Jaguar Health Q2 2024 Earnings Call Transcript

Quartr
Provided by Quartr
August 13, 2024

There are 5 speakers on the call.

Operator

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 ks 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.

Operator

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 item 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.

Operator

At this time, it is now my pleasure to turn the call over to Lisa Conti, Jaguar Health's Founder, President and Chief Executive Officer. Lisa, the floor is yours.

Speaker 1

Thank you. Thank you. Hello, and thank you all for joining our investor webcast today. My name, as you heard, is Lisa Conti, 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.

Speaker 1

As announced, this is an earnings webcast for the Q2 of 2024. I'm going to steal the thunder of our CFO, Carol Isaac, who will be speaking at the end of this webcast, as I am pleased to report our combined net Q2 2024 revenue of approximately $2,720,000 for prescription and non prescription products increased approximately 16% versus net Q1 twenty twenty four revenue, which was $2,350,000,000 and it increased approximately 2% versus net Q2 2023 revenue of $2,670,000 We're very pleased with that. In addition, on this webcast, I will be joined by my colleagues Doctor. Pravin Chadderevedi, our Chief Scientific Officer and Kathy Kallis, 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.

Speaker 1

In the initial data from our recently completed pivotal Phase 3 on target trial of prophylamer for the prophylaxis of diarrhea in adult cancer patients with solid tumors, all solid tumors receiving targeted therapy with or without standard chemotherapy. Again, the signal was seen in the 2 subgroups of breast and lung cancer. Today, Pravin will also discuss Jaguar's other clinical core focus areas for the development of Crefilamer for 2 targeted rare and orphan disease indication. Microvillous inclusion disease we refer to as MVID, which is an ultra rare 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 crosvelamer or MVID and SBA in the U.

Speaker 1

S. And the MENA regions, Middle East, North Africa regions, with results, proof of concept results expected by the end of this year 2024 and throughout the beginning of 2025. Provelamir 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 in rare disease business model for these indications. We're very pleased to announce last week that the required import permit for crosvelamer has been granted in Abu Dhabi in the UAE, United Arab Emirates for the planned investigator initiated proof of concept trial patients for MVID and SVS, 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, Kathy 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.

Speaker 1

S. Market. This is our 3rd prescription product launch. Oral mucositis also called ChemoMouth has emerged as the most significant adverse event in oncology according to the National Comprehensive Cancer Network Task Force. Kathy was instrumental in executing Jaguar's in license agreement for Jel Claire.

Speaker 1

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 Leizak, will provide a recap of the financial highlights for the Q2 of 2024. So before I introduce Pravin, just a reminder that our ambitious Phase 3 on target 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 of which have a reported rate of diarrhea of more than 50% and with or without standard chemotherapy.

Speaker 1

So quite a heterogeneous population, quite important that we were looking to understand how we could mitigate diarrhea in with the broadest potential label. We observed the meaningful clinical signals in breast and lung cancer patients, 2 of the most common cancer diagnoses. We are collaborating with our clinical and scientific advisors 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 prophylamer, 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 that standard of care and treatment policy for cancer patients in the on target 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.

Speaker 1

Because of this and given the rich and extensive database from on target, there is a great deal of work still ahead to analyze data for numerous pre specified and non pre specified 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.

Speaker 2

Good morning, Lisa, and good morning, all, and thank you for joining today's investor webcast.

Speaker 1

Okay, Pravin. It's been 2 weeks since we announced the clinically meaningful signals in the subpopulations of breast and lung cancer patients in the ONTARGATE trial. I know this has been a focus of yours for many years now. Since that time, we also announced significant positive results with prophylmer 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.

Speaker 1

Pravin will begin by explaining the relevance of those study results and analyses which have come out since we preliminary results and on target. So the relevance of those study results and analyses to the on target results.

Speaker 2

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 Crefilma 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 loose watery stool frequency, loose watery stool consistency and other bowel endpoints, depending on the indication within a chronic multi month study.

Speaker 2

That's what these 2 recent diarrhea predominant IPS studies showed. Just to remind, similarly, we analyzed the pivotal trial for the currently approved indication of Crefilma for HIV related diarrhea, which was based on the proportion of patients with an acceptable number of loose 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 pre specified primary endpoint in the on target 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 wattage tools per week compared to placebo that was seen in the breast and lung cancer patients in months 23 of the 3 month treatment period of the on target study.

Speaker 2

Clinical relevance for this analysis has been informed by a cancer patient survey that we conducted prior to the start of the on target 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 mortuary 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 improved quality of life. And I'll provide some more technical details about the responder analysis in the on target trial subgroups. Since this is an these are exploratory analyses in subgroups of breast and lung cancer patients receiving targeted therapies, the sample size for each of these subgroups is smaller.

Speaker 2

As we had designed the trial to be all inclusive for adult solid tumor patients that were eligible to receive diureogenic targeted therapies in at least 50% of the patients receiving those therapies. And it was a multicenter, double blind, placebo controlled study that included U. S. And ex U. S.

Speaker 2

Sites and it used patient reported outcomes, PROs, as the primary determinant of their clinical responses. When we combined all the breast and lung cancer patients receiving different targeted therapies that achieved the monthly responder status in months 23, defined as those patients having less than or equal to 7 water stools per week at least 50% of the time, it showed that 79% of the patients in Crefilma group had achieved this threshold compared to 68% 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 the hurdle for on target 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 ratio value.

Speaker 2

We are also looking at odds or hazard ratios. For sake of clarity, an odds ratio analysis is similar to a hazard ratio assessment, which measures the frequency of an event in 2 groups over time and a ratio being greater than 1 is deemed favorable for Crefilmer. When we evaluated all the breast cancer patients receiving 3 different types of targeted therapies, the proportion of monthly responders for months 23 that achieved less than 7 watery stools per week at least 50 percent of the time, Crefilma 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 2 and 3 was 69% for the Cresemba group versus 58% for the placebo group. And the odds ratio for this group, this subgroup was 1.796 over the 3 month period.

Speaker 2

Continuing with breast cancer patients, those patients that received protuzumab that were monthly responders in months 2 and 3 having at least less than 7 what we stool per week for 50% of the time. It was 87% of patients in the pro filmer 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 water stools per week was 81% in the Crefilma arm compared to 64% in the placebo group. Had the sample sizes being larger in these subgroups, these same differences that were observed would have reached statistical significance. These exploratory odds ratio analysis for each subgroup are also being evaluated using nonparametric rank sum tests due to the skewness of the data in both groups, but especially in the placebo group.

Speaker 2

To be more specific, the range of average number of weekly loose watery stools for the prophylla group was 0 to 30 compared and 0 to 42 for the placebo group across all tumor types and targeted therapies in the on target study. The wide variation in the average number of weekly loose water stools contributes to the skewness of the data. 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 are able to discern in breast and lung cancer patients.

Speaker 2

We have seen pro form a benefit patients in multiple studies and in multiple patient populations. I will underscore your comment, Lisa. We are energized and hopeful as we undertake more analyses and potentially further reveal important and potentially clinically 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 on target study called Stage 2, which is for the whole study, we know about 2 thirds 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 Crefilma continues to show improvement in various gastrointestinal indications due to its novel paradigm shifting mechanism of action, physiologic mechanism of action.

Speaker 2

We had previously conducted 2 diurepyridone and IBS D clinical trials and Crefloamer showed improvement in abdominal pain and discomfort 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. 2 independent scientific and clinical thought leaders in gastroenterology at the Beth Israel Deaconess Hospital at Harvard Medical School and at the University of Texas in Houston, studied KRYPHELMER in refractory diarrhea subgroups of 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?

Speaker 1

Well, thank you for that detailed response, Ravin. It's a snapshot of just how rich this database is and how complex this trial was, the on target trial. But I know Pravin that you have personally designed many of the successful trials with gophelamer 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 on target trial and the plan specifically related to our goal of meeting with the FDA, which is the gating item to get crosvelamer, my testi to people living with cancer therapy related diarrhea?

Speaker 2

Thanks, Lisa. It's a good question. The plan is to continue with the responder analysis and show the robustness of our findings, particularly in the subgroups of breast and lung cancer patients in the on target trial. We will discuss the findings of our exploratory analysis with our clinical and regulatory key opinion leaders and evaluate other gastrointestinal endpoints from our 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 Crefilmer. Since ONTARGET is a pivotal Phase 3 trial, we will prepare a briefing document for the FDA after our meetings with our internal KOLs on the obligatory pre specified statistical analyses.

Speaker 2

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 incidence, severity and duration of diarrhea from the on target 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 Crefilmer. Since Crefilmer 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 Crefilma related serious adverse events in the 10 plus year of commercialization history, the assessment of benefit risk ratio adds to support Crefilma's value for the cancer therapy related diarrhea, CTD indication in at least the subgroups of breast and lung cancer patients.

Speaker 1

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 on target trial added more clinical evidence or did the impact add more clinical evidence than the previous Phase 2 study that was conducted in breast cancer patients?

Speaker 2

Thanks for bringing that up, Lisa. I think you're referring to the HALT D Phase 2 trial that was conducted in breast cancer patients receiving pertuzumab with standard chemotherapy. The HAALTY study, which was a prophylactic study, helped inform us about conducting a longer duration study and hence the on target study was designed to have an overall period of treatment of 24 weeks with the initial analysis being conducted at 12 weeks. The on target study also identified that Crefilmer in addition to its effects in breast cancer patients receiving targeted therapies is also beneficial to lung cancer patients receiving target therapy with kinase inhibitor. That's a feature of having this all inclusive solid tumor trial, the on target study.

Speaker 2

So that's useful.

Speaker 1

Yes, which I agree is a 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 like to call it leaving no statistical analysis stone unturned here and it's likely going to go into 2025.

Speaker 1

So we have the most comprehensive briefing package prepared for the FDA. I'd like to address the robustness of the prophylamer mechanism of action, you called it 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 krofelmer of SPS short bowel syndrome and MVID for prophylmer, which have both received, of course, as I mentioned, orphan drug What is the disease progression like for these patients and their standard of care?

Speaker 2

Thanks, Lisa. Continuing this discussion into the orphan and rare disease indication for Crefilmer is very important to me. We have made significant progress in achieving clinical and regulatory milestones for the rare and orphan disease indications of Schrodt Dahl syndrome with intestinal failure, PSPS IF, as well as microvillous inclusion disease, MPID, or prophylmer. As I mentioned earlier, Crefilmer shows a consistency in symptomatic management of diarrhea and other gastrointestinal symptoms in various clinical indications. Adult or pediatric patients with short 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.

Speaker 2

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 fluids, 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 Agency, EMA, which is the European counterpart of the U. S.

Speaker 2

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 Crefilma's benefits in SPS IF patients. It is important for everyone to understand that these SPS IF patients are monitored very closely. And due to the shortened length of the intestinal tract, an oral delayed release tablet formulation of Crefilma currently on the market here in the U. S.

Speaker 2

Is not viable for these patients. Our team developed a novel, proprietary, highly concentrated lyophilized powder for oral solution, which can be administered orally to these patients in very small volumes to evaluate the effects of prophylmer on various clinical symptoms of SBS IH patients, including reductions in their stool volume output and the need for reduced parenteral support as a result of Crefilmer's effects. The collateral benefit of the novel lyophilized oral powder for solution Crefilma formulation is that we can also administer that orally to pediatric patients that have the ultra rare congenital diarrheal disorder called microvillous inclusion disease. MVID patients do have a full length cut, 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 nutritional and caloric needs and these patients fail to thrive, which means they don't grow as a normal child would.

Speaker 2

Thus, MVID is associated with significant morbidity and mortality. We have an active U. S. IND for MVID and we are initiating a pioneer in clinical study to evaluate the benefit Kroefelmer 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.

Speaker 2

An important near term milestone for us will be the support we are providing for an investigator initiated trial with 1 of our key opinion leaders and a member of my Scientific Advisory Board in the MENA region, Doctor. Mohammad Meghdadi, who is evaluating the effects of Crefilmer in his pediatric patients with either microvillous 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 Crefilma 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.

Speaker 1

Thank you, Pravin, for that. And I do want to mention, I've known Doctor. McDade for about 6 years and I've 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 3 different continents.

Speaker 1

And what we hear is 2 of the most devastating toxic 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 patients' disorders, but also the focus on supportive care, quality of life, patient comfort, patient dignity. So, also Pravin, I've asked you to describe some of the key learnings from these meetings that inform the protocol development.

Speaker 2

Thanks, Lisa. As you know, both MVID and SPS 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 tetaglutide, which is a growth hormone in GLP-two for the management of adult and pediatric SPS IH patients. It's given parenterally by injection. Since the approval of tetraglutide, several additional biosimilars are also under clinical development and their clinical effects are very similar to tetraglutide 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.

Speaker 2

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 tadaluglutide or any of the biosimilars and other growth hormones cannot be used in cancer patients that have Schrodt Ball syndrome because it's a growth hormone. And tadaluglutide 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 for the membrane and they have limited ability to grow any absorptive villi in the intestine with a growth hormone mechanism of action. So in our travels and discussions with KOLs, Trofelmer 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 thus reducing diarrhea, our clinical investigators across the U.

Speaker 2

S, the EU and the MENA region, they welcome the opportunity to evaluate Crefilma because of its truly novel and well tolerated therapy for their adult SPSI F and pediatric MBID patients. I couldn't be more grateful to all these clinical investigators who are going to study the patients because they are looking forward to giving a new therapy to their patients with Crefilmer. Thank you.

Speaker 1

Thank you, Pravin. And I could not be more grateful to the Jaguar NAPO team. This is truly a pipeline within a product with Crefloamer and no other mechanism of action out there like that. And it's a lot going on in a small company and you got a snapshot here of just how complex clinical trial planning, execution, implementation and analysis is. And we are committed to get crosvelimab to all the patient populations that can benefit in the most efficient way possible.

Speaker 1

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 the discussion Kathy Collis is going to leave and talk about our planned October 2024 commercial launch of Joclar, 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.

Speaker 1

So I'm so pleased that we have 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 Kathy, over to you. Good morning, Lisa, and good morning to all of you joining us today. As Lisa has alluded and many

Speaker 3

of you are aware, oral mucositis is among the most common painful and debilitating cancer treatment related side effects. GELClare is a protective drill with a mechanical action indicated for the management of pain and relief of pain by adhering to the mucusole surface of the mouth, soothing oral lesions of various etiologies, including oral mucositisstomatitis. It is a clinically proven FDA approved convenient and easy to use product that provides rapid and long lasting pain relief and improves 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 patients feel a loss of control over their life, their treatment and their supportive care needs.

Speaker 3

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 GELClare 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 GELClare 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.

Speaker 3

While up to 40% of all patients treated with chemotherapy develop oral mucositis, this percentage rises to approximately 90% for patients with hepatic 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 field 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 GELClare is executed with sharp strategic focus. We're enhancing our educational, promotional and sales representative team to cover cancer related supportive care specialists.

Speaker 3

This positions us well as we anticipate future commitments in the cancer supportive care space. To kick off the GELClare 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.

Speaker 1

Thank you. Thank you so much, Kathy. 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 is 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 effect, 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.

Speaker 1

This belief is a core message of our ongoing Make Cancer Lets 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 3 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.

Speaker 1

The primary social media channel for the Make Cancerless Shitty campaign is ex Twitter under the handle Cancer Suck Less. We'll now hear from our CFO, Carol Lizaak, regarding the financial highlights from the Q2 of 2024 and then I will be back.

Speaker 4

Good morning, Carol. 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 Q2 of 2024. The combined net second quarter 2024 revenue of approximately $2,720,000 for prescription and non prescription products increased approximately 16% versus net first quarter 2024 revenue of $2,350,000 2 percent versus net second quarter 2023 revenue of $2,670,000 Mytesse prescription volume increased in the Q2 of 2024 compared to the Q1 of 2024 by 5.2%. Prescriptions decreased slightly by 0.4% in the Q2 of 2024 compared to the same period in 2023.

Speaker 4

Prescription volume differs from invoiced 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 $900,000 from $8,100,000 in the quarter ended June 30, 2023 to $7,200,000 during the same period in 2024. Non GAAP recurring EBITDA for the Q2 of 2024 and the Q2 of 2023 were a net loss of $8,800,000 $7,700,000 respectively. Net loss attributable to common shareholders decreased by approximately $2,600,000 from $12,100,000 in the quarter ended June 30, 2023 to $9,500,000 in the same period in 2024. Well, that concludes my recap of high level financials for the Q2 of 2024.

Speaker 4

And I will now hand the discussion back to Lisa Conti.

Speaker 1

Thank you, Carol. Thank you, Kathy. 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.

Speaker 1

Again, our mission at Jaguar and the family of Napa Companies is to change patients' lives, of course, for the better. Our mission is unwavering, and we're inspired by the potential that Crefilmer'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 GELClara launch October just around the corner of this year. Patients are and always remain the heart of our mission. Through the process of sustainably bringing Crevelamer 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 for and the indication currently approved as adults living with HIV AIDS who have non infectious diarrhea.

Speaker 1

We have gained a great deal of experience about educating healthcare professionals and patients and payers about the novel paradigm shifting mechanism. We've learned also from the veterinary and pet parent response to our prescription product, Canalevia CA1, which is conditionally approved by the FDA, interestingly, for the treatment of chemotherapy induced diarrhea in dogs. Yes, you have our dog in the United States with cancer on chemotherapy and diarrhea, you can receive a prescription for crosvelamer. 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 and your patience as drug development is a long process.

Speaker 1

And we thank you once again for joining today's webcast. All please be well.

Operator

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

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Earnings Conference Call
Jaguar Health Q2 2024
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