Earnings Call Transcript - JAGX Q3 2024

Operator, Operator

Before I hand over the call to management, I want to remind everyone that management may discuss forward-looking statements regarding the company's growth, market acceptance of products, competition and pricing, industry trends, and product initiatives, including those still in development that might not meet scientific goals or regulatory changes. These forward-looking statements carry risks and uncertainties that could result in actual outcomes differing significantly from those projected. They are based on presently available information and management's current assumptions, expectations, and forecasts about future events. While management considers these assumptions, expectations, and projections to be reasonable given the current information, we advise caution in relying too heavily on these forward-looking statements. The company's actual results could differ materially from what is discussed today due to various factors, including those mentioned in the forward-looking statements and Risk Factors outlined in the company's Form 10-K for the year 2023, filed on April 1, 2024, and in other SEC filings, which are available in the Investor Relations section of Jaguar's website. Except as legally mandated, Jaguar is not obligated to update or amend any forward-looking statements in this presentation based on new information or future events. Additionally, please be aware that the company complements its condensed consolidated financial statements, which are presented in accordance with GAAP, by including non-GAAP EBITDA and recurring EBITDA. Jaguar believes that these non-GAAP disclosures provide investors with extra insights reflecting how management evaluates and operates the business. These non-GAAP financial measures should not be viewed in isolation or as replacements for GAAP figures such as net sales and net loss, nor should they be considered superior to GAAP measures of financial performance. Lastly, please note that today's conference call is being recorded. It is now my pleasure to turn the call over to Lisa Conte, Founder, President, and CEO of Jaguar Health. Lisa, the floor is yours.

Lisa Conte, CEO

Thank you, Matt. Good morning, everybody. Thank you all for joining our investor webcast today. As you heard, my name is Lisa Conte. I'm the Founder, President and CEO of Jaguar Health and our wholly owned subsidiary, Napo Pharmaceuticals, and I'm the Chairman of our Italian subsidiary, Napo Therapeutics in Milano. As usual, I may use the words Jaguar and Napo interchangeably when I'm referring to the company. As announced, this is an earnings webcast. And once again, I'm going to steal the thunder from our CFO, Carol Lizak, as we're pleased to report our net third quarter 2024 revenue of approximately $3.1 million, an increase of approximately 14% versus the net in the second quarter of 2024, which was $2.7 million revenue, and it increased approximately 11% compared to net Q3 2023, last year's revenue of approximately $2.8 million. So it's an earnings call; those are the numbers. I couldn't just stop right there, but I'm going to continue. Because as you see here, I'm going to address our ongoing commercial and development efforts. We have multiple near-term catalysts in the fourth quarter of this year, in the next two months and continuing early into 2025, and we view these as important and value-enhancing catalysts for the recognition of the value in the company. On the topic of key milestones, we are so pleased that we achieved significant results in the recently completed analysis from our Phase III OnTarget trial in the prespecified subgroup of breast cancer patients. This result has been accepted for a poster presentation on December 11, 2024, at the very prestigious San Antonio Breast Cancer Symposium, which is the largest international breast cancer symposium and also, I believe, the second largest cancer symposium in the United States after ASCO. Patients with breast cancer accounted for the majority of the participants in the OnTarget trial, which really is an unprecedented global prophylactic clinical trial for diarrhea in adult patients with all solid tumors receiving 24 different targeted therapies with or without standard chemotherapy. It's what we call a basket trial, attempting to address the treatment-related side effect of chronic diarrhea commonly suffered by all solid tumor patients. This was an ambitious trial. We were putting an inclusive hub around all patients that could potentially benefit— all solid tumor patients. And while the study did not achieve its primary endpoint for all solid tumor types included in the trial, we did achieve meaningful clinical signals in breast cancer, as you just heard, and also in lung cancer patients, two of the most common cancer diagnoses. We are very, very happy, very pleased that this important abstract on breast cancer results has been accepted for San Antonio. And as announced, a second late-breaking abstract related to the OnTarget trial based on data from the placebo arm of the trial has also been accepted for a poster presentation and that too will occur on December 11. The value of the data in this poster is to shine a light with much greater precision on the rates and impact of cancer therapy-related diarrhea on patients beyond the summary and somewhat unsatisfactory descriptions of side effects, in particular diarrhea, that appear in package inserts for many of the targeted cancer therapies. And the impact, in particular, that this can have on the ability of patients to remain on their cancer therapy— to not have a reduction, interruption or termination of their cancer therapy based on side effects, and of course, in particular, because of diarrhea. My longtime colleague, Dr. Pravin Chaturvedi, my brother from another mother, our Chief Scientific Officer and Chair of our Scientific Advisory Board, he'll speak in a few minutes to discuss the regulatory and development plans for crofelemer for cancer therapy-related diarrhea, how we can, as efficiently as possible, get the benefits from crofelemer to cancer patients. And also— and separately and also our orphan designated indications for crofelemer of microvillus inclusion disease, which is a congenital diarrheal disorder in pediatric patients when they're born, and short bowel syndrome with intestinal failure. This is crofelemer, but it is a different product than Mytesi, which is the commercial brand name for the product that's currently on the market and the product for cancer therapy-related diarrhea. This is a different formulation that is clinically and medically appropriate for these patients with intestinal failure. And then after Pravin speaks, our CFO, Carol Lizak, she'll provide a recap in more detail of the financial highlights for the third quarter of 2024. On our expanding commercialization front, which is very exciting, Jaguar launched the FDA-approved oral mucositis prescription product, Gelclair, our third commercialized prescription product. We launched it in the United States about a month ago, a little less than a month ago, and it's another important milestone in support of our deep commitment to supportive care and the needs of people, in particular those undergoing cancer treatment. Oral mucositis is among the most common painful and debilitating cancer treatment-related side effects. And for those who don't specifically know what mucositis is, I can give you a firsthand assessment. I had an odd reaction two years ago to a COVID treatment, and I ended up with grade 4 oral mucositis. It feels like broken glass in your mouth, all day long, and with a Habanero pepper on top of it. It is remarkably painful. What Gelclair does is it's a gel; it has a mechanical action, and it's indicated for the management and relief of pain, soothing the pain by adhering to the mucosal surface of the mouth. It coats and protects, which soothes and supports healing. Oral mucositis, which sometimes is called chemo mouth, it has emerged as the most significant adverse event in oncology according to the National Comprehensive Cancer Network. Up to 40% of all patients treated with chemo develop oral mucositis. And the same thing that I was mentioning about with our placebo results, it can impact the ability of the patient to stay on their cancer therapy, their life-saving therapy. When we talk about patients with head and neck cancers treated with chemotherapy and/or radiation experiencing severe oral mucositis, this impacts a patient's ability to swallow, to speak, to eat, to drink and of course, again, can lead to their cancer treatment disruption and discontinuation. Essentially, it hits about 100% of almost every single patient that is dealing with head and neck radiation and bone marrow transplant. So as we have launched, our core target audience are, in fact, the patients with head and neck cancer and the team that supports them— the oncology radiologists, nurses, nurse practitioners, dietitians, all the support groups. The National Cancer Institute estimates that about 71,000— more than 71,000 cases of cancer in the oral cavity, pharynx and larynx will occur in the United States each year, in this year 2024. One subset of the prescribers that has been quick to adopt and repeat Gelclair prescriptions are nurse practitioners. Recognizing the importance that nurses play in the management of cancer patients overall treatment, we had the opportunity to meet with many of these providers at the American Academy of Nurse and Patient Navigators Conference just last week. Many of the nurses that we spoke with were familiar with Gelclair and recognized the lasting and soothing benefits it provides to oral mucositis patients versus other treatments, which don't last long, can sting, can burn, can cause numbing and really are not satisfactory when put in the mouth. This is a wide open space for us to open with the benefits from Gelclair. We also met with many providers for this patient population at the American Society of Radiation Oncology Conference earlier in October and heard strong, strong support for the availability of this as an alternative treatment option for their patients with oral mucositis, again, to relieve pain, improve quality of life, and allow the patient to stay on their cancer therapy. Our other key area for near-term catalysts on the clinical development front, so going back to the clinical development front is crofelemer, as I mentioned, for rare and orphan diseases. MVID, microvillus inclusion disease is this congenital diarrheal disorder, which is an ultra-rare pediatric congenital diarrheal disorder, and short bowel syndrome and intestinal failure, which we refer to here as SBS-IF. We have two Phase II trials in the fourth quarter of this year, in the next two months, and we are supporting multiple investigator-initiated proof-of-concept studies for these two indications, including territories in the United States, Europe and the MENA regions, the UAE in particular, with results from the proof-of-concept studies expected potentially by the end of this year, over the next two months and throughout the beginning of 2025. These are five different clinical efforts that I just mentioned, initiating essentially now in real-time, that have been in development for almost two years of regulatory filings, meeting with key opinion leaders, assessing the needs that are relevant to patients and providers, designing protocols, and they're all coming to fruition now and providing this opportunity for, again, what we feel will be value-enhancing catalysts starting right now. We do have orphan drug designation for crofelemer in both the United States and Europe for both MVID and the SBS indications. In accordance with the guidelines of specific European countries, published data from clinical investigations proof-of-concept studies could support reimbursed early patient access to crofelemer for these debilitating conditions before there is full regulatory approval; early patient access programs that don't exist in the United States and is part of the reason why we have our subsidiary, Napo Therapeutics, in Europe with a team that has the capability and the experience to move on this important strategy to get products to patients that need them. Rare diseases are really a very important business model. And there are many companies that are built around only focusing on rare diseases. It's a program within Jaguar, but it's important to recognize that crofelemer for these indications represents a relatively small population, high morbidity, high mortality, and high expense taking care of these patients— highly activated patient support groups. It's a different business model, different pricing. And as I mentioned, it is crofelemer, yet it is a different product because of the different formulation. Before I hand the discussion over to Pravin, I'd like to let you all know that we will have a brief Q&A at the end of the webcast. If there are any questions, we won't be able to— hopefully, there are questions, and if there are questions, we may not be able to get to them all; they can be submitted in writing and can be submitted via the webcast link for the event right now that's on the Events and Presentations page of the Investor Relations section of Jaguar's website. The URL for the website is jaguar.health. Pravin, I'm now going to hand this over to you. Good morning, and we look forward to your update.

Pravin Chaturvedi, Chief Scientific Officer

Good morning, Lisa, and good morning all. Thank you for taking part in today's investor webcast. As Lisa stated, we are thrilled with the abstract of the results of the breast cancer subgroup responder analysis from the OnTarget Phase III trial being accepted for presentation at the San Antonio Breast Cancer Symposium. Additional analysis of the OnTarget data is ongoing, and these additional analyses may result in future submissions to other appropriate scientific forums. We plan to submit the breast cancer subgroup responder analysis to a peer-reviewed journal for publication in the future. Furthermore, the content of the breast cancer subgroup responder analysis will serve as the basis for preparing a briefing document that we plan to submit to the FDA for further discussion. We plan to request a meeting with the GI division of the FDA in the first half of 2025 to discuss potential regulatory pathways for crofelemer approval for the subgroup of, say, breast cancer patients. As a reminder, the crofelemer formulation that was studied in the OnTarget study is Mytesi formulation, which is currently approved by the FDA for the HIV indication. Hence, the safety and manufacturing sections of the new drug application have already been reviewed and approved by the GI division of the FDA for fulfillment delayed-release tablets. The breast cancer subgroup results from the OnTarget study that are being presented at the San Antonio Breast Cancer Symposium are our responder analysis, which is also the analysis for the primary endpoint in the pivotal Phase III ADVENT trial that led to the FDA approval of crofelemer for its current indication of symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy. Crofelemer has consistently shown clinical benefit in other clinical studies based on responder analysis of gastrointestinal function that results from two independent investigator-initiated trials for crofelemer in functional diarrhea and chronic idiopathic diarrhea in irritable bowel syndrome patients based on responder analysis that were recently presented last month at the American College of Gastroenterology Annual Scientific Meeting in Philadelphia. We continue to evaluate crofelemer in patients with gastrointestinal unmet needs and observe— have observed crofelemer shows benefit in various patient populations that have secretory diarrhea. As Lisa mentioned, development of crofelemer has also been initiated for the orphan and rare disease indications of microvillous inclusion disease, MVID, and short bowel syndrome with intestinal failure, SBS-IF, which are a key focus for the company. We have focused on developing appropriate clinical study design and clinical endpoints that would meet regulatory requirements and also support clinical outcomes. By the end of 2024 in the EU, we expect to activate the Phase II trial in adult SBS-IF patients requiring total parenteral support, which includes total parenteral nutrition, TPN, with additional supplementary intravenous IV fluids, if needed. Our Italian subsidiary, Napo Therapeutics S.p.A. has received the initial regulatory clearance for conducting the adult SBS-IF trial from the European Medicines Agency. For the pediatric MVID trial, we are initiating a Phase II trial in the United States and at additional clinical sites in Europe and the Middle East, North Africa, MENA regions. The pediatric MVID clinical protocol has received regulatory clearances from the FDA and European Medicines Agency. Additionally, we are supporting some investigator-initiated proof-of-concept studies in adult and pediatric SBS-IF patient populations at Cleveland Clinic in the U.S. and at Sheikh Khalifa Medical City in Abu Dhabi, UAE, to evaluate the benefits of crofelemer in patients requiring total parenteral support to meet their requisite daily needs for nutrition, electrolytes and fluids from total parenteral support. Upon obtaining some initial results in these investigator-initiated studies and with published proof-of-concept data, we also have the potential to move towards reimbursed early patient access in certain European markets prior to full product approval in Europe, a program which does not exist in the United States. This is also an important strategic advantage for our Napo Therapeutics subsidiary. Adult or pediatric patients with SBS-IF are unable to absorb adequate calories for oral intake due to the anatomic or functional reasons of their intestinal failure, which means they have lost a part of their intestine, either anatomically or functionally or both. In some cases, these patients' caloric requirements are predominantly provided through total parenteral nutrition, potentially up to 20 hours a day, sometimes for all seven days of the week. Obviously, this is a catastrophic situation for these patients and their families. In addition, some patients require TPN, along with more supplementary intravenous fluids as they risk dehydration due to severe diarrhea. As a reminder, crofelemer is a novel inhibitory intestinal chloride ion channel modulator that decreases the intestinal secretion of chloride ions and the accompanying fluid in the gut. This antisecretory mechanism of action of crofelemer reduces fluid and electrolyte accumulation in the GI tract and improves stool consistency. Importantly, due to the shortened length of the intestinal tract in SBS-IF patients, the oral formulation of crofelemer was not suitable or viable. Our team has developed a novel proprietary, highly concentrated lyophilized crofelemer powder for oral solution formulation, which will be administered orally to these patients in very small volumes to evaluate the effects of crofelemer on various clinical symptoms, including reduction in stool volume output and the requirements for total parenteral support. As you may know, both the FDA and EMA, European Medicines Agency, have approved a growth hormone for the management of adult and pediatric SBS-IF patients, but not for MVID. The approved growth hormone is a GLP-2 analog, which promotes growth of villi in the intestinal mucosa, meaning it helps increase the length of the villi after surgery or other interventions to help SBS patients, short bowel syndrome patients, increase fluid and/or nutrient absorption from their intestine, thus allowing for the reduction of TPN by about 20% over a 24-week period. There are some biosimilars in clinical development by other companies, and their clinical effects are similar to those previously reported for the approved GLP-2 analog. It should be noted that this growth hormone mechanism is not considered standard of care for SBS-IF; standard of care remains total parenteral nutrition. A key limitation of the mechanism of action of growth hormone is that they cannot be used in cancer patients and in patients with abnormal hyperproliferative medical conditions. As I said earlier, GLP-2 growth hormone or any other therapies are not approved for pediatric MVID patients and cannot be expected to provide any benefit because these patients, although they have a fully intact gut, do not have any villi and have no brush border membrane, hence the name microvillous inclusion disease, and there are needs for new approaches that are potentially provided by crofelemer to reduce stool volume output and some reduction in their total parenteral support requirements. Since crofelemer is also not a growth hormone, it does not have any of the limitations of the GLP-2 analogs. Crofelemer is a locally acting drug in the gastrointestinal tract without significant oral absorption, providing the ability to reduce chloride secretion into the gut and accompanying fluid accumulation, which will then result in reduction of stool volume output and potentially reduction of total parenteral support requirements. Nevertheless, with the approval of GLP analogs, the regulatory endpoint for reduction of total parenteral nutrition has been established. The GLP-2 analog costs approximately $500,000 per year per patient in the U.S. and the cost of TPN with or without supplementary fluids is not included in that. It is in addition to the cost of the GLP-2 analog. Lisa, that's the overall summary, and I will hand it back to you for continuing the discussion. Thank you.

Carol Lizak, CFO

Wonderful. Good morning, Lisa, and thank you to all of you who have joined our webcast today. I'll give my review of our financials for the third quarter of 2024. The total net revenue for the company's Mytesi and Canalevia-CA1 prescription products, the company's nonprescription products, and license revenue was approximately $3.1 million in the third quarter of 2024, representing an increase of approximately 14% versus the total net revenue in the second quarter of 2024, which totaled approximately $2.7 million, and an increase of approximately 11% over the total net revenue in the third quarter of 2023, which totaled approximately $2.8 million. Mytesi prescription volume increased in the third quarter of 2024 compared to the second quarter of 2024 by 10.9%. Prescriptions increased by 2.7% in the third quarter of 2024 compared to the third quarter of twenty-23 last year. Prescription volume differs from the invoice sales volume, which reflects, among other factors, varying buying patterns among specialty pharmacies in the closed network as they manage their inventory levels. Now loss from operations decreased by $1.5 million from $8.8 million in the quarter ended September 30, 2023, to $7.3 million during the same period in 2024. Non-GAAP recurring EBITDA for the third quarter of 2024 and the third quarter of 2023 were a net loss of $9.2 million and $6.2 million, respectively. Net loss attributable to common shareholders increased by approximately $2.1 million from $7.8 million in the third quarter ended September 30 of last year, 2023, to $9.9 million in the same period in 2024. Well, that concludes my recap of the high-level financials for the third quarter of 2024. I will now hand the discussion back to Lisa.

Lisa Conte, CEO

Thanks, Carol. Again, thanks, Pravin. Before I go to a couple of the written questions, there are a couple of other comments I want to make. With the catalysts anticipated over the next 6 months—and literally, you've heard about many in the remainder of 2024 over the next two months in all of our core programs, including crofelemer for cancer therapy-related diarrhea, the very exciting presentations at San Antonio, the development in the clinical initiatives for MVID and short bowel syndrome intestinal failure, and the ongoing commercial launch of Gelclair, which will have revenues that we'll be reporting in 2025 for the fourth quarter, the company's third prescription product; by the way, the Board of Directors has no intention of implementing a reverse split of the company's common stock. So I do get that question often, so let me just preempt that and say the Board of Directors has no intention of implementing a reverse split with these important catalysts and what we feel will be value-enhancing and value recognition. I also want to comment on the company's mission to change patients' lives for the better and especially, of course, in the supportive care area of complex diseases like cancer, as we have done in HIV. We believe that any cancer therapy-related side effect, whether it's diarrhea or oral mucositis or fatigue, neuropathy, chronic pain—there are about 21 different documented side effects associated with cancer care; these should not ever be viewed as acceptable or tolerable. One of the most insulting things you can say to a cancer patient, and in particular a metastatic patient, who is likely to be on some sort of therapy or targeted therapy for the rest of their life, is that this is a reported side effect that is a tolerable toxicity. Tolerable to who? This is a belief of the core message of our ongoing Make Cancer Less Shitty campaign, which seeks to broadly acknowledge the rigors of both short-term and perpetual treatment by sharing the voices and the stories of individuals that are living with this experience. The point is to live with the cancer experience, not just exist. The Make Cancer Less Shitty campaign now has six patient ambassadors, and you can learn about and hear these remarkable people and our commitment to the campaign on the website, www.makecancerlessshitty; I think everybody knows how to spell that. The primary social media channel for the Make Cancer Less Shitty campaign is Twitter X under the handle CancerSuckLess. So with that, I will—before signing off, let me go look to see if there are any written questions. So give me a second here. Okay, question number one: Are we looking to partner with the right company to enhance the pipeline? Are you looking into institutional investors? So absolutely, we are looking for institutional investors. We have great liquidity in the stock JAGX, which is a reflection of the large retail holding that we have, which is terrific. Liquidity is wonderful for everyone, and liquidity is also a factor that attracts institutional investors. So with the key catalysts we have coming up, I am absolutely putting effort right now, a major effort into introducing the story or reintroducing the story to institutional investors on a global basis, in particular, as I mentioned, because we do have clinical trials going on around the world and often that can be an opening of interest to investors in different geographical areas. As far as partnering, we have global unencumbered rights to crofelemer. We do have partners; for example, we have a partnership with a wonderful company, Gen Ilac, in Turkey, about seven different Eastern European countries. We have another partnership in the Middle East. Right now, in Europe, those rights are encompassed within Napo Therapeutics, our subsidiary in Milan. There is always the opportunity; there are always business development discussions going on for the potential to have an appropriate partner for late-stage development and commercialization to bring in non-dilutive dollars. So there is the balance of the long-term commercial impact that is given up if we partner now versus taking the product a little further down the development pathway. That opportunity for non-dilutive dollars is always out there, and we balance that with the current value of the company. So Pravin, I'm going to send this to you. It's a question about the extension data from the 12 weeks in the OnTarget trial. Maybe you could explain—remind everybody what that extension period is and what we intend to do with that data?

Pravin Chaturvedi, Chief Scientific Officer

Thank you for the question. Currently, we are focused on the placebo-controlled blinded early 12-week stage of the study, which involves the responder analysis we are preparing to submit for the San Antonio Breast Cancer Conference. We have also gathered data from patients who opted to continue into another 12-week period, irrespective of whether they were on placebo or active treatment since the dose was not known. Our protocol did not permit patients to receive open-label crofelemer, so only a smaller group of patients who were randomized in Stage I proceeded to Stage 2. We will evaluate that data once we complete the Stage 1 analysis. As I mentioned earlier, when we prepare to engage with the FDA, our primary focus will be on the responder analysis from the first 12 weeks. We will also consider the findings from Stage 2, particularly within the breast cancer subgroup. It's important to note that not all patients in Stage 2 were exclusively from the breast cancer subgroup. We anticipate completing a subset of this analysis within the next three to six months and will include those results in our discussions with the FDA. However, the formal completion of the analysis for both Stage 1 and Stage 2 will take longer, likely appearing in the mid to late second half of next year for the entire study. I hope this clarifies how we plan to proceed.

Lisa Conte, CEO

Thank you. And I got one more question here. Question about achieving profitability in the biotech sector in development-stage pharmaceutical companies. Crofelemer, Mytesi for HIV is a positive contributor to the company's profitability. Gelclair, which has just been launched, obviously, we put together a commercialization plan to get to a positive contribution as soon as possible. The big blockbuster opportunities. And when I say blockbuster, I mean first and foremost, the impact on patients and the unmet needs, which is a commonly used phrase, but absolutely clear in our indications. For example, the white space—nothing available for that is satisfactory for mucositis for cancer therapy-related diarrhea. So patients can stay on their targeted therapy in a metastatic situation for the rest of their lives in a curative situation for months and years, sometimes the 21 different unmet side effects. These require development— clinical development. Clinical development is a risk-based expensive activity. We have minimized the risk as much as possible with, for example, putting our major development efforts into late-stage clinical development of crofelemer, the product, an active ingredient that's already approved with chronic safety with manufacturing, the two most common reasons why new drug applications get pushed back or fail. So we are focusing on major blockbuster needs with as much risk reduction as possible in the investment into that, and the blockbuster impact will be for all the stakeholders—not just patients but the healthcare professionals, shareholders, and, as I mentioned, all the stakeholders in the company, and that's what the mission of this company is all about. So I think I've hit all the questions, or I certainly have hit all the questions that I see on my computer here. So thank you all. There is one more? What did I miss?

Pravin Chaturvedi, Chief Scientific Officer

I think it's directed at me. Can discussions with FDA be fast-tracked?

Lisa Conte, CEO

Okay. I just saw that. Go ahead.

Pravin Chaturvedi, Chief Scientific Officer

Yes. The short answer is no. The FDA is absolutely efficient in responding to everything. But they have so many requests for meetings and everything. So it is first in, first out, and it depends on the unmet need and the impact factor. The FDA does the best job to expedite whatever is necessary, but they do a thorough job because, ultimately, they are first a consumer safety organization. They take a very careful approach to evaluating. So the discussions with the FDA cannot be fast-tracked. They can give a fast-track designation or a breakthrough designation to the development plans of the drug if they determine that, that is actually worthwhile. So that's a discussion—that's a separate discussion, but not the timing of when we can meet with them. Hope that answers it Lisa, back to you.

Lisa Conte, CEO

Yes. And just to clarify, that's referring to the cancer discussions, which is Mytesi, which is a product that's already approved. So these are discussions about the efficacy results. We often hear risk-benefit. I'd like to talk about it as benefit-risk when we discuss Mytesi because the benefit is the benefit that we'll be presenting at San Antonio, and the risk for a product that's been on the market for almost a decade at this point with no serious drug-related adverse events, the risk is very, very low, if not zero. So what happens when you have benefit divided by zero? It goes to infinity and beyond. Okay. With that, we will finish up this call. Thank you all for listening. Thank you all for your support of Jaguar, Napo, Napo Therapeutics. Have a wonderful holiday, a wonderful year, and we will be back doing this in 2025.

Operator, Operator

That concludes today's teleconference. You may disconnect your lines at this time. Thank you again for your participation.