Q2 2022 CorMedix Inc Earnings Call

Greetings and welcome to the call Medics, Inc. Second quarter 2022 earnings call.

Operator: Greetings and welcome to the CorMedix Inc. second quarter 2022 earnings call.

Operator: At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation.

Operator: Thank you for joining us.

This time, all participants are in a listen only mode.

A question and answer session, we'll call it formal presentation.

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Operator: As a reminder, this conference is being recorded.

As a reminder, this conference is being recorded.

Operator: I would now like to turn the conference over to your host, Dan Ferry, from

Operator: You may now disconnect your lines.

I'd now like to turn the countries is it your host Gunty somewhat soft with largest please go ahead.

Dan Ferry: Lifesize Advisors.

Good morning, and welcome to the <unk> second quarter 2022 earnings Conference call.

Dan Ferry: Please go ahead.

Leading the call today is Joseph <unk>, Chief Executive Officer of Carmax.

He is joined by Dr. David Executive Vice President and CFO Dr.

Dr. Phoebe mounts EVP General counsel.

And head of technical operations and mystery.

Dan Ferry: Good morning and welcome to the CorMedix second quarter 2022 earnings conference call.

SVP of commercial.

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.

Regarding managements expectations beliefs goals and plans about the Companys prospects include.

Including its clinical development program manufacturing activities and marketing approval.

For <unk> in the U S and other product candidates future financial position future revenues and projected costs.

And potential market acceptance defend cast neutrolin and other product candidates.

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

And the timing of 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 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.

Yes.

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.

[noise] approvals and commercialization.

These risks are described in greater detail chromatics 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 cosmetics corvette.

<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.

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

Dan Ferry: Leading the call today is Joseph Todisco, Chief Executive Officer of CorMedix, and he is joined by Dr. Matt David, Executive Vice, President and CFO, Dr. Phoebe Mounts, EVP, General Counsel, and Head of Technical Operations, Erin Mistry, SVP of Commercial.

At this time, it's now my pleasure to turn the call over to Joe to Disco Chief Executive Officer of cosmetics, Joe. Please go ahead.

Dan Ferry: 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 meeting set forth in the Private Securities Litigation Reform Act of 1995.

Thanks, Dan.

Good morning, everyone and thank you for joining us on this call.

Dan Ferry: 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 regarding management's expectations, beliefs, goals, and plans about the company's prospects, including its clinical development program, manufacturing activities, and marketing approval for defend-cath in the U.S. and other product candidates, future financial position, future revenues and projected costs, and potential market acceptance of defend-cath, neutral, and other product candidates.

This call marks my first full quarter at the helm of core medics and I remain as excited about the future potential for the company and our lead product defend Casper as I was the day I joined over the last three months. The company has made progress on all fronts working diligently in support of our CMO as they underwent a critical FDA inspection as well as undertaking multiple steps.

Dan Ferry: More specifically, forward-looking statements include any statements about our clinical development plans and the 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, 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. 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 CoreMedix 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 CoreMedix.

Dan Ferry: CoreMedix may not actually achieve the goals or plans described in these forward-looking statements, and investors should not place undue reliance on these statements.

Dan Ferry: Please note that CoreMedix does not intend to update these forward-looking statements,

To be ready for commercialization as quickly as possible following a potential FDA approval.

Dan Ferry: except as required by law.

Unfortunately, as core medics announced on Monday F.

Have they informed us that the defend cat M. D E cannot be approved until satisfactory resolution of the efficiencies at the CMO and how that manufacturing facility of our heparin supplier.

While I am disappointed that the application received a complete response letter I believe the actions we are taking in support of our existing CMO and heparin supplier as well as adding another CMO in the U S alchemy, and adding another heparin supplier gives the company multiple pathways toward obtaining FDA approval of the NDA.

Dan Ferry: At this time, it is now my pleasure to turn the call over to Joe Tedisco, Chief Executive Officer of CoreMedix.

As Phoebe will explain in more detail.

The FDA conducted a preapproval inspection at the existing CMO and the CMO submitted full responses and corrective action plans in a timely manner.

Joseph Todisco: Joe, please go ahead.

Unfortunately, there was not sufficient time between the close of the inspection and our original <unk> date of August 25th cause it.

Simo to fully implement all corrective actions and obtain fda's verification thereof.

In addition, our API supplier, we issued a warning letter for deficiencies unrelated to heparin.

And although they are working aggressively to remediate the issues. They were also unable to fully implement corrective actions and obtain FDA verification prior to our <unk> date.

I am optimistic that both organizations have the capability to remediate these issues and the ensuing months ahead clearing the way for a potential FDA approval of the product.

Notably the C. R. L cited no other deficiencies related to defend cast or requirements for NDA resubmission.

<unk> works with the CMO to resolve the deficiencies and resubmit. The NDA. It is also working to be prepared to commercialize as early as the first quarter of 2023.

In addition, FDA has also notified the company that all know although the trade named defend cats had been conditionally approved previously.

The agency has now identified a potential confusion with another pending product name with a market application under review.

The ultimate acceptability of our proposed trade name is dependent upon which application is approved first.

As a precaution cosmetics has already submitted an alternative prep proprietary name to the agency, which will undergo overview.

From a commercial standpoint on Monday August 1st the center for Medicare and Medicaid services or CMS published in the Federal Register the conditional new technology add on payment or end cap reimbursement for defend cast a $4387 50.

For average hospital stay which assumes three vials of deferred cash utilized for catheter locks following three dialysis session.

As we discussed on the last earnings call. The end cap is conditioned upon defend cats, obtaining final FDA approval of the N D. A.

Here to July 1st of 2023 and would take effect in the first calendar quarter. Following FDA approval of the NDA.

And cap reimbursement would be specific to hospital inpatient utilization of defend cats.

And the $1462.50 per vial reimbursement is derived from an expected WAC price.

$1950 per vial.

The WAC price of a pharmaceutical which is the wholesale acquisition cost is essentially the gross list price for a drug product and not necessarily representative of the ultimate net price charged to a hospital institution or clinic.

As we stated previously we expect to have a higher net price and the hospital inpatient setting where utilization is lower and less frequent than in the outpatient dialysis setting where utilization is expected to be much higher.

Due to the nature of our health care reimbursement system. We are required to have only one WAC price regardless of setting of care, but the net price in each setting may be different.

The company intends to submit a duplicate and tap application to CMS. This October in order to preserve our ability to obtain a new end cap should final FDA approval and not be obtained prior to July one 2023.

While our end cap is specific to inpatient reimbursement.

We continue to take a two pronged approach with respect to outpatient reimbursement.

First we remain committed to our efforts to secure a transitional drug add on payment adjustment or to dapple as soon as practicable after securing our anticipated FDA approval.

Dapper is an incremental payment to the renal dialysis surface bundle allocated by CMS to outpatient dialysis clinics.

While we do see to dapper as a viable reimbursement pathway to drive utilization of defend cats. We believe there are compelling arguments that defend caf does not fall within the scope of.

Products and services calculated as part of the dialysis bundle under the current statute and therefore should be reimbursed separately by CMS as an outpatient drug product with unique J code.

We believe a unique J code and separate reimbursement better incentivize dialysis operators to utilize the product for the betterment of patient outcomes.

To be clear any decision to separately reimbursed defend cap or to grant defend cats a dapper.

Ultimately at the sole discretion of CMS.

But we will be working diligently over these next few months along with other key stakeholders, such as hospital systems dialysis clinics and patient advocacy groups to make these arguments to CMS.

Final FDA approval of defend cast is required before we were able to submit a formal application for the dapper or unique J code and the estimated timing to a decision from CMS is approximately six months from submission of the application in both instances.

Joseph Todisco: Thanks, Dan.

At this time I'd like to turn the call over to Phoebe who will provide an update on regulatory affairs manufacturing JV.

Joseph Todisco: Good morning, everyone, and thank you for joining us on this call.

Joseph Todisco: Today's call marks my first full quarter at the helm of CoreMedix, and I remain as excited about the future potential for the company and our lead product, Defendcast, as I was the day I joined.

Thanks, Joe and good morning, everyone.

Joe mentioned earlier, the FDA has issued a second complete response letter for the defense cap N D. A.

Joseph Todisco: Over the last three months, the company has made progress on all fronts, working diligently in support of our CMO as they underwent a critical FDA inspection, as well as undertaking multiple steps to be ready for commercialization as quickly as possible following a potential FDA approval.

As part of the NDA review process.

<unk> conducted a preapproval inspection at two locations for CMO that are listed in the NDA is being utilized in the manufacturer testing and release of the product.

Joseph Todisco: Unfortunately, as CorMedix announced on Monday, FDA informed us that the DefenCath NDA cannot, be approved until satisfactory resolution of deficiencies at the CMO and at a manufacturing facility of our heparin supplier.

Joseph Todisco: While I am disappointed that the application received a complete response letter, I believe, the actions we are taking in support of our existing CMO and heparin supplier, as well as adding another CMO in the U.S., Alchemy, and adding another heparin supplier, give the company multiple pathways toward obtaining FDA approval of the NDA.

This was the first physical inspection conducted by FDA at the CMO for the NDA review.

That's da conducted only a desk review of documents following the original NDA submission.

The primary site received for inspection observations.

So overall quality systems standard operating procedures or S O P and operating equipment.

Joseph Todisco: As Phoebe will explain in more detail, the FDA conducted a preapproval inspection at, the existing CMO, and the CMO submitted full responses and corrective action plans in a timely manner. Unfortunately, there was not sufficient time between the close of the inspection and our, original PDUFA date of August 25th for the CMO to fully implement all corrective actions and obtain FDA's verification thereof. In addition, our API supplier issued a warning letter for deficiencies unrelated to heparin, and although they are working aggressively to remediate the issues, they were also unable to fully implement corrective actions and obtain FDA verification prior to our PDUFA date.

Our CMO developed a robust corrective action plan and submitted responses to FDA within the required 15 day period.

Joseph Todisco: I am optimistic that both organizations have the capability to remediate these issues in, the ensuing months ahead, clearing the way for a potential FDA approval of the product. Notably, the CRL cited no other deficiencies related to defend casts or requirements for, NDA resubmission.

Joseph Todisco: While Chromedics works with the CMO to resolve the deficiencies and resubmit the NDA, it, is also working to be prepared to commercialize as early as the first quarter of 2023.

As part of the response and corrective actions, our CMO has committed to providing the agency with ongoing periodic reports outlining progress on corrective actions and also requested a meeting with FDA to discuss the implementation of the corrective actions.

F D. A has not yet responded to the meeting request.

Joseph Todisco: In addition, FDA has also notified the company that although the trade name defend cast had, been conditionally approved previously, the agency has now identified a potential confusion with another pending product name with a market application under review. The ultimate acceptability of our proposed trade name is dependent upon which application, is approved first. As a precaution, Chromedics has already submitted an alternative proprietary name to the agency, which will undergo review.

Just in the laboratory facility, which is utilized in testing and release it would depend cat.

Joseph Todisco: From a commercial standpoint, on Monday, August 1st, the Center for Medicare and Medicaid Services, or CMS published in the Federal Register the Conditional New Technology Add-on Payment or NCAT reimbursement for defend casts of $4,387.50 per average hospital stay which assumes three vials of defend cast utilized for catheter locks following three dialysis sessions. As we discussed on the last earnings call, the NTAP is conditioned upon defend cast obtaining, final FDA approval of the NDA prior to July 1st of 2023 and would take effect in the first calendar quarter following FDA approval of the NDA. NTAP reimbursement would be specific to hospital inpatient utilization of defend cast and the, $1,462.50 per vial reimbursement is derived from an expected WAC price of $1,950 per vial.

Joseph Todisco: The WAC price of a pharmaceutical, which is the wholesale acquisition cost, is essentially, the gross list price for a drug product and not necessarily representative of the ultimate net price charged to a hospital, institution, or clinic.

Joseph Todisco: As we have stated previously, we expect to have a higher net price in a hospital inpatient, setting where utilization is lower and less frequent than in the outpatient dialysis setting where utilization is expected to be much higher.

Joseph Todisco: Due to the nature of our healthcare reimbursement system, we are required to have only one WAC, price regardless of setting of care, but the net price in each setting may be different.

Joseph Todisco: The company intends to submit a duplicate NTAP application to CMS this October in order, to preserve our ability to obtain a new NTAP should final FDA approval not be obtained prior to July 1st of 2023.

Joseph Todisco: While our NTAP is specific to inpatient reimbursement, we continue to take a two-pronged approach, with respect to outpatient reimbursement.

Joseph Todisco: First, we remain committed to our efforts to secure a transitional drug add-on payment, adjustment or to DAPA as soon as practicable after securing our anticipated FDA approval. DAPA is an incremental payment to the renal dialysis service bundle allocated by CMS to, outpatient dialysis clinics.

<unk> also received inspection observations.

Joseph Todisco: While we do see to DAPA as a viable reimbursement pathway to drive utilization of DefendCast, we believe there are compelling arguments that DefendCast does not fall within the scope of products and services calculated as part of the dialysis bundle under the current statute and therefore should be reimbursed separately by CMS as an outpatient drug product with a unique J-code.

Joseph Todisco: We believe a unique J-code and separate reimbursement better incentivizes dialysis operators to, utilize the product for the betterment of patient outcomes.

Joseph Todisco: To be clear, any decision to separately reimburse DefendCast or to grant DefendCast to DAPA, is ultimately at the sole discretion of CMS, but we will be working diligently over these next few months along with other key stakeholders such as hospital systems, dialysis clinics, and patient advocacy groups to make these arguments to CMS.

As these observations did not involve any equipment or processes supporting our NDA.

Joseph Todisco: Final FDA approval of DefendCast is required before we are able to submit a formal application, forward to DAPA or a unique J-code, and the estimated timing to a decision from CMS is approximately six months from submission of the application in both instances.

Included the confidential information of other third parties, we do not have any visibility into the specific observations.

Our CMO has informed us that responses have been submitted to FDA in a timely manner.

Our sand, though has also committed to the agency to engage external consultants, who are very experienced in sba's requirements Christina G. M. P compliant.

Those consultants have been identified and the CMO is in the process of finalizing agreements with them to accelerate implementation of appropriate corrective actions.

F D as procedures require classification of inspection observations as either voluntary action indicated or B a.

Or official action indicated Oh, Hey, hi.

Our classification of VII does not lock new approvals from our facility and would not be expected to have any impact on the approval timing of the NDA.

However classification is O AI may result in compliance action by FDA in certain circumstances, and they block any pending product approvals listing facility in the application.

We have not been informed of a classification determination for the inspection and observations at the CMO.

Yeah.

Unrelated to any preapproval inspection for the N D a.

<unk> was informed by our current heparin API supplier.

The FCA conducted an inspection of its manufacturing facility.

The inspection was unrelated to the manufacturer of heparin and resulted in inspection observations that culminated in the warning letter due to deviations from current good manufacturing practices for an unrelated and API.

Our API supplier utilize multiple sites in the manufacturing process for heparin in the warning letter is specific to a site where only early stage processing of heparin is done and involves building equipment and personnel that are not utilized in the manufacturer of heparin.

The classification of the inspection observations was official action indicated.

When FDA issued a warning letter we sought guidance from the agency as to whether the warning letter would impact the approval timing as defend counts.

We worked with our API supplier to submit to FDA, a robust package outlining the facilities personnel and quality system utilized in the manufacturer of heparin as being distinct and separate from those utilized to manufacture the unrelated API and that we do not anticipate any.

Any impact to heparin quality as a result of decided deficiencies.

By way of C. I R L.

The FDA has now informed us that resolution of the warning letter deficiencies will be necessary to obtain NDA approval of defend cats in its present form.

Our heparin supplier has also engaged an independent cgmp consultants to help the company expedite resolution of the deficiencies communicated in the warning letter.

Yeah.

We intend to continue to work collaboratively with our manufacturer API supplier and the agency to obtain NDA approval as quickly as possible from the existing CMO facility.

At the same time.

We believe it is important to establish an alternative supply chain to mitigate any long term risks should these compliance concerns take longer than expected to resolve.

In this regard we recently announced that we have finalized an agreement with Alchemy Corporation.

U S based contract manufacturer with proven capabilities for manufacturing commercial sterile parenteral drug product.

How can he will function as an additional manufacturing site for defense for the U S market.

We have been working diligently over the last several months to transfer the 10 cap manufacturing process into an al can you cite.

And cosmetics is expected to be able to submit a supplement without any data to its NDA application around the end of the first quarter of 2023.

As part of the technology transfer and validation of the manufacturing process that alchemy.

<unk> has procured and is planning to qualify an additional supplier of heparin API sourced from a major U S manufacturer.

Alchemy as well as a new supplier of heparin API have robust history of U S. F. D. A C. G M P inspections and approvals.

Yeah.

Just to be clear from a timing perspective, our fastest pathway to market remains FDA clearance of the compliance deficiencies at our existing CMO and API supplier.

Because the C. R. L does not require any additional work like chromatics for Resubmission of the NDA.

On the other hand, the submission with alchemy requires validation of the manufacturing process and generation of information, including stability data.

Which we expect to be available by the end of the first quarter of 2023.

While I too have been disappointed to have received a second T. R. L. I am gratified that there were no product specific issues for corn next to address before resubmission and proud of the hard work and the progress the team has made.

Core medical will continue to work with our existing CMO and heparin supplier in parallel with alchemy.

Cure marketing approval for novel anti microbial catheter lock solution to address the unmet medical need for dialysis patients.

Joseph Todisco: At this time, I'd like to turn the call over to Phoebe who will provide an update on regulatory affairs and manufacturing.

I would now like to turn the call over to Matt who will provide a financial update for the quarter Matt.

Phoebe Mounts: Phoebe?

Thanks Phoebe.

Phoebe Mounts: Thanks, Joe, and good morning, everyone.

Good morning, I'm pleased to be here today to provide an overview of our second quarter and first half of 2022 financial results as well as an update on our cash position.

Phoebe Mounts: As Joe mentioned earlier, the FDA has issued a second complete response letter for the, DefendCast NDA. As part of the NDA review process, FDA conducted a preapproval inspection at two locations, for our CMO that are listed in the NDA as being utilized in the manufacture, testing, and release of the product. This was the first physical inspection conducted by FDA at the CMO for the NDA review, as FDA, conducted only a desk review of documents following the original NDA submission. The primary site received four inspectional observations related to overall quality systems, standard operating procedures, or SOPs, and operating equipment.

Phoebe Mounts: Our CMO developed a robust corrective action plan and submitted responses to FDA within, the required 15-day period. As part of the response and corrective actions, our CMO has committed to providing the agency, with ongoing periodic reports outlining progress on corrective actions and also requested a meeting with FDA to discuss the implementation of the corrective actions. FDA has not yet responded to the meeting request. The CMO's laboratory facility, which is utilized in testing and release of DefendCast, also, received inspectional observations.

Phoebe Mounts: As these observations did not involve any equipment or processes supporting our NDA, and included the confidential information of other third parties, we do not have any visibility into the specific observations, but our CMO has informed us that responses have been submitted to FDA in a timely manner.

Phoebe Mounts: Our CMO has also committed to the agency to engage external consultants who are very experienced, in FDA's requirements for CGMP compliance. Those consultants have been identified, and the CMO is in the process of finalizing agreements, with them to accelerate implementation of appropriate corrective actions.

Phoebe Mounts: FDA's procedures require classification of inspectional observations as either voluntary, action indicated, or VAI, or official action indicated, or OAI. A classification of VAI does not block new approvals from a facility and would not be, expected to have any impact on the approval timing of the NDA.

Phoebe Mounts: However, classification as OAI may result in compliance action by FDA in certain circumstances, and may block any pending product approvals listing the facility in the application.

The company has filed its report on Form 10-Q for the second quarter ended June 32022, I urge you to read the information contained in the report for a more complete discussion of our financial results.

Phoebe Mounts: We have not been informed of a classification determination for the inspectional observations, at the CMO.

Phoebe Mounts: Unrelated to any pre-approval inspection for the NDA, Cormetics was informed by our current, Heparin API supplier that FDA conducted an inspection of its manufacturing facility. The inspection was unrelated to the manufacture of Heparin and resulted in inspectional observations, that culminated in a warning letter due to deviations from current good manufacturing practices for an unrelated API. Our API supplier utilizes multiple sites in the manufacturing process for Heparin, and, the warning letter is specific to a site where only early-stage processing of Heparin is done and involves buildings, equipment, and personnel that are not utilized in the manufacture of Heparin.

Phoebe Mounts: The classification of the inspectional observations was official action indicated. When FDA issued a warning letter, we sought guidance from the agency as to whether the, warning letter would impact the approval timing of DefendCount.

Phoebe Mounts: We worked with our Heparin API supplier to submit to FDA a robust package outlining the, facilities, personnel, and quality systems utilized in the manufacture of Heparin as being distinct and separate from those utilized to manufacture the unrelated API, and that we do not anticipate any impact to Heparin quality as a result of the cited deficiencies.

With respect to our second quarter of 2022 financial results.

Our net loss was approximately $7 6 million or <unk> 19 per share compared with a loss of $4 6 million or <unk> 12 per share in the second quarter of 2021.

The higher net loss recognized in 2022 compared with 2021 included an increase in both SG&A expenses and R&D expenses versus the second quarter of 2021.

Operating expenses in the second quarter of 2022 increased approximately 41% to $8 3 million compared with $5 9 million in the second quarter of 2021.

R&D expense increased by approximately 28% to $3 2 million driven by an increase in costs related to the manufacturing of the venkat prior to its potential marketing approval, partially offset by net decreases in personnel expenses consulting fees and clinical trial expenses.

SG&A expense increased approximately 50% to $5 1 million compared with $3 4 million in the second quarter of 2021.

This increase was primarily attributable to an increase in costs related to market research studies and prelaunch activities in preparation for the potential marketing approvals to venkat.

Our net increase in personnel expenses and increases in legal fees and non cash charges for stock based compensation.

With respect to our first half of 2022 financial results.

Total operating expenses during the first half of 2022 amounted to $15 3 million compared with $13 1 million in the first half of 2021, an increase of 17%.

R&D expense increased 6% to $5 5 million driven primarily by an increase in costs related to the manufacturing of <unk> prior to its potential marketing approval, partially offset by net decreases in personnel expenses and clinical trial expenses and consulting fees.

SG&A expense increased approximately 23% to $9 8 million compared with the first half of 2021, primarily driven by an increase in legal fees and increase in personnel expenses and an increase in costs related to market research studies and prelaunch activities in preparation for the potential marketing approval.

Okay. Thank god.

We recorded net cash used in operations during the first half of 2020 to $12 2 million.

Compared with net cash used in operations of $9 8 million in the first half of 2021 did.

The difference was primarily driven by an increase in net loss primarily attributable to an increase in operating expenses as compared to the same period in 2021.

<unk> remains in a good position from a balance sheet perspective, the company had cash and equivalents of $64 6 million as of June 32022.

This includes approximately $11 4 million raised during the first half of 2022 through our ATM program and approximately <unk> 6 million from the sale of unused New Jersey Nols.

We believe our cash and equivalents gives the company flexibility to fund its operations at least through the third quarter of 2023 after taking into consideration costs related to manufacturing activities and costs related to the potential commercial launch for defend cap.

As Joe and Phoebe have discussed today, we remain optimistic about our progress toward an anticipated FDA approval for defense costs, 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 facing what we hope and believe will be a pivotal time ahead.

Headaches as we seek to bring defend cap to patients in the hemodialysis setting.

I will now turn the call back over to Joe for closing remarks.

Thanks, Matt.

As I look towards our next few months I remain excited about the opportunities and optimistic about the challenges that lay ahead.

Defend cats has the potential to address a critical unmet medical need and if approved by FDA can significantly improve patient outcomes. While also having an impact on the health equity disparity that is pervasive in our health care system.

Related bloodstream infections or C or B S eyes places a heavy financial burden on the U S Health U S health care system estimated at roughly $2 $3 billion per year of incremental cost.

Hemodialysis patients with a C or b S. Si have double the rate of hospitalization as non infected H D patients with an average duration of stay that is four times longer than a three times higher fatality rate.

In addition African Americans represent under 14% of the U S population, but account for more than 35% of patients undergoing hemodialysis to.

To that extent African Americans are disproportionately at risk for catheter related bloodstream infection compared to other demographic groups.

And cats in clinical trials reduce C. R. B S high occurrence by 71% in hemodialysis patients compare to the existing standard of care heparin.

Taken in totality, the strong clinical profile defend cash and potential to significantly improve patient outcomes and health equity, while also potentially decreasing the overall cost burden on the health care system.

I continue to see defend cast as a critical drug product and strong platform asset for growth from which core medics can bill.

Phoebe Mounts: By way of the CRL, the FDA has now informed us that resolution of the warning letter deficiencies, will be necessary to obtain NDA approval of Defend-Cas in its present form.

Phoebe Mounts: Our heparin supplier has also engaged an independent CGMP consultant to help the company expedite, resolution of the deficiencies communicated in the warning letter.

While the CR, while the CRM is an unfortunate speed bump our quickest pathway to market remains resolution of deficiencies at our existing CMO and API supplier and core medics is committed to mobilizing all resources to achieve that objective.

Phoebe Mounts: We intend to continue to work collaboratively with our manufacturer, API supplier, and the, agency to obtain NDA approval as quickly as possible from the existing CMO facility, while at the same time, we believe it is important to establish an alternative supply chain to mitigate any long-term risk should these compliance concerns take longer than expected to resolve.

Phoebe Mounts: In this regard, we recently announced that we have finalized an agreement with Alchemy, Corporation, a U.S.-based contract manufacturer with proven capabilities for manufacturing commercial sterile parenteral drug products. Alchemy will function as an additional manufacturing site for Defend-Cas for the U.S. market. We have been working diligently over the last several months to transfer the Defend-Cas, manufacturing process into an Alchemy site, and CoreMedix expects to be able to submit a supplement with Alchemy data to its NDA application around the end of the first quarter of 2023.

I remain confident in our ability to bring this product to market in order to address a significant unmet medical need.

Thank you for your continued support of and interest in cosmetics.

At this time, we will be conducting a question and answer session.

We would like to ask a question to space Star one on your telephone keypad.

Formation channel indicate you're likely seem to Christian Q.

Yeah, My pristine too if he would like to remove your question from the queue.

All participants using speaker equipment might be may succeed pickup your handset before pressing the star keys, one moment please call for questions.

My first question is from Jason Butler of JMP Securities. Please go ahead.

Phoebe Mounts: As part of the technology transfer and validation of the manufacturing process at Alchemy, CoreMedix has procured and is planning to qualify an additional supplier of heparin API sourced from a major U.S. manufacturer.

Hi, it's Roy on for Jason Thanks for taking our questions I had a few on the manufacturing.

Phoebe Mounts: Alchemy, as well as a new supplier of heparin API, have robust histories of U.S.

But first I guess can you just tell us the location of the current heparin supplier.

I mean, it's alchemy just unclear is how can we work with that supplier as well or just a new supplier and then Conversely is that its a current contract manufacturer I'm also gonna began work with a new heparin supply source or are they going to stick with the old source.

Okay. Thanks, right and in terms of the API supplier that we are comfortable saying it's in it's in Europe .

Alchemy will will only be working with the the new heparin supplier for the time being that's the the work stream that we are focused on our existing CMO will will remain with the existing heparin supplier.

And that's that's that's the current way we've set up the the work streams.

Okay, Great and then if if you submit the supplement at the end of one Q next year, what do you expect to get for a review period, assuming X except accepted.

And then on the reimbursement bid for the outpatient part.

Do you guys have any examples of companies that have argued to CMS for the J code and not the TDAP and been successful. Thanks.

Phoebe Mounts: FDA CGMP inspections and approvals.

Well to address the first question first on timelines I'm going to turn that over to Phoebe if you.

Phoebe Mounts: Just to be clear from a timing perspective, our fastest pathway to market remains FDA, clearance of the compliance deficiencies at our existing CMO and API supplier, because the CRL does not require any additional work by CoreMedix for resubmission of the NDA.

Phoebe Mounts: On the other hand, the submission with Alchemy requires validation of the manufacturing, process and generation of information, including stability data, which we expect to be available by the end of the first quarter of 2023.

Do you want to comment on the review period.

Phoebe Mounts: While I, too, am disappointed to have received a second CRL, I am gratified that there were, no product-specific issues for CoreMedix to address before resubmission, and proud of the hard work and the progress the team has made.

Certainly thanks for the question right it depends on what you're referring to is it's the submission in the first quarter of 2023 and as we hope I'm the deficiencies can be addressed quickly.

Phoebe Mounts: CoreMedix will continue to work with our existing CMO and heparin supplier in parallel, with Alchemy to secure marketing approval for a novel antimicrobial catheter lock solution to address an unmet medical need for dialysis patients.

Phoebe Mounts: I would now like to turn the call over to Matt.

Matthew David: We will provide a financial update for the quarter.

Matthew David: Matt?

That submission that would be in place would be.

Our resubmission of the NDA with the current CMO.

And we would expect that to properly be a class one.

Which has a shorter review period of two months because as I said, there's nothing on the product side that needs to be submitted in the NDA and we will presumably hasn't. It go ahead from FDA for Resubmission. So we would expect that to be a quick review.

However, the Resubmission is.

We're involved in a new CMO.

We obviously have manufacturing information that we'll need to be reviewed by FDA for the facility and that well should properly be a class two resubmission and that would be a six month review period.

Okay. Thanks.

Thanks, David and on the reimbursement question look to that as a relatively new program. So there's not a whole lot of history there.

In terms of what arguments companies have made with respect to adapt or separate reimbursement. In addition, those discussions with CMS or fairly confidential between the companies and CMS. So we don't have any there's no public record I can point to with an example, so.

It's possible we are a unique and making this argument is as our product is somewhat unique.

Okay makes sense. Thank you.

Our next question is from Joon Lee of Jewish. Please go ahead.

Matthew David: Thanks, Phoebe.

Good morning. This is less on for Julien. Thank you for taking my questions Joe.

Matthew David: Good morning.

Joe I guess, we'll start on the pricing I. Thank you for that color that you've provided can you provide a little bit more details I guess on how this how do you expect to play out closer to approval and when do you think you'll be in a position to announce finalized pricing.

Matthew David: I'm pleased to be here today to provide an overview of our second quarter, and first half of 2022 financial results, as well as an update on our cash position.

Matthew David: The company has filed its report on Form 10-Q for the second quarter ended June 30, 2022. 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 2022 financial results, our net loss was approximately, $7.6 million, or $0.19 per share, compared with a loss of $4.6 million, or $0.12 per share, in the second quarter of 2021.

Matthew David: The higher net loss recognized in 2022 compared with 2021 included an increase in both SG&A expenses and R&D expenses versus the second quarter of 2021. Operating expenses in the second quarter of 2022 increased approximately 41% to $8.3 million, compared with $5.9 million in the second quarter of 2021. R&D expense, increased by approximately 28% to $3.2 million, driven by an increase in costs related to the manufacturing of the FENCAF prior to its potential marketing approval, partially offset by net decreases in personnel expenses, consulting fees, and clinical trial expenses.

Matthew David: SG&A expense increased approximately 50% to $5.1 million, compared with $3.4 million in the second quarter of 2021. This increase was primarily attributable to an increase in costs related to market research studies and prelaunch activities in preparation for the potential marketing approval of the FENCAF, a net increase in personnel expenses, and increases in legal fees and non-cash charges for stock-based compensation.

Matthew David: With respect to our first half of 2022 financial results, total operating expenses during the first half of 2022 amounted to $15.3 million, compared with $13.1 million in the first half of 2021, an increase of 17%. R&D expense increased 6% to $5.5 million, driven primarily by an increase in costs related, to the manufacturing of the FENCAF prior to its potential marketing approval, partially offset by net decreases in personnel expenses, clinical trial expenses, and consulting fees.

Joseph Todisco: I will now turn the call back over to Joe for closing remarks.

Matthew David: SG&A expense increased approximately 23% to $9.8 million, compared with the first half, of 2021, primarily driven by an increase in legal fees, an increase in personnel expenses, and an increase in costs related to market research studies and prelaunch activities in preparation for the potential marketing approval of the FENCAF.

Joseph Todisco: Joe?

Matthew David: We recorded net cash used in operations during the first half of 2022 of $12.2 million, compared with net cash used in operations of $9.8 million in the first half of 2021. The difference was primarily driven by an increase in net loss, primarily attributable to an increase in operating expenses as compared to the same period in 2021.

Joseph Todisco: Thanks, Matt.

Matthew David: Chromatics remains in a good position from a balance sheet perspective. The company has, cash in equivalents of $64.6 million as of June 30, 2022. This includes approximately $11.4 million raised during the first half of 2022 through our ATM program, and approximately, We believe our cash and equivalents gives the company flexibility to fund its operations at least through the third quarter of 2023, after taking into consideration costs related to manufacturing activities and costs related to the potential commercial launch for DefendCat.

Joseph Todisco: As I look toward our next few months, I remain excited about the opportunities and optimistic about the challenges that lay ahead.

Matthew David: As Joe and Phoebe have discussed today, we remain optimistic about our progress toward an anticipated FDA approval for DefendCat.

Joseph Todisco: DefendCat has the potential to address a critical unmet medical need and, if approved by FDA, can significantly improve patient outcomes, while also having an impact on the health equity disparity that is pervasive in our healthcare system.

Matthew David: 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 facing what we hope and believe will be a pivotal time ahead for CorMedix, as we seek to bring DefendCat to patients in the hemodialysis setting.

Joseph Todisco: Catheter-related bloodstream infections, or CRBSIs, place a heavy financial burden on the U.S. healthcare system, estimated at roughly $2.3 billion per year of incremental cost. Hemodialysis patients with a CRBSI have double the rate of hospitalization as non-infected HD patients, with an average duration of stay that is four times longer and a three times higher fatality rate.

Joseph Todisco: In addition, African Americans represent under 14% of the U.S. population, but account for more than 35% of patients undergoing hemodialysis. To that extent, African Americans are disproportionately at risk for catheter-related bloodstream infection compared to other demographic groups. DefendCat, in clinical trials, reduced CRBSI occurrence by 71% in hemodialysis patients compared to the existing standard of care, Heparin.

Joseph Todisco: Taken in totality, the strong clinical profile of DefendCat and potential to significantly improve patient outcomes and health equity, while also potentially decreasing the overall cost burden on the healthcare system, I continue to see DefendCat as a critical drug product and strong platform asset for growth from which CoreMedix can build.

Good.

Well look we've we've.

Listen a whack as part of our end cap application certainly we are not bound.

To list at that WAC.

As we said in the prepared comments, we have to set one wax a even though we do expect to have different net pricing across different settings of care.

We're not going to comment at this time on on net pricing and in those specific settings other than to say, we do expect outpatient to be to be lower than what we see on the inpatient side.

I think in terms of net pricing.

Don't know that we're gonna be publishing specific pricing by setting of care or.

Each customer, but we'll we'll try to get some guidance as we get closer to commercialization.

Got it that's helpful. And then in regards to your AP supplier, what kind of timeframe is appropriate for resolution of the warning letter.

And then do you think be the warning letter needs to be closed out before the NDA can be filed.

Yeah.

So your question was only specific to the to the API supplier.

Correct.

Phoebe do you want to.

Do you want to address certainly sure. Thanks.

Thanks Liz.

You know it does that timeline for resolution of warning letters totally depends on the interactions between the facility and F. D. A and we're obviously not part of that process. We are aware of information provided by the API supplier that they are working as fast as possible to get the issues resolve.

Hum.

And we have been told by SBA that defend cat M D E and needs to have those issues resolved before we can resubmit them. So I think where we intend to monitor the situation as closely as possible, but there is no statutory time for resolution of issues.

The warning letter, it's up to the agency's discretion.

That is helpful on the <unk>.

With alchemy, that's how can he have similar capacity to the current EU CMO.

And also it sounds like you've identified the alternate source for heparin API supplier, how quickly could that be put into place and will they just work alongside of alchemy.

Tom.

Yeah. Thanks, less so in terms of capacity alchemy has sufficient capacity.

To handle our commercial needs should should we need them to.

In terms of the alternate or the additional API source the timeline would be similar.

Similar to are identical to the timeline of getting alchemy approved those would work in tandem that that submission would go in with the new API and when that.

When or if that submission is approved the new API would be approved with it.

Got it. Thank you and then last one for me would be on the.

You mentioned the trade name issues can you just clarify that a little bit more what are your options here.

The potential for renaming and how does that affect any impact that you already have completed.

On your marketing efforts and any issue with re filing the NDA for that too. Thank you now.

Thanks, Les there's really no issue here and this is not unusual it happens periodically win applications are under review when they go in.

There may not be any names that that have sounded like complex, but you know overtime as new named gets submitted to the FDA identifies the source of confusion notifies both application holders that theres a potential conflict and you have the ability to submit an additional name the application that gets approved first gets the the.

The original name and Ah the.

Application that gets approved second we get in all alternative names. We've identified an alternative name I am I think both names are adequate for our marketing purposes in which every name we move forward with them I'm confident theres no change in value.

Got it thank you.

Yeah.

Yeah.

Our next question is from Needham.

Needham <unk> co. Please go ahead.

Hi, This is Ryan on for Serge Thanks for taking our questions.

In terms of the <unk> reimbursement, there's a conditional approval by July 2023.

Are you able to extend the date that they can't be met and are you just talking about the options there.

Thanks, Alright, you know as I as I said in my prepared remarks, we're gonna submit a duplicative application. This October to get into the next and tap review cycle with the expectation that we would still be eligible for approval as we are as we were this year.

So to the extent that we did not get final NDA approval by July one of 2023, and this and tap.

It did not take effect, we would have that application hopefully approved by that point in time.

Thanks, and then another one regarding the pre filled syringe product just based on where we are now how much of a priority is that.

I guess, how do you expect to move that forward.

Thanks for it so I mean, I really see the PFS was more of a lifecycle management. Obviously, it's it's nice to have it it's not critical to approval to launch.

We are focused on getting approval of the NDA and now will we will we will continue to move PFS Ford, but once we have final approval of the NDA.

Yeah.

Thank you.

I'll now hand, the call over to Ken for you so anyway some questions Dan.

Joseph Todisco: While the CRL is an unfortunate speed bump, our quickest pathway to market remains resolution of deficiencies at our existing CMO and API supplier, and CoreMedix is committed to mobilizing all resources to achieve that objective.

Joseph Todisco: I remain confident in our ability to bring this product to market in order to address a significant unmet medical need.

Thank you operator.

Did you have a few written questions here Joe the first one is given the CRM.

Joseph Todisco: Thank you for your continued support of and interest in CoreMedix.

And continued delays on the regulatory side.

Could you walk us through what the commercial team is focusing on.

What can we expect over the coming months.

Operator: One moment, please, while we poll for questions.

Sure. Thanks, Dan.

So there's a lot of I'll call it pre commercial activities that still need to take today.

Operator: The first question is from Jason Butler of J&P Securities.

Certainly on the infrastructure and systems side, as we're preparing to be able to warehouse distribute ship product collect cash.

Operator: Please go ahead.

You know those work streams all continue unimpeded.

Royan: Hi, it's Royan for Jason.

And then there's also a large number of activities on the on the well call. It the true marketing side I'm going to let Aaron.

Aaron comment a little bit, but there's certainly a lot of disease state awareness with respect to see our BSI that needs to take place.

Royan: Thanks for taking our questions.

Aaron do you want to add some commentary.

Sure. Thanks for the question the commercial team, we're going to continue to focus and refine the inpatient and outpatient markets.

Royan: I had a few on the manufacturing bit first.

Royan: I guess, can you just tell us the location of the current Heparin supplier?

Royan: And is Alchemy, just so I'm clear, is Alchemy going to work with that supplier as well, or just a new supplier?

Royan: And then conversely, is the current contract manufacturer also going to begin work with the new Heparin source, or are they going to stick with the old source?

There's a lot of market dynamics, specifically going on with the Medicare advantage plans and the evolving risk share arrangements in both settings of care.

And those risk sharing arrangements are both financial and outcomes based.

Got continued segmentation there. We also will work with conversations with hospital PMT Committee members and key opinion leaders and as Joe mentioned, there was heavy heavy marketing efforts around the disease awareness campaign and our engagement with some of those key conferences.

Regardless of that there is a lot of advocacy and political support for the reimbursement in the outpatient setting will continue to work with those key stakeholders as well.

Joseph Todisco: Okay, thanks, Roy.

Thanks Erin.

Thanks, Joe Thanks, Sharon.

Yeah.

But what is factored into the current cash guidance when you say through three Q of 2023.

All right. Thanks, Thanks, Dan I'm going to let Matt comment on that.

Joseph Todisco: In terms of the API supplier, I think we're comfortable saying it's in Europe.

Joseph Todisco: Alchemy will only be working with the new Heparin supplier for the time being.

Sure No problem alright, thanks, guys.

Yeah.

Cash guidance. We gave today. This includes ongoing manufacturing activities are commercial launch supply and other commercial prep.

Joseph Todisco: That's the workstream that we are focused on, and the existing CMO will remain with the existing Heparin supplier.

Joseph Todisco: And that's the current way we've set up the workstream.

Royan: Okay, great.

Royan: And then if you submit the supplement at the end of 1Q next year, what do you expect to get for a review period, assuming it's accepted?

Royan: And then on the reimbursement bit for the outpatient part, do you guys have any examples of companies that have argued to CMS for the J code and not the Tdap and been successful?

Royan: Thanks.

Clearly, we would plan to moderate our cash burn to align with the timeline for a potential regulatory approval for example.

Joseph Todisco: Well, to address the first question first on timelines, I'm going to turn that over to Phoebe if you want to comment on review period.

Phoebe Mounts: Certainly.

Airing of the field force and other larger items.

Phoebe Mounts: Thanks for the question, Roy.

Phoebe Mounts: It depends on what you're referring to as the submission of the first quarter of 2023. If, as we hope, the deficiencies can be addressed quickly, then the submission that would be in place would be a resubmission of the NDA with the current CMO.

Phoebe Mounts: And we would expect that to properly be a Class I, which has a shorter review period of two months because, as I said, there's nothing on the product side that needs to be submitted in the NDA.

Phoebe Mounts: And we will presumably have the go ahead from FDA for resubmission.

Alright, Thank you, Matt and I have another one here for you does the company need to do a large financing.

Fund ongoing spend.

Phoebe Mounts: So we would expect that to be a quick review.

Phoebe Mounts: If, however, the resubmission involves the new CMO, then we obviously have manufacturing information that will need to be reviewed by FDA for the facility, and that should properly be a Class II resubmission, and that would be a six-month review period.

Okay. Thanks for the question.

We don't need to do a significant amount of financing given our cash runway takes us at least through the third quarter of 2023 as we have said in the past for medics is always looking at a range of opportunities to fund our ongoing business and we have both a shelf on file as well as an ATM in place if needed.

Royan: Okay.

Phoebe Mounts: Thanks.

Joseph Todisco: Thanks, Phoebe.

Joseph Todisco: And on the reimbursement question, TADAP is a relatively new program, so there's not a whole lot of history there in terms of what arguments companies have made with respect to TADAP or separate reimbursement.

Joseph Todisco: In addition, those discussions with CMS are fairly confidential between the companies and CMS, so we don't have any – there's no public record I can point to with an example.

Joseph Todisco: So it's possible we're unique in making this argument, as our product is somewhat unique.

Royan: Okay.

Operator: Good morning.

Royan: Makes sense.

Les: This is Les on for June.

Royan: Thank you.

Les: Thank you for taking my questions.

Operator: Our next question is from June Lee of Truist, please go ahead.

Les: Joe, I guess we'll start on the pricing.

Les: Thank you for that color that you provided.

Matthew David: As we have said in the past, Formedex is always looking at a range of opportunities to fund our ongoing business, and we have both a shell phone file as well as an ATM in place if needed.

Les: Can you provide a little bit more details, I guess, on how this, how do you expect to, play out closer to approval, and when do you think you'll be in a position to announce finalized pricing?

Matthew David: Thanks, Matt.

Les: Thank you.

Joseph Todisco: Well, look, we've listed a WAC as part of our NTAP application.

Joseph Todisco: Certainly we are not bound to list at that WAC.

Operator: Operator, this concludes the written question portion of the Q&A session.

Joseph Todisco: As we've said in the prepared comments, we have to set one WAC, even though we do expect, to have different net pricing across different settings of care.

Joseph Todisco: We're not going to comment at this time on net pricing in those specific settings, other, than to say we do expect outpatient to be lower than what we see on the inpatient side.

Joseph Todisco: I think in terms of net pricing, I don't know that we're going to be publishing specific, pricing by setting of care or customer, but we'll try to get some guidance as we get closer to commercialization.

Thanks, Matt.

Les: Got it.

Les: That's helpful.

Operator. This concludes the written question portion of the Q&A session. You may now close the call.

Les: And then in regards to the APA supplier, what kind of timeframe is appropriate for resolution, of the warning letter?

Les: And then do you think the warning letter needs to be closed out before the NDA can be refiled?

Les: So the question was only specific to the API supplier?

Les: Correct.

Operator: You may now close the call.

Phoebe Mounts: Okay.

Operator: Thank you.

Phoebe Mounts: Phoebe, do you want to address that?

Operator: Ladies and gentlemen,

Phoebe Mounts: Certainly.

Phoebe Mounts: Sure.

Phoebe Mounts: Thanks.

Thank you ladies and gentlemen that does conclude today's conference. Thank you for joining US you may now disconnect your lines.

Phoebe Mounts: Thanks, Les.

Operator: that does conclude today's conference.

Phoebe Mounts: You know, the timeline for resolution of warning letters totally depends on the interactions, between the facility and FDA, and we're obviously not part of that process. We are aware of information provided by the API supplier that they're working as fast, as possible to get the issues resolved.

Phoebe Mounts: And we have been told by FDA that the DefendCast NDA needs to have those issues resolved before, we can resubmit.

Phoebe Mounts: So I think we intend to monitor the situation as closely as possible, but there's no statutory, time for resolution of issues in a warning letter.

Phoebe Mounts: It's up to the agency's discretion.

Les: That is helpful.

Les: With ALCHEMY, does ALCHEMY have similar capacity to the current EU CMO?

Les: And also, it sounds like you've identified the alternate source for HEPRIN API supplier.

Yeah.

Les: You know, how quickly could that be put into place?

Les: And will they just work alongside of ALCHEMY at the same time?

Yeah.

Joseph Todisco: Yeah.

Joseph Todisco: Thanks, Les.

Joseph Todisco: So in terms of capacity, ALCHEMY has sufficient capacity to handle our commercial needs, should, we need them to. In terms of the alternate or the additional API source, the timeline would be similar, to or identical to the timeline of getting ALCHEMY approved. Those would work in tandem.

Mhm.

Joseph Todisco: That submission would go in with the new API.

Joseph Todisco: And when or if that submission is approved, the new API would be approved with it.

[music].

Les: Thank you.

Les: And then the last one for me would be on the, you mentioned the trade name issues.

Les: Can you just clarify that a little bit more?

Les: What are your options here?

Les: Is there potential, for renaming?

Les: And does that, you know, affect any impact that you already have completed on your marketing efforts?

Les: And is there any issue with refiling on the NDA for that too?

Joseph Todisco: Thank you.

Joseph Todisco: No, thanks, Les.

Joseph Todisco: There's really no issue here.

Joseph Todisco: And this is not unusual.

Joseph Todisco: It happens periodically, when applications are under review.

Joseph Todisco: When they go in, there may not be any names that have sound-alike conflicts.

Joseph Todisco: But, you know, over time, as new names get submitted, the FDA identifies the source of confusion, notifies both application holders that there's a potential, conflict, and you have the ability to submit an additional name. The application that gets approved first gets the original name. And the application that gets approved second would get an alternative name.

Joseph Todisco: We've identified an alternative name.

Joseph Todisco: I think both names are adequate for our marketing purposes.

Joseph Todisco: And whichever name we move forward with, I'm confident there's no change in value.

Les: Got it.

Operator: Thank you.

Operator: Our next question is from Marie Besson of Needham & Co.

Operator: Please go ahead.

Rohit: Hi.

Rohit: This is Rohit on FirstSurge.

Rohit: Thanks for taking our questions.

Rohit: In terms of the NTAP, reimbursement, there's a conditional approval by July 2023.

Rohit: Are you able to extend the date if this date can't be met?

Rohit: And just talk about the options there.

Joseph Todisco: Thanks, Rohit.

Joseph Todisco: You know, as I said in my prepared remarks, we're going to submit a duplicative, application this October to get into the next NTAP review cycle with the expectation that, you know, we would still be eligible for approval as we were this year.

Joseph Todisco: So, to the extent that we did not get final NDA approval by July 1st of 2023 and this NTAP did not take effect, we would have that application hopefully approved by that point in time.

Rohit: Thanks.

Rohit: And then another one regarding the prefilled syringe product.

Rohit: Just based on where, we are now, how much of a priority is that?

Rohit: And then, I guess, how do you expect to move that forward?

Rohit: Thanks.

Joseph Todisco: Thanks, Rohit.

Joseph Todisco: So, I mean, I really see the PFS as more of a lifecycle management.

Joseph Todisco: Obviously, it's nice to have.

Joseph Todisco: It's not critical to approval or to launch.

Joseph Todisco: You know, we are focused on getting approval of the NDA.

Joseph Todisco: And, you know, we will continue to move PFS forward, but once we have final approval of the NDA.

Rohit: Thank you.

Operator: I'll now hand the call over to Dan Philly for any written questions.

Dan Ferry: Dan?

Dan Ferry: Thank you, operator.

Dan Ferry: We do have a few written questions here, Jo.

Dan Ferry: The first one is, given the CRL, and continued delays on the regulatory side, could you walk us through what the commercial team is focusing on?

Joseph Todisco: What can we expect over the coming months?

Joseph Todisco: Sure, thanks Dan.

Joseph Todisco: So there's a lot of, I'll call it pre-commercial activities that still, need to take place.

Joseph Todisco: Certainly on the infrastructure and systems side, as we're preparing to be able to warehouse, distribute, ship product, collect cash, you know, those work streams all continue unimpeded.

Joseph Todisco: Then there's also a large number of activities on the, we'll call it the true marketing side.

Joseph Todisco: I'm going to let Erin comment a little bit, but there's certainly a lot of disease state awareness with respect to CRBSI that needs to take place.

Erin Mistry: Erin, do you want to add some commentary?

Erin Mistry: Sure, thanks for the question.

Erin Mistry: The commercial, team, we're going to continue to focus and refine the inpatient and outpatient markets.

Erin Mistry: There's a lot of market dynamics specifically going on with the Medicare Advantage plans, and the evolving risk share arrangements on both settings of care. And those risk share arrangements are both financial and outcomes-based.

Erin Mistry: So we've got continued segmentation there.

Erin Mistry: We also will work with conversations with hospital P&T committee members and key opinion, leaders.

Erin Mistry: And as Joe mentioned, there's heavy marketing efforts around the disease awareness campaign and our engagement with some of those key conferences.

Erin Mistry: Regardless of that, there's a lot of advocacy and political support for the reimbursement in the outpatient setting.

Erin Mistry: We'll continue to work with those key stakeholders as well.

Erin Mistry: Thanks, Erin.

Joseph Todisco: Thanks, Joe.

Joseph Todisco: Thanks, Erin.

Dan Ferry: I have another, question.

Dan Ferry: What is factored into the current cash guidance when you say through 3Q of 2023?

Dan Ferry: Thanks, Dan.

Matthew David: I'm going to let Matt comment on that.

Matthew David: Sure.

Matthew David: No problem.

Matthew David: Thanks, guys.

Matthew David: In terms of the cash guidance we give today, this includes ongoing manufacturing activities, commercial launch supply, and other commercial prep. Clearly, we would plan to moderate our cash burn to align with the timeline for potential regulatory approval.

Matthew David: For example, the hiring of the field force and other larger items.

Matthew David: All right.

Matthew David: Thank you, Matt.

Dan Ferry: I have another one here for you.

Dan Ferry: Does the company need to do a large financing to fund ongoing spend?

Dan Ferry: Okay.

Matthew David: Thanks for the question.

Matthew David: We don't need to do a significant amount of financing given our, cash runway takes us at least through the third quarter of 2023.