# EDGAR Filing Document

**Accession Number:** 0001604191
**File Stem:** 0001104659-23-037147
**Filing Date:** 2023-3
**Character Count:** 55336
**Document Hash:** bc8ab9a695eb226b44345ae6138abec1
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001104659-23-037147.hdr.sgml**: 20230327

**ACCESSION NUMBER**: 0001104659-23-037147

**CONFORMED SUBMISSION TYPE**: 424B3

**PUBLIC DOCUMENT COUNT**: 2

**FILED AS OF DATE**: 20230327

**DATE AS OF CHANGE**: 20230327

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** First Wave BioPharma, Inc.
- **CENTRAL INDEX KEY:** 0001604191
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 464993860
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 424B3
- **SEC ACT:** 1933 Act
- **SEC FILE NUMBER:** 333-270723
- **FILM NUMBER:** 23764908

**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

**Filed Pursuant to Rule 424(b)(3)**

**Registration No. 333-270723**

 **PROSPECTUS**![](tm2310389d1_424b3img001.jpg)

**3,069,054 Shares of Common Stock**

This prospectus relates to the resale of up to 3,069,054 shares of First Wave BioPharma, Inc. (the "Company," "we," "our" or "us") common stock, par value $0.0001 per share (the "Common Stock"), by the selling stockholders listed in this prospectus or their permitted transferees (the "Selling Stockholders"). The shares of Common Stock registered for resale pursuant to this prospectus include:

· 128,000 shares of Common Stock (the "Shares")

· 895,018 shares of Common Stock (the "Pre-Funded Warrant Shares") issuable upon exercise of pre-funded warrants (the "Pre-Funded Warrants") issued to selling stockholders in the private placement offering (the "Private Placement") which closed on March 15, 2023; and

· 2,046,036 shares of Common Stock (the "Common Warrant Shares" and together with the Pre-Funded Warrant Shares, the "Warrant Shares") issuable upon exercise of common warrants (the "Common Warrants" and together with the Pre-Funded Warrants, the "Warrants") issued to selling stockholders in the Private Placement.

For additional information about the Private Placement, see "*Private Placement*."

The Pre-Funded Warrants have an exercise price of $0.0001 per share, are exercisable immediately upon issuance and will expire when exercised in full. The Common Warrants have an exercise price of $3.66 per share and will expire five years from the initial exercise date.

We are registering the shares on behalf of the Selling Stockholders, to be offered and sold by them from time to time. We are not selling any securities under this prospectus and will not receive any of the proceeds from the sale of shares by the Selling Stockholders.

The Selling Stockholders may sell the shares of Common Stock described in this prospectus in a number of different ways and at varying prices. See *Plan of Distribution* on page 9 of this prospectus for more information about how the Selling Stockholders may sell the shares of Common Stock being registered pursuant to this prospectus. The Selling Stockholders may be an "underwriter" within the meaning of Section 2(a)(11) of the Securities Act of 1933, as amended (the "Securities Act").

We will pay the expenses incurred in registering the shares, including legal and accounting fees. See *Plan of Distribution* on page 9 of this prospectus.

Our Common Stock is currently listed on The Nasdaq Capital Market under the symbol "FWBI". On March 24, 2023, the last reported sale price of our Common Stock on The Nasdaq Capital Market was $3.03.

***Investing in our securities involves risks. See "Risk Factors" beginning on page 3 of this prospectus for a discussion of the risks that you should consider in connection with an investment in our securities.***

**Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.**

The date of this prospectus is March 27, 2023.

**TABLE OF CONTENTS**

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| | |
|:---|:---|
| [PROSPECTUS SUMMARY](#a_001) | [1](#a_001) |
| [RISK FACTORS](#a_002) | [3](#a_002) |
| [CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS](#a_003) | [5](#a_003) |
| [PRIVATE PLACEMENT](#a_004) | [7](#a_004) |
| [SELLING STOCKHOLDERS](#a_005) | [8](#a_005) |
| [USE OF PROCEEDS](#a_006) | [10](#a_006) |
| [PLAN OF DISTRIBUTION](#a_007) | [11](#a_007) |
| [DESCRIPTION OF SECURITIES](#a_008) | [13](#a_008) |
| [LEGAL MATTERS](#a_009) | [17](#a_009) |
| [EXPERTS](#a_010) | [18](#a_010) |
| [WHERE YOU CAN FIND MORE INFORMATION](#a_011) | [19](#a_011) |
| [INCORPORATION OF CERTAIN INFORMATION BY REFERENCE](#a_012) | [20](#a_012) |

---

**PROSPECTUS SUMMARY**

*This summary highlights information contained elsewhere in this prospectus. This summary does not contain all of the information that you should consider before deciding to invest in our securities. You should read this entire prospectus carefully, including the "Risk Factors" section in this prospectus and under similar captions in the documents incorporated by reference into this prospectus. In this prospectus, unless otherwise stated or the context otherwise requires, references to "First Wave BioPharma", "AzurRx", "Company", "we", "us", "our" or similar references mean First Wave BioPharma, Inc. and its subsidiaries on a consolidated basis. References to "First Wave BioPharma" refer to First Wave BioPharma, Inc. on an unconsolidated basis. References to "First Wave Bio" refer to First Wave Bio, Inc., First Wave BioPharma's wholly-owned subsidiary.*

**Overview**

We are engaged in the research and development of targeted, non-systemic therapies for the treatment of patients with gastrointestinal ("*GI*") diseases. Non-systemic therapies are drugs that act locally, i.e. in the intestinal lumen, skin or mucosa, without reaching an individual's systemic circulation.

We are developing our product candidates for a host of GI diseases where there are significant unmet clinical needs and limited therapeutic options, resulting in painful, life threatening and discomforting consequences for patients. Our mission is to help protect the health and restore quality of life for the millions of people afflicted by these GI diseases.

We are currently focused on developing our pipeline of gut-restricted GI clinical product candidates, including the biologic adrulipase (formerly MS1819), a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients, and niclosamide, an oral small molecule with anti-inflammatory properties.

**Corporate Information**

We were incorporated on January 30, 2014 in the State of Delaware. In September 2021, we acquired First Wave Bio through a merger transaction, and changed our name to First Wave BioPharma, Inc. Our principal executive offices are located at 777 Yamato Road, Suite 502, Boca Raton, Florida 33431. Our telephone number is (561) 589-7020. We maintain a website at www.firstwavebio.com. The information contained on our website is not, and should not be interpreted to be, a part of this prospectus.

**The Private Placement**

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|:---|:---|
| **Shares of common stock offered by the Selling Stockholders** | 3,069,054 shares of Common Stock consisting of: |

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· 128,000 Shares

· 895,018 Pre-Funded Warrant Shares; and

· 2,046,036 Common Warrant Shares.

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| | |
|:---|:---|
| **Use of proceeds** | We are not selling any securities under this prospectus and will not receive any of the proceeds from the sale of the shares of Common Stock covered hereby by the Selling Stockholders. |

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| | |
|:---|:---|
| **Terms of this offering** | The Selling Stockholders, including their transferees, donees, pledgees, assignees and successors-in-interest, may sell, transfer or otherwise dispose of any or all of the shares of common stock offered by this prospectus from time to time on The Nasdaq Capital Market or any other stock exchange, market or trading facility on which the shares are traded or in private transactions. The shares of common stock may be sold at fixed prices, at market prices prevailing at the time of sale, at prices related to prevailing market price or at negotiated prices. |

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|:---|:---|
| **Nasdaq symbol** | Our common stock is listed on The Nasdaq Capital Market under the symbol "FWBI". |

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|:---|:---|
| **Risk Factors** | Investing in our securities involves significant risks. Before making a decision whether to invest in our securities, please read the information contained in or incorporated by reference under the heading "Risk Factors" in this prospectus, the documents we have incorporated by reference herein, and under similar headings in other documents filed after the date hereof and incorporated by reference into this prospectus. See "*Incorporation of Certain Information by Reference" and "Where You Can Find More Information*". |

---

**RISK FACTORS**

*An investment in our securities involves a high degree of risk. Before deciding whether to purchase our securities, including the shares of common stock offered by this prospectus, you should carefully consider the risks and uncertainties described under "Risk Factors" in our[<u>Annual Report on Form 10-K for the fiscal year ended December 31, 2022</u>,](http://www.sec.gov/ix?doc=/Archives/edgar/data/1604191/000141057823000299/fwbi-20221231x10k.htm) any subsequent Quarterly Report on Form 10-Q and our other filings with the SEC, all of which are incorporated by reference herein. If any of these risks actually occur, our business, financial condition and results of operations could be materially and adversely affected and we may not be able to achieve our goals, the value of our securities could decline and you could lose some or all of your investment. Additional risks not presently known to us or that we currently believe are immaterial may also significantly impair our business operations. If any of these risks occur, our business, results of operations or financial condition and prospects could be harmed. In that event, the market price of our common stock and the value of the warrants could decline, and you could lose all or part of your investment.*

**Risks Related to This Offering**

***A substantial number of shares of common stock may be sold in the market following this offering, which may depress the market price for our common stock.***

Following this offering, a large number of shares of Common Stock may be sold in the market, which may depress the market price of our Common Stock. Sales of a substantial number of shares of our Common Stock in the public market following this offering could cause the market price of our Common Stock to decline. A substantial majority of the outstanding shares of our Common Stock are, and the shares of Common Stock issuable upon exercise of the Warrants will be, freely tradable without restriction or further registration under the Securities Act, unless owned or purchased by our "affiliates" as that term is defined in Rule 144 under the Securities Act.

***Our failure to maintain compliance with Nasdaq's continued listing requirements could result in the delisting of our Common Stock.***

Our common stock is currently listed for trading on The Nasdaq Capital Market. We must satisfy the continued listing requirements of Nasdaq, to maintain the listing of our common stock on The Nasdaq Capital Market.

As we have previously reported, on November 26, 2021, we received notice from the Listing Qualifications Staff (the "Staff") of The Nasdaq Stock Market LLC ("Nasdaq") indicating that we were not in compliance with the $2.5 million minimum stockholders' equity requirement for continued listing of the Common Stock on Nasdaq, as set forth in Nasdaq Listing Rule 5550(b)(1) (the "Minimum Stockholders' Equity Rule").

On January 10, 2022, we submitted a plan to the Staff to regain compliance with the Minimum Stockholders' Equity Rule and on February 15, 2022, the Staff notified us that Nasdaq had granted us an extension through May 25, 2022, to regain compliance. On May 26, 2022, we received a letter from the Staff indicating that, based upon our continued non-compliance with the Minimum Stockholders' Equity Rule, the Staff had determined to delist the Company's securities from Nasdaq unless we timely requested a hearing before a Nasdaq Hearing Panel (the "Panel").

Additionally, on May 16, 2022, we received notice from the Staff indicating that, based upon the closing bid price of the Common Stock for the prior 30 consecutive business days, we were not in compliance with the requirement to maintain a minimum bid price of $1.00 per share for continued listing on Nasdaq, as set forth in Nasdaq Listing Rule 5550(a)(2) (the "Bid Price Rule"). We had 180 days from May 16, 2022, or through November 14, 2022, to regain compliance with the Bid Price Rule. After receiving stockholder approval at the annual meeting of stockholders, on August 26, 2022, we effected a one-for-thirty reverse stock split of the Common Stock (the "Prior Reverse Split"). By letter dated September 12, 2022, Nasdaq advised us that we had regained compliance with the Bid Price Rule.

We timely requested a hearing before the Panel. Following the hearing, on July 11, 2022 the Panel granted our request for continued listing of our common stock (the "Extension"). The Extension was subject to a number of significant conditions that had to be satisfied on or before specific deadlines set forth in the Extension. The final term of the Extension expired on November 22, 2022. On December 20, 2022, we received a letter from the Panel confirming that we had regained compliance with the Minimum Stockholders' Equity Rule.

On December 14, 2022, we received a deficiency notice from the Staff of Nasdaq indicating that, based upon the closing bid price of our common stock for the prior 30 consecutive business days, we were not in compliance with the Bid Price Rule. After receiving stockholder approval at a special meeting of stockholders on January 13, 2023, we effected a 1:7 reverse stock split on January 18, 2023. On February 6, 2023, we received a letter from the Panel indicating that we have regained compliance with the Minimum Bid Price Rule and that the Panel's oversight process of us is now closed.

Additionally, in 2020, the SEC approved a previously proposed Nasdaq rule change to expedite delisting of securities with a closing bid price at or below $0.10 for 10 consecutive trading days during any bid price compliance period and that have had one or more reverse stock splits with a cumulative ratio of one for 250 or more shares over the prior two-year period. In addition, if a company falls out of compliance with the $1.00 minimum bid price after completing reverse stock splits over the immediately preceding two years that cumulatively result in a ratio one for 250 shares, the company will not be able to avail itself of any bid price compliance periods under Rule 5810(c)(3)(A), and Nasdaq will instead require the issuance of a Staff delisting determination. We could appeal the determination to a hearings panel, which could grant us a 180-day exception to remain listed if it believes we would be able to achieve and maintain compliance with the bid price requirement. Following the exception, the company would be subject to the procedures applicable to a company with recurring deficiencies (Nasdaq Rule 5815(d)(4)(B)),

If our common stock were delisted from Nasdaq, trading of our common stock would most likely take place on an over-the-counter market established for unlisted securities, such as the OTCQB or the Pink Market maintained by OTC Markets Group Inc. An investor would likely find it less convenient to sell, or to obtain accurate quotations in seeking to buy, our common stock on an over-the-counter market, and many investors would likely not buy or sell our common stock due to difficulty in accessing over-the-counter markets, policies preventing them from trading in securities not listed on a national exchange or other reasons. In addition, as a delisted security, our common stock would be subject to SEC rules as a "penny stock," which impose additional disclosure requirements on broker-dealers. The regulations relating to penny stocks, coupled with the typically higher cost per trade to the investor of penny stocks due to factors such as broker commissions generally representing a higher percentage of the price of a penny stock than of a higher-priced stock, would further limit the ability of investors to trade in our common stock. In addition, delisting would materially and adversely affect our ability to raise capital on terms acceptable to us, or at all, and may result in the potential loss of confidence by investors, suppliers, customers and employees and fewer business development opportunities. For these reasons and others, delisting would adversely affect the liquidity, trading volume and price of our common stock, causing the value of an investment in us to decrease and having an adverse effect on our business, financial condition and results of operations, including our ability to attract and retain qualified employees and to raise capital.

**CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS**

This prospectus, and any documents we incorporate by reference, contain certain forward-looking statements that involve substantial risks and uncertainties. All statements contained in this prospectus and any documents we incorporate by reference, other than statements of historical facts, are forward-looking statements including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.

The words "anticipate", "believe", "estimate", "expect", "intend", "may", "plan", "predict", "project", "target", "potential", "will", "would", "could", "should", "continue" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among other things, statements about:

· our ability to maintain compliance
with the continued listing requirements of The Nasdaq Capital Market;

· our ability to satisfy our payment obligations in connection with the acquisition of First Wave Bio, Inc.;

· statements regarding the impact of the COVID-19 pandemic and other geopolitical events, including the war in Ukraine and their effects on our operations, access to capital, research and development and clinical trials and potential disruption in the operations and business of third-party vendors, contract research organizations ("CROs"), contract development and manufacturing organizations ("CDMOs"), other service providers, and collaborators with whom we conduct business;

· the availability of capital to satisfy our working capital requirements;

· our current and future capital requirements and our ability to raise additional funds to satisfy our capital needs;

· the integration and effects of our acquisitions, including the acquisition of First Wave Bio, Inc., and other strategic transactions;

· the accuracy of our estimates regarding expense, future revenue and capital requirements;

· our ability to continue operating as a going concern;

· our plans to develop and commercialize our product candidates, including the biologic adrulipase (formerly MS1819) and niclosamide;

· our ability to initiate and complete our clinical trials and to advance our principal product candidates into additional clinical trials, including pivotal clinical trials, and successfully complete such clinical trials;

· regulatory developments in the U.S. and foreign countries;

· the performance of our third-party vendor(s), CROs, CDMOs and other third-party non-clinical and clinical development collaborators and regulatory service providers;

· our ability to obtain and maintain intellectual property protection for our core assets;

· the size of the potential markets for our product candidates and our ability to serve those markets;

· the rate and degree of market acceptance of our product candidates for any indication once approved;

· the success of competing products and product candidates in development by others that are or become available for the indications that we are pursuing;

· the loss of key scientific, clinical and nonclinical development, and/or management personnel, internally or from one of our third-party collaborators; and

· other risks and uncertainties, including those listed in the "*Risk Factors*" section of this prospectus and the documents incorporated by reference herein.

These forward-looking statements are only predictions and we may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, so you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our business, financial condition and operating results. We have included important factors in the cautionary statements included in this prospectus that could cause actual future results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.

You should read this prospectus with the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by applicable law.

**PRIVATE PLACEMENT**

On March 12, 2023, pursuant to a Securities Purchase Agreement (the "Purchase Agreement") with a single institutional investor (the "Purchaser"), we closed the Private Placement in which we issued an aggregate of (i) 128,000 Shares, (ii) Pre-Funded Warrants to purchase up to an aggregate of 895,018 shares of Common Stock, and (iii) Common Warrants to purchase up to an aggregate of 2,046,036 shares of Common Stock at a purchase price of $3.66 per Share (or Pre-Funded Warrant in lieu thereof) and accompanying Common Warrant.

The Pre-Funded Warrants have an exercise price of $0.0001 per share, are exercisable immediately upon issuance and will expire when exercised in full. The Common Warrants have an exercise price of $3.66 per share and will expire five years from the initial exercise date. We received gross proceeds of approximately $4 million from the Private Placement, before deducting the fees owed to the placement agent and other Private Placement expenses. We intend to use the net proceeds from the Private Placement for working capital purposes.

As compensation to Roth Capital Partners, LLC (the "Placement Agent"), as the exclusive placement agent in connection with the Private Placement, the Company agreed to pay the Placement Agent a cash fee of approximately $180,000 and payment of certain expenses and legal fees.

In connection with the Private Placement, on March 12, 2023, we entered into a Registration Rights Agreement (the "Registration Rights Agreement") with the Purchaser pursuant to which we are required to file a registration statement with the Securities and Exchange Commission (the "SEC") to register for resale the Shares and the Warrant Shares no later than the earlier of (i) thirty days following the date of the agreement or (ii) five days following the date the Company files its annual report with the SEC and to use our commercially reasonable efforts to cause the registration statement to be declared effective by the SEC by May 11, 2023.

**SELLING STOCKHOLDERS**

This prospectus relates to the sale from time to time by the Selling Stockholders of up to 3,069,054 shares of our Common Stock. When we refer to the "Selling Stockholders" in this prospectus, we mean the persons and entities listed in the table below, and their respective pledgees, donees, permitted transferees, assignees, successors and others who later come to hold any of the Selling Stockholders' interests in shares of our common stock other than through a public sale.

The Selling Stockholders may sell some, all or none of its shares. We do not know how long the Selling Stockholders will hold the shares before selling them, and we currently have no agreements, arrangements or understandings with the Selling Stockholders regarding the sale of any of the shares.

The following table presents information regarding the Selling Stockholders and the shares that they may offer and sell from time to time under this prospectus. The number of shares common stock beneficially owned by the Selling Stockholders is determined under rules promulgated by the SEC. Except as described above, there are currently no agreements, arrangements or understandings with respect to the resale of any of the securities covered by this prospectus.

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|:---|:---|:---|:---|:---|:---|:---|:---|
| | **Shares Beneficially<br> Owned<br> Prior to Private** |  | **Maximum Number of<br> Shares Being<br> Offered Pursuant to this** |  | **Shares Beneficially <br> Owned<br> After this Private<br> Placement(3)** | **Shares Beneficially <br> Owned<br> After this Private<br> Placement(3)** | **Shares Beneficially <br> Owned<br> After this Private<br> Placement(3)** |
| <br>**Name of Selling Stockholder** | **Placement(1)(2)(3)** |  | **Prospectus** |  | **Number(3)** |  | **Percent(4)** |
| Armistice Capital Master Fund Ltd. (5) | 4793368 | (6) | 3069054 | (7) | 81475 | (8) | 4.99% |

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(1) Except as noted below, beneficial ownership is determined in accordance with the rules of the SEC and generally includes voting or investment power with respect to securities. All entries exclude beneficial ownership of shares issuable pursuant to warrants, options or other derivative securities that have not vested or that are not otherwise exercisable as of the date hereof or which will not become vested or exercisable within 60 days of March 20, 2023.

(2) Based upon the internal books and records of the Company.

(3) Includes shares of Common Stock which are not being offered pursuant to this prospectus.

(4) All percentage calculations are based on 1,549,581 shares of Common Stock outstanding as of March 20, 2023 and are rounded to the nearest tenth of a percent. Warrants, options or other derivative securities that are presently exercisable or exercisable within 60 days are deemed to be beneficially owned by the person holding such securities for the purpose of calculating the percentage ownership of that person, but are not treated as outstanding for the purpose of calculating the percentage ownership of any other person.

(5) These securities are directly held by Armistice Capital Master Fund Ltd. (the "Master Fund"), a Cayman Islands exempted company, and may be deemed to be indirectly beneficially owned by Armistice Capital, LLC ("Armistice"), as the investment manager of the Master Fund; and (ii) Steven Boyd, as the Managing Member of Armistice Capital. Armistice and Steven Boyd disclaim beneficial ownership of the reported securities except to the extent of their respective pecuniary interests therein. The address of the Master Fund is c/o Armistice Capital, LLC, 510 Madison Avenue, 7<sup>th</sup> Floor, New York, NY 10022.

(6) The number of shares of Common Stock owned by the selling shareholder prior to this offering consists of: (i) common warrants to purchase up to an aggregate of 1,724,332 shares of Common Stock (without giving effect to the 4.99% beneficial ownership limitation contained in such common warrants); (ii) 128,000 Shares issued in the Private Placement; (iii) Pre-Funded Warrants issued in the Private Placement to purchase up to an aggregate of 895,018 shares of Common Stock (without giving effect to the 9.99% beneficial ownership limitation contained in such Pre-Funded Warrants); and (iv) Common Warrants issued in the Private Placement to purchase up to an aggregate of 2,046,036 shares of Common Stock (without giving effect to the 4.99% beneficial ownership limitation contained in such Common Warrants).

(7) The maximum number of shares being offered pursuant to this prospectus consists of: (i) 128,000 Shares issued in the Private Placement; (iii) Pre-Funded Warrants issued in the Private Placement to purchase up to an aggregate of 895,018 shares of Common Stock (without giving effect to the 9.99% beneficial ownership limitation contained in such Pre-Funded Warrants); and (iv) Common Warrants issued in the Private Placement to purchase up to an aggregate of 2,046,036 shares of Common Stock (without giving effect to the 4.99% beneficial ownership limitation contained in such Common Warrants).

(8) The shares beneficially owned after this private placement give effect to the 4.99% beneficial ownership limitation contained in the common warrants held by the selling shareholder.

Issuances of our Common Stock to the Selling Stockholders will not affect the rights or privileges of our existing stockholders, except that the economic and voting interests of each of our existing stockholders will be diluted as a result of any such issuance. Although the number of shares of Common Stock that our existing stockholders own will not decrease, the shares owned by our existing stockholders will represent a smaller percentage of our total outstanding shares after any such issuance to the Selling Stockholders identified herein.

**USE OF PROCEEDS**

The Common Stock to be offered and sold using this prospectus will be offered and sold by the Selling Stockholders named in this prospectus. Accordingly, we will not receive any proceeds from any sale of shares of Common Stock in this offering. We will pay all of the fees and expenses incurred by us in connection with this registration.

**PLAN OF DISTRIBUTION**

Each Selling Stockholder of the securities and any of their pledgees, assignees and successors-in-interest may, from time to time, sell any or all of their securities covered hereby on The Nasdaq Capital Market or any other stock exchange, market or trading facility on which the securities are traded or in private transactions. These sales may be at fixed or negotiated prices. A Selling Stockholder may use any one or more of the following methods when selling securities:

· ordinary brokerage transactions
and transactions in which the broker-dealer solicits purchasers;

· block trades in which the broker-dealer will attempt to sell the securities as agent but may position and resell a portion of the block as principal to facilitate the transaction;

· purchases by a broker-dealer as principal and resale by the broker-dealer for its account;

· an exchange distribution in accordance with the rules of the applicable exchange;

· privately negotiated transactions;

· settlement of short sales;

· in transactions through broker-dealers that agree with the Selling Stockholders to sell a specified number of such securities at a stipulated price per security;

· through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise;

· a combination of any such methods of sale; or

· any other method permitted pursuant to applicable law.

The Selling Stockholders may also sell securities under Rule 144 or any other exemption from registration under the Securities Act of 1933, as amended (the "Securities Act"), if available, rather than under this prospectus.

Broker-dealers engaged by the Selling Stockholders may arrange for other brokers-dealers to participate in sales. Broker-dealers may receive commissions or discounts from the Selling Stockholders (or, if any broker-dealer acts as agent for the purchaser of securities, from the purchaser) in amounts to be negotiated, but, except as set forth in a supplement to this Prospectus, in the case of an agency transaction not in excess of a customary brokerage commission in compliance with FINRA Rule 2121; and in the case of a principal transaction a markup or markdown in compliance with FINRA Rule 2121.

In connection with the sale of the securities or interests therein, the Selling Stockholders may enter into hedging transactions with broker-dealers or other financial institutions, which may in turn engage in short sales of the securities in the course of hedging the positions they assume. The Selling Stockholders may also sell securities short and deliver these securities to close out their short positions, or loan or pledge the securities to broker-dealers that in turn may sell these securities. The Selling Stockholders may also enter into option or other transactions with broker-dealers or other financial institutions or create one or more derivative securities which require the delivery to such broker-dealer or other financial institution of securities offered by this prospectus, which securities such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).

The Selling Stockholders and any broker-dealers or agents that are involved in selling the securities may be deemed to be "underwriters" within the meaning of the Securities Act in connection with such sales. In such event, any commissions received by such broker-dealers or agents and any profit on the resale of the securities purchased by them may be deemed to be underwriting commissions or discounts under the Securities Act. Each Selling Stockholder has informed the Company that it does not have any written or oral agreement or understanding, directly or indirectly, with any person to distribute the securities.

The Company is required to pay certain fees and expenses incurred by the Company incident to the registration of the securities. The Company has agreed to indemnify the Selling Stockholders against certain losses, claims, damages and liabilities, including liabilities under the Securities Act.

We agreed to keep this prospectus effective until the earlier of (i) the date on which the securities may be resold by the Selling Stockholders without registration and without regard to any volume or manner-of-sale limitations by reason of Rule 144, without the requirement for the Company to be in compliance with the current public information under Rule 144 under the Securities Act or any other rule of similar effect or (ii) all of the securities have been sold pursuant to this prospectus or Rule 144 under the Securities Act or any other rule of similar effect. The resale securities will be sold only through registered or licensed brokers or dealers if required under applicable state securities laws. In addition, in certain states, the resale securities covered hereby may not be sold unless they have been registered or qualified for sale in the applicable state or an exemption from the registration or qualification requirement is available and is complied with.

Under applicable rules and regulations under the Exchange Act, any person engaged in the distribution of the resale securities may not simultaneously engage in market making activities with respect to the common stock for the applicable restricted period, as defined in Regulation M, prior to the commencement of the distribution. In addition, the Selling Stockholders will be subject to applicable provisions of the Exchange Act and the rules and regulations thereunder, including Regulation M, which may limit the timing of purchases and sales of the common stock by the Selling Stockholders or any other person. We will make copies of this prospectus available to the Selling Stockholders and have informed them of the need to deliver a copy of this prospectus to each purchaser at or prior to the time of the sale (including by compliance with Rule 172 under the Securities Act).

Our Common Stock is quoted on The Nasdaq Capital Market under the symbol "FWBI".

**DESCRIPTION OF SECURITIES**

*The following summary of the rights of our capital stock is not complete and is subject to and qualified in its entirety by reference to our Charter and Bylaws, copies of which are filed as exhibits to our <u>[Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 20, 2023](https://www.sec.gov/ix?doc=/Archives/edgar/data/1604191/000141057823000299/fwbi-20221231x10k.htm)</u><u>,</u> and the Certificate of Designations and forms of securities, copies of which are filed as exhibits to the registration statement of which this prospectus forms a part , which are incorporated by reference herein.*

**General**

Our authorized capital stock consists of:

· 50,000,000 shares of common stock,
par value $0.0001 per share; and

· 10,000,000 shares of preferred stock, par value $0.0001.

As of March 20, 2023, there were 50,000,000 shares of Common Stock authorized, and 10,000,000 shares of preferred stock authorized, of which a series of 5,194.81 shares of Series B Convertible Preferred Stock (the "Series B Preferred Stock"), a series of 75,000 shares of Series C 9.00% Convertible Junior Preferred Stock (the "Series C Preferred Stock"), a series of 150 shares of Series D Preferred Stock, a series of 150 shares of Series E Preferred Stock and a series of 7,000 shares of Series F Preferred Stock have been designated.

As of March 20, 2023, there were 1,549,581 shares of Common Stock issued and outstanding, approximately 545.94 shares of Series B Preferred Stock issued and outstanding, zero shares of Series C Preferred Stock issued and outstanding, zero shares of Series D Preferred Stock issued and outstanding, zero shares of Series E Preferred Stock issued and outstanding and zero shares of Series F Preferred Stock issued and outstanding.

The additional shares of our authorized capital stock available for issuance may be issued at times and under circumstances so as to have a dilutive effect on earnings per share and on the equity ownership of the holders of our common stock. The ability of our board of directors to issue additional shares of stock could enhance the board's ability to negotiate on behalf of the stockholders in a takeover situation but could also be used by the board to make a change of control more difficult, thereby denying stockholders the potential to sell their shares at a premium and entrenching current management. The following description is a summary of the material provisions of our capital stock. You should refer to our certificate of incorporation, as amended (the "Charter"), and our bylaws, as amended and restated (the "Bylaws"), both of which are on file with the SEC as exhibits to previous SEC filings, for additional information. The summary below is qualified by provisions of applicable law.

**Common Stock**

Holders of our common stock are entitled to one vote for each share held of record on all matters on which the holders are entitled to vote (or consent pursuant to written consent). Directors are elected by a plurality of the votes present in person or represented by proxy and entitled to vote. Our Charter and Bylaws do not provide for cumulative voting rights.

Holders of our common stock are entitled to receive, ratably, dividends only if, when and as declared by our board of directors out of funds legally available therefor and after provision is made for each class of capital stock having preference over the common stock.

In the event of our liquidation, dissolution or winding-up, the holders of common stock are entitled to share, ratably, in all assets remaining available for distribution after payment of all liabilities and after provision is made for each class of capital stock having preference over the common stock.

Holders of our common stock have no preemptive, conversion or subscription rights, and there are no redemption or sinking fund provisions applicable to the common stock. The rights, preferences and privileges of the holders of common stock are subject to, and may be adversely affected by, the rights of the holders of shares of any series of our preferred stock that we may designate and issue in the future.

**Transfer Agent**

The transfer agent and registrar for our common stock is Colonial Stock Transfer Co., Inc., 7840 S. 700 E., Sandy, Utah 84070, Tel: (801) 355-5740.

**Preferred Stock**

We currently have up to 10,000,000 shares of preferred stock, par value $0.0001 per share, authorized and available for issuance in one or more series. Our board of directors is authorized to divide the preferred stock into any number of series, fix the designation and number of each such series, and determine or change the designation, relative rights, preferences, and limitations of any series of preferred stock. The board of may increase or decrease the number of shares initially fixed for any series, but no decrease may reduce the number below the shares then outstanding and duly reserved for issuance. As of March 20, 2023, approximately 5,194.81 shares were designated as Series B Preferred Stock, of which approximately 545.94 shares were issued and outstanding, 75,000 shares were designated as Series C Preferred Stock, of which none were issued and outstanding, 150 shares were designated as Series D Preferred Stock, of which none were issued and outstanding, 150 shares were designated as Series E Preferred Stock, of which none were issued and outstanding and 7,000 shares were designed as Series F Preferred Stock, of which none were issued and outstanding.

**Anti-Takeover Effects of Certain Provisions of Delaware Law and of Our Charter and Bylaws**

Certain provisions of Delaware law, our Charter and Bylaws discussed below may have the effect of making more difficult or discouraging a tender offer, proxy contest or other takeover attempt. These provisions are expected to encourage persons seeking to acquire control of our company to first negotiate with our Board of Directors. We believe that the benefits of increasing our ability to negotiate with the proponent of an unfriendly or unsolicited proposal to acquire or restructure our company outweigh the disadvantages of discouraging these proposals because negotiation of these proposals could result in an improvement of their terms.

*Delaware Anti-Takeover Law.*

We are subject to Section 203 of the Delaware General Corporation Law (the "DGCL"). Section 203 generally prohibits a public Delaware corporation from engaging in a "business combination" with an "interested stockholder" for a period of three years after the date of the transaction in which the person became an interested stockholder, unless:

· prior to the date of the transaction, the Board of Directors of the corporation approved either the business combination or the transaction which resulted in the stockholder becoming an interested stockholder;

· upon consummation of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced, excluding specified shares; or

· at or subsequent to the date of the transaction, the business combination is approved by the Board of Directors and authorized at an annual or special meeting of stockholders, and not by written consent, by the affirmative vote of at least 66 2/3% of the outstanding voting stock which is not owned by the interested stockholder.

Section 203 defines a "business combination" to include:

· any merger or consolidation involving the corporation and the interested stockholder;

· any sale, lease, exchange, mortgage, pledge, transfer or other disposition of 10% or more of the assets of the corporation to or with the interested stockholder;

· subject to exceptions, any transaction that results in the issuance or transfer by the corporation of any stock of the corporation to the interested stockholder;

· subject to exceptions, any transaction involving the corporation that has the effect of increasing the proportionate share of the stock of any class or series of the corporation beneficially owned by the interested stockholder; or

· the receipt by the interested stockholder of the benefit of any loans, advances, guarantees, pledges or other financial benefits provided by or through the corporation.

In general, Section 203 defines an "interested stockholder" as any person that is:

· the owner of 15% or more of the outstanding voting stock of the corporation;

· an affiliate or associate of the corporation who was the owner of 15% or more of the outstanding voting stock of the corporation at any time within three years immediately prior to the relevant date; or

· the affiliates and associates of the above.

Under specific circumstances, Section 203 makes it more difficult for an "interested stockholder" to effect various business combinations with a corporation for a three-year period, although the stockholders may, by adopting an amendment to the corporation's certificate of incorporation or bylaws, elect not to be governed by this section, effective 12 months after adoption.

Our Charter and Bylaws do not exclude us from the restrictions of Section 203. We anticipate that the provisions of Section 203 might encourage companies interested in acquiring us to negotiate in advance with our Board of Directors since the stockholder approval requirement would be avoided if a majority of the directors then in office approve either the business combination or the transaction that resulted in the stockholder becoming an interested stockholder.

*Charter and Bylaws.*

Provisions of our Charter and Bylaws may delay or discourage transactions involving an actual or potential change of control or change in our management, including transactions in which stockholders might otherwise receive a premium for their shares, or transactions that our stockholders might otherwise deem to be in their best interests. Therefore, these provisions could adversely affect the price of our common stock.

*Stockholder Action by Written Consent*

Our Bylaws provide that our stockholders may take action by written consent or electronic transmission, setting forth the action so taken, signed or e-mailed by the holders of outstanding stock having not less than the minimum number of votes that would be necessary to authorize or take such action at a meeting for such purpose.

*Potential Effects of Authorized but Unissued Stock*

We have shares of common stock and preferred stock available for future issuance without stockholder approval. We may utilize these additional shares for a variety of corporate purposes, including future public offerings to raise additional capital, to facilitate corporate acquisitions or payment as a dividend on the capital stock.

The existence of unissued and unreserved common stock and preferred stock may enable our board of directors to issue shares to persons friendly to current management or to issue preferred stock with terms that could render more difficult or discourage a third-party attempt to obtain control of us by means of a merger, tender offer, proxy contest or otherwise, thereby protecting the continuity of our management. In addition, the board of directors has the discretion to determine designations, rights, preferences, privileges and restrictions, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences of each series of preferred stock, all to the fullest extent permissible under the DGCL and subject to any limitations set forth in our Charter. The purpose of authorizing the board of directors to issue preferred stock and to determine the rights and preferences applicable to such preferred stock is to eliminate delays associated with a stockholder vote on specific issuances. The issuance of preferred stock, while providing desirable flexibility in connection with possible financings, acquisitions and other corporate purposes, could have the effect of making it more difficult for a third party to acquire, or could discourage a third party from acquiring, a majority of our outstanding voting stock.

**LEGAL MATTERS**

The validity of the securities offered hereby will be passed upon for us by Lowenstein Sandler LLP, New York, New York.

**EXPERTS**

The consolidated audited financial statements incorporated by reference in this prospectus and elsewhere in the registration statement have been incorporated by reference in reliance upon the report of Mazars USA LLP, independent registered public accounting firm, upon the authority of said firm as experts in accounting and auditing. The 2022 and 2021 audited annual consolidated financial statements of First Wave BioPharma, Inc., as of and for the years ended December 31, 2022 and 2021, have been audited by Mazars USA LLP, independent registered public accounting firm. The audit report dated March 20, 2023 for the 2022 audited annual consolidated financial statements includes an explanatory paragraph which states that certain circumstances raise substantial doubt about our ability to continue as a going concern.

**WHERE YOU CAN FIND MORE INFORMATION**

We are subject to the informational requirements of the Exchange Act and in accordance therewith we file annual, quarterly, and other reports, proxy statements and other information with the Commission under the Exchange Act. Such reports, proxy statements and other information, including the Registration Statement, and exhibits and schedules thereto, are available to the public through the Commission's website at www.sec.gov.

We make available free of charge on or through our website our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, as soon as reasonably practicable after we electronically file such material with or otherwise furnish it to the Commission.

We have filed with the Commission a registration statement under the Securities Act of 1933, as amended, relating to the offering of these securities. The registration statement, including the attached exhibits, contains additional relevant information about us and the securities. This prospectus does not contain all of the information set forth in the registration statement. You can obtain a copy of the registration statement, at prescribed rates, from the Commission at the address listed above, or for free at www.sec.gov. The registration statement and the documents referred to below under "*Incorporation of Certain Information by Reference*" are also available on our website, www. firstwavebio.com/investors/regulatory-filings.

We have not incorporated by reference into this prospectus the information on our website, and you should not consider it to be a part of this prospectus.

**INCORPORATION OF CERTAIN INFORMATION BY REFERENCE**

The following documents filed with the SEC are incorporated by reference into this prospectus:

· our Annual Report on Form 10-K for the year ended December 31, 2022, filed on [March 20, 2023](http://www.sec.gov/ix?doc=/Archives/edgar/data/1604191/000141057823000299/fwbi-20221231x10k.htm) ;

· our Current Reports on Form 8-K, filed on [January 17, 2023](https://www.sec.gov/ix?doc=/Archives/edgar/data/0001604191/000110465923004102/tm233436d1_8k.htm) , [February 7, 2023](https://www.sec.gov/ix?doc=/Archives/edgar/data/0001604191/000110465923011499/tm235300d1_8k.htm) and [March 15, 2023](https://www.sec.gov/ix?doc=/Archives/edgar/data/1604191/000110465923032650/tm239569d1_8k.htm) (other than any portions thereof deemed furnished and not filed);

· our definitive proxy statement on Schedule 14A, filed on [July 25, 2022](https://www.sec.gov/Archives/edgar/data/1604191/000114036122026876/ny20004369x4_def14a.htm) ; and

· the description of our common stock which is registered under Section 12 of the Exchange Act, in our registration statement on Form 8-A, filed on [August 8, 2016](https://www.sec.gov/Archives/edgar/data/1604191/000141588916006709/azurrx8a12b_aug82016.htm) , as supplemented and updated by the description of our capital stock set forth in Exhibit 4.31 of our Annual Report on Form 10-K for the year ended December 31, 2022, filed on [March 20, 2023](https://www.sec.gov/ix?doc=/Archives/edgar/data/0001604191/000141057823000299/fwbi-20221231x10k.htm) , including any amendment or reports filed for the purposes of updating this description.

We also incorporate by reference all documents we file pursuant to Section 13(a), 13(c), 14 or 15 of the Exchange Act (other than any portions of filings that are furnished rather than filed pursuant to Items 2.02 and 7.01 of a Current Report on Form 8-K) after the date of the initial registration statement of which this prospectus is a part and prior to effectiveness of such registration statement. All documents we file in the future pursuant to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act after the date of this prospectus and prior to the termination of the offering are also incorporated by reference and are an important part of this prospectus.

Any statement contained in a document incorporated or deemed to be incorporated by reference herein shall be deemed to be modified or superseded for the purposes of this registration statement to the extent that a statement contained herein or in any other subsequently filed document which also is or deemed to be incorporated by reference herein modifies or supersedes such statement. Any statement so modified or superseded shall not be deemed, except as so modified or superseded, to constitute a part of this registration statement.

**3,069,054 Shares of Common Stock**

![](tm2310389d1_424b3img001.jpg)

**PROSPECTUS**

We have not authorized any dealer, salesperson or other person to give any information or to make any representations not contained in this prospectus. You must not rely on any unauthorized information. This prospectus is not an offer to sell these securities in any jurisdiction where an offer or sale is not permitted.