UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 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): July 8, 2019
AZURRX BIOPHARMA, INC.
(Exact name of Registrant as specified in its Charter)
| Delaware | 001-37853 | 46-4993860 |
(State or Other Jurisdiction of Incorporation or Organization) | (Commission File Number) | (I.R.S. Employer Identification No.) |
760 Parkside Avenue Downstate Biotechnology Incubator, Suite 304 Brooklyn, New York | | 11226 |
| (Address of principal executive offices) | | (Zip Code) |
Registrant’s telephone number, including area code:(646) 699-7855
(Name, address, including zip code, and telephone number, including area code, of agent for service of process)
NOT APPLICABLE
(Former Name or Former Address, if Changes Since Last Report)
Check the appropriate box below if the Form 8-K 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))
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| Common Stock, par value $0.0001 per share | AZRX | Nasdaq Capital Market |
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) ☒
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 ☐
Item 7.01 Regulation FD Disclosure.
See Item 7.01.
Item 8.01. 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 7.01 of this Current Report on Form 8-K, including the information set forth in Exhibits 99.1 and 99.2, is being furnished and shall not be deemed “filed” for purposes of Section 18 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.
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: July 8, 2019 | By: | /s/ Johan M. Spoor | |
| | | Name: Johan M. Spoor | |
| | | Title: Chief Executive Officer | |
Exhibit Index
| Exhibit Number | | Description |
| | |
| | Press Release, dated July 8, 2019 |
| | Corporate Presentation, date July 8, 2019 |
