Q3 2023 Aspira Women's Health Inc Earnings Call

Speaker 1: Good afternoon, ladies and gentlemen, and welcome to the Aspera Women's Health Incorporated third quarter 2023 earnings conference call at this time, all participants.

Good afternoon, ladies and gentlemen, and welcome to the spear of Women's Health incorporated third quarter 2023 earnings Conference call.

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

Speaker 1: Following management's prepared remarks, we will open the call for your questions.

Following managements prepared remarks, we will open the call for your questions.

As a reminder, this call is being recorded today.

Speaker 1: Leading the call today is Nicole Sanford, President and Chief Executive Officer. Joining her is Dr. Torsten Hombach, Chief Financial Officer. After the prepared remarks, we will

Leading the call today is Nicole Sanford, President and Chief Executive Officer, joining her is Doctor Torsten Hombach Chief Financial Officer. After their prepared remarks, we will open the call for Q&A.

Speaker 1: Before we begin, I would like to remind everyone that forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995 will be made during this call, including statements related to the SPEAR's expected future performance, future business prospects, and future events or plans.

Before we begin I would like to remind everyone that forward looking statements as defined under the private Securities Litigation Reform Act of 1995 will be made during this call including statements related to our spirits expected future performance future business prospects and future events or plans.

Speaker 1: Although the company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions, actual outcomes and results are subject to risks and uncertainties, and could differ materially from those anticipated due to the impact of many factors beyond the SPHERA Women's Health Control.

Although the company believes that the expectations reflected in such forward looking statements are based upon reasonable assumptions actual outcomes and results are subject to risks and uncertainties and could differ materially from those anticipated due to the impact of many factors beyond the sphere of women's health.

Control.

Speaker 1: The company assumes no obligation to update or supplement any forward-looking statement.

The company assumes no obligation to update or supplement any forward looking statements.

Speaker 1: whether as to a result of new information, future events, or otherwise, except as required by law.

Whether as to whether result of new information future events or otherwise.

As required by law.

Speaker 1: Participants are directed to the cautionary notes set forth in today's press release, as well as the risk factors set forth in ASPERA's most recent annual report on Form 10-K and quarterly report on Form 10-Q , filed with the SEC for a description of factors that could cause actual results to differ materially from those anticipated in the forward-looking statement.

Participants are directed to the cautionary notes set forth in today's press release as well as the risk factors set forth in our spirits. Most recent annual report on Form 10-K, and quarterly report on Form 10-Q filed with the S. E. C for a description of factors that could cause actual results.

To differ materially from those anticipated in the forward looking statements.

Speaker 2: At this time, I'd like to turn the call over to Nicole Sanford, President and Chief Executive Officer. Please go ahead. Thank you, Operator, and good afternoon, everyone. I would like to welcome you to our third quarter 2023 conference call. We'll start the call with highlights from this quarter before handing it to our CFO , Torsten Holmbach, to review our financial performance in more detail. As always, I'm pleased to welcome you to our conference call.

At this time I'd like to turn the call over to Nicole Sanford President and Chief Executive Officer. Please go ahead.

You operator, and good afternoon, everyone I would like to welcome you to our third quarter 2023 conference call I will start the call with highlights from this quarter before handing it to our CFO Torsten home back to review our financial performance in more detail.

As always I'll start with growth.

We were excited to see CMS preliminary approval of our request to crosswalk pricing from over one to Overwatch and the 'twenty 'twenty four preliminary laboratory test to reschedule.

If approved is expected later this month the pricing will apply to all Medicare beneficiaries beginning in January 2024.

Elsewhere on the growth front, we welcomed back Michel Schneider as our senior Vice President of commercial strategy and operations.

Speaker 2: She rejoins Aspira following successful leadership roles at Sonic Laboratories and FEMA IV. Michelle and I have been collaborating closely on the execution of the next phase of our commercial refresh including the development of a physician-focused omni-channel strategy, the reinvigoration of our inside sales organization, and the launch of several high-impact campaigns including our recent physician-focused Overwatch KOL webinar that attracted over 400 participants.

Should we joined this virus following successful leadership roles at Sonic laboratories, and see muscle or Mr.

Michel and I have been collaborating closely on the execution.

Phase of our commercial refresh, including the development of a physician focused omni channel strategy. The reinvigoration of our inside sales organization and the launch of several high impact campaigns, including a recent physician focused of watch kalo webinar that attracted over 400 participants.

We also launched a point of care practice, they had to help health care providers talk to their patients about a knuckle method and how our noninvasive, obviously product can help assess the risk of cancer.

Speaker 2: We believe these efforts will continue to drive our Oversuite test into the patient care pathway and increase provider adoption.

We believe these efforts will continue to drive our overseas test into the patient care pathway and increased provider adoption.

Speaker 2: We have created a new vice president of business development role and recruited a talented executive with extensive healthcare relationships to accelerate our commercial expansion plan.

We've created a new vice president of business development role and recruited a talented executive with extensive health care relationships to accelerate our commercial expansion plan.

Speaker 2: Elsewhere in sales, we turned around several underperforming territories, further reinforcing a performance culture in the commercial organization. We implemented a new relationship with a contract sales organization to improve flexibility and have seen immediate improvements in many of those territories as a result.

Elsewhere in cells, we turned around several underperforming territories further reinforcing our performance culture and the commercial organization.

Implemented a new relationship with a contract sales organization to improve flexibility and I've seen immediate improvements in many of those territories as a result.

Speaker 2: This quarter, we continue our track record of year-over-year growth for Oversweep since I became CEO . Product revenues for the third quarter were $2.2 million, representing growth of 9% compared to the third quarter of 2022.

This quarter, we continue our track record of year over year growth for Oversleep since I became CEO.

Revenues for the third quarter were $2 2 million representing growth of 9% compared to the third quarter of 2022.

Speaker 2: The number of Oversweet tests performed this quarter was 5,783, an increase of 5% compared to the third quarter of 2022, with Overwatch contributing nearly 20% of that volume.

The number of Oversea test performed this quarter. It was 5783, an increase of 5% compared to the third quarter of 2022 with Overwatch contributing nearly 20% of that volume.

Speaker 2: We've performed 18,331 oversweet tests in the first nine months of this year, an increase of 16% versus the same period of 2022.

Performed 18331 August we tested in the first nine months of this year, an increase of 16% versus the same period of 2022.

Speaker 2: The volume growth was driven by a much leaner sales team, which demonstrates our commitment to eliminating unprofitable and underperforming territories and the renewed focus on partnerships to drive profitable growth that can sustain the company as we bring new and expanded product lines to market.

The volume growth was driven by a much leaner sales team, which demonstrates our commitment to eliminating unprofitable and underperforming territories and a renewed focus on partnerships to drive profitable growth.

Sustained the company as we bring new and expanded product lines market.

Speaker 2: Turning to our average unit price, I continue to be pleased with our progress. Since we began billing Overwatch under its unique PLA code on April 1st, our Overwatch AUP has shown a steady increase to $347, a 7% increase over the second quarter. Oversuite AUP declined to $383 from $396 in the second quarter. However, as Torsten will cover in more detail shortly, the ongoing focus on cost containment helped to hold gross margin at 59%.

Turning to our average unit price I continue to be pleased with our progress.

We began billing overwatch under its unique P. L. A code on April 1st our Overwatch E. P has shown a steady increase of $347.

7% increase over the second quarter of a suite a P declined to $383 from $396 in the second quarter. However, as thorsten will cover in more detail shortly.

<unk> focus on cost containment helped to hold gross margin at 59%.

Speaker 2: operating expenses dropped again in the third quarter, returning to levels the company has not achieved since 2020, while simultaneously achieving growth in both product revenues and volumes. Let me now turn to innovation.

Operating expenses dropped again in the third quarter returning to levels. The company has not achieved since 2020, while simultaneously achieving growth in both product revenues and volumes.

Let me now turn to innovation.

This quarter, we welcomed Dr. Jody Berry to our senior leadership team.

Speaker 2: Jodi joined Aspira as Chief Scientific Officer in September following a distinguished academic and commercial career in biochemistry and diagnostics research and development.

Jody joined as Fireeye as Chief Scientific Officer in September following a distinguished academic and commercial career in biochemistry and diagnostics research and development.

Speaker 2: Most recently, Jody served as the Chief Scientific Officer of Orisher Technologies, where he led the breakthrough discovery of the first integrated swab test for COVID-19.

Most recently Jodi served as the Chief Scientific officer of Orasure technologies, where he led the breakthrough discovery of the first integrated swab tests for COVID-19.

Speaker 2: Not only is he a prolific and award-winning researcher, but he is also passionate about women's health, an interest that goes all the way back to his earliest work in pelvic inflammatory disease and HIV.

Not only is he a prolific and award winning researcher but he is also passionate about women's health and interest that goes all the way back to his earliest work and pelvic inflammatory disease and HIV.

Speaker 2: We made great progress in our effort to expand our OvaSuite portfolio, tests that use machine learning to provide a personalized risk of malignancy score for patients with anaxomasses. OvaWatch was designed.

We made great progress in our effort to expand our oldest meat portfolio tests that use machine learning to provide personalized risk of malignancy score for patients with a macro masses.

Overwatch was designed to be commercially launched in.

Speaker 2: In two stages, the first stage was a point in time application for initial clinical assessment, which has now been ordered by positions 2440 times with more than 40% of those tests coming in just this last quarter.

In two stages. The first stage was a point in time application for initial clinical assessment, which has now been order by position 2440 times with more than 40% of those tests coming in just this last quarter.

Speaker 2: I'm pleased to report that we have completed a critical step towards the second stage launch of Overwatch as a longitudinal monitoring application. Our clinical study of the real-world use of Overwatch as a tool for monitoring low-risk patients has been completed, and we have submitted the resulting paper for peer review and publication. We are in the process of completing final launch activities and expect to begin offering the longitudinal monitoring test by the end of the year as planned.

I'm pleased to report that we have completed a critical step towards the second stage launch of Overwatch is a longitudinal monitoring application.

Our clinical study of the real world use of Overwatch is a tool for monitoring low risk patients has been completed and we have submitted the resulting paper for peer review and publication. We're in the process of completing final launch activities and expect to begin offering the longitudinal monitoring tests by the end of the year as planned.

Speaker 2: Looking beyond Overwatch, we are excited about adding other modalities to expand our OVC portfolio. As we recently announced, Dr. Kevin Elias, Director of the Gynecologic Oncology Laboratory at Brigham and Women's Hospital, an Assistant Professor of Obstetrics, Gynecology, and Reproductive Biology at Harvard Medical School, recently presented a poster related to an in-development microRNA-based ovarian cancer test at the American Association of Cancer Research Special Conference for Ovarian Cancer.

Looking beyond the Overwatch, we're excited about adding other modalities to expand our OSB portfolio as we recently announced Dr. Kevin Elias director of the Gynecologic oncology laboratory at Brigham and Women's Hospital.

Professor obstetrics gynecology and reproductive biology at Harvard Medical School recently presented a poster related to and in development micro RNA based ovarian cancer tests at the American Association of Cancer Research Special conference for ovarian cancer.

Speaker 2: Dr. Elias highlighted data showing microRNA's potential to improve the diagnostic accuracy of noninvasive blood tests for women with anexal masses based on his extensive ovarian cancer research. The study combined serum protein and patient clinical information from Aspire's ovarian cancer clinical studies with microRNA identified by the Elias Laboratory in collaboration with a consortium of world-renowned academic research.

Dr. Elias highlighted data showing micro Rnas potential to improve the diagnostic accuracy of noninvasive blood test for women with the Knoxville masses based on his extensive ovarian cancer research. The study combined C O M protein and patient clinical information from aspire ovarian cancer clinical studies with micro RNA identified by the <unk>.

Lives laboratory in collaboration with the consortium of World renowned academic researchers.

Among other findings the presentation concluded that the combination of micro Rnas and proteins and metadata identified 90% of early stage and a 100% of wage they late stage ovarian cancer in the study population.

This research form the basis of all the Mdx, which is expected to become part of the company's oversleep portfolio under a previously announced licensing agreement.

Speaker 2: We are currently finalizing an advisory agreement with an experienced lab to assist our team with platform migration and test validation, which we expect will significantly accelerate the development, validation, and launch of a commercial product.

We are currently finalizing an advisory agreement with an experienced lab to assist our team with platform migration and test validation, which we expect will significantly accelerate the development validation and launch of a commercial product.

Work under this agreement will begin shortly with the support and collaboration of Doctor Alliance.

Moving now to Endo check our first generation noninvasive protein based blood test to aid in the detection of endometriosis.

Speaker 2: We continue our verification and validation of the test, utilizing samples acquired from both our endo check study sites and the University of Oxford through a material transfer agreement.

We continue our verification and validation of the test utilizing samples acquired from both our Endo check study sites and the University of Oxford through a material transfer agreement.

Speaker 2: Upon validation, we will follow a similar launch strategy as was utilized for Overwatch, with a small-scale rollout to clinicians who have been involved in the development of the test to be followed by a broader commercial launch upon publication of peer-reviewed data.

Upon validation, we will follow a similar launch strategy as was utilized for overwatch well the small scale rollout to clinicians who have been involved in the development of the test to be followed by a broader commercial launch upon publication of peer reviewed data.

Speaker 2: We continue to develop endo-MDX in parallel with the protein-based endocheck test.

We continue to develop and O M D acts in parallel with a protein based endo check test and.

Speaker 2: EndoMDX, which will combine proteins and microRNA for a higher-performing test, is being developed through our sponsored research collaboration with a consortium of academic institutions led by Dana-Farber Cancer Institute. We made a second milestone payment of $125,000 in July following the delivery of a signature. We are now working closely with the collaborators to finalize the platform migration and validation strategy for a commercial test.

So mdx, which will combine proteins micro RNA for a higher performing test is being developed through our sponsored research collaboration with the consortium of academic institutions led by Dana Farber Cancer Institute.

We made a second milestone payment of $125000 in July following the delivery of his signature. We are now working closely with our collaborators to finalize the platform migration of validation strategy for a commercial path.

Speaker 2: Finally, we established a new clinical advisory board as an element of the company's overall mission to develop and commercialize high-impact diagnostic tools for gynecologic disease.

Finally, we established a new clinical advisory Board is an element of the company's overall mission to develop and commercialize high impact diagnostic tools for gynecologic disease.

Speaker 2: The Clinical Advisory Board will provide clinical input and guidance throughout the development of the company's portfolio of products and will be chaired by ASPIRA's Director of Medical Affairs, Dr. Leo Twigg.

The clinical advisory board will provide clinical and putting guidance throughout the development of the company's portfolio of products and will be chaired by Spyros director of Medical Affairs, Dr. Leal twig.

Speaker 2: Our three members include Dr. Levi Downs, Medical Director for Gynecologic Oncology with Park Nicollet Health System at Methodist Hospital, Dr. Nisha Garg, Gynecologic Surgeon with Arizona Gynecology Consultants, and Dr. Tameka See, the Founder and Owner of Advanced Women's Care Center.

Our three members include Doctor, we buy Downs medical director for Gynecologic oncology with Park Nicolette helps system.

Hospital, Dr. Nisha Guard gynecologic surgeon with Arizona, Gynecology consultants and Doctor to make us see the founder and owner of advance Women's care Center.

Speaker 2: Turning now to operational excellence, we have once again decreased cash used in operations to $3.3 million in the third quarter, representing a 56% reduction when compared to the prior year, while still showing sustained growth.

Turning now to operational excellence, we have once again decreased cash used in operations to $3 3 million in the third quarter, representing a 56% reduction when compared to the prior year, while still showing sustained growth.

Speaker 2: We strengthened our balance sheet with a recent equity raise to support our long-term strategic vision. We have a team that is determined to set a new standard of care and gynecologic health while setting an industry standard for prudent, high-impact capital deployment.

We strengthened our balance sheet with the recent equity raise to support our long term strategic vision. We have a team that is determined to set a new standard of care in gynecologic health, while setting an industry standard for prudent high impact capital deployment.

Speaker 2: Now I would like to turn the call over to Torsten for a review of our financial performance. Torsten?

Now I would like to turn the call over to Torsten for a review of our financial performance of course then.

Speaker 3: Thank you, Nicole, and good afternoon, everyone. It is my pleasure to be here today to provide you with an update on our financial performance.

Thank you Nicole and good afternoon, everyone. It is my pleasure to be here today to provide you with an update on our financial performance.

Speaker 3: Product revenue for the three months ended September 30, 2023, was $2.2 million, an increase of 9% compared to $2 million for the same period in 2022.

Product revenue for the three months ended September 32023 was $2 $2 million in it.

Increase of 9% compared to $2 million for the same period in 2022.

Speaker 3: The increase in revenue was driven by an increase in over three tests performed during the quarter, which increased 5% to 5,783 compared to 5,524 for the same period in 2022 revenue per.

The increase in revenue was driven by an increase in the oversea test prep.

During the quarter, which increased 5% to 5783 compared to 5524 for the same periods in 2022.

Revenue grew over three tests performed.

Speaker 3: For the three months ended September 30, 2023 increased 4% to $383 compared to $369 for the same period in 2022.

For the three months ended September 32023 increased 4% to $383 compared to $369.

Same periods in 2022.

Speaker 3: Total gross profit margin for the three months ended September 30, 2023 was 59% compared to 55.8% for the same period last year.

Total gross profit margin for the three months ended September 32023 was 59% compared to 55, 8% for the same period last year.

Speaker 3: Research and development expenses for the three months ended September 30, 2023, were $1 million compared to $2.2 million for the same period in 2022.

Research and development expenses for the three months ended September 32023, well $1 billion compared to $2 $2 million for the same periods in 2022.

Speaker 3: The decrease of 54% was primarily due to decreases in collaboration consulting costs.

The decrease of 54% was primarily due to decreases in collaborations consulting costs.

Speaker 3: Sales and marketing expenses for three months ended September 30, 2023 were $1.7 million compared to $4 million, a decrease of 57% versus the same period last year.

Sales and marketing expenses for the three months ended September 32023, well, one 7 million compared to $4 million a decrease of 57%.

Same period last year.

Speaker 3: The decrease was primarily due to decreased personnel cost due to our focus of eliminating unprofitable territories and improving bottom line results.

The decrease was primarily due to decreased personnel costs due to our focus off eliminating unprofitable territories and improving bottom line results.

Speaker 3: General administrative expenses for the three months ended September 30, 2023 with $2.7 million compared to $3.6 million, a decrease of 25% versus the same period last year.

General and administrative expenses for the three months ended September 32023, with $2 $7 million compared to $3 $6 million, a decrease of 25% versus the same period last year.

Speaker 3: This decrease was primarily due to a decrease in personnel expenses and outside legal costs.

This decrease was primarily due to a decrease in personnel expenses and I would say you could call it.

Speaker 3: Total cash equivalents and restricted cash as of September 30, 2023 was approximately $5.4 million.

Total cash cash equivalents and restricted cash as of September 32023.

It was approximately $5 $4 million.

Speaker 3: Cash used in operations for the three months ended September 30, 2023 was $3.3 million compared to $7.5 million in the same period of last year and $3.4 million in the second quarter of this year.

Cash used in operations for the three months ended September 32023 was $3 $3 million compared to $7 $5 million in the same period of last year and $3 4 million in the same as the second quarter of this year.

Speaker 3: Our cash balance this quarter benefited from the registered direct offering we completed in July , where we raised $4.2 million in net proceeds.

Our cash balance this quarter benefited from the registered direct offering we completed in July we raised hope and $2 million in net proceeds.

Speaker 3: The company reiterates its operating cash utilization guidance for the second half of 2023 to between $6 million and $8 million. I will now turn it back over to Nicole.

The company reiterates its operating cash utilization guidance for the second half of 2023 to between 6 million and $8 million.

I will now turn it back over to Nicole.

Nicole.

Thank you Thorsten.

Speaker 2: My goal has been to be very clear with our investors about our plan and then focus on execution to meet those goals. We've taken many important steps this quarter. While we experienced some moderate seasonal impacts in the third quarter, we grew both volume and revenue with a leaner and more efficient sales team. The submission of the Overwatch Longitudinal Monitoring Paper is a significant achievement which will expand the addressable market for our Oversuite test portfolio.

My goal has been to be very clear with our investors about our plan and then focus on execution to meet those goals.

Taken many important steps this quarter, while we experienced a moderate seasonal impacts in the third quarter. We grew both volume and revenue with a leaner and more efficient sales team. The submission of the Overwatch longitudinal monitoring paper is a significant achievement, which will expand the addressable market for oversea test portfolio exciting progress was made in the.

Speaker 2: Exciting progress was made in the development of our other near-term products including OvaMDX, EndoCheck, and EndoMDX.

Development of our other near term products, including Oba Mdx and their check and Endo mdx.

Speaker 2: In addition, we remain committed to our operational excellence goals and our spending less to achieve more as a result. We are excited to move into 2024 from a position of strength.

In addition, we remain committed to our operational excellent schools and are spending less to achieve more as a result.

We are excited to move into 'twenty 'twenty four from a position of strength.

Speaker 2: With that, I would like to now open the call for questions. Operator?

With that I would like to now open the call for questions operator.

Speaker 1: Thank you. Ladies and gentlemen, at this time we will be conducting a question and answer session.

Thank you ladies and gentlemen at this time, we will be conducting a question and answer session.

Speaker 1: If you'd like to ask a question, you may press star 1 on your telephone keypad.

If you'd like to ask you a question you May press star one on your telephone keypad.

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

Speaker 1: You may press star 2 if you would like to remove your question from the queue.

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

For participants using speaker equipment it.

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May be necessary to pick up your handset before pressing the starkey.

Our first question comes from the line of.

Speaker 1: Ben Hainer with Alliance Global Partners. Please proceed with your question.

Ben Hayner with Alliance Global Partners. Please proceed with your question.

Speaker 4: Good afternoon, guys. Thanks for taking the questions. Just first off for me, on the clinical laboratory fee schedule, Medicare reimbursement, you know, congrats on that development. Just wondering how quickly do you anticipate that will sort of diffuse out to other payers?

Good afternoon, guys. Thanks for taking the questions.

Just first off for me is on the clinical laboratory fee schedule Medicare reimbursement you know congrats on that development.

Just wondering how quickly do you anticipate that all sort of diffuse out our other payers.

Yeah.

Speaker 2: Hey, Ben. Thanks for the question. Really challenging to answer that, to be honest with you. You know, it does take some time. We are in the process of a full-scale blitz to any holdouts that we have, both with OVA-1 and with Overwatch, with an updated set of materials, including when approved, it will also include the CMS pricing decision and the crosswalk.

Hey, Ben Thanks for thanks for the question.

It really challenging to answer that to be honest with you you know it does take some time, we are in the process of a full scale blitz to any hold outs that we have both with over one and with Overwatch with an updated set of materials, including what when when.

Approved it will also include the CMI pricing.

Pricing decision and the crosswalk, but.

Speaker 2: But, you know, the process is a little difficult to predict.

But you know the processes is a little difficult to predict.

Speaker 2: I know it's a difficult question, but I thought I'd see if there are any grand insights there. I wish I could give you a more satisfying answer, but I'm sure you're not surprised that it's just a little challenging to get there with the environment the way it is.

Yeah, I know, it's a difficult question.

Thought I'd see if there are any grants.

Hello.

I wish I could give you a more satisfying answer but I'm sure you're not surprised that it's just a little challenging to get there.

No.

Speaker 4: Yeah, yeah, completely understandable. And then on, you know, the folks that were using OVA1 Plus kind of, you know, off-label, if you will, what, you know, do you think that the kind of cannibalization that's happened with Overwatch has kind of run its course now, or are folks still doing it the previous way?

Yep.

Clearly understandable and then on.

The folks that were using over one plus kind of what you do.

Off label, if you will.

Hum.

What are do you think that the kind of cannibalization that's happened with Overwatch has kind of run its course now or are folks are.

Still it's still doing the previous way.

Speaker 2: Well, I think that we're going to continue to see people choose the test that's best for each situation. For us, we don't really think about it in terms of cannibalization because, as you would imagine, we don't think about the use of OVA-1, so, you know, it's really...

Well I think that we're going to continue to see people choose the test that's best for each situation for US we consider that we don't really think about it in terms of cannibalization because as youre not as you would imagine we don't make money.

Use of over one so.

Speaker 2: it's revenue regardless, right? It's revenue we wouldn't have recognized if they were using OVA-1 off-label, even with contracted payers, we wouldn't get paid. So every test that we run for Overwatch is an improvement over the off-label use of OVA-1. However, we are seeing both tests are growing independently of one another. So, you know, I do think that we've seen

Really.

It's revenue regardless right. Its revenue we wouldn't have recognized if they were using over one off label, even with contracted payers. We didn't we wouldn't get paid so every.

Every test that we run for Overwatch is is is an improvement over the off label use of a Hawaii. However, we are seeing.

Both tests are are growing independently of one another so I do think that we've seen.

Speaker 2: We've seen probably the experimentation is behind us.

We've seen probably the experimentation is behind us.

Speaker 4: Okay, fair enough. It makes sense. And then, I think you gave the number on the Q2 call and kind of a test volume per field representative. Do you have that handy by any chance? I do.

Okay fair enough.

Makes sense and then on the I think you gave the number on the Q2 call and that kind of a test volume per field representative Joe do you have that handy by any chance.

Thank you I'm gonna.

Speaker 5: I'm gonna go pull it from Ernie's release because I believe it was in there. Oh, sorry, I must have missed that.

Go Paul I need to go pull it from our earnings release, because I believe it was important.

Oh, sorry, I misunderstood.

Speaker 2: It wasn't enough. I don't have it handy.

It wasn't enough.

I don't have it handy.

Speaker 2: I should have it handy, I apologize for that, but let me see what I can do to find it before we drop.

I should have it handy I apologize for that but let me, but I can do to find it.

Yeah.

Speaker 4: Okay, I got it. And lastly, for me, you mentioned in the press release, the revenue per test is expected to be volatile during 2023.

Okay.

Got it and then lastly for me.

And in the in the press release the revenue per test is expected to be volatile during 2023.

Speaker 4: Upside, downside, magnitude, what's the right way to kind of think of the volatile terminology there?

Yeah.

Upside downside magnitude whats the right way to kind of think of the the volatile terminology there.

Speaker 2: So, it's another challenging question to answer, because some of it depends a little bit on timing of collection, because we're kind of working on a rolling order. Torsten, anything in addition to that that you'd add?

So it's it's another challenging question to answer because some of it depends a little bit on timing of collections, because where you're kind of working out of Boeing.

Quarters towards to anything in addition to that.

Speaker 2: I mean, by by definition, volatile is challenging to predict, right? But we can see.

Anybody by definition volatile is challenging to predict rate, but we can see.

Baird.

Speaker 2: Our team has been doing a great job all year. So every dollar of revenue that's available to us, they're capturing.

The actions our team has been doing a great job all year.

So every dollar of revenue that's available to us that they're capturing.

Oh.

Speaker 6: Got it. I think that's all I had today. Thanks a lot, guys. Thanks, Ben.

Got it.

That's all I have today, thanks, a lot guys.

Thanks Ben.

As a reminder, it is star one to ask a question.

Speaker 1: Our next question comes from the line of Andrew Brackman with William Blair. Please proceed with your question.

Our next question comes from the line of Andrew Blackman with William Blair. Please proceed with your question.

Speaker 7: Hey, everyone, this is Dustin online for Andrew. Thanks for taking our questions. First on endo check. Good to hear. Yeah. Hi. How are you? On endo check. Good to hear progress going on there. Just wondering what the update timeline is for the launch. I think he said previously, the fourth quarter and then when that's launched. Just what metrics are you guys going to use to see that.

Hey, everyone. This is Dustin online for Andrew Thanks for taking our questions Firsthand Endo chart. Good day here, Yeah, Hi, how are you.

On Endo check the Deere progress going on there I'm just wondering what the updated timeline for the launch I think you said previously in the fourth quarter and then when that's launched just what metrics are you guys going to use to see that this launch you know has been successful and what kind of goals are you.

Speaker 7: this launch has been successful and what kind of goals are you laying out for yourself there?

Turning out for yourself Sir.

Speaker 2: Sure, so we're not changing any of the timeline today. Our goal has been and continues to be the launch of a test.

Sure. So we're not changing any of the timeline today. Our goal has been and continues to be the launch of a test them for commercial use by the end of the year and we're still focused on that provided we're able to fully validate the test and and have a whole lot.

Speaker 2: for commercial use by the end of the year. We're still focused on that, provided we're able to fully validate the test and have a rollout.

Speaker 2: Similar to what we did for overwatch, where we had a period of time where overwatch was primarily being offered to physicians who were familiar with the development of the technology we're planning on doing the same thing. That's really been the playbook we planned on following with a much broader commercial launch of the 1st generation test in the 1st quarter of next year.

Similar to what we did for Overwatch, where we had a period of time, where Overwatch was primarily being offered to physicians who were familiar with the development of the technology. What we're planning on doing the same thing that's really been the playbook. We plan on following with a much broader commercial launch of <unk>.

The first generation test in the first quarter of next year.

Speaker 7: And then, on OVACheck, great to see you guys got the proposed rule there with CMS.

Understood.

And then on the Oba checks are great to see you guys got the proposed rule there with CMS.

Speaker 7: How confident are you guys in that being finalized and then?

How confident are you guys and that being finalized and then.

Speaker 7: how would that actually influence the longitudinal monitoring product, if at all, in terms of

How would that actually influence the longitudinal monitoring product if at all in terms of pricing there.

Speaker 2: So, we don't expect there to be any impact on longitudinal monitoring. We believe that the test will be reimbursed at the same level. The likelihood that the crosswalk that was preliminarily approved becomes final, I would rate it at high. However, you know, CMS ultimately holds the pen. The comment period is behind us. We submitted a comment.

So we don't expect there to be any impact on longitudinal monitoring we believe that the test will be reimbursed at the same level.

The likelihood that the test Oh that the crosswalk that was preliminarily approved.

Becomes final I would rate it at high However, you know CMI ultimately has the hold the pen the comment period is behind US we submitted a comment we were very very confident in the case that we put forward for the crosswalk I mean, there's there's.

Speaker 2: You know we were very very confident in the case that we put forward for the crosswalk. I mean, there's there's Almost every factor that they look at for a crosswalk request was in our favor In terms of you know the process the platform the analyze if you name it So you know the case was as strong as it could possibly be You know we did submit a comment letter and that the final is expected in the next several weeks

Almost every factor that they look at for a crosswalk request what are in our favor in terms of you know the process. The platform. The analyzed you name. It. So you know the the case was as strong as it could possibly be we did submit a comment letter and that the final is expected in the.

Next several weeks.

Speaker 7: Understood. Thank you. And then maybe looking out to 2024, just any high-level thoughts on volumes and ASP growth. I know you're going to have a couple new tests launching at different price points, but anything high-level you can give us there and how that compares to the third quarter results.

Understood. Thank you and then maybe looking out to 'twenty four just any high level thoughts on.

Volumes in E. S. P growth I know you are going to have a couple of new test launching.

At different price points, but.

Hi.

Give us there and how that compares to the third quarter results.

Speaker 7: We're not really in a position to give any 2024 guidance at this point, Dustin, but thanks for trying. Yep. Thought I'd give it a shot.

Yeah, we're not really in a position to give any 2020 for guidance at this point duct and but.

Yeah.

Thanks for trying.

[laughter] Yep sounds like given the shock.

And yeah, just one more spending.

Speaker 7: out spending and burn any color on how you guys are thinking about runway.

Spending in burn any color on how you guys are thinking about runway and.

Speaker 7: Obviously, a lot has been done across the organization to help extend that, but just how are you thinking about that? Thank you.

Obviously, a lot has been done across the organization to help extend that but just how are you. How are you thinking about that thank you.

Speaker 3: Yeah, this is Torsten. So in terms of runway, we have reiterated our cash guidance, cash burn guidance.

Yes.

This is torsten so in terms of runway we have.

Alright did our cash guidance cash burn guidance.

Speaker 3: to use cash in operations in the second half of this year to be between 6 and 8 million US dollars.

To use cash in operations some into the second half of this year to be between six and $8 million. We have cash in the bank as of September 30 off a total of $5 4 million that includes cash and restricted cash.

Speaker 3: We have cash in the bank as of September 30 of a total of 5.4 million that includes cash and restricted cash.

Speaker 3: And our cash burn for the third quarter was $3.3 million after $3.4 million in the second quarter and $5.7 million in the first quarter.

And our cash burn for the third quarter was $3 3 million up to $3 4 million in the second quarter and $5 $7 million in the first quarter.

Speaker 3: So, what you can see is that we continue to be very focused on controlling more cash burn, bringing that further down going forward on a quarter-to-quarter basis. And as any other biotech company, definitely public biotech company, we're constantly looking into dilutive and non-dilutive ways of funding mechanisms to fund the company going forward.

So what you can see us there'll be continued to be very focused on controlling more cash burden, bringing me back for the down going forward.

On a quarter to quarter basis, and if there's any other biotech company definitely public biotech companies, we're constantly looking into dilutive and non dilutive.

Ways of funding funding mechanisms to to fund the company going forward, we do have as a reminder.

Speaker 3: We do have, as a reminder, a two ATM or equity line of credit.

To ATM or equity line of credit one is with Cantor and the other one is with Lincoln Park.

Speaker 3: One is with Cantor and the other one is with Lincoln Park that are available to us. And while these are not true funding instruments, they definitely help the company on high trading volume days to draw certain dollars from that very line. So it's a safety net that we have and we continue to look into various ways to continue to fund the company going forward.

Billable to us that while these are not true funding instruments.

It definitely helped the company on high trading volume days too.

Draw certain dollars from that very long. So it's a safety net that we have and we continue to look into there is ways to continue to fund the company going forward.

Okay, Great appreciate that that's it from us thank you.

Thank you.

Speaker 1: There are no further questions in the queue. I'd like to hand the call back to Nicole Sanford for closing remarks.

There are no further questions in the queue I'd like to hand, the call back to Nicole Sanford for closing remarks.

Speaker 1: Thank you, Doug. And thank you to all of our participants for joining today. I wish all of you a wonderful Thanksgiving holiday and look forward to connecting again in the new year. Thank you. Ladies and gentlemen, this does conclude today's teleconference.

Thank you Doug and thank you to all of our participants for joining today I wish all of you a wonderful Thanksgiving holiday and look forward to connecting again in the new year. Thank you.

Sure.

Ladies and gentlemen, this does conclude today's teleconference. Thank you for your participation you may disconnect. Your lines at this time and have a wonderful day.