Jaguar Health Provides Replay Link & High-level Overview of January 14th Investor Webcast
To access the audio recording and slides from the webcast, click here.
"Due to the unprecedented volume of participants for yesterday's webcast, a number of parties were unable to join the live event," stated
Key points from Jaguar's
- The Company is prioritizing plans to explore the possibility of obtaining conditional marketing authorization in
Europeto support development and commercialization of crofelemer, the Company's novel proprietary drug, for the proposed indication of prophylaxis and/or symptomatic relief of inflammatory diarrhea, initially to be studied in a "long-hauler" COVID-19 recovery patient population in Europe. The Company believes there is an urgent need to address patients who have been infected with coronavirus and their "long-hauler" symptoms, and that the urgency of this need is being heightened by the recent detection of mutated, more transmissible strains of the virus. The Company is expending resources with international regulatory experts to prepare a regulatory package for the European Medicines Agency(EMA), Swissmedic, and the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdomas part of the Company's efforts to put a plan in place to pursue conditional approval for this potential COVID-related indication for crofelemer.
- As also announced
January 13, 2021, Jaguar has entered into a securities purchase agreement with institutional investors including a high-net-worth family office for the purchase and sale of 4,437,870 shares of common stock at a purchase price of $3.38per share for gross proceeds of approximately $15.0 millionin a registered direct offering priced above-the-market under Nasdaq rules.
- The Company views crofelemer as a pipeline within a product, and believes that each potential crofelemer follow-on indication under development - including cancer therapy-related diarrhea, irritable bowel syndrome, functional diarrhea, inflammatory bowel disease, and rare disorders such as short bowel syndrome and congenital diarrheal disorders - represents ‘another shot on goal' for the Company for a pharmaceutical agent that has already demonstrated safety for chronic use in its approved indication in adult patients with HIV/AIDS on antiretroviral therapy and for which a fully operational global manufacturing supply chain exists.
- As also announced
January 13, 2021, Jaguar has entered a binding agreement of terms for $6.0 millionbacked by a partial right to proceeds from the sale of a possible tropical disease priority review voucher that Jaguar's wholly owned subsidiary, Napo Pharmaceuticals, Inc.("Napo") plans to pursue as incentive for the development of Napo's lechlemer drug product candidate for the indication of the symptomatic relief of diarrhea in cholera patients.
- Napo EU: The potential COVID-related indication for crofelemer is the subject of the proposed exclusive license from Jaguar's
U.S.-based Napo Pharmaceuticalssubsidiary to Napo EU, a subsidiary being established by the Company in Italy. Napo EU is the proposed target of a special purpose acquisition company (SPAC) in Europe, where target companies can be named. The timeline to incorporate Napo EU in Italyis being impacted by pandemic-necessitated reductions in administrative and government office operating hours and staffing, and, in some cases, administrative and government office closures. With a process that started in 2020, Napo EU is expected to be established in Italyin the next weeks, not months.
- The Company believes its plans to pursue conditional marketing authorization in
Europefor the COVID-related indication may add additional value to such indication, which is the subject of a proposed license to Napo EU. Napo EU will have an exclusive license for Europe(excluding Russia) for crofelemer, the Company's novel proprietary drug, and obligations to develop crofelemer for the indications of inflammatory diarrhea and HIV-related diarrhea.
- The Company completed a ‘test the waters' roadshow in December with approximately 150 European institutional investors in four countries/six cities. More than one potential
SPACsponsor has expressed interest in the potential Napo EU target. The Company expects to select its desired financing pathway for the proposed Napo EU crofelemer indications no later than the end of this quarter, including, hopefully, from an informed and value-enhanced position based on interaction with the EMA regarding a conditional approval pathway.
Mytesi® (crofelemer delayed release tablets), the only oral plant-based prescription medicine approved under FDA Botanical Guidance, is a novel, first-in-class anti-secretory agent which has a basic normalizing effect locally on the gut, and this mechanism of action has the potential to benefit multiple disorders. Mytesi is a non-opiate chloride ion channel modulating antidiarrheal medicine that is approved in the
Mytesi® (crofelemer delayed release tablets) 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%).
More information and complete Prescribing Information are available 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.
Certain statements in this press release constitute "forward-looking statements." These include statements regarding the possibility of obtaining conditional marketing authorization in