8-K

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): May 29, 2018

AZURRX BIOPHARMA, INC.

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))

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 5.02

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

             On May 29, 2018, AzurRx BioPharma, Inc. (the “Company”) appointed Dr. James E. Pennington to serve as the Company’s Chief Medical Officer. A copy of the press release announcing Dr. Pennington’s appointment is attached to this Current Report on Form 8-K as Exhibit 99.1

Dr. Pennington, age 75, has over 30 years of experience in the pharmaceutical industry. Prior to joining the Company, Dr. Pennington served as Senior Clinical Fellow from 2010 to 2018 and Executive Vice President and Chief Medical Officer from 2007 to 2010 at Anthera Pharmaceuticals, Inc. (NASDAQ: ANTH). From 2004 to 2007, Dr. Pennington served as Executive Vice President and Chief Medical Officer at CoTherix, Inc., and has served in various executive positions at a number of other pharmaceutical companies, including InterMune Inc., Shaman Pharmaceuticals and Bayer Corporation. In addition, Dr. Pennington has sat on several editorial boards, and has authored numerous original research publications and reviews. Dr. Pennington is currently a Clinical Professor of Medicine with the University of California San Francisco, where he has taught since 1986. Prior to that, he was a professor at Harvard Medical School. Dr. Pennington received a Bachelor of Arts from the University of Oregon and a Doctor of Medicine from the University of Oregon School of Medicine, and is Board Certified in internal medicine and infectious diseases. 

Dr. Pennington has no direct or indirect material interest in any transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K, has no arrangement or understanding between him and any other person required to be disclosed pursuant to Item 401(b) of Regulation S-K, and has no family relationships required to be disclosed pursuant to Item 401(d) of Regulation S-K.

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: June 1, 2018	By:	/s/ Johan M. Spoor
		Name: Johan M. Spoor
		Title: Chief Executive Officer

Exhibit Index

Exhibit Number	Description
99.1	Press Release issued by AzurRx BioPharma, Inc., dated May 30, 2018

EX-99.1

 Exhibit 99.1

AzurRx Announces Appointment of Dr. James Pennington as Chief Medical Officer

NEW YORK, May 30, 2018 (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 the appointment of Dr. James Pennington as the Company’s Chief Medical Officer.

“We are delighted to welcome Jim to the senior management team as we rapidly advance our clinical programs,” commented Thijs Spoor, CEO of AzurRx BioPharma. “Jim is a highly accomplished pharmaceutical industry executive with extensive medical and clinical experience, as well as hands-on experience in regulatory affairs. His appointment is timely as 2018 is shaping up to be a pivotal year for AzurRx, with a number of upcoming and potentially value enhancing milestones including the initiation of the MS1819 Phase 2 study in cystic fibrosis patients and the filing of the investigational drug application (“IND”) in the U.S. for MS1819. We look forward to Jim’s leadership and contributions as these programs move forward.”

“I am excited to join the AzurRx team at this exciting time for the Company,” said Dr. Pennington, “We look forward to initiating a cystic fibrosis study later this year. MS1819, which has generated promising interim results in the ongoing study in chronic pancreatitis patients, addresses a billion-dollar market in exocrine pancreatic insufficiency. It has the potential to become best in class due to the high pill burden, patient compliance issues, and manufacturing/supply chain challenges of the current animal-derived therapies.”

Dr. Pennington brings over 30 years of experience in the pharmaceutical industry. He served as Vice President at Bayer Corporation where, under his direct supervision, Bayer received ten product approvals from the U.S. Food & Drug Administration (“FDA”) and ten product approvals from foreign regulatory authorities. Dr. Pennington also held senior positions at multiple therapeutics companies, including CMO roles at Anthera Pharmaceuticals and CoTherix Inc. and Senior VP of Research, Development and Clinical Affairs at Alpha Therapeutics Corp. Dr. Pennington has participated in many FDA pre-IND meetings and has also participated in several FDA Advisory Panel meetings. He has served on various editorial boards as well as professional societies, such as the American Association of the Advancement of Science. He is involved in academia and is currently Clinical Professor of Medicine at the University of California in San Francisco. Dr. Pennington holds a B.A. from the University of Oregon and an M.D. from the University of Oregon Medical School and is Board Certified in internal medicine and infectious diseases.

About AzurRx BioPharma, Inc.

AzurRx BioPharma aims to become a leader in developing non-systemic, recombinant protein therapies for the treatment of gastrointestinal diseases and infectious diseases. MS1819 recombinant lipase for exocrine pancreatic insufficiency is the Company’s lead development program, and additional early stage research is being conducted for the prevention of hospital-acquired infection. The Company is headquartered in New York, NY, with scientific operations based in Langlade, France.

Company website address: 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. Additional information concerning the Company and its business, including factors that potentially could materially affect the Company’s financial results, are contained in the Company’s 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