Jaguar Health, Inc. Q2 FY2026 earnings call

• Strategic Transformation

  • Completed a transformative non-dilutive outlicense of U.S. commercial rights for Mitessi (FDA-approved Cofelomer for HIV/AIDS-related diarrhea) and Canalevia CA1 (conditionally approved Cofelomer for canine chemotherapy-induced diarrhea) to FuturePAC in January 2026.
  • The transaction delivered $18 million in total upfront non-dilutive capital ($16 million at closing, $2 million received in August 2026 after satisfying post-closing conditions), with up to an additional $17 million in future milestone payments. Jaguar remains the manufacturer of both products for FuturePAC at a profit.
  • The company has repositioned as a pure-play rare GI disease company, with 100% of human development efforts focused on its novel oral powder formulation of crofilomer for rare intestinal failure indications, which has orphan drug designation in the U.S. and Europe.

• Intestinal Failure Program Clinical Progress

  • Lead indication is pediatric microvillus inclusion disease (MVID), an ultra-rare lethal condition with no approved therapies, followed by the larger rare indication short bowel syndrome with intestinal failure (SBSIF).
  • Presented groundbreaking 12+ month clinical data at the June 2026 ESPGHAN meeting: an MVID patient saw a 48% reduction in weekly parenteral support (PS) requirements, and two SBSIF patients saw up to 40% PS reduction, with no crofilomer-related safety issues. All patients relapsed when taken off treatment per protocol, confirming efficacy.
  • An additional MVID infant treated via expanded access has seen meaningful PS reduction and is thriving after one year, a previously unheard of outcome for the lethal condition.
  • The pivotal randomized double-blind placebo-controlled trial for pediatric MVID is fully enrolled across U.S., Italian, and UAE sites, and all patients have been approved to enter a treatment-only extension phase after the blinded trial concludes. The Phase II trial for adult SBSIF is ongoing in Germany and Italy.

• Market Opportunity & Competitive Positioning

  • Third-party estimates value the global 2033 intestinal failure market at ~$8 billion for SBSIF and over $1 billion for MVID, with no competing products in development for MVID.
  • Crofilomer works via a unique first-in-class anti-secretory mechanism, compared to the only approved SBSIF therapy (GLP-2 growth hormone), which has limited efficacy (10-15% PS reduction), significant contraindications (cannot be used in ~30% of patients, including cancer patients), and cannot be used long-term. Crofilomer can be used chronically and alongside GLP-2.
  • Jaguar holds 185 issued patents, and crofilomer's FDA approval under botanical guidance creates de facto perpetual exclusivity with no practical generic pathway, eliminating the standard patent cliff.

• Animal Health Update

  • The company is preparing for imminent commercial launch of Neonorm Dog, a new non-prescription plant-based anti-secretory product to support normal stool consistency and GI balance in dogs. It will be sold through online and retail channels including Amazon and Chewy, leveraging existing veterinary relationships built for the previously owned Canalevia CA1.

Jaguar Health reports two core business segments: Human Rare Disease Drug Development and Commercial Products (Human Prescription + Animal Health).

• Human Prescription Products: Q2 2026 net revenue was $1.2 million, 60% lower than Q2 2025 ($2.9 million) and 2% lower than Q1 2026 ($1.2 million). The decline is due to the January 2026 outlicensing of Mitessi and Canalevia CA1 to FuturePAC; current revenue primarily consists of cost-plus product sales of Mitessi to FuturePAC. Additional Q2 2026 license revenue included $43,000 from a European partner agreement, plus $25,520 in federal grant revenue for canine chemotherapy-induced diarrhea clinical research. Total Q2 2026 revenue from this segment accounted for over 95% of the company's total current revenue.
• Animal Health: This segment currently contributes minimal reported revenue in Q2 2026, as the new non-prescription Neonorm Dog product is pending imminent commercial launch. The existing Neonorm franchise (for foals and calves) is small and not material to Q2 2026 results.

• Management expects to finalize the full clinical package for MVID NDA submission by the end of 2026, with NDA submission to the FDA planned for the second quarter of 2027.
• With breakthrough therapy designation, the company expects potential FDA approval for MVID in the U.S. by the end of 2027, with EMA approval in Europe expected to follow in 2028.
• NDA results from the SBSIF Phase II trial are expected to be available coincident with the MVID NDA submission in mid-2027, with SBSIF approval planned to follow MVID approval in subsequent years.
• Management is actively engaged in business development discussions for the intestinal failure program and expects to secure a transformative non-dilutive partnership deal aligned with the large market opportunity and mature clinical data the company holds.
• The imminent launch of Neonorm Dog will bring the first product of this new animal health franchise to market in the very near term.

• Forward-looking statements (including clinical, regulatory, and partnership expectations) are inherently uncertain, and actual results may differ materially from management projections due to risks including: failure of clinical trials to meet efficacy or safety endpoints, failure to obtain regulatory approval in expected timelines, lack of market acceptance for products, and competition from existing or new products.
• The company reported an operating loss of $7.6 million in Q2 2026 and a net loss attributable to common shareholders of $12.7 million, so it remains reliant on external non-dilutive or dilutive capital to fund the intestinal failure development program.
• Rare disease development for ultra-rare conditions like MVID relies on a very small patient population, which may create regulatory or reimbursement challenges despite the unmet medical need.
• The company's intestinal failure program is in late-stage development, and there is no guarantee that the FDA or EMA will approve the product on the projected timeline or at all.

There were no questions asked during this earnings call, as the presentation concluded before the Q&A portion was opened.