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CorMedix (NASDAQ:CRMD) Q1 2020 Earnings Call

CorMedix (NASDAQ:CRMD) Q1 2020 earnings call, held 2020-05-11. Watch the replay and read the transcript on 6ix.

Mon, May 11, 2020 at 4:30 PMendedReplay
CorMedix (NASDAQ:CRMD) Q1 2020 Earnings Call
Company
CorMedix Inc. (NASDAQ:CRMD)
Period
Q1 2020 earnings call
Date
Mon, May 11, 2020, 4:30 PM ET
Replay
Watch the replay on this page · 41 min
Results news release
CorMedix Inc. Reports First Quarter 2020 Financial Results and Provides Business Update · Mon, May 11, 2020

On 6ix: 6ix.com/event/cormedix-inc-crmd-q1-2020-earnings-call

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Transcript

Automated transcript · Written by software from the replay's audio. It can mishear names and figures; the replay is the record.

0:00 Please stand by. We're about to begin. Good day, everyone, and welcome to the CoreMedix Incorporated First Quarter 2020 Earnings Conference Call. Today's call is being recorded. At this time, I would like to turn the conference over to Dan Ferry from LifeSci Advisors. Please go ahead. Good afternoon, and welcome to the CoreMedix First Quarter 2020 Earnings Conference Call. Leading the call today is Kosa Belush. Chief Executive Officer of CoreMedix. He is joined by Phoebe Mounts, Executive Vice President and General Counsel, Paul Chu, Chief Medical Officer, and Matt David, 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 meeting set forth in the Private Securities Litigation Reform Act of 1995.

0:54 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 for Neutrolin in the U.S. and other product candidates, future financial position, future revenues and projected costs, and potential market acceptance of 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, expectations as to the timing and nature of anticipated regulatory actions, possible product licensing or other business development transactions, any commercial plans and expectations, market projections for our product candidates, and expectations as to manufacturing and product component costs.

2:02 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. and more, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from CoreMedix. 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. Please note that CoreMedix does not intend to update these forward-looking statements except as required by law.

2:47 At this time, it is now my pleasure to turn the call over to Mr. Koso Baluch. Chief Executive Officer of CoreMedix. Koso, please go ahead. Thank you, Dan. Good afternoon, everyone, and thank you for joining us on this call. On today's call, we will cover several topics with you on the overall progress CoreMedix is making in bringing nutrition to the U.S. market for the first indication for use as a capital loss solution for human dialysis patients. with subsequent expansion into other indications, plus an update on the number of topics pertinent to call medics. Joining me in this call are C.B., Paul, and our new Chief Financial Officer, Matt David.

3:37 We will cover five topics. First, I'm pleased to inform you that our first-year CFO to take the potential job has been completed. I'd like to introduce our new CFO, Matt David. Matt brings a wealth of capital markets and advisory experience, having spent the majority of his career in the healthcare investment banking world, with a variety of financial institutions, including the Bank of America, Merrill Lynch, and previously, Fergan Partners, Thomas Riles, and Piper Jeffrey, as well as experience on the research side at Lehman Brothers. In addition, Matt trained as a physician at NYU, which has helped him effectively communicate the strategy, positioning of the company, while he's played a key role, including most recently at Ovis Therapeutics.

4:33 We're pleased to have Matt join us at this critical stage in co-medics development. We're also fortunate that Bob Cook is available to assist Matt to ensure a seamless transition. Although today is Matt's first day, we have already started the process of bringing Matt up to speed on ongoing activities and strategic priorities for the company. Secondly, as we've previously stated, our next public communication regarding the new drug application for Nutrilite will occur once we have received a response from the FDA regarding the acceptance to file of our rolling submission. As we've previously stated, Nutrient is the first product to have successfully completed a phase three study for the prevention of CRBSIs in human dialysis and has done so in spectacular fashion with a reduction of over 70% in CRBSIs with a p-value of 30,0006.

5:51 CRBSIs are a leading cause of death for patients with catheters and impose enormous costs to our healthcare system. As a result, mutual address is both a critical unmet medical need and will also significantly reduce costs to the healthcare system. This is why we're so excited about the opportunity to bring our data to the Center for Medical Care and Medicaid Services, CMS, which pays the healthcare costs for around 90% of the patients who are receiving hemodialysis. CMS pays for a significant amount of the cost of hemodialysis under the program for end-stage renal disease patients referred to as the bundle, a fixed reimbursement arrangement which has historically been an impediment to the adoption of new technology and better care for patients undergoing hemodialysis.

6:56 However, in recognition of this issue, CMS now has a program to accelerate the adoption of new treatments that can both improve patient care and or reduce costs. This program is called TDAPA, which stands for Transitional Drug Add-on Payment Adjustment, which allows for reimbursement of new technologies outside the bundle while the necessary utilization data is collected to determine how to incorporate the cost of these products. In principle, T-WAPA designation lasts for two years. However, other products already in T-WAPA have been included in this program for beyond a two-year period.

7:41 We believe, and so do external experts, that Nutrient is qualified for reimbursement under T-WAPA, and CoreMedix is preparing its T-WAPA application, which will be submitted under FDA approval of Nutrient NDA. We believe that a T-DAP approval will dramatically speed the acceptance of nutrients as a standard of care for the prevention of CRDSI in hemodialysis. Now I would like to address the market opportunity for nutrients in hemodialysis and other indications for use. As previously stated, we believe the U.S. market opportunity in human dialysis to be approximately 80 million vials per year by 2025.

8:27 While we have not yet discussed our pricing plans for Nutri, we believe that the product can garner significant market share based on the support of clinical data regarding the reduction of CRDSI infections. The potential cost savings to the healthcare system The lack of alternatives and for these patients to reimburse with coverage under the GWAPA program. Our current value-based pricing model demonstrates that there is a substantial opportunity in the hemodialysis setting alone. Please also keep in mind that this does not include or take into account other indications such as oncology and TPM.

9:13 which effectively more than doubles the market opportunity once CoreMedix is able to secure FDA approval for those indications. We are excited as we continue through the regulatory process and begin preparing for the commercial launch of Nutrient. Our goal is to do it as quickly and efficiently as possible while maximizing value to our shareholders. Matt David, as well as other recent hires are all necessary and welcome additions to our management team, and they will help us achieve our goals. I'd also like to turn our attention to two other topics, namely the new brand name in the U.S. and selected international markets for our capital loss solution and a parallel event that we have just scheduled.

10:01 When we begin with the brand name, As Phoebe will discuss, FDA regulates the brand name that any company uses for its drug product, and the agency must review and approve the brand name prior to use. I'm pleased to inform you that we have received conditional approval from the FDA for the name of DefendCat, spelled as D-E-S-E-N-C-A-T-H, DefendCat, for our catalog solutions. This is very exciting and provides us the opportunity to build the brand equity going forward. Over time, you will see that the name Defeat Camp will be used for the U.S., Canada, and other markets where we have not yet launched.

10:48 In existing markets, such as the European and Middle East markets, the brand name Defeat Camp will continue to be used as a catalog solution. Now moving on to the KOL event. I'm pleased to inform you that CoreMedix will be hosting a KOL event for investors on May 19, 2020, beginning at noon. The title of the event will be Antimicrobial Resistance, Catheter-Related Blood Screen Infection, CRBSI, and the Potential for Neutrin. Paul will be providing you further details during this call. Please review the 10Q that we are filing today. As we previously announced, CoreMedix was approved to sell 5.5 million of our new Jersey net operating losses through the state tax certificate program and raise approximately 5.2 million net of commissions.

11:46 We will also note that in April 2020, CoreMedix was awarded a small business waiver of the MDA filing fee by the FDA. We paid that filing fee in Q1, which we reported on our March 31, 2020 balance sheet, as a refundable deposit, and which was reimbursed by the FDA in April. The filing fee amount was $2.9 million. We were pleased to be given the waiver and a refund very quickly. As a result of the New Jersey NRL sale and the reimbursement of the FDA filing fee, Our pro forma cash position as of March 31st, 2020 was $31.3 million. Now, let's start with our newly appointed Chief Financial Officer, Matt Raven.

12:35 Matt? Thank you, Coco, for the warm welcome and kind introduction. I'm thrilled to be joining Core Medix at such an exciting time for the company. As the FENCAP approaches a potential regulatory approval later this year, and many more. As Koso mentioned in the introduction, I have spent the majority of my career as an investment banker focused on advising small therapeutics companies on everything from various forms of capital raising to strategic initiatives.

13:25 I'm eager to bring my experience in finance, capital markets, and strategy to the broader Cormetics team as we move closer to the company's first approval and subsequent launch into the hemodialysis markets. As both a physician and a biopharma executive, I am enthusiastic about the prospects of DefendCast for the targeted patient population and the healthcare system broadly. While we are living in unprecedented times with the COVID-19 pandemic, I am a firm believer that the biopharma industry will triumph in the long run. Companies like Cormatic are solving clinical problems, aiming to fill unmet needs. and have the potential to generate substantial value for patients and stakeholders alike in the long run. Let me hand back to Koso.

14:13 Thank you, Matt. I'll let you do a regular update with Phoebe. Thank you, Koso. It is a pleasure to be here again, and let me start with the granting by FDA of our request for the small business waiver and the prompt refund of NDA filing fees. We appreciate FDA's continuing efforts to work with us during the coronavirus pandemic, which has resulted in challenges and work adjustments for all of us. We are grateful for their continuing effort as we work through the NDA submission process. Next, as Koso mentioned, we are very happy to announce the new name of DefendCas for the CoreMedix catheter lock solution that is intended for the U.S. market. As you know, Neutralin is regulated as a medical device in Europe and has been CE marked for commercial distribution in several markets outside of the U.S. In the U.S., where FDA is regulating the catheter lock solution as a new drug, part of the pre-market review of a product that is the subject of an NDA requires that FDA approve the proprietary name for the new product prior to launch.

15:31 CoreMedix saw it as an opportunity to identify a strong brand name to distinguish Neutrolin as a drug in the U.S. CoreMedix went through a rigorous process to select potential names that it believed would meet FDA's requirements. As part of the premarket review process, FDA evaluates both safety and promotional aspects of the product's proposed proprietary names. The evaluations are intended to minimize medication errors and to ensure compliance with promotional requirements by avoiding implied claims. For example, FDA conducts look-alike and sound-alike analyses to prevent medication errors in the prescribing, dispensing, and administration of the drug product to the patient.

16:23 We look forward to final approval by the FDA of DefendCast as the proprietary name when the NDA is approved. Next, as you know from previous updates, our primary focus has been on submitting modules for the new drug application for DefendCAS to secure marketing authorization in the U.S. for the initial indication for use in hemodialysis patients. As Koso stated, our next public communication regarding our NDA filing will occur once we have received a response from the FDA regarding the acceptance to file of our rolling submission. At this time, we are maintaining our guidance for an anticipated decision of approval of the NDA in the second half of 2020.

17:14 Finally, in addition to continuing with the submission of the NDA for preventing catheter-related bloodstream infections in adult hemodialysis patients, We are working on developing the regulatory pathway for additional indications for use in oncology patients and for patients requiring total parenteral nutrition or TPN. While we focus on securing the first indication for use in adult hemodialysis patients with the data from LOCIT 100, we are developing protocols for expanding the indications for use into pediatric hemodialysis patients and other patients with central venous catheters. With that summary, let me pass the floor to Paul to cover the KO element.

18:01 Paul? Thanks, Phoebe. Good afternoon, everyone. I'm pleased to be back and share with you the exciting event we have planned on May 19th, a webinar on preventable infection in hemodialysis patients with central venous catheters. The webinar is designed for new and existing investors. Why now? Today's COVID-19 pandemic threatens the world and shows in stark relief the importance of preventing infection. But the constant threat of life-threatening infection is nothing new to hemodialysis patients with catheters. In fact, COVID-19 was reported early in the pandemic in hemodialysis clinics, where immunocompromised patients are closely seated together for hours at a time. Every day they face the threat of life-threatening infection, especially from organisms resistant to last-resort antibiotics.

18:52 Thank you for joining us. The daily challenges and unmet medical needs of infection prevention in the hemodialysis clinic and the potential for the FENCAP to address both of these challenges. The call will feature Dr. Bruce Polsky from the Long Island School of Medicine and NYU Winter Hospital, Dr. Bruce Reidenberg from Weill Cornell Medicine, and Dr. Nelson Kopit from the Lehigh Valley Health Network.

19:44 They'll be available to answer questions following the webinar. The invitation and press release for the webinar are available on the Corpsmanix website, and I hope many of you will be able to attend. With that, let me turn the floor back to Kozo. Thank you, Paul. As I stated, our goal is to maximize shareholders' value. Because human resources is a very concentrated payout provider market, We continue our preparations to commercialize the FinCAP in the U.S., whether on our own or with a strategic or commercial partner. All options on the table and will be evaluated with this one goal in mind. We have begun building internal functions by hiring individuals to fill senior roles in the commercial area. This gradual buildup will help us move forward in preparing and refining our launch plans as we move closer to an anticipated decision Over the last several weeks, we have expanded the team with additional market access payer experts. We intend to incrementally build out the team over the course of the year, followed at the end by the hiring of the field sales folks if we are in a go-to-learn scenario with a strategic or commercial partner.

21:04 We are now in position to step up and focus a great deal of our energy on engaging specifically with the various stakeholders within the dialysis market through direct contact with the large dialysis providers and with the peers, including seniors. This will provide CoreMedix with strong foundation required to launch as soon as possible after the initial approval. Once again, let me remind you that this huge market represents a very large unmet medical need, as today there are no pharmacological agents approved in the U.S. for the prevention of CRPSR in central venous catheters. I therefore believe should the same class be approved by the FDA, it would rapidly become the standard of care in the U.S.

21:53 Now let me provide you with a top-line review of the first quarter 2020. As I previously mentioned, I urge you to read the information containing the report for a more complete discussion on our financial results. Total cash on hand in short-term investments as of March 31, 2020 is $23.2 million, excluding restricted cash of $0.2 million. In accordance, the company made selective use of its ATM program, raising approximately 2.5 million net of commissions by selling approximately 368,000 shares at an average cost of about $6.92 per share.

22:46 Additionally, we received approximately $0.4 million in proceedings from the exercise of search and balance. We also announced that we were approved to sell 5.5 million of our New Jersey net operating losses through the Safe Tax Certificate Program and raise approximately 5.2 million net of commissions. These funds were received in April. With these funds, plus the 2.9 million refunded from the FDA that we received in April, in connection with the Small Business Waiver of the NDA filing fee, We have a pro forma cash position as of March 31, 2020 of $31.3 million. $31.3 million. We believe that there are sufficient resources to fund operations into the second quarter of 2021, including initial preparation for commercial launch of the same cash after approval by the FDA.

23:50 For company cash spending, defined as first use in operation was $8 million during the first quarter 2020. While this was substantially higher than the previous quarter, a large portion of that burn was represented by the refundable signing fees, plus approximately $0.7 million on incremental jury spend, primarily to support pre-launch activities. Excluding the impact of the refunded MBA filing fee, our going rate is likely to modestly increase over the next two quarters as we continue preparation for commercialization and commence manufacturing of the same cast for the sale after approval.

24:37 So let me summarize the key takeaways from this call. What Max, Phoebe, and Paul covered with you hopefully provides you with insight into the work effort on which we are focused and that has occurred over the last two months. I'm pleased about the progress we're making despite challenges imposed by the coronavirus pandemic. I'd like to re-emphasize. First, I'm delighted that Max has joined CoreMedix as we prepare for approval of the FinCAP. Two, we are extremely pleased that the effort to move the regulatory process forward with the FDA is on track. We are maintaining our guidance for an anticipated decision on approval of the FDA in the second half of 2020.

25:22 We are pleased with the conditional approval from the FDA for the CAST brand name. This provides us with a tremendous opportunity to start the process to build equity around this name. and finally, we're continuing our financial strategy, which is to explore available alternatives to ensure the companies are properly funded to execute on our plans. Our current cash is sufficient to fund a portion of the industry required for land and to build some of the commercial leadership infrastructure. Finally, a reminder that while we initially focus on the human assets market, we are determined to seek additional indications for different cash We have had previous discussions with the FDA on clinical trials designed for use as a catalog solution in oncology and TPM and are working to develop the protocols with a goal of finalizing the regulatory pathway for these patient groups.

26:27 Our goal is to maximize shareholders' value. I continue to believe that once the FinCAP is approved, it will become the standard of care for preventing cap-related bloodstream infections in rheumatologist patients. As previously discussed, Velocity has been very productive in moving the FinCAP through the required regulatory process with a diligent focus on securing U.S. marketing approval. I'm very pleased with the strength of our management team. Each of the team members bring a unique The strategy we embarked on a few years ago will continue to move forward at an ever-increasing pace.

27:15 I look forward to providing you with material development updates via the CoreMedix website, press release, and conference call. Thank you for your continued support of CoreMedix, and let me hand the call back to the operator. Thank you. Thank you very much. If you would like to ask a question, please press star 1 on your telephone keypad. If you are on a speakerphone, please pick up your handset to allow your signal to reach our equipment. Once again, please press star 1 if you would like to ask a question. We'll take our first question from Andrew DeSilva with B Riley FBR. Hey, good afternoon. Thanks for taking my questions. Glad to hear everyone sounds healthy. Just a couple quick ones for me.

28:00 I think you mentioned your team might be out later today, but just so I have it, could you let me know what depreciation and amortization and stock-based comp was for the quarter? And then while you're pulling that, could you give us just a little bit of color on COVID-19's impact, if any, on just your ability to acquire talent? Have you been able to continue to identify appropriate members that you would expect to onboard closer to an approval position? or has there been substantial disruption due to COVID-19? And I'm specifically interested as it relates to sales and marketing. Okay. Thank you, Andy, for your question. The first part of your question, I would suggest if you look at our turnkey, whether it's submitted and we will then do a follow-up with you post this call to answer if you still have any questions there.

28:54 As it relates to the COVID-19, we need to use some further background. You know, we need to stop our employees and our families. We close our Berkeley high-nutriency office in the middle of March, and we ask our employees to work remotely from home, and they are continuing to work very collaboratively in a remote setting. And as you can see, we have been hiring individuals as I've outlined. Matt is one of them, but there are other individuals we have been hiring during this period. So it has not impacted our ability to continue to move our programs forward, and specifically in terms of hiring in the moment. There's a lot of video conferencing capabilities, and we've moved our face-to-face meetings to video conferencing, and that has done a pretty good job.

29:49 Okay, great, great. And just as it relates to Tadaka, you had a lot of commentary on that during the prepared remarks. Did anything new evolve related to Tadaka, or... Were you just effectively reiterating your belief that you should be able to qualify under it? Thank you. The way we are reiterating our firm belief and where we stand on GDPR, and as we have brought on board individuals in the market access environment, coding, and reimbursement and many more aspects. We also had an opportunity to continue to kick the tires and begin to have discussions not just internally but externally to the company with experts in that space and the belief continues to be very firm that we will be eligible for DDAPA and expect to get DDAPA once we have the approval.

30:59 That would be great to see, absolutely. And just kind of lumping two COVID-19 questions together, the discussion around infectious diseases has to be extremely relevant right now. Has that changed anything with just your discussions with regulators or potential partners, likes of Bovita or Fresenius? And then as it relates to COVID-19 and your NDA, has the FDA loosened any of the earlier restrictions just related to ex-U.S. facility inspections? And that's everything for me. Thank you very much. Okay. Phoebe, I will ask you to please respond as far as the FDA regulatory comments are concerned. And then I'll come back to cover the other discussions.

31:46 So, Phoebe? Yes, thank you for the question, Andy. We have not had any follow-up from FDA to suggest that there will or will not be any delays in the XUS facility inspection. So I think everyone is still hoping very much that we can turn things around quickly, but at the moment, as you know, FDA is under travel restrictions. And then we see a question about discussions with dialysis providers. You know, we are always having discussions with a whole range of individuals, including the large dialysis providers. You know, obviously the substance of those discussions are not the prime time at present.

32:32 As I said during the prepared remarks, We will continue to have deeper and more specific discussions with individuals in the dialysis provider setting, but also with CMS as we go forward and we prepare ourselves for the approval or once we get approval of the MCAS here in the U.S. Okay, great. Thank you very much. Please stay safe and best of luck going forward. Thank you. Thank you. And with no further questions in the queue, at this time I would like to turn the call back over to Dan Ferry for some additional questions.

33:18 Thank you, Operator. I have some questions that we have received from the audience from investors leading up to today's earnings call. The first one is for Paul. Paul, is there going to be any new information available shared during this KOL event that you referenced. Thanks, Dan. The KOL event next week will provide information to investors and analysts from the perspective of clinical experts. We're moving through uncharted territory with COVID-19, and this has impacted our hemodialysis patients and our KOLs. We'll share the challenges these very vulnerable patients are facing going through this as well as CRBSI.

34:04 This is an opportunity for investors to talk to KOLs who have their own thoughts on their patients and the market for current medical need. Great. Thanks, Paul. The second question is from Matt. Matt, as you have not been a CFO in the past, why do you think you can do this role? Sure. No problem. Happy to take the question. Sure. As part of my experience as a healthcare investment banker for many years, I've worked closely with many CFOs and am familiar with the role and responsibilities that go with it. Given where CoreMedix is now as a company, the capital markets and strategic advisor experience may be particularly relevant here.

34:54 I've spent the last couple of years working within companies, including most recently as head of strategy at Office Therapeutics, a public company, where I was responsible for financing strategy and investor relations. Lastly, I'm grateful to have the support of a talented team and Bob's experience close at hand during this transition. I hope that helps. Thanks, Matt. Okay, and Phoebe, I have a couple for you. So, Phoebe, with the rolling submission, is the FDA reviewing each section as it is submitted? And if not, what is the value of the rolling submission? Those are good questions, Dan. Thank you. FDA's program provides both for the rolling submission and rolling review of modules. So we're very grateful that the FDA granted us the opportunity to use the rolling submission and review program and appreciate the agency's efforts to help us address as quickly as possible the unmet medical need of reducing CRBSIs for hemodialysis patients.

36:02 for the second question on the value of the rolling submission and review. It is intended to provide efficiency and time saving to both the sponsor and the FDA. The sponsor can submit sections or modules of related information as it is completed and the FDA can begin reviewing information as it is received. FDA can then request additional information as it's needed for the submitted module while the sponsor works on the preparation and submission of additional modules and responses to the request for additional information from the agency in real time. So thank you. Thanks, Phoebe. And as you can imagine, I have a few more here.

36:48 What percentage of the NDA modules has been submitted? And why not tell us when you have completed the filing? Well, as I'm sure everyone knows, or as I've said in the past on the calls, there's a significant amount of information that needs to be submitted for an NDA, and there is ongoing dialogue with the FDA during the process, as I just noted. We appreciate your interest in our progress on submission of the modules, but the critical information is really when the FDA has accepted the NDA for filing. because it has deemed that the NDA is sufficiently complete for FDA to review it. So I can assure you that preparation of the NDA is a priority for core medics and we are all aware of the imperative to work diligently to prepare and submit the information.

37:46 Thank you. Great. And Phoebe, one last one. Thank you again for your time. Do you still believe that you can potentially get approval in the second half of 2020. At this time, we are maintaining our guidance for an anticipated decision on approval of the NDA in the second half of 2020. We are all very cognizant of preparing an NDA that is complete and provides all of the information in the agency's required format to ensure an efficient review. We focused on discussions with FDA in 2019 to make sure that we understood the FDA's expectations to evaluate the manufacturing as well as safety and effectiveness of the SYNCAP.

38:38 We also believe that by being attentive to the quality and completeness of the submission that we are assisting the FDA to achieve an efficient review process to enable approval in the second half of 2020. Thank you. Okay, thanks, Phoebe. Matt, I have another one for you. The question is, you do not have cash to cover your burn rate, and therefore, you're going to need to do a financing in the near term. Question mark. What are your plans? You guys are going to dilute us. Question mark. We're happy to take that one. This is Matt David. We've stated that we have sufficient cash into 2Q of 21.

39:25 As any biopharma company, we have multiple routes toward funding the company, and we'll evaluate these alternatives while maintaining shareholder value in mind. Beyond that, we are not going to discuss timing or other specifics related to potential financing or strategic activities. Great. Thanks, Matt. And Koso, one final question for you. Have you talked or spoken to any strategic partners? Thank you. I have previously stated publicly that, you know, we will actively pursue whatever process is in the best interest of our shareholders, and that includes looking at strategic partners. Clearly, we will not provide any information of such matters, discussions, or any of that, until and when disclosure is required.

40:17 Thank you. Okay, thank you, Koso. Those are the questions that I have prepared based on the activity leading up to this call. I'd like to turn it back over to you, Koso, for closing remarks. Thanks, Dan. So, CoreMedix remains committed to bringing different tasks to the U.S. market, whether on its own or with a strategic or commercial partner, to help patients in need of protection from Thank you all for your time and attention and have a good evening. Goodbye. And again, this does conclude today's conference.

41:04 We thank you for your participation. You may now disconnect.

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