Intelligent Bio Solutions Inc. (NASDAQ: INBS) is a medical technology company pioneering innovative, non-invasive, real-time point-of-care testing solutions. The company's Intelligent Fingerprinting Drug Testing Solution (the “Solution”) is revolutionizing portable drug testing through fingerprint sweat analysis. The Solution comprises a two-part drug screening system for on-site screening, and a confirmatory drug test kit and procedure for confirmatory lab testing. This rapid, cost-effective, and highly accurate solution plays a critical role in safeguarding workplace safety across high-risk industries and has the potential for broader applications in additional fields.
The company has over 400 accounts across 19 countries. Its Drug Testing Solution is currently being utilized across multiple industries including construction, mining, manufacturing and engineering, transport and logistics, drug treatment, law enforcement, and forensics. With FDA 510(k) submission planned in the fourth calendar quarter of this year and entry into the US market planned for the first half of 2025, Intelligent Bio Solutions is capitalizing on the growing drug screening products market, estimated to have a CAGR of ~12.1% and Total Addressable Market of ~$15 billion by 20301.
Comprehensive, hygienic, and cost-effective, the company's Drug Testing Solution is an invaluable tool for employers in safety-critical industries. The Intelligent Fingerprinting Drug Screening System detects recent drug use (within a 16-24 hour period), ensuring employees are 'fit for work' at the time of testing and reducing safety risks associated with potential impairment. With sample collection in under one minute and results displayed in less than ten minutes, the System detects drugs commonly found in the workplace, including cannabis, opiates, cocaine, and methamphetamine.
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Headquarters: New York, New York
Investor Contact: Valter Pinto, KCSA Strategic Communications - INBS@kcsa.com
1Research And Markets’ ‘Drug Screening - Global Strategic Business Report'
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Intelligent Bio Solutions At A Glance
Intelligent Bio Solutions Inc. (NASDAQ: INBS) is a medical technology company pioneering innovative, non-invasive, real-time point-of-care testing solutions. The company's Intelligent Fingerprinting Drug Testing Solution analyzes fingerprint sweat to detect recent drug use, including opiates, cocaine, methamphetamine, and cannabis. The Solution comprises a two-part drug screening system for on-site screening, and a confirmatory drug test kit and procedure for confirmatory lab testing. It is uniquely suited to high-risk industries where safety and operational efficiency are critical. The portable, rapid, and non-invasive nature of the drug screening system makes it a valuable tool for organizations seeking reliable, on-the-spot drug screening.
Intelligent Bio Solutions’ first-of-its-kind solution addresses a growing global demand for non-invasive, rapid, and reliable testing technology, positioning the company as a leader in workplace drug screening and broader markets. The company operates globally, with more than 400 accounts across 19 countries.
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Market Growth and Regulatory Compliance
Intelligent Bio Solutions’ Drug Screening System is available in 19 countries with clear strategic plans for further geographical expansion. The company adheres to strict regulatory standards and is preparing an FDA 510(k) submission, which is expected in calendar Q4 of this year. Obtaining FDA clearance will unlock significant growth opportunities for the company throughout the US.
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Corporate Presentation Video - Noble Capital Markets Conference
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Source: Noble Capital Markets
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Intelligent Bio Solutions Account Overview
Intelligent Bio Solutions Inc. (NASDAQ: INBS) is a medical technology company pioneering innovative, non-invasive, real-time point-of-care testing solutions. The company's Intelligent Fingerprinting Drug Testing Solution is transforming the traditional drug testing landscape through fingerprint sweat analysis. This rapid, cost-effective, and highly accurate solution plays a critical role in safeguarding workplaces across high-risk industries, including transportation, mining, construction, and manufacturing. The technology is designed to detect drug use within a 16-24 hour period, aiming to ensure employees are ‘fit for work’ at the time of testing and reducing risks associated with potential impairment. The company has over 400 active accounts across 19 countries,
The company's Drug Testing Solution comprises a two-part drug screening system for on-site screening, and a confirmatory drug test kit and procedure for confirmatory lab testing. The Intelligent Fingerprinting Drug Screening System consists of single-use, tamper-proof Drug Screening Cartridges (for sample collection) and the portable Drug Screening Reader for analysis.
The System simplifies drug screening by delivering results in under ten minutes from a quick fingerprint sweat sample, removing the need for more invasive urine, saliva or blood tests. With over 1,000 readers deployed globally, the System has proven reliable and efficient, particularly in safety-critical industries where quick decisions and operational efficiency are vital. The System screens for major drugs of abuse, including opiates, cocaine, methamphetamine, and cannabis.
Looking ahead, Intelligent Bio Solutions is poised to significantly impact the US market, with a 510(k) submission to the United States Food and Drug Administration (FDA) planned in the fourth calendar quarter of 2024. A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is as safe and effective as a legally marketed device already approved by the FDA. If the FDA agrees, the device can be sold without undergoing the more stringent Premarket Approval (PMA) process. The company intends to enter the US market in 2025 with its advanced drug screening technology.
FDA 510(k) clearance will pave the way for the company's anticipated product launch in the first half of 2025, unlocking substantial growth potential in a market increasingly focused on rapid, non-invasive testing technologies. With stringent regulatory requirements and a heightened focus on workplace safety, the company is well-positioned to meet these demands with its innovative solution.
Source: Company Documents
See the Intelligent Fingerprinting Drug Screening System in Action
Watch this brief 1-minute video to learn how Intelligent Bio Solutions’ innovative Drug Screening System simplifies testing, delivering fast, accurate results through non-invasive fingerprint sweat analysis.
Source: Company Documents
Market Opportunity
Growing Drug Consumption
The global landscape of drug consumption continues to evolve, marked by significant increases in use across multiple substances. The United Nations Office on Drugs and Crime (UNODC) World Drug Report 2024 reveals that over 292 million people used drugs globally in 2022, reflecting a steady rise over the past decade. Cannabis remains the most widely used drug, with over 228 million users, making up around 4% of the global population. While opioids have a smaller user base of 60 million, they are one of the deadliest drug categories, with fentanyl and other potent synthetic opioids associated with high levels of drug-related mortality in North America. The use of stimulants remains high, with approximately 30 million people using amphetamine-type stimulants (ATS) such as methamphetamine, and 23.5 million people using cocaine. Both substances are contributing to growing public health concerns as their use expands across multiple regions.
This rise in drug consumption, driven by social, economic, and health factors, underscores the growing demand for robust drug screening solutions. As more individuals face the consequences of drug misuse, the need for fast, non-invasive, and reliable testing becomes critical, not just in workplace settings but across society at large. Intelligent Bio Solutions is positioned to meet this growing demand through its innovative drug screening technology, offering an effective solution for organizations looking to combat drug misuse with minimal disruption to their operations.
Source: Company Documents
Drug Use in the Workplace
Workplace drug use is a significant issue, as more than 70% of adults abusing alcohol or illicit drugs in the US are employed1. In safety-critical industries such as construction, transportation, and manufacturing, this can lead to a higher risk of accidents, absenteeism, and lower productivity. Testing programs across these industries employ traditional testing methods that can be time-consuming, invasive, and costly. Intelligent Bio Solutions offers a rapid, non-invasive alternative with its Intelligent Fingerprinting Drug Screening System, helping organizations identify potential safety risks quickly and efficiently, reducing the risk of drug-related workplace accidents.
1 Centers for Disease Control and Prevention, Mental Health, Alcohol Use, and Substance Use Resources for Workers and Employers
Source: Company Documents
USA Market Potential
The US drug screening products market is projected to reach $14.9 billion by 20302, driven by stricter regulations, a focus on workplace safety, demand for faster testing technologies, and growth in substance abuse cases. With its planned FDA 510(k) submission and anticipated US launch in 2025, Intelligent Bio Solutions is well-positioned to capture a significant market share. The company's unique fingerprint sweat-based drug screening technology addresses the demand for faster, more convenient testing, disrupting the traditional testing landscape.
2 Research And Markets’ ‘Drug Screening - Global Strategic Business Report’
Source: Company Documents
Products & Technology
Simpler Drug Testing
Intelligent Bio Solutions is revolutionizing drug testing with its Intelligent Fingerprinting Drug Screening System, which uses fingerprint sweat to detect recent drug use. Unlike traditional methods that require urine, saliva, or blood samples, this system provides a fast, non-invasive alternative, allowing organizations to maintain workplace safety without the discomfort and biohazard risks associated with other testing methods. The System screens for commonly abused drugs, including opiates, cocaine, methamphetamine, and cannabis, making it ideal for industries where safety is paramount. The technology is hygienic and cost-effective and delivers results in less than ten minutes, minimizing downtime and ensuring quick decision-making.
The two-part Drug Screening System consists of single-use, tamper-proof Drug Screening Cartridges (for sample collection) and the portable Drug Screening Reader for analysis. This simple collection method eliminates the need for trained personnel and specialized facilities, reducing cost and complexity. Additionally, its compact, portable design allows for easy deployment across various locations, enabling organizations to conduct on-site drug tests anywhere and anytime, regardless of size or location.
Source: Company Documents
How It Works
The Intelligent Fingerprinting Drug Screening System uses advanced technology to detect recent drug use through fingerprint sweat analysis. The Drug Screening Cartridge uses lateral flow assay technology and fluorescence-labeled antibodies to selectively detect specific drugs and drug metabolites in the eccrine sweat collected from fingerprints. Metabolites are chemicals produced by the body’s metabolic processes when a substance is ingested or injected. Detection of specific metabolites in body fluids, such as fingertip sweat, can indicate recent drug use.
Ten fingerprint sweat samples (one from each finger) are collected onto the Drug Screening Cartridge sample application pad in a process that takes less than a minute. If drug metabolites are present in the sweat, the antibodies in the cartridge will bind to them. As these antibodies attach to the drug metabolites, they emit a fluorescent signal, invisible to the naked eye but detectable by the DSR-Plus Reader. The Reader then scans the cartridge and analyzes the strength of the fluorescent signal, providing a clear and accurate result in under ten minutes.
Because the system is highly sensitive to even small amounts of drug metabolites, it ensures high accuracy. Unlike traditional urine or saliva tests, which can be invasive and lengthy to process, the Intelligent Fingerprinting Drug Screening System allows for quick, non-invasive testing. In cases where further confirmation is needed, samples can be sent for laboratory testing. Speed, reliability, and ease of use make the System ideal for workplace safety and compliance, particularly in industries where rapid decision-making is essential.
Source: Company Documents
Competitive Advantages
Competitive Advantages
Intelligent Bio Solutions' Intelligent Fingerprinting Drug Testing Solution offers several advantages over traditional drug testing solutions, such as urine and saliva tests. It provides a quick, non-invasive, and hygienic alternative, making it an appealing option for organizations in safety-critical industries.
Below are nine important competitive advantages of the Intelligent Fingerprinting Drug Testing Solution:
1. A Complete Drug Testing Solution
The comprehensive Drug Testing Solution includes training of nominated personnel, a two-part system for on-site screening, and a confirmatory drug test kit and procedure for when a non-negative screening result requires lab confirmation.
2. Non-Invasive Testing
Unlike urine and saliva tests, which can be uncomfortable and require sample collection in private settings, the fingerprint-based method is entirely non-invasive. Fingerprint sweat samples are collected in just a few seconds, reducing discomfort for the individual being tested and protecting their privacy and dignity.
3. Faster Results
Traditional drug tests, especially those involving urine samples, can often take hours or even days to organize, collect and process. In contrast, the Intelligent Fingerprinting Drug Screening System takes minutes, from sample collection to delivering results, providing organizations with immediate insights. This speed is particularly crucial for safety-critical industries where rapid decision-making is essential, such as transportation, construction, and manufacturing.
4. Hygienic and Convenient
Collecting urine or saliva samples can introduce biohazard risks that require special handling and disposal procedures. The fingerprint sweat collection method is non-biohazardous and does not require specialized storage or disposal, making the process far more convenient and hygienic. The Intelligent Fingerprinting Drug Screening System reduces the complexity of drug testing programs and minimizes the potential for cross-contamination.
5. Reduced Risk of Tampering
Urine and saliva samples are susceptible to tampering or substitution, which can compromise the integrity of drug tests. The fingerprint sweat collection method is far more difficult to manipulate due to the System’s tamper-evident cartridges, providing organizations with greater confidence in the accuracy and reliability of test results.
6. Wider Applicability and Portability
The Drug Screening Reader is portable and easy to use in various environments, from on-site workplace testing to more remote locations. This portability allows for more flexible and scalable testing programs than traditional methods requiring trained personnel and designated collection areas. The ability to conduct tests anytime and anywhere gives organizations greater control and flexibility in their drug testing processes.
7. Comparable Accuracy
While traditional methods like urine and saliva testing have been the standard choices for drug testing, the Intelligent Fingerprinting Drug Screening System provides a comparable level of accuracy, ensuring reliable results. Its sensitivity to drug metabolites in fingerprint sweat ensures that even small traces of drugs are detected, making it a competitive and reliable option for workplace drug screening.
8. Cost Savings
The Intelligent Fingerprinting Drug Screening System is more cost-effective than traditional drug testing methods due to the time savings involved in the testing process. Traditional methods often involve additional expenses for specialized facilities, trained personnel, and biohazardous material disposal. The System requires minimal training and no special collection facilities, eliminating the need for complex disposal procedures. With faster results and batch testing capability, organizations save time and resources by avoiding the delays and administrative burdens associated with traditional methods and lab-based testing.
Other Drug Testing Systems
The Intelligent Fingerprinting Drug Screening System is the only commercially available platform to use fingerprint sweat analysis for drug testing. Most testing methods rely on urine, saliva, or blood samples. Intelligent Bio Solutions uniquely provides this combination of non-invasive testing, speed, and portability.
Source: Company Documents
Current Accounts Base
Current Accounts Base
Intelligent Bio Solutions has a diverse and growing accounts base spanning multiple industries and regions. The company's Intelligent Fingerprinting Drug Screening System is deployed across 19 countries and 400+ active account sites in key industries such as construction, transportation, manufacturing, and engineering. These industries are highly safety-sensitive, making the fast, non-invasive nature of the System particularly valuable in reducing risk and maintaining compliance with workplace safety standards.
The company's product footprint continues to grow, with significant penetration in the United Kingdom, Europe and, more recently, Asia Pacific. High-profile accounts include businesses in safety-critical sectors and organizations focused on drug treatment and rehabilitation. These partnerships demonstrate the versatility and scalability of the technology. As a testament to the System’s reliability, many accounts report substantial improvements in the efficiency and effectiveness of their drug testing programs.
Source: Company Documents
Account Testimonials highlight how the non-invasive sweat-based testing method has significantly reduced costs and the discomfort and privacy concerns typically associated with urine or saliva testing. Employers in safety-critical sectors have praised the System’s speed and portability, allowing them to conduct on-site testing with minimal disruption to operations while maintaining high workplace safety standards.
Source: Company Documents
Regulatory Strategy
Regulatory Strategy
Intelligent Bio Solutions has developed a comprehensive regulatory strategy to ensure that its Intelligent Fingerprinting Drug Testing Solution meets the necessary standards for global markets. The company is preparing for a critical milestone with its planned 510(k) submission to the US Food and Drug Administration (FDA) in the fourth calendar quarter of 2024. This submission aims to demonstrate that the company's Intelligent Fingerprinting Drug Screening System is equivalent to existing, legally marketed devices. The company anticipates launching its product in the US market in the first half of 2025.
In addition to its FDA efforts, Intelligent Bio Solutions adheres to stringent quality standards in other regions. The company is ISO 13485:2016 certified, an international standard that ensures compliance with medical device regulations for manufacturing, design, and quality management. This certification is essential for selling medical devices in markets such as the US, Canada, Europe, Japan, Singapore, Malaysia, and Saudi Arabia, further solidifying the company's global presence.
To support its entry into new regions, the company has also established partnerships with regulatory bodies and laboratories to ensure compliance with local regulations. These efforts are integral to the company's expansion strategy, enabling it to introduce its innovative technology to a growing number of markets while maintaining the highest quality and safety standards.
R&D and Innovation Pipeline
R&D and Innovation Pipeline
The company is focused on enhancing the Drug Screening Reader with improved connectivity and user interface upgrades, allowing for seamless data integration with healthcare systems. These developments will further strengthen Intelligent Bio Solutions’ position as a leader in workplace safety and healthcare diagnostics, providing adaptable solutions for a range of industries and applications.
Sales & Distribution Strategy
Sales & Distribution Strategy
Intelligent Bio Solutions has developed a multifaceted sales and distribution strategy designed to scale its operations globally and capitalize on the growing demand for rapid, non-invasive drug testing solutions. The company employs a combination of direct sales efforts and strategic partnerships to penetrate key markets, particularly in the United Kingdom, Europe, and Australia. These safety-conscious regions present significant opportunities for the company's Intelligent Fingerprinting Drug Testing Solution.
The company's direct sales team focuses on building relationships with employers in safety-critical industries, such as construction, mining, manufacturing and engineering, transport, and logistics. By targeting these sectors, the company ensures that its Solution is positioned where the need for fast, reliable drug testing is paramount. The sales team is trained to demonstrate how the Intelligent Fingerprinting Drug Screening System can streamline operations and reduce the risks associated with workplace drug use, particularly by highlighting its speed, non-invasive nature, and cost-effectiveness.
In addition to direct sales, Intelligent Bio Solutions leverages strategic distribution partnerships to expand its footprint in regions where local knowledge and networks are essential for market entry. These partnerships with established distributors enable the company to reach smaller organizations and markets that would otherwise be difficult to access through direct sales alone. By partnering with distributors who understand regional regulatory requirements, the company ensures smooth market entry and compliance with local standards.
The company's ongoing commitment to regulatory approvals is essential to its sales and distribution strategy. As it prepares for its planned FDA 510(k) submission and anticipated launch in the US in 2025, Intelligent Bio Solutions is looking into a distribution network to ensure the product is available to a broad range of industries. This strategy is complemented by a focus on scalability, with the company investing in account support and training infrastructure to support growth in both direct and indirect sales channels. Through this approach, Intelligent Bio Solutions is working to establish itself as the go-to provider for rapid, non-invasive, and cost-effective drug testing in multiple global markets.
Intellectual Property Protection
Intellectual Property Protection
Intelligent Bio Solutions has a robust intellectual property (IP) portfolio to protect its cutting-edge fingerprint sweat-based technology, ensuring a competitive advantage in the rapidly evolving drug testing and diagnostics market. The company has obtained patents in the US, United Kingdom, Europe, Australia, Japan, China, and Canada, securing legal protection in critical markets where demand for non-invasive testing is expected to grow. These patents cover multiple facets of the company's technology, from core diagnostic methodologies to device innovations, providing a comprehensive defense against competitors.
At the heart of Intelligent Bio Solutions’ IP portfolio are patents related to its lateral flow test strips, cartridge technology, and lateral flow test strip reader, all of which are integral to the company's commercial products. The company holds a primary patent, filed in 2014, which covers the broad concept of using lateral flow strips in diagnostic testing. This patent is projected to remain in force until 2034-2035, securing long-term protection for one of the company's most critical innovations.
In addition to the core cartridge technology, Intelligent Bio Solutions has protected the Drug Screening Reader, the device responsible for analyzing fingerprint sweat samples and generating test results. The patent related to this reader ensures the company controls the core hardware that powers its Intelligent Fingerprinting Drug Screening System. Another primary patent covers the Confirmation Cartridge, further solidifying the company's stronghold on the testing process and the tools required to carry it out. With patents lasting through 2040-2041, Intelligent Bio Solutions is well-positioned to maintain exclusivity in the market, shielding its products from reverse engineering or duplication by larger players looking to enter the non-invasive diagnostics space.
The company's complete patent suite covers virtually all aspects of fingerprint diagnostics, including chemistry, screening cartridge technology, collection cartridge technology, fingerprint quantitation, fingerprint-controlled medication dispensers, lab testing of fingerprints, accessories, and lateral flow test strip readers.
Financial Overview
Financial Overview
Intelligent Bio Solutions is positioned for sustained growth, with revenue increasing significantly as its innovative drug screening technology gains traction. For the fiscal year ending June 30, 2024, the company's revenues were $3.11 million, a 148% year-over-year growth from $1.26 million in fiscal 2023. This strong performance reflects the growing adoption of the company's Intelligent Fingerprinting Drug Testing Solution across key industries such as construction, transportation, and manufacturing.
The company's balance sheet provides the resources necessary to fuel continued expansion. As of June 30, 2024, the company had Cash and cash equivalents of $6.30 million, up from $1.54 million the previous year. The company's strong working capital positions it to sustain its operations and invest in areas such as product development, geographical expansion, and regulatory compliance to drive future growth.
Source: Company Documents
Management Team
Management Team
A highly experienced executive team leads Intelligent Bio Solutions with deep healthcare, financial management, and corporate governance expertise. Their leadership has driven the company's growth and innovation in the drug screening and diagnostics sectors.
Harry Simeonidis, President and Chief Executive Officer
Harry Simeonidis has more than 25 years of experience in healthcare, pharmaceutical and life sciences across various senior management positions throughout Asia, Australia and New Zealand. Before joining Intelligent Bio Solutions, he was the General Manager, Surgery, Asia Pacific, at GE Healthcare where he oversaw significant expansion of the business’ market share. Prior to this, Harry spent nine years as the President and CEO of GE Healthcare ANZ.
Spiro Sakiris, Chief Financial Officer
Spiro Sakiris has 34 years’ experience in accounting and taxation, IPOs and capital raising, and business system designs, including the application of IFRS and US GAAP for the life science industry. Mr. Sakiris is a member of the Institute of Chartered Accountants of Australia & New Zealand.
Dr. Stephen Boyages, Chairman of the Board
Dr. Stephen Boyages is a practicing clinician in endocrinology with more than 30 years of experience in medicine. As Chairman of the Board since July 2020, Dr. Boyages provides strategic oversight and guidance, drawing from his extensive background in healthcare leadership. He previously served as Chief Executive of the Sydney West Area Health Service and held leadership roles in New South Wales Health, where he implemented health reform initiatives and managed a $2 billion budget. His expertise in healthcare, public policy, and research development adds invaluable insight to the company's strategic direction.
Lead Drug Candidate: Crofelemer
Crofelemer, brand name Mytesi®, is a prescription drug made from the sap of the Croton lechleri tree found in the Amazon rainforest. Indigenous peoples in South America have used this tree sap for centuries to treat a variety of ailments, including diarrhea.
Scientists studied why the sap helped with diarrhea and found it contains chemicals called proanthocyanidins that help normalize fluid secretion in the intestines.
Crofelemer is considered a "first-in-class" drug because it is the first approved drug to work as a gastrointestinal chloride channel modulator (GCCM). The cells lining the intestines have tiny channels that regulate fluid secretion. Crofelemer acts on chloride channels called CFTR and CaCC to reduce the excessive fluid loss into the intestines that causes diarrhea.
Source: Company Documents
This unique mechanism of action is vital because other antidiarrheal drugs, such as Imodium or loperamide, derived from opioids, work differently by slowing down gut motility. The unintended side-effect of reducing motility is that it can cause constipation. In contrast, crofelemer targets the root cause of secretory diarrhea to return patients to more normal GI function.
After being studied for decades, crofelemer was first approved by the FDA in 2012 to treat noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Since then, crofelemer has been undergoing rigorous testing in clinical trials to evaluate the drug’s effectiveness for the treatment of diarrhea from other conditions like cancer therapy and rare diseases.
For example, a crofelemer drug called Canalevia-CA1 is now FDA-conditionally approved for the treatment of chemotherapy-induced diarrhea in dogs. Testing in dogs supports potential use in humans for this same indication. Crofelemer is also being studied in rare "orphan" diseases like short bowel syndrome (SBS) and microvillus inclusion disease (MVID) with intestinal failure – two devastating conditions that require patients to be dependent on parenteral (IV) nutrition.
By leveraging its unique mechanism of action normalizing fluid secretion, crofelemer may provide a broadly effective treatment for multiple chronic GI conditions beyond just the treatment of HIV-related diarrhea. More label expansions and partnerships could occur if ongoing studies demonstrate crofelemer's efficacy across additional gastrointestinal diseases.
About Mytesi - Mytesi (crofelemer) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Mytesi is not indicated for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting Mytesi. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen. In clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%). See full Prescribing Information at Mytesi.com. Crofelemer, the active ingredient in Mytesi, is a botanical (plant-based) drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon rainforest. Napo has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity.
Important Safety Information About Canalevia - For oral use in dogs only. Not for use in humans. Keep Canalevia-CA1 (crofelemer delayed-release tablets) in a secure location out of reach of children and other animals. Consult a physician in case of accidental ingestion by humans. Do not use in dogs that have a known hypersensitivity to crofelemer. Prior to using Canalevia-CA1, rule out infectious etiologies of diarrhea. Canalevia-CA1 is a conditionally approved drug indicated for the treatment of chemotherapy-induced diarrhea in dogs. The most common adverse reactions included decreased appetite, decreased activity, dehydration, abdominal pain, and vomiting. Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use only as directed. It is a violation of Federal law to use this product other than as directed in the labeling. Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552. See full Prescribing Information at Canalevia.com.
How Crofelemer Works
Crofelemer is a prescription medicine that comes from the sap of a tree sustainably harvested from the Amazon rainforest and works differently than other treatments for gastrointestinal (GI) problems like diarrhea.
With most chronic diarrhea, too much water flows into the GI tract. This action causes loose, watery stools as the extra fluid mixes in. Crofelemer helps normalize water secretion into the intestines.
Inside the lining of the intestines are tiny channels that control the flow of water and salts like chloride into the GI tract. In some diseases, these channels become hyperactive, allowing too much fluid to enter the intestines. This fluid imbalance results in watery diarrhea.
Crofelemer acts directly on two critical intestinal channels called CFTR and CaCC to reduce their hyperactivity. Crofelemer normalizes the amount of fluid secreted into the intestines by calming these overactive channels.
With less extra water flowing into the intestines, stools become more solid, and patients have fewer loose, watery bowel movements.
In contrast, other antidiarrheal drugs like Imodium and loperamide work by slowing down the GI tract. But this opioid approach can cause side effects such as constipation.
Crofelemer treats the root cause of secretory diarrhea – too much fluid secretion into the intestines. It acts locally in the GI tract, normalizing water flow through chloride channel modulation. And it is non-opioid, so it does not cause opioid side effects.
By targeting and modulating the specific chloride channels involved in excess intestinal fluid secretion, crofelemer can effectively reduce chronic diarrhea without slowing overall GI motility like opioids. This novel mechanism of action makes crofelemer well-suited for chronic use in conditions like HIV-associated diarrhea.
Source: Company Documents
About Mytesi - Mytesi (crofelemer) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Mytesi is not indicated for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting Mytesi. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen. In clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%). See full Prescribing Information at Mytesi.com. Crofelemer, the active ingredient in Mytesi, is a botanical (plant-based) drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon rainforest. Napo has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity.
Jaguar/Napo Product Portfolio – Crofelemer Pipeline
Jaguar Health is developing multiple formulations of its key product, crofelemer, to treat different gastrointestinal diseases. Crofelemer is a prescription drug derived from tree sap that modulates intestinal fluid secretion to alleviate diarrhea. Jaguar has an extensive development pipeline for crofelemer ranging from the initial preclinical research stage to an already approved product. The goal is to expand crofelemer's use across multiple chronic GI conditions.
Source: Company Documents
Mytesi® for HIV-Related Diarrhea
Mytesi (crofelemer) is an FDA-approved drug for the treatment of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. It normalizes fluid transport in the intestines to reduce chronic diarrhea. Mytesi was Jaguar's first approved crofelemer product, generating revenue since its launch in 2016.
Crofelemer for Cancer Therapy-related Diarrhea
Jaguar is conducting a Phase 3 clinical trial of crofelemer for cancer therapy-related diarrhea in patients receiving targeted therapies. These cancer agents often damage the gut lining, causing loose stools. Crofelemer could reduce this side effect.
Crofelemer Powder for Rare Orphan Diseases: Short Bowel Syndrome & Microvillus Inclusion Disease
A powder formulation of crofelemer is in development for short bowel syndrome (SBS) and microvillus inclusion disease (MVID) patients with intestinal failure who require IV nutrition. By modulating intestinal fluid, crofelemer may reduce chronic diarrhea in these patients. Orphan-drug incentives could support development. The FDA activated the company’s Investigational New Drug application for crofelemer for the treatment of MVID on August 7, 2023.
Crofelemer for Irritable Bowel Syndrome
Crofelemer has undergone clinical evaluation for patients with diarrhea-predominant IBS. Crofelemer may provide symptomatic relief for chronic loose, watery stools by controlling intestinal fluid secretion.
NP-300 for Cholera Diarrhea
NP-300 is a second-generation anti-secretory antidiarrheal in development for the relief and treatment of moderate-to-severe diarrhea from bacterial, viral, and parasitic infections, including Vibrio cholerae, the bacterium that causes cholera. In September 2023, the FDA activated the company’s Investigational New Drug (IND) application for NP-300 for crofelemer for this indication. NP-300 has a similar mechanism of action as crofelemer but is less costly to produce.
About Mytesi - Mytesi (crofelemer) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Mytesi is not indicated for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting Mytesi. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen. In clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%). See full Prescribing Information at Mytesi.com. Crofelemer, the active ingredient in Mytesi, is a botanical (plant-based) drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon rainforest. Napo has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity.
Videos – Jaguar Health: Improving Lives
Please watch the following videos for more information about Jaguar Health and how the company is working to improve lives.
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From Tree to Bottle
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December 2021 Discussion About CTD by Lee Schwartzberg, MD, FACP, Professor of Medicine, University of Tennessee Health Science Center, and Napo Pharmaceuticals Scientific Advisory Board (SAB) Member.
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Lisa Conte Interview with Sandra M. Swain, MD, FACP, FASCO (member of Jaguar/Napo Scientific Advisory Board).
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Lisa Conte Interview with Dr. Kelly Shanahan, a former clinician and a metastatic breast cancer patient who is now a full-time independent patient advocate and a member of the Jaguar/Napo Scientific Advisory Board.
Source: Company Documents
Global Market Growth Opportunities
Jaguar Health is pursuing a pipeline of crofelemer formulations that span from supportive care for overactive bowel – which includes symptoms such as chronic debilitating diarrhea, GI urgency, and GI incontinence – to potential disease-modifying products in areas of high unmet need. The company’s initiatives represent an expansion into higher-value markets with greater potential to impact patient outcomes and lower the cost of care. The global prescription and OTC gastrointestinal agent market alone is projected to reach $21 billion by 2025, presenting sizable commercial opportunities if Jaguar can successfully develop and differentiate its products.
Source: Company Documents
In HIV-related diarrhea, Mytesi is the only FDA-approved treatment. About 70% of HIV/AIDS patients in the US are now over 50 and have lived with the virus for over ten years, often causing chronic gut complications that require symptomatic relief.
For cancer therapy-related diarrhea (CTD), 1.9 million new cancer cases were projected in the US for 2023. Up to 80% of chemotherapy patients experience diarrhea, requiring treatment delays/changes. By preventing CTD, crofelemer could support better adherence and outcomes. The global market for a comparable supportive care indication, chemotherapy-induced nausea and vomiting (CINV), is projected by market research firm iHealthcareAnalyst to reach a value of $3.9 billion by 2029
In short bowel syndrome (SBS) and congenital diarrheal disorders like microvillus inclusion disease (MVID), crofelemer may reduce dependence on parenteral nutrition. About 10,000-20,000 people in the US have SBS. MVID is an ultra-rare disease affecting a couple of hundred patients globally. The global SBS market alone is projected to grow to $4.6 billion by 2027, according to market research firm Vision Research Reports.
For diarrhea-predominant IBS, which impacts an estimated 15% of US adults, crofelemer would target the root cause of chronic watery diarrhea, unlike current treatments. Competitors have estimated peak US sales above $1 billion annually for drugs in this category. Effective relief of IBS-D symptoms remains a major unmet need.
Finally, in infectious diarrhea from pathogens like Vibrio cholerae, the company’s NP-300 drug product candidate may qualify for a Priority Review Voucher (PRV) from the FDA. PRVs are transferable and, in past transactions by other companies, have sold for values ranging from $67 million to $350 million. Additionally, it may meet a global need for affordable infection control in developing markets. In September 2023, the FDA activated the company’s Investigational New Drug (IND) application for NP-300 for crofelemer for this indication.
In summary, Jaguar Health's crofelemer pipeline spans high-value offerings in potential multi-billion-dollar markets where it can fill significant unmet needs related to diarrhea control and intestinal fluid regulation if successfully developed and commercialized.
About Mytesi - Mytesi (crofelemer) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Mytesi is not indicated for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting Mytesi. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen. In clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%). See full Prescribing Information at Mytesi.com. Crofelemer, the active ingredient in Mytesi, is a botanical (plant-based) drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon rainforest. Napo has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity.
2023 Critical Activities to Unlock Jaguar Health's Value Potential
Jaguar Health has laid out several important goals and targets for 2023 through 2024:
A major milestone will be the expected availability in late October 2023 of the primary endpoint data for Napo’s pivotal Phase 3 OnTarget trial of crofelemer for preventative treatment of chemotherapy-induced overactive bowel (CIOB) in adults with cancer on targeted therapy. The primary endpoint looks at the study's main goal – evaluating crofelemer's effectiveness in reducing diarrhea rates. Jaguar Health anticipates being able to present additional data from this pivotal trial data at a medical conference in December 2023.
An independent pilot phase 2 study of crofelemer for the management of neratinib-associated diarrhea in patients with HER2+ early-stage breast cancer indicates that crofelemer, Napo’s FDA-approved drug, may be effective for the management of neratinib-induced diarrhea. The results of the study, which was designed by the study's principal investigator, Jo Chien, MD, and published in the peer-reviewed journal Clinical Breast Cancer, are consistent with the results of a preclinical dog study evaluating the effects of crofelemer in improving diarrhea associated with neratinib, a tyrosine kinase inhibitor (TKI), presented at the American Association for Cancer Research Virtual Annual Meeting II in June 2020.
Jaguar Health's pipeline includes pursuing crofelemer for short bowel syndrome (SBS) and congenital diarrheal disorders (CDD), which both qualify as rare diseases.
Source: Company Documents
Jaguar Health is supporting proof-of-concept clinical trials of crofelemer conducted by independent investigators for SBS and CDD. Proof-of-concept trials can provide early evidence that a drug may be effective. Jaguar Health expects that results from SBS and CDD proof-of-concept studies will be available before the end of 2023 in the first half of 2024.
The company believes the SBS and CDD proof-of-concept data could support expanded patient access to crofelemer through early access programs in specific European countries starting as early as 2024. Early access programs allow patients to receive a medicine before it is fully approved and can generate revenue while also allowing faster access for patients with serious diseases.
Also, in the second half of 2023, Jaguar Health expects the results of a canine study they completed evaluating crofelemer for preventing chemotherapy-related diarrhea in dogs to be published. This canine data could further support crofelemer's use for managing diarrhea from cancer treatments in humans.
Jaguar Health is targeting business development partnerships related to its pipeline and global commercialization efforts in 2023. Partnerships with other companies can help extend crofelemer's reach by licensing rights in certain geographies and disease areas.
Jaguar Health’s major clinical trial readouts, publications, and regulatory milestones spanning multiple programs slated for 2023-2024 all bode well for the company. Meeting these ambitious goals could significantly advance crofelemer toward approvals in cancer therapy-related diarrhea, SBS, and CDD while also expanding real-world evidence and patient access. Jaguar Health aims to execute new partnerships to extend commercial reach globally. Delivering on these key milestones will be critical for Jaguar Health's value and future growth potential.
About Mytesi - Mytesi (crofelemer) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Mytesi is not indicated for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting Mytesi. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen. In clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%). See full Prescribing Information at Mytesi.com. Crofelemer, the active ingredient in Mytesi, is a botanical (plant-based) drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon rainforest. Napo has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity.
Important Safety Information About Canalevia - For oral use in dogs only. Not for use in humans. Keep Canalevia-CA1 (crofelemer delayed-release tablets) in a secure location out of reach of children and other animals. Consult a physician in case of accidental ingestion by humans. Do not use in dogs that have a known hypersensitivity to crofelemer. Prior to using Canalevia-CA1, rule out infectious etiologies of diarrhea. Canalevia-CA1 is a conditionally approved drug indicated for the treatment of chemotherapy-induced diarrhea in dogs. The most common adverse reactions included decreased appetite, decreased activity, dehydration, abdominal pain, and vomiting. Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use only as directed. It is a violation of Federal law to use this product other than as directed in the labeling. Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552. See full Prescribing Information at Canalevia.com.
Commercial Rights and Partnerships
Source: Company Documents
Jaguar Health holds global commercial rights to Mytesi® (crofelemer), its FDA-approved drug for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar also holds global rights to developing and commercializing crofelemer for multiple possible follow-on indications, including cancer therapy-related diarrhea.
In the animal health area, Jaguar holds the global rights to Canalevia®-CA1, its oral prescription drug FDA conditionally approved for the treatment of chemotherapy-induced diarrhea (CID) in dogs. Jaguar is focused on commercializing Canalevia-CA1 for CID in dogs in the United States.
In Europe, Jaguar has licensed the rights to crofelemer for short bowel syndrome, congenital diarrheal disorders, and HIV-related diarrhea to Jaguar family company Napo Therapeutics. This initiative provides Napo Therapeutics the exclusive rights to develop and commercialize crofelemer in Europe for these indications.
Additionally, Jaguar has partnered with Quadri Pharma for the potential commercialization of Mytesi in select countries in the Middle East and North Africa region. Quadri Pharma has exclusive promotional, distribution, and commercialization rights for Mytesi in these territories, following any necessary regulatory approvals.
Jaguar also has an agreement with Knight Therapeutics for the potential commercialization of Mytesi and other Jaguar prescription products in Canada and Israel. Knight holds exclusive distribution and commercialization rights in these territories.
Overall, Jaguar retains global rights to Mytesi, Canalevia-CA1, and the crofelemer pipeline while also retaining the ability to execute select partnerships to extend commercialization in key international markets. The company’s partnerships give Jaguar control over its core assets while leveraging partners to maximize the global value of its products.
About Mytesi - Mytesi (crofelemer) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Mytesi is not indicated for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting Mytesi. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen. In clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%). See full Prescribing Information at Mytesi.com. Crofelemer, the active ingredient in Mytesi, is a botanical (plant-based) drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon rainforest. Napo has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity.
Important Safety Information About Canalevia - For oral use in dogs only. Not for use in humans. Keep Canalevia-CA1 (crofelemer delayed-release tablets) in a secure location out of reach of children and other animals. Consult a physician in case of accidental ingestion by humans. Do not use in dogs that have a known hypersensitivity to crofelemer. Prior to using Canalevia-CA1, rule out infectious etiologies of diarrhea. Canalevia-CA1 is a conditionally approved drug indicated for the treatment of chemotherapy-induced diarrhea in dogs. The most common adverse reactions included decreased appetite, decreased activity, dehydration, abdominal pain, and vomiting. Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use only as directed. It is a violation of Federal law to use this product other than as directed in the labeling. Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552. See full Prescribing Information at Canalevia.com.
Jaguar and Magdalena Biosciences Collaboration
Source: Company Documents
Beyond its core focus, Jaguar Health has invested in an intriguing new venture targeting mental health disorders through natural plant-based prescription drugs. This initiative, known as the Entheogen Therapeutics Initiative (ETI), exemplifies Jaguar Health's long-term vision to leverage its extensive knowledge of ethnobotanical plant medicine to develop innovative therapies across various disease areas.
The ETI is centered around exploring plants with potential mental health benefits, with an initial focus on discovering treatments for depression. This novel program aligns with Jaguar Health's mission to sustainably develop first-in-class medicines from rainforest plants through collaborations with indigenous communities. Jaguar Health's recent formation of the joint venture Magdalena Biosciences crystallizes the ETI strategy into a concrete drug development vehicle targeting major mental health needs.
Origins of Jaguar Health's Mental Health Focus
Jaguar Health's interest in expanding into mental health traces back to the experience of its management team members at the company's predecessor, Shaman Pharmaceuticals. In the 1990s, Shaman conducted extensive global ethnobotanical research, yielding a library of over 2,300 medicinal plants used in traditional healing systems. The team's field studies in Nigeria investigated Native African plants like Picralima nitida, which traditional healers have used to treat psychotic disorders.
When Jaguar Health acquired this plant library from the bankruptcy of Shaman in 2001, it gained a unique asset bridging indigenous medicine and Western pharmaceutical science. Jaguar Health has continued to build upon this library through additional rainforest research. Hence, Jaguar Health possesses unparalleled knowledge of medicinal plants, including many with potential but unexplored effects on the mind and mental health.
The Entheogen Therapeutics Initiative
Building upon this foundation, in 2021, Jaguar Health launched the Entheogen Therapeutics Initiative to formally pursue drug candidates from psychoactive plants for various mental health indications. The term "entheogen" refers to plants that induce spiritual or mystical experiences, many of which have traditional ceremonial uses. Jaguar Health's ETI goes beyond exploring recreational uses, focusing instead on developing rigorously tested prescription drugs for specific medical needs.
The ETI is advised by a Scientific Strategy Team of leading ethnobotanists, physicians, and pharmacologists, including several experts involved in the original Shaman library of plants. This team's knowledge of plant-based medicine and connections with indigenous communities is invaluable for identifying promising new drug candidates. Jaguar Health also chairs an ETI Ethics Board to ensure activities adhere to ethical standards regarding traditional knowledge and fair benefit-sharing.
Initially, the ETI is targeting the discovery of plant-based treatments for mood disorders like depression, anxiety, and PTSD. Depression, in particular, represents a significant unmet medical need, with over 21 million Americans affected each year. Existing antidepressant drugs like SSRIs have limitations in efficacy and side effects, creating demand for new therapeutic approaches. Plants offer a rich starting point for psychiatric drug discovery, given their long use in traditional healing systems.
The ETI has already pinpointed lead compounds from Jaguar Health's library for further investigation. One example is alstonine, a compound derived from the Picralima nitida plant used by traditional healers in Nigeria to treat psychiatric conditions. While still early stage, alstonine could provide a novel treatment mechanism compared to existing antidepressant drugs.
Formation of Magdalena Biosciences Joint Venture
To accelerate ETI's long-term mission, Jaguar Health recently established an exciting joint venture called Magdalena Biosciences, focused specifically on developing plant-based drugs for mental health disorders. Formed in January 2023 in partnership with the Canadian company Filament Health and with backing from One Small Planet, Magdalena Biosciences represents a milestone in Jaguar Health's bold push into mental health.
Magdalena Biosciences is leveraging Jaguar Health's extensive plant library along with Filament Health's drug development expertise. The joint venture has an exclusive license to evaluate plants and extracts from Jaguar Health's collection for specified mental health indications.
The first goal is to identify and optimize plants that may have promise for treating adult ADHD. ADHD is a common disorder affecting over 10 million adults in the U.S., yet existing stimulant treatments have misuse potential. Non-stimulant drugs are limited, creating an opportunity for plant-based alternative prescription drugs with new mechanisms of action and improved safety profiles.
In the future, Magdalena Biosciences plans to pursue additional mood disorders like anxiety, depression, and PTSD. The ultimate vision is to partner with pharmaceutical companies to fully develop and commercialize the venture's botanical drug candidates.
Jaguar Health owns approximately 40% of Magdalena Biosciences, initially valued at $5 million based on One Small Planet's seed investment of $1 million. This ownership stake provides Jaguar Health equity participation in Magdalena Biosciences' long-term success. Jaguar Health also benefits near-term from the $1 million infusion into its plant library and ethnobotanical expertise.
Strategic Context and Implications
Jaguar Health's pursuit of plant-based mental health drugs represents a bold long-term diversification, leveraging the company's unparalleled botanical knowledge and a large library of plants with potential medicinal benefits into new disease areas beyond core gastrointestinal indications. The ETI and Magdalena Biosciences joint venture strategically expands Jaguar Health's pipeline, targeting major conditions like mood disorders and ADHD, which affect millions of patients globally.
The ETI focuses on natural plant compounds that differentiate Jaguar Health's drug candidates from conventional synthetic psychiatric medications. These new drugs may offer improved efficacy, safety, and abuse potential profiles that drive adoption. Additionally, the basis of traditional plant medicine aligns with growing consumer interest in natural remedies over conventional medicines.
Of course, Jaguar Health faces formidable obstacles in proving the safety and efficacy of complex botanical drugs for mental illness. Clinical development timelines are lengthy, costs substantial, and failure rates high. But Jaguar Health is taking a prudent long-term approach through the ETI and Magdalena Biosciences, leveraging its unparalleled experience in ethnobotanical drug discovery.
If ultimately successful, Jaguar Health's novel plant-based therapies could transform the treatment of depression, ADHD, and other psychiatric conditions. This effort would enable Jaguar Health to tap into a multibillion-dollar market and drive significant shareholder value. In the nearer term, the ETI and the Magdalena Biosciences joint venture expand Jaguar Health's portfolio pipeline beyond gastrointestinal medicine, mitigating risk through therapeutic diversification.
Overall, the promise of plant-based mental health prescription drugs makes this an intriguing, if still highly speculative, new frontier for Jaguar Health, warranting close monitoring in the years ahead.
Financial Summary
Jaguar Health, Inc. (NASDAQ: JAGX) is a commercial-stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with GI distress, specifically overactive bowel, which includes symptoms such as chronic debilitating diarrhea, GI urgency, and GI incontinence.
In 2022, Jaguar reported total revenues of $12 million, a significant 175.8% increase compared to revenues of $4.3 million in 2021. The revenue growth was primarily driven by increased sales of their human drug Mytesi® for symptomatic relief of noninfectious diarrhea in HIV/AIDS patients. This growth reflects the company's transition from a wholesaler distribution model to distribution through specialty pharmacies, resulting in lower discounts, rebates, and fees than the prior year. Jaguar also launched sales of their new animal drug Canalevia®-CA1 for chemotherapy-induced diarrhea in dogs in 2022, generating $167,000 in initial revenues.
Source: Company Documents
Despite strong revenue growth, Jaguar continued to report net losses in 2022 of $48.4 million, although this was an 8% improvement from net losses of $52.6 million in 2021. The losses are attributed to high operating expenses related to R&D for Jaguar's pipeline programs, including crofelemer for cancer therapy-related diarrhea and commercialization activities for Mytesi and Canalevia-CA1. Key expense items in 2022 included R&D expenses of $17.6 million, sales and marketing expenses of $8.8 million, and G&A expenses of $17.9 million.
Jaguar is progressing with developing crofelemer for additional indications beyond HIV-related diarrhea, including chemotherapy-induced overactive bowel (CIOB) and inflammatory bowel diseases. Crofelemer is the subject of the OnTarget study, Napo’s ongoing pivotal Phase 3 clinical trial for preventative treatment of CIOB in adults with cancer. Top-line data for the primary endpoint from this trial is expected at the end of October 2023.
The company has received orphan drug designations from the FDA and EMA for crofelemer for two rare diseases: short bowel syndrome (SBS) and microvillus inclusion disease (MVID, a congenital diarrheal disorder (CDD). Jaguar is supporting third-party investigational proof-of-concept studies of crofelemer for these indications that could enable early patient access in Europe, possibly in 2024. Further pipeline programs include NP-300, a second-generation anti-secretory agent for the treatment of moderate-to-severe diarrhea from bacterial, viral, and parasitic infections, including Vibrio cholerae, the bacterium that causes cholera. In September 2023, the FDA activated the company’s Investigational New Drug (IND) application for NP-300 for crofelemer for this indication. NP-300 has a similar mechanism of action as crofelemer but is less costly to produce. Jaguar also formed a joint venture in 2023 with Filament Health, called Magdalena Biosciences, to develop novel plant-based drugs for mental health indications, including ADHD, depression, and anxiety.
In animal health, Jaguar now markets Canalevia-CA1 for the treatment of chemotherapy-induced diarrhea in dogs under FDA conditional approval.
For long-term investors, Jaguar Health represents an early-stage biopharma with high-risk but potentially high reward as it aims to establish a differentiated pipeline of first-in-class plant-based medicines.
About Mytesi - Mytesi (crofelemer) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Mytesi is not indicated for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting Mytesi. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen. In clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%). See full Prescribing Information at Mytesi.com. Crofelemer, the active ingredient in Mytesi, is a botanical (plant-based) drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon rainforest. Napo has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity.
Important Safety Information About Canalevia - For oral use in dogs only. Not for use in humans. Keep Canalevia-CA1 (crofelemer delayed-release tablets) in a secure location out of reach of children and other animals. Consult a physician in case of accidental ingestion by humans. Do not use in dogs that have a known hypersensitivity to crofelemer. Prior to using Canalevia-CA1, rule out infectious etiologies of diarrhea. Canalevia-CA1 is a conditionally approved drug indicated for the treatment of chemotherapy-induced diarrhea in dogs. The most common adverse reactions included decreased appetite, decreased activity, dehydration, abdominal pain, and vomiting. Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use only as directed. It is a violation of Federal law to use this product other than as directed in the labeling. Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552. See full Prescribing Information at Canalevia.com.
Analyst Coverage
Jaguar Health is followed by several seasoned biopharma analysts at leading investment banks and research boutiques. This sell-side coverage provides important visibility and insights on Jaguar Health to the institutional investment community.
Source: Company Documents
A Deep and Seasoned Leadership Team
Jaguar Health has assembled an experienced leadership team with decades of combined expertise across pharmaceutical R&D, clinical development, manufacturing, business development, commercialization, legal, and financial operations.
The management team is led by Lisa Conte, the company's founder, president, and CEO, who has over 30 years of experience pioneering plant-based prescription medicines. Other key executives include Pravin Chaturvedi, Ph.D., the company’s Chief Scientific Officer and Chair of the Scientific Advisory Board, and Chief Medical Officer Dr. Darlene Horton, who has over 25 years of experience overseeing clinical development in the biopharma industry. This seasoned leadership team provides Jaguar Health with the strategic vision and operational capabilities to advance the company's pipeline of novel plant-based therapies.
Source: Company Documents
Lisa Conte is the founder, president, and chief executive officer, and a member of the board of directors of Jaguar Health, a commercial-stage pharmaceuticals company committed to discovering, developing, and commercializing plant-based prescription medicines for urgent global health needs. In July 2017, two companies founded by Ms. Conte—Napo Pharmaceuticals, a human-focused pharmaceuticals company, and Jaguar Animal Health, the veterinary-focused licensor of all of Napo’s technology—merged and now comprise Jaguar Health. In 1989, Ms. Conte founded Shaman Pharmaceutical and pioneered plant-based prescription medicine investigation and development for more than 30 years. Ms. Conte is a member of the board of directors of Healing Forest Conservatory, serves on the Editorial Advisory Board of Life Science Leader magazine, and serves on the Leadership Council of Pure Earth. She holds an MS in Physiology and Pharmacology from the University of California, San Diego, and an MBA and AB in Biochemistry from Dartmouth College.
Steven King, Ph.D., has served as Chief of Sustainable Supply, Ethnobotanical Research, and Intellectual Property since 2020. He joined the company in 2002 as Senior Vice President of Sustainable Supply, Ethnobotanical Research, and IP. Before that, he was Vice President of Ethnobotany and Conservation at Shaman Pharmaceuticals. He has a Ph.D. in Biology from the Institute of Economic Botany at the New York Botanical Garden and City University of New York and an MS in Biology from the same institutions.
Pravin Chaturvedi, Ph.D., has been Chief Scientific Officer since 2022 and serves as Chair of the Scientific Advisory Board. He has over 30 years of experience in the pharmaceutical industry and has participated in developing multiple approved drugs. He was previously President and CSO of Napo from 2006-2013. He co-founded several biotech companies, including Scion Pharmaceuticals, IndUS Pharmaceuticals, and Oceanyx Pharmaceuticals. He has a Ph.D. in Pharmaceutical Sciences from West Virginia University and a Bachelor's in Pharmacy from the University of Bombay.
Carol R. Lizak has been Chief Financial Officer since 2021. She joined the company in 2019 as Vice President of Finance and Corporate Controller and was promoted to Chief Accounting Officer and then Senior Vice President of Finance before becoming CFO. She has over 20 years of finance experience, including roles at Zosano Pharma, Quantum Secure, Alexza Pharmaceuticals, and HID Global. She holds an MBA from Pepperdine University Graziadio School of Business and Management and a BS in Business Administration from the University of Santo Tomas.
Karen J. Brunke, Ph.D., brings to Jaguar over 30 years of scientific, operational, clinical, senior executive, and corporate development experience in both large and small biotechnology companies. Dr. Brunke has been primarily responsible for negotiating multiple partnerships and licenses in business and corporate development. Dr. Brunke received her BA degree in Biochemistry and a Ph.D. in Microbiology from the University of Pennsylvania.
Darlene Horton, MD, brings over 25 years of clinical research and development, medical affairs, senior executive, and consulting experience in developing investigational and commercialized biopharmaceutical and drug-device combination products. She has extensive clinical development experience in multiple therapeutic areas. Before joining Napo Pharmaceuticals, she led clinical development and regulatory strategy as CMO at Coherus Biosciences, Itero Biopharmaceuticals, and SMC Biotechnology. Dr. Horton completed her Pediatric Cardiology fellowship and Pediatrics Residency at UCSF. She earned an MD and BS in Microbiology from the University of Florida.
David Sesin, Ph.D., is a pharmaceutical scientist with more than 30 years of experience, from drug discovery to manufacturing. Before serving as Jaguar’s CMO, he was Director of Chemistry and QHSE at Bayer CropScience and Director of Chemistry at AgraQuest, Inc. he spent nine years with Shaman Pharmaceuticals. Dr. Sesin holds a Ph.D. from the University of Utah.
Jonathan S. Wolin, JD, has been Chief of Staff and General Counsel since 2019. Before being promoted, he joined the company in 2018 as Chief Compliance Officer and Corporate Counsel. Previously he was an independent consultant, Chief Administrative Officer at Braden Partners, and Chief Compliance Officer at Natera and Braden Partners, among other roles. He holds a JD from The Catholic University of America Columbus School of Law, an MBA from The George Washington University School of Business, and a BS in Accounting from the University of Maryland
Ian Wendt has been Chief Commercial Officer since 2020 after joining as VP of Commercial Strategy in 2019. He has over 15 years of experience in pharmaceutical and biotech sales, marketing, and operations at companies including Gilead Sciences, Boehringer Ingelheim, and Roxane Laboratories. He has an MBA from Dalhousie University in Nova Scotia and a BSc from Acadia University.
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