorithm with a commercial perimeter S-series OCT system. Image Clear enables users to achieve better quality images up to 441 percent signal-to-noise ratio increase, and importantly, reduce scan times by 28 percent. We are now working to upgrade all installed S-series systems with image clear before the end of the year.

Adrian Mendes: Dr. Gunther's white paper is available on our website, and I encourage you to review it there if you haven't already had a chance to do so. Finally, our additional focus on gathering user feedback in order to apply an agile approach to continuously improve our product offering resulted in the first of its kind installation of our new image clear AI image enhancement algorithm with a commercial Perimeter S-series OCT system. ImageClear enables users to achieve better quality images, up to a 441% signal-to-noise ratio increase, and importantly, reduce scan times by 28%.

Speaker Change: Dr. Gunter's white paper is available on our website and I encourage you to review it there if you haven't already had a chance to do that.

Speaker Change: Finally, our additional focus on gathering user feedback in order to apply an Agile approach to continuously improve our product offering resulted in the first-of-its-kind installation of our new imageClear AI image enhancement algorithm with a commercial perimeter S-series OCT system.

Speaker Change: ImageClear enables users to achieve better quality images, up to 441% signal-to-noise ratio increase, and importantly, reduce scan times by 28%.

Adrian Mendes: We are now working to upgrade all installed S-series systems with image clear before the end of the year. And so to summarize, we're seeing positive commercial traction with S-Series OCT, as demonstrated by our install base and revenue growth in Q2 and the achievement of our 1,000th patient scanned milestone in July. The ongoing pivotal trial Evaluating the Use of our NextGen B-Series OCT with ImageAssist AI during breast-conserving surgeries is progressing well and is now expected to complete patient enrollment in the third quarter.

Speaker Change: We are now working to upgrade all installed S-Series systems with ImageClear before the end of the year.

Adrian Mendes: And so to summarize, we're seeing positive commercial traction with S-series OCT as demonstrate of our install base and revenue growth in Q2 and the achievement of 1,000 patients scanned milestone in July. The ongoing pivotal trial evaluating use of our next Gen B-series OCT with images SIS AI during breast-conserving surgeries is progressing well and is now expected to complete patient enrollment in the third quarter. There's a growing body of clinical evidence, including Dr. Gunter's recent white paper, which points to the potential offer OCT-based technologies to advance the standard of care, improve patient outcomes, and reduce healthcare costs.

Speaker Change: And so to summarize, we're seeing positive commercial traction with S-Series OCT as demonstrated by our install base and revenue growth in Q2, and the achievement of our 1,000th patient scanned milestone in July.

Speaker Change: The ongoing pivotal trial evaluating use of our next-gen B-series OCT with ImageAssist AI during breast conserving surgeries is progressing well and is now expected to complete patient enrollment in the third quarter.

Adrian Mendes: There's a growing body of clinical evidence, including Dr. Gunter's recent white paper, which points to the potential of our OCT-based technologies to advance the standard of care, improve patient outcomes, and reduce healthcare costs. And finally, we continue to leverage our extensive AI and medtech expertise to find ways to deploy AI models like imageClear throughout our technology stack to improve the customer experience and searchable output. We look forward to keeping you updated on our progress through 2024 and are excited by the important milestones a lay ahead. And with that, I now open up the call for your questions. Operator?

Speaker Change: There's a growing body of clinical evidence, including Dr. Gunter's recent white paper, which points to the potential of our OCT-based technologies to advance the standard of care, improve patient outcomes, and reduce healthcare costs.

Adrian Mendes: And finally, we continue to leverage our extensive AI and MetTech expertise to find ways to deploy AI models like Image Clear throughout our technology staff to improve the customer experience and surgical outcomes.

Speaker Change: And finally, we continue to leverage our extensive AI and medtech expertise to find ways to deploy AI models, like ImageClear, throughout our technology stack to improve the customer experience and searchable outcomes.

Adrian Mendes: We look forward to keeping you updated in our progress through 2024 and are excited by the important milestones that lay ahead.

Speaker Change: We look forward to keeping you updated on our progress through 2024, and are excited by the important milestones a lay ahead. And with that, I now open up the call for your questions. Operator?

Adrian Mendes: And with that, I now open up the call for your questions. Operator? Thank you.

Operator: 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 touch tone, following. You will hear a prop that your hand has been raised. Should you wish to decline from the polling process, please press the star followed by the number two. If you are using a speaker phone, please leave the handset before pressing any. One moment, please, for your first question.

Operator: Thank you. 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 touchtone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star followed by the number two. If you are using a speakerphone, please leave the handset before pressing any.

Speaker Change: Thank you.

Speaker Change: We will now begin the question and answer session. Should you have a question, please press the star followed by the number 1 on your touchtone phone.

Speaker Change: You will hear a prop that your hand has been raised. Should you wish to decline from the polling process, please press the star followed by the number 2. If you are using a speakerphone, please lift the handset before pressing any keys.

Operator: One moment, please, for your first question. Your first question comes from Scott McAuley of Paradigm Capital. Please go ahead. Hi, everyone.

Speaker Change: One moment, please, for your first question.

Operator: Q22024 conference call. At this time, all lines are in listen only mode. Following the presentation, we will conduct a question and answer session.

Scott McAuley: Your first question comes from Scott McAuley of Faradayme Capital. Please go ahead. Hi everyone. Thanks for taking the questions. Great to hear on all the activity and kind of six installations year to date. Could you begin that into that a little more. What's the total number of systems that are currently installed, and maybe how many kind met new in Q2?

Speaker Change: Your first question comes from Scott McCauley of Paradigm Capital. Please go ahead.

Scott McAuley: Thanks for taking the questions. Great to hear on all the activity and kind of six installations year to date. Could you dig into that a little more? Kind of what's the total number?

Operator: If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Wednesday, August 13, 2024.

Scott McCauley: Hi everyone, thanks for taking the questions. Great to hear on all the activity and kind of six installations year to date. Could you dig into that a little more? What's the total number of systems that are currently installed and maybe how many kind of met new in Q2?

Unknown Executive: Systems that are currently installed, and maybe how many kind of net new in Q2. Yeah, hey, Scott, thanks for joining. Good question.

Stephen Kilmer: I would now like to turn the conference over to Stephen Kilmer investor relations. Please go ahead. Thank you.

Adrian Mendes: Yeah, hey Scott.

Unknown Executive: So we're up to 12 systems now that are currently installed and earning revenue for us, and four of them, four of the total have been in the second quarter. So we've been accelerating, you know, quarter after quarter, for those Tics and Cutes. Yeah, that's, that's great. And then maybe a bit on the type of facilities that those kinds of recent installations have been in? Are they hospitals or surgical centers? And are these new sites?

Adrian Mendes: Thanks for joining. Good question. So we're up to 12 systems now that are currently installed and earning revenue for us, and four of them. Four of the total have been in the second quarter. So we've been accelerating, you know, quarter after quarter. Four of those six in Q2. Yeah, that's great.

Stephen Kilmer: Good afternoon everyone. Let me start out by pointing out that this conference call will include four looking statements within the meaning of applicable security flaws. These may include statements regarding the future financial position, business strategy and strategic goals, commercial activities and timing, competitive conditions, research and development activities, projected costs and capital expenditures, research and clinical testing outcomes, the potential benefits of our products, including perimeter S-series OCT, perimeter B-series OCT and perimeter image assist, perimeter's ability to broaden its user base and the expected approval of its proprietary AI, AI, expectations regarding new products and the timing thereof, and expectations regarding opportunities for market expansion.

Speaker Change: Thank you for watching, see you next time.

Stephen Kilmer: Four of the statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time to time in our public filings and press releases which are posted on cedar.ca. Our results made different materially from those projected on today's call. No four-looking statement can be guaranteed. Primary rider takes no obligation to us publicly update or revise any four-looking statement, whether it's results of new information, future events or otherwise, other than it is required by law.

Speaker Change: Yeah, hey Scott, thanks for joining. Good question. So we're up to 12 systems now that are currently installed and earning revenue for us.

Speaker Change: And four of them, four of the total have been in the second quarter. So we've been accelerating, you know, quarter after quarter for those six in Q2.

Adrian Mendes: And then maybe a bit on the type of facilities that those kind of recent installations have been in or the hospitals, surgical centers, and are these new sites, are these, you know, sites that are acquiring their second system or part of your national chain or things like that. Yeah, they're all hospitals. You know, hospital system surgery, they actually follow very, very similar to the same profile that we have been winning to date. So it's, you know, it's just sort of expansion into the place we've had success already. Yeah, got it.

Speaker Change: Yeah, that's great. And then maybe a bit on the type of facilities that those recent installations have been in. Are they hospitals, surgical centers, and are these

Unknown Executive: Are these, you know, sites that are acquiring their second system or part of your national chains or things like that? Yeah, they're all hospitals. Unknown Speaker, Hospital system surgery, actually follows very, very closely the same profile that we have been winning today. So it's, you know, it's just sort of expansion into the place we've had success already. Got it.

Speaker Change: New sites are these sites that are acquiring their second system or part of your national chains or things like that.

Speaker Change: Yeah, they're all hospitals.

Speaker Change: Hospital System Surgery, they actually follow very, very similar to the same profile that we have been winning to date.

Speaker Change: So it's, you know, it's just sort of expansion into the place we've had success already.

Unknown Executive: That's great. And then, I guess, on the balance of the year, kind of how you're seeing the pipeline growing and moving through the sales cycle. Yeah, you know, strong pipeline; we expect to see these sort of growth rates continue through the third quarter and fourth quarter, expanding into new facilities and expanding to new states. So I think we're, you know, sort of pushing sort of what I said earlier is one of the things that we've all been working really hard here, just make sure we're establishing sort of the foundational structure in the company that will help us grow sustainably, you know, over time. So it's not just like running really hard, closing a bunch of deals, and then going into a drought.

Adrian Mendes: And then I guess on the balance of the year, kind of how you're seeing the pipeline growing and moving through the sales cycle. Yeah, you know strong pipeline. We expect to see these sort of growth rates continue through third quarter and fourth quarter. Expanding into new facilities, fans, and new states.

Speaker Change: Yeah.

Speaker Change: Got it. That's great. And then I guess on the balance of the year, kind of how you're seeing the pipeline growing and moving through the sales cycle.

Stephen Kilmer: For the benefit of those who are new to the perimeter story, I would also like to take a moment to summarize our business. We are a medical technology company working to transform cancer surgery with ultra-high resolution real-time advanced imaging tools to address areas of high unmetaneous medical needs. Our FDA-cleared perimeter S-series OCT system provides real-time cross-sexual visualization at that size tissues at the cellular level. Our breakthrough device designated investigational perimeter B-series OCT with image assist AI represents our next generation artificial intelligence technology. B-series OCT with image assist AI is currently being evaluated in an ongoing pivotal clinical trial in breast-conserving cancer surgeries.

Speaker Change: Yeah, you know, strong pipeline. We expect to see these sort of growth rates continue through the third quarter and fourth quarter.

Speaker Change: Unknown Speaker 08.29.15

Adrian Mendes: So I think we're, you know, sort of just kind of push sort of refer back to something I said earlier is one of the things that we've all been working really hard here to just make sure we're establishing sort of the foundational structure in the company. That will help us grow sustainably, you know, over time. So it's not just like running really hard, closing a bunch of deals, and then going into a drought. And so we've seen that when we look at our pipeline, we see things kind of stage nicely through the entire pipeline through phases, and with increasing quantities of time goes on.

Speaker Change: Expanding it to new facilities, expanding it to new states.

Speaker Change: So I think we're, you know, sort of just

Speaker Change: kind of push sort of what refer back to something I said earlier is one of the things that we've all been working really hard here just make sure we're establishing sort of the foundational structure in the company.

Speaker Change: That will help us grow sustainably, you know, over time, so it's not just like running really hard, closing a bunch of deals and then going into a drought. And so we've seen that when we look at our pipeline, we see things.

Unknown Executive: And so we've seen that when we look at our pipeline, we see things kind of stage nicely through the entire pipeline through phases, and with increasing quantities as time goes on. So we're encouraged that this is a story that's sustainable that we can keep going. That's great.

Speaker Change: kind of stage nicely through the entire pipeline through phases and with increasing quantities as time goes on. So we're encouraged that this is a story that's sustainable that we can keep going.

Adrian Mendes: So where it hurts that this is a story that's sustainable. Now we can keep going. That's great.

Stephen Kilmer: On the call representing the company are Adrian Mendez, perimeter chief executive officer, Andrew Berkeley, perimeter chief innovation officer, and Sarah bringing the company's chief financial officer.

Unknown Executive: I guess on the trial, fantastic to hear that the recruitment is going faster than expected and will be finished soon. So I guess if the recruitment is finished in two, three, could you talk through a bit on when we could expect to see the top line data and then your potential update submission and approval? Yeah, so the hope is that we'll be able to talk about top-line data in the fourth quarter before year end, and then with a goal of submitting to the FDA early next year, like early Q1.

Adrian Mendes: I guess on the trial, you know, fantastic to hear that the recruitment is going faster than expected and to be finished soon.

Speaker Change: That's great!

Speaker Change: I guess on the on the trial, you know, fantastic to hear that the recruitment.

Sarah Brien: With that said, I'll now turn the call over to Sarah. Thank you, Steve. Good afternoon, everyone, and welcome to our second quarter, 2024 conference call. On behalf of the management team and everyone at perimeter, I would like to thank you for your ongoing interest in our company. For those of you who are shareholders, we appreciate your continued interest and support. I will turn the call over to Adrian in a moment after an update, for an update on our strategic plans and commercial activities.

Speaker Change: is going faster than expected and should be finished soon. So I guess if the recruitment is finished in Q3, could you talk through a bit on, you know, when we could expect to see the top line data and then, you know, potential updates, submission and approval?

Adrian Mendes: So yes, if the recruitment is finishing to three, could you talk through a bit on, you know, when we could expect to see the top line data and then your potential update submission and approval. Yeah, so the hope is that we'll be able to talk about top line data in the fourth quarter before year end. And then, with a goal of submitting to the FDA early next year, like early Q1. And then we're planning right now. We're anticipating approval sometime towards the end of 2025 or early 2026. A6. We have breakthrough device designation, so that we're hopeful help speed things through internally.

Speaker Change: Yeah, so the hope is that we'll be able to talk about top-line data in the fourth quarter before year-end.

Speaker Change: And then with a goal of submitting to the FDA early next year, like early Q1. And then we're planning right now, we're anticipating approval sometime towards the end of 2025 or early 2026.

Sarah Brien: However, before I do, I'd like to provide a brief update on our Q2 2024 financial results. To streamline things, all of our numbers we refer to today have been rounded so they are approximate. We also report in US dollars. For the three month period ending June 30th, 2024, the company recorded revenue of $246,000. That consistent of the sale of consumables and system leases. For the first time we entered into an equipment service plan, warranty program with two customers, which includes annual preventive maintenance for the ocean.

Unknown Executive: And then we're planning right now, we're anticipating... Approval sometime towards the end of 2025 or early 2020. We have breakthrough device designation so that we hope will help speed things through internally. We're sort of preparing everything. I mean, we have been preparing everything to prepare everything just to make sure there is no [inaudible] wait time between a request from the FDA and when we can submit something or the trial ending and when we can submit something.

Speaker Change: We have breakthrough device designation, so that we hope will help speed things through internally. We're sort of preparing everything. I mean, we have been preparing everything to prepare everything just to make sure there is no.

Adrian Mendes: We're sort of preparing everything. I mean, we have been preparing everything to prepare everything just to make sure there is no wait time between a request from the FDA and when we can submit something, or the trial ending and when we can submit something.

Speaker Change: You know, wait time between a request from the FDA and when we can submit something or the trial ending and when we can submit something. So the one of the biggest, highest priorities we've got within the company is just to get through to get that series beyond the market as quickly as possible.

Unknown Executive: So one of the biggest, highest priorities we've developed in the company is just to get through to get that series beyond the market as quickly as possible. Absolutely. And so I broke it up a little bit using kind of data before the end of the year and then submission in Q1. That's right.

Adrian Mendes: So the one of the biggest highest priors we bought in the company is just to get through to get that tears beyond the market as quickly as possible. Absolutely. And so I broke up a little bit using kind of data before the end of the year, and then submission to Q1. That's right.

Sarah Brien: The total contract value was approximately $139,000 and will be recognized over the three year term of the contract as services are rendered starting next quarter. Operating expenses for the second quarter were approximately $5.5 million compared to approximately $3.4 million for the same period in 2023. Second quarter, 2024 net loss improved 35% to approximately $3.2 million or $5 per common share compared to $4.9 million or $8 per common share in the three months ended June 30th, 2023.

Speaker Change: Absolutely. And so I broke up a little bit using kind of data before the end of the year and then submission in Q1.

Unknown Executive: And on the white paper, you know, great to see the data in that form. Any other kind of white papers or studies, kind of real world evidence that you guys are working on to put out there? Yes, absolutely. As we mentioned, we've got 1000 patients through right now. And so we've got that data. We've got a few papers going through a peer-reviewed process. In the first white paper, the first paper was a white paper; the next ones will be peer reviewed.

Adrian Mendes: And on the white paper, you know, the great to see that those data in that form. Any other kind of white papers or studies, kind of real world evidence that you guys are working on to put out there? Yes, absolutely. So, like we mentioned, we've got 1,000 patients through right now, and so we've got that data. We've got a few papers going through a peer-reviewed process. You know, the first white, the first paper was a white paper. The next ones will be peer reviewed.

Speaker Change: That's right.

Speaker Change: Got it. And on the white paper, you know, great to see those data in that form. Any other kind of white papers or studies, kind of real-world evidence that you guys are working on to put out there?

Speaker Change: Yes, absolutely. So like we mentioned, we've got 1000 patients through right now. And so we've got that data. We've got a few papers going through a peer reviewed process. In the first white, the first paper was a white paper, the next ones will be peer reviewed.

Sarah Brien: Cash used in operating activities in the three months ended June 30th, 2024 was approximately $7.5 million, relatively flat compared to approximately $7.2 million in Q2 2023. As of June 30th, 2024, cash and cash equivalent for approximately $6.5 million. This amount does not include a super grant receivable of approximately $1.8 million as of the end of the quarter 2024.

Unknown Executive: We've also set up a registry now, a formal registry, so we're gathering data in a more sort of structured manner. I suppose you'll start to see that flow of clinical evidence start to pick up, you know, starting later this year and into the future. That's great. It's good to get more of that data, especially if it's peer-reviewed.

Adrian Mendes: We've also set up a registry now formal registry. So we're gathering data in a more structured manner, I suppose. So you'll start to see that flow of clinical evidence, start to pick up, you know, starting later this year and into the future. That's great. I could get more of that data, especially if it's peer reviewed. Yeah. I guess on, you know, obviously, great to reach that 1000 scan benchmark. Can you kind of speak to either how many procedures were done in the quarter or what you're seeing from a monthly run rate? You know, a bit about that kind of the utilization and what you're hoping to see going forward.

Speaker Change: We've also set up a registry now, a formal registry, so we're gathering data in a more sort of structured manner, I suppose. So you'll start to see that flow of clinical evidence start to pick up, you know, starting later this year and into the future.

Speaker Change: That's great. Good to get more of that data, especially if it's peer-reviewed.

Unknown Executive: Yeah, I guess on, you know, obviously great to reach that thousand scan benchmark. Can you kind of speak to either, you know, how many procedures were done in the quarter or what you're seeing from a monthly run rate or, you know, a bit about that kind of the utilization and what you're hoping to see going forward? I think, I don't have this precise numbers on the on the at the monthly level.

Speaker Change: Yeah, I guess on, you know, obviously great to reach that thousand scan benchmark.

Adrian Mendes: With that, I'll now turn over the call to Adrian. Adrian? Thanks, Sarah, and thanks again, everyone, for your time and attention today. As Steve mentioned at the start of the call, we are committed to making a real difference in the lives of patients by creating and commercializing innovative interoperative imaging technologies. The fact is, surgeons have worked for years to innovate every step of the diagnosis and treatment plan for their cancer patients with the ultimate goal of improving survivability and quality of life.

Speaker Change: Can you kind of speak to either, you know, how many procedures were done in the quarter or what you're seeing from a monthly run rate or, you know, a bit about that kind of the utilization and what you're hoping to see going forward?

Unknown Executive: It's safe to say that it is increasing. Every new device that we put on the field, you know, it's also increasing. If you recall, one thing that we did throughout, you know, since the time I've been here is really staff up the clinical team. That helps with customers and helps train them and get them onboarded.

Adrian Mendes: I think I don't have this precise numbers on the monthly level. It's safe to say that it is increasing every new device that we put on the field. You know, it's also adding.

Speaker Change: I think I don't have this precise numbers on the monthly level. It's safe to say that it is increasing.

Speaker Change: Every new device we put on the field, it's also adding to the field.

Adrian Mendes: If you recall, one thing that we did throughout, you know, since the time I've been here is really staffed up the clinical team that helps with customers and helps train them and get them onboarded. So a big part, therefore, because it's just making sure that we're out, you know, we're getting more and more customers through and our blinds up. So that has been increasing over time, you know, on a monthly basis, and we anticipate to continue to increase. Definitely. That's great.

Adrian Mendes: Yes, interoperative margin assessment remains one of their most pressing problems. We're working hard to change that. Permiters S-Series OCT technology gives surgeons the most advanced interoperative margin visualization available as they strive to reduce re-excisions, clarity on margin status and the OR versus waiting days for pathology results to confirm, and actionable real-time insights to tailor clinical decisions to each patient. In a way, our product promise is greater peace of mind. Both to the surgeon who, no matter how skilled, currently faces nearly one in five odds that means perform repeat surgery due to positive margins.

Adrian Mendes: And also to their patients who, under the current treatment pathway, typically need to wait and worry for two to seven days for their surgeon to receive a post-off pathology report, which will determine whether they will have to go through the emotional and fiscal trauma of a second surgery due to cancer left behind.

Speaker Change: team that helps with customers and helps train them and get them onboarded. So a big part of their focus is just making sure that we're getting more and more customers through and our volumes up. So that has been increasing over time on a monthly basis, and we anticipate to continue to increase.

Unknown Executive: So a big part of their focus is just making sure that we're out, you know, we're getting more and more customers through in our volumes. So that has been increasing over time, you know, on a monthly basis, and we anticipate it to continue increasing. Definitely. That's great. And I guess lastly, you know, image clear, certainly kind of new for me, hadn't heard about that. So good to hear that those product improvements are continuing.

Unknown Executive: So that, that algorithm kind of didn't need FDA approval. And you're just kind of no necessarily costs or anything like that to people you're planning on just rolling that out. And that I would assume would be included in the B series. And I didn't impact any kind of regulatory pathway or any of that process.

Adrian Mendes: And I guess lastly, you know, image clear, certainly kind of new for me hadn't heard about that. So good to hear that those products and improvements are continuing. So that that algorithm kind of didn't need FDA approval. And you're just kind of no necessarily costs or anything like that to people you're planning on just rolling that out. And that I would have shown being included in the B series, and that doesn't impact any kind of regulatory pathway or any of that process. Yeah, that's all correct. Yeah, yeah, didn't need to go through any sort of regulatory approval.

Speaker Change: Thank you very much for watching this video, and if you enjoyed this video, please leave a like and share this video with your friends and family.

Speaker Change: Definitely. That's great.

Speaker Change: And I guess lastly, you know, image clear, certainly kind of new for me, hadn't heard about that. So good to hear that.

Speaker Change: Those products and improvements are continuing. So that that algorithm kind of didn't need FDA approval and you're just kind of

Speaker Change: no necessarily costs or anything like that to people you're planning on just rolling that out and that I would assume would be included in the B series and that again doesn't impact any kind of the regulatory pathway or any of that process.

Unknown Executive: Yeah, that's all correct. Yeah, yeah, I didn't need to go through any sort of regulatory approval. And, you know, the most important thing about that is, and one thing I'm really happy what the team's been able to do, is really start to get this process of collecting feedback from customers and then having engineers work on some of those challenges and solve them and deploy that in the field. And the big one with ImageClear, frankly, is the fact that it does cut down the scan time in the operating room. You know, like every minute counts in the operating room.

Speaker Change: Yeah, that's all correct. Yeah, yeah, it didn't need to go through any sort of regulatory approval.

Adrian Mendes: And you know, the most important thing about that is, and one thing that really happy what the team's been able to do is really start to get this process of collecting feedback from customers and then having engineers work. On some of those challenges and solve them and deploy that into the field. And the big one with image clear, frankly, is the fact that it does cut down the scan time in the operating room. And you know, like every minute counts in the operating room. So that's really great. The team has ideas on how to make that even faster.

Adrian Mendes: But as compelling a clinical value proposition that are S-Series OCT represents, it will be our execution of a well thought out and carefully planned market entry strategy that will drive perimeter's ultimate commercials. To that end, ever since the company completed the Leadership Transition in mid-2023, we've been laying down a number of foundational things. And I'm pleased to report that each of the pillars of our strategy are starting to bear fruit. We're currently commercializing our first FDA-cleared interoperative imaging technology, the S series OCT, which provides surgeons with image resolutions capable of visualizing tissue structures at the federal level down to the critical two millimeter depth, when assessing margins real time in the operating room.

Speaker Change: And, you know, the most important thing about that is, and one of the things I'm really happy what the team's been able to do is really start to get this process of collecting feedback from customers and then having engineers work.

Speaker Change: on some of those challenges and solve them and deploy that in the field. And the big one with ImageClear, frankly, is the fact that it does cut down the scan time in the operating room.

Unknown Executive: So that's really great. The team has ideas on how to make that even faster. So that's good. You know, I think we've got a nice development, product development trajectory on that as well. Yeah, I guess what ways would be the kind of with that image clear the kind of average scan time that a surgeon would take?

Speaker Change: like every minute counts in the operating room. So that's really great. Team has ideas on how to make that even faster. So that's good. I think we've got a nice development, product development trajectory on that as well.

Adrian Mendes: So that's good. You know, I think we've got a nice development product development trajectory on that as well.

Adrian Mendes: Yeah, I guess what would be the kind of with that image clear, the kind of average scan time that a surgeon would take? Yeah, so from a scan time on the average lump size, it goes from about 12 minutes down to about 9 minutes. That's great. Yeah, and that's it. Thanks for taking the questions. I'll hop back into you.

Speaker Change: Yeah, I guess what what is what would be the kind of with that image clear to kind of average scan time that a surgeon would take

Unknown Executive: Yeah, so from a scan time on the average lump size, it goes from about 12 minutes down to about nine minutes. That's correct. Yeah, and that's it. Thanks for taking the questions. I'll, I'll talk to you later.

Speaker Change: Yeah, so from a scan time on the average lump size, it goes from about 12 minutes down to about 9 minutes.

Speaker Change: That's great

Speaker Change: Yeah, and that's it. Thanks for for taking the questions. I'll, I'll talk back to you.

Adrian Mendes: It is clear, it is cleared under a general indication, and it's not been evaluated by the FDA specifically for use of breast tissue, breast cancer, or other types of cancer, margin evaluation, and reduce for excision rates. Our goal has been to seed the market with S series OCT in order to create a strong network of early adopters in preparation for a potential FDA clearance of our next generation system, B Series OCT with Image Assist AI.

Scott McAuley: Thanks God. Thank you.

Scott McAuley: Thanks, Scott. Thank you. Your next question comes from Rahul Sarugaser of Fremont James. Please go ahead. Hi Adrian, Sara.

Rahul Sarugaser: Your next question comes from Rahul Sarugaser of Fremontchains. Please go ahead. Hi, Adrian Sarah. Thanks for taking our questions. So Scott covered off most of it with the really several questions.

Scott McCauley: Thanks, Scott.

Speaker Change: Thank you. Your next question comes from Rahul Sargesar of Fremont James. Please go ahead.

Rahul Sarugaser: Thanks for taking our questions. So, Scott covered off most of it with several questions, so really kind of one for me then today. Could you talk about the balance sheet, you know, given sort of the current cash on hand, cash burn, and then how you guys are looking at managing the balance sheet? Um, yeah, absolutely. So right now, you know, we've got cash into early next year, we've been managing pretty tightly to make sure that that runaway stays consistent, planning all year.

Rahul Sarugaser: So really kind of one for me then today.

Sarah: Can you talk about balance sheet, you know, given certain current cash on hand, cash burn, and then how you guys are looking at managing the balance sheet? Yeah, absolutely. So right now, you know, we've got cash into early next year. We've been managing pretty tightly to make sure that that runway stays consistent. That's sort of consistent. We've been planning all year.

Adrian Mendes: Led by principal investigator, Dr. Alistair Thompson, at Baylor College Medicine, Perimeter is conducting a multi-center, randomized, two-armed clinical trial to measure the effectiveness of this AI-enabled OCT technology in reducing the number of unaddressed pods of margins and breast lumpectomy procedures when used in addition to standard interoperative margin assessment. Our focus on improving the level and pace of execution across all aspects of printer's business has contributed to, among other things, the acceleration of patient enrollment in the pivot trial, resulting in it tracking well ahead of schedule.

Rahul Sargesar: Can you talk about balance sheet, you know, given the current cash on hand, cash burn, and then how you guys are looking at managing the balance sheet?

Rahul Sargesar: Action!

Speaker Change: Yeah, absolutely. So right now, you know, we've got cash into early next year, we've been managing pretty tightly to make sure that that runaway stays consistent. And that's sort of consistent that we've been planning all year.

Rahul Sarugaser: We will need to fundraise before then, and so, as consistent as we've talked about before, you know, that's still part of our plan. So, you know, that's part of what a big focus of our management team and board is on these folks. Perfect, that's all for today. Just maybe one more, then, and then I'll get back in the queue.

Sarah: We will need to fundraise before then. And so, as consistent with what we've talked about before, you know, so that's still part of our plans. So, you know, that's that's that's part of what a big focus of our management team and board is based folks on right now. Perfect. That's not like that.

AdConsism: We will need to fundraise before then and so as consistent what we've talked about before, you know, that's still part of our plans.

AdConsism: So, you know, that's that's that's part of what a big focus of our management team and board is focused on right now

Adrian Mendes: We announced today that we now anticipate patient enrollment to be completed in Q3, a quarter ahead of previous expectations. Moving forward from there, since we have already received FDA breakthrough device designation for a B Series system, we anticipate the readout from this study will be a significant catalyst for our business. If positive, these data will support the full commercial launch of Series B OCT technology, representing the next major step in our go-to-market strategy, and an opportunity to significantly broader and use your base across the US.

Rahul Sarugaser: And to take one more, then, and then I'll get back in the queue. It's good to see the visibility on the top line data in queue four. I've seen this calendar key four. And then hopefully followed by the commission and approval.

Speaker Change: Perfect. That's all for today. Maybe one more then, and then I'll get back in the queue.

Unknown Executive: It's good to see the visibility on the top line data in Q4, as soon as calendar Q4, and then hopefully followed by FDA submission and approval. Perhaps you could maybe leap forward a year or so and talk about how you plan on leveraging the data into marketing the device. Yeah, absolutely. So what, once we get approval, and we'll build toward this over time, there's really two things that we're preparing for fundamentally two major things we're preparing for to sort of accelerate. One is the fact that having AI makes it a lot easier for surgeons to adopt. It makes it easier to use. It's like a coal pilot.

Speaker Change: It's good to see the visibility on the top line data in Q4, as soon as calendar Q4.

Speaker Change: and then, you know, hopefully followed by FDA, you know, FDA submission and approval. Perhaps you could maybe, you know, leap forward a year or so and talk about, you know, how you plan on leveraging the data into marketing the device.

Adrian Mendes: Perhaps you could maybe, you know, leap forward a year or so and talk about, you know, how you plan on leveraging the data into marketing. Yeah, absolutely. So, once we get approval and we'll build tour this overtime, there's really two things that we're preparing for: fundamentally, two major things we're preparing for to sort of accelerate growth. One is the fact that having AI makes it a lot easier for surgeons to adopt it. It makes it easier to use. It's like a co-pilot. And so what we're doing right now and what we will do leading up to that is make sure that we're starting to lay down those railroad tracks, whatever, with surgeons and building out that pipeline.

Speaker Change: Yeah, absolutely. So what, once we get approval, and we'll build toward this over time, there's really two things that we're preparing for, fundamentally two major things we're preparing for to sort of accelerate growth.

Adrian Mendes: In the meantime, as you can see from today's press release, the growth pillars we've been laying down are starting to produce tangible results. For example, restructuring our sales organization, which also while also implementing some key process of improvement, have helped drive increased commercial adoption of perimeter S Series OCT both in terms of installed base growth and existing system utilization. To put that in perspective, we've already closed six S Series OCT placement so far this year compared to three in all of 2023.

Speaker Change: One is the fact that having AI makes it a lot easier for surgeons to adopt it.

Unknown Executive: And so what we're doing right now and what we will do leading up to that is make sure that we're starting to lay down those [inaudible] Railroad tracks, whatever, with surgeons and building out that pipeline. So so search and adoption will go up. And that's it. That's that's a big thing that will happen once we get BCers. Unknown Speaker, The other thing that it'll do is it'll give us labels, like data labels on breasts and breast cancer, which then allows us to market much more strongly than we're able to market right now to surgeons and patients about the fact that we do reduce re-excision.

Speaker Change: It makes it easier to use. It's like a co-pilot. And so what we're doing right now and what we will do leading up to that is making sure that we're starting to lay down those

Speaker Change: Railroad tracks, whatever, with surgeons and building out that pipeline. So search and adoption will go up and that's it. That's a big thing that will happen once we get B.C. or some other case.

Adrian Mendes: So, so surgeon adoption will go up and that's it. That's a big thing that will happen once we get BC or some markets. The other thing that they'll do is it'll give us labels like data labels on breast and breast cancer, which then allows us to market much more strongly than we're able to market right now to surgeons and patients about the fact that we do reduce reactations. You know, we will be able to reduce reactations with these series. We will be able to do it in the breast cancer market. We don't have that evidence right now.

Adrian Mendes: Also in Q2, also Q2 revenues, which are recurring since their derived from sales consumables and system leases, grew 83% year over year, and 150% sequentially from the first quarter of 2024. Finally, just after the end of the quarter, the 1,000 paid perimeter Series OCT patient scan was performed, marking an important clinical and commercial milestone, for us. In addition, our strengthens commitment to methodical data collection help facilitate Dr. Amelia Gunter, authoring an exciting white paper in June.

Speaker Change: The other thing that it'll do is it'll give us labels like data labels on breasts and breast cancer

Speaker Change: which then allows us to market much more strongly than we're able to market right now to surgeons and patients about the fact that we do reduce re-excisions.

Unknown Executive: You know, we will be able to reduce re-excisions with B-series. We will be able to do it in the breast cancer market. We don't have that evidence right now. The S-series is not clear for that, but the B-series will be.

Speaker Change: You know, we will be able to reduce re-excisions with B-series. We will be able to do it in the breast cancer market. We don't have that evidence right now. The S-series is not cleared for that, but the B-series will be. So that's another inflection point that will really help our marketing message and our commercial sort of messaging and strategy towards the end of next year.

Rahul Sarugaser: The S series is not clear for that, but the BC will be so that's another inflection point that really helps our marketing message and our commercial sort of messaging and strategy towards the end of next year. Does that answer question, Raoul? Oh, yes, that's perfect. Thanks very much. I'll get back in one few.

Unknown Executive: So that's another inflection point that will really help our marketing message and our commercial sort of messaging and strategy towards the end of next. Does that answer your question, Rahul? Yes, that's perfect. Thanks very much. I'll get back in with you. Great, thanks Rahul. That concludes our question and answer session. I'd like to turn the conference back to Adrian Mendes for closing remarks. Okay.

Adrian Mendes: It reported re-operation rates among 72 patients in practice who underwent OCT imaging during breast conserving surgery. The research demonstrated that OCT helped achieve a re-operation rate of 5.6 percent as compared to the national average of 19.9 percent. Also, while the national re-operation rate in patients with a certain type of breast cancer called ductal carcinoma in situ, DCIS, was 30.8 percent versus 13.3 percent in patients where OCT was used. And in patients with invasive ductal carcinoma IDC, the national rate re-operation was shown to be 18 percent, while our S-series OCT operation rate was 0 percent.

Speaker Change: . . .

Speaker Change: [inaudible]

Speaker Change: Does that answer your question, Rahul?

Operator: Great, thanks, Rahul. That concludes our question-and-answer session.

Speaker Change: Yes, that's perfect. Thanks very much. I'll get back in with you.

Speaker Change: Great, thanks Rahul.

Adrian Mendes: I'd like to turn to conference back to Adrian Mendes for closing remarks. Okay, thank you. Thanks everyone for the time for following us and the supports. The team here is extremely excited about what we have coming on. We're sitting here at the start of, you know, you've seen some good news today. There's more to come. So keep following us, and we look forward to talking to you next quarter. Thank you.

Speaker Change: That concludes our question and answer session. I'd like to turn the conference back to Adrian Mendes for closing remarks.

Adrian Mendes: Thank you. Thanks, everyone, for the time and for following us and the support. The team here is extremely excited about what we have coming up. I guess we're sitting here at the start of, you know, you've seen some good news today. There's more to come. So keep following us, and we look forward to talking to you next quarter. Thank you. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect, www.unc.org.au

Adrian Mendes: Okay, thank you. Thanks, everyone, for the time and for following us and the support. The team here is extremely excited about what we have coming up.

Speaker Change: I guess we're sitting here at the start of, you know, you've seen some good news today. There's more to come. So keep following us. We look forward to talking to you next quarter. Thank you.

Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect. Thank you.

Adrian Mendes: Dr. Gunter's white paper is available on our website, and I encourage you to review it there if you haven't already had a chance to do that. Finally, our additional focus on gathering user feedback in order to apply an agile approach to continuously improve our product offering resulted in the first of its kind installation of our new image clear AI image enhancement algorithm with a commercial perimeter S-series OCT system. Image clear enables users to achieve better quality images up to 441 percent signal to noise ratio increase, and importantly, reduce scan times by 28 percent. We are now working to upgrade all installed S-series systems with image clear before the end of the year.

Speaker Change: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

Adrian Mendes: And so to summarize, we're seeing positive commercial traction with S-series OCT as demonstrate of our install base and revenue growth in Q2 and the achievement of 1,000 patient scanned milestone in July. The ongoing pivotal trial evaluating use of our next Gen B-series OCT with images SIS AI during breast-conserving surgeries is progressing well and is now expected to complete patient enrollment in the third quarter. There's a growing body of clinical evidence, including Dr. Gunter's recent white paper, which points to the potential offer OCT based technologies to advance the standard of care, improve patient outcomes, and reduce healthcare costs. And finally, we continue to leverage our extensive AI and MetTech expertise to find ways to deploy AI models like Image Clear throughout our technology staff to improve the customer experience and surgical outcomes.

Adrian Mendes: We look forward to keeping you updated in our progress through 2024 and are excited by the important milestones that lay ahead.

Adrian Mendes: And with that, I now open up the call for your questions. Operator? Thank you.

Operator: 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 touch tone following. You will hear a prop that your hand has been raised. Should you wish to decline from the polling process, please press the star followed by the number two. If you are using a speaker phone, please leave the handset before pressing any. One moment please for your first question.

Scott McAuley: Your first question comes from Scott McAuley of Faradayme Capital. Please go ahead. Hi everyone. Thanks for taking the questions. Great to hear on all the the activity and kind of six installations year to date. Could you begin that into that a little more. What's the total number of systems that are currently installed and maybe how many kind of met new in Q2? Yeah, hey Scott. Thanks for joining. Good question. So we're up to 12 systems now that are currently installed and earning revenue for us and four of them.

Scott McAuley: Four of the total have been in the second quarter. So we've been accelerating, you know, quarter after quarter. Four of those six in Q2. Yeah, that's great. And then maybe a bit on the type of facilities that those kind of recent installations have been in or the hospitals, surgical centers and are these new sites are these, you know, sites that are acquiring their second system or part of your national chain or things like that.

Scott McAuley: Yeah, they're all hospitals. You know, hospital system surgery, they actually follow very, very similar to the same profile that we have been winning to date. So it's, you know, it's just sort of expansion into the place we've had success already. Yeah, got it. And then I guess on the balance of the year, kind of how you're seeing the pipeline growing and moving through the sales cycle. Yeah, you know strong pipeline, we expect to see these sort of growth rates continue through third quarter and fourth quarter.

Scott McAuley: Expanding into new facilities, fans and new states. So I think we're, you know, sort of just kind of push sort of refer back to something I said earlier is one of the things that we've all been working really hard here to just make sure we're establishing sort of the foundational structure in the company. That will help us grow sustainably, you know, over time. So it's not just like running really hard, closing a bunch of deals and then going into a droughts.

Scott McAuley: And so we've seen that when we look at our pipeline, we see things kind of stage nicely through the entire pipeline through phases and with increasing quantities of time goes on. So where it hurts that this is a story that's sustainable. Now we can keep going. That's great. I guess on the trial, you know, fantastic to hear that the recruitment is going faster than expected and to be finished soon. So yes, if the recruitment is finishing to three, could you talk through a bit on, you know, when we could expect to see the top line data and then your potential update submission and approval.

Scott McAuley: Yeah, so the hope is that we'll be able to talk about top line data in the fourth quarter before your end. And then with a goal of submitting to the FDA early next year, like early Q1. And then we're planning right now. We're anticipating approval sometime towards the end of 2025 or early 2020. A6. We have breakthrough device designation, so that we hopeful help speed things through internally. We're sort of preparing everything.

Scott McAuley: I mean, we have been preparing everything to prepare everything just to make sure there is no wait time between a request from the FDA and when we can submit something or the trial ending and when we can submit something. So the one of the biggest highest priors we bought in the company is just to get through to get that tears beyond the market as quickly as possible. Absolutely. And so I broke up a little bit using kind of data before the end of the year, and then submission to Q1.

Scott McAuley: That's right. And on the white paper, you know, the great to see that those data in that form, any other kind of white papers or studies, kind of real world evidence that you guys are working on to put out there. Yes, absolutely. So like we mentioned, we've got 1000 patients through right now, and so we've got that data. We've got a few papers going through a peer reviewed process. You know, the first white, the first paper was a white paper.

Scott McAuley: The next ones will be peer reviewed. We've also set up a registry now formal registry. So we're gathering data in a more structured manner, I suppose. So you'll start to see that flow of clinical evidence, start to pick up, you know, starting later this year and into the future. That's great. I could get more of that data, especially if it's peer reviewed. Yeah. I guess on, you know, obviously, great to reach that 1000 scan benchmark.

Scott McAuley: Can you kind of speak to either how many procedures were done in the quarter or what you're seeing from a monthly run rate? You know, a bit about that kind of the utilization and what you're hoping to see going forward. I think I don't have this precise numbers on the monthly level. It's safe to say that it is increasing every new device that we put on the field. You know, it's also adding.

Scott McAuley: If you recall, one thing that we did throughout, you know, since the time I've been here is really staffed up the clinical team that helps with customers and helps train them and get them onboarded. So a big part, therefore, because it's just making sure that we're out, you know, we're getting more and more customers through and our blinds up. So that has been increasing over time, you know, on a monthly basis and we anticipate to continue to increase.

Scott McAuley: Definitely. That's great. And I guess lastly, you know, image clear, certainly kind of new for me hadn't heard about that. So good to hear that those products and improvements are continuing. So that that algorithm kind of didn't need FDA approval. And you're just kind of no necessarily costs or anything like that to people you're planning on just rolling that out. And that I would have shown being included in the B series and that doesn't impact any kind of regulatory pathway or any of that process.

Scott McAuley: Yeah, that's all correct. Yeah, yeah, didn't need to go through any sort of regulatory approval. And you know, the most important thing about that is and one thing that really happy what the team's been able to do is really start to get this process of collecting feedback from customers and then having engineers work. On some of those challenges and solve them and deploy that into the field. And the big one with image clear, frankly, is the fact that it does cut down the scan time in the operating room.

Scott McAuley: And you know, like every minute counts in the operating room. So that's really great. The team has ideas on how to make that even faster. So that's good. You know, I think we've got a nice development product development trajectory on that as well. Yeah, I guess what would be the kind of with that image clear, the kind of average scan time that a surgeon would take? Yeah, so from a scan time on the average lump size, it goes from about 12 minutes down to about 9 minutes. That's great. Yeah, and that's it. Thanks for for taking the questions. I'll hop back into you. Thanks God.

Scott McAuley: Thank you.

Rahul Sarugaser: Your next question comes from Rahul Sarugaser of Fremontchains. Please go ahead. Hi, Adrian Sarah. Thanks for taking our questions. So Scott covered off most of it with the really several questions. So really kind of one for me then today.

Adrian Mendes: Can you talk about balance sheet, you know, given certain current cash on hand cash burn and then how you guys are looking at managing the balance sheet, yeah, absolutely. So right now, you know, we've got cash into early next year. We've been managing pretty tightly to make sure that that runway stays consistent. That's sort of consistent. We've been planning all year. We will need to fundraise before then. And so as consistent with what we've talked about before, you know, so that's still part of our plans. So, you know, that's that's that's part of what a big focus of our management team and board is based folks on right now. Perfect. That's not like that.

Rahul Sarugaser: And to take one more then and then I'll get back in the queue. It's good to see the visibility on the top line data in queue four. I've seen this calendar key four. And then hopefully followed by the commission and approval.

Adrian Mendes: Perhaps you could maybe, you know, leap forward a year or so and talk about, you know, how you plan on leveraging the data into marketing. Yeah, absolutely. So what once we get approval and we'll build tour this overtime, there's really two things that we're preparing for fundamentally two major things we're preparing for to sort of accelerate growth. One is the fact that having AI makes it a lot easier for surgeons to adopt it.

Adrian Mendes: It makes it easier to use. It's like a co-pilot. And so what we're doing right now and what we will do leading up to that is make sure that we're starting to lay down those railroad tracks, whatever, with surgeons and building out that pipeline. So, so surgeon adoption will go up and that's it. That's a big thing that will happen once we get BC or some markets. The other thing that they'll do is it'll give us labels like data labels on breast and breast cancer, which then allows us to market much more strongly than we're able to market right now to surgeons and patients about the fact that we do reduce reactations.

Adrian Mendes: You know, we will be able to reduce reactations with these series. We will be able to do it in the breast cancer market. We don't have that evidence right now. The S series is not clear for that, but the BC will be so that's another inflection point that really help our marketing message and our commercial sort of messaging and strategy towards the end of next year. Does that answer question, Raoul? Oh, yes, that's perfect. Thanks very much. I'll get back in one few. Great, thanks, Rahul.

Operator: That concludes our question and answer session.

Adrian Mendes: I'd like to turn to conference back to Adrian Mendes for closing remarks. Okay, thank you. Thanks everyone for the time for following us and the supports. The team here is extremely excited about what we have coming on. We're sitting here at the start of, you know, you've seen some good news today. There's more to come. So keep following us and we look forward to talking to you next quarter. Thank you.

Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

Operator: Thank you.