Core Viewpoint - Jaguar Health's subsidiary, Napo Pharmaceuticals, is providing a novel crofelemer powder for oral solution under FDA-authorized expanded access programs to treat pediatric intestinal failure patients with microvillus inclusion disease (MVID) [1] Group 1: Company Initiatives - Napo Pharmaceuticals is committed to supplying the crofelemer formulation as an investigational drug for two patients, as deemed medically necessary by their physician caregivers [1] - The initiative aims to mitigate the sequela from the progression of MVID disease [1] Group 2: Regulatory Aspects - The programs are being conducted under separate Single-Patient Investigational New Drug (sIND) applications in the United States [1] - The expanded access programs have received authorization from the U.S. Food and Drug Administration (FDA) [1]

Summary of Jaguar Health Conference Call Company Overview - **Company Name**: Jaguar Health (NasdaqCM:JAGX) - **Industry**: Pharmaceutical - **Focus**: Developing proprietary prescription medicines derived from plants for gastrointestinal distress in humans and animals [2][3] Key Points and Arguments - **Catalysts and Business Development**: The company is in a critical phase of business development, aiming to secure non-dilutive funding to support cash needs and move towards profitability [3][4] - **Key Asset**: Crofelemer, marketed as Mytesi, is the only FDA-approved oral drug under botanical guidance, providing exclusivity without a generic pathway [4][5] - **Current Indications**: Mytesi is currently approved for HIV-related diarrhea, with ongoing studies for cancer therapy-related diarrhea and intestinal failure associated with short bowel syndrome and MVID [5][6] - **FDA Meetings**: Recent FDA meetings have focused on expediting approval pathways for expanding Mytesi's indications to include breast cancer patients [6][7] - **Orphan Drug Designation**: The company has filed for orphan drug designation for metastatic breast cancer, which allows for greater regulatory flexibility and support [7][8] - **Market Size**: The orphan population for metastatic breast cancer is approximately 150,000 patients, with specific focus on those with brain metastases [8][9] - **Animal Health Product**: Crofelmer has received conditional approval for treating chemotherapy-induced diarrhea in dogs, with a grant of $250,000 to support confirmatory trials [10][11] - **Corporate Partnerships**: The company is actively seeking corporate partners to expand indications and secure funding, particularly in the context of rare diseases [14][16] Additional Important Information - **Regulatory Strategy**: The shift towards orphan indications has broadened discussions with potential corporate partners, enhancing the company's funding prospects [16][17] - **Future Expectations**: The company anticipates receiving comments on its orphan drug designation filings within the next four to six weeks [19]

Company Strategy - The company is in discussions with multiple potential animal health partners to expand the indication and commercialize Canalevia for the treatment of general diarrhea globally [1] - Canalevia, known as Canalevia-CA1, is currently conditionally approved for chemotherapy-induced diarrhea (CID) in dogs [1] Financial Support - The company has received notice of a $250,000 grant from the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM) [1]

Core Insights - Jaguar Health's subsidiary, Napo Pharmaceuticals, has submitted an orphan drug designation application to the FDA for crofelemer, aimed at treating diarrhea in adult patients with breast cancer that has metastasized to the brain [1] - The application is based on significant responder analysis results from the OnTarget study, which were presented at the Multinational Association of Supportive Care in Cancer 2025 Annual Meeting and the 2024 San Antonio Breast Cancer Symposium [1] - The FDA's Office of Orphan Products Development recognizes brain metastasis of any cancer as a distinct disease or condition from the primary site of origin [1] Company Developments - The submission of the orphan drug designation for crofelemer highlights the company's focus on addressing specific needs in the oncology space, particularly for patients with advanced breast cancer [1] - The potential treatment could enhance the therapeutic options available for patients undergoing targeted therapy with or without standard chemotherapy [1] Industry Context - The recognition of brain metastasis as a separate condition by the FDA underscores the evolving understanding of cancer treatment and the need for specialized therapies [1] - The ongoing research and development in the field of supportive care for cancer patients reflect a growing emphasis on improving quality of life alongside traditional cancer treatments [1]

Company Announcements - Jaguar Health, Inc. announced that Lisa Conte, the company's founder, president, and CEO, will present virtually at two upcoming conferences [1] - The first presentation will take place on September 25, 2025, at the Emerging Growth Conference from 2:55 - 3:05 PM Eastern Time [1] - The second presentation is scheduled for September 30, 2025, at the Lytham Partners Fall 2025 Conference [1] Presentation Details - Participation in the Emerging Growth Conference will be online, with a registration link provided [1] - An archived webcast of the presentation will be available on EmergingGrowth.com and the Emerging Growth YouTube Channel [1]

Group 1 - Jaguar Health, Inc. (NASDAQ:JAGX) is recognized as a fundamentally strong penny stock, having signed securities purchase agreements for the issuance of nearly 951 shares of Series N Perpetual Preferred Stock, raising $2.38 million for working capital and other corporate purposes [1] - The year 2025 is pivotal for Jaguar Health, with management highlighting clinical and regulatory catalysts that could transform the company, focusing on business development partnerships for licensed rights [2] - The company is enhancing its product portfolio by supporting investigator-initiated trials for adult patients with short bowel syndrome and intestinal failure, with results expected in 2026 [3] Group 2 - Jaguar Health, headquartered in San Francisco, specializes in plant-based prescription medicines for gastrointestinal distress, operating through two segments: Animal Health and Human Health [4]

Summary of Jaguar Health Conference Call Company Overview - Jaguar Health trades on NASDAQ under the symbol JAGX and is a commercial stage pharmaceuticals company focused on developing proprietary prescription medicines derived from plants in rainforest areas for gastrointestinal distress in humans and animals [1] Core Points and Arguments - The company has a product on the market called Mytesi, which is approved for HIV-related diarrhea [2][3] - Two follow-on indications in late-stage development for Crofelmer are: - Cancer therapy-related diarrhea - Orphan indications for intestinal failure, specifically short bowel syndrome and MVID [3] MVID (Microvillus Inclusion Disease) - MVID is an ultra-rare disease affecting approximately 200 patients globally [4] - The company has demonstrated a 27% reduction in parenteral nutrition for MVID patients, which is groundbreaking [4][7] - A face-to-face meeting with the FDA has been granted to discuss expediting approval for this product for the ultra-rare population [4] - Patients with MVID require total parenteral nutrition from birth due to the inability to absorb nutrients, leading to severe quality of life issues and high mortality rates [5][6] Short Bowel Syndrome - The short bowel syndrome market is estimated to be a $5 to $7 billion opportunity [10] - The same product is being tested for both MVID and short bowel syndrome, with potential regulatory approval for MVID by 2026 [9] Cancer Program - The company has met with the FDA regarding an expedited pathway for regulatory approval in metastatic breast cancer patients [12] - Profilimab is also approved for chemotherapy-induced diarrhea in dogs, showcasing the product's relevance in both human and veterinary medicine [12] Additional Important Information - The company is engaged in ongoing business development and partnering conversations related to these indications [10][12] - There are currently four MVID patients in clinical trials, with one patient requiring compassionate use of the product after a relapse [11] - The company is actively promoting education about Profelamer for cancer patients experiencing diarrhea in the veterinary context, highlighting a disparity in treatment promotion between humans and animals [12] Conclusion - The updates presented indicate significant potential for Jaguar Health's products in addressing critical health issues in both humans and animals, with transformative implications for the company's value recognition and market opportunities [3][10]

Financial Data and Key Metrics Changes - The combined net revenue for Q2 2025 was approximately $3 million, representing a 35% increase compared to Q1 2025 and a 10% increase compared to Q2 2024 [6][29] - Loss from operations increased by $800,000 from $7.2 million in Q2 2024 to $8 million in Q2 2025 [30] - Net loss attributable to common shareholders increased by approximately $900,000 from $9.5 million in Q2 2024 to $10.4 million in Q2 2025 [30] Business Line Data and Key Metrics Changes - Mytesi prescription volume increased by approximately 6.5% in 2025 compared to 2024, with Q2 2025 volume equal to Q2 2024 [29] - The company is focusing on business development partnerships for licensing rights to its products, aiming to generate non-dilutive funding [7] Market Data and Key Metrics Changes - The company is conducting trials for Crofelimer in pediatric patients with MVID and short bowel syndrome, with initial results showing significant benefits [10][11] - The prevalence of MVID is estimated to be just a couple of hundred patients globally, indicating a niche market opportunity [12] Company Strategy and Development Direction - The company aims to seek business development partnerships to enhance funding opportunities during a period of reduced investor support for emerging pharma companies [7] - The strategy includes expanding the indication of Crofelimer for cancer therapy-related diarrhea, targeting metastatic breast cancer patients [23][24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the convergence of key clinical and regulatory catalysts in 2025, which are expected to enhance value for stakeholders [6][31] - The company is preparing to submit a protocol to the FDA for a pivotal treatment trial for Crofelimer in metastatic breast cancer patients [23] Other Important Information - The company is also pursuing regulatory approval for Canalevia, a product for chemotherapy-induced diarrhea in dogs, with plans to expand its indication [25][26] - The company is in discussions with potential partners for both human and animal health products [26] Q&A Session Summary - No specific questions or answers were recorded in the provided content, indicating that the session may have concluded without a formal Q&A segment [34]

[PART I — FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20%E2%80%94%20FINANCIAL%20INFORMATION) This section presents the company's condensed consolidated financial statements and related disclosures [Item 1. Condensed Consolidated Financial Statements](index=4&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements) The financial statements show decreased assets, increased net loss, and significant cash reduction, raising going concern doubts [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $48.3 million, driven by a significant cash drop, while liabilities and equity remained stable Condensed Consolidated Balance Sheet Highlights (in thousands of USD) | Balance Sheet Item | June 30, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $2,207 | $8,002 | | Total current assets | $27,903 | $32,198 | | Total assets | $48,268 | $53,425 | | **Liabilities & Equity** | | | | Total current liabilities | $29,218 | $19,704 | | Total liabilities | $41,388 | $44,446 | | Total stockholders' equity | $6,880 | $6,494 | | **Total liabilities and stockholders' equity** | **$48,268** | **$53,425** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Net losses increased to $21.2 million for the six months, driven by higher operating expenses despite a slight revenue increase Statements of Operations Summary (in thousands of USD, except per share data) | Metric | Q2 2025 | Q2 2024 | 6 Months 2025 | 6 Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Total revenue, net | $2,979 | $2,721 | $5,193 | $5,072 | | Total operating expenses | $10,986 | $9,918 | $22,621 | $20,484 | | Loss from operations | $(8,007) | $(7,197) | $(17,428) | $(15,412) | | Net loss | $(10,560) | $(9,628) | $(21,156) | $(18,996) | | Net loss per share | $(10.26) | $(2.66) | $(26.78) | $(7.80) | [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash decreased by $5.8 million, with $13.5 million used in operations and reduced financing activities Cash Flow Summary for Six Months Ended June 30 (in thousands of USD) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(13,509) | $(15,217) | | Net cash used in investing activities | $0 | $(16) | | Net cash provided by financing activities | $7,621 | $24,842 | | **Net increase (decrease) in cash** | **$(5,795)** | **$9,580** | | Cash at beginning of period | $8,002 | $6,469 | | **Cash at end of period** | **$2,207** | **$16,049** | [Notes to Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail a going concern warning, revenue concentration, debt instruments, and equity transactions - The company has incurred recurring operating losses and has an accumulated deficit of **$367.4 million** as of June 30, 2025. Management has substantial doubt about the company's ability to continue as a going concern as current cash balances are not sufficient to fund operations for the next year[37](index=37&type=chunk)[38](index=38&type=chunk) - The company is highly dependent on two major customers, which accounted for **58%** and **30%** of total revenue for the three months ended June 30, 2025[53](index=53&type=chunk) - The company manages its operations through two segments: human health and animal health, with the human health segment focused on developing and commercializing products like Mytesi[36](index=36&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=78&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses plant-based medicines, OnTarget trial results, Gelclair launch, and critical liquidity concerns [Overview](index=78&type=section&id=Overview) Jaguar Health focuses on plant-based GI medicines, with mixed OnTarget trial results, a new Gelclair launch, and orphan disease development - The OnTarget Phase 3 clinical trial for prophylaxis of diarrhea in adult cancer patients did not meet its primary endpoint for all tumor types, but a prespecified subgroup analysis of breast cancer patients showed **statistical significance**[341](index=341&type=chunk) - The company entered into an exclusive 5-year in-license agreement for Gelclair, a prescription product for oral mucositis, and initiated its commercial launch in October 2024 to expand its cancer-related supportive care offerings[345](index=345&type=chunk) - Napo Therapeutics, a subsidiary, is focused on expanding crofelemer access in Europe for orphan diseases, initially targeting Short Bowel Syndrome (SBS-IF) and Microvillus Inclusion Disease (MVID)[346](index=346&type=chunk) [Results of Operations](index=91&type=section&id=Results%20of%20Operations) Revenue slightly increased, but operating expenses rose significantly due to sales and marketing for Gelclair, widening the operating loss Comparison of Results for Six Months Ended June 30 (in thousands of USD) | Item | 2025 | 2024 | Variance | Variance % | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $5,193 | $5,072 | $121 | 2.4% | | Cost of product revenue | $1,042 | $857 | $185 | 21.6% | | Research and development | $6,995 | $7,965 | $(970) | (12.2)% | | Sales and marketing | $4,960 | $2,967 | $1,993 | 67.2% | | General and administrative | $9,624 | $8,695 | $929 | 10.7% | | Loss from operations | $(17,428) | $(15,412) | $(2,016) | 13.1% | | Net loss | $(21,156) | $(18,996) | $(2,160) | 11.4% | - The increase in Sales and Marketing expense was primarily due to a **$1.1 million** increase in personnel costs and a **$0.7 million** increase in direct marketing fees to support the Gelclair launch[414](index=414&type=chunk)[418](index=418&type=chunk) - The decrease in Research and Development expense was largely due to a **$0.9 million** reduction in clinical and contract manufacturing costs as the Phase 3 OnTarget Clinical Trial concluded[413](index=413&type=chunk)[415](index=415&type=chunk) [Liquidity and Capital Resources](index=103&type=section&id=Liquidity%20and%20Capital%20Resources) Cash reserves are critically low at $2.2 million, insufficient for future operations, necessitating additional funding to avoid curtailing activities - As of June 30, 2025, the company had cash of **$2.2 million** and an accumulated deficit of **$367.4 million**[438](index=438&type=chunk)[439](index=439&type=chunk) - Management acknowledges that current capital resources are not sufficient to fund the operating plan for at least one year, and if additional financing is not obtained, the company will need to curtail planned activities and reduce costs[439](index=439&type=chunk)[441](index=441&type=chunk) Cash Flow Summary for Six Months Ended June 30 (in thousands of USD) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(13,509) | $(15,217) | | Net cash provided by financing activities | $7,621 | $24,842 | | Net increase (decrease) in cash | $(5,795) | $9,580 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=107&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states that quantitative and qualitative disclosures about market risk are not applicable - The company states that quantitative and qualitative disclosures about market risk are not applicable[458](index=458&type=chunk) [Item 4. Controls and Procedures](index=107&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of June 30, 2025 - Based on an evaluation as of June 30, 2025, the CEO and Principal Financial and Accounting Officer concluded that the company's disclosure controls and procedures were effective[460](index=460&type=chunk) - Management concluded that as of June 30, 2025, the company's internal control over financial reporting was effective based on the COSO 2013 framework[461](index=461&type=chunk) [PART II — OTHER INFORMATION](index=109&type=section&id=PART%20II.%20%E2%80%94%20OTHER%20INFORMATION) This section provides additional information including legal proceedings, risk factors, and equity security sales [Item 1. Legal Proceedings](index=109&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently subject to any material legal proceedings, though it may encounter routine legal actions - The company is not currently subject to any material legal proceedings[463](index=463&type=chunk) [Item 1A. Risk Factors](index=109&type=section&id=Item%201A.%20Risk%20Factors) Key risks include substantial minimum royalty payments starting in 2026 and potential FDA review delays impacting product approvals - The company's royalty interests require minimum royalty payments, totaling approximately **$36.0 million**, which will commence in 2026, potentially straining cash resources regardless of product sales levels[467](index=467&type=chunk)[468](index=468&type=chunk) - Disruptions at the FDA, including layoffs and the departure of senior scientists, could lead to slower review cycles and delayed approvals for the company's product candidates, materially harming the business[469](index=469&type=chunk)[472](index=472&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=111&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company conducted several unregistered equity sales, including common and preferred stock exchanges for debt, and issued warrants and convertible notes - Issued common stock and Series L and M Preferred Stock in multiple transactions to Iliad and Streeterville in exchange for reductions of outstanding royalty interest debt[473](index=473&type=chunk)[475](index=475&type=chunk)[480](index=480&type=chunk) - In a private placement on May 20, 2025, issued unregistered warrants to purchase up to **492,612** shares of common stock to institutional investors[476](index=476&type=chunk) - On June 24, 2025, completed a private exchange of approximately **$2.57 million** of new convertible promissory notes and new warrants for existing convertible notes[477](index=477&type=chunk)[478](index=478&type=chunk) [Item 6. Exhibits](index=114&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including certificates, warrants, agreements, and officer certifications

Summary of Conference Call Records Company Overview Clean Inc. (NASDAQ: CLNN) - Clean Inc. is a late-stage clinical biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, particularly ALS [1][2]. Sono Group NV (OTCQB: SEVCF) - Sono Group NV, through its subsidiary Sono Motors GmbH, is pioneering solar technology integration into commercial vehicles, aiming to revolutionize mobility by making every commercial vehicle solar [20][22]. Key Points from Clean Inc. Conference Call Core Insights - Clean Inc. met with the FDA in June to discuss the evaluation of neurofilament as a biomarker for ALS, which is indicative of neuronal damage [2][4]. - The company is leveraging a $45 million grant from the NIH to fund a study involving 180 ALS patients, with data collection starting next month [4][5]. - Clean Inc. aims to submit a new drug application (NDA) to the FDA by the end of the year, contingent on positive data regarding neurofilament levels and survival rates [6][7]. - A confirmatory Phase 3 clinical trial is planned, focusing on survival as the primary endpoint, with the first patients expected to start treatment by the end of this year [9][10]. Additional Insights - Neurofilament levels can indicate ALS progression before clinical symptoms appear, and Clean Inc. is the only company in a Phase 2 study showing a reduction in neurofilament [12][14]. - The company is also exploring other neurodegenerative diseases, including multiple sclerosis (MS), Parkinson's, and Huntington's disease, with ongoing discussions with the FDA regarding MS [15][17]. Key Points from Sono Group NV Conference Call Core Insights - Sono Group is focused on integrating solar technology into commercial vehicles, with a patent portfolio of nine granted patents and over 30 pending patents [24][25]. - The company has received orders from six large OEMs and expects significant revenue growth in Q3 and Q4, with an average revenue per unit projected to reach €8,000 [29][30]. - Sono Group aims to uplist to a major national exchange, enhancing visibility and liquidity, which is expected to drive long-term shareholder value [32][34]. Additional Insights - The company has won a green innovation award and received national type certification for solar bus kits in Germany, simplifying the installation process across fleets [27][28]. - The solar solutions are designed to work across various vehicle types, including diesel, hybrid, and electric, providing immediate CO2 reductions and cost benefits [25][33]. - The management team emphasizes a commitment to sustainability, with employees actively participating in eco-friendly practices [31]. Conclusion Both Clean Inc. and Sono Group NV are positioned in innovative sectors with significant growth potential. Clean Inc. is advancing in the biopharmaceutical space with a focus on ALS, while Sono Group is leading in solar mobility solutions for commercial vehicles. Both companies are preparing for critical developments in the near future, including regulatory submissions and market expansions.