8-K
GridAI Technologies Corp. (GRDX)
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<br><br> incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
| 777 Yamato Road, Suite 502<br><br> <br>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<br><br> registered |
|---|---|---|
| Common Stock, par value $0.0001 per share | FWBI | 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 (§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 3.1
| Delaware<br>The First State<br>Page 1<br><br>5474088 8100 Authentication: 203479364<br>SR# 20242146035 Date: 05-15-24<br>You may verify this certificate online at corp.delaware.gov/authver.shtml<br>I, JEFFREY W. BULLOCK, SECRETARY OF STATE OF THE STATE OF<br>DELAWARE, DO HEREBY CERTIFY THE ATTACHED IS A TRUE AND CORRECT<br>COPY OF THE CERTIFICATE OF AMENDMENT OF “FIRST WAVE BIOPHARMA,<br>INC.”, CHANGING ITS NAME FROM "FIRST WAVE BIOPHARMA, INC." TO<br>"ENTERO THERAPEUTICS, INC.", FILED IN THIS OFFICE ON THE<br>FIFTEENTH DAY OF MAY, A.D. 2024, AT 11:49 O`CLOCK A.M.<br>AND I DO HEREBY FURTHER CERTIFY THAT THE EFFECTIVE DATE OF<br>THE AFORESAID CERTIFICATE OF AMENDMENT IS THE SEVENTEENTH DAY<br>OF MAY, A.D. 2024. |
|---|
Exhibit 99.1
FirstWave BioPharma Changes Name to Entero Therapeutics
Rebrandingintroduced as Company advances toward Phase 3 clinical trial with lead asset – latiglutenase for the treatment of celiac disease
NewNasdaq 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 EnteroTherapeutics
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-LookingStatements
This press release may contain certain statements relating to future results which are forward-looking statements. It is possiblethat the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financialcondition indicated in these forward-looking statements, depending on factors including whether any financing or licensing transactionmay be completed, completed with different terms, in an untimely manner, or not at all; whether the Company will be able to realize theexpected benefits of its acquisition of ImmunogenX; the Company’s ability to integrate the assets and contemplated commercial operationsacquired from ImmunogenX into the Company’s business; whether results obtained in preclinical and nonclinical studies and clinicaltrials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trialwill be indicative of the final results of the trial; whether the Company will be able to maintain compliance with Nasdaq’s continuedlisting criteria and the effect of a delisting from Nasdaq on the market for the Company’s securities; the size of the potentialmarkets 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’scurrent and future capital requirements and its ability to raise additional funds to satisfy its capital needs. Additional informationconcerning the Company and its business, including a discussion of factors that could materially affect the Company’s financialresults are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securitiesand Exchange Commission (“SEC”) on March 29, 2024, as well as the Company’s subsequent filings with the SEC, includingits proxy statements on Schedule 14A, Quarterly Report on Form 10-Q and Current Reports on Form 8-K. All forward-looking statements includedin this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update orcorrect any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.
For moreinformation:
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