Q2 2021 CorMedix Inc Earnings Call
[music].
Operator: And welcome to the Core Medics, Inc. second quarter, 2021 earnings conference call. At this time, all participants are in a listen-only mode.
Greetings and welcome to the core of Medics, Inc. Second quarter 2021 earnings Conference call. At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation. If he would like to ask a question.
Operator: A question and answer session will follow the formal presentation. If you would like to ask a question, please press Star One on your telephone keypad. If anyone should require operator assistance during the conference, please press Star Zero on your telephone keypad.
Please press star one on your telephone keypad.
If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad. As a reminder, this conference is being recorded it is now my pleasure to introduce your host Dan Ferry with lifestyle advisors. Thank you. Please go ahead.
Operator: As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Dan Ferry, with Lifeside Advisors. Thank you, please go ahead.
Daniel Ferry: Good afternoon, and welcome to the Corps Medics second quarter 2021 earnings conference call. Leading the call today is Koso Beloshe, chief executive officer of Corps Medics. He is joined by Dr. Phoebe Mounce, Executive Vice President and General Counsel, and Dr. Matt David, Executive Vice President and Chief Financial Officer. 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 may include, but are not limited to, any of the following:
Good afternoon, and welcome to the <unk> second quarter 2021 earnings conference call, leading the call today is coastal below <unk> Chief Executive Officer of Carmax. He is joined by Dr. Phoebe mounts Executive Vice President and General Counsel and Dr. Matt, David Executive Vice President and Chief Financial Officer.
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.
Daniel Ferry: Any statements other than statements of historical fact regarding management expectations, beliefs, goals, and plans about the company's prospects, including its clinical development program and marketing approval for DefendCath in the U.S. and other product candidates, future financial position, future revenues, and projected costs, and potential market acceptance of the Femned CAF, Neutralin, and other product candidates More specifically, forward-looking statements include any statements about our clinical development plans and the timing, cost results, and interpretations thereof, projections as to the company's future capital raising and spending, and cash position.
Any statements other than statements of historical facts regarding managements expectations beliefs goals and plans about the company's prospects.
<unk> its clinical development program and marketing approval for defend Caf in the U S and other product candidates future financial position future revenues and projected costs and potential market acceptance with defense calf Neutrolin and other product candidates.
More specifically forward looking statements include any statements about our clinical development plans.
And the timing.
Cost results and interpretations thereof.
Projections as to the company's future capital, raising and spending and cash position.
Daniel Ferry: Expectations as to the timing and nature of anticipated regulatory actions, possible product licensing, business development, or other transactions; commercial plans and expectations, market projections for our product candidates, and expectations as to manufacturing and product component costs.
Expectations as to the timing and nature of anticipated regulatory actions possible product licensing business development or other transactions any commercial plans and expectations market projections for our product candidates.
And expectations as to manufacturing and product component costs.
Daniel Ferry: 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 Cormetics' filings with the SEC, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from Corbett. CoreMedics may not actually achieve the goals or plans described in these forward-looking statements, so investors should not place undue reliance on these statements.
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 SEC 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.
Daniel Ferry: Please note that CoreMedics 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 Mr. Kosel Belosh, Chief Executive Officer of Kormac. Koso, please go ahead.
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 Mr. Kosta <unk> Chief Executive Officer of cosmetics Caso. Please go ahead.
Koso Beloshe: Thank you, Dan. Good afternoon, everyone, and thank you for joining us on this call. On today's earnings call, we will discuss the second quarter 2021 financial information and the overall progress CoreMedics is making in bringing DefendCats to the US market for its first indication for use as a Catholic solution for haemodialysis patients to reduce catheter-related bloodstream infections. Joining me on this call are Phoebe and Matt.
Thank you Dan.
Good afternoon, everyone and thank you for joining us on this call.
On today's earnings call, we will discuss the second quarter 2021 financial information and the overall progress cosmetics is making in bringing defense the U S market.
First indication for use as a catheter lock solution for hemodialysis patients to reduce catheter related bloodstream infections.
Joining me on this call are Phoebe and Matt.
Koso Beloshe: Let me begin the first item of discussion. During the last earnings call on May 13th, we provided an update on the progress that CallMedics has made to date on addressing the deficiencies identified by the FDA at the third-party manufacturing facility. The work has continued, and we are reiterating that, at present, we are on schedule to be able to resubmit the DefendCaf NDA in quarter four, 2021. Phoebe will provide information on our progress since our last update.
Let me begin the first item for discussion.
During the last earnings call on May 13, we provided an update on the progress. The cosmetics has made to date on addressing the deficiencies identified by the FDA.
The third party manufacturing facility.
The work has continued and we are reiterating that at present, we are on schedule to be able to resubmit the pink F N b a in quarter four 2021.
Phoebe will provide information on our progress since our last update.
Koso Beloshe: We are also balancing our preparation for launching DefendCath while limiting our cash burn so that, financially, we have the resources required to efficiently bring Defendcast to patients in the US market when FDA approval is obtained. Matt will provide you an update on our second quarter 2021 financials and provide color regarding the strength of CoreMedics balance. Despite the continued COVID pandemic, CoreMedics has continued to function efficiently with a total I will provide an update on the potential impact of COVID-19 on CoreMedics.
We are also balancing our preparation for launching defend cats.
While limiting our cash burn so that financially we have the resources required to.
To efficiently bring defend cat two patients in the U S market when FDA approval is received.
Matt will provide you an update on our second quarter 2021 financials and provide color regarding the strength of core Medicare balance sheet.
Despite the continued COVID-19 pandemic cosmetics has continued to function.
Efficiently with a total remote workforce.
I will provide an update on the potential impact of COVID-19 on core medics.
Koso Beloshe: Now let's move to the first topic, which is a regulatory update. Phoebe, thank you, Koso, and good afternoon, everyone. I will start by assuring you that we remain on schedule to resubmit the new drug application or NDA in the fourth quarter of 2021. We have continued to work diligently to resolve deficiencies identified by FDA at the third-party manufacturing facility or CMO. As I have explained previously, we have successfully completed the manual extraction study required by FDA in the complete response letter or CRL sent by FDA to CREMET. We have demonstrated that the labeled volume of DefendCath can be consistently withdrawn from the solution.
Now, let's move to the first topic that is with a regulatory update Phoebe.
Thank you Kosta and good afternoon, everyone.
I will start by assuring you that we remain on schedule to resubmit, the new drug application or NDA.
Fourth quarter of 2021.
We have continued to work diligently to resolve deficiencies identified by FDA.
Third party manufacturing facility, where CMO.
As I have explained previously we have successfully completed the manual extraction study required by FDA.
Complete response letter where C. R L I.
By the FDA to permanent.
Have demonstrated that the labels volume of defend cap can be consistently withdrawn from the mines.
Phoebe Mounts: Also, as we have explained previously, Resolution of the deficiencies at the manufacturing facility identified in the post-application action letter sent to the CMO has required additional process qualifications with subsequent validations for the vial filling process. The process qualification and validation are done by the manufacturing facility, and we are working closely with them and CMC consultants engaged by Cormetics to ensure that we are addressing FDA's concerns appropriately. The deficiencies communicated to the CMO by FDA need to be satisfactorily addressed for approval of the DefendCath NDA; the CMC and regulatory teams of CoreMedics are working collaboratively with the CMO to ensure the generation of the required data and documentation to resubmit the NDA in the fourth quarter of 2021.
Also as we have explained previously.
Resolution of the deficiencies at the manufacturing facility identified in the post application action letter sent to the CMO has required additional process qualification with subsequent validation for the vial filling process.
Process qualification and validation are done by the manufacturing facility and we are working closely with them and CMC consultants engaged by paramedics to ensure that we are addressing fda's concerns appropriately.
The deficiencies communicated to the CMO by FDA needs to be satisfactorily addressed or approval or is it different than cat M. D. A.
The CMT and regulatory teams of core metrics.
Our working collaboratively with the CMO to ensure the generation of the required data and documentation to resubmit the NDA in the fourth quarter of 2021.
Phoebe Mounts: As previously described, FDA has informed Core Medics and the CMO that all corrections to facility deficiencies need to be complete at the time of resubmission of the DefendCath NDA. Corrective actions to address the deficiencies at the manufacturing facility will be submitted to FDA by the CMO. FDA has also informed us that corrective actions may be verified during an on-site evaluation of the manufacturing facility, subsequent to the resubmission of the NDA. As you may know, FDA announced in May that only mission-critical inspections of foreign facilities would be conducted, and the COVID-19 pandemic will continue to impede in-person inspections of foreign facilities in 2021. Congress and industry have questioned the impact of delayed inspections on drug approval decisions that result in delays in providing patient access to needed drugs.
As previously described.
He has informed core Medicare and the CMO.
That all corrections to facility deficiency need to be complete at the time of Resubmission of the defend cat M D. A.
Corrective actions to address the deficiencies that the manufacturing facility.
Will be submitted to FDA by the CMO.
FDA has also informed us.
The corrective actions maybe their site during its onsite evaluation of the manufacturing facility subsequent to the Resubmission of the NDA.
As you May know FDA announced in May that only mission critical inspection. So foreign facilities would be conducted in the COVID-19 pandemic will continue to impede any person inspections of foreign facilities in 2021.
Congress and industry have question the impact of delayed inspections on drug approval decisions that result in delays for providing patient access to needed drugs.
Phoebe Mounts: While our goal is to submit sufficient data and documentation to convince FDA that the manufacturing facility is ready to support commercial operation for Defendcast without the need for an inspector, we intend for the CMO to be prepared for an in-person or remote interactive evaluation by FDA. FDA can decide that it may be appropriate to conduct a remote interactive evaluation for a pre-approval inspection to assess the marketing application. However, we are not aware of criteria that the agency uses to determine when a remote interactive inspection is appropriate.
While our goal is to submit sufficient data and documentation to convince FDA that the manufacturing facility is ready to support commercial operation for defense calf.
Without the need for an inspection.
We intend for the CMO to be prepared for it in person or a remote interactive evaluation by FDA.
Yeah, Yeah. He can decide that it may be appropriate to conduct remote interactive evaluation for preapproval inspection to assess the marketing application, we are not aware of criteria.
The agency uses to determine when a remote interactive inspection as appropriate.
Phoebe Mounts: If travel restrictions remain due to the pandemic, we hope that this option will be used by the agency to avoid delays for assessing DefendCath manufacturing when the FDA has recognized the potential of DefendCath to address an unmet medical need for reducing life-threatening catheter-related bloodstream infections. Thank you, and I will now turn the call over to Matt to cover financial results and cash guidance. Thanks, Phoebe.
Travel restrictions remain due to the pandemic, we hope that this option will be used by the agency to avoid delays for assessing venkat manufacturing when the FDA has recognized the potential of defend Ken to address an unmet medical need in reducing life threatening catheter.
Related bloodstream infections.
Thank you and I will now turn the call over to Matt to cover financial results and cash guidance Matt.
Matthew T. David: I'm pleased to be here today to provide an overview of our second quarter 2021 financial results, as well as an update on Cormetics's cash position. The company filed this report on Form Tank Q for the second quarter ended June 30th, 2021. I urge you to read the information contained in the report for a more complete discussion of our financial results. With respect to our second quarter of 2021 financial results, the company had cash and equivalence of $78.3 million as of June 30th, 2021. Our net loss was approximately $4.6 million, or $0.12 per share, compared with a loss of $3.8 million, or $0.14 per share, in the second quarter of 2020.
Thanks Phebe I'm.
I am pleased to be here today to provide an overview of our second 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 second quarter ended June 30th 2021.
I urge you to read the information contained in the report for a more complete discussion of our financial results.
With respect to our second quarter of 2021 financial results.
The company has cash and equivalents of $78.3 million as of June 32021.
Our net loss was approximately $4.6 million or <unk> 12 per share compared with a loss of $3.8 million or <unk> 14 per share in the second quarter of 2020, the higher net loss recognized in 2021 compared with 2020 included increased personnel expenses.
Matthew T. David: The higher net loss recognized in 2021 compared with 2020 included increased personnel expenses and a lower tax benefit received from the New Jersey NOL program, partially offset by a raw material purchase during the second quarter of 2020. We recorded an increase in SG&A and a decrease in R&D experience. Operating expenses in the second quarter of 2021 decreased approximately 34% to 5.9 million compared with 8.9 million in the second quarter of 2020.
A lower tax benefit received from the New Jersey, NOL program, partially offset by our raw material purchase during the second quarter of 2020.
We recorded an increase in SG&A and a decrease in R&D expenses.
Operating expenses in the second quarter of 2021 decreased approximately 34% to $5.9 million compared with $8.9 million in the second quarter of 2020.
Matthew T. David: R&D expense decreased by approximately 56% to 2.5 million, driven primarily by the purchase of raw materials during the same period in 2020 for the manufacturing of Defendcast prior to its potential marketing approval, which amounted to $3.4 million. SG&A expense increased approximately 4% to 3.4 million compared with 3.2 million in the second quarter of 2020.
R&D expense decreased by approximately 56% to $2.5 million driven primarily by the purchase of raw material. During the same period in 2020 for the manufacturing of defend cast prior to its potential marketing approval, which amounted to $3.4 million.
SG&A expense increased approximately 4% to $3.4 million compared with $3.2 million in the second quarter of 2020.
Matthew T. David: This increase was driven primarily 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 consulting. Total operating expenses during the first half of 2021 amounted to $13.1 million compared with $14.6 million in the first half of 2020, a reduction of 10%. R&D expense declined 37% to 5.2 million, driven primarily by the purchase of raw materials during the same period in 2020 for the manufacturing of DefenseCath prior to its potential marketing approval.
This increase was driven primarily by an increase in noncash charges for stock based compensation and an increase in personnel expenses. As a result result of additional hires partially offset by a decrease in consulting fees.
With respect to our first half of 2021 financial results.
Total operating expenses during the first half of 2021 amounted to $13.1 million compared with $14.6 million in the first half of 2020, a reduction of 10%.
R&D expense declined 37% to $5.2 million driven primarily by the purchase of raw material. During the same period in 2020 for the manufacturing of defend cap prior to its potential marketing approval.
Matthew T. David: SGNA expense increased approximately 24% compared with the first half of 2020 as a result of higher personnel experience. We recorded net cash used in operations during the first half of 2021 of 9.8 million compared with net cash used in operations of 8.7 million in the first half of 2020. The difference was primarily driven by lower proceeds from the New Jersey NOL sale, 1.3 million in 2021 versus 5.2 million in 2020, which resulted in a higher net loss in the first half of 2021, as well as lower R&D experience.
SG&A expense increased approximately 24% compared with the first half of 2020 as a result of higher personnel expenses.
We recorded net cash used in operations during the first half of 2021 of $9.8 million compared with net cash used in operations of $8.7 million in the first half of 2020. The difference was primarily driven by lower proceeds from the New Jersey NOL sale, one 3 million in 2002.
'twenty, one versus $5.2 million in 2020, which resulted in a higher net loss in the first half of 2021 as well as lower R&D expenses in the first half of 2021, driven by the raw material purchase made during the same period of the prior year.
Matthew T. David: expenses in the first half of 2021, driven by the raw material purchase made during the same period of the prior year. However, Cormetics remains in a strong position from a balance sheet perspective. We believe our cash and equivalence of 78.3 million gives the company flexibility to fund its operations through, at least through 2022. After taking into consideration the costs for resubmission of the DefendCath NDA and initial preparations for the commercial launch of DefendC.
<unk> remains in a strong position from a balance sheet perspective, we believe our cash and equivalents of $78.3 million gives the company flexibility to fund its operations through at least through 2022 after taking into consideration the cost for Resubmission of the defense cap NDA and Ines.
Preparations for the commercial launch for defense calf.
As outlined by coastal and Phoebe we remain optimistic about our continued progress towards the goal of Resubmission of the NDA in the fourth quarter of 2021.
Matthew T. David: As outlined by Koso and Phoebe, we remain optimistic about our continued progress toward the goal of resubmission of the NDA in the fourth quarter of 2021. In addition to our 10Q, we are filing today a refresh shelf registration as well as an ATM program. These filings allow us to be prepared for the future, given we are approaching what we hope will be a pivotal year ahead for Cormetics as we seek to launch FENCAP into the HEMA dialysis setting. With that, I would like to pass the floor back to COSO.
In addition to our 10-Q, we are filing today, our refreshed shelf registration as well as an ATM program.
These filings allow us to be prepared for the future. Given we are approaching what we hope will be a pivotal year ahead for <unk> as we seek to launch defend cap into the hemodialysis setting.
I would like to pass the floor back to Costar.
Thank you Matt.
We're gratified that despite ongoing pandemic, we've not had significant disruption to cosmetics.
SPV described there remains uncertainty on fda's ability to conduct foreign inspection offer third party CMO.
Koso Beloshe: Thank you, Matt. We're gratified that, despite the ongoing pandemic, we've not had significant disruption to core methods. As Phoebe described, there remains uncertainty about FDA's ability to conduct foreign inspections of our third-party CMO. However, our employees have been able to adjust to a remote working environment very effectively, and there has not been a direct impact on our financial resources by COVID-19. Despite the pandemic, there remains an unmet medical need for a broad-spectrum antibacterial and antifungile Cateralloc solution for haemodilysis patients.
Our employees have been able to adjust to a remote working environment very effectively.
And there has not been a direct impact on our financial resources by COVID-19.
Despite the pandemic there remains an unmet medical need for a broad spectrum antibacterial and antifungal catheter lock solution for hemodialysis patients.
In fact, there's been a number of patients infected by COVID-19.
Experienced the need for dialysis during their hospitalization.
In a large cohort analysis, covering 67 hospitals conducted by Gupta and others and published in the Journal of American Society of Nephrology at least 20% of the COVID-19 patients admitted to the ICU required dialysis. During this day in the ICU and <unk>.
Koso Beloshe: In fact, there have been a number of patients infected by COVID-19 who have experienced the need for dialysis during their hospitalization. In a large cohort analysis covering 67 hospitals conducted by Gupta and others and published in the Journal of the American Society of Nephology, at least 20% of the COVID-19 patients admitted to the ICU required dialysis during their stay in the ICU, and one in three continued to require di CoreMedics is dedicated to driving forward on our goal of bringing defense cats to the U.S. market for the hemo-dialysis segment, which represents a significant market with very large unmet medical needs.
Three continue to require dialysis at discharge.
Core medics is dedicated to driving forward on our goal of bringing different cash to the U S market for the.
The hemodialysis segment, which represents a significant market with a very large unmet medical need.
Today, there is no pharmacological agent approved in the U S where patients urgently need an antimicrobial catheter lock solution.
Prevention of <unk> in central venous catheter.
Defend cats would be the first antimicrobial catheter lock solution approved by the FDA in the U S where deaths occur and as many as 35% of hemodialysis patients experiencing let's see our BSI.
Koso Beloshe: Today, there is no pharmacological agent approved in the US, where patients urgently need an antimicrobial Catholic solution for prevention of CRBSI and central venous catheter. DefendCath would be the first antimicrobial Catholic solution approved by the FDA in the US, where deaths occur in as many as 35% of hemodialysis patients experiencing a CRBSI. To summarize, we continue to focus on our app, expeditiously resolving the third-party manufacturing deficiencies with a plan to resubmit the quarter for 2021.
To summarize we continue to focus our weapon.
Expeditiously resolved in the third party manufacturing deficiencies with a plan to resubmit in quarter four 2021.
We are carefully balancing our cash burn while preparing for the launch of deferred cost once we have approval of the NDA by the FDA.
Yeah.
And we are continuing to plan to broaden the opportunity for defense GAAP following its approval in areas such as oncology and TPN.
Koso Beloshe: We are carefully balancing our cash burn while preparing for the launch of DefendCaf once we have approval of the NDA by the FDA. And we are continuing to plan to broaden the opportunity for defense gaps following its approval in areas such as oncology and TPS, and continue to aim to maximize the value of our Tiroladi technology in areas where it benefits patients. We remain confident that we have the right team and appropriate resources in place to resolve the third-party manufacturing deficiencies that have been identified and bring defense cats to hemodialysis patients in the U.S. We expect to continue to provide updates through this process. Thank you for your continued support of CoreMedics. Let me hand the call back to the operator.
And continue to aim to maximize the value of actuality technology in areas, where it benefits patients.
We remain confident that we have the right team and appropriate resources in place to resolve the third party manufacturing deficiencies.
That have been identified and defend cats to hemodialysis patients in the U S.
We expect to continue to provide updates through this process.
<unk> for your continued support of core medics.
Let me hand, the call back to the operator.
Thank you the floor is now open for questions. If he would like to ask a question. Please press star one on your telephone keypad at this time.
A confirmation tone will indicate your line is in the question queue. You May press star two if he would like to remove your question from the queue.
Operator: Thank you. The floor is now open to questions. If you would like to ask a question, please press Star 1 on your telephone keypad at this time. A confirmation tone will indicate your line is in the question queue.
For participants using speaker equipment, it may be necessary to pick up your handset before pressing the starkey.
Once again that is star one to register questions at this time are.
Our first question is coming from Jason Butler of JMP Securities. Please go ahead.
Operator: You may press star 2 if you would like to remove your question from the list. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start button. Once again, that is star one to register questions at this time. Our first question is from Jason Butler of JMP Securities. Please go ahead.
Hi, Thanks for taking the questions and congrats on all the progress in the quarter am I I have one for Phoebe.
Could you just confirm that you're still in full agreement with the with the contract manufacturer on what needs to be done and how to accomplish the the additional process qualification work and then I have a follow up.
Jason Nicholas Butler: Hi, thanks for taking the questions and congratulations on all the progress in the quarter. One for Phoebe, could you just confirm that you're still in full agreement with the contract manufacturer on what needs to be done and how to accomplish the additional process qualification work? And then I have a follow-up. Yes, I can confirm that.
Yes, I can confirm that.
Okay, Great and then cause so you mentioned some capital efficient.
Work that you can view that youre doing to prepare for commercialization of to think how can you maybe give us a little bit more detail there on what the work you can do over the next few months and and and and how it it's capital efficient. Thanks.
Sure. So clearly you know my pre prepared remarks, I talked about the preparation for launch while trying to balance.
Phoebe Mounts: Great. And so you mentioned some capital efficient work that you can do that you're doing to prepare for commercialization of the fan cap. Can you maybe give us a little bit more detail there on what the work you can do over the next few months and and how it's capital efficient? Thanks.
And so our cash burn so that you know we have enough dry powder at the time, we're ready to launch different tests in the U S. So we've really focused on a couple of key initiatives.
Koso Beloshe: Sure. So, clearly, you know, in my pre-prepared remarks, I talked about the preparation for launch while trying to balance and conserve our cash burns so that, you know, we have enough dry powder at the time. We're ready to launch DefendCath in the U.S.
And you've heard me in previous.
The conference calls to discuss it so payer reimbursement and access strategy is very critical and we are focusing for the rapid their disease state and brand launch plans, we're continuing to refine them.
Koso Beloshe: So we've really focused on a couple of key initiatives, and you've heard me on previous conference calls discuss them. So pay or reimbursement and access strategy is very critical, and we are focusing further on that. There, disease state and brand launch plans were continuing to refine them, and Salesforce resourcing plans were beginning to put those into place. And also, what we have done is engage directly with the leadership of various organizations, be it professional, provider, or patient organizations.
Salesforce Resourcing plans, we're beginning to put those into place and also what we have done is engaged directly with the leadership of various organizations to get professional provider of patient organization. So those are critical elements that we are focusing our efforts on right now.
Great really helpful. Thanks for taking my questions.
Thank you.
Thank you. Our next question is coming from Joon Lee of Truth Securities. Please go ahead.
Alright, Thank you for the questions after the update.
Regarding the process qualification of Biofuels and the vial filling process.
Koso Beloshe: So those are the critical elements that we are focusing our efforts on right now. Great, really helpful. Thanks for taking the questions. Thank you. Thank you. Our next question is coming from June Lee of Truist Securities. Please go ahead. All right, thank you for the questions and for the update. Regarding the process, publication of the vial filling process, and the manual extraction studies, did those require production of new batches of Descentcast? And if so, will you need stability data from those new batches before you can submit? the NBA or during the process of an NDA.
The manual extraction studies.
It does require production of new batches of defend cat and if so will you need stability data from dose need batches before you can submit the.
The NDA or or during the process of FDA briefing.
So I think that's for me Yep Yep. Thank you.
Yeah, Yeah, I mean, as I've explained them, we need to do some.
As you said process qualification and then you need to validate that by generating additional batches and part of the program for any manufactured batches that are intended for commercial use.
Those batches into our stability program and to generate stability data to demonstrate in fact that the product is stable and continues to meet specifications. We have an abundance of.
Joon So Lee: So I think that's for me? Yes, for you. Yes, as I've explained, we needed to do some process qualification, as you said, and then you need to validate that by generating additional batches. And part of the program for any manufactured batches that are intended for commercial use is to put those batches into a stability program and to generate stability data to demonstrate, in fact, that the product is stable. and continues to meet specifications. We have an abundance of data on stability from other masses that have been produced, and so we expect to be able to show consistency.
Data on stability.
Other batches that had been produced and so we expect to be able to show consistency.
Those new batches that will need for which you need stability data for it.
<unk> months stability data.
It just stability program that goes on for many years.
And those can be submitted during the NDA review and post or how does that work in terms of I was just wondering if this is gonna be a rate limiting step or ultimate approval.
Phoebe Mounts: Those new batches that you will need for which you need stability data, that's a 12-month step stability data program. It's a stability program that goes on for many years. I see, and those can be submitted, you know, during the MDA review and post, or how does that work in terms of, I'm just wondering if this is going to be a rate-limiting step or ultimate approval. No, it's not a right-limiting step. And FDA accepts updates to disability data. Thank you. Thank you. Our next question is coming from Chad Messer of Needham and Company. Please go ahead.
No, it's not a rate limiting step and FDA accept updates the stability data.
Thank you.
Thank you. Our next question is coming from Chad Messer of Needham and company. Please go ahead.
Yeah.
Great. Thanks, good evening.
Congratulations on the.
Progress during the quarter.
Good to hear that we are on track for for Resubmission.
Just wondering about the potential for an FDA.
Inspection I know you guys are.
Hoping you don't get one but wanted to be prepared for one.
Chad Messer: Great, thanks. Good evening. Congratulations on the progress during the quarter. It is good to hear that we are on track for resubmission. Just wondering about the potential for an FDA inspection. I know you guys are hoping we don't get one, but want to be prepared for one, or at least make sure you do everything you can to ensure your third party manufacturer is prepared if you get one. Is it possible for you to give us a little bit of a sort of historical perspective on what kind of issues we may or may not have?
Or at least make sure you're.
You do everything you can that your third party manufacturers prepare to if you get one.
Is it possible for you to give us a little bit of sort of historical perspective on what kind of issues, we may or may not have.
We have to deal with it in an inspection like that.
Thank you Chad Phoebe.
Yeah, I'm not sure what you're getting at and then there's an abundance of information and FDA database warning letters, where FDA has gone in selected manufacturing facilities. So it's obvious the kinds of things that the agency looks for when it doesn't inspection.
Phoebe Mounts: have to deal with in an inspection like that. Thank you, Chad. Yeah, I'm not sure what you're getting at.
Phoebe Mounts: There's an abundance of information in FDA's database from warning letters where FDA has gone into an inspected manufacturing facility. So it's obvious the kinds of things that the agency looks for when it does an inspection. So that certainly can provide you with a historical perspective. Well, okay, thank you. I will. I know what I have to work on this evening, then. Okay. Maybe just one other question. I know last quarter we talked about your interest in exploring a pediatric program for Defendcast and that you had submitted a clinical protocol. Just wondering if there's any updates on that.
So that certainly can provide you with a historical perspective.
Alright, well okay.
Thank you Alright, I will I know what I have to work on this evening Ben.
Yes.
Yeah.
It may be just one other question I know last quarter, we talked about your interest in.
Exploring a pediatric program for for defend Cas.
<unk> submitted a clinical protocol just wondering if there's any updates on that.
Phoebe Mounts: So we have submitted the pediatric protocol, and we will only have an update once we have the NDA for different cats approved, not prior to them. Okay, thanks, guys. Thank you, Chad.
So we have submitted the pediatric protocol.
We will only have an update once we have the NDA for different cap approved not prior to them.
Right.
Okay. Thanks, guys.
Daniel Ferry: Thank you. At this time, I'd like to turn it over to Mr. Ferry for previously submitted questions. Thank you, operator. Phoebe, this first one is for you.
Thank you Chad.
Thank you at this time I'd like to turn it over to Mr. Ferry for previously submitted questions.
Thank you operator.
Phoebe This first one is for you.
Phoebe Mounts: Um, has the FDA given you any update on whether or not an on-site inspection will be required as opposed to a review of new records submitted? Thanks, Dan. I'm sure FDA will review this very carefully because this is new information that has been submitted. And probably based on that review, decide whether or not it has questions that would necessitate submission of additional information or whether it needs to conduct a remote interactive evaluation and or an on-site inspection.
A C FDA given you any update.
Excuse me on whether or not an onsite inspection will be required.
As opposed to a review of New records submitted.
Thanks, Dan.
Sure FDA will review very carefully.
There's no new information that is submitted.
And probably based on that review.
Side, whether or not it has questions that wouldnt necessitate submission of additional information.
Or whether it needs to conduct remote interactive evaluation.
You handle more an onsite inspection so I think the FDA will likely proceed through that sequence based on the information.
Phoebe Mounts: So I think the FDA will likely proceed through that sequence based on the information and its assessment. Great, thanks, Phoebe. I have another follow-up here, you know, in the same vein. To your knowledge, has the FDA engaged in any remote interactive evaluations? And is this still a possibility?
Uh huh.
Great. Thanks, Amy I have another follow up here, you know and in the same vernacular.
To your knowledge has the FDA engaged in any remote interactive evaluations.
And is this still a possibility.
Phoebe Mounts: Yes, I think that's an important question. As I said in my prepared comments, the agency, as a result of the pandemic, may continue to have travel restrictions that impede travel for on-site inspections. So I've been very careful to talk to industry experts, and the fact that FDA has not withdrawn its guidance document on remote interactive inspections leads me to assume that it remains an option for the agency. Okay, great. I have one for Matt here. Matt, I see you filed a universal shelf and new ATM program today. Can you explain why now on the timing?
Yeah, I think that's an important question as I said in my prepared comments and the agency as a result of the pandemic may continue to have travel restrictions that impede traveled for onsite inspections.
I've been very careful to talk to industry experts.
And the fact that FDA has not withdrawn its guidance document on remote interaction inspections.
Leads me to assume that it remains an option for the agency.
Yeah.
Okay great.
I have one for Matt here, Matt I see you filed a universal shelf.
Our new ATM program today can you explain why now on the timing.
Matthew T. David: Yeah, yeah, sure. Thanks, thanks for the question. Well, we certainly, you know, and we currently have enough cash runway through 2022, as we described on the call. We believe it is sensible from a corporate finance perspective to plan for the future, given we are approaching what we hope will be a pivotal year ahead for CoreMETA.
Yeah sure. Thanks, Thanks for the question.
You certainly you know when we currently have enough cash runway through 2022 as we described on the call. We believe it is sensible from a corporate finance perspective.
For the future given we are approaching what we hope will be a pivotal year ahead for <unk>.
Matthew T. David: Excellent. Thanks, Nat. Koso, that is all I have for previously submitted questions.
Excellent thanks for that.
So that is all I have for our previously submitted questions I would like to turn the floor back over to you for closing remarks.
Koso Beloshe: I'd like to turn the floor back over to you for closing remarks. Thank you, Dan. CoreMedics has an experienced team of executives who have taken pharmaceuticals through the various phases of clinical studies, registration, and successfully launched products in the U.S. market. We remain committed to bringing defend caps to the US market, whether on our own or with a strategic or commercial partner, to help patients in need of protection from life-threatening infections.
Thank you Dan.
Core Medicare has an experienced team of executives who have taken pharmaceuticals through the various phases of clinical studies registration and successfully launched products in the U S market.
We remain committed to bringing defend cats to the U S market.
Whether on our own or with the strategic or commercial partner to help patients need of protection from life threatening infections.
Koso Beloshe: The importance of reducing the incident of infections and keeping patients out of hospitals is even more apparent during this ongoing coronavirus pandemic. Despite this delay in the NDA approval, please keep in mind that the potential for more than 10 years of market exclusivity remains because it will not commence until the NDA for DefendCath is approved.
The importance of reducing the incidence of infections and keeping patients out of the hospital, even more apparent during the ongoing coronavirus pandemic.
Despite the delay in the NDA approval. Please keep in mind that the potential for more than 10 years of market exclusivity remains because it will not commence until the FDA for defense cap is approved.
Operator: Thank you for your time and attention, and have a good evening. Ladies and gentlemen, this goes to conclude today's event. You may disconnect your lines or log off the webcast at this time. And have a wonderful day. Thank you.
Thank you for your time and attention and have a good evening.
Ladies and gentlemen, thank you for your participation.
Conclude todays event you may disconnect your lines of log off the webcast at this time and have a wonderful day.
[music].
Operator: Then, and I'm going to be.