FWBI First Wave BioPharma Inc

 

 

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): May 15, 2024

 

	Entero Therapeutics, Inc.
	(Exact name of registrant as specified in its charter)

 

Delaware		001-37853		46-4993860
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

 

777 Yamato Road, Suite 502 Boca Raton, Florida		33431
(Address of principal executive offices)		(Zip Code)

 

Registrant’s telephone number, including area code: (561) 589-7020

 

First Wave BioPharma, Inc.

(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:

 

¨	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		FWBI		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 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ¨

 

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 5.03

Amendments to Articles of Incorporation or Bylaws

 

On May 15, 2024, First Wave BioPharma, Inc. (the “Company”) filed an amendment to its Amended and Restated Certificate of Incorporation with the Secretary of State of Delaware to change its corporate name from "First Wave BioPharma, Inc." to "Entero Therapeutics, Inc." (the "Name Change Amendment"). Pursuant ot the Name Change Amendment, this name change is effective as of May 17, 2024. The Name Change Amendment is filed as Exhibit 3.1 to this Current Report on Form 8-K and incorporated herein by reference.

 

Item 7.01

Regulation FD Disclosure.

 

The information contained in Item 8.01 of this Current Report on Form 8-K is incorporated herein by reference.

 

Item 8.01

Other Events.

 

On May 16, 2024, the Company issued a press release announcing the Name Change Amendment (the "Press Release").

 

As described in the Press Release, in connection with the Name Change Amendment, the Company's ticker symbol for its common stock, par valule $0.0001 per share, listed on the Nasdaq Capital Market, will be changed as of market open on May 17, 2024, from "FWBI" to "ENTO".

 

A copy of this Press Release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

Item 9.01

Financial Statements and Exhibits.

 

(d)

Exhibits.

 

The following Exhibits are being filed with this Current Report on Form 8-K.

 

Exhibit No.		Description
3.1		Certificate of Amendment to the Company's Amended and Restated Certificate of Incorporation
99.1		Press Release, dated May 16, 2024
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

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.

 

	Entero Therapeutics, Inc.
May 16, 2024	By:	/s/ James Sapirstein
	Name:	James Sapirstein
	Title:	Chief Executive Officer

 

 

 

Exhibit 99.1

 

 

 

First Wave BioPharma Changes Name to Entero Therapeutics

 

Rebranding introduced as Company advances toward Phase 3 clinical trial with lead asset – latiglutenase for the treatment of celiac disease

 

New Nasdaq new ticker symbol is “ENTO” effective May 17, 2024

 

BOCA RATON, Fla., May 16, 2024 (GLOBE NEWSWIRE) – Entero Therapeutics, Inc. (formerly First Wave BioPharma, Inc.) (Nasdaq: ENTO) (“Entero” or the “Company”), a late clinical-stage biopharmaceutical company focused on the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today unveiled its new corporate name and website. The rebranding follows the recent business combination with ImmunogenX and reflect the Company’s focus on addressing unmet needs in GI health that include celiac disease, an indication for which there are no approved medicines today. Entero’s common stock will commence trading on May 17, 2024 on the Nasdaq Capital Market under the new ticker symbol of ENTO.

 

James Sapirstein, Chairman and Chief Executive Officer of Entero Therapeutics, said, “The rebranding aligns our corporate identity with our mission of bringing to market new treatments for the gut and intestine. We have accelerated this by adding latiglutenase to our pipeline. This is an opportunity to address significant medical need and market opportunity for celiac disease. As we prepare for a Phase 3 study with this program and advance our other drug candidates, we want to make sure that our branding better reflects the Company’s GI focus.”

 

Latiglutenase is an oral biotherapeutic composed of two gluten-specific recombinant proteases that has demonstrated effectiveness in alleviating GI symptoms of celiac disease and protecting against intestinal damage in three Phase 2 trials. The Phase 3 clinical plan for latiglutenase has been reviewed by the GI Division of the FDA, and the Company expects to initiate the trial in early 2025.

 

Today, in honor of Celiac Awareness Month in May, Entero will partner with Celiac Journey, a celiac disease patient advocacy organization, to share an awareness digital display on the Nasdaq Tower in Times Square at 4:25 p.m. ET. The digital display will also be shown at night as part of the international “Shine a Light on Celiac Disease” initiative to illuminate famous landmarks in green.

 

For more information about Entero Therapeutics, visit www.enterothera.com and connect on X and LinkedIn.

 

 

 

 

About Entero Therapeutics

 

Entero Therapeutics, Inc., is a late clinical-stage biopharmaceutical company focused on the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company’s programs address significant unmet needs in GI health and include: latiglutenase, a Phase 3-ready, potentially first-in-class, targeted, oral biotherapeutic for celiac disease; capeserod, a selective 5-HT4 receptor partial agonist for indications including gastroparesis; and adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients in cystic fibrosis and chronic pancreatitis patients with exocrine pancreatic insufficiency. For more information visit www.enterothera.com. 

 

Forward-Looking Statements 

 

This press release may contain certain statements relating to future results which are forward-looking statements. 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, depending on factors including whether any financing or licensing transaction may be completed, completed with different terms, in an untimely manner, or not at all; whether the Company will be able to realize the expected benefits of its acquisition of ImmunogenX; the Company’s ability to integrate the assets and contemplated commercial operations acquired from ImmunogenX into the Company’s business; 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 will be indicative of the final results of the trial; whether the Company will be able to maintain compliance with Nasdaq’s continued listing criteria and the effect of a delisting from Nasdaq on the market for the Company’s securities; the size of the potential markets for the Company’s drug candidates and its ability to service those markets; the effects of the First Wave Bio, Inc. acquisition, the related settlement and their effect on the Company’s business, operating results and financial prospects; and the Company’s current and future capital requirements and its ability to raise additional funds to satisfy its capital needs. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 29, 2024, as well as the Company’s subsequent filings with the SEC, including its proxy statements on Schedule 14A, Quarterly Report on Form 10-Q and Current Reports on Form 8-K. 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: 

 

Entero Therapeutics, Inc. 

777 Yamato Road, Suite 502 
Boca Raton, FL 33431 
Phone: (561) 589-7020 
info@enterothera.com 

 

Media contact: 

 

Russo Partners 

David Schull or Liz Phillips 

(347) 956-7697 

david.schull@russopartnersllc.com 

elizabeth.phillips@russopartnersllc.com 

 

 

v3.24.1.1.u2

Cover	May 15, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	May 15, 2024
Current Fiscal Year End Date	--12-31
Entity File Number	001-37853
Entity Registrant Name	First Wave BioPharma, Inc.
Entity Central Index Key	0001604191
Entity Tax Identification Number	46-4993860
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	777 Yamato Road
Entity Address, Address Line Two	Suite 502
Entity Address, City or Town	Boca Raton
Entity Address, State or Province	FL
Entity Address, Postal Zip Code	33431
City Area Code	561
Local Phone Number	589-7020
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	FWBI
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

---