Item 8.01     Other Events.

As previously disclosed, on April 2, 2020, Jaguar Health, Inc. (the “Company”) submitted a request to the U.S. Food and Drug Administration (“FDA”) pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (“FDCA”) for Emergency Use Authorization (“EUA”) for crofelemer (Mytesi®) for the symptomatic relief of diarrhea and other gastrointestinal symptoms in patients with COVID-19 and for patients with COVID-19 who have diarrhea associated with certain antiviral treatments. On April 7, 2020, the FDA notified the Company that it was declining to issue an EUA for crofelemer at this time based on its consideration of section 564 of the FDCA and prioritization factors for the review of EUA requests, including but not limited to the public health need for the product and the urgency of treatment need.

Notwithstanding the FDA’s response to the Company’s EUA request, the Company continues to be in discussions with the National Institute of Allergy and Infectious Diseases (“NIAID”) regarding NIAID’s potential evaluation of antiviral activity of crofelemer against SARS-CoV-2. Given crofelemer’s previous antiviral activity against other RNA viruses, the Company believes that crofelemer may reduce viral replication in the gastrotintestinal tract. This would reduce inflammation in the gut as well as mitigate fecal viral shedding, which could be a source of fecal-oral transmission.

This Current Report on Form 8-K contains “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, including statements related to NIAID’s potential evaluation of antiviral activity of crofelemer against SARS-CoV-2 and the Company’s belief that crofelemer may reduce viral replication in the gastrointestinal tract. The words “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.  While the Company believes its plans, intentions and expectations reflected in those forward-looking statements are reasonable, these plans, intentions or expectations may not be achieved. The Company’s actual results, performance or achievements could differ materially from those contemplated, expressed or implied by the forward-looking statements. For information about the factors that could cause such differences, please refer to the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, including the information discussed under the captions “Item 1 Business,” “Item 1A. Risk Factors” and “Item 7 Management’s Discussion and Analysis of Financial Condition and Results of Operations,” as well as the Company’s various other filings with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The Company assumes no obligation to update any forward-looking statement.