Perimeter Medical Imaging AI, Inc. (OTCPK:PYNKF) Q3 2023 Earnings Convention Name November 14, 2023 5:00 PM ET
Firm Contributors
Jodi Regts – IR
Adrian Mendes – CEO
Convention Name Contributors
Rahul Sarugaser – Raymond James
Operator
Good afternoon, women and gents and welcome to the Perimeter Medical Q3 2023, Convention Name. At the moment all wines are in pay attention solely mode. [Operator Instructions]. This name is being recorded on Tuesday, November 14, 2023.
I’d now like to show the convention over to Jodi Regts. Please go forward.
Jodi Regts
Thanks. Good afternoon. Thanks for becoming a member of us on this name and webcast to offer the third quarter 2023, outcomes for Perimeter Medical Imaging AI. Becoming a member of me on as we speak’s name is Adrian Mendes, Perimeter’s Chief Government Officer, who will present an outline of Perimeter’s progress throughout the enterprise together with Sarah Bryan, Chief Monetary Officer and Andrew Berkeley Perimeters Chief Innovation Officer who can be found to reply questions once we open up the decision for Q&A, after our ready remarks.
Please be suggested that in this name, we’ll make quite a lot of statements which are forward-looking, together with statements concerning the longer term monetary place, enterprise technique and strategic targets, industrial actions and timing, aggressive situations analysis and growth actions, projected prices and capital expenditures analysis and medical testing outcomes. The potential advantages of our merchandise, together with Perimeter S-Collection OCT, Perimeter B-Collection OCT and Perimeter ImgAssist, the efficacy of our medical trial designs, the timing and anticipated enrollment in our medical trials and the timing of potential publication or presentation of future medical information.
Ahead-looking statements are topic to quite a few dangers and uncertainties, lots of that are past our management, together with the dangers and uncertainties described sometimes in our SEDAR filings. Our outcomes could differ materially from these projected on as we speak’s name. We undertake no obligation to publicly replace any forward-looking assertion. For added details about dangers and uncertainties going through our enterprise, administration encourages you to assessment the corporate’s public filings and press releases, that are posted on sedarplus.ca. The information launch summarizing this quarterly replace is obtainable below the Traders part of our web site at perimetermed.com and filed with SEDAR+.
Now I wish to flip the decision over to Adrian.
Adrian Mendes
Thanks, Jodi. Good afternoon. Thanks, everybody for becoming a member of our name. At the moment I’ll stroll you thru a number of the highlights from the quarter and nil win on developments made inside each the medical growth and industrial sides of our enterprise. Earlier than entering into these detailed updates, I wished to offer some excessive degree observations on progress made throughout the enterprise.
Since becoming a member of the corporate this previous summer season, now we have made some key adjustments on the management degree, that are all pushed by our targets to enhance crew morale, improve worker retention and take away any silos stopping efficient collaboration throughout the group as an entire, all with the intent of enormously growing our tempo of execution.
Throughout our final quarter, we welcome Sara Brien as our CFO and Andrew Berkeley, one in every of Perimeters Co-Founders to his new function as Chief Innovation Officer.
At the moment, I wish to lengthen a heat welcome to Adam Hodges, who joined Perimeter Senior Management crew as our Vice President of Gross sales and Advertising and marketing in early September. Adams costly med tech backhoe represents an awesome match for us along with his concentrate on advancing class first, novel know-how that problem the medical commonplace of care and add worth to the healthcare system.
Actually, I imagine he has already made a constructive affect each in his division and throughout the corporate. And we anticipate that our gross sales and advertising and marketing crew will proceed to profit from his management as we increase the variety of surgeon champions and geographic areas adopting our commercially out there S-Collection imaging platform and finally, the adoption of our subsequent gen AI enabled B-Collection know-how when it reaches a industrial rollout stage.
We have now been very deliberate in how we have approached these all adjustments as we’re hyper conscious of the significance of not simply attracting but in addition retaining high expertise. I am pleased with the crew now we have in place and as we develop I imagine we’re creating a powerful tradition that may allow us to attain our formidable enterprise targets.
Let’s dig in now on the medical growth aspect of the enterprise and the progress made once more throughout our subsequent gen AI growth and the continuing pivotal trial. This quarter we reported the outcomes of our constructive interactions with the FDA that resulted in us reaching alignment on key parts of our medical trial, which is evaluating Perimeters B-Collection gadget when used throughout breast conserving surgical procedures, in any other case often known as lumpectomies.
The B-Collection gadget combines Perimeters revolutionary OCT platform with our picture help AI know-how, which is able to additional speed up buyer adoption of Perimeter resolution. This quarter marked an essential milestone in our medical growth program. First, we obtain regulatory approval to implement our considerably enhanced AI algorithm within the ongoing pivotal medical trial below the prevailing research protocol.
Consequently, all medical trial websites are actually utilizing the up to date AI as sufferers proceed to enroll within the ongoing research. Andrew spoke on our final name about a number of the anticipated important advantages of the brand new enhanced AI, which takes benefit of extra coaching information in Perimeters newest AI developments that reveal improved sensitivity, specificity, precision and recall. It’s anticipated that this up to date model of picture help AI will contribute to extra correct classification, in addition to fewer false positives and false negatives.
Second, we now have a deliberate interim evaluation within the trial, which is able to present us with an early readout of outcomes primarily based on using the latest algorithm. If key endpoints are met on the time of the interim evaluation, we could choose to conclude the trial and start getting ready regulatory submissions supporting market clearance.
Alternatively, the interim evaluation might assist persevering with the trial to construct a stronger submission package deal for extra topics. Finally, our objective is to expedite the event of our subsequent gen AI know-how and ship it to our surgeon clients to enhance medical and financial outcomes in breast surgical oncology.
Third, we’re permitted to enroll extra topics as much as 531. And have obtained clearance to extend the variety of trial websites with the objective of additional supporting and expediting affected person enrollment. I am happy to report that we not too long ago added a medical trial website on the College of Washington, Fred Hutch Most cancers Middle, situated in Seattle. As a fast observe on to the latest website initiations at Baptist MD Anderson and Mayo Clinic in Jacksonville, Florida. Importantly, affected person enrollment is monitoring effectively and barely higher than modeled. And we proceed to information that we anticipate an interim evaluation within the second quarter of 2024.
If we decide that extra information is required, anticipate research completion by the tip of 2024. We proceed to listen to from KOLs that the potential of mixing AI with ultra-high decision inter operative imaging has the potential to develop into a brand new commonplace of care throughout breast conservation surgical procedure. Our medical growth crew is extraordinarily pushed to conduct a well-run research that gives us with essential information, permitting us to chart a transparent path ahead to our subsequent gen know-how. We sit up for retaining you up to date on our progress.
Turning now to our 510 cleared Perimeter S-Collection Expertise. Briefly for these newer to the Perimeter story. That is our flagship inter-operative OCT imaging know-how, which gives surgeons with resolutions able to visualizing tissue constructions on the mobile degree, right down to the crucial two millimeter depth with 10x larger picture decision that X ray and ultrasound and 100x higher picture decision that MRI.
Most cancers surgeons have lengthy acknowledged the problem of attaining clear margins whereas preserving wholesome tissue throughout surgical procedure. And because it’s a number of days or perhaps weeks earlier than pathology studies on margin standing can be found, in the event that they present constructive margins, sufferers should sometimes return to the working room for an additional process attributable to most cancers left behind.
We carried out a radical assessment of the enterprise once I got here on Board as CEO, and I firmly imagine that there continues to be a compelling product market match for Perimeter’s commercially out there S-Collection OCT. Our focus as we speak is to construct a community of early adopters succesful and pushed to make use of our groundbreaking know-how. Whereas this does start to determine an early stage income pipeline, maybe extra importantly, it permits us to have a transparent channel to clients to assemble product suggestions.
We’re making use of an agile method to our industrial enterprise to be taught within the area with the objective of continually iterating and bettering upon the present state. The identical early champions in reference websites will tackle an much more essential function once we launch our next-gen AI enabled tech, to achieve our objective of considerably broadening our consumer base within the U.S.
Our crew continues to make good progress reaching these focused clients. We have now a transparent recreation plan to additional increase our set up base by connecting with excessive potential surgeons, leveraging current institutional relationships inside healthcare networks and figuring out the optimum geographic areas. Particularly, these which supply the bottom boundaries and prices offering picture coaching helps.
A number of extra prices on our commonest pricing mannequin. Healthcare amenities sometimes obtain a free placement of the Perimeter S-Collection gadget, after which pay per process with the acquisition of our proprietary specimen immobilizer consumables, which we generally seek advice from as a razor blade mannequin.
Importantly, assuming we established medical validation, regulatory approval for AI know-how, the console may be simply up to date with the brand new AI characteristic. Trying forward, we imagine we are able to leverage this mixture of imaging and AI throughout a number of indications as we develop our enterprise.
Our go to market technique is additional supported by a powerful IP place. We maintain six difficulty patents and a proprietary picture database of over 2 million photos associated to breast most cancers alone. We additionally acknowledge that there are additional alternatives exterior of breast most cancers. Trying forward, we proceed to establish viable progress alternatives by means of the growth of indications and tissue sorts, in addition to exploring new factors within the most cancers surgical procedure workflow. For instance, utilizing Perimeter know-how to help the pathologist in addition to the surgeon.
I additionally wished to spotlight the Perimeter is shortlisted in a grant funding course of sponsored by the Superior Analysis Initiatives Company for Well being, in any other case often known as ARPAH. Below its precision surgical interventions, or PSI program.
We attended a proposer keep in early September, and subsequently submitted an summary which has been chosen to advance to the following stage of the grant funding course of. We stay on observe to submit a full proposal by the deadline simply as we are saying.
Clearly, we’re excited to take part on this essential Biden Most cancers Moonshot Initiative, and thrilled that the Federal Superior Analysis Initiatives Company for Well being has chosen Dallas as one of many two regional hubs in its $2.5 billion Well being Innovation Community. Along with being a possible supply of non-dilutive funding for the corporate, the targets of the PSI program align exactly with the mission of Perimeter and additional validates the numerous more healthy downside that our crew has dedicated to fixing, making certain that no affected person must return for repeat surgical procedure attributable to most cancers left behind.
Okay, turning briefly to our monetary place. As of September 30 2023, money and money equivalents have been roughly $18.1 million. For extra particulars, please seek advice from the quarterly report and press launch filed as we speak. With the robust money place, our prudent fiscal administration, and extra secret grant cash nonetheless out there to us, we’re assured we’ll have the ability to assist our plan, medical growth actions, and fund the continued industrial rollout of our merchandise.
In abstract, on behalf of the entire Perimeter crew, we’re very excited concerning the future forward. We imagine no different know-how comes near what now we have, and Perimeters know-how is completely positioned to deal with a extensively accepted $750 million downside in breast oncology within the U.S. alone, and plenty of multiples of that throughout different indications and different geographies, to not point out the numerous emotional challenges with as we speak’s commonplace of care.
We proceed so as to add and redeploy sources to assist the important thing areas of our enterprise. And we stay targeted on our targets that embrace, increasing our base of key opinion leaders who will champion using Perimeter S-Collection, supporting ongoing enrollment in our pivotal trial, utilizing the improved AI algorithm, exploring extra tissue indications and different workflow growth alternatives, and persevering with to develop a excessive efficiency crew that’s pushed to remodel most cancers surgical procedure.
And with that, I’ll now open up the decision for questions. Operator.
Query-and-Reply Session
Operator
[Operator Instructions] Your first query comes from Rahul Sarugaser, from Raymond James. Please go forward.
Rahul Sarugaser
Good night, Adrian. Thanks a lot for taking my questions. And I apologize for the background noise. And I additionally apologize that I obtained dumped off the decision for a little bit bit once you have been speaking concerning the AI trial and doubtlessly have the ability to speed up the 510(okay) software. So it would be nice to listen to a little bit bit extra about what you are seeing when it comes to timeline, numbers of sufferers, any extra parameters and or thresholds that we ought to be searching for as we attempt to get extra decision on that?
Adrian Mendes
Certain. Sure. Thanks for the query, Rahul. So, we’re — so proper now we have — so if we run the trial all the best way to the tip, we ought to be full within the fourth quarter of 2024. As talked about, now we have the chance to have an interim evaluation. And that on the present charges we’re at proper now projections will likely be in Q2. Proper now, as of the tip of November — sorry, finish of October, we’re monitoring a little bit bit forward of our projections, possibly about 15% forward in our affected person enrollment charges. So we’re truly fairly comfortably in a position to hit these deadlines.
We introduced on as talked about, possibly you did not hear it within the name, once you have been kicked off. However we introduced on mayo, and MD Anderson in Florida, in addition to the College of Washington earlier this quarter. In order that’ll actually decide up the speed of enrollments. So we’re feeling fairly comfy proper now that we’ll have the ability to hit the dates that we described.
Rahul Sarugaser
Nice. Thanks very a lot for that. And so when it comes to that interim evaluation, are you able to give us a way of form of the quantity, the quantity within the dataset, and any thresholds that we ought to be searching for so as to derisk the probability of enchancment?
Adrian Mendes
Sure, so the, the first end result that will enable us to have {that a} profitable interim evaluation could be for us to have what they name conversion, so six conversions out of the 186 enrollments that we might have at that cut-off date. So mainly, six sufferers that if it weren’t for using OCT of their process, would have needed to come again for a second surgical procedure, as a result of the margins wouldn’t be the place they have to be.
However for having used OCT, to surgeon discovered the insufficient margins and was in a position to right that inside the first surgical procedure. In order that’s actually the goal that we’re searching for on the interim evaluation level. Sadly, we’re blinded to the info proper now. So it is laborious for us to the truth is, we simply do not actually understand how we’re progressing towards that.
Nevertheless, once we have a look at, from anecdotal data from our industrial aspect of the home, which does not, after all, use the AI enabled product, however does use OCT in all of the websites now we have on the market, we’re seeing very, excellent outcomes there from these surgeons. So we have a excessive diploma of confidence, we’ll have the ability to hit this trial. Hopefully, by the point we get to interim evaluation, however actually by the point we run all the trial.
Rahul Sarugaser
Nice, thanks. After which simply why do not I only one final query, then. Driving FDA clearance is one factor, after which having robust sufficient information to vary hearts and minds of docs is one other. And so whilst you’ve expressed confidence and have the ability to gen AI an FDA clearance, how do you see that information taking part in when it comes to as a advertising and marketing software to have the ability to drive adoption? And that’s all for me. Thanks.
Adrian Mendes
Sure. So I believe that is the place the choice of whether or not we truly do, even when we obtain that end result on the early evaluation level, whether or not we select to proceed to run the trial to the tip, simply to assemble extra information. In order that’ll be one side of that.
The opposite aspect of it when it comes to the advertising and marketing aspect of even past the AI piece is absolutely the outcomes we’re seeing from the S-Collection within the industrial world proper now, which as I stated, you realize, anecdotally could be very constructive. And there is information that we’re seeking to pull collectively to have the ability to publish over the approaching few months.
Rahul Sarugaser
Nice. Thanks a lot for taking our questions. I want you the perfect of luck. I will get again within the queue.
Operator
Thanks. [Operator Instructions] Okay, there aren’t any additional questions presently. I will flip it again to Jodi, for closing remarks.
Jodi Regts
Thanks, Colin. Thanks, everybody for becoming a member of us as we speak. This concludes our Q3 name. Thanks.
Operator
Women and gents, this concludes your convention name for as we speak. We thanks for collaborating and ask that you simply please disconnect your traces.
