Item 1.01 Entry into a Definitive Material Agreement.

License Agreement with First Wave Bio, Inc.

On December 31, 2020, AzurRx BioPharma, Inc. (the "Company") entered into a License Agreement (the "License Agreement") with First Wave Bio, Inc. ("First Wave"), a privately-held Delaware corporation. Pursuant to the License Agreement, First Wave granted the Company a worldwide, exclusive right to develop, manufacture, and commercialize First Wave's proprietary immediate release and enema formulations of niclosamide for the fields of treating Immune Checkpoint Inhibitor-Associated Colitis ("ICI-AC") and Severe Acute Respiratory Syndrome Coronavirus 2 ("COVID") gastrointestinal infections ("GI") in humans (the "Product"). The Product uses First Wave's proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor. The Company plans to commence in 2021 both a Phase 2 trial of the Product for COVID in GI and a Phase 1b/2a trial for ICI-AC.

In consideration of the license and other rights granted by First Wave, AzurRx will pay First Wave a $9.0 million upfront cash payment and an additional payment of $1.25 million due on June 30, 2021. In addition, AzurRx is obligated to pay potential milestone payments to First Wave totaling up to $37.0 million for each indication, based upon the achievement of specified development and regulatory milestones. The Company is also obligated to pay First Wave royalties as a mid-single digit percentage of net sales of the Product, subject to specified reductions. The Company is also obligated to issue to First Wave junior convertible preferred stock, initially convertible into $3.0 million worth of common stock, par value $0.0001 per share (the "Common Stock") of the Company, based upon the volume weighted average price of the Common Stock for the five-day period immediately preceding the date of the License Agreement, or $0.9118 per share. The preferred stock will convert automatically into Common Stock upon the Stockholder Approval (as defined and further described below). The purchase agreement pursuant to which the preferred stock is issued will contain customary demand and piggyback registration rights with respect to the Common Stock issuable upon conversion.

The Company is now solely responsible, and has agreed to use commercially reasonable efforts, for all development, regulatory and commercial activities related to the Products in the ICI-AC and COVID fields. The Company may sublicense its rights under the License Agreement and, if it does so, will be obligated to pay milestone payments and royalties to First Wave based on the sublicensee's development and commercialization of the Licensed Products.

Pursuant to the License Agreement, First Wave retains rights to develop and commercialize the licensed niclosamide formulations outside the ICI-AC and COVID fields, and to develop and commercialize other niclosamide formulations that are not licensed to Company. However, if prior to April 30, 2021, First Wave seeks to outlicense, sell to or otherwise grant rights to a third party related to any products containing niclosamide for use outside the ICI-AC or COVID fields to develop or commercialize a product containing niclosamide for use outside of the Field then First Wave shall provide to AzurRx written notice of such proposal, in reasonable detail and AzurRx shall have the right and option to negotiate with First Wave with respect to a definitive agreement for the acquisition of First Wave. Pursuant to the License Agreement, the Company grants First Wave a worldwide, non-exclusive, royalty-free, perpetual, irrevocable license for use outside the ICI-AC and COVID fields, with the right to grant sublicenses, under any Program IP and other intellectual property owned by the Company and incorporated into the Product.

The License Agreement terminates on a country-by-country basis and product-by-product basis upon the expiration of the royalty term for such product in such country. Each royalty term begins on the date of the first commercial sale of the licensed product in the applicable country and ends on date of expiration of the last to expire royalty term with respect to the country. The License Agreement may be terminated earlier in specified situations, including termination for uncured material breach of the License Agreement by either party, termination by AzurRx in specified circumstances, termination by First Wave in specified circumstances, termination by AzurRx for convenience with advance notice, and termination upon a party's insolvency or bankruptcy. After expiration of the royalty term, AzurRx shall have a non-exclusive, fully-paid, perpetual, royalty-free right and irrevocable license with respect to any Product in any country within the Territory.

In certain circumstances set forth in the License Agreement, in the event that First Wave seeks to outlicense, sell or otherwise grant to a third party rights relating to its proprietary formulations of niclosamide (or any products containing niclosamide) for use outside the ICI-AC and the COVID field, then First Wave must provide the Company written notice and engage in good faith negotiations with the Company for a period of time to try to reach agreement on the terms of an acquisition of First Wave by the Company. In the event that First Wave and the Company fail to reach an agreement, then First Wave shall be free to negotiate a transaction, and the right of first refusal shall be of no further force or effect.

The License Agreement also contains customary representations, warranties and covenants by both parties, as well as customary provisions relating to indemnification, confidentiality and other matters.

A copy of the License Agreement will be filed as an exhibit in an amendment to this Current Report on Form 8-K or in a subsequent periodic report to be filed . . .

Item 3.02 Unregistered Sales of Equity Securities.

The information set forth above in Item 1.01 is hereby incorporated by reference into this Item 3.02. The issuance of the Series C Preferred Stock, the Warrants, and the Placement Agent Warrants and any related shares of Common Stock was made pursuant to Section 4(a)(2) of the Securities Act, and the rules promulgated thereunder, to accredited investors.

Item 7.01. Regulation FD Disclosure

Press Releases

On January 4, 2020, the Company issued press releases announcing the License Agreement and the Offerings. Copies of the press releases are furnished as Exhibits 99.1 and 99.2.

Conference Call Instructions

On Monday, January 4, 2021 at 8:30 a.m. Eastern Time, the Company's management team will host a conference call and live audio webcast relating to the License Agreement described herein.

Interested participants and investors may access this conference call by dialing 877-407-0784 (domestic) or 201-689-8560 (international) fifteen minutes before the conference call begins and reference the conference passcode 13714501. The live conference call can be accessed via audio webcast at http://public.viavid.com/index.php?id=142841.

A replay of the call will be available on the "Investor Relations" section of the Company's website (www.azurrx.com).

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 Exchange Act, nor shall such information or Exhibits 99.1 or 99.2 be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.




Item 8.01. Other Events

Corporate Presentation

On December 31, 2020, the Company posted on its corporate website an updated copy of its corporate presentation, a copy of which is filed as Exhibit 99.3 to this Current Report on Form 8-K.

Item 9.01. Financial Statements and Exhibits.



  (d) Exhibits.



Exhibit No. Description

  4.1       Form of Pre-Funded Warrant
  4.2       Form of Private Placement Warrant
  10.1      Form of Purchase Agreement
  10.2      Form of Registration Rights Agreement
  99.1      Press Release dated January 4, 2021
  99.2      Press Release dated January 4, 2021
  99.3      Corporate Presentation

IMPORTANT ADDITIONAL INFORMATION WILL BE FILED WITH THE SEC

The Company plans to file with the Securities and Exchange Commission (the "SEC") and mail to its stockholders a proxy statement in connection with the Stockholder Approval and the transactions described herein. The proxy statement will contain important information about the Company, the Offerings, the Stockholder Approval, and related matters. Investors and other security holders are urged to read the proxy statement carefully when it is available. Investors and other security holders will be able to obtain free copies of the proxy statement and other documents filed with the SEC by the Company through the SEC's website at www.sec.gov. In addition, Investors and other security holders will be able to obtain free copies of the proxy statement from the Company by contacting the Chief Financial Officer at (646) 699-7855.

The Company and its directors and executive officers may be deemed to be participants in the solicitation of proxies with respect to the Stockholder Approval. Additional information regarding interests of such participants is included in the Company's definitive proxy statement for its 2020 Annual Meeting of Stockholders, which was filed with the SEC on August 11, 2020.

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