See Item 9.01.

Item 9.01. Other Events.

On July 8, 2019, AzurRx BioPharma, Inc. (the “Company”) issued a press release announcing that it has initiated a Phase 2 clinical trial to investigate MS1819-SD, the Company’s lead product candidate, as a potential combination treatment with standard porcine enzyme replacement therapy for patients with cystic fibrosis suffering from severe exocrine pancreatic insufficiency. A copy of the press release is attached hereto as Exhibit 99.1.

The Company also announced that members of its management team will host an R&D update call on July 8, 2019 at 4:30 pm ET. A copy of the presentation utilized during the R&D update call is attached hereto as Exhibit 99.2.

The information in this Item 9.01 of this Current Report onForm8-K,including the information set forth in Exhibits99.1 and 99.2, is being furnished and shall not be deemed “filed” for purposes of Section18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall Exhibits 99.1 or 99.2 filed herewith be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

In addition, this Current Report on Form 8-K and the exhibit(s) 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.

Item 9.01.Financial Statements and Exhibits.

See Exhibit Index.

AzurRx BioPharma, Inc. Exhibit
EX-99.1 2 ex99-1.htm PRESS RELEASE ex99-1   Exhibit 99.1      AzurRx BioPharma Announces Initiation of Phase 2 Clinical Study for MS1819-SD in combination with standard PERT for Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency     ● Dose escalation study of MS1819-SD in combination with standard porcine pancreatic enzyme replacement therapy (PERT) in CF patients with severe exocrine pancreatic insufficiency (EPI).   ● Patients in study have persistent malnutrition and clinical symptoms of fat malabsorption despite being on the maximum daily doses of PERTs.   ● First patient visits have been completed in Hungary.   ● Preliminary data expected in early 2020.   ● MS1819 R&D Update webcast call scheduled for Monday,…
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About AZURRX BIOPHARMA, INC. (NASDAQ:AZRX)

AzurRx BioPharma, Inc. is a clinical development-stage biopharmaceutical company. The Company is engaged in the research and development of non-systemic biologics for the treatment of patients with gastrointestinal (GI) disorders. The Company’s product pipeline consists of two therapeutic proteins, such as MS1819 and AZX1101. MS1819 is an acid-resistant secreted lipase produced by Yarrowia lipolytica, known as LIP2, that the Company is developing through recombinant deoxyribonucleic acid (DNA) technology for the treatment of exocrine pancreatic insufficiency (EPI), associated with chronic pancreatitis (CP) and cystic fibrosis (CF). AZX1101 is a recombinant-lactamase combination of bacterial origin under development for the prevention of hospital-acquired infections by resistant bacterial strains induced by parenteral administration of b-lactam antibiotics (known as nosocomial infections), as well as the prevention of antibiotic-associated diarrhea (AAD).