8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of report (Date of earliest event reported):  March 2, 2020

Commission File Number:  021-214723

AzurRx BioPharma, Inc.

(Exact name of registrant as specified in its charter.)

Delaware (State or other jurisdiction of incorporation or organization) 46-4993860 (IRS Employer Identification No.)

760 Parkside Ave., Suite 304, Brooklyn, New York 11226
(Address of principal executive offices)

646-699-7855
(Registrant's Telephone number)

Not Applicable
(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR 230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR 240.12b-2)

Emerging growth company [ ]

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [ ]

Securities registered pursuant to Section 12(b) of the Act:

Title of each class
Common Stock, par value $0.0001 per share Trading Symbol(s)
AZRX Name of exchange on which registered
Nasdaq Capital Market

Item 8.01 Other Events.

On March 2, 2020, AzurRx BioPharma, Inc. (the "Company") announced that it has benefited from certain tax credits applicable to French technology companies through its wholly-owned subsidiary, AzurRx SAS resulting in a credit of over 1 million Euros in the French Crédit d’impôt Recherche ("CIR"), a French tax credit aimed at stimulating research activities. A copy of the press release is attached hereto as Exhibit 99.1.

This Current Report on Form 8-K and the exhibit attached hereto may contain, among other things, certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, (i) statements with respect to the Company's plans, objectives, expectations and intentions; and (ii)other statements identified by words such as "may", "could", "would", "should", "believes", "expects", "anticipates", "estimates", "intends", "plans" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties.

Exhibit Index

Exhibit No.	Description
EX-99.1	Press Release issued by the Company, dated March 2, 2020.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	AzurRx BioPharma, Inc.
Date: March 2, 2020	By: /s/ Daniel Schneiderman
	Name: Daniel Schneiderman
	Title: Chief Financial Officer

EX-99.1

Exhibit 99.1

AzurRx BioPharma Receives $1.13 million in 2018 CIR (French Research Tax Credit)

●

CIR provides up to 30% in non-dilutive R& D tax relief to eligible research-based French companies

●

CIR offers significant source of support for on-going MS1819 Phase 2 clinical studies in Europe

NEW YORK, March 2, 2020 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ:AZRX) (“ AzurRx” or the “ Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced it has received over 1 million Euros in 2018 CIR (French Research Tax Credit) following the successful conclusion of an audit. The French R&D tax credit initiative (“ Crédit d’Impôt Recherche”, or CIR) gives eligible research-based French companies, which are subject to corporate tax in France, the ability to claim tax relief of up to 30% on costs incurred in R&D activities.

“ The 30% tax relief on R&D activities provides a significant non-dilutive funding source for our on-going research and clinical trial activities in France and Europe through our AzurRx SAS subsidiary,” said James Sapirstein, the CEO of AzurRx. “ The CIR allows the Company additional flexibility to hire top-tier research scientists in France and to fund our ongoing clinical trials such as our Phase 2 MS1819 studies in Chronic Pancreatitis and Cystic Fibrosis, and our AZX1103 pre-clinical development program. We are greatly appreciative of the French government’s continued support of AzurRx SAS.”

About CIR

The Research Tax Credit (CIR) is a tax incentive provided by the French Government to encourage the growth of businesses competitiveness by favoring research and development (R&D) and innovative activities. It is particularly adapted to the needs of small and medium-sized enterprises.

About MS1819

MS1819, supplied as an oral non-systemic biologic capsule, is a recombinant lipase enzyme that is derived from the yarrowia lipolytica lipase, and unlike the standard of care, does not contain any animal products.

About Exocrine Pancreatic Insufficiency

Exocrine Pancreatic Insufficiency (EPI) is a condition characterized by deficiency of the exocrine pancreatic enzymes, resulting in the inability to digest food properly, or maldigestion. This deficiency can be responsible for greasy diarrhea, fecal urge and weight loss.There are approximately 90,000 patients in the U.S. with EPI caused by chronic pancreatitis according to the National Pancreas Foundation, and more than 30,000 patients with EPI caused by CF according to the Cystic Fibrosis Foundation. The current therapeutic standard of care for these patients are porcine pancreatic enzyme replacement pills.

About AzurRx BioPharma, Inc. 

AzurRx BioPharma, Inc. (NASDAQ:AZRX) is engaged in the research and development of non-systemic biologics for the treatment of patients with gastrointestinal disorders. MS1819 recombinant lipase for EPI is the Company's lead development program, and additional early stage research is being conducted for the prevention of hospital-acquired infections. The Company is headquartered in Brooklyn, NY, with scientific operations based in Langlade, France. Additional information on the Company can be found at

This press release may contain certain statements relating to future results which are forward-looking statements. These statements are not historical facts, but instead represent only the Company’s belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company’s control. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results, including those related to the clinical development of MS1819 and final results of the Phase 2 OPTION study, are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

For more information:

AzurRx BioPharma, Inc.

760 Parkside Avenue, Suite 304

Brooklyn, NY 11226

Phone: (646)-699-7855

info@azurrx.com

Investor Relations contact: 

LifeSci Advisors, LLC. 

Hans Vitzthum, Managing Director 

1 International Place, Suite 1480

Boston, MA 02110

Phone: 617-430-7578

hans@lifesciadvisors.com

www.lifesciadvisors.com