Q3 2021 CorMedix Inc Earnings Call

[music].

Good afternoon, and welcome to the core metrics third quarter earnings Conference call.

Today's conference call is being recorded.

There will be a question and answer session at the end of today's presentation and instructions on how to ask a question will be given at that time.

At this time I would like to turn the conference call over to Daniel Ferry from lifestyle Advisors. Please go ahead.

Good afternoon, and welcome to the <unk> third quarter 2021 earnings Conference call.

Leading the call today is Dr. Matt David Interim Chief Executive Officer, and Executive Vice President and Chief Financial Officer of <unk>.

He is joined by Dr. Phoebe mounts executive Vice President and General Counsel.

Before we begin I would like to remind everyone that during the call management may make what are known as forward looking statements within the meaning set forth in the private Securities Litigation Reform Act of 1995.

These statements are subject to certain risks and uncertainties.

And include but are not limited to any of the following.

Any statements other than statements of historical fact.

Guarding managements expectations beliefs goals and plans about the company's prospects, including its clinical development program manufacturing activities and marketing approval of defense cost in the U S and other product candidates.

<unk> financial position.

Future revenues and projected costs.

And potential market acceptance of the Sun cats, Neutrolin and other product other product candidates.

More specifically forward looking statements include any statements about our clinical development plans.

And the submission and timing.

Cost progress results estimates and interpretations thereof.

Projections as to the company's future capital, raising and spending and cash position.

Expectations as to the timing and nature of anticipated regulatory actions.

Hospital product licensing business development or other transactions.

Any commercial plans and expectations.

Projections for our product candidates and expectations as to manufacturing and product component costs.

Actual results may differ materially from these projections or estimates due to a variety of important factors, including but not limited to uncertainties related to clinical development.

Regulatory approvals and commercialization.

These risks are described in greater detail in <unk> filings with the SEC copies of which are available free of charge at the SEC's website at www Dot FCC dot gov or upon request from <unk>.

<unk> may not actually achieve the goals or plans described in these forward looking statements and investors should not place undue reliance on these statements.

Please note that <unk> does not intend to update these forward looking statements except as required by law.

At this time it is now my pleasure to turn the call over to Dr. David <unk> interim Chief Executive Officer of <unk>, Matt. Please go ahead.

Good afternoon, everyone and thank you for joining us on this call today marks the first earnings call since Phoebe and I have taken on additional roles within the company as we announced on October 4th well. It has been an incredibly busy months. We are pleased to be here. This afternoon to discuss <unk> updates as well as reflect on.

And our priorities as a company over the coming months on today's earnings call. We will discuss the third quarter 2021 financial information and the overall progress <unk> is making in bringing defend cap to the U S market for its first indication for use as a catheter lock solution for hemodialysis patients to reduce.

Catheter related bloodstream infections.

Let's begin with the topics for discussion today.

In September we announced that <unk> had encountered delays and its third party contract manufacturer or CMO and we were informed by the CMO that there were issues that are unrelated to defend caf manufacturing activities. We also indicated that the timeline for <unk> and the CMO to address deficiencies at the <unk>.

<unk> that are required for resubmission of the defend cap NDA became uncertain.

The defense team, including a group of specialized consultants has continued to work closely with our CMO and we are pleased to share with you that we are making progress on this front VB will provide information on our progress here since the last update.

Also we are balancing our preparations for launching defend cath, while limiting our cash burn so that financially we have the resources required to efficiently bring defend cats the patients in the U S market. When FDA approval is received I will provide an update on our third quarter 2021 financials.

And provide color regarding the strength of <unk> balance sheet.

A couple of weeks ago in October we shared some abstracts that the <unk> team has now presented at two recent conferences Association of managed care Pharmacy, and American Society of Nephrology.

Analysis is described in these abstracts and the epidemiologic data that stem from this work are incredibly important as they underscore the purpose of the work we're doing here at <unk>.

I will provide some additional color on these items and how we plan to use these data as we prepare to bring defend cap to patients in hemodialysis community, who are at risk for life threatening catheter related bloodstream infections.

Now, let's move to the first topic, Phoebe will provide the regulatory and manufacturing update phebe.

Thank you, Matt and good afternoon, everyone.

I am pleased to report that Hermetic and a third party contract manufacturer have been able to resume work on validation of the <unk> manufacturing process.

As noted by Matt and as we disclosed in early September.

There was a delay as a result of issues that CMO that were unrelated to the manufacturer defend Ken.

We've been able to resume manufacturing activities and are continuing to complete the work that is required to address the deficiencies identified by the FDA.

Specifically, we have discussed previously that FDA had identified deficiencies involving activities associated with the vial filling lines for <unk>.

At the CMO in particular, the targets filling up volume.

After analyzing available data parameters of the filling operation were adjusted and we determined that qualification of the filling operation was required.

It will require some time to complete testing and preparation of documentation to resubmit the manufacturing module of the new drug application or NDA or defend Kent.

Until we have completed all of the testing, we will not be able to give specific guidance regarding the timing of resubmission.

As a reminder, core medical has not denounce to resubmit any information relating to the clinical data from the lock It 100 study.

I can assure you that we will continue working diligently to resubmit the defend cat M B a.

As we have stated previously we are committed to providing updates over the coming months and we will provide an update on resubmission when we have clarity on the timeline.

We have been extremely fortunate to have well qualified and experienced consultants.

Also had been working with us to ensure the CMC module to be resubmitted by Chromatics will meet fda's regulatory requirements.

<unk> the NDA requires sufficient data and documentation to demonstrate to FDA that the manufacturing facility is ready to support commercial operation for defense.

As we have explained SBA informed core medical and the CMO.

That resolution of all six of the deficiencies that the manufacturing facility identified by FDA in the post application action letter sent to the CMO will be required for resubmission of the NDA.

Corrective actions to address the deficiencies that the manufacturing facility will be submitted to FDA by the CMO.

<unk> also informed us that corrective actions may be there by doing an on site evaluation.

The manufacturing facility subsequent to Resubmission of the NDA.

Well our goal is to resubmit submission sufficient data and documentation to convince FDA that the manufacturing facility is ready to support commercial operation for defense cap without the need for an inspection.

We intend for the CMO to be prepared for it in person or remote interactive evaluation by FDA.

We are hopeful that FDA will work quickly to review and approve the N D. A.

<unk> was a recognition by FDA of the potential for defend cat to address an unmet medical need in reducing life threatening catheter related bloodstream infections.

Thank you and I will now turn the call back to Matt.

Cover financial results cash guidance and a recent industry conference activity Matt.

Thanks, David.

Next I'll provide an overview of our third quarter 2021 financial results as well as an update on <unk> cash position.

The company has filed its report on Form 10-Q for the third quarter ended September 32021, I urge you to read the information contained in the report for a more complete discussion of our financial results.

With respect to our third quarter of 2021 financial results. The company has cash and equivalents of 72 million as of September 32021.

Our net loss was approximately $8 6 million or <unk> 22 per share compared with a net loss of $6 6 million or <unk> 22 per share in the third quarter of 2020, the higher net loss recognized in 2021 compared with 2020 included increased R&D costs associated with our man.

Are you factoring efforts as well as increased personnel expenses and increased noncash charges for stock based compensation, we recorded an increase in SG&A and an increase in R&D expenses.

Operating expenses in the third quarter of 2021 increased approximately 30% to $8 6 million compared with $6 6 million in the third quarter of 2020.

R&D expense increased by approximately 62% to $4 7 million driven primarily by an increase in costs related to the manufacturing of <unk> prior to its potential marketing approval.

And to a lesser extent by an increase in personnel expenses and an increase in noncash charges for stock based compensation.

SG&A expense increased approximately 4% to $3 8 million compared with $3 7 million in the third quarter of 2020.

Unknown Executive: 3.7 million in the third quarter of 2020. This increase was driven by an increase in non-cash charges for stock-based compensation and an increase in personnel expenses as a result of additional hires, partially offset by a decrease in cost related to market research studies in preparation for the potential marketing approval of the FEMCAS and a decrease in consulting fees. With respect to our year-to-date 2021 financial results, total operating expenses during the nine months of 2021 amounted to 21.7 million compared with 21.2 million in the first nine months of 2020, an increase of 2%.

This increase was driven by an increase in noncash charges for stock based compensation and an increase in personnel expenses as a result of additional hires partially offset by a decrease in costs related to market research studies in preparation for the potential marketing approval defense cost and a decrease in consulting fees.

With respect to our year to date 2021 financial results.

Total operating expenses during the nine months of 2021 amounted to $21 7 million compared with $21 2 million in the first nine months of 2020, an increase of 2%.

Unknown Executive: R&D expense declined 11% to 9.9 million, driven primarily by a net decrease in costs related to the manufacturing of the FENCAS prior to its potential marketing approval. SG&A expense increased approximately 17% compared with the first nine months of 2020 as a result of higher non-cash charges for stock-based compensation and higher personnel expenses.

R&D expense declined 11% to <unk>.

$9 9 million driven primarily by a net decrease in costs related to the manufacturing of defend cats prior to its potential marketing approval.

SG&A expense increased approximately 17% compared with the first nine months of 2020 as a result of higher non cash charges for stock based compensation and higher personnel expenses.

Unknown Executive: We recorded net cash used in operations during the first nine months of 2021 of $15.3 million, compared with net cash used in operations of $16 million in the nine months of 2020. The difference was primarily driven by an increase in accrued expenses compared to a larger decrease for the same period in 2020, partially offset by an increase in net loss, mainly attributable to lower cash received from the NOL sale in the nine months of 2021 compared to the same period in 2020.

We recorded net cash used in operations during the first nine months of 2021 of $15 3 million compared with net cash used in operations of $16 million in the nine months of 2020.

The difference was primarily driven by an increase in accrued expenses compared to a larger decrease for the same period in 2020, partially offset by an increase in net loss mainly attributable to lower cash received from the NOL sale in the nine months of 2021 versus the same period in 2020.

Okay.

Unknown Executive: Cormetics remains in a strong position from a balance sheet perspective. We believe our cash and equivalence of $72 million gives the company flexibility to fund its operations at least through 2022 after taking into consideration the costs of resubmission of the DefendCath NDA and initial preparations for the commercial launch of DefendC. We remain optimistic about our continued progress toward the goal of resubmission of the NDA to the FDA. As highlighted previously, we believe that our current cash and equivalents, as well as the potential mechanisms available to us for capital raising, allow us to be prepared for the future.

<unk> remains in a strong position from a balance sheet perspective, we believe our cash and equivalents of $72 million gives the company flexibility to fund its operations at least through 2022 after taking into consideration the costs for Resubmission of the <unk> NDA and initial preparations for the commercial launch for defend cap.

We remain optimistic about our continued progress towards the goal of Resubmission of the NDA to the FDA.

As highlighted previously we believe that our current cash and equivalents as well as the potential mechanisms available to us for capital raising allow us to be prepared for the future. Given we are approaching what we hope and believe will be a pivotal year ahead for <unk> as we seek to bring defend cap to patients in the hemodialysis study.

Unknown Executive: Given we are approaching what we hope and believe will be a pivotal year ahead for Cormetics, as we seek to bring the FENCAP to patients in the hemodialysis setting. As a third topic today, I would like to highlight our efforts to expand our understanding of catheter-related bloodstream infections or CRBSIs in the hemadialysis setting. We announced in October that Cormetics had three abstracts accepted for presentation at two industry conferences.

Yeah.

Yeah.

As the third topic today I would like to highlight our efforts to expand our understanding of catheter related bloodstream infections or <unk> in the hemodialysis setting.

We announced in October that <unk> had three abstracts accepted for presentation at two industry conferences.

Unknown Executive: These include one abstract presented in October at the Association of Managed Care Pharmacy's Nexus Conference and two abstracts presented last week at the American Society of Nephrology. The presentations highlight retrospective analyses that were conducted integrating multiple clinical and claims databases that CMS and dialysis organizations use to track patient care and quality metrics in end-stage renal disease or ESRD patients. The conclusions from these retrospective studies underscore the significant incidence of and mortality related to CRBSIs and economic costs related to these infections.

These include one abstract presented in October at the Association of managed care Pharmacy next conference and two abstracts presented last week at the American Society of Nephrology Conference the.

The presentation.

Light retrospective analyses that were conducted integrating multiple clinical and claims databases that CMS and dialysis organizations use to track patient care and quality metrics.

Stage renal disease or <unk> patients.

The conclusions from these retrospective studies underscore the significant incidents and mortality related to <unk> and economic costs related to these infections. These.

Unknown Executive: These findings are especially important since approximately 80% of patients undergoing hemodialysis start with a central venous catheter or CBC as their first vascular access. Key findings include approximately 29% of the 56,000 hemodialysis patients in the cohort had an occurrence of CRBSI post-C insertion. Additionally, over 54% of the first CRBSIs occurred within three months following CVC insertion. Approximately 17% of these patients died within 30 days, and 30% died within three months of the CRBSI event. Not only are these infections common, but they are also associated with significant mortality.

These findings are especially important since approximately 80% of patients undergoing hemodialysis start with a central venous catheter or CVC has their first SaaS dealer access.

Key findings include approximately 29% of the 56000 hemodialysis patients in the cohort how did occurrence of CRB Si post CVC insertion over 54% of the FERC RBS is occurred within three months following CVC insertion.

Yeah.

Approximately 17% of these patients died within 30 days and 30% died within three months of the CRB Psi event not only are these infections common but they are also associated with significant mortality.

Unknown Executive: CRBSIs lead to more hospital admissions, longer stays, and a more complicated clinical trial. There is significantly higher incremental risk for CRBSI patients of dysrhymia, endocarditis, heart failure, myocardial infarction, and stroke. Analysis estimates $2.3 billion in direct costs from CBC CRBSIs annually.

<unk> lead to more hospital admission longer stays and a more complicated clinical course.

There is significantly higher incremental risk in <unk> patients of Dysrhythmias endocarditis heart failure myocardial infarction stroke.

Analysis estimates $2 3 billion indirect cost from CVC <unk> annually.

Unknown Executive: The feedback from clinicians caring for hemadialysis patients has been incredibly supportive, as they see firsthand the challenges and complications stemming from CRBSIs in this patient population. As there have been minimal comprehensive data available regarding the incidence and associated mortality of CRBSIs among CBC haemodialysis patients in the U.S., we are incredibly proud of the work that our team has been doing to elucidate the magnitude of CRBSI as a significant burden to patients, providers, and payers alike.

The feedback from clinicians carrying for hemodialysis patients has been incredibly supportive as they see firsthand the challenges and complications stemming from <unk> in this patient population.

As there had been minimal comprehensive data available regarding the incidents and associated mortality of CRB size among CVC hemodialysis patients in the U S. We are incredibly proud of the work that our team has been doing to elucidate the magnitude of CRB Psi as a significant burden to patients providers.

And payers alike.

Okay.

Unknown Executive: As we continue to prepare to bring Fenncast to patients in the U.S. following its approval, we will seek to leverage these data and similar work to inform our messaging as we speak with hemodialysis providers and payers, including CMS, across the continuum of care. Although we have encountered unexpected delays in our pathway to bring the FNCAT to market, the Cormetics team remains steadfast in our commitment to these patients who are in need of alternatives that can reduce the RBSIs that contribute to such a significant level of morbidity and mortality.

As we continue to prepare to bring defend catheter patients in the U S. Following its approval we will seek to leverage these data and similar work to inform our messaging as we speak with hemodialysis providers and payers, including CMS across the continuum of care.

Although we have encountered unexpected delays in our pathway to bring defend catheter market, but chromatics team remains steadfast in our commitment to these patients who are in need of alternatives that can reduce <unk> that contribute to such a significant level of morbidity and mortality.

To summarize what Phoebe and I have discussed today, we continue to focus our efforts on the following.

First we intend to expeditiously resolve the third party manufacturing deficiencies, so that the defense Cath NDA can be resubmitted as soon as possible.

Unknown Executive: To summarize what Phoebe and I discussed today, we continue to focus our efforts on the following. First, we intend to expeditiously resolve the third-party manufacturing deficiencies so that the DefendCath NDA can be resubmitted as soon as possible. In addition, we are carefully balancing our cash burn while preparing for the commercial introduction of DefendCath once we have approval of the NDA by FDA. Additionally, we are continuing to plan to broaden the opportunity for FEMCath following its approval and continuing to expand our understanding of opportunities such as hemodialysis across a variety of settings, TPN, and oncology.

In addition, we are carefully balancing our cash burn while preparing for the commercial introduction of defend cap. Once we have approval of the NDA by FDA.

Also we are continuing to plan to broaden the opportunity for defense calf following its approval and continuing to expand our understanding of opportunities such as hemodialysis across a variety of settings TPN oncology.

Finally, we continue to aim to maximize the value of our <unk> technology in areas, where it may benefit patients.

In conclusion, we remain confident that we have a strong team and appropriate resources in place to resolve the third party manufacturing deficiencies that had been identified by the FDA and bring defend cath to hemodialysis patients in the U S. We will continue to provide updates throughout this process.

Unknown Executive: Finally, we continue to aim to maximize the value of our Therolodein technology in areas where it may benefit patients. In conclusion, we remain confident that we have a strong team and appropriate resources in place to resolve the third-party manufacturing deficiencies that have been identified by the FDA and bring FENCAST to hemadialysis patients in the U.S. We will continue to provide updates throughout this process. Thank you for your continued support of an interest in Cormat. Operator, please open the call for questions. Thank you. At this time, we'll be conducting a question and answer session.

Thank you for your continued support of and interest in <unk>.

Operator, please open the call for questions.

Thank you at this time, we'll be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You May press star two if you'd like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset.

Before pressing the star keys, one moment, please while we pull for questions.

Our first question comes from the line of Jason Butler with JMP Securities. Please proceed with your question.

Hi, Thanks for taking my questions and congrats on the progress and I appreciate the updates I guess first question.

Operator: Thank you. At this time, we'll be conducting a question and answer session. If you'd like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

As you mentioned that you first announced the <unk>.

CMO delay back in September.

Should we read into that as essentially a two month delay and the work that you had to either complete or are there. Other factors that we should think about and then I know I've asked you guys. This question before but I just.

I think it's important to keep addressing.

Full alignment with the CMO on the work that needs to be completed and how it.

How that work needs to be done to be to address the <unk> items.

This is cindy thanks for the question Jason.

Operator: One moment, please, while we poll for questions. Our first question comes from the line of Jason Butler with JMP Securities. Please proceed with your question. Hi, thanks.

The delay them over the past couple of months getting.

Affect us in terms of our product, but it did affect our facility.

And so it was not possible for us to continue our manufacturing activities. However, though is obviously other work that was ongoing to address some of the other aspects of that.

Jason Nicholas Butler: Hi, thanks for taking the questions, and congrats on the progress and appreciate the updates. I guess the first question, as you mentioned, was that you first announced the CMO's delay back in September. Should we read into that as essentially a two-month delay in the work that you had to complete, or are there other factors that we should think about? And then, I know I've asked you guys this question before, but I think it's important to keep asking, are you still in full alignment with the CMO on the work that needs to be completed and how that work needs to be done to address the CRL items?

And we were continuing to work.

Unfortunately, it was the specific manufacturing activities that were delayed and so the good news now is is that the manufacturing has resumed.

So we're in the process of doing the testing from those batches to make sure that they meet specifications and that we have in fact, a validated manufacturing process.

And yes, we remain in full alignment with the CMO.

Phoebe Mounts: This is Phoebe, yeah, thanks for the questions, Jason. Um, the lay, um, over the past couple of months hasn't affected us in terms of our product, but it did affect the facility. And so it was not possible for us to continue our DefendCath manufacturing activities. However, there was obviously other work that was ongoing to address some of the other aspects of the deficiencies. So we were continuing to work, but unfortunately, it was the specific manufacturing activities that were delayed.

Both entities are working very hard.

The team is very dedicated and conscientious and working with us and addressing the issues.

So we're cautiously optimistic.

We will soon have all of the information that we need to resubmit, the NDA and respond to FDA.

Great and then just one more for me.

The data you presented recently in terms of the <unk>.

Economic and health burden.

All of infections in patients with catheters, you mentioned, Matt that you got positive feedback from physicians have you already shared this data with payers or had any feedback.

Phoebe Mounts: And so the good news now is that the manufacturing has resumed, and so we're in the process of doing the testing on those batches to make sure that they meet specifications and that we have, in fact, validated the manufacturing process. And yes, we remain in full alignment with the CMO. Both entities are working very hard. The CMO's team is very dedicated and conscientious about working with us and addressing the issues. So we're cautiously optimistic that we will soon have all of the information that we need to resubmit the NDO in response to FDA.

On this data with payers or dialysis providers.

Yeah, I think we're not prepared to give specifics on that front, but as we have mentioned before Jason.

Our company is in continuous dialogue with folks across across the spectrum of the industry right.

<unk> providers Payors and alike.

As part of the work we're doing to make sure that we're prepared.

For our launch of deferred costs once it's approved.

Okay, great. Thanks, a lot guys. Congrats again on the progress.

Thank you Jason Thanks, Jay.

Unknown Executive: Great, and then just one more for me. The data you presented recently in terms of the economic and health burden of infections in patients with catheters, you mentioned, Matt, that you got positive feedback from physicians. Have you already shared this data with payers or had any feedback on this data from payers or dialysis providers?

Our next question comes from Joon Lee with Truest Securities. Please proceed with your question.

Good evening. This is less on for June. Thank you for taking my questions.

Regarding the resumption of.

Factoring and it seems like you've resolved the vial filling deficiency.

What is the qualification process on that consist of and how long in your opinion has that typically.

Unknown Executive: Yeah, I think we're not prepared to give specifics on that front, but as we have mentioned before, Jason, the company is in continuous dialogue with, you know, folks across the spectrum of the industry, right? KOLs, providers, payers, and the like.

<unk>.

Has FDA spending guidelines.

In this regard.

Also do you plan for the new batches manufactured to be re inspected prior to distributions.

Okay.

Hi.

What I should clarify for you is that thank you Ross for the question the vial filling activity yes.

Unknown Executive: So as part of the work we're doing to make sure that we're prepared, you know, for a launch of Defendcast once it's approved. Okay, great. Thanks, again, and congratulations.

We are currently undertaking involves manufacturing of defend count.

During that process is that we are doing the testing that FDA requires to demonstrate that the processes. In fact qualifying so its a validation process. That's ongoing that actually requires the manufacturing activity, which is why when there was a delay.

Unknown Executive: Okay, great. Thanks again and congrats again on the progress.

I mean, we have a problem in doing the manufacturing. So now that the manufacturing has resumed we can continue generating the data.

Operator: Our next question comes from June Lee with the truest security. Please proceed with your question.

Leszek Sulewski: Good evening. This is Les on for June.

And the documentation that we need to submit to FDA.

Unknown Executive: Thank you for taking my questions. Just regarding the resumption of manufacturing, and seems like you resolved the vial filling deficiency, what is the qualification process for that consists of and how long, in your opinion, has that typically taken? Has FDA said any guidelines in this regard? Also, and do you plan for the new batches? They are manufactured to be re-inspected prior to distribution?

And the new batches are part of that process. So obviously, we're manufacturing batches as we go and analyzing batches to collect the data in general.

Unknown Executive: What I should clarify for you is that, thank you for the questions, the vial filling activities that we're currently undertaking involve manufacturing DefendCath, and it's during that process that we are doing the testing that FDA requires to demonstrate that the process is, in fact, qualified. So it's a validation process that's ongoing that actually requires manufacturing activities, which is why when there was a delay, we had a problem with doing the manufacturing.

Unknown Executive: So now that the manufacturing has resumed, we can continue generating the data and the documentation that we need to submit to FDA. And the new basses are part of that process. So obviously, we're manufacturing batches as we go and analyzing those batches to collect the data and generate documentation.

It is a great question and I appreciate their right to look at it definitely it definitely feeds into it as you can imagine [laughter] part of what was presented talks about you know the real cost of these on a big picture basis, you know and and just how common and how significant the the mortality and morbidity is related this infection. So it absolutely.

Unknown Executive: Got it, that is helpful. And then lastly, have the delays and respect for the NBA submission.

Unknown Executive: Has that impacted your progress with Paii and the reverseness strategy, and can we kind of provide more details there? Matt, thank you. Yeah, no. I think I appreciate the question. I think the short answer is no.

Feeds into it we've always said in the past that are priced discussions that will stem from the formal economics. The costs that are going to be saved to the system from use of defend cats, but beyond that we're not prepared to talk about pricing until we're closer to the approval.

Unknown Executive: Look, we've had delays that have been unexpected, as you all know, but we've continued forward. Part of that is elucidated, and we wanted to highlight today for everyone the abstracts and what the commercial team is doing and how they're using that to really help prepare the market for once we get on the other side of the approval. Great, that's helpful. Maybe I can squeeze one more in regards to the abstract presentations you just presented.

Thank you.

Our next question comes from the line of a row hit basin with Needham and company. Please proceed with your question.

Hi. This is wrote it on for search Thanks for taking my question just in regards to across the board heparin pricing increases have have there been any you know talks of any shortages or any issues in terms of a supply chain issues, where you could you see the possibly being an issue done the line.

Unknown Executive: How has the newly presented pharma economic data steered your pricing strategy forward? Just kind of your outlook on that. Thank you.

None none that I'm aware of maybe do you have anything to add to that.

Yes, actually we have the experienced in the past as you're probably aware and and the Genesis for your question. There have been shortages of heparin for various reasons until we have been very conscientious of making sure that we have adequate inventory to go forward with her activity.

Unknown Executive: Well, no, it's a great question, and I appreciate that read. Look, it definitely feeds into it, as you can imagine. Part of what was presented talks about, you know, the real cost of these infections on a big picture basis and just how common and how significant the mortality and morbidity are related to this infection.

So that has been an area of concern in the past and we've learned our lessons and we're making sure that we're covered.

Unknown Executive: So it absolutely feeds into it. We've always said in the past that our price discussions will stem from the formal economics, the costs that are going to be saved to the system from the use of FENCAP. But beyond that, we're not prepared to talk about pricing until we're closer to approval.

Great. Thank you.

Ladies and gentlemen at this time there are no further audio questions I'd like to turn the call over to Dan fairy for pre submitted written questions.

[noise] thanks, operator.

Okay. Our first question is cormedix referred to Specialised consultants and a recent press release.

Operator: Our next question comes from the line of Rohit Basin with Needham and Company. Please proceed with your question.

Can you elaborate on this and discuss how they are assisting the company with the Resubmission process.

Rohit Bhasin: Hi, this is Rohit from search. Thanks for taking my question. Just in regards to the across the board Heparin pricing increases, have there been any talks of any shortages or any issues in terms of supply chain issues where you see

Thank you could I question I think it's a good question obviously, we have.

Chromatic specialist, but because of the importance of these activities and you need to have everything done as quickly as possible. We have engaged the team of external consultants to provide additional expertise on F. D. A the expectations for addressing the specific deficiencies at the name.

Unknown Executive: None that I'm aware of. B., do you have anything to add to that? Yes, actually we do.

Unknown Executive: Yes, actually, we have experienced in the past, as you're probably aware, in the genesis of your question, shortages of heparin for various reasons. And so we have been very conscientious of making sure that we have adequate inventory to go forward with our activity. So that has been an area of concern in the past, and we've learned our lessons, and we're making sure that we're covered.

Factoring facility.

And two assistant preparations for a preapproval inspections. So we wanted to make sure that we had adequate resources and sufficient knowledge of what afternoon would be looking for to make sure that we were being comprehensive incomplete and all of our activities.

Operator: Ladies and gentlemen, at this time, there are no further audio questions. I'd like to turn the call over to Dan Ferry for pre-submitted written questions.

[noise]. Okay. Thank you Phoebe has the company focused on securing an additional CMO.

Yes, as we have discussed in the past Cormedix continues to pursue the identification of additional mean factoring capacity in the United States, we're continuing that process and we intend to announce detail when we have finalized contracts in hand.

Daniel Ferry: Okay, our first question is, CoreMedics referred to specialized consultants in a recent press release. Can you elaborate on this and discuss how they are assisting the company with the resubmission process?

Unknown Executive: Thanks for that question. I think it's a good question.

Okay. Thank you.

The next question is what is Cormedix plan regarding other potential indications for a defined calf.

Unknown Executive: Obviously, we have a chromatic specialist, but because of the importance of these activities and the need to have everything done as quickly as possible, we have engaged a team of external consultants to provide additional expertise on FDA's expectations for addressing the specific deficiencies at the manufacturing facility and to assist in preparations for a pre-approval inspection. We wanted to make sure that we had adequate resources. and sufficient knowledge of what FDA will be looking for to make sure that we are being comprehensive and complete in all of our activities.

You know for example, pediatrics T P N.

Maybe oncology.

No no problem fixed up the company remains interested as I think I alluded to pursuing additional indications for defend cap and potential uses for our quality and technology. We've got in the past that we would aim to pursue a clinical trial program on a post approval basis with an emphasis on safety.

Okay, great. Thanks for that.

The next question is our our commercial launch activities contemplated and your current cash guidance.

Unknown Executive: Okay, thank you, Phoebe. Has the company focused on securing an additional CMO?

Yeah, I'll take that one as well as we've described cash guidance includes spending for the initial stages of Orange.

Unknown Executive: Yes, as we have discussed in the past, Cormetics continues to pursue the identification of additional manufacturing capacity in the United States. We are continuing that process, and we intend to announce details when we have finalized contracts in hand.

Okay, great have there been any changes to head count at Cormedix.

Thanks, Thanks for that one too then.

Among the areas, where we have been focused making sure that we have stability among our highly experienced team Ah Cormedix and also making sure we have the relevant talent to keep things moving forward with defend Cat. In addition to seeing no significant changes in head count. We're also seeing interest from highly experienced prefer.

Unknown Executive: Next question is, what is CoreMedics' plan regarding other potential indications for DefendCast? You know, for example, pediatrics, TPN, maybe in college.

Unknown Executive: No problem, thanks, Dan. The company remains interested, as I think I alluded to, in pursuing additional indications for DefendCath and potential uses for our trolleadine technology. We have said in the past that we would aim to pursue a clinical trial program on a post-approval basis with an emphasis on safety.

Nationals, who seek to join the Cormedix team.

Okay great.

And last question here can you comment on the pending litigation.

Oh, well, we cannot comment on pending litigation I can assure you that cormedix intends to vigorously contest to clean.

Thank you.

Okay great.

Matt I'd like to pass the the call back to you for closing remarks.

Unknown Executive: Okay, great. Thanks, Matt. The next question is, are commercial launch activities contemplated in your current cash guidance?

Thanks, Dan.

And Thanksgiving.

<unk> has an experienced team of professionals, who have taken pharmaceuticals through the various phases of clinical studies registered and successfully launched products in the U S market.

Unknown Executive: Yes, I'll take that one as well. As we have described, cash guidance includes spending for the initial stages of the loan.

<unk> remains committed to bringing defend cats to the U S market to help patients in need of protection from life threatening infections, the importance of reducing the incidence of infections and keeping patients out of the hospital is even more apparent during the ongoing COVID-19 pandemic.

Unknown Executive: Okay, great. Have there been any changes to the head count at CoreMedic?

Unknown Executive: Thanks for that one too, Dan. Among the areas where we have been focused, making sure that we have stability among our highly experienced team at Cormetics and also making sure we have the relevant talent to keep things moving forward with DefendCath. In addition to seeing no significant changes in headcount, we are also seeing interest from highly experienced professionals who seek to join the Cormetics team.

Thank you for your time and attention and have a good evening.

Ladies and gentlemen. This concludes today's conference you may disconnect. Your lines at this time. Thank you all for your participation.

[music].

Unknown Executive: And last question here: can you comment on the pending litigation?

Unknown Executive: While we cannot comment on pending litigation, I can assure you that Core Medicine tends to vigorously contest claims. Thank you.

Unknown Executive: Matt, I'd like to pass the call back to you for your closing remarks.

Unknown Executive: Cormetics has an experienced team of professionals who have taken pharmaceuticals through the various phases of clinical studies, registered, and successfully launched products in the U.S. market. Cormetics remains committed to bringing Fentcalf to the U.S. market to help patients in need of protection from life-threatening infections. The importance of reducing the incidence of infections and keeping patients out of the hospital is even more apparent during the ongoing COVID-19 pandemic. I thank you for your time and attention, and have a good evening.

Operator: Ladies and gentlemen, this concludes today's conference. You may disconnect your lines at this time. Thank you all for your participation.

Unknown Participants: Thank you. Thank you. Thank you. Thank you.