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 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 the 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 the webcast for a variety of reasons, including those described in the forward-looking statements and risk factor sections of the company's Form 10-K for 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 new information, future events, or otherwise. Today's conference is being recorded. At this time, it's my pleasure to turn the call over to Lisa Conte, Jaguar Health's Founder, President, and Chief Executive Officer. Lisa, the floor is yours. Thank you. Thank you. Hello, and thank you for joining our investor webcast today. To all who are listening, 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. As usual, I may use the words Jaguar and Napo interchangeably to refer to the company. Now, let's get right to it. We announced earlier today that the initial results of our unprecedented OnTarget trial, a study that included 10 different solid tumor types, did not meet its primary endpoint across all tumor types. We are, however, pleased the trial did reveal clinically relevant signals for crofelemer in pre-specified subgroups of patients with breast and respiratory cancers, including lung cancer. I am here with our Chief Scientific Officer and Chair of our Scientific Advisory Board, Dr. Pravin Chaturvedi, the architect of the OnTarget trial design, and also for full reference, Dr. Chaturvedi was also the architect of the successful ADVENT trial that supported the approval of crofelemer under the brand name Mytesi, which is currently commercialized under the current approved indication of HIV-related diarrhea. And he has seven approved NDAs to his name. He knows his way around the regulatory pathway. Pravin, I have a few questions for you. So let's, and by the way, good morning. And, let's explore the meaning of this announcement. First, why is this called an unprecedented supportive care trial? Thank you for the question, Lisa, and good morning, everybody. We chose to be patient-centric and designed a trial to include all patients, regardless of their tumor type or targeted therapy. We designed a clinical study that was informed by the patients for addressing their bowel control habits, regardless of their targeted therapy or cancer. OnTarget study is unprecedented trial because it's truly the first trial of its kind. It was prophylactic, randomized, double-blind, placebo-controlled study in patients who are receiving targeted therapies, which, as you know, Lisa, are cytostatic and are administered chronically, unlike cytotoxic chemotherapies, which are given as a cycle every three weeks or so. We conducted this prophylactic study in a real-world setting, where the primary endpoint was determined based on patient-reported outcomes of their bowel habits. This trial was truly patient-centric and included all adult solid tumor patients receiving targeted therapies, which are appropriate for their tumors, contributing to the heterogeneity of the patient population and their treatments. We randomized patients across 10 solid tumor types who received 24 different targeted therapies, which had differing mechanisms of action. Thus, the patients and the therapies that were included in the trial were based on the diversity and heterogeneity and included drugs that caused an incidence of more than 50% all-grade diarrhea. These numbers are not available in the public domain, as oncology drugs only report Grade 3 and 4 diarrheas. To put it into context, Grade 3 diarrhea is more than seven loose, watery stools per day, every day, and targeted therapies are taken for prolonged periods, sometimes indefinitely. It is deemed that Grade 1 and 2 diarrhea, which is between 3 and 6 loose, watery stools every day, which is 21 to 42 loose, watery bowel movements per week, are manageable. We were unprecedented because we do not believe that this should be acceptable, nor should anyone live with that much toxicity every day. Hence, we call it an unprecedented trial. Thank you. In the trial, the OnTarget trial showed a clinically relevant signal in breast cancer and lung cancer patients. What does clinically relevant mean? So clinically relevant refers to what is important to the patients. As Dr. Pablo Okhuysen, who is the national PI from MD Anderson Cancer Center, stated in this morning's press release, that it is important to note that the pre-specified secondary outcomes for this study were based on outcomes that were considered to be meaningful to the patients experiencing diarrhea due to their targeted therapy. We designed an endpoint for OnTarget study that was based on a patient survey on what was important to the patients. It is clinically relevant because unlike an expectation of no diarrhea, which means no loose watery stools per day, cancer patients are remarkable. A majority of the patients, almost three out of four, told us that if we can reduce their loose, watery bowel movements per week to about 14 per week, which is about two a day, they would be able to tolerate their cancer regimens and take the required medication to treat their cancers. Based on this input, we designed a trial to assess the proportion of patients that would have achieved their stated, clinically meaningful and acceptable bowel control outcomes. Hence, in our pre-specified subgroup analysis, we evaluated patients achieving this secondary clinical outcome, which makes it relevant to the patients. Okay, thank you for that. So with regard to the breast cancer and the respiratory, basically the lung cancer patients, where the study showed a clinically relevant signal, what does a pre-specified subgroup mean? And tell me about those patients. During the OnTarget study, we have stratified patients based on their tumor types and the various targeted therapy mechanisms of action. We had pre-specified subgroups, including respiratory and breast, as they represent a significant portion of the patients that are eligible for targeted therapies that are quite diarrheagenic. To be more specific, each of the targeted therapies that were included in this trial, including those for breast and respiratory, were reported to have greater than 50% incidence of diarrhea. For instance, the breast cancer therapy pertuzumab has a diarrhea incidence rate up to 71%. Abemaciclib has a diarrhea rate up to 85%, and lung cancer therapy patients that receive osimertinib have a diarrhea rate up to 58% of the patients. Of the 287 patients enrolled in OnTarget study, 37 patients had respiratory cancers and 180 patients had breast cancer. Combined, these two groups alone were about 217 patients. That represented 75% of the patients randomized in the OnTarget study. It was important to have these subgroups analyzed. Okay, so Pravin, we've worked together a long time to bring crofelemer to, for example, people living with HIV, AIDS on antiretroviral therapy. What do we do next here in this patient population? Thank you for asking that. As you know, we've just received the initial results from the analysis of the first 12 weeks of this double-blind, placebo-controlled study. We've seen that the pre-specified subgroups of breast and respiratory cancer patients have an improvement in the incidence of diarrhea over the first 12 weeks. We appreciate that the majority of subjects also chose to continue on to the stage two part of the study, which is also blinded, and so we have to look at those data. So what we plan to do is to conduct further analysis of all the data from both Stage 1 and Stage 2, with a pre-specified and exploratory endpoint for various subgroups. Subsequently, we will engage in discussions with the FDA to explore options available to us to bring crofelemer to at least the subgroups in which crofelemer is showing a clinically relevant effect. That's what our plan is at this time. Okay, and as always, I love to hear it. Can you comment on the paradigm-shifting mechanism of action of crofelemer, why this is important to get this product out? Thank you for that. So, for those of you who don't know, crofelemer is a first-in-class chloride ion channel modulator that does not have any effect on gastrointestinal motility. Furthermore, it is negligibly absorbed orally and acts locally in the gut lumen. It does not belong to the class of opioids and therefore does not present the risk of constipation. It is also unlike any other currently grandfathered antidiarrheals such as antimotility drugs, anticholinergic drugs, adsorbent drugs, or bile acid sequestrants that are commonly administered to manage the toxicity and, of diarrhea, specifically in oncology patients. Due to its unique mechanism of action and lack of systemic absorption, crofelemer's safety profile over the years when we have studied it and developed and commercialized it, has been consistently not different from placebo. So that makes it a paradigm shift in terms of safety and tolerability. Okay. You referred to the trial as a real-world evidence trial. What does that mean? So as I said a little earlier, we had designed the OnTarget study to be a prophylactic protocol that allowed for the inclusion of all solid tumor types and their standard of care treatments that included targeted therapies. We wanted to remain patient-centric and did not want to dictate their cancer treatment based on the OnTarget study protocol. So what that means is that the patients got whatever drugs were appropriate for their cancer care, and then whatever other drugs their providers were administering them for control of their adverse events, including opioids for pain and any other interventions for their diarrhea, as deemed appropriate by their healthcare professional. This made for a very complicated analysis. It contributed to the heterogeneity as well as the lengthy duration of the time required for the analysis of this study. It's a real-world study because we did not change any other parameter for the patients being treated for their cancer. Thank you for that. Are you expecting to present and/or publish the results from this trial? Absolutely. Obviously, we have more analysis to conduct for both the stage one and stage two portions. We intend to collaborate with our clinical and scientific advisors to evaluate the significance of the clinical outcome signals, especially in these pre-specified subgroups, and we will present that in a setting that allows peer-reviewed presentations and publications. So we are very, very hopeful about that. Thank you very much, Pravin, and thank you for all the hard work to the team for implementing this trial, and especially the patients who participated in the trial, the healthcare providers, the nurses, et cetera. I'd like to let all of you who are listening to us today know that both Pravin and I are cancer survivors. In my case, it was breast cancer last year, after the trial was already planned and started, and included treatment with targeted therapy, the same as the majority of the patients in the OnTarget trial, same patient population, where there's a clinically relevant signal. So Pravin and I know firsthand that no cancer therapy-related side effect should ever be viewed as acceptable or tolerable. The patient perspective, and certainly in my case, it was unanticipated, and it's extraordinary, this perspective, in driving home the unmet need for supportive care to address patient dignity, patient quality of life, the ability of patients to stay on their life-saving cancer therapy and continue with their life, not a new normal, continue with their life. This is all at the heart of Jaguar's mission. We're now gonna play a series of short video clips from four important thought leaders. The amazing patient thought leader, who is a member of our scientific advisory board, Stacy Tiano. She's an 11-year cancer survivor who founded the nonprofit organization, Advocates for Collaborative Education, and who serves on our scientific advisory board. Stacy is leading the charge with Napo's Make Cancer Less Shitty patient engagement program, which we premiered at Napo's exhibit booth at the San Antonio Breast Cancer Symposium last December. We would fully expect to be there this coming December, and at the past April's Oncology Nursing Society Congress. The program is designed to provide a voice to cancer survivors who are no longer willing to accept debilitating side effects of cancer treatments as an acceptable trade-off for survival. Patients don't want to just exist, they want to live. Following Stacy, Dr. Lee Schwartzberg will discuss the significant unmet medical need of cancer therapy-related diarrhea. He is a leading breast cancer medical oncologist and hematologist who serves as chief medical oncology and hematology at the Renown Health William N. Pennington Cancer Institute in Reno, Nevada. Also, a member of our scientific advisory board, involved in the design of the OnTarget study with Dr. Chaturvedi. We'll then view a short recording from oncologist, Dr. Allison Simon, Napo's Vice President of Clinical Research and Medical Affairs. After Allison speaks, we're gonna hear from Dr. Magdy Ghaly. He's a well-known radiation oncologist and oral mucositis expert with Northwell Health Cancer Institute, Monter Cancer Center, speaking about oral mucositis. As a reminder, we recently expanded Jaguar's Cancer Supportive Care portfolio through our in-license of the FDA-approved oral mucositis prescription product, Gelclair, for the U.S. market, and we plan to conduct the commercial launch of Gelclair in the fourth quarter of this year. Another topic near and dear to my heart, because one of my side effects in my cancer care was oral mucositis. Today's webcast will end after the videos finish. I want to thank you all. Drug development is a long-term process. We are committed. We've brought crofelemer under the trade name, Mytesi, to people living with HIV/AIDS as a first indication. We are committed to patient supportive care, not only with crofelemer, but as you can see, with Gelclair, and there's 21 side effects that are reported in the supportive care world and unmet needs for cancer supportive care. So we're gonna start picking them off one at a time. Dr. Chaturvedi, Pravin, we've worked together a long time. Are there any final words you would like to say about the drug development process? No, I think you summarized it well. I thank also all the patients and all the participants and the investigators for the OnTarget study. Work to be done, and it's in the right direction. Thank you so much for the opportunity to speak to the listeners. Thank you. And to those of you who can stay on another 12 minutes or so, there'll be some really informative webcasts, right, or videos right now as part of this webcast. Thank you again.