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): November 17, 2020

AzurRx BioPharma, Inc.

(Exact Name of Registrant as Specified in Charter)

Delaware	021-214723	46-4993860
(State or Other Jurisdiction<br><br><br>of Incorporation)	(Commission<br><br><br>File Number)	(I.R.S. Employer<br><br><br>Identification No.)

760 Parkside Avenue

Downstate Biotechnology Incubator, Suite 304

Brooklyn, New York 11226

(Address of Principal Executive Offices, and Zip Code)

(646) 699-7855

Registrant’s Telephone Number, Including Area Code

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 (see General Instruction A.2. below):

[  ]

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<br>Stock, par value $0.0001 per share	AZRX	Nasdaq<br>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 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter).

Emerging growth company [X]

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 3.01 Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.

As previously reported, on August 21, 2020, AzurRx BioPharma, Inc. (the “Company”) received a letter from the Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market LLC, notifying the Company that it was not in compliance with Listing Rule 5550(b)(1) based on a deficit in stockholders’ equity reported as of June 30, 2020.

On November 17, 2020, the Company received a follow up letter from the Staff, notifying the Company that it has regained compliance with Nasdaq Listing Rule 5550(b)(1) based on its Form 10-Q filed November 16, 2020, which reported stockholders’ equity of approximately $14.1 million as of September 30, 2020.

Accordingly, the Staff has determined that the matter is now closed.

Item 8.01 Other Events.

On November 17, 2020, the Company announced that it will be submitting a protocol amendment request to the U.S. Food and Drug Administration for its Phase 2b OPTION 2 trial of MS1819 for the treatment of exocrine pancreatic insufficiency in patients with cystic fibrosis. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated by reference herein.

Exhibit Index

Exhibit No.	Description
EX-99.1	Press Release issued by the Company, dated November<br>17, 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.

November<br>17, 2020	AzurRx BioPharma, Inc.<br><br><br><br><br><br>By:<br>/s/ James<br>Sapirstein<br><br><br>Name: <br>James Sapirstein<br><br><br>Title:   <br>President and Chief Executive Officer

ex99-1

Exhibit 99.1

AzurRx BioPharma Requests Protocol Amendment to Phase 2b OPTION 2 Study of MS1819 in Cystic Fibrosis Patients

Potential to add additional study arm utilizing immediate release capsules

Trial objectives, endpoints and statistical analysis to remain the same

DELRAY BEACH, Florida, Nov. 17, 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 that it will be submitting a protocol amendment request to the U.S. Food and Drug Administration (FDA) for its Phase 2b OPTION 2 trial of MS1819 for the treatment of exocrine pancreatic insufficiency in patients with cystic fibrosis.  The proposed amendment will add a study arm that uses an immediate release MS1819 capsule, allowing the Company to compare data from the existing arm that uses enteric (delayed release) capsules with data from the new arm, and ultimately select the optimal delivery method.

“We are pleased to announce that our OPTION 2 trial is well ahead of schedule and almost fully enrolled without any safety issues being observed,” said Dr. James Pennington, Chief Medical Officer of AzurRx. “As this trial progresses, we believe there may be significant clinical value in adding a study arm that uses our immediate release capsules. Our intention is to identify the optimal delivery method and potentially provide additional scientific support and optionality for MS1819.”

Dr. Pennington added, “The key objectives of any Phase 2 program are to test for safety and efficacy, but another important goal is to determine appropriate doses and drug delivery method prior to entering the Phase 3 portion of the clinical program. If the amendment is accepted by the FDA, we anticipate enrollment into the new study arm to begin in December 2020.”

James Sapirstein, CEO of AzurRx commented, “The protocol amendment represents an opportunity to gain valuable additional clinical data with no significant increase in overall trial costs or delays to our timeline projections. We remain on target to release top line data in the first quarter of 2021, as has been our guidance to date.”

About AzurRx BioPharma, Inc.

AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a biopharmaceutical company specialized in the research and development of non-systemic biologics for gastrointestinal disorders. The Company is focused on the development of its lead drug candidate, MS1819. AzurRx is currently conducting two Phase 2 clinical trials of MS1819: the OPTION 2 monotherapy trial, and the Combination therapy trial, consisting of MS1819 in conjunction with porcine-derived pancreatic enzyme replacement therapy, the current standard of care. The Company is headquartered in Delray Beach, Florida with clinical operations in Hayward, California. Additional information on the Company can be found at www.azurrx.com.

Forward-Looking Statements

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, including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial such as the interim results presented will be indicative of the final results of the trial. 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, the results of its clinical trials, and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations and current and planned clinical trials, including, but not limited to delays in clinical trial recruitment and participation are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 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 327F

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