Full Press Release Details
Jaguar Health, Inc. (NASDAQ: JAGX)
Overview - May 2025 Exhibit 99.1
Forward-Looking Statements This
presentation contains "forward-looking statements" within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this presentation, including
statements regarding plans by Jaguar Health, Inc. ("Jaguar" or the "Company"), Napo Pharmaceuticals, Inc. and Napo Therapeutics (formerly known as "Napo EU") to develop and commercialize crofelemer in Europe for
HIV-related diarrhea, short bowel syndrome, congenital diarrheal disorders, and other indications; expectations related to the timing of the commercial launch of products in any market; the expectation that Magdalena Biosciences will leverage
Jaguar's proprietary medicinal plant library and Filament Health's proprietary drug development technology; the expectation that US$1,000,000 will be invested in Magdalena Biosciences by One Small Planet; the expectation that Magdalena
Biosciences may develop a potential plant-based alternative drug for adult ADHD or other indications that is both safe and efficacious; Jaguar's plans to pursue additional business development deals; plans to expand the geography for
commercialization of crofelemer; statements related to the powder formulation of crofelemer, NP-300, and the timing of the initiation, completion, results, and publication of Phase 2 studies, Phase 3 studies, proof-of-concept studies, field studies,
investigator-initiated trials, sponsored studies, and other studies; statements about crofelemer's possible eligibility for, and possible future participation in, the European Medicines Agency's (EMA) PRIME program, the U.S. Food and
Drug Administration's (FDA) Breakthrough Therapy program, and early patient access programs; statements about the planned submission of Investigational New Drug (IND) applications, New Drug Applications (NDA) and supplemental NDAs to FDA;
statements about plans to pursue a Priority Review Voucher (PRV) and the potential value of a PRV; statements about the possible market size/potential of indications; and statements about expected milestones appearing on the list of "Upcoming
Milestones", are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future
results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should,"
"expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate,"
"predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this presentation are only predictions. We have based these forward-looking
statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the
date of this presentation and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control. Please see the risk factors identified in our Annual Report on
Form 10-K and our other filings with the U.S. Securities and Exchange Commission. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected
in the forward-looking statements. Readers are also advised that our projected sales do not take into account the royalties and other payments we will need to make to our licensors and strategic partners. Moreover, we operate in a dynamic industry
and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly
update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. NASDAQ:JAGX
What We Do: Develop New Ways and Novel
Plant-Based Medicines to Treat Gastrointestinal Disorders NASDAQ:JAGX From Tree to Bottle Crofelemer was discovered through the science of ethnobotany Mytesi (crofelemer 125mg delayed-release tablets) is FDA-approved for symptomatic relief of
noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy Canalevia -CA1 is conditionally approved by the FDA for the treatment of chemotherapy-induced diarrhea in dogs
Jaguar/Napo Product Portfolio -
Crofelemer Pipeline in a Product *NP-300 and crofelemer have a similar physiological anti-secretory mechanism of action to reduce chloride ion secretion into the gut lumen and improve stool consistency. The Company has previously presented Phase 2
data on crofelemer for the treatment of devastating dehydration in cholera patients from the renowned International Centre for Diarrhoeal Disease Research (icddr,b) in Bangladesh. *Potential opportunity for Priority Review Voucher (PRV)
How Crofelemer Works NASDAQ:JAGX
Crofelemer is a non-opioid that works differently from other treatments for GI dysfunction With crofelemer, it's about waterflow Crofelemer normalizes waterflow in the GI tract Less water flowing into your GI tract = less watery diarrhea =
greater nutrient absorption opportunity Crofelemer acts locally in the GI tract Opioid medicines (e.g., Imodium, loperamide) work by slowing down your GI tract, i.e., opioid constipation risk Crofelemer is a non-opioid, non-antibiotic, non-addictive
drug approved in the US for a chronic use Secretion Absorption
Rare disease: Four Phase 2 studies
started since December 2024 Two are investigator-initiated proof-of-concept (POC) trials What's different: Patients identified at principal investigator sites Initial POC data presented in April 2025; additional POC data expected throughout
2025 / early 2026 Key value driver: Reduction in total parenteral nutrition (TPN) Potential for: PRIME designation through European Medicines Agency (EMA) Breakthrough Therapy designation through U.S. Food and Drug Administration (FDA) Early patient
access in certain European countries NASDAQ:JAGX Near-Term Catalysts Leading to Potential Opportunities for Business Development Deals-What's Different?
Presented April 26, 2025: Initial
Proof-of-Concept Results Show Crofelemer Reduced Total Parenteral Nutrition (TPN) in Patients with MVID and SBS-IF - Potential to Modify Disease Progression in Intestinal Failure Patients Novel liquid formulation of crofelemer reduced the
required TPN and/or supplementary intravenous fluids, collectively referred to as parenteral support, in patients with intestinal failure due to MVID and SBS by up to 27% and 12.5% respectively Crofelemer reduced stool volume output and/or frequency
of watery stools, and increased urine output - an indicator of improved nutrient oral absorption These initial results were presented April 26, 2025 at the Annual ELITE PED-GI Congress by Dr. Mohamad Miqdady, a recognized leader in pediatric
gastroenterology and the principal investigator for this ongoing exploratory, single-arm open label non-randomized investigator-initiated trial Based on these initial findings, crofelemer's novel antisecretory mechanism of action appears to
have potential to provide a novel therapeutic option to modify disease progression in MVID and SBS-IF patients and improve their quality of life NASDAQ:JAGX The Annual Elite Ped-GI Congress is designed to provide high level, clinically significant
updates and comprehensive trends relevant to the practice of pediatric gastroenterological, nutrition and liver disorders. Replay Link to Jaguar's April 30, 2025 Investor Webcast About the Initial Study Results:
Crofelemer achieved statistically
significant improvement in monthly responder analysis in prespecified subgroup of adult patients with breast cancer from OnTarget Crofelemer more than twice as effective as placebo in monthly breast cancer patient responders Data presented at Dec
2024 San Antonio Breast Cancer Symposium (SABCS) Late-breaker abstract on additional significant results in breast cancer patients accepted for presentation at MASCC (Multinational Association of Supportive Care in Cancer) Jun 2025 Annual Meeting
Breast cancer patients accounted for more than 63% of patients in trial (183 of 287) Potential impact on outcome of cancer treatment: 60-100% of breast cancer patients on placebo had to adjust their dose due to diarrhea Patient Advocacy -
"Tush Push" NASDAQ:JAGX Goal: Submit supplemental NDA for crofelemer to FDA for adult breast cancer patients on targeted therapy Jaguar Reports Statistically Significant Improvement in Breast Cancer Patients in OnTarget Phase 3 Study of
Crofelemer Q2 2025 meeting with FDA
Increasing Market Value: Progression
from Supportive Care to Impact on Outcome/Cost of Care to Treatment Modifying NASDAQ:JAGX Indication # of Competitors Market Size/Potential HIV-related diarrhea 0 Jaguar estimates the U.S. market revenue potential for Mytesi to be ~$30-$50
million in gross annual sales Cancer therapy-related diarrhea (CTD) 0 Projected to be 2.0 million new cancer cases in US in 20241 Annual US breast cancer incidence >315,000;2 prevalence ~4 mm3 Comparable supportive care (CINV) global market
projected to reach $4.3 billion by 20314 Short bowel syndrome (SBS) with intestinal failure / Microvillus inclusion disease (MVID), a congenital diarrheal disorder (CDD) 0 ~Global SBS market projected to reach $4.6 billion by 2027 with a CAGR of 26%
from 2020 to 20275 (doesn't include potential contribution from crofelemer's novel mechanism of action) IBS - diarrhea predominant (IBS-D) 2 ~15% of adult population Most IBS products have estimated revenue potential >$1.0 billion6
Symptomatic relief and treatment of diarrhea from cholera and other pathogens 0 *Potential opportunity for Priority Review Voucher (PRV) PRVs are transferable, and in past transactions by other companies have sold for values ranging from $67 million
to $350 million7 1 American Cancer Society. Cancer Facts & Figures 2024. Atlanta: American Cancer Society; 2024 2
https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2025/2025-cancer-facts-and-figures-acs.pdf 3 Miller KD, Siegel RL, Lin CC, et al. Cancer treatment and survivorship statistics, 2022.
CA Cancer J Clin. 2022:1-23 4 https://www.ihealthcareanalyst.com/global-chemotherapy-induced-nausea-vomiting-drugs-market/ 5
Rodman & Renshaw estimate peak annual sales of Synergy Pharmaceuticals' Trulance at $2.3 bn in 2021 (Source: https://www.benzinga.com/analyst-ratings/analyst-color/17/03/9224181/analyst-synergy-pharma-could-achieve-sustainable-profita) 7
Catalysts and Robustness:
Financially, Clinically, Commercially NASDAQ:JAGX Financial Robustness: Net 2024 revenue increased approximately 20% versus net 2023 revenue Clinical Robustness/Near-Term Catalysts: Crofelemer in development for multiple possible follow-on
indications: Four Phase 2 studies in rare diseases, near-term POC data Cancer Therapy-Related Diarrhea: Statistically significant Phase 3 data in prespecified subgroup of breast cancer, May 2025 meeting scheduled with FDA Significant results in two
investigator-initiated trials of crofelemer in IBS-D; data presented at October 2024 American College of Gastroenterology Annual Meeting Proprietary anti-secretory antidiarrheal drug for cholera-related diarrhea (potential opportunity for FDA
tropical disease priority review voucher) - IND approved Jaguar JV Magdalena Biosciences opportunity to file Investigational New Drug (IND) applications for three psychoactive botanical drug candidates in 2025 - 2026 Commercial Robustness:
October 2024 commercial launch of the FDA-approved oral mucositis prescription product Gelclair in U.S.
NORMAL DIARRHEA Chloride ion
(Cl-) channels in the GI tract maintain a balance of salts-including chloride ions-and water that allows normal stool formation This can further disrupt the balance of chloride ions and water flow into the GI lumen, leading to
secretory diarrhea Mytesi Mytesi works by regulating two chloride ion channels (CFTR and CaCC) in the GI tract, which normalizes the salt-water balance, leading to a decrease in chloride and water flow1-3 Chloride ion (salt) Chloride ion
channel Gut lining Water Inflammation/damage Mytesi HIV or its treatment can cause damage to the GI tract, creating inflammation and a leaky gut; targeted cancer therapy and inflammatory bowel disease cause similar damage References: 1.
Mytesi [package insert]. San Francisco, CA: Napo Pharmaceuticals, Inc; 2020. 2. Tradtrantip L, Namkung W, Verkman AS. Mol Pharmacol. 2010;77(1):69-78. 3. Holodniy M, Koch J, Mistal M, et al. Am J Gastroenterol.1999;94(11):3267-3273
Mytesi (crofelemer) acts at the common last step in a physiological pathway, regardless of cause, thereby normalizing defective secretion, specifically mitigating dehydration Acts locally in the gut via allosteric modulation of chloride
channels Crofelemer does not cause constipation or alter motility Crofelemer is a First-in-Class Intestinal Chloride Channel Modulator NASDAQ:JAGX
NASDAQ:JAGX Our crofelemer clinical
development programs
Jaguar Health's Strategic
Focus on Rare Diseases NASDAQ:JAGX SHORT BOWEL SYNDROME WITH INTESTINAL FAILURE MICROVILLUS INCLUSION DISEASE (A congenital diarrheal disorder) DIARRHEA FROM CHOLERA (Designated as orphan disease in US) Rare diseases, when taken together, are not
that rare at all 30 million Americans1, or 10 percent of the population, have one of the approximately 7,000 known rare diseases2 An estimated 30 to 40 million people in the EU3 and 400 million worldwide4 have a rare disease Definition of
a rare or orphan disease by region: US: When a disease affects <200,000 people5 EU: When a disease affects <1 in 2,000 people6 EU: "Ultra-rare disease": When a disease affects no more than 1 in 50,000 people7 Rare diseases
generally have high clinical unmet needs, making it easier to obtain a large market share and get reimbursement for high prices; support from patient advocacy groups can help drive reimbursement 1 & 2 Source:
https://phrma.org/Scientific-Innovation/Progress-in-Fighting-Rare-Diseases 3 Source: Harari S. Why We Should Care About Ultra-Rare Disease. Eur Respir Rev. 2016 Jun;25(140):101-3. doi: 10.1183/16000617.0017-2016 4 Source:
European Commission Regulation (EU) No.536/2014 of the European Parliament and of the Council of April 16, 2014, on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. 2014. Available from:
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014R0536&qid=1421232837997&from=EN Orphan Drug Designation: SBS and MVID, US and EU
NASDAQ:JAGX Microvillus Inclusion
Disease (MVID): An Ultrarare Congenital Diarrheal Disorder (CDD) * Adverse events could negatively affect the timeliness of submitting the Investigational New Drug (IND) application. There is a probability that the FDA may not approve
Company's IND application. MVID is an ultrarare CDD that affects newborns and children and leads to significant morbidity and mortality from severe secretory diarrhea, intestinal failure, lifelong parenteral nutrition Presented April 26, 2025:
Initial proof-of-concept results show crofelemer reduced TPN in patients with MVID and SBS-IF - potential to modify disease progression in intestinal failure patients Novel highly concentration liquid formulation Key endpoint demonstrating
benefit Reduction in TPN Enhanced urine output Reduction in stool volume
NASDAQ:JAGX There are currently no
approved drug treatments for MVID The standard of care is TPN-the delivery of electrolytes & nutrients via IV up to 20 hours a day, 7 days a week-a catastrophic chronic situation for patients and families In the Company's
opinion, having just a very small number of MVID patients showing benefit from crofelemer in proof-of-concept studies could potentially qualify crofelemer for participation in PRIME, a fast-track European Medicines Agency program providing enhanced
interaction PRIME pathway could lead to full approval of crofelemer for MVID in all 27 E.U. countries at once, possibly as early as the end of 2026 Proof-of-concept data could also provide opportunity for reimbursed early patient access in selected
European countries PRIME is similar to FDA's Breakthrough Therapy program If a drug is designated by the FDA as breakthrough therapy, the FDA will expedite the development and review of the drug The Absence of Any Approved Treatment for MVID
Creates Important Opportunities for Jaguar and Patients- initial focus on European Union
Short Bowel Syndrome: Loss of Bowel
with Quality-of-Life Changes NASDAQ:JAGX SBS: Catastrophic loss of bowel (normal 15-25 feet to 5 or less feet) in adults/children (also may be congenital in children). SBS with Intestinal Failure (SBS-IF): Body is unable to absorb enough nutrients.