Jaguar Health, Inc. (NASDAQ:JAGX) Q2 2024 Earnings Call Transcript

Jaguar Health, Inc. (NASDAQ:JAGX) Q2 2024 Earnings Call Transcript August 13, 2024

Jaguar Health, Inc. misses on earnings expectations. Reported EPS is $-4.04013 EPS, expectations were $-1.2.

Operator: [Call starts abruptly] Before I turn the call over to the management, I would like to remind you that the 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 productive initiatives, including products in the development stage which may not achieve scientific objectives or meet stringent regulatory requirements. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated in such forward-looking statements. These statements are based on currently 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 section of the company’s Form 10-K for the year 2023 which was filed April 1, 2024 and its other filings with the SEC which are available on the Investor Relations section of the Jaguar’s website. Except as required by the law, Jaguar undertakes no obligation to update or revise any forward-looking statements contained in this presentation to reflect new information, future events or otherwise.

Additionally, please note that the company supplements its condensed consolidated financial statements presented on a GAAP basis by providing non-GAAP EBITDA and non-GAAP recurring EBITDA. Jaguar believes that the disclosure items of these non-GAAP measures provide investors with additional information that reflects the basis upon which company’s management assesses and operates the business. These non-GAAP financial measures should not be viewed in isolation or as substitute for GAAP net sales and GAAP net loss and are not substitutes for or superior to measures of financial performance in conformity with GAAP. Today’s conference is being recorded. At this time, it is now 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. Hello and thank you all, for joining our investor webcast today. My name, as you heard, is Lisa Conte, the Founder, President and CEO of Jaguar Health and our wholly owned subsidiary, Napo Pharmaceuticals and I’m also the Chairman of our Italian subsidiary, Napo Therapeutics. As usual, I may use the words Jaguar and Napo interchangeably when I’m referring to our company and our activities. As announced, this is an Earnings Webcast for the Second Quarter of 2024. I’m going to steal the thunder of our CFO, Carol Lizak, who will be speaking at the end of this webcast, as I am pleased to report our combined net second quarter 2024 revenue of approximately $2.72 million for prescription and non-prescription products, increased approximately 16% versus net Q1 2024 revenue which was $2.350 million.

Q&A Session

And it increased approximately 2% versus net Q2 2023 revenue of $2.67 million. We’re very pleased with that. In addition, on this webcast, I will be joined by my colleagues, Dr. Pravin Chaturvedi, our Chief Scientific Officer; and Cathy Collis, our recently appointed Senior Vice President of Growth Strategy to speak to the robustness of our clinical pipeline and commercial activities. Pravin will further review the data and regulatory strategy for the clinically meaningful results we reported on July 23, 2024, clinically meaning results identified in patients in the subgroups of breast and lung cancer. In the initial data from our recently completed pivotal Phase III OnTarget trial of crofelemer, for the prophylaxis of diarrhea in adult cancer patients with solid tumors, all solid tumors receiving targeted therapy with or without standard chemotherapy.

Again, this signal was seen in the two subgroups of breast and lung cancer. Today, Pravin will also discuss Jaguar’s other clinical core focus areas for the development of crofelemer for two targeted rare and orphan disease indication, microvillus inclusion disease, we refer to as MVID which is an ultrarare pediatric congenital diarrheal disorder and also short bowel syndrome with intestinal failure with the acronym SBS-IF or we’ll refer to just as SBS. As announced with Jaguar leadership and participation from the Jaguar Family company, Napo Therapeutics based in Milan, Italy. We are also supporting independent investigator-initiated proof-of-concept studies of crofelemer for MVID and SBS in the U.S. and the MENA regions, Middle East, North Africa regions.

With the results, proof-of-concept results expected by the end of this year 2024 and throughout the beginning of 2025. Crofelemer has already received orphan drug designation in both the United States and EU and for both MVID and SBS indications and allows us to pursue that strategy and rare disease business model for these indications. We’re very pleased to announce last week that the required import permit for crofelemer has been granted in Abu Dhabi in the UAE, United Arab Emirates, for the planned investigator-initiated proof-of-concept trial in pediatric patients for MVID and SBS which is an important and critical regulatory event that we worked on for some time and have known the principal investigator there for many years who is excited to treat patients.

After Pravin speaks, Cathy will provide a brief overview of our planned October 2024 this year, commercial launch of the FDA-approved oral mucositis prescription product Gelclair for the U.S. market. Well this is our third prescription product launch. Oral mucositis also called the chemo mouth has emerged as the most significant adverse event in oncology according to the National Comprehensive Cancer Network task force. Cathy was instrumental in executing Jaguar’s in-license agreement for Gelclair. She is results-oriented. She’s commercial leader with more than 25 years of experience in the biopharmaceutical industry. We’re thrilled she has joined Jaguar’s team in this important role as Head of Growth strategy and we’re very excited about this important product launch with a side effect that is so devastating to cancer patients.

Towards the end of the webcast, our CFO, finally, Carol Lizak, will provide a recap of the financial highlights for the second quarter of 2024. So before I introduce Pravin, just a reminder that our ambitious Phase III OnTarget trial broadly and boldly studied the prophylaxis of diarrhea in adult cancer patients with 10 distinct types of solid tumors, receiving any of 24 different targeted therapy drugs, all the which have a reported rate of diarrhea of more than 50% and with or without standard chemotherapy. So quite a heterogeneous population, quite important that we were looking to understand how we could miniate diarrhea in — with the broadest potential label. We observed the meaningful clinical signals in breast and lung cancer patients, two of the most common cancer diagnoses.

We are collaborating with our clinical and scientific advisers to elevate the significance of these clinical outcomes signals in order to prepare for potential scientific publications as well as submissions to support clinical and regulatory meetings as we seek to explore potential pathways of FDA approval to make crofelemer which is our novel, oral plant-based prescription medicine which is already available for people living with HIV/AIDS and diarrhea, available to patient populations of breast and/or lung cancer patients for cancer therapy-related diarrhea. So looking for an opportunity to expand the label. It is important to emphasize its standard of care and treatment policy for cancer patients in the OnTarget trial was patient-centric, including, though not limited to the full journey of their treatment, rescue therapies, reductions changes or holidays to the cancer agents causing side effects, many side effects, including diarrhea and other supportive care interventions which impact gut function at different times in different patient populations.

Because of this and given the rich and extensive database from OnTarget, there is a great deal of work still ahead to analyze data for numerous prespecified and non-prespecified subgroups from the trial. Complex programming is necessary to address statistical rules for censoring data, for handling missing data points, addressing intercurrent events and data imputations, among others. We are absolutely encouraged by the results we’ve seen thus far, in what are relatively small sample sizes represented by the aforementioned subgroups because they are subgroups of patients with breast and lung cancer and we are energized with anticipation as the analyses continue to reveal important insights and signals to achieve our clinical and regulatory goals.

So with that, good morning Pravin.

Pravin Chaturvedi: Good morning, Lisa and good morning all and thank you for joining today’s investor webcast.

Lisa Conte: Okay Pravin, it’s been 2 weeks since we announced the clinically meaningful signals in the subpopulation of breast and lung cancer patients in the OnTarget trial. I know this has been a focus of yours for many years now. Since that time, we also announced significant positive results with crofelemer benefiting subgroups of diarrhea predominant irritable bowel syndrome and that’s an acronym IBS-D, irritable bowel syndrome patients with chronic refractory diarrhea. And by the way, each of those studies and results have been accepted for poster presentations at the American College of Gastroenterology Annual Scientific Meeting ACG which is also in October of this year. Pravin will begin by explaining the relevance of those study results and analyses which have come out since preliminary results on OnTarget, for the relevance of those study results and analysis to the OnTarget results.

Pravin Chaturvedi: Thank you, Lisa. I think I’ll go into some specific details. As you stated last week, we were very excited about the fact that crofelemer continues to demonstrate clinical robustness in the responder analysis for multiple gastroenterology conditions, including functional diarrhea and chronic idiopathic diarrhea in the subgroups of diarrhea predominant irritable bowel syndrome patients. These analyses are done by what is called responder analysis and that’s the keyword. Simply put, a responder analysis is a preponderance of weeks of improvement in lose watery stool frequency, lose watery stool consistency and other bowel end points, depending on the indication within a chronic multi-month study. That’s what these two recent diarrhea predominant IBS study showed.

Just to remind, similarly, we analyzed the pivotal trial for the currently approved indication of crofelemer for HIV-related diarrhea which was based on the proportion of patients with an acceptable number of lose watery stools per week for 50% of the time. Our responder analysis is where we saw the initially clinically important signals in patients with breast and lung cancer. And although it is not a prespecified primary endpoint in the OnTarget study, it’s clinically important. Clinical importance is defined as a greater than 10 percentage point difference in the proportion of subjects with less than or equal to less than 7 watery stools per week compared to placebo, that was seen in the breast and lung cancer patients in months 2 and 3, of the 3-month treatment period of the OnTarget study.

Clinical relevance for this analysis has been informed by a cancer patient survey that we conducted prior to the start of the OnTarget study that indicated that the patients wanted to get to less than or equal to 2 watery stools per day, i.e., less than or equal to 14 watery stools per week which would be clinically meaningful to the patients which would reflect an improvement in their bowel control habits, presumably leading to more comfort and improve quality of life. And I’ll provide some more technical details about the responder analysis in the OnTarget trial subgroups. Since this is — these are exploratory analyses and subgroups of breast and lung cancer patients receiving targeted therapies, the sample size for each of these subgroups is smaller.

As we had designed the trial to be all inclusive for adult solid tumor patients that were eligible to receive diarrheagenic targeted therapies in at least 50% of the patients receiving those therapies. And it was a multi-center, double-blind, placebo-controlled study that included U.S. and ex-U.S. sites and it used patient-reported outcomes, PROs, as the primary determinant of the clinical responses. When we combined all the breast and lung cancer patients receiving different targeted therapies that achieved the monthly responder status in months 2 and 3, defined as those patients having less than or equal to 7 watery stools per week, at least 50% of the time, it showed that 79% of the patients in crofelemer group had achieved this threshold compared to 68% and in the placebo group patients.

As a reminder for our audience, it was a prophylactic trial which means the patients not come in with diarrhea. The one-sided p-value was 0.027 which is nearly statistically significant as a hurdle for OnTarget study design is less than 0.025. And the difference was clinically important. As the subgroup sample size gets smaller, the p-value is further impaired as the study was not powered to detect these signals at a statistically significant value. We are also looking at odds or hazard ratios. For sake of clarity and odds ratio analysis is similar to a hazard ratio assessment which measures the frequency of an event in two groups over time. And a ratio being greater than 1 is deemed favorable for crofelemer. When we evaluated all the breast cancer patients receiving three different types of targeted therapies, the proportion of monthly responders for months 2 and 3 that achieved less than 7 watery stools per week, at least 50% of the time, crofelemer group had 78% responders compared to 68% in the placebo group.

For breast cancer patients receiving abemaciclib, the monthly responder rate was for having less than 7 watery stools for months 2 and 3 was 69% for the crofelemer group versus 58% of the placebo group. And the odds ratio for this group, the subgroup was 1.796 over the 3-month period. Continuing with breast cancer patients, those patients that received pertuzumab, that were monthly responders in months 2 and 3 having at least less than 7 water stools per week for 50% of the time. It was 87% of patients in the crofelemer arm compared to 75% in the placebo arm. And the odds ratio was 1.44. Similarly, lung cancer patients receiving kinase inhibitors, achieving a monthly responder status for months 2 and 3 with less than 7 watery stools per week was 81% in the crofelemer arm compared to 64% in the placebo group.

Had the sample sizes being larger in these subgroups, these same differences that we observed would have reached statistical significance. This exploratory odds ratio analysis for each sub group but also being evaluated using nonparametric rank sum tests due to the skewness of the data in both groups but especially in the placebo group. To be more specific, the range of average number of weekly lose watery stools for the crofelemer group was 0 to 30, compared 0 to 42 for the placebo group across all tumor types and targeted therapies in the OnTarget study. The wide variation in the average number of weekly loose watery stools contributes to the skewness of the data. But we are very encouraged by the signals we are seeing in these small subgroups, while different tumor types, different treatment regimens and complex handling of data for various intercurrent events in each individual patient’s journey have limited the subgroup patient sizes.

We are grateful for the consistency of the signals and the benefit we’re able to discern in breast and lung cancer patients. We have seen crofelemer benefit patients in multiple studies and in multiple patient populations. I will underscore your comment, Lisa. We are energized and helpful as we undertake more analyses and potentially further reveal important and potentially statistically significant results in these complex data sets. As an important example, we have not yet evaluated the responder analysis for patients who continued into the extension phase of the OnTarget study called Stage 2 which is for the whole study, we know about 2/3 of the patients continued to receive the treatment for another 3 months and we plan to analyze those as well.

In addition to these clinically important signals in breast and lung cancer patients receiving targeted therapies, I’d like to add that crofelemer continues to show improvement in various gastrointestinal indications due to its novel paradigm shifting mechanism of action, physiologic mechanism of action. We had previously conducted two diarrhea predominant IBS-D clinical trials and crofelemer showed improvement in abdominal pain and discomfort and stool consistency in those studies. The change in stool consistency together with improvement in abdominal pain and discomfort are now regulatory and clinically specified primary endpoints for drugs being developed for diarrhea predominant irritable bowel syndrome patients. Two independent scientific and clinical thought leaders in gastroenterology at the Beth Israel Deaconess Hospital at Harvard Medical School and at the University of Texas and Houston, studied crofelemer in refractory diarrhea subgroups or diarrhea predominant IBS patients with functional and chronic idiopathic diarrhea, respectively.

And they submitted their abstracts that were accepted for poster presentations, at the American College of Gastroenterology meeting later this year. Any questions now, Lisa?

Lisa Conte: Well, thank you for that detailed response Pravin, it’s a snapshot of just how rich this database is and how complex this trial was the OnTarget trial. But I know Pravin that you have personally designed many of the successful trials with crofelemer in different patient populations. So definitely appreciate that detailed explanation. Pravin, I’d like you please now explain the plan with the responder analysis in the OnTarget trial and the plan specifically related to our goal of meeting with the FDA which is the gating item to get crofelemer, Mytesi to people living with cancer therapy-related diarrhea.

Pravin Chaturvedi: Thanks, Lisa. That’s a good question. The plan is to continue with the responder analysis and detect — show the robustness of our findings, particularly in the subgroups of breast and lung cancer patients in the OnTarget trial. We will discuss the findings of our exploratory analyses with our clinical and regulatory key opinion leaders and evaluate other gastrointestinal endpoints now a very rich and extensive patient-reported outcomes database which will better inform us about the preponderance of evidence for the clinical meaningfulness of what we are seeing, with crofelemer. Since OnTarget is a pivotal Phase III trial, we will prepare a briefing document for the FDA after our meetings with our internal KOLs. On the obligatory specified statistical analysis.

We will also prepare a report on the additional exploratory responder analysis and provide the FDA the findings and the results of our findings in these subgroups of breast and lung cancer. By providing more information on the incident, severity and duration of diarrhea from the OnTarget trial which we’ll particularly see in the placebo group, we will also have more informed discussion with the FDA about patient impact. And the appropriate clinical endpoints and analyses to be able to provide them with an assessment of the benefit/risk ratio of crofelemer. Since crofelemer delayed release tablets are already approved by the FDA under the brand name Mytesi for HIV-related diarrhea. And the drug acts locally in the gut without any food or drug interactions and we have seen no crofelemer related serious adverse events in the 10-plus year of commercialization history.

The assessment of benefit risk ratio adds to the totality of evidence to support crofelemer’s value for the cancer therapy-related diarrhea, CTD indication, in at least the subgroups of breast and lung cancer patients.

Lisa Conte: A very important point that benefit/risk ratio. And it’s interesting to see if there’s any analogous situations out there with a drug that has been on the market for such a long period of time. with this safety record. Pravin, let’s also just remind everybody of the previous work that has been done in cancer patients, in particular, in breast cancer patients, the OnTarget trial added more clinical evidence or did they, in fact, add more clinical evidence than the previous Phase II study that was conducted in breast cancer patients?

Pravin Chaturvedi: Thanks for bringing that up, Lisa. I think you’re referring to the HALT-D Phase II trial that was conducted in breast cancer patients receiving pertuzumab with standard chemotherapy. The HALT-D study which was a prophylactic study, helped inform us about conducting a longer-duration study. And hence, the OnTarget study was designed to have an overall period of treatment of 24 weeks, with the initial analysis we conducted at 12 weeks. The OnTarget study also identified that crofelemer in addition to its effects in breast cancer patients receiving targeted therapies, is also beneficial to lung cancer patients receiving targeted therapy with kinase inhibitor. That’s a feature of having this all-inclusive solid tumor trial, the OnTarget study. So it was useful.

Lisa Conte: Yes which I agree is the gift of this trial design that we were able to find this benefit in lung cancer patients as well. I know a lot of work has to be done to understand the significance of the rich and extensive database from OnTarget and I hope everybody got a feeling for that from your presentation here. And I know this work will take some time. I’d like to call it, leaving no statistical analysis stone unturned here and it’s likely going to go into 2025. So we have the most comprehensive briefing package prepared for the FDA. I’d like to just address the robustness of the crofelemer mechanism of action you called the paradigm shifting and other near-term pipeline opportunities for data reveal. With this in mind, Pravin, please now tell us about the targeted rare disease indications for crofelemer of SBS or bowel syndrome and MVID for crofelemer which have both received, of course, as I mentioned, orphan drug designation in the U.S. and Europe.

And describe how we expect crofelemer to work in these patient populations, what is the disease progression like for these patients and their standard of care?

Pravin Chaturvedi: Thanks, Lisa. Continuing this discussion into the orphan and rare disease indication for crofelemer is very important to me. We have made significant progress in achieving clinical and regulatory milestones, for the rare and orphan disease indications of short bowel syndrome with intestinal failure, SPS-IF as well as microvillus inclusion disease, MVID, or crofelemer. As I mentioned earlier, crofelemer shows a consistency in symptomatic management of diarrhea and other gastrointestinal symptoms in various clinical indications. Adult or pediatric patients which showed bowel syndrome with intestinal failure, are unable to absorb adequate calories from their oral intake due to intestinal failure which can be due to either anatomic or functional reasons for their intestinal failure which basically means that they have lost a part of their intestinal tract.

Hence, these patients require their daily caloric and nutritional requirements to be supplemented, to using total parenteral nutrition potentially up to 20 hours a day and up to 7 days a week in some cases. Obviously, this is a catastrophic situation for the patients and their families. In addition, some patients require TPN, total parenteral nutrition with more supplemental IV fluid, intravenous fluids as they are at risk for dehydration due to severe diarrhea. We are initiating a clinical trial in 2024 in the European Union. In adult, SBS-IF, short bowel syndrome with intestinal failure patients requiring TPN, with regulatory clearance from the European Medicines Agency, EMA which is the European counterpart of the U.S. FDA. In addition, we are supporting a couple of investigator-initiated exploratory studies in adult and pediatric SPS-IF patients, adult being at Cleveland Clinic and pediatric being at the Sheikh Khalifa Medical City in Abu Dhabi, for evaluating crofelemer’s benefits in SBS-IF patients.

It is important for everyone to understand that these SBS-IF patients are monitored very closely. And due to the shortened length of the intestinal tract and oral delayed-release tablet formulation of crofelemer currently on the market here in the U.S. is not viable for these patients. Our team developed a novel, proprietary, highly concentrated like-for-like part of oral solution which can be administered orally to these patients in very small volumes to evaluate the effects of crofelemer on various clinical symptoms of SBS-IF patients, including reductions in the stool volume output and the need for reduced parenteral support as a result of crofelemer’s effects. The collateral benefits of the novel lyophilized oral powder resolution, crofelemer formulation is that we can also administer that orally to pediatric patients that have the ultra-rare congenital diarrheal disorders called microvillus inclusion disease.

MVID patients do have a full length gut but they do not have what is called a brush border membrane in their intestines and therefore, they cannot absorb their required daily intake of nutrients or electrolytes. Hence, these patients also require lifelong total parenteral nutrition support to support their nutrition and caloric needs. And these patients fail to thrive. which means they don’t grow as a normal child would. Thus MVID is associated with significant morbidity and mortality. We’ve an active U.S. IND for MVID and we’re initiating a pioneer in clinical study to evaluate the benefit of crofelemer in pediatric MVID patients receiving TPN with or without supplemental IV fluids in 2024. We are also adding clinical sites in the European Union and in the Middle East, North Africa, MENA region as the incidence of MVID in those geographies is higher than the United States due to consanguineous marriages.

An important near-term milestone for us will be the support we are providing for an investigator-initiated trial with one of our key opinion leaders and a member of my Scientific Advisory Board in the MENA region, Dr. Mohamad Miqdady, who was evaluating the effects of crofelemer in his pediatric patients with either microvillus inclusion disease or short-bowel syndrome with intestinal failure. As you mentioned at the beginning of this webcast, we just received clearance for an import permit for shipping crofelemer to our SAB member in Abu Dhabi. And we are looking forward to his first patient being dosed there and proof-of-concept results as early as potentially in Q4 of this year.

Lisa Conte: Thank you. I do want to mention I’ve known Dr. Miqdady for about 6 years and I met him several times in Abu Dhabi. And the fortitude and the persistence he showed in going through all the regulatory paperwork to bring the product to his patients and the care that he has for these patients and the lack of alternative treatments, again, with pediatric MVID congenital diarrheal disorders, nothing else other than TPN. And key members of the Jaguar Napo team including myself and Pravin have visited many KOLs on three different continents. And what we hear is two of the most devastating top six things that you administer to patients for their situation in both cancer and intestinal failure are chemotherapy and TPN, respectively.

So it is remarkable the commitment and the care that these physicians have to not only treating the patient’s disorders but also the focus on supportive care, quality of life, patient comfort, patient dignity. So also, Pravin, I have asked you to describe some of the key learnings from these meetings that inform the protocol development.

Pravin Chaturvedi: Thanks, Lisa. As you know, both MVID and SBS-IF are malabsorptive syndromes and much of the focus of clinicians have been on improving absorption of nutritional and caloric intake in these patients. Both FDA and EMA have approved a drug called teduglutide which is a growth hormone of GLP-2 for the management of adult and pediatric SBS-IF patients, it’s given parenterally by injection. Since the approval of teduglutide, several additional biosimilars are also under the clinical development. And their clinical effects are very similar to teduglutide and their only differentiating feature relies on ease or convenience of administration to these patients, such as instead of giving daily, you give it once or twice a week.

It is important for the audience to understand that a standard of care for short bowel syndrome intestinal failure patient, is total parenteral nutrition TPN. And teduglutide or any of the biosimilars and other growth hormones cannot be used in cancer patients that have showed bowel syndrome because it’s a growth hormone. And teduglutide is not approved for pediatric MVID patients. And it cannot be expected to provide benefit in these patients — in MVID patients, that is, because they don’t even have a brush problem membrane and they have limited ability to grow any absorbed through villi in the intestine with a growth hormone mechanism of action. So in our travels and discussions with KOLs, crofelemer not having any such limitations of a growth hormone because it acts locally in the gut lumen without significant oral absorption and provides the ability to reduce chloride secretion in the gut, along with the accompanying gut fluid accumulation that’s reducing diarrhea.

All clinical investigators across the U.S., the EU and the MENA region. We welcome the opportunity to evaluate crofelemer because of its truly novel and well-tolerated therapy for their adult SBS-IF and pediatric MVID patients. I couldn’t be more grateful to all these clinical investigators who are willing to study the patients because they are looking forward to giving a new therapy to their patients with crofelemer. Thank you.

Lisa Conte: Thank you, Pravin. And I could not be more grateful to the Jaguar Napo team. This is truly a pipeline within a product with crofelemer and no other mechanism of action out there like that and it’s a lot going on in a small company and you’ve got a snapshot here of just how complex clinical trial planning, execution, implementation and analysis is and we are committed to get crofelemer to all the patient populations that can benefit in the most efficiently possible. So Pravin, I think we should let you get back to work now, because clearly, you have a lot to do. And we are now going to move the discussion over to the expansion of our commercial pipeline with a discussion Cathy Collis is going to leave and talk about our planned October 2024 commercial launch of Gelclair which is FDA approved for mucositis.

And I will just bring on a personal point. We had a mucositis experience in our family. And I can tell you, when that side effect occurs, all the focus is on eliminating the side effect and not on the treatment of the cancer or the underlying cause because it is so devastating. But I’m so pleased that we have a commercial launch and a product opportunity in this area to again address patient comfort, their ability to stay on their cancer care which affects the outcome and also the dignity of the patient. So Cathy, over to you.

Cathy Collis: Good morning, Lisa and good morning to all of you joining us today. As Lisa has alluded and many of you are aware, oral mucositis is among the most common, painful and debilitating cancer treatment-related side effects. Gelclair is a protective gel with a mechanical action indicated for the management of pain and relief of pain by adhering to the mucosal surface of the mouth soothing oral lesions of various etiologies, including oral mucositis/stomatitis. It is a clinically proven FDA-approved convenient and easy-to-use product that provides rapid and long-lasting pain relief and approves the ability of oral mucositis patients to eat, drink, swallow, speak and sleep. Unlike other products for oral mucositis, it is not a numbing agent and does not sting the mouth.

We all know cancer is chaotic because relations feel a loss of control over their life, their treatment and their supportive care needs. Jaguar’s mission is to change patients’ lives for the better, especially in the area of supportive care for complex disease states like cancer. We are excited about our planned commercial launch of Gelclair in October 2024 because we believe we can help cancer patients by giving them a supportive care product for oral mucositis that provides soothing, pain relief without numbing and which is effective and safe. Our focus for the Gelclair launch will be patients with head and neck cancer. Head and neck cancers account for nearly 4% of all cancers in the United States according to the National Cancer Institute.

Counting cancers of the oral cavity, pharynx and larynx, the NCI National Cancer Institute estimates that about 71,110 cases will occur in the United States this year, while up to 40% of all patients treated with chemotherapy develop oral mucositis, this percentage rises to approximately 90% for patients with cancers treated with chemotherapy and radiotherapy. Of the latter, 19% may end up being hospitalized, experiencing a delay in their cancer treatment for high-grade mucositis management resulting in a reduction of the quality of life, a worse prognosis and an increase in patient management costs. Those of us working in the oncology feel — know the impact that side effect related delays or cessation of cancer treatment can have on the overall survival and the efficacy of treatment of patients with head and neck cancers treated with chemotherapy and radiotherapy, who develop oral mucositis, half the cases are typically considered severe, meaning oral mucositis of grade 3 or 4 which typically puts a patient in the hospital, requiring parenteral nutrition and IV hydration.

And, of course, the morbidity and expense associated with those treatments. We’re dedicating a great deal of effort to ensuring that our commercial launch plan for Gelclair is executed with sharp strategic focus. We’re enhancing our educational, promotional and sales representative team to cover cancer-related supportive care specialists. This positions us well as we anticipate future commitments in the cancer supportive care space. To kick off the Gelclair launch, we plan to exhibit at several key oncology conferences in Q4 of this year. There will also be a strong digital component to our launch, providing information and education for patients to self-advocate. With that, I’ll hand the conversation back to Lisa.

Lisa Conte: Thank you so much, Cathy. And I’m so pleased about that last point of the opportunity to educate, inform patients for their ability to self-advocate. Jaguar’s mission clearly used to change patients’ lives for the better, especially in the area of supportive care for complex disease states like cancer, we do not believe that any cancer therapy-related side effects whether it’s oral mucositis, debilitating diarrhea, extreme fatigue, neuropathy, chronic pain, I mean the list goes on and on and on, should ever, ever be viewed as acceptable or tolerable. This belief is a core message of our ongoing Make Cancer Less Shitty campaign which seeks to broadly acknowledge the rigors of both short-term and perpetual treatment cancer treatments for the metastatic patients which are remarkable, allowing patients to live 5, 10, 15, 20 years with cancer as a chronically managed state.

And with the Make Cancer Less Shitty campaign, allowing patients to share the voices and the stories with a live — lived experience. We launched the Make Cancer Less Shitty campaign with three remarkable patient ambassadors and you can find their stories and our commitment on the campaign website which is www.makecancerlessshitty.com. Shitty is S-H-I-T-T-Y. The primary social media channel for the Make Cancer Less Shitty Campaign is X, Twitter under the handle CancerSuckLess. We’ll now hear from our CFO, Carol Lizak, regarding the financial highlights from the second quarter of 2024 and then I will be back. Good morning, Carol.

Carol Lizak: Good morning, Lisa and thank you to all of you who have joined our webcast today. I’ll begin my review of our financials for the second quarter of 2024. The combined second quarter 2024 revenue of approximately $2.72 million for prescription and non-prescription products, increased approximately 16% versus net first quarter 2024 revenue of $2.35 million and 2% versus net second quarter 2023 revenue of $2.67 million. Mytesi prescription volume increased in the second quarter of 2024 compared to the first quarter of 2024 by 5.2%. Prescriptions decreased slightly by 0.4% in the second quarter of 2024, compared to the same period in 2023. Prescription volume differs from invoice sales volume which reflects, among other factors, varying buying patterns among specialty pharmacies in the closed network as they manage their inventory levels.

Loss from our operations decreased by $0.9 million from $8.1 million in the quarter ended June 30, 2023, to $7.2 million during the same period in 2024. Non-GAAP recurring EBITDA for the second quarter of 2024 and the second quarter of 2023 were a net loss of $8.8 million and $7.7 million, respectively. Net loss attributable to common shareholders decreased by approximately $2.6 million from $12.1 million in the quarter ended June 30, 2023, to $9.5 million in the same period in 2024. All that concludes my recap of high-level financials for the second quarter of 2024. And I will now hand the discussion back to Lisa Conte.

Lisa Conte: Thank you, Carol. Thank you, Cathy. Thank you Pravin. Thank all of you who joined this webcast and are interested in support Jaguar Health. And I also would like to thank Peter Hodge, who handles our Investor Relations. Again, our mission at Jaguar and the family of Napo Companies is to change patients’ lives, of course, for the better. Our mission is unwavering and we’re inspired by the potential of a crofelemer’s novel and paradigm shifting mechanism of action may have to impact outcomes for certain complex diseases by providing that supportive care. We’re also very excited about our upcoming Gelclair launch, October just around the corner of this year. Patients are and always remain at the heart of our mission.

Through the process of sustainably bringing crofelemer from a tree in the rainforest, to an FDA-approved prescription product and that is, of course, the trade name Mytesi, in pharmacies across the United States for supportive care indication or the indication currently approved is adults living with HIV/AIDS, who have non-infectious diarrhea, we have gained a great deal of experience about educating health care professionals and patients and payers about the novel paradigm shifting mechanism. We’ve learned also from the veterinary and pet parent response to our crofelemer prescription product, Canalevia CA1 which is conditionally approved by the FDA. Interestingly, for the treatment of chemotherapy-induced diarrhea in dogs. Yes, our dog in the United States with cancer on chemotherapy and diarrhea, you can receive a prescription for crofelemer.

We thank you, our shareholders, for your support and your dedication to our mission to bring innovative and novel prescription products to patients in need around the world. plant-based products from our basic enabling discovery technology. We thank you for your persistence in your patients as drug development is a long process and we thank you once again for joining today’s webcast. All please be well.

End of Q&A: Thank you. This concludes today’s teleconference. You may disconnect your lines at this time. Thank you for your participation.