Jaguar Health, Inc.

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 risk and uncertainties that would 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 result 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 relation section of the Jaguars 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 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. 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.

Thank you. 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 Isaac, 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 $2,350,000. 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 Kathy Collis, our recently appointed Senior Vice President of Growth Strategy, to speak to the robustness of our clinical pipeline and commercial activities. PRVN will further review the data and regulatory strategy for the clinically meaningful results reported on July 23rd, 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 three on target trial of profilamer, 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 two subgroups of breast and lung cancer. Today, Praveen will also discuss JAGUA's other clinical core focus areas for the development of cofilomer for two targeted rare and orphan disease indication, microvirus 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 NAPCO Therapeutics based in Milan, Italy, We are also supporting independent investigator-initiated proof-of-concept studies of crofilomer for MVID and SBAs in the U.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. Crofilomer 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 Crofilumab 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 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's 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 GelClear for the U.S. market. This is our third prescription product launch. Oral mucositis, also called chemo mouth, has emerged as the most significant adverse event in ecology, according to the National Comprehensive Cancer Network Task Force. Kathy was instrumental in executing Jaguar's in-license agreement for GelClear She is results-oriented. She's a 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 Liza, will provide a recap of the financial highlights. for the second quarter of 2024. So before I introduce Preven, just a reminder that our ambitious phase three 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. So quite a heterogeneous population, quite important that we were looking to understand how we could mitigate diarrhea 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 advisors to elevate the significance of these clinical outcome 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 profilamer, 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. 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 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. 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.

Good morning, Lisa, and good morning, all, and thank you for joining today's Investor Webcast.