Jaguar Health, Inc. (NASDAQ:JAGX) Q3 2024 Earnings Call Transcript

Jaguar Health, Inc. (NASDAQ:JAGX) Q3 2024 Earnings Call Transcript November 15, 2024

Operator: [Call Starts Abruptly] before I turn the call over to management, I’d like to remind you that management may make forward-looking statements relating to such matters as continued growth prospects for the company, uncertainties regarding market acceptance of products, the impact of competitive products and pricing, industry trends and product initiatives, including products in the development stage, which may not make — achieve scientific objectives or meet changing regulatory requirements. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those complicated in such forward-looking statements. These statements are based on current available information and management’s current assumptions, expectations and projections about future events.

While management believes its assumptions, expectations and projections are reasonable in view of currently available information, you are cautioned not to place undue reliance on these forward-looking statements. The company’s actual results may differ materially from those discussed during this webcast for a variety of reasons, including those described in the forward-looking statements and Risk Factors sections in the company’s Form 10-K in the year 2023, which was filed on April 1, 2024, and its other filings with the SEC, which are available on the Investor Relations section of Jaguar’s website. Except as required by law, Jaguar undertakes no obligation to update or revise any forward-looking statements contained in this presentation to reflect your information, future events or otherwise.

Additionally, please note that the company supplements its condensed consolidated financial statements presented on a GAAP basis with providing non-GAAP EBITDA and non-GAAP recurring EBITDA. Jaguar believes that the disclosure items in these non-GAAP measures provide investors with additional information that reflects the basis upon which the company management assesses and operates the business. These non-GAAP financial measures should not be viewed in isolation or as substitutes for GAAP net sales and GAAP net loss and are not substitutes for or superior to measures of financial performance and conformality with GAAP. As a reminder, today’s conference call is being recorded. And at this time, it is my pleasure to turn the call over to Lisa Conte, Jaguar Health’s Founder, President and Chief Executive Officer.

Lisa, the floor is yours.

Lisa Conte: 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 of our CFO, Carol Lizak, as we’re pleased to report our net third quarter 2024 revenue of approximately $3.1 million, increased approximately 14% versus the net in the second quarter of 2024, which was $2.7 million revenue, and it increased approximately 11% versus net Q3 2023 last year’s revenue of approximately $2.8 million.

Q&A Session

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 2 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 recently completed Phase III OnTarget trial in the prespecified subgroup of breast cancer patients. This result has been accepted for a poster presentation and it’s on December 11, 2024, so next month, 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 a big 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 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, and interruption or a termination of their cancer therapy based on side effects, and of course, in particular, because of diarrhea.

My long-time 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 for — 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, the 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, medically administration 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, deep commitment to supportive care and needs of people and, in particular, 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, it’s — I can give you actually a firsthand assessment. I had an odd reaction 2 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. And what Gelclair does, it’s a gel. It has a mechanical action, and it’s indicated for the management and relief of pain, the soothing of the pain by adhering to the mucosal surface of the mouth. It coats and protects, which soothes and supports healing. It has — oral mucositis, which commonly sometimes is called chemo mouth, it has emerged as the most significant adverse event in oncology according to 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. And it essentially hits about 100% 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 and 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 as an option for their patients with oral mucositis, again, to relieve the patient, the pain, the 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 now 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 with intestinal failure, which will refer to here shorthand SBS-IF.

We have 2 Phase II trials in the fourth quarter of this year, in the next 2 months, and we are supporting multiple investigator-initiated proof-of-concept studies for these 2 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 2 months and throughout the beginning of 2025. These are 5 different clinical efforts that I just mentioned, initiating essentially now real-time, that have been in the development for almost 2 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 a specific European countries, published data from clinical investigations proof-of-concept studies could — for both of these indications 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, relatively small population, high morbidity, high mortality, high expense, taking care of these patients highly activated patient support groups. And 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. And 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 they 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: 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 have been accepted for presentation at the San Antonio Breast Cancer Symposium. Additional analysis of the OnTarget data are ongoing, and these additional analysis 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, 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 or 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 2 independent investigator-initiated trials for crofelemer in functional diarrhea and chronic idiopathic diarrhea in irritable bowel syndrome patients based on responder analysis 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, 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 patient 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 population at Cleveland Clinic in the U.S. and at Sheikh Khalifa Medical City in Abu Dhabi, UAE, to value with crofelemer benefits 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 therapeutic subsidiary.

Adult or pediatric patients with SBS-IF are unable to absorb adequate calories for the 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. And in some cases, these are provided — their caloric requirements are provided predominantly through total parenteral nutrition, potentially up to 20 hours in a day, sometimes for all 7 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 supplemental intravenous fluids as they risk dehydration due to severe diarrhea. As a reminder, crofelemer is a novel inhibitory intestinal chloride ion channel modulator, which 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 — not 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 and its functions. It functions by promoting growth of villi in the intestinal mucosa, which means it helps increase the length of the villi after surgery or other interventions to help SBS patients, short bowel syndrome patients increase your 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 the 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 full intact gut, they do not have any villi and they have brushwater — they have no brushwater membrane and hence the name microvillous inclusion disease and there are needs for new approaches that are potentially provided by crofelemer to reduce the 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 and it provides 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 cost 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’ll hand it back to you for continuing the discussion. Thank you.

Lisa Conte: Thank you very much, Pravin. Thank you for everything you do. Hang on in case there are any questions for you. Carol, we’ll turn it over to you now.

Carol Lizak: 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 ’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 the 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 high-level financials for the third quarter of 2024. I will now hand the discussion back to Lisa.

Lisa Conte: Thanks, Carol. Again, thanks, Pravin. Before I go to a couple of the written questions, there’s a couple of other comments I want to make. With the catalysts anticipated over the next 6 months, and literally, you’ve heard many in the remainder of 2024 over the next 2 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, the ongoing commercial launch of Gelclair, which will have revenues then 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 and whether it’s diarrhea or is oral mucositis or fatigue, neuropathy, chronic pain, there’s 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 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? And 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. And the point is to live with the cancer experience, not just exist. The Make Cancer Less Shitty campaign now has 6 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. And the primary social media channel for 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.

A – Lisa Conte: 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 to 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, 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 7 different Eastern European countries. We have another partnership in the Mid 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 and 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 nondilutive 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: Okay. Thank you for the question. So we, right now, have been focused singularly on the placebo-controlled blinded early 12 — first 12-week stage of the study, which is the responder analysis that we were preparing to submit and which is accepted for the San Antonio Breast Cancer Conference. We have also collected the data for those patients who self-selected whether they were on placebo or active to continue into another 12-week period because the dose would not have been known. Our protocol did not allow patients to get open label crofelemer. So a smaller number of patients and the patients that were randomized in the Stage I went into Stage 2. And we are going to evaluate that data after we’ve gone through the Stage 1 analysis completed.

So currently, we are, as I mentioned in my briefing to all of you, that as we prepare to go talk to the FDA, our emphasis of the data will primarily be on the responder analysis of the first 12 weeks, but we will also take the signals that we get in the second — Stage 2, specifically for breast cancer subgroup. So remember, not all patients were only subgroup of breast cancer that went into Stage 2. So we think that we will have a subset of the analysis done in the next 3 to 6 months, and we will include that in our discussion with the FDA. And a formal completion of the analysis of Stage 1 and Stage 2 with the primary [indiscernible] that’s a longer and a bigger proposition. So it will take some longer time it will appear sometime in the mid to late — mid- to second half of next year for the entire study.

Hopefully, Lisa, that gives you the answer about what we — how we are planning to do it.

Lisa Conte: Thank you. And I got 1 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, product an active ingredient that’s already approved with chronic safety with manufacturing, the 2 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 in the health care professionals, but 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 1 more? What did I miss?

Pravin Chaturvedi: I think it’s directed at me. Can discussions with FDA be fast-tracked?

Lisa Conte: Okay. I just saw that. Go ahead.

Pravin Chaturvedi: Yes. So the short answer is no. The FDA is absolutely efficient in responding to everything. So — 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. So 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. And so they take a very careful approach to evaluating. So the discussions with 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: 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. And the — we often hear risk benefit. I’d like to talk about it benefit-risk when we talk about 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 0. So what happens when you have benefit divided by 0 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: That concludes today’s teleconference. You may disconnect your lines at this time. Thank you again for your participation.