0001104659-24-035598.txt : 20240318 0001104659-24-035598.hdr.sgml : 20240318 20240318164034 ACCESSION NUMBER: 0001104659-24-035598 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20240318 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240318 DATE AS OF CHANGE: 20240318 FILER: COMPANY DATA: COMPANY CONFORMED NAME: First Wave BioPharma, Inc. CENTRAL INDEX KEY: 0001604191 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] ORGANIZATION NAME: 03 Life Sciences IRS NUMBER: 464993860 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-37853 FILM NUMBER: 24759650 BUSINESS ADDRESS: STREET 1: 777 YAMATO ROAD STREET 2: SUITE 502 CITY: BOCA RATON STATE: FL ZIP: 33431 BUSINESS PHONE: 561-589-7020 MAIL ADDRESS: STREET 1: 777 YAMATO ROAD STREET 2: SUITE 502 CITY: BOCA RATON STATE: FL ZIP: 33431 FORMER COMPANY: FORMER CONFORMED NAME: AzurRx BioPharma, Inc. DATE OF NAME CHANGE: 20141103 FORMER COMPANY: FORMER CONFORMED NAME: BioPharma d'Azur, Inc. DATE OF NAME CHANGE: 20140331 8-K 1 tm249108d1_8k.htm FORM 8-K
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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): March 18, 2024

 

  First Wave BioPharma, 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

 

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:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

x 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 8.01 Entry into a Material Definitive Agreement.

 

On March 18, 2024, the First Wave BioPharma, Inc. (the “Company”) issued a press release announcing that two abstracts have been accepted for presentation at the 2024 Digestive Disease Week Conference taking place from May 18-21, 2024, in Washington, D.C. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.  

 

Item 9.01 Financial Statements and Exhibits.

 

Forward Looking Statements

 

Any statements in this Current Report about the future expectations, plans and prospects of the Company, including without limitation, statements regarding: the Company’s acquisition of ImmunogenX, Inc., a Delaware Corporation (“ImmunogenX”) (the acquisition of ImmunogenX by the Company, the “Merger”), stockholder approval of the conversion of the Series G Preferred Stock, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hypothesize,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, but not limited to those set forth under the caption “Risk Factors” in this Current Report on Form 8-K and in the Company’s most recent Annual Report on Form 10-K filed with the SEC, as supplemented by its subsequent Quarterly Reports on Form 10-Q and in other filings that makes with the SEC. In addition, any forward-looking statements included in this Current Report represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. The Company specifically disclaims any intention to update any forward-looking statements included in this Current Report.

 

No Offer or Solicitation; Important Information About the Merger and Where to Find It

 

This Current Report on Form 8-K is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the Merger and shall not constitute an offer to sell or a solicitation of an offer to buy the securities of the Company or ImmunogenX, nor shall there be any sale of any such securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offer of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the Securities Act or an exemption therefrom.

 

The Company expects to file a proxy statement with the SEC relating to (i) the approval of the conversion of shares of Series G Preferred Stock into shares of the Company’s common stock in accordance with the rules of the Nasdaq Stock Market LLC and (ii) if deemed necessary or appropriate by the Company or as otherwise required by applicable law or contract, the approval of an amendment to the Company’s certificate of incorporation to authorize sufficient shares of common stock for the conversion of the Series G Preferred Stock issued pursuant to the merger agreement with ImmunogenX (the “Meeting Proposals”). The definitive proxy statement will be sent to all Company stockholders. Before making any voting decision, investors and security holders of the Company are urged to read the proxy statement and all other relevant documents filed or that will be filed with the SEC in connection with the Meeting Proposals as they become available because they will contain important information about the Merger Agreement and related transactions and the Meeting Proposals to be voted upon. Investors and security holders will be able to obtain free copies of the proxy statement and all other relevant documents filed or that will be filed with the SEC by the Company through the website maintained by the SEC at www.sec.gov.

 

Participants in Solicitation

 

The Company, ImmunogenX, and their respective directors, executive officers and employees may be deemed to be participants in the solicitation of proxies in respect of the Merger. Information regarding the Company’s directors and executive officers is available under the sections entitled “Director Compensation,” “Executive Compensation” and “Beneficial Ownership of Principal Stockholders and Management and Related Stockholder Matters” in the Company’s Definitive Proxy Statement filed with the SEC on May 15, 2023, available at https://www.sec.gov/Archives/edgar/data/1604191/000110465923060891/tm2315787d1_def14a.htm. Information regarding the persons who may, under the rules of the SEC, be deemed participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the proxy statement and other relevant materials to be filed with the SEC when they become available.

 

(d) Exhibits.

 

 The following Exhibits are being filed or furnished, as applicable, with this Current Report on Form 8-K.

 

Exhibit No. Description
99.1 Press Release of First Wave BioPharma, Inc. dated March 18, 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.

 

  First Wave BioPharma, Inc.
   
March 18, 2024 By: /s/ James Sapirstein
  Name: James Sapirstein
  Title: Chief Executive Officer

 

 

 

 EX-99.1 2 tm249108d1_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

First Wave BioPharma Announces Two Abstracts on Celiac Disease Research Accepted for Presentation at the 2024 Digestive Disease Week (DDW) Conference

 

Poster presentations to highlight new quantitative and serologic diagnostic methods for Celiac Disease detection and determination of intestinal mucosal health

 

New tools may serve as companion diagnostics for identifying seroactive patients and for monitoring the efficacy of Latiglutenase, the Company’s Celiac Disease therapeutic program

 

BOCA RATON, Fla., March 18, 2024 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ: FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that two abstracts have been accepted for presentation at the 2024 Digestive Disease Week Conference (DDW 2024) taking place May 18-21, 2024, in Washington, D.C.

 

The first presentation, titled, “A Composite Mucosal Scale for Celiac Disease Encompassing both Morphology and Inflammation,” will highlight VCIEL, a new quantitative composite scale, combining the histologic scales of villus height to crypt depth ratio (Vh:Cd) and density of intraepithelial lymphocytes (IEL), designed to enhance the accuracy and precision for measuring small intestinal mucosal health of celiac disease (CeD) patients with particular benefit for histologic endpoint measurements in clinical trials. The second presentation, titled, “Dynamics of Serologic Change to Gluten in Celiac Disease Patients,” will report research involving the largest database of CeD clinical results and will explore key issues related to the diagnostics of CeD, such as the effects of resuming a gluten-containing diet on seropositivity and the correlation between two different tTG-IgA assays.

 

“The abstracts accepted for presentation at DDW 2024 showcase significant advancements in the field of gastroenterology, particularly in the precision diagnosis and management of celiac disease through the innovative VCIEL scale that our team has developed,” stated James Sapirstein, Chairman and CEO of First Wave BioPharma.

 

“The invitation to present our findings on the VCIEL scale for measuring mucosal health of the small intestine as well as our research on the impact of gluten reintroduction as a diagnostic intervention for serologic measurements at one of the most influential meetings on gastrointestinal disease validates the potential for our work to advance better understanding and treatment of celiac disease,” said Jack Syage, PhD, President and Chief Operating Officer of First Wave.

 

 

 

 

Details on the presentations are as follows:

 

Presentation Title:  A Composite Mucosal Scale for Celiac Disease Encompassing both Morphology and Inflammation
Presenters: 

Jack Syage, PhD. President & Chief Operating Officer, First Wave BioPharma

Jennifer Sealy-Voyksner, PhD., Vice President R&D, First Wave BioPharma

Session Title:  Celiac Disease and Gluten Related Disorders 
Date and Time:  May 19, 2024, from 12:30 PM to 1:30 PM EDT

 

Presentation Title:  Dynamics of Serologic Change to Gluten in Celiac Disease Patients
Presenters: 

Jack Syage, PhD. President & Chief Operating Officer, First Wave BioPharma

Jennifer Sealy-Voyksner, PhD., Vice President R&D, First Wave BioPharma

Session Title:  Celiac Disease and Gluten Related Disorders 
Date and Time:  May 19, 2024, from 12:30 PM to 1:30 PM EDT

 

About Celiac Disease

 

Celiac disease is a chronic, hereditary autoimmune and inflammatory disease triggered by gluten consumption. Celiac disease is characterized by damage to the lining of the small intestine, causing malabsorption, gastrointestinal dysfunction and debilitating symptoms. Over the course of a lifetime, untreated or poorly managed celiac disease is often associated with deteriorating general health, multiple serious intestinal and extra-intestinal medical complications, and increased morbidity and mortality. Celiac disease is a global disease and affects approximately 1% of the population worldwide and is increasing in prevalence with improved diagnostic tools and improved awareness.

 

About First Wave BioPharma, Inc.

 

First Wave BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company is currently advancing a therapeutic development pipeline with multiple late-stage clinical programs built around three proprietary technologies – latiglutenase, a Phase 3-ready, potentially first-in-class, targeted, oral biotherapeutic for celiac disease; capeserod, a selective 5-HT4 receptor partial agonist being developed for 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. First Wave BioPharma is headquartered in Boca Raton, Florida. For more information visit www.firstwavebio.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, 2022, 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:

 

First Wave BioPharma, Inc.

777 Yamato Road, Suite 502

Boca Raton, FL 33431

Phone: (561) 589-7020

info@firstwavebio.com

 

Media contact:

 

Tiberend Strategic Advisors, Inc.

David Schemelia

(609) 468-9325

dschemelia@tiberend.com

 

 

 

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