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ST. LOUIS, MO / ACCESS Newswire / June 23, 2025 / Kennedy Capital Management LLC (KCM), a specialist in micro, small, and mid-cap investment management services, is proud to announce that its small cap value fund (KVALX) has received an initial 4-Star¹ overall Morningstar Rating™. This total return achievement is measured against 477 funds in Morningstar’s Small Cap Value Category as of May 31, 2025, and is calculated based on Morningstar Risk-Adjusted Returns. This recognition underscores Kennedy’s commitment to delivering strong, risk-adjusted returns over time.

The 4-star rating for KVALX is particularly significant given the long-standing success of its underlying investment strategy, which has been a cornerstone of our firm since 1983. The fund benefits from the adept management of Frank Latuda, Jr., CFA^®, who has guided the strategy for over two decades, and McAfee Burke, CFA^®, who has brought valuable perspective and experience to the portfolio management team in recent years. While the strategy was made available in a mutual fund format in 2022, this Morningstar rating validates its enduring strength and success across both the institutional and retail worlds. Furthermore, as per the NADSAQ² eVestment™ database, the Small Cap Value strategy ranks in the top quartile for the 1, 3, 5, and 10-year periods ending March 31, 2025, highlighting its consistent outperformance over time.

KVALX benefits from the experience of a dedicated centralized team of research analysts. This cohesive team employs a fundamental, bottom-up investment approach, meticulously investigating individual companies within their investable universe. Under the guidance of Mr. Latuda and Mr. Burke, the fund seeks to identify companies across the value spectrum with favorable cash flow values relative to their current market capitalization, aiming for a portfolio with valuations below and growth characteristics at or above those of the benchmark.

“We established KVALX with investor demand in mind. The underlying strategy, professionally managed by Frank and McAfee, has long been available to institutional investors but has now been opened up to others,” says Don Cobin, CFA^®, CEO of KCM. “Achieving a 4-star¹ rating for our small cap value fund is a testament to the skill and dedication of our investment team and the consistent application of our disciplined research process. We are proud to offer investors a range of compelling options within the equity space.”

About Kennedy Capital Management LLC

Founded in 1980, St. Louis-based Kennedy Capital Management LLC delivers investment strategies to corporate and public pension funds, endowments, foundations, multi-employer plans, and high-net-worth individuals. As of March 31^st, 2025, KCM managed $4.5 billion in assets. The privately held registered investment adviser specializes in the management of small and mid-cap strategies across the growth-value spectrum. KCM integrates environmental, social, and governance (ESG) considerations into its research process and has nearly 20 years’ experience managing socially responsible client accounts. For more information, visit www.kennedycapital.com or email funds@kennedycapital.com.

¹Past performance is no guarantee of future results. Rating reflects fee waivers in effect; in their absence, the rating may have been lower.

Investors should consider the Funds’ investment objectives, risks, charges, and expenses carefully before investing. This and other important information is contained in the Funds’ full prospectuses and summary prospectuses, which can be obtained by visiting www.kennedycapital.com or by calling (833) 737-7788. Please read carefully before investing.

Important Risk Information: Equity securities (stocks) are generally more volatile and carry more risk than fixed income securities (bonds) and money market investments. The net asset value per share of the Small Cap Value fund (the Fund) will fluctuate as the value of the securities in the portfolio changes. Common stocks, and funds investing in common stocks, generally provide greater returns over long time periods than fixed income securities. The Fund is comprised primarily of equity securities and is subject to market risk. Stocks may decline due to general market and economic conditions or due to company specific circumstances. The Fund is comprised of small capitalization (“small cap”) stocks. Small cap stocks typically carry additional risk, since smaller companies generally have a higher risk of failure, and historically have experienced a greater degree of volatility. Small capitalization companies generally have a greater risk of failure, and their stocks generally have greater volatility than large companies. Mutual fund investing involves risk, including loss of principal.

Risks specific to KVALX: Value investing is subject to the risk that the market will not recognize a security’s inherent value for a long time or at all.

Index definitions and technical terms:

The Russell 2000^® Value Index is used as the benchmark for the Kennedy Capital Small Cap Value Fund and strategy. The Russell 2000^® Value Index measures the performance of small-cap value segment of the U.S. equity universe. It includes those Russell 2000 companies with relatively lower price-to-book ratios, lower I/B/E/S forecast medium term (2 year) growth and lower sales per share historical growth (5 year). The Russell 2000^® Value Index is constructed to provide a comprehensive and unbiased barometer for the small-cap value segment. The Index is completely reconstituted annually to ensure new and growing equites are included and that the represented companies continue to reflect value characteristics. You cannot invest directly into an index.

© 2025 Morningstar, Inc. All rights reserved. The information contained herein: (1) is proprietary to Morningstar and/or its content providers; (2) may not be copied or distributed; and (3) is not warranted to be accurate, complete, or timely. Neither Morningstar nor its content providers are responsible for any damages or losses arising from any use of this information.

The Morningstar Rating^TM for funds, or “star rating”, is calculated for managed products (including mutual funds, variable annuity and variable life subaccounts, exchange-traded funds, closed-end funds, and separate accounts) with at least a three-year history. Exchange-traded funds and open-ended mutual funds are considered a single population for comparative purposes. It is calculated based on a Morningstar Risk-Adjusted Return measure that accounts for variation in a managed product’s monthly excess performance, placing more emphasis on downward variations and rewarding consistent performance. The Morningstar Rating does not include any adjustment for sales loads. The top 10% of products in each product category receive 5 stars, the next 22.5% receive 4 stars, the next 35% receive 3 stars, the next 22.5% receive 2 stars, and the bottom 10% receive 1 star. The Overall Morningstar Rating for a managed product is derived from a weighted average of the performance figures associated with its three-, five-, and 10-year (if applicable) Morningstar Rating metrics. The weights are: 100% three-year rating for 36-59 months of total returns, 60% five-year rating/40% three-year rating for 60-119 months of total returns, and 50% 10-year rating/30% five-year rating/20% three-year rating for 120 or more months of total returns. While the 10-year overall star rating formula seems to give the most weight to the 10- 3 year period, the most recent three-year period actually has the greatest impact because it is included in all three rating periods. As of 5/31/25, KVALX was rated against 477 Small Value funds for the 3-year period. KVALX received 4 stars for this period. The Small Value category includes funds that typically invest in small US companies with valuations and growth rates below other small-cap peers. Stocks in the bottom 10% of the capitalization of the US equity market are defined as small cap. Value is defined based on low valuations (low price ratios and high dividend yields) and slow growth (low growth rates for earnings, sales, book value, and cash flow).

²eVestment and its affiliated entities (collectively, “eVestment”) collect information directly from investment management firms and other sources believed to be reliable; however, eVestment does not guarantee or warrant the accuracy, timeliness, or completeness of the information provided and is not responsible for any errors or omissions. Performance results may be provided with additional disclosures available on eVestment’s systems and other important considerations such as fees that may be applicable.

Kennedy Capital Management LLC is an investment adviser registered with the U.S. Securities and Exchange Commission and the adviser to the Funds.

The Funds are distributed by IMST Distributors, LLC.

Safe Harbor Statement

This press release is not intended as a recommendation or as investment advice of any kind, shall not constitute an offer to sell or a solicitation to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer or solicitation or sale would be unlawful prior to registration or qualification under the laws of such state or jurisdiction. All content has been provided for informational or educational purposes only.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains certain statements that may include “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All statements, other than statements of historical fact, included herein are “forward-looking statements.” Although Kennedy Capital Management LLC believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including those discussed in the Fund’s reports that are filed with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Other than as required by law, Kennedy Capital Management, Inc. does not assume a duty to update this forward-looking statement. 2025060024

Contact

Sarah Burkemper
sburkemper@kennedycapital.com
(314) 743-8221

SOURCE: Kennedy Capital Management, LLC

View the original press release on ACCESS Newswire

Designed to combine sustainability, flexibility, and seamless user experience.

DUBAI, UNITED ARAB EMIRATES / ACCESS Newswire / June 23, 2025 / In a landmark partnership set to reshape the region’s telecom landscape, Basatne MENA, the regional arm of global circular economy leader Basatne, has partnered with Likewize, the global leader in device lifecycle services, to launch ‘Upgrade & Protect’, the Middle East’s first subscription-based smartphone program designed to combine sustainability, flexibility, and seamless user experience.

With smartphone users in the GCC replacing devices every 12-18 months and over 50 million active handsets in circulation, ‘Upgrade & Protect’ transforms traditional instalment plans into a dynamic monthly subscription that empowers consumers to swap, upgrade, or protect their devices anytime. For telcos, the model unlocks new recurring revenue streams while aligning with growing ESG mandates.

This innovation arrives at a pivotal time, with UAE and GCC markets moving rapidly toward Net Zero and green digital transformation. The program aligns closely with the UAE’s Net Zero by 2050 Strategy and the GSMA’s Circular Economy for Mobile Devices initiative, supporting a shift away from linear consumption toward a more regenerative, technology-enabled future.

An Integrated Ecosystem Powering Circular Innovation ‘Upgrade & Protect’ is enabled by Basatne’s regional infrastructure, combining the power of Cartlow’s re-commerce and trade-in platform with Ardroid’s AI-powered reverse logistics engine. Together, they provide telcos with a complete circular framework, from seamless device collection and grading to resale, refurbishment, and responsible recycling.

Likewize brings its global expertise to ensure scalability and telco readiness. Its risk-free operational model gives mobile operators access to a full turnkey solution with measurable economic returns and environmental impact.

The Market Opportunity

The GCC is primed for the shift to device-as-a-service models:

• Smartphone penetration exceeds 90% across GCC markets.

• Handset replacement cycles average 12-18 months, creating strong upgrade demand.

• The global device subscription market is projected to exceed USD 25 billion by 2027.

• By 2026, 5G adoption is expected to cover 73% of GCC mobile subscriptions.

• The regional smartphone market is forecasted to grow from 60 million units in 2024 to nearly 99 million by 2033.

“Our partnership with Likewize marks a pivotal evolution in device ownership across the Middle East,” said Mahmoud Abusway, Chief Commercial Officer of Basatne MENA. “By embedding circular economy principles into the telco model, ‘Upgrade & Protect’ delivers a flexible, sustainable solution that reduces waste, maximises asset value, and transforms the device lifecycle for both consumers and operators.”

With this program, Basatne MENA and Likewize are setting a new benchmark for telecom innovation in the region, one that blends sustainability, digitisation, and consumer empowerment. ‘Upgrade & Protect’ is not just a service; it represents a shift in how the region thinks about technology ownership and circular value creation.

About Basatne

Basatne is a global leader in circular technology, sustainable trade solutions, and reverse logistics, dedicated to reshaping the future of commerce. Through proprietary platforms, advanced logistics, and strategic partnerships, Basatne extends product lifecycles, reduces environmental impact, and optimizes global supply chains. Operating across six continents, Basatne is committed to delivering smarter, more responsible trade solutions while driving innovation in the circular economy. For more information, visit www.basatne.com.

For media inquiries, please contact:
Nick Jankowski, CMO
nick@basatne.com or info@basatne.com
469-646-0949

SOURCE: Basatne

View the original press release on ACCESS Newswire

Celebrated for exceptional workplace culture and employee satisfaction

FAIRFAX, VA / ACCESS Newswire / June 23, 2025 / Chainbridge Solutions announced today it has been recognized as a 2025 Top Workplaces by The Washington Post, based on independently gathered feedback from current Chainbridge employees. The honor was announced at The Washington Post’s 2025 Top Workplaces Awards Ceremony, held June 18 in Washington, D.C.

“We are deeply honored to be named a Top Workplace for 2025,” said Aarti Smith, Founder and CEO of Chainbridge Solutions. “This award is incredibly meaningful because it comes directly from our team. It reflects the culture we’ve worked hard to build and maintain – one rooted in respect, flexibility, and a shared belief that people do their best work when they feel supported and seen. I’m proud of what we’ve built together.”

The survey measures key culture drivers that are critical to organizational success, including alignment, execution, connection, and employee well-being – celebrating companies that prioritize their people and foster a culture of excellence, purpose, and support.

“Here, we are committed to ensuring a safe and collaborative environment that fosters communication, encourages autonomy, and lays the foundation for a successful and fulfilling employee experience,” said Monica Janik, Director of Human Resources at Chainbridge Solutions.

Chainbridge Solutions was founded in 2010 and has since grown into a team of over 100 professionals. Now in its 15th year, the company remains focused on creating an environment where mission and culture go hand in hand.

To learn more about life at Chainbridge, careers, and workplace benefits, visit the company’s career site: https://chainbridgesolutions.com/careers/#life

SOURCE: Chainbridge Solutions

View the original press release on ACCESS Newswire

PORTLAND, ME / ACCESS Newswire / June 23, 2025 / Luke’s Lobster, the Certified B Corp known for its best‑in‑class, traceable, and sustainable seafood, today announced closing on a minority growth equity financing led by Relentless Consumer Partners with participation from Whole Foods Market.

“Since day one, Luke’s has been laser‑focused on building transparent supply chains that deliver industry leading value to the harvesters, cut out middlemen, and offer premium seafood at the best price to our customers. Our vision is to become the world’s most trusted seafood company and this investment is a validation and accelerant towards achieving that mission,” said Luke Holden, founder & CEO of Luke’s Lobster. “Closing on this funding coming from such highly value-added investors provides significant financial resources as well as customer-facing expertise to continue growth in our restaurants, branded consumer packaged goods, and wholesale seafood lines of business.”

Relentless Consumer Partners, an investment firm specializing in brands who redefine the consumer experience, identified Luke’s Lobster as a leader in sustainably sourced seafood and consumer loyalty, with a substantial untapped opportunity for growth. “Luke’s checks every box: exceptional product quality, unwavering mission, and a passionate customer base,” noted John Burns, CEO at Relentless Consumer Partners. “We’re thrilled to help support Luke and the team in accelerating the next phase of growth without compromising the brand’s core values.”

For Whole Foods Market, participation in the investment round deepens the relationship with Luke’s Lobster, a longstanding supplier for the retailer who was awarded top honors in 2018 as Whole Foods Market’s Supplier of the Year, and sets the stage for Luke’s Lobster to continue the growth of their seafood business as a whole including across a variety of seafood species beyond lobster. “Our customers consistently look to Whole Foods Market for an unparalleled seafood selection that meets our rigorous standards for sustainability and quality, as well as our Seafood Code of Conduct,” said Jennifer Coccaro, Vice President of Meat & Seafood for Whole Foods Market. “We look forward to what’s next for Luke’s Lobster, and continuing our longstanding collaboration with a brand that is beloved by our stores and customers.”

The investment capital will expand Luke’s Lobster’s branded consumer packaged goods product offerings and distribution footprint, support new restaurant openings around the country, and drive innovation and growth within the seafood industry as a whole.

Under the terms of the transaction, Luke’s current leadership team will maintain day‑to‑day operational control, while Relentless Consumer Partners and Whole Foods Market will provide strategic guidance and resources.

###

About Luke’s Lobster

Luke’s Lobster was born out of the dream of Maine native and third-generation lobsterman Luke Holden to bring the quality, affordable lobster rolls of his youth to NYC. After meeting his co-founder Ben Conniff on Craigslist, the two twenty-somethings, along with Luke’s dad, Jeff Holden, who is the very first licensed lobster processor in the state of Maine opened their first lobster shack in a 250 square foot space in NYC’s East Village in October 2009. Nearly 16 years later, the family business now includes Luke’s brothers Bryan and Mike.

In 2018, Luke’s furthered their growing seafood company’s commitment to sustainability and socially conscious business practices by becoming a certified B Corporation®, reflecting Luke’s Lobster’s deep devotion to each of its communities, its family of teammates, and the environment. Luke’s is now the highest scoring B Corp Certified seafood company in the US, and in 2024 was a recipient of Travel + Leisure’s Global Vision Award. Please visit www.lukeslobster.com for more information.

About Relentless Consumer Partners

Relentless acquires and invests in high-potential consumer brands, taking an active role in driving outsized shareholder returns. We have a relentless devotion to supporting entrepreneurs as they push the boundaries between passion and obsession, and we are fanatical about elevating products, services, and experiences that empower people to live better lives. For two decades we have partnered with extraordinary founders and teams to build brands that are redefining consumer experience across health, wellness, consumer healthcare, sports and fitness. For more information visit www.relentlessconsumer.com.

SOURCE: Luke’s Lobster

View the original press release on ACCESS Newswire

BUFFALO, NEW YORK / ACCESS Newswire / June 23, 2025 / ZeptoMetrix® is pleased to announce the launch of NATtrol™ Influenza A H5N1 Quantitative Stock, a groundbreaking advancement in molecular diagnostic quality assurance. Leveraging phage-like particle encapsulated RNA technology, this product sets a new standard for accuracy and reliability in avian influenza (H5N1) detection, addressing critical gaps in laboratories’ ability to validate end-to-end testing workflows.

As H5N1 outbreaks continue to rise globally, the need for robust quality control materials has never been greater. ZeptoMetrix’s Influenza A H5N1 Quantitative Stock offers laboratories a comprehensive quality control material that requires RNA extraction, unlike traditional naked RNA products. This novel solution includes three encapsulated H5N1 gene segments within a phage-like particle, ensuring realistic validation of extraction, amplification, and detection steps.

“The ongoing H5N1 pandemic highlighted the urgent need for reliable diagnostic tools,” said Dr. Karuna Sharma, PhD, Vice President & Chief Scientific Officer of Antylia Diagnostics division. “This launch represents a significant advancement in diagnostic quality control. By encapsulating RNA within a phage-like particle, we enable labs to have confidence in their results at every step. This is not just innovation; it is vital in the fight against H5N1 and other emerging RNA viruses.”

NATtrol Influenza A H5N1 Quantitative Stock (Product Code: 0831198) is NATtrol inactivated to enhance stability and provided with precision quantification at 1,000,000 gene copies/mL of each gene segment, verified by digital PCR (dPCR). The ready-to-use 1 mL format integrates seamlessly with ZeptoMetrix’s -STQ product line, streamlining workflow adoption.

More information on how to order and additional ZeptoMetrix products can be found at: www.zeptometrix.com

About ZeptoMetrix®

ZeptoMetrix, an Antylia Scientific company, is an established industry leader in the design, development, and delivery of innovative, quality solutions to the infectious disease diagnostics market. Our expertise and abilities in molecular diagnostics, including external quality controls, verification panels, proficiency panels, customized and OEM products/services, have set the industry standard for performance and reliability and make ZeptoMetrix the preferred choice for independent third-party quality control materials.

Product Page: https://www.zeptometrix.com/us/en/nattrol-influenza-a-h5n1-quantitative-stock-1-x-10-ml-15355

Contact Information

Andrew Zenger
Global Product Manager
andrew.zenger@antylia.com
(716) 715-7417

SOURCE: ZeptoMetrix

View the original press release on ACCESS Newswire

RALEIGH, NC / ACCESS Newswire / June 23, 2025 / iAccess Alpha’s Virtual Best Ideas Summer Investment Conference will take place on June 24-25, 2025, bringing together top micro-cap companies and investors for two days of high-quality insights and investing opportunities. The lineup has recently been updated to include additional presenters.

The event begins on Tuesday, June 24, 2025, with a series of live-streamed company presentations, beginning at 9:00 AM ET. The following day, Wednesday, June 25, will be dedicated to 1×1 meetings between presenting companies and investors, starting at 8:00 AM ET.

How to Attend:

Investors and industry professionals can register to watch the presentations and request 1×1 meetings by visiting the official event website: Register Here

Conference Schedule – June 24, 2025 (All Times ET):

Time	Company	Ticker	Webcast Link
9:00am	Inuvo Inc.	NYSE/AMEX:INUV	View Presentation
9:30am	Digi Power X Inc.	NASDAQ:DGXX /TSXV:DGX	View Presentation
10:00am	Surgepays Inc.	NASDAQ:SURG	View Presentation
10:30am	Coya Therapeutics Inc.	NASDAQ:COYA	View Presentation
11:00am	MIND Technoloy Inc.	NASDAQ:MIND	View Presentation
11:30am	Data IO Corp.	NASDAQ:DAIO	View Presentation
12:00pm	Gaia Inc.	NASDAQ:GAIA	View Presentation
12:30pm	Upexi Inc.	NASDAQ:UPXI	View Presentation
1:00pm	DocGo Inc.	NASDAQ:DCGO	View Presentation
1:30pm	SKYX Platforms Corp.	NASDAQ:SKYX	View Presentation
2:00pm	HeartBeam Inc.	NASDAQ:BEAT	View Presentation
2:30pm	Heritage Global Inc.	NASDAQ:HGBL	View Presentation
3:00pm	Mobilicom Ltd.	NASDAQ:MOB	View Presentation
3:30pm	Envela Corp.	NYSE/AMEX:ELA	View Presentation

About iAccess Alpha’s Virtual Best Ideas Investment Conferences

iAccess Alpha hosts four virtual investment conferences annually (March, June, September, and December), showcasing high-potential small and micro-cap investment opportunities. The conferences feature live company presentations on Day 1, followed by exclusive 1×1 investor meetings on Day 2. Since 2019, iAccess Alpha has co-organized leading microcap-focused events, connecting top-tier investors with high-potential companies.

For more information, contact:
info@iaccessalpha.com
www.iaccessalpha.com

SOURCE: iAccess Alpha

View the original press release on ACCESS Newswire

Enrollment in company’s first-of-its-kind placebo-controlled Phase 2 study to evaluate the efficacy of crofelemer for microvillus inclusion disease (MVID) in pediatric patients has reached approximately 25%

As recently announced, initial proof-of-concept results of the ongoing investigator-initiated trial (IIT) show crofelemer reduced the required total parenteral nutrition in patients with intestinal failure due to MVID and short bowel syndrome by up to 27% and 12.5% respectively; data from the third patient enrolled is expected

Company strategy: Seek business development partnerships for license to develop and commercialize Jaguar’s intestinal failure products, resulting in non-dilutive funding for Jaguar

SAN FRANCISCO, CA / ACCESS Newswire / June 23, 2025 / Jaguar Health, Inc.(NASDAQ:JAGX) (Jaguar) today provided updates on the company’s orphan disease intestinal failure program. Jaguar, through Jaguar family companies Napo Pharmaceuticals (Napo) and Napo Therapeutics, is currently supporting two independent proof-of-concept investigator-initiated trials (IITs), and conducting two placebo-controlled Phase 2 studies, of crofelemer, Jaguar’s novel plant-based anti-secretory prescription drug, in patients with intestinal failure due to microvillus inclusion disease (MVID) and short bowel syndrome (SBS-IF) in the United States, European Union, and/or Middle East/North Africa regions.

As announced, and as presented April 26, 2025 at the Annual ELITE PED-GI Congress, initial proof-of-concept results from the ongoing exploratory, single-arm open label non-randomized IIT of crofelemer in Abu Dhabi in pediatric intestinal failure patients show that crofelemer reduced the required total parenteral nutrition (TPN) and supplementary intravenous fluids in the first participating MVID patient by up to 27% and in the first participating SBS-IF patient by up to 12.5%. In addition, this data showed that crofelemer reduced stool volume output and/or frequency of watery stools, and increased urine output – an indicator of improved nutrient oral absorption. Data from the third patient enrolled in the IIT is expected.

Completion of Napo’s randomized double-blind, placebo-controlled Phase 2 study of crofelemer in pediatric MVID patients is expected in mid-2026 as planned.

“Our strategy is to seek business development partnerships for license rights for development and commercialization of Jaguar’s intestinal failure products – with the goal of generating non-dilutive funding for Jaguar,” said Lisa Conte, Jaguar’s Founder and CEO. “I attended the BIO International Convention in Boston last week and took part in productive meetings at the event.”

“Given the ultrarare nature of MVID, and the groundbreaking initial proof-of-concept results from the ongoing IIT in Abu Dhabi, even a small number of MVID patients showing benefit with crofelemer may allow Napo to explore pathways for expedited regulatory approval,” said Conte.

“We’re excited to report that enrollment in the company’s first-of-its-kind placebo-controlled Phase 2 study to evaluate the efficacy of crofelemer for MVID in pediatric patients is at approximately 25% and patient screening is continuing. For the company’s placebo-controlled Phase 2 study to evaluate the efficacy of crofelemer for SBS-IF in adults, enrollment is above 10%, and patient screening is continuing,” said Conte. “Additionally, enrollment is continuing in the two ongoing proof-of-concept IITs. These are important milestones in development efforts for crofelemer for the treatment and management of intestinal failure related to these devastating orphan diseases and will continue to generate IIT data.”

Based on the initial findings of the ongoing IIT in Abu Dhabi, crofelemer’s paradigm-shifting antisecretory mechanism of action appears to have the potential to provide a novel therapeutic option to reduce TPN and associated complications, including liver, renal, and cognitive deficits, as well as infections from IV infusion, in patients with intestinal failure due to MVID and short bowel syndrome. The observed groundbreaking TPN reduction is particularly compelling for MVID, an ultrarare pediatric disease characterized by severe diarrhea and malabsorption that requires intensive parenteral support for nutritional and fluid management and for which no approved drug treatments exist, or any potential approach to reduce TPN.

The initial proof-of-concept data in MVID supports crofelemer’s potential inclusion in the European Medicines Agency’s (EMA) PRIMEprogram that may accelerate regulatory approval pathways in the EU. This data may also support qualification of crofelemer for the FDA’s Breakthrough Therapyprogram for expedited regulatory approval in the US. Additional proof-of-concept results from IITs are expected throughout 2025 and will provide additional preliminary data on the safety and potential effectiveness of crofelemer for these highly unmet clinical needs. In accordance with the guidelines of specific EU countries, published data from clinical investigations in MVID and SBS-IF could support reimbursed early patient access to crofelemer for these debilitating conditions.

About Crofelemer
Crofelemer is a novel, oral plant-based prescription medicine purified from the red bark sap, also referred to as “dragon’s blood,” of the Croton lechleri tree in the Amazon Rainforest. Napo Pharmaceuticals has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for indigenous communities.

About the Jaguar Health Family of Companies
Jaguar Health, Inc. (Jaguar) 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 gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar’s Entheogen Therapeutics Initiative(ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.

For more information about:
Jaguar Health, visit https://jaguar.health/
Napo Pharmaceuticals, visit www.napopharma.com
Napo Therapeutics, visit napotherapeutics.com
Magdalena Biosciences, visit magdalenabiosciences.com

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Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements.” These include statements regarding Jaguar’s expectation that completion of Napo’s Phase 2 study of crofelemer in pediatric MVID patients will occur mid-2026, Jaguar’s expectation that the two ongoing proof-of-concept IITs will continue to generate data, Jaguar’s expectation that data from the third patient enrolled in the IIT in Abu Dhabi is expected, Jaguar’s expectation that its strategy of seeking business development partnerships for license rights for development and commercialization of Jaguar’s intestinal failure products may support generation of non-dilutive funding for Jaguar, Jaguar’s expectation that even a small number of MVID patients showing benefit with crofelemer may allow Napo to explore pathways for expedited regulatory approval of crofelemer for MVID, Jaguar’s expectation that crofelemer’s mechanism of action may have the potential to provide a novel therapeutic option to reduce TPN and associated complications, including liver, renal, and cognitive deficits, as well as infections from IV infusion, in pediatric MVID and SBS-IF patients, Jaguar’s expectation that proof-of-concept data in MVID may support crofelemer’s potential inclusion in the EMA’s PRIME program for expediated and assisted regulatory approval and in the FDA’s Breakthrough Therapy program for expedited regulatory approval in the US, Jaguar’s expectation that additional proof-of-concept results from IITs will be available throughout 2025, and Jaguar’s expectation that published data from clinical investigations in MVID and SBS-IF could support reimbursed early patient access to crofelemer for MVID and SBS-IF. 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 release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar’s control. Except as required by applicable law, Jaguar does 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.

Contact:
hello@jaguar.health
Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

View the original press release on ACCESS Newswire