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An Undervalued Pharma Stock : Jaguar Health (JAGX)

|Includes: Jaguar Health, Inc. (JAGX), KHTRF, PBYI, RHHBY
Summary

The company shares went to IPO and traded above 105$ in early 2015 and now JAGX trades below 25 cents a share.

Jaguar Health has a strong pipeline and high growth potential.

Revenue-Generating Biopharma With an FDA-Approved Drug.

On September 24, 2018, Jaguar signed a Distribution, License and Supply Agreement with Knight Therapeutics Inc.

The company is in a pre-IND phase for Cholera (hydration maintenance) PRV (Lechlemer) and may support efforts to receive Priority Review Voucher from US FDA. Priority Review Vouchers are transferable and may fetch between $67million - $350million.

Jaguar Health, Inc., a commercial stage natural-products pharmaceuticals company, focuses on developing gastrointestinal products for human prescription use and animals worldwide. Jaguar Health, Inc. is headquartered in San Francisco, California. The company, through its wholly-owned subsidiary, Napo Pharmaceuticals, Inc., focuses on developing and commercializing proprietary human gastrointestinal pharmaceuticals for the global marketplace from plants used traditionally in rainforest areas. It has Mytesi which is an antidiarrheal indicated for symptomatic relief of noninfectious diarrhea in adult patients with human immunodeficiency virus HIV/acquired immune deficiency syndrome (AIDS) on antiretroviral therapy.Its other products includes Canalevia, Equilevia, Neonorm Calf, and Neonorm Foal.

Investment Highlights :

  1. Mytesi: FDA Approved Human Drug 
  • Only FDA-approved diarrhea treatment that’s been studied specifically in adults with HIV / AIDS
  • Extensive global rights
  • Commercial manufacturing in place
  • Approved with chronic safety/locally acting in gut

2.  Broad Human Product Pipeline

  • Potential multiple follow-on human indications of Mytesi with potential blockbuster market and patient opportunity
  • Clinical trials include Phase 1 and Phase 2 data

3. Priority Review Voucher

  • Potential opportunities for non-dilutive funding
  • Current market values of PRVs may exceed the current market value of JAGX

4. Strong Management Team

  • Key management has been with the company for >15 years
  • Chairman of board and key investors have invested for >25 years
  • Original discoverer and developer of successful FDA-approved first-in-class anti-secretory agent, crofelemer – only oral product approved under botanical guidance

5. Proprietary Position

  • Company patents issued through present: About 140 (majority do not expire until 2027 - 2031)
  • Patent applications pending: About 40 (human health)
  • Botanical guidance protection. Unique botanical sourcing infrastructure
  • Orphan-drug designation

6. Risk-Mitigated Product Development

  • Safety to support approved chronic administration
  • Already FDA approved commercial manufacturing facility for crofelemer
  • KOL, protocol generation and possible SPA approach to help mitigate regulatory risk
  • Safe and well tolerated with no SAEs reported through present

Upcoming Milestones:

  • Q1 2019: Interim IIT results for CTD
  • Q1 2019: First shipment of Equilevia
  • Q1 2019: Meet FDA for CTD pivotal protocol agreement
  • April 2019: File Q4 2018 earnings report as part of 2018 10-K on or before April 1 deadline
  • Q2 2019: Complete filing of Canalevia NADA for CID in dogs
  • Mid-May 2019: File Q1 2019 earnings report
  • Mid-2019: File IND and initiate CDD IIT in Abu Dhabi
  • H1 2019: File IND for CTD supplemental indication
  • Mid-August 2019: File Q2 2019 earnings report
  • H1 & H2 2019: Additional business development deals (non dilutive financing)
  • H2 2019: File IND for lechlemer/cholera (subject to funding)
  • Mid-November 2019: File Q3 2019 earnings report

(Courtesy of this information : Jaguar Health Presentation at NobleCon: January 28, 2019 and jaguar.health website)

Look at the slide for the Pipeline in Products

Disclosure: I am/we are long JAGX.

Additional disclosure: Investment is subject to market risks. Please do enough due diligence before investing.