Financial Performance - The combined net revenue for Q2 2024 was approximately $2.72 million, representing a 16% increase from Q1 2024 and a 2% increase from Q2 2023[2] - Mytesi's net revenue in Q2 2024 was approximately $2.64 million, reflecting a 15% increase from Q1 2024 and a 1% increase from Q2 2023[5] - The loss from operations decreased to $7.2 million in Q2 2024, down from $8.1 million in Q2 2023, marking a 13% improvement[6] - Net loss attributable to common shareholders decreased to $9.5 million in Q2 2024, compared to $12.1 million in Q2 2023, a reduction of approximately 28%[8] - Non-GAAP recurring EBITDA for Q2 2024 was a net loss of $8.8 million, compared to a loss of $7.7 million in Q2 2023[9] - The total cost of product revenue decreased by approximately $70,000 from $0.50 million in Q2 2023 to $0.43 million in Q2 2024[6] Research and Development - Research and Development expenses decreased by $0.6 million to $3.7 million in Q2 2024, primarily due to winding down activities related to the phase 3 OnTarget clinical trial[6] - An import permit for crofelemer has been granted for a proof-of-concept trial in pediatric patients in Abu Dhabi[3] - The company is exploring possible approval pathways for crofelemer in breast and lung cancer based on phase 3 trial results[4] - Results from investigator-initiated and IND proof-of-concept studies of crofelemer for MVID and SBS with intestinal failure are anticipated to be available by the end of 2024 and throughout 2025[18] - The company may engage in discussions with the FDA regarding the clinical outcome signals from the OnTarget trial[18] - An approval pathway may exist to make crofelemer available to breast and lung cancer patients for CTD[18] - Published data from clinical investigations of crofelemer in MVID and SBS could support early patient access in specific EU countries[18] Product Launch - The company plans to commercially launch Gelclair, its third prescription product, in October 2024[4] - The company expects to begin the commercial launch of Gelclair in October 2024[18]

Financial Performance - Jaguar Health, Inc. reported a net loss of $19.0 million for the six months ended June 30, 2024, compared to a net loss of $24.7 million for the same period in 2023[257]. - The company reported a net loss of $18.996 million for the six months ended June 30, 2024, a 23.1% improvement from a net loss of $24.688 million in the same period of 2023[270]. - Net loss attributable to common stockholders decreased by $2.658 million from $12.150 million for the three months ended June 30, 2023, to $9.492 million in 2024[289]. - Net cash used in operating activities for the six months ended June 30, 2024, was $15.2 million, compared to $19.0 million for the same period in 2023[309]. Revenue and Sales - Product revenue for the six months ended June 30, 2024, was $5.072 million, a 9.1% increase from $4.648 million in the same period of 2023[270]. - Gross product sales increased to $7.045 million for the six months ended June 30, 2024, compared to $6.304 million in 2023, reflecting an 11.8% growth[273]. - Product revenue for the three months ended June 30, 2024, was $2.721 million, an increase of $45,000 or 1.7% compared to $2.676 million in the same period in 2023[289]. Expenses - Research and development expenses are expected to increase due to the start-up costs associated with clinical trials for new indications[262]. - Research and development expenses decreased by $1.087 million, or 12.0%, from $9.052 million in the six months ended June 30, 2023, to $7.965 million in 2024[278]. - Sales and marketing expenses decreased by $490,000, or 14.2%, from $3.457 million in the six months ended June 30, 2023, to $2.967 million in 2024[280]. - Total operating expenses for the three months ended June 30, 2024, were $9.918 million, a decrease of $860,000 or 8.0% compared to $10.778 million in the same period in 2023[289]. - General and administrative expenses decreased by $555,000 from $9.25 million for the six months ended June 30, 2023, to $8.7 million in the same period in 2024, primarily due to a $308,000 decrease in personnel and related benefits[282]. Debt and Financing - Gain on extinguishment of debt was $1.245 million for the six months ended June 30, 2024, compared to no gain in the same period of 2023[270]. - Gain on extinguishment of debt increased by $1.2 million from zero in the six months ended June 30, 2023, to $1.2 million for the same period in 2024[287]. - Cash provided by financing activities increased to $24.8 million in the six months ended June 30, 2024, from $22.2 million in the same period in 2023[313]. Market and Product Development - The global market for Short Bowel Syndrome (SBS) is projected to exceed $4.6 billion by 2027, with approximately 10,000 to 20,000 people affected in the U.S.[249]. - Jaguar plans to launch Gelclair, an FDA-approved oral mucositis prescription product, in the fourth quarter of 2024, which addresses a common side effect of cancer treatment[244]. - Crofelemer, Jaguar's lead product, is in development for multiple indications, including chemotherapy-induced diarrhea (CID) and diarrhea-predominant irritable bowel syndrome (IBS-D)[251]. - The company has initiated clinical development of crofelemer for SBS patients, leveraging the EMA's accelerated conditional marketing authorization pathway[249]. - Jaguar's joint venture, Magdalena, focuses on developing plant-based medicines for mental health, including ADHD, utilizing a library of 2,300 medicinal plants[253]. - Canalevia-CA1, an oral plant-based prescription drug for CID in dogs, has received conditional approval from the FDA and is available through multiple veterinary distributors[255]. Cost Management - Direct labor costs in the cost of product revenue decreased by $144,000, or 26.5%, from $544,000 in 2023 to $400,000 in 2024[275]. - Material costs decreased by $79,000, or 19.4%, from $407,000 in 2023 to $328,000 in 2024, due to increased production efficiency[276]. - Interest expense decreased by $5.1 million from $5.6 million for the six months ended June 30, 2023, to $503,000 for the same period in 2024[285]. - Interest expense decreased from $3.5 million in Q2 2023 to $108,000 in Q2 2024, primarily due to changes in accounting for certain debt instruments[303]. Internal Controls and Legal Matters - As of June 30, 2024, the company concluded that its internal control over financial reporting was effective, providing reasonable assurance regarding the reliability of financial reporting in accordance with U.S. GAAP[316]. - The company is classified as a smaller reporting company and is not subject to auditor attestation requirements under applicable SEC rules[317]. - There were no changes in the internal control over financial reporting that materially affected or are likely to materially affect the internal control[317]. - The company is not currently subject to any material legal proceedings, which could have adverse effects due to defense and settlement costs[319].

Summary of Jaguar Health, Inc. Conference Call (July 23, 2024) Company Overview - **Company**: Jaguar Health, Inc. (NASDAQ:JAGX) - **Subsidiaries**: Napo Pharmaceuticals, Napo Therapeutics Key Industry and Company Insights OnTarget Trial Results - The OnTarget trial, which included 10 different solid tumor types, did not meet its primary endpoint across all tumor types [5][6] - Clinically relevant signals were observed for crofelemer in prespecified subgroups of patients with breast and respiratory cancers, including lung cancer [5][10] Trial Design and Patient-Centric Approach - The OnTarget trial was designed to be patient-centric, including all patients regardless of tumor type or targeted therapy [7][8] - It was a prophylactic, randomized, double-blind, placebo-controlled study focusing on patient-reported outcomes related to bowel habits [8][9] - The trial included patients receiving targeted therapies known to cause significant diarrhea, with over 50% incidence rates reported for certain drugs [9][15] Clinical Relevance and Patient Outcomes - Clinically relevant outcomes were defined based on patient feedback, with a majority indicating that reducing loose watery bowel movements to about 14 per week would be tolerable [12][11] - The trial included significant patient populations: 180 breast cancer patients and 37 respiratory cancer patients, representing 75% of the study cohort [15] Future Plans and Regulatory Engagement - Further analysis of data from both stages of the trial will be conducted, focusing on prespecified and exploratory endpoints [17] - Discussions with the FDA will be initiated to explore options for bringing crofelemer to the identified subgroups showing clinically relevant effects [17] Product Mechanism and Safety Profile - Crofelemer is a first-in-class chloride ion channel modulator that acts locally in the gut and does not affect gastrointestinal motility [19] - It has a safety profile consistent with placebo, making it a significant advancement in managing diarrhea related to cancer therapies [19] Supportive Care Initiatives - Jaguar Health has expanded its cancer supportive care portfolio with the in-license of Gelclair, an FDA-approved oral mucositis product, set for commercial launch in Q4 2024 [28] - The company emphasizes the importance of addressing quality of life and dignity for cancer patients, aligning with its mission to improve supportive care [25] Patient Advocacy and Engagement - The "Make Cancer Less Shitty" campaign aims to highlight the challenges faced by cancer patients and improve supportive care options [35] - The campaign is supported by patient advocates and aims to share real experiences to drive change in the perception of treatment side effects [34] Conclusion - Jaguar Health is committed to addressing unmet needs in cancer supportive care, focusing on innovative solutions for managing treatment-related side effects, particularly diarrhea and oral mucositis [29][40]

Core Viewpoint - Jaguar Health (NASDAQ:JAGX) stock has significantly declined following the failure of a Phase 3 clinical trial for crofelemer, which did not meet its primary endpoint [2][3]. Group 1: Clinical Trial Results - The Phase 3 clinical trial evaluated crofelemer for the prophylaxis of diarrhea in adult cancer patients with solid tumors, covering 10 different tumor types [4]. - Crofelemer was only effective in patients with breast and respiratory cancers, indicating limited efficacy across the studied tumor types [2][4]. - The trial's failure has led to heavy trading activity, with over 12 million shares changing hands, far exceeding the average daily trading volume of approximately 800,000 shares [3]. Group 2: Stock Market Impact - As of Tuesday afternoon, JAGX stock has dropped by 55.2% due to the negative trial results [6]. - The significant decline in stock price has prompted traders to sell shares aggressively, reflecting investor sentiment following the trial's outcome [3][6].

Core Viewpoint - Jaguar Health is implementing a one-for-60 reverse stock split to increase its share price and comply with Nasdaq's minimum bid price rule, aiming to attract institutional investors [3]. Group 1: Reverse Stock Split Details - The reverse stock split will consolidate 60 shares of JAGX into one share, with trading on a split-adjusted basis starting Thursday [1]. - Post-split, shares will continue to trade under the JAGX ticker on the Nasdaq Capital Market, with a new CUSIP number of 47010C805 [2]. Group 2: Market Reaction - As of Monday morning, JAGX stock has decreased by 40.3% [4].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-36714 JAGUAR HEALTH, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction ...

Jaguar Health (NASDAQ:JAGX) stock is rocketing higher on Tuesday after the pharmaceutical company announced a new license for a chemo mouth treatment.Jaguar Health is looking to treat chemo mouth, a side effect of chemotherapy, with Gelclair. This treatment already has approval from the Food and Drug Administration (FDA).Jaguar Health is licensing Gelclair from U.K.-based Venture Life Group. The product is a gel that makes it easier for patients undergoing chemotherapy to eat, drink, swallow, speak and slee ...

Former meme stock Jaguar Health (NASDAQ:JAGX) has won the approval of certain measures meant to help maintain its Nasdaq listing. These include an extension to Aug. 13 to regain compliance by getting its price over $1 as well as JAGX stockholder approval of a potential reverse stock split.Jaguar Health is delaying the reverse split as it seeks approval on a preventative treatment of cancer therapy-related diarrhea. The study is called OnTarget.This news is sending JAGX stock up 20% as of this writing. The s ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to COMMISSION FILE NO. 001-36714 JAGUAR HEALTH, INC. (Exact name of registrant as specified in its charter) Delaware 46-2956775 (State or other jurisd ...

Jaguar Health, Inc. (NASDAQ:JAGX) Q3 2023 Earnings Conference Call November 14, 2023 8:30 AM ET Company Participants Lisa Conte - President & CEO Carol Lizak - CFO Operator Good morning. 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 Contenued growth prospects for the company, uncertainties regarding market acceptance of products, the impact of competitive products and pricing, industry trends, and product ini ...