# EDGAR Filing Document

**Accession Number:** 0001429260
**File Stem:** 0001104659-23-018490
**Filing Date:** 2023-2
**Character Count:** 106389
**Document Hash:** 724d199393a84c2dd4689bce88a49e2b
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001104659-23-018490.hdr.sgml**: 20230210

**ACCESSION NUMBER**: 0001104659-23-018490

**CONFORMED SUBMISSION TYPE**: S-3

**PUBLIC DOCUMENT COUNT**: 8

**FILED AS OF DATE**: 20230210

**DATE AS OF CHANGE**: 20230210

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Fortress Biotech, Inc.
- **CENTRAL INDEX KEY:** 0001429260
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 205157386
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** S-3
- **SEC ACT:** 1933 Act
- **SEC FILE NUMBER:** 333-269687
- **FILM NUMBER:** 23611694

**BUSINESS ADDRESS:**
- **STREET 1:** 1111 KANE CONCOURSE
- **STREET 2:** SUITE 301
- **CITY:** BAY HARBOR ISLANDS
- **STATE:** FL
- **ZIP:** 33154
- **BUSINESS PHONE:** 781-652-4500

**MAIL ADDRESS:**
- **STREET 1:** 1111 KANE CONCOURSE
- **STREET 2:** SUITE 301
- **CITY:** BAY HARBOR ISLANDS
- **STATE:** FL
- **ZIP:** 33154

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** CORONADO BIOSCIENCES INC
- **DATE OF NAME CHANGE:** 20080310

**As filed with the Securities and Exchange Commission on February 10, 2023**

**Registration No. 333-**

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

**FORM S-3**

**REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933**

**FORTRESS BIOTECH, INC.**

(Exact name of registrant as specified in its charter)

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| | |
|:---|:---|
| **Delaware** | **20-5157386** |
| (State or other jurisdiction of<br> incorporation or organization) | (I.R.S. Employer<br> Identification No.) |
| **1111 Kane Concourse, Suite 301**<br> **Bay Harbor Islands, FL**  | **33154** |
| (Address, including zip code, and telephone number,<br> including area code, of registrant's principal executive offices) | (Zip Code) |

---

---

| |
|:---|
| **Lindsay A. Rosenwald, M.D. *<br> Executive Chairman,*** |
| ***Chief Executive Officer and President***<br> **1111 Kane Concourse, Suite 301**<br> **Bay Harbor Islands, FL 33154**<br> **(781) 652-4500** |

---

(Name, address, including zip code, and telephone number,

including area code, of agent for service)

**Copy to:**

 **Rakesh Gopalan**<br> **McGuireWoods LLP**<br> **201 North Tryon Street, Suite 3000**<br> **Charlotte, North Carolina 28202**<br> **(704) 373-2275**<br>

**Approximate date of commencement of proposed sale to the public:** From time to time after the effective date of this Registration Statement.

If the only securities being registered on this Form are being offered pursuant to dividend or interest reinvestment plans, please check the following box. ◻

If any of the securities being registered on this form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. ⌧

If this form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ◻

If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ◻

If this Form is a registration statement pursuant to General Instruction I.D. or a post-effective amendment thereto that shall become effective upon filing with the Commission pursuant to Rule 462(e) under the Securities Act, check the following box. ◻

If this Form is a post-effective amendment to a registration statement filed pursuant to General Instruction I.D. filed to register additional securities or additional classes of securities pursuant to Rule 413(b) under the Securities Act, check the following box. ◻

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of "large accelerated filer," "accelerated filer," "smaller reporting company," and "emerging growth company" in Rule 12b-2 of the Exchange Act.

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| | | | |
|:---|:---|:---|:---|
| Large accelerated filer | ◻ | Accelerated filer | ◻ |
| Non-accelerated filer | ⌧ | Smaller reporting company | ⌧ |
|  |  | 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 7(a)(2)(B) of the Securities Act. ◻

**The Registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.**

**The information in this prospectus is not complete and may be changed. The selling stockholders named in this prospectus may not sell these securities until the registration statement becomes effective. This prospectus is not an offer to sell these securities, and the selling stockholders named in this prospectus are not soliciting offers to buy these securities in any jurisdiction where the offer for sale is not permitted.**

**Subject To Completion, Dated February 10, 2023**

**PROSPECTUS**

![](tm235864d1_s3-img01.jpg)

**647,000 Shares of Common Stock**

This prospectus relates to the resale by the selling stockholders (the "Selling Stockholders") identified in this prospectus under the section "The Selling Stockholders," or their pledgees, donees, transferees or other successors in interest, from time to time, of up to 647,000 shares of our Common Stock, par value $0.001 per share (the "Common Stock"), issuable in connection with the Dividend Payment and Exchange Agreement dated as of December 27, 2022 (the "Dividend Agreement") executed by Fortress Biotech, Inc. for the benefit of the holders of Urica Therapeutics, Inc. 8% Cumulative Redeemable Perpetual Class B Preferred Stock (the "Urica Preferred Stock"), and pursuant to the terms of the Urica Preferred Stock. We are registering the Common Stock on behalf of the Selling Stockholders, to be offered and sold from time to time, to satisfy certain registration rights that we have granted to the Selling Stockholders.

The Selling Stockholders may resell or dispose of the Common Stock, or interests therein, at fixed prices, at prevailing market prices at the time of sale or at prices negotiated with purchasers, to or through underwriters, broker-dealers, agents, or through any other means described in the section of this prospectus entitled "Plan of Distribution". The Selling Stockholders will each bear their respective commissions and discounts, if any, attributable to the sale or disposition of the Common Stock, or interests therein, held by such Selling Stockholder. We will bear all costs, expenses and fees in connection with the registration of the Common Stock. We will not receive any of the proceeds from the sale of the Common Stock by the Selling Stockholders.

The Common Stock is listed on The Nasdaq Capital Market, or Nasdaq, under the symbol "FBIO." On February 9, 2023, the last reported sale price of our Common Stock was $0.761 per share. You are urged to obtain current market quotations for our Common Stock.

**Investing in our securities involves risks. You should review carefully the risks and uncertainties described under the heading "Risk Factors" contained in this prospectus and under similar headings in the other documents that are incorporated by reference into this prospectus as described on page 4 of this prospectus.**

**Neither the Securities and Exchange Commission (the "SEC") nor any state securities commission has approved or disapproved of these securities or passed upon the accuracy or adequacy of this prospectus. Any representation to the contrary is a criminal offense.**

The date of this Prospectus is , 2023

**TABLE OF CONTENTS**

---

| | |
|:---|:---|
| Prospectus | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Page |
| [ABOUT THIS PROSPECTUS](#sp1a_001) | [ii](#sp1a_001) |
| [FORWARD-LOOKING STATEMENTS](#sp1a_002) | [iii](#sp1a_002) |
| [SUMMARY](#sp1a_003) | [1](#sp1a_003) |
| [THE OFFERING](#sp1a_004) | [3](#sp1a_004) |
| [RISK FACTORS](#sp1a_005) | [4](#sp1a_005) |
| [USE OF PROCEEDS](#sp1a_006) | [5](#sp1a_006) |
| [THE SELLING STOCKHOLDERS](#sp1a_007) | [6](#sp1a_007) |
| [DESCRIPTION OF SECURITIES BEING REGISTERED](#sp1a_008) | [9](#sp1a_008) |
| [CERTAIN U.S. FEDERAL INCOME TAX CONSIDERATIONS](#sp1a_009) | [10](#sp1a_009) |
| [PLAN OF DISTRIBUTION](#sp1a_010) | [15](#sp1a_010) |
| [LEGAL MATTERS](#sp1a_011) | [17](#sp1a_011) |
| [EXPERTS](#sp1a_012) | [17](#sp1a_012) |
| [WHERE YOU CAN FIND MORE INFORMATION](#sp1a_013) | [18](#sp1a_013) |
| [INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE](#sp1a_014) | [18](#sp1a_014) |

---

i

**ABOUT THIS PROSPECTUS**

This prospectus provides you with a general description of the Common Stock that may be resold by the Selling Stockholders. In certain circumstances, we may provide a prospectus supplement that will contain specific information about the terms of a particular offering by the Selling Stockholders. We also may provide a prospectus supplement to add information to, or update or change information contained in, this prospectus. To the extent there is a conflict between the information contained in this prospectus and any prospectus supplement, you should rely on the information in the prospectus supplement, provided that if any statement in one of these documents is inconsistent with a statement in another document having a later date — for example, a document incorporated by reference in this prospectus or any prospectus supplement — the statement in the later-dated document modifies or supersedes the earlier statement.

You should read both this prospectus and any applicable prospectus supplement together with the additional information about our company to which we refer you in the sections of this prospectus entitled "Where You Can Find More Information" and "Incorporation of Certain Documents by Reference." You should rely only on the information contained in or incorporated by reference into this prospectus and any prospectus supplement. Neither we nor the Selling Stockholders have authorized any dealer, sales person or other person to provide you with different information. You should not assume that the information in this prospectus or any prospectus supplement is accurate as of any date other than the date on the front of those documents or that any document incorporated by reference is accurate as of any date other than its filing date. You should not consider this prospectus to be an offer or solicitation relating to the Common Stock in any jurisdiction in which such an offer or solicitation relating to the Common Stock is not authorized. Furthermore, you should not consider this prospectus to be an offer or solicitation relating to the Common Stock if the person making the offer or solicitation is not qualified to do so, or if it is unlawful for you to receive such an offer or solicitation.

Unless the context indicates otherwise, when we refer to "Fortress," "we," "our," "us" and the "Company" in this prospectus, we mean Fortress Biotech, Inc., unless otherwise specified. When we refer to "you," we mean the potential holders of the applicable series of Common Stock.

ii

**FORWARD-LOOKING STATEMENTS**

This prospectus, including the documents that we incorporate by reference, may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as Amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. Statements in this prospectus, and documents we incorporate by reference, that are not descriptions of historical facts are forward-looking statements that are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. For such forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. We have attempted to identify forward-looking statements by terminology including "anticipates," "believes," "can," "continue," "could," "estimates," "expects," "intends," "may," "might," "plans," "potential," "predicts," "should," or "will" or the negative of these terms or other comparable terminology. Factors that could cause actual results to differ materially from those currently anticipated include those set forth under "Risk Factors" including, in particular, risks relating to:

&nbsp;&nbsp;&nbsp;&nbsp;· our growth strategy;

&nbsp;&nbsp;&nbsp;&nbsp;· our ability to continue to commercialize products;

&nbsp;&nbsp;&nbsp;&nbsp;· our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis;

&nbsp;&nbsp;&nbsp;&nbsp;· financing and strategic agreements, acquisitions and relationships;

&nbsp;&nbsp;&nbsp;&nbsp;· our need for substantial additional funds and uncertainties relating to financings;

&nbsp;&nbsp;&nbsp;&nbsp;· our ability to attract, integrate and retain key personnel;

&nbsp;&nbsp;&nbsp;&nbsp;· the early stage of products under development;

&nbsp;&nbsp;&nbsp;&nbsp;· the results of research and development activities;

&nbsp;&nbsp;&nbsp;&nbsp;· uncertainties relating to preclinical and clinical testing;

&nbsp;&nbsp;&nbsp;&nbsp;· our ability to secure and maintain third-party manufacturing, marketing and distribution of our products;

&nbsp;&nbsp;&nbsp;&nbsp;· dependence on third-party suppliers;

&nbsp;&nbsp;&nbsp;&nbsp;· government regulation;

&nbsp;&nbsp;&nbsp;&nbsp;· patent and intellectual property matters; and

&nbsp;&nbsp;&nbsp;&nbsp;· competition.

You should read this prospectus and the documents that we reference herein completely and with the understanding that our actual future results may be materially different from what we currently expect. You should assume that the information appearing in this prospectus and any document incorporated by reference is accurate as of its date only. Because the risk factors referred to above could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements made by us or on our behalf, you should not place undue reliance on any forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and we undertake no obligation to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for us to predict which factors will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. We qualify all of the information presented in this prospectus, any accompanying prospectus supplement and any document incorporated herein by reference, and particularly our forward-looking statements, by these cautionary statements.

iii

**SUMMARY**

*This summary highlights information contained elsewhere in or incorporated by reference into this prospectus. Because this is a summary, it may not contain all of the information that may be important to you and to your investment decision. The following summary is qualified in its entirety by the more detailed information and financial statements and notes thereto included elsewhere in this prospectus and the documents incorporated herein by reference and other documents to which we refer. You should read "Risk Factors" beginning on page 4 of this prospectus, as well as the information appearing under the caption "Item 1A. Risk Factors" in our [Annual Report on Form 10-K for the fiscal year ended December 31, 2021](https://www.sec.gov/ix?doc=/Archives/edgar/data/1429260/000155837022004487/fbio-20211231x10k.htm) and "Item 1A. Risk Factors" in our Quarterly Reports on Form 10-Q for the quarters ended [March 31, 2022](https://www.sec.gov/ix?doc=/Archives/edgar/data/1429260/000155837022008557/fbio-20220331x10q.htm), [June 30, 2022](https://www.sec.gov/ix?doc=/Archives/edgar/data/1429260/000155837022013275/fbio-20220630x10q.htm) and [September 30, 2022](https://www.sec.gov/ix?doc=/Archives/edgar/data/1429260/000155837022017763/fbio-20220930x10q.htm), as may be updated by our subsequently filed Exchange Act reports, for more information about important risks that you should consider carefully before buying our Common Stock.*

**Overview**

Fortress Biotech, Inc. ("Fortress" or the "Company") is a biopharmaceutical company dedicated to acquiring, developing and commercializing pharmaceutical and biotechnology products and product candidates, which the Company does at the Fortress level, at its majority-owned and majority-controlled subsidiaries and joint ventures, and at entities the Company founded and in which it maintains significant minority ownership positions. Fortress has a talented and experienced business development team, comprised of scientists, doctors and finance professionals, who identify and evaluate promising products and product candidates for potential acquisition by new or existing partner companies. Fortress, through its partner companies, has executed such arrangements in partnership with some of the world's foremost universities, research institutes and pharmaceutical companies, including City of Hope National Medical Center, Fred Hutchinson Cancer Center, St. Jude Children's Research Hospital, Dana-Farber Cancer Institute, Nationwide Children's Hospital, Cincinnati Children's Hospital Medical Center, the University of Pennsylvania, Mayo Foundation for Medical Education and Research, AstraZeneca plc and Dr. Reddy's Laboratories, Ltd.

**Business Strategy**

Following the exclusive license or other acquisition of the intellectual property underpinning a product or product candidate, Fortress leverages its business, scientific, regulatory, legal and financial expertise to help the partners achieve their goals. Partner companies then assess a broad range of strategic arrangements to accelerate and provide additional funding to support research and development, including joint ventures, partnerships, out-licensings, and public and private financings. To date, four partner companies are publicly-traded, and two have consummated strategic partnerships with industry leaders AstraZeneca plc, as successor-in-interest to Alexion Pharmaceuticals, Inc., ("AstraZeneca") and Sentynl Therapeutics, Inc. ("Sentynl").

Our subsidiary and partner companies that are pursuing development and/or commercialization of biopharmaceutical products and product candidates include Avenue Therapeutics (Nasdaq: ATXI, "Avenue"), Aevitas Therapeutics, Inc. ("Aevitas"), Baergic Bio, Inc. ("Baergic", a subsidiary of Avenue), Cellvation, Inc. ("Cellvation"), Checkpoint Therapeutics, Inc. (Nasdaq: CKPT, "Checkpoint"), Cyprium Therapeutics, Inc. ("Cyprium"), Helocyte, Inc. ("Helocyte"), Journey Medical Corporation (Nasdaq: DERM, "Journey" or "JMC"), Mustang Bio, Inc. (Nasdaq: MBIO, "Mustang"), Oncogenuity, Inc. ("Oncogenuity") and Urica Therapeutics, Inc. ("Urica").

**Corporate Information**

Our principal executive offices are located at 1111 Kane Concourse Suite 301 Bay Harbor Islands, FL 33154, and our telephone number is 781-652-4500. We maintain a website on the Internet at www.fortressbiotech.com and our e-mail address is info@fortressbiotech.com. Our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to reports filed or furnished pursuant to Sections 13(a) and 15(d) of the Exchange Act are available, free of charge, under the Investor Relations tab of our website as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC. The SEC also maintains an Internet website located at www.sec.gov that contains the information we file or furnish electronically with the SEC. Information found on, or accessible through, our website is not a part of, and is not incorporated into, this prospectus, and you should not consider it part of this prospectus.

**Dividend Payment and Exchange Agreement**

On December 27, 2022, we executed the Dividend Agreement for the benefit of the holders of Urica Preferred Stock, pursuant to which we agreed to pay cumulative dividends on the Urica Preferred Stock in shares of our Common Stock.

In addition, in connection with the Dividend Agreement, we entered into a Registration Rights Agreement with the Selling Stockholders (the "Registration Rights Agreement") in which we agreed to prepare and file with the SEC a registration statement with respect to resales of the Common Stock issued to the Selling Stockholders as dividends on the Urica Preferred Stock. Accordingly, as required by the Registration Rights Agreement, the registration statement of which this prospectus is a part relates to the offer and resale of the Common Stock issued to the Selling stockholders under the terms of the Urica Preferred Stock and in connection with the Dividend Agreement.

In connection with the issuance of shares of Common Stock as dividends on the Urica Preferred Stock, Urica will issue to the Company, as consideration therefor, a number of shares of Urica common stock, par value $0.0001 per share, with a fair market value equal to the fair market value of any shares of Common Stock so issued as dividends.

**THE OFFERING**

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| | |
|:---|:---|
| Issuer | Fortress Biotech, Inc. |
| Securities Offered by Selling Stockholders | 647,000 shares of the Company's Common Stock, per share issuable as to the Selling Stockholders in accordance with the terms of the Urica Preferred Stock and Dividend Agreement. |
| Terms of the Offering | The Selling Stockholders will each determine when and how they will sell the Common Stock offered in this prospectus, as described in the "Plan of Distribution." |
| Use of Proceeds | We will not receive any proceeds from the sale of the Common Stock by the Selling Stockholders in this offering. See "Use of Proceeds." |
| Risk Factors | See "Risk Factors" incorporated by reference into this prospectus from our most current Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, for a discussion of certain factors you should carefully consider before deciding to invest in shares of our Common Stock. |
| Nasdaq Capital Market Symbol | FBIO |

---

**RISK FACTORS**

Investing in our Common Stock involves a high degree of risk. You should consider carefully the risks and uncertainties described below, together with all of the other information in our [Annual Report on Form 10-K for the fiscal year ended December 31, 2021](https://www.sec.gov/ix?doc=/Archives/edgar/data/1429260/000155837022004487/fbio-20211231x10k.htm), including the consolidated financial statements and the related notes, and in our Quarterly Reports on Form 10-Q for the quarters ended [March 31, 2022](https://www.sec.gov/ix?doc=/Archives/edgar/data/1429260/000155837022008557/fbio-20220331x10q.htm), [June 30, 2022](https://www.sec.gov/ix?doc=/Archives/edgar/data/1429260/000155837022013275/fbio-20220630x10q.htm) and [September 30, 2022](https://www.sec.gov/ix?doc=/Archives/edgar/data/1429260/000155837022017763/fbio-20220930x10q.htm) as well as the risks, uncertainties and other information set forth in the reports and other materials filed or furnished by our partners and affiliates Journey, Checkpoint, Mustang, and Avenue with the SEC, before deciding to invest in our Common Stock, as well as any amendment or update to our risk factors in subsequent filings with the SEC, and other information in our consolidated financial statements, all of which are incorporated by reference into this prospectus. If any of the following risks, the risk factors incorporated by reference hereto or the risks included in the public filings of Journey, Checkpoint, Mustang or Avenue were to materialize, our business, financial condition, results of operations, and future growth prospects could be materially and adversely affected. In that event, the market price of our Common Stock could decline, and you could lose part of or all of your investment in our Common Stock. In addition, you should be aware that the below stated risks should be read as being applicable to our partners and affiliates such that, if any of the negative outcomes associated with any such risk is experienced by one of our partners or affiliates, the value of Fortress' holdings in such partner or affiliate (if any) may decline.

**USE OF PROCEEDS**

We will not receive any proceeds from the sale of the Common Stock covered by this prospectus and any accompanying prospectus supplement. All proceeds from the sale of the Common Stock will be for the respective accounts of the Selling Stockholders named herein.

We will bear all other costs, fees and expenses incurred in effecting the registration of the Common Stock covered by this prospectus and any accompanying prospectus supplement, including, without limitation, all registration and filing fees, Nasdaq listing fees and fees and expenses of our counsel and our accountants, in accordance with the terms of the Urica Preferred Stock. Each Selling Stockholder will pay any discounts, commissions, and fees of underwriters, selling brokers, dealer managers or similar securities industry professionals incurred by such Selling Stockholder in disposing of the Common Stock covered by this prospectus.

**THE SELLING STOCKHOLDERS**

We have prepared this prospectus to allow the Selling Stockholders or their pledgees, donees, transferees or other successors in interest, to sell or otherwise dispose of, from time to time, Common Stock issuable as dividends pursuant to the terms of the Urica Preferred Stock and the Dividend Agreement.

On December 27, 2022, we entered into the Dividend Agreement for the benefit of the holders of Urica Preferred Stock, pursuant to which we agreed to pay cumulative dividends on the Urica Preferred Stock in shares of our Common Stock. In connection with certain registration rights that we granted to the Selling Stockholders pursuant to the Registration Rights Agreement, we filed with the SEC a registration statement on Form S-3, of which this prospectus forms a part, with respect to the resale or other disposition of the Common Stock offered by this prospectus from time to time on Nasdaq, in privately negotiated transactions or otherwise. We have agreed to prepare and file amendments and supplements to the registration statement to the extent necessary to keep the registration statement effective for the period of time required under our agreement with the Selling Stockholders.

All information with respect to the Selling Stockholders' ownership of the Common Stock has been furnished by or on behalf of the Selling Stockholders and is as of February 7, 2023. The percentage ownership data is based on 108,259,353 shares of Common Stock issued and outstanding as of September 30, 2022. We believe, based on information supplied by the Selling Stockholders, that except as may otherwise be indicated in the table below, the Selling Stockholders and their affiliates listed in any footnote to the table below have sole voting and dispositive power with respect to the Common Stock reported as beneficially owned by them.

The aggregate number of shares of Common Stock that the Selling Stockholders may offer and sell pursuant to this prospectus is based upon a good faith estimation of the amount of Common Stock that may be issued to the Selling Stockholders pursuant to the terms of the Urica Preferred Stock. Therefore, if needed, we will file a post-effective amendment to the registration statement or additional registration statements, to add such aggregate number of Common Stock each Selling Stockholder may offer and sell. The Selling Stockholders may sell some, all or none of the Common Stock. We do not know how long the Selling Stockholders will hold the shares of Common Stock before selling them, and we currently have no agreements, arrangements or understandings with any Selling Stockholders regarding the sale or other disposition of any of the Common Stock. The Common Stock may be offered and sold from time to time by the Selling Stockholders pursuant to this prospectus.

Because the Selling Stockholders may sell some or all of the Common Stock included in this prospectus, and because there are currently no agreements, arrangements or understandings with respect to the sale of any of the Common Stock, no estimate can be given as to the number of shares of Common Stock available for resale hereby that will be held by the Selling Stockholders in the future. In addition, the Selling Stockholders may have sold, transferred or otherwise disposed of, or may sell, transfer or otherwise dispose of, at any time and from time to time, the Common Stock they hold in transactions exempt from the registration requirements of the Securities Act after the date on which they provided the information set forth in the table below. We have, therefore, assumed for the purposes of the following table, that the Selling Stockholders will sell all of the shares of Common Stock owned beneficially by them and their affiliates listed in any footnote to the table below that are covered by this prospectus.

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| | | | | |
|:---|:---|:---|:---|:---|
| **Selling Stockholder Information:** | **Selling Stockholder Information:** | **Selling Stockholder Information:** | **Selling Stockholder Information:** | **Selling Stockholder Information:** |
| **Selling Stockholders<sup>(1)</sup>** | **Shares Owned<br> Immediately Prior<br> to the Offering** | **Shares Being<br> Offered for<br> Resale Under this<br> Prospectus** | **Number of <br> Shares<br> Beneficially <br> Owned After <br> Sale of Shares<sup>(2)</sup>** | **Percentage of<br> Outstanding Shares<br> of Common Stock<br> Beneficially Owned<br> Immediately<br> Following the Sale of<br> Shares<sup>(3)</sup>** |
| Alejandro Messmacher |  | 19000 | 19000 | 0.0% |
| Andrew R. McDonald |  | 4000 | 4000 | 0.0% |
| Anthony Van Hoven |  | 38000 | 38000 | 0.0% |
| Brian Dummann |  | 24000 | 24000 | 0.0% |
| Bryan K. Melvin |  | 10000 | 10000 | 0.0% |
| Claude Roussel |  | 4000 | 4000 | 0.0% |
| Doug Tiffan |  | 5000 | 5000 | 0.0% |
| Douglas Battaglia |  | 16000 | 16000 | 0.0% |
| Geoffrey C. Maddock |  | 10000 | 10000 | 0.0% |
| Gregory Konsor | 4432 | 19000 | 23432 | 0.0% |
| Hochman Family LLLP |  | 5000 | 5000 | 0.0% |
| James Ellinwood |  | 10000 | 10000 | 0.0% |
| James O. Ellinwood |  | 19000 | 19000 | 0.0% |
| John and Jane Herbert Revocable Trust |  | 28000 | 28000 | 0.0% |
| JSGM Trust |  | 6000 | 6000 | 0.0% |
| Keith Schroeder | 2807 | 28000 | 30807 | 0.0% |
| Kevin Stein | 1545 | 186000 | 187545 | 0.2% |
| Leon Goldschmidt | 6071 | 3000 | 9071 | 0.0% |
| Lori Kelley |  | 6000 | 6000 | 0.0% |
| Mark Bradley | 3254 | 5000 | 8254 | 0.0% |
| Mark Wiltse |  | 10000 | 10000 | 0.0% |
| Michael Thielen |  | 4000 | 4000 | 0.0% |
| MONEST LLC |  | 19000 | 19000 | 0.0% |
| Paul Glauber |  | 5000 | 5000 | 0.0% |
| Paul Hoyle | 772 | 11000 | 11772 | 0.0% |
| Rick and Kristine Zabel |  | 5000 | 5000 | 0.0% |
| Robert and Brenda Tully |  | 14000 | 14000 | 0.0% |
| Roger and Christie Gildehaus |  | 19000 | 19000 | 0.0% |
| Steven Zaloga | 1545 | 10000 | 11545 | 0.0% |
| T. Mrak Sledge |  | 6000 | 6000 | 0.0% |
| The Holroyd Family Revocable Trust |  | 15000 | 15000 | 0.0% |
| The Michael C. Fox Revocable Trust |  | 11000 | 11000 | 0.0% |
| Thomas E. andenberg |  | 16000 | 16000 | 0.0% |
| Tom Kreszl |  | 5000 | 5000 | 0.0% |
| Vincent Shoemaker |  | 19000 | 19000 | 0.0% |
| Vito LaVopa |  | 5000 | 5000 | 0.0% |
| William Bonifas | - | 4000 | 4000 | 0.0% |
| **Total** | 20805 | 647000 | 667805 | 0.6% |

---

(1) The principal business address and address for notice to the Selling Stockholders will be the address
set forth in our books and records.

(2) Assumes the Selling Stockholders sell all of the shares of Common Stock being offered by this prospectus.

(3) Percentage calculated based upon the assumption that the Selling Stockholders sell all of the shares of
Common Stock offered by this prospectus.

**Relationship with the Selling Stockholders**

*Dividend Payment and Exchange Agreement*

As discussed above under the section "Summary — Dividend Payment and Exchange Agreement," on December 27, 2022, we executed the Dividend Agreement for the benefit of the holders for the Urica Preferred Stock, pursuant to which we agreed to pay cumulative dividends on the Urica Preferred Stock in shares of our Common Stock.

*Registration Rights Agreement*

Pursuant to the Registration Rights Agreement with the Selling Stockholders, we agreed to prepare and file with the SEC the registration statement, of which this prospectus forms a part, that permits the resale of the Common Stock and, subject to certain exceptions, to use reasonable best efforts to keep such registration statement effective under the Securities Act until (i) all Common Stock registered by the registration statement have been sold, transferred or otherwise disposed of by the Selling Stockholders, (ii) the Common Stock is sold, transferred or otherwise disposed of pursuant to Rule 144 of the Securities Act, or (iii) the Common Stock has become eligible for sale by the Selling Stockholders pursuant to Rule 144 without any restriction on the volume or manner of such sale and all restrictive legends and stop transfer instructions have been removed with respect to all book entries representing the Common Stock.

We have also agreed, among other things, to indemnify the Selling Stockholders and their officers, directors, members, employees and agents, successors and assigns, and any person who controls any of the Selling Stockholders (within the meaning of the Securities Act or the Exchange Act) from all losses and liabilities arising out of or relating to any untrue statement or alleged untrue statement or omission or alleged omission of material fact relating to the Common Stock in this prospectus or the registration statement of which this prospectus forms a part.

Except as described above, neither the Selling Stockholders nor any persons having control over such Selling Stockholders have held any position or office with us or our affiliates within the last three years or has had a material relationship with us or any of our predecessors or affiliates within the past three years, other than as a result of the ownership of shares of our Common Stock or other securities.

**DESCRIPTION OF SECURITIES BEING REGISTERED**

We are registering 647,000 shares of our Common Stock issuable in connection with the Dividend Agreement for the benefit of the holders of Urica Preferred Stock, and pursuant to the terms of the Urica Preferred Stock.

**Common Stock**

The Company's Certificate of Incorporation, as amended, authorizes the Company to issue up to 200,000,000 shares of Common Stock. Our Common Stock is traded on The Nasdaq Capital Market under the symbol "FBIO."

The terms, rights, preference and privileges of the Common Stock are as follows:

*Voting Rights*

Each holder of Common Stock is entitled to one vote per share of Common Stock held on all matters submitted to a vote of the stockholders, including the election of directors. The Company's certificate of incorporation and bylaws do not provide for cumulative voting rights.

*Dividends*

Subject to preferences that may be applicable to any then-outstanding preferred stock, the holders of the Company's outstanding shares of Common Stock are entitled to receive dividends, if any, as may be declared from time to time by the Company's Board of Directors out of legally available funds.

*Liquidation*

In the event of the Company's liquidation, dissolution or winding up, holders of Common Stock will be entitled to share ratably in the net assets legally available for distribution to stockholders after the payment of all of the Company's debts and other liabilities, subject to the satisfaction of any liquidation preference granted to the holders of any outstanding shares of preferred stock.

*Rights and Preference*

Holders of the Company's Common Stock have no preemptive, conversion or subscription rights, and there is no redemption or sinking fund provisions applicable to our 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 the Company's preferred stock that are or may be issued.

*Fully Paid and Nonassessable*

All of the Company's outstanding shares of Common Stock are fully paid and nonassessable.

**CERTAIN U.S. FEDERAL INCOME TAX CONSIDERATIONS**

The following discussion summarizes certain U.S. federal income tax considerations of the acquisition, ownership and disposition of the Common Stock offered by this prospectus but does not purport to be a complete analysis of all potential tax effects. This discussion does not address effects of other U.S. federal tax laws, such as estate and gift tax laws, or of state, local, non-U.S or other tax considerations that may be relevant to a purchaser or holder of the Common Stock in light of their particular circumstances. This discussion is based on the U.S. Internal Revenue Code of 1986, as amended (the "Code"), the Treasury regulations promulgated thereunder, judicial decisions, and published rulings and administrative pronouncements of the U.S. Internal Revenue Service (the "IRS"), in each case as of the date hereof. These authorities may change, possibly with retroactive effect, or may be subject to differing interpretations that may adversely affect a holder of the Common Stock. There can be no assurance the IRS or a court will not take a contrary position to that discussed below regarding the acquisition, ownership and disposition of the Common Stock.

This discussion is limited to holders that hold the Common Stock as a capital asset within the meaning of Section 1221 of the Code (generally property held for investment). This discussion does not describe all of the U.S. federal income tax consequences that may be relevant to a holder in light of its particular circumstances, including the impact of the alternative minimum tax and of the Medicare contribution tax on net investment income. In addition, it does not address consequences for holders subject to special rules, including without limitation:

● U.S. expatriates and former citizens or long-term residents of the United States;

● persons holding the Common Stock as part of a hedge, straddle, conversion, or other integrated transaction;

● banks, insurance companies, and other financial institutions;

● brokers, dealers or traders in securities;

● "controlled foreign corporations," "passive foreign investment companies," and corporations that accumulate earnings to avoid U.S. federal income tax;

● S corporations or entities or arrangements that are treated as partnerships for U.S. federal income tax purposes (and investors therein);

● tax-exempt organizations or governmental organizations;

● real estate investment trusts or regulated investment companies;

● U.S. persons whose functional currency is not the U.S. dollar;

● persons subject to special tax accounting rules;

● persons who hold or receive the Common Stock pursuant to the exercise of any employee stock option or otherwise as compensation;

● persons deemed to sell our Common Stock under the constructive sale provisions of the Code;

● tax-qualified retirement plans, individual retirement accounts or other tax-deferred accounts; and

● "qualified foreign pension funds" as defined in Section 897(l)(2) of the Code.

If a partnership (or any other entity treated as a partnership for U.S. federal income tax purposes) holds the Common Stock, the U.S. federal income tax treatment of a partner of that partnership generally will depend upon the status of the partner and the activities of the partnership. If you are a partnership or a partner of a partnership holding the Common Stock, you should consult your tax advisors as to the particular U.S. federal income tax consequences of holding and disposing of the Common Stock.

**This discussion is for information purposes only and is not tax advice. You should consult your own independent tax advisor concerning the application of the U.S. federal income tax laws to your particular circumstances as well as any tax consequences for the acquisition, ownership, or disposition of the Common Stock arising under other U.S. federal tax laws and the laws of any state, local or non-U.S. tax jurisdiction or under any applicable income tax treaty.**

For purposes of this discussion, a "U.S. holder" is a beneficial owner of our Common Stock that, for U.S. federal income tax purposes, is or is treated as:

● an individual who is a citizen or resident of the United States;

● a corporation created or organized under the laws of the United States, any state thereof, or the District of Columbia;

● an estate the income of which is subject to U.S. federal income taxation regardless of its source; or

● a trust that (i) is subject to the primary supervision of a U.S. court and the control of one or more "United States persons" (within the meaning of Section 770 1(a)(30) of the Code) or (ii) has a valid election in effect to be treated as a United States person for U.S. federal income tax purposes.

A "non-U.S. holder" is any beneficial owner of our Common Stock that is not a U.S. holder.

**U.S. Holders**

***Distributions in General***

If distributions are made with respect to the Common Stock, such distributions will be treated as dividends to the extent of our current or accumulated earnings and profits as determined under the Code. Subject to customary conditions and limitations, dividends will be eligible for the dividends-received deduction in the case of U.S. holders that are (or are treated for U.S. federal income tax purposes) as corporations. Dividends paid to non-corporate U.S. holders generally will qualify for taxation at preferential rates if those holders meet certain holding period and other applicable requirements. Dividends received by non-corporate U.S. holders may also be subject to the additional 3.8% tax on net investment income. Any portion of a distribution that exceeds our current and accumulated earnings and profits will first be applied to reduce a U.S. holder's tax basis in the Common Stock, but not below zero. Distributions in excess of our current and accumulated earnings and profits and in excess of a U.S. holder's tax basis in its shares will be taxable as gain from the disposition of the Common Stock, the tax treatment of which is discussed below.

***Extraordinary Dividends***

Dividends that exceed certain thresholds in relation to a U.S. holder's tax basis in the Common Stock could be characterized as "extraordinary dividends" under Section 1059 of the Code. Corporate U.S. holders that have held our Common Stock for two years or less before the dividend announcement date and that receive an extraordinary dividend will generally be required to reduce their tax basis in the stock by the nontaxed portion of the dividend due to the dividends-received deduction. If the amount of reduction exceeds the U.S. holder's tax basis in the stock, the excess will be taxable as gain from the disposition of the stock, the tax treatment of which is discussed below. Non-corporate U.S. holders that receive an extraordinary dividend will be required to treat any losses on the sale of our Common Stock as long-term capital losses to the extent of the extraordinary dividends such U.S. holders receive that qualify for taxation as the preferential rates discussed above under "— Distributions in General." U.S. holders are urged to consult their tax advisors with respect to the eligibility for and amount of any dividend received deduction and the application of Section 1059 of the Code to any dividends they receive.

***Disposition of Common Stock by Sale, Exchange or Redemption***

Upon any sale or disposition (other than certain redemptions, as discussed below) of the Common Stock, a U.S. holder generally will recognize capital gain or loss equal to the difference between the amount realized by the U.S. holder and the U.S. holder's adjusted tax basis in the Common Stock. Such capital gain or loss will be long-term capital gain or loss if the U.S. holder's holding period for the Common Stock is longer than one year. Non-corporate U.S. holders may be eligible for preferential tax rates on long-term capital gains but also may be subject to the additional 3.8% tax on net investment income. The deductibility of capital losses is subject to limitations.

A redemption of the Common Stock will be treated as a sale or exchange described in the preceding paragraph if the redemption, based on the facts and circumstances, is treated for U.S. federal income tax purposes as (i) a "complete termination" of your interest in the Common Stock, (ii) a "substantially disproportionate" redemption of your Common Stock, or (iii) is "not essentially equivalent to a dividend", each within the meaning of Section 302 of the Code. In determining whether any of these tests has been met, you must take into account not only the Common Stock and other equity interests that you actually own but also other equity interests that you constructively own under U.S. federal income tax rules.

If you meet none of the alternative tests described above, the redemption will be treated as a distribution subject to the rules described under "—Distributions In General." If a redemption of the Common Stock is treated as a distribution that is taxable as a dividend, you are urged to consult your tax advisor regarding the allocation of your tax basis as between the redeemed and remaining shares of Common Stock.

***Information Reporting and Backup Withholding***

We or an applicable withholding agent will report to our U.S. holders and the IRS the amount of dividends (including deemed dividends) paid during each year and the amount of any tax withheld with respect to the Common Stock. Certain non-corporate U.S. holders may be subject to U.S. backup withholding at a rate of 28% on payments of dividends on the Common Stock unless the holder furnishes the payor or its agent with a taxpayer identification number, certified under penalties of perjury, and certain other information or otherwise establishes an exemption from backup withholding. Backup withholding tax is not an additional tax. Any amounts withheld under the backup withholding rules may be allowed as a refund or a credit against a U.S. holder's U.S. federal income tax liability, provided the U.S. holder timely furnishes the required information to the IRS.

**Non-U.S. Holders**

***Distributions***

If distributions are made with respect to the Common Stock, such distributions will be treated as dividends to the extent of our current or accumulated earnings and profits as determined under the Code and may be subject to withholding as discussed below. Any portion of a distribution that exceeds our current and accumulated earnings and profits will first be applied to reduce the Non-U.S. holder's basis in the Common Stock, but not below zero. If the distribution exceeds our current and accumulated earnings and profits and the Non-U.S. holder's basis, the excess will be treated as gain from the disposition of the Common Stock, the tax treatment of which is discussed below.

In addition, if we are classified as a U.S. real property holding corporation (a "USRPHC") within the meaning of Section 897(c) of the Code and any distribution exceeds our current and accumulated earnings and profits, we will need to satisfy our withholding requirements either by (a) treating the entire distribution (even if in excess of earnings and profits) as a dividend subject to the withholding rules described below and withhold at a minimum rate of 15% or such lower rate as may be specified by an applicable income tax treaty for distributions from a USRPHC; or (b) treating (i) only the amount of the distribution equal to our reasonable estimate of our current and accumulated earnings and profits as a dividend subject to the withholding rules in the following paragraph; and (ii) the excess portion of the distribution as subject to withholding at a rate of 15% (or such lower rate as may be specified by an applicable income tax treaty), as if such excess were the result of a sale of shares in a USRPHC, with a credit generally allowed against the Non-U.S. holder's U.S. federal income tax liability for the tax withheld from such excess. We believe that we currently are not a USRPHC, and we do not expect to become a USRPHC for the foreseeable future (see discussion of USRPHCs below under "— *Disposition of Common Stock, Including Redemptions*").

Dividends (including amounts distributed by a USRPHC and subject to withholding as dividends per the preceding paragraph) paid to a Non-U.S. holder of the Common Stock will be subject to withholding of U.S. federal income tax at a 30% rate or such lower rate as may be specified by an applicable income tax treaty. However, dividends that are treated as being effectively connected with the conduct of a trade or business by the Non-U.S. holder within the United States (and, where a tax treaty applies, are attributable to a permanent establishment maintained by the Non-U.S. holder in the United States) are not subject to this withholding tax, provided that certain certification and disclosure requirements are satisfied including completing IRS Form W-8ECI (or other applicable form). Instead, such dividends are subject to U.S. federal income tax on a net income basis in the same manner as if the Non-U.S. holder were a United States person (as defined under the Code), unless an applicable income tax treaty provides otherwise. Any such effectively connected dividends received by a foreign corporation may be subject to an additional "branch profits tax" at a 30% rate or such lower rate as may be specified by an applicable income tax treaty.

A Non-U.S. holder of the Common Stock who wishes to claim the benefit of an applicable treaty rate and avoid backup withholding for dividends, as discussed below, will be required to (i) complete IRS Form W-8BEN or Form W-8BEN-E (or other applicable form) and certify under penalty of perjury that such holder is not a United States person as defined under the Code and is eligible for treaty benefits, or (ii) if the Common Stock is held through certain foreign intermediaries, satisfy the relevant certification requirements of applicable Treasury regulations. A Non-U.S. holder of the Common Stock eligible for a reduced rate of U.S. withholding tax pursuant to an income tax treaty may obtain a refund of any excess amounts withheld by timely filing an appropriate claim for refund with the U.S. Internal Revenue Service.

***Disposition of Common Stock, Including Redemptions***

Any gain realized by a Non-U.S. holder on the disposition of the Common Stock generally will not be subject to U.S. federal income or withholding tax unless:

● the gain is effectively connected with the conduct of a trade or business by the Non-U.S. holder in the United States (and, if required by an applicable income tax treaty, attributable to a permanent establishment maintained by the Non-U.S. holder in the United States);

● the Non-U.S. holder is an individual who is present in the United States for 183 days or more in the taxable year of disposition, and certain other conditions are met; or

● we are or have been a USRPHC, as defined in Section 897(c) of the Code, and a Non-U.S. holder owned directly or pursuant to applicable attribution rules at any time during the five-year period ending on the date of disposition more than 5% of the Common Stock — assuming that the Common Stock is regularly traded on an established securities market, within the meaning of Section 897(c)(3) of the Code.

A Non-U.S. holder described in the first bullet point immediately above will generally be subject to tax on the gain derived from the sale under regular graduated U.S. federal income tax rates in the same manner as if the Non-U.S. holder were a United States person as defined under the Code, and, if it is a corporation, may also be subject to branch profits tax equal of 30% (generally applicable to its effectively connected earnings and profits) or at such lower rate as may be specified by an applicable income tax treaty.

An individual Non-U.S. holder described in the second bullet point immediately above will be subject to a flat 30% tax (or at such reduced rate as may be provided by an applicable tax treaty) on the gain derived from the sale, which may be offset by U.S. source capital losses, even if the individual is not considered a resident of the United States for U.S. federal income tax purposes.

A Non-U.S. holder described in the third bullet point above will be subject to U.S. federal income tax under regular graduated U.S. federal income tax rates with respect to the gain realized in the same manner as if the Non-U.S. holder were a United States person as defined under the Code. A corporation is a USRPHC if it is a U.S. corporation and the fair market value of its U.S. real property interests equals or exceeds 50% of the sum of the fair market value of its worldwide real property interests and its other assets used or held for use in a trade or business. We believe that we currently are not a USRPHC for U.S. federal income tax purposes, and we do not expect to become a USRPHC for the foreseeable future. Our Common Stock will be listed on the NASDAQ Capital Market and we believe that, for as long as we continue to be so listed, our Common Stock will be treated as regularly traded on an established securities market. However, if we become a USRPHC and our Common Stock is regularly traded on an established securities market, a Non-U.S. holder generally will be subject to U.S. federal income tax on any gain from the disposition of such stock if such Non-U.S. holder has owned or is deemed to have owned more than 5% of our Common Stock, at any time within the shorter of the five-year period preceding the disposition or such holder's holding period for such stock.

If a Non-U.S. holder is subject to U.S. federal income tax on any sale, exchange, redemption (except as discussed below), or other disposition of the Common Stock, the Non-U.S. holder will recognize capital gain or loss equal to the difference between the amount realized by the Non-U.S. holder and the Non-U.S. holder's adjusted tax basis in the Common Stock. Such capital gain or loss will be long-term capital gain or loss if the Non-U.S. holder's holding period for the Common Stock is longer than one year. A Non-U.S. holder should consult its own independent tax advisors with respect to applicable tax rates and netting rules for capital gains and losses. Certain limitations exist on the deduction of capital losses by both corporate and non-corporate taxpayers.

If a Non-U.S. holder is subject to U.S. federal income tax on any disposition of the Common Stock, a redemption of shares of the Common Stock will be a taxable event. If the redemption is treated as a sale or exchange, instead of as a dividend, a Non-U.S. holder generally will recognize capital gain or loss, equal to the difference between the amount of cash received and fair market value of any property received and the Non-U.S. holder's adjusted tax basis in the Common Stock redeemed (except that to the extent that any cash received is attributable to any accrued but unpaid dividends), and such capital gain or loss will be long-term capital gain or loss if the Non-U.S. holder's holding period for such Common Stock exceeds one year,. A payment made in redemption of the Common Stock may be treated as a dividend (subject to taxation as discussed above under "—*Disposition of Common Stock, Including Redemptions*"), rather than as payment in exchange for the Common Stock, in the same circumstances discussed above under "— *Disposition of Common Stock, Including Redemptions*." Each Non-U.S. holder of the Common Stock should consult its own independent tax advisors to determine whether a payment made in redemption of the Common Stock will be treated as a dividend or as payment in exchange for the Common Stock.

***Information reporting and backup withholding.***

We must annually report to the IRS and to each Non-U.S. holder the amount of dividends (including constructive dividends) paid to such Non-U.S. holder and the tax withheld with respect to such dividends, regardless of whether withholding was required. Copies of the information returns reporting such dividends and withholding may also be made available under the provisions of an applicable tax treaty or agreement with the tax authorities in the country in which the non-U.S. holder resides. U.S. backup withholding will generally apply to the payment of dividends to non-U.S. holders unless such non-U.S. holders furnish to the payor an IRS Form W-8BEN or Form W-8BEN-E (or other applicable form) or otherwise establish an exemption.

Payment by a U.S. office of a broker of the proceeds of a sale of shares of our Common Stock is subject to both backup withholding and information reporting unless the non-U.S. holder, or beneficial owner thereof, as applicable, certifies that it is a non-U.S. holder on Form W-8BEN or Form W-8BEN-E (or other suitable substitute or successor form), or otherwise establishes an exemption. Subject to certain exceptions, backup withholding and information reporting generally will not apply to a payment of proceeds from the sale of shares of our Common Stock if such sale is effected through a foreign office of a broker, provided that the broker does not have certain U.S. connections. Any amount withheld under the backup withholding rules from a payment to a non-U.S. holder is allowable as a credit against such holder's U.S. federal income tax liability (if any), which may entitle the holder to a refund if in excess of such liability, provided that the holder timely provides the required information to the IRS. Non-U.S. holders are urged to consult their own tax advisers regarding the application of backup withholding in their particular circumstances and the availability of and procedure for obtaining an exemption from backup withholding under current Treasury Regulations.

***Foreign Account Tax Compliance Act.***

Sections 1471 to 1474 of the Code (such sections, and the Treasury Regulations and administrative guidance issued thereunder, commonly referred to as FATCA) impose a 30% U.S. withholding tax on certain "withholdable payments" made to a "foreign financial institution" or a "nonfinancial foreign entity." "Withholdable payments" include payments of dividends and the gross proceeds from a disposition of certain property (such as shares of our Common Stock), if such disposition occurs after December 31, 2018. In general, if a holder is a "foreign financial institution" (which includes investment entities such as hedge funds and private equity funds), the 30% withholding tax will apply to withholdable payments made to such holder, unless such holder enters into an agreement with the U.S. Department of Treasury to collect and provide substantial information regarding its U.S. account holders, including certain account holders that are foreign entities with U.S. owners, and to withhold 30% on certain "pass-through payments." If such holder is a "non-financial foreign entity," FATCA also generally will impose a withholding tax of 30% on withholdable payments made to such holder unless the holder provides the withholding agent with a certification that it does not have any "substantial United States owners" or a certification identifying its direct and indirect substantial United States owners. Intergovernmental agreements between the United States and a holder's resident country may modify some of the foregoing requirements.

Although withholding under FATCA would also have applied to payments of gross proceeds from the sale or other disposition of the Common Stock on or after January 1, 2019, Treasury Regulations proposed in late 2018 eliminate FATCA withholding on payments of gross proceeds entirely. Taxpayers generally may rely on these proposed Treasury Regulations until final Treasury Regulations are issued.

We will not pay any additional amounts to holders of the Common Stock in respect of any amounts withheld. Non-U.S. holders should consult their own tax advisers with respect to the U.S. federal income tax consequences of FATCA on their ownership and disposition of shares of our Common Stock.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Documentation that holders provide in order to be treated as FATCA compliant may be reported to the IRS and other tax authorities, including information about a holder's identity, its FATCA status and if applicable, its direct and indirect U.S. owners. Prospective investors should consult their tax advisers about how information reporting and the possible imposition of withholding tax under FATCA may apply to their investment in the Common Stock.

**PLAN OF DISTRIBUTION**

The Selling Stockholders, which as used herein includes donees, pledgees, transferees or other successors-in-interest selling shares of Common Stock or interests in shares of Common Stock received after the date of this prospectus from a Selling Stockholder as a gift, pledge, partnership distribution or other transfer, may, from time to time, sell, transfer or otherwise dispose of any or all of their shares of Common Stock or interests in shares of Common Stock on any stock exchange, market or trading facility on which the shares are traded or in private transactions. These dispositions may be at fixed prices, at prevailing market prices at the time of sale, at prices related to the prevailing market price, at varying prices determined at the time of sale, or at negotiated prices.

The Selling Stockholders may use any one or more of the following methods when disposing of shares or interests therein:

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

● block trades in which the broker-dealer will attempt to sell the shares 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;

● short sales effected after the date the registration statement of which this prospectus is a part is declared effective by the SEC;

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

● broker-dealers may agree with the Selling Stockholders to sell a specified number of such shares at a stipulated price per share;

● a combination of any such methods of sale; and

● any other method permitted by applicable law.

The Selling Stockholders may, from time to time, pledge or grant a security interest in some or all of the shares of Common Stock owned by them and, if they default in the performance of their secured obligations, the pledgees or secured parties may offer and sell the shares of Common Stock, from time to time, under this prospectus, or under an amendment to this prospectus under Rule 424(b)(3) or other applicable provision of the Securities Act amending the list of Selling Stockholders to include the pledgee, transferee or other successors in interest as Selling Stockholders under this prospectus. The Selling Stockholders also may transfer the shares of Common Stock in other circumstances, in which case the transferees, pledgees or other successors in interest will be the selling beneficial owners for purposes of this prospectus.

In connection with the sale of our Common Stock 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 Common Stock in the course of hedging the positions they assume. The Selling Stockholders may also sell shares of our Common Stock short and deliver these securities to close out their short positions, or loan or pledge the Common Stock 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 the creation of one or more derivative securities which require the delivery to such broker-dealer or other financial institution of shares offered by this prospectus, which shares such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).

The aggregate proceeds to the Selling Stockholders from the sale of the Common Stock offered by them will be the purchase price of the Common Stock less discounts or commissions, if any. Each of the Selling Stockholders reserves the right to accept and, together with their agents from time to time, to reject, in whole or in part, any proposed purchase of Common Stock to be made directly or through agents. We will not receive any of the proceeds from this offering.

The Selling Stockholders also may resell all or a portion of the shares in open market transactions in reliance upon Rule 144 under the Securities Act of 1933, provided that they meet the criteria and conform to the requirements of that rule.

The Selling Stockholders and any underwriters, broker-dealers or agents that participate in the sale of the Common Stock or interests therein may be "underwriters" within the meaning of Section 2(11) of the Securities Act. Any discounts, commissions, concessions or profit they earn on any resale of the shares may be underwriting discounts and commissions under the Securities Act. Selling Stockholders who are "underwriters" within the meaning of Section 2(11) of the Securities Act will be subject to the prospectus delivery requirements of the Securities Act.

To the extent required, the shares of our Common Stock to be sold, the names of the Selling Stockholders, the respective purchase prices and public offering prices, the names of any agents, dealer or underwriter, any applicable commissions or discounts with respect to a particular offer will be set forth in an accompanying prospectus supplement or, if appropriate, a post-effective amendment to the registration statement that includes this prospectus.

In order to comply with the securities laws of some states, if applicable, the Common Stock may be sold in these jurisdictions only through registered or licensed brokers or dealers. In addition, in some states the Common Stock may not be sold unless it has been registered or qualified for sale or an exemption from registration or qualification requirements is available and is complied with.

We have advised the Selling Stockholders that the anti-manipulation rules of Regulation M under the Exchange Act may apply to sales of shares in the market and to the activities of the Selling Stockholders and their affiliates. In addition, to the extent applicable we will make copies of this prospectus (as it may be supplemented or amended from time to time) available to the Selling Stockholders for the purpose of satisfying the prospectus delivery requirements of the Securities Act. The Selling Stockholders may indemnify any broker-dealer that participates in transactions involving the sale of the shares against certain liabilities, including liabilities arising under the Securities Act.

We have agreed to indemnify the Selling Stockholders against liabilities, including liabilities under the Securities Act and state securities laws, relating to the registration of the shares offered by this prospectus.

We have agreed with the Selling Stockholders to keep the registration statement of which this prospectus constitutes a part effective until the earlier of (1) such time as all of the shares covered by this prospectus have been disposed of pursuant to and in accordance with the registration statement or (2) the date on which all of the shares may be sold without restriction pursuant to Rule 144 of the Securities Act.

**LEGAL MATTERS**

Certain legal matters will be passed upon for us by McGuireWoods LLP, Charlotte, North Carolina. Additional legal matters may be passed upon for us or any underwriters, dealers or agents, by counsel that we will name in the applicable prospectus supplement.

**EXPERTS**

The consolidated financial statements of Fortress Biotech, Inc. as of December 31, 2021, and for the year ended December 31, 2021, have been incorporated by reference in this Prospectus, in reliance on the report of KPMG LLP, independent registered public accounting firm, incorporated by reference herein, and upon the authority of said firm as expert in accounting and auditing.

The consolidated financial statements as of and for the year ended December 31, 2020 incorporated by reference in this Prospectus have been so incorporated in reliance on the report of BDO USA, LLP, an independent registered public accounting firm, incorporated herein by reference, given on the authority of said firm as expert in auditing and accounting.

**WHERE YOU CAN FIND MORE INFORMATION**

We have filed with the SEC a registration statement on Form S-3 under the Securities Act with respect to the Common Stock offered hereby. This prospectus does not contain all of the information set forth in the registration statement and the exhibits and schedules thereto. For further information with respect to the Company and its Common Stock, reference is made to the registration statement and the exhibits and any schedules filed therewith. Statements contained in this prospectus as to the contents of any contract or other document referred to are not necessarily complete and in each instance, if such contract or document is filed as an exhibit, reference is made to the copy of such contract or other document filed as an exhibit to the registration statement, each statement being qualified in all respects by such reference. A copy of the registration statement, including the exhibits and schedules thereto, may be read and copied at the SEC's Public Reference Room at 100 F Street, N.E., Washington, D.C. 20549. Information on the operation of the Public Reference Room may be obtained by calling the SEC at 1-800-SEC-0330. In addition, the SEC maintains an internet site at www.sec.gov, from which interested persons can electronically access the registration statement, including the exhibits and any schedules thereto.

We are subject to the information reporting requirements of the Exchange Act, and we file periodic reports and other information with the SEC. All documents filed with the SEC are available for inspection and copying at the addresses set forth above. We also maintain an internet site at www.fortressbiotech.com. Our website and the information contained therein or connected thereto shall not be deemed to be incorporated into this prospectus or the registration statement of which it forms a part.

**INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE**

The SEC allows us to "incorporate by reference" information we file with it into this prospectus, which means that we can disclose important information to you by referring you to other documents. The information incorporated by reference is considered to be part of this prospectus, and information that we file later with the SEC and incorporate by reference will automatically update and supersede this information. We incorporate by reference into this prospectus the documents listed below and all future filings made by us with the SEC under Section 13(a), 13(c), 14 or 15(d) of the Exchange Act, except for information "furnished" under Items 2.02, 7.01 or 9.01 on Form 8-K or other information "furnished" to the SEC which is not deemed filed and not incorporated in this prospectus, until the termination of the offering of securities described in the applicable prospectus supplement.

We hereby incorporate by reference the following documents:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) [our Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on March 28, 2022;](https://www.sec.gov/ix?doc=/Archives/edgar/data/1429260/000155837022004487/fbio-20211231x10k.htm)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2022, June 30, 2022
and September 30, 2022, filed with the SEC on [May 12, 2022](https://www.sec.gov/ix?doc=/Archives/edgar/data/1429260/000155837022008557/fbio-20220331x10q.htm) , [August 11, 2022](https://www.sec.gov/ix?doc=/Archives/edgar/data/1429260/000155837022013275/fbio-20220630x10q.htm) and [November 14, 2022](https://www.sec.gov/ix?doc=/Archives/edgar/data/1429260/000155837022017763/fbio-20220930x10q.htm) , respectively;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) our Current Reports on Form 8-K filed with the SEC on [June 27, 2022](https://www.sec.gov/ix?doc=/Archives/edgar/data/1429260/000155837022010325/fbio-20220621x8k.htm) , [July 11, 2022](https://www.sec.gov/ix?doc=/Archives/edgar/data/1429260/000155837022010620/fbio-20220711x8k.htm) , [July 22, 2022](https://www.sec.gov/ix?doc=/Archives/edgar/data/1429260/000155837022010916/fbio-20220721x8k.htm) , [October 28, 2022](https://www.sec.gov/ix?doc=/Archives/edgar/data/1429260/000110465922112516/tm2229153d1_8k.htm) , [November 4, 2022](https://www.sec.gov/ix?doc=/Archives/edgar/data/1429260/000110465922114895/tm2229531-1_8k.htm) , [December 19, 2022](https://www.sec.gov/ix?doc=/Archives/edgar/data/1429260/000155837022018778/fbio-20221214x8k.htm) and February 9, 2023; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) the description of our Common Stock included in our registration statements on Form 8-A12B, filed
with the SEC on [December 7, 2011](https://www.sec.gov/Archives/edgar/data/1429260/000119312511332854/d266679d8a12b.htm) and [November 7, 2017](https://www.sec.gov/Archives/edgar/data/1429260/000114420417056958/tv478817_8a12b.htm) , and any amendment or report filed for the purpose of further updating
such descriptions.

Any statement contained in this prospectus or in a document incorporated by reference into this prospectus will be deemed to be modified or superseded for purposes of this prospectus to the extent that a statement contained in this prospectus modifies or supersedes such statement. Any statement so modified or superseded will not be deemed, except as so modified or superseded, to constitute a part of this prospectus.

We will furnish without charge to you, on written or oral request, a copy of any or all of the documents incorporated by reference, including exhibits to these documents. You should direct any requests for documents in writing to: Fortress Biotech, Inc., 1111 Kane Concourse Suite 301 Bay Harbor Islands, FL 33154, Attention: Corporate Secretary, tel: 781-652-4500. These documents are also available on the Investors section of our website, which is located at www.fortressbiotech.com, or as described under "Where You Can Find More Information" above. The reference to our website address does not constitute incorporation by reference of the information contained on our website.

You should rely only on information contained in, or incorporated by reference into, this prospectus. We have not authorized anyone to provide you with information different from that contained in this prospectus or incorporated by reference in this prospectus. We are not making offers to sell the securities in any jurisdiction in which such an offer or solicitation is not authorized or in which the person making such offer or solicitation is not qualified to do so or to anyone to whom it is unlawful to make such offer or solicitation.

![](tm235864d1_s3-img02.jpg)

**Fortress Biotech, Inc.**

**647,000 Shares of Common Stock**

**PROSPECTUS**

**, 2023**

**PART II<br> INFORMATION NOT REQUIRED IN PROSPECTUS**

**Item 14. Other Expenses of Issuance and Distribution**

---

| | |
|:---|:---|
|  | **Amount to Be Paid** |
| U.S. Securities and Exchange Commission registration fee | $53.55 |
| Legal fees and expenses | $50000.00 |
| Accounting fees and expenses | $75000.00 |
| Miscellaneous | $0.00 |
| Total | $125053.55 |

---

**Item 15. Indemnification of Directors and Officers**

Under the General Corporation Law of the State of Delaware ("DGCL"), a corporation may include provisions in its certificate of incorporation that will relieve its directors of monetary liability for breaches of their fiduciary duty to the corporation, except under certain circumstances, including a breach of the director's duty of loyalty, acts or omissions of the director not in good faith or which involve intentional misconduct or a knowing violation of law, the approval of an improper payment of a dividend or an improper purchase by the corporation of stock or any transaction from which the director derived an improper personal benefit. The Company's Amended and Restated Certificate of Incorporation eliminates the personal liability of directors to the Company or its stockholders for monetary damages for breach of fiduciary duty as a director with certain limited exceptions set forth in the DGCL.

Section 145 of the DGCL grants to corporations the power to indemnify each officer and director against liabilities and expenses incurred by reason of the fact that he or she is or was an officer or director of the corporation if he or she acted in good faith and in a manner he or she reasonably believed to be in or not opposed to the best interests of the corporation and, with respect to any criminal action or proceeding, had no reasonable cause to believe his or her conduct was unlawful. The Company's Amended and Restated Certificate of Incorporation and Bylaws provide for indemnification of each officer and director of the Company to the fullest extent permitted by the DGCL. Section 145 of the DGCL also empowers corporations to purchase and maintain insurance on behalf of any person who is or was an officer or director of the corporation against liability asserted against or incurred by him in any such capacity, whether or not the corporation would have the power to indemnify such officer or director against such liability under the provisions of Section 145 of the DGCL.

**Item 16. Exhibits and Financial Statement Schedules**

The exhibits to the Registration Statement are listed in the Exhibit Index attached hereto and incorporated by reference herein.

**EXHIBIT INDEX**

---

| | |
|:---|:---|
| &nbsp;&nbsp; **Exhibit <br> Number** | &nbsp;&nbsp; **Description** |
| &nbsp;&nbsp;[4.1](https://www.sec.gov/Archives/edgar/data/1429260/000119312511189437/dex41.htm) | &nbsp;&nbsp;[Specimen certificate evidencing shares of common stock, filed as Exhibit 4.1 to Form 10-12G on July 15, 2011 (File no. 000-54463) and incorporated herein by reference.](https://www.sec.gov/Archives/edgar/data/1429260/000119312511189437/dex41.htm) |
| &nbsp;&nbsp;[4.2](https://www.sec.gov/Archives/edgar/data/1429260/000114420417056956/tv478827_ex3-1.htm) | &nbsp;&nbsp;[Certificate of Designation of Rights and Preferences 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock (incorporated by reference to Exhibit 3.1 of the Registrant's Current Report on Form 8-K (file No. 001-35366) filed with the SEC on November 7, 2017).](https://www.sec.gov/Archives/edgar/data/1429260/000114420417056956/tv478827_ex3-1.htm) |
| &nbsp;&nbsp;[5.1\*](tm235864d1_ex5-1.htm) | &nbsp;&nbsp;[Opinion of McGuireWoods LLP](tm235864d1_ex5-1.htm) |
| &nbsp;&nbsp;[23.1\*](tm235864d1_ex5-1.htm) | &nbsp;&nbsp;[Consent of McGuireWoods LLP (to be included in Exhibit 5.1)](tm235864d1_ex5-1.htm) |
| &nbsp;&nbsp;[23.2\*](tm235864d1_ex23-2.htm) | &nbsp;&nbsp;[Consent of BDO USA, LLP, Independent Registered Accounting Firm](tm235864d1_ex23-2.htm) |
| &nbsp;&nbsp;[23.3\*](tm235864d1_ex23-3.htm) | &nbsp;&nbsp;[Consent of KPMG LLP, Independent Registered Accounting Firm](tm235864d1_ex23-3.htm) |
| &nbsp;&nbsp;[24.1\*](#sp1a_015) | &nbsp;&nbsp;[Power of Attorney (included on signature page to this registration statement)](#sp1a_015) |
| &nbsp;&nbsp;[107\*](tm235864d1_exfilingfees.htm) | &nbsp;&nbsp;[Filing Fee Table](tm235864d1_exfilingfees.htm) |

---

\* Filed herewith.

**Item 17. Undertakings**

(a) The undersigned registrant hereby undertakes:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1. To file, during any period in which offers or sales are being made, a post-effective amendment to this
registration statement:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i) To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii) To reflect in the prospectus any facts or events arising after the effective date of the registration
statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change
in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities
offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or
high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if,
in the aggregate, the changes in volume and price represent no more than 20 percent change in the maximum aggregate offering price set
forth in the "Calculation of Registration Fee" table in the effective registration statement;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii) To include any material information with respect to the plan of distribution not previously disclosed
in the registration statement or any material change to such information in the registration statement;

provided, however, that paragraphs (i), (ii) and (iii) above do not apply if the information required to be included in a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the Commission by the registrant pursuant to Section 13 or Section 15(d) of the Exchange Act that are incorporated by reference in the registration statement, or, is contained in a form of prospectus filed pursuant to Rule 424(b) that is part of the registration statement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2. That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective
amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities
at that time shall be deemed to be the initial bona fide offering thereof.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3. To remove from registration by means of a post-effective amendment any of the securities being registered
which remain unsold at the termination of the offering.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5. That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(A) Each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(B) Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing the information required by Section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial *bona fide* offering thereof. *Provided, however*, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6. That, for the purpose of determining liability of the registrant under the Securities Act of 1933 to any
purchaser in the initial distribution of the securities, the undersigned registrant undertakes that in a primary offering of securities
of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities
to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned
registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i) Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required
to be filed pursuant to Rule 424;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii) Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant
or used or referred to by the undersigned registrant;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii) The portion of any other free writing prospectus relating to the offering containing material information
about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iv) Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser.

(b) The undersigned registrant hereby undertakes that, for purposes of determining any liability under the
Securities Act of 1933, each filing of the registrant's annual report pursuant to Section 13(a) or 15(d) of the Securities
Exchange Act of 1934 (and, where applicable, each filing of an employee benefits plan's annual report pursuant to Section 15(d) of
the Securities Exchange Act of 1934) that is incorporated by reference in the registration statement shall be deemed to be a new registration
statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial
bona fide offering thereof.

(h) Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to
directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been
advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the
Securities Act of 1933, as amended, and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities
(other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant
in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection
with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling
precedent, submit to a court of appropriate jurisdiction the question of whether such indemnification by it is against public policy as
expressed in the Securities Act of 1933, as amended, and will be governed by the final adjudication of such issue.

(i) The undersigned registrant hereby undertakes that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1) For purposes of determining any liability under the Securities Act of 1933, the information omitted from
the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus
filed by the registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be
part of this registration statement as of the time it was declared effective.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2) For the purpose of determining any liability under the Securities Act of 1933, each post-effective amendment
that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and
the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

**SIGNATURES**

Pursuant to the requirements of the Securities Act of 1933, the registrant has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized.

---

| | | |
|:---|:---|:---|
|  | **FORTRESS BIOTECH, INC.** | **FORTRESS BIOTECH, INC.** |
| February 10, 2023 | By: | /s/ Lindsay A. Rosenwald, M.D. |
|  |  | Lindsay A. Rosenwald, M.D.<br> Chairman, President and Chief Executive Officer<br> (Principal Executive Officer) |

---

**POWERS OF ATTORNEY**

KNOW ALL MEN BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Lindsay A. Rosenwald, M.D., his true and lawful attorney-in-fact and agent, with full power of substitution and resubstitution, for him and his name, place and stead, in any and all capacities, to sign any or all amendments (including pre-effective and post-effective amendments) to this registration statement, and to file the same, with all exhibits thereto and other documents in connection therewith, including any Registration Statement filed pursuant to Rule 462(b) under the Securities Act of 1933, with the SEC, granting unto said attorney-in-fact and agent, full power and authority to do and perform each and every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorney-in-fact and agent or any of his substitutes, may lawfully do or cause to be done by virtue hereof.

Pursuant to the requirements of the Securities Act of 1933, as amended, this registration statement has been signed by the following persons in the capacities indicated as of February 10, 2023.

---

| | | |
|:---|:---|:---|
| **Signature** | &nbsp;&nbsp; **Title** | &nbsp;&nbsp; **Date** |
| /s/ Lindsay A. Rosenwald, M.D. | &nbsp;&nbsp;Chairman of the Board of Directors, | &nbsp;&nbsp;February 10, 2023 |
| Lindsay A. Rosenwald, M.D.<br>| &nbsp;&nbsp;President and Chief Executive Officer <br> (*Principal Executive Officer*) |  |
| /s/ David Jin | &nbsp;&nbsp;Chief Financial Officer | &nbsp;&nbsp;February 10, 2023 |
| David Jin | &nbsp;&nbsp;(*Principal Financial Officer and Principal <br> Accounting Officer*) |  |
| /s/ Eric K. Rowinsky, M.D. | &nbsp;&nbsp;Vice Chairman of the Board of Directors | &nbsp;&nbsp;February 10, 2023 |
| Eric K. Rowinsky, M.D. |  |  |
| /s/ Michael S. Weiss. | &nbsp;&nbsp;Executive Vice Chairman, Strategic | &nbsp;&nbsp;February 10, 2023 |
| Michael S. Weiss | &nbsp;&nbsp;Development and Director |  |
| /s/ Jimmie Harvey, Jr., M.D. | &nbsp;&nbsp;Director | &nbsp;&nbsp;February 10, 2023 |
| Jimmie Harvey, Jr., M.D. |  |  |
| /s/ Malcolm Hoenlein | &nbsp;&nbsp;Director | &nbsp;&nbsp;February 10, 2023 |
| Malcolm Hoenlein |  |  |
| /s/ Dov Klein | &nbsp;&nbsp;Director | &nbsp;&nbsp;February 10, 2023 |
| Dov Klein |  |  |
| /s/ J. Jay Lobell | &nbsp;&nbsp;Director | &nbsp;&nbsp;February 10, 2023 |
| J. Jay Lobell |  |  |
| /s/ Kevin L. Lorenz, J.D. | &nbsp;&nbsp;Director | &nbsp;&nbsp;February 10, 2023 |
| Kevin L. Lorenz, J.D. |  |  |
| /s/ Lucy Lu, M.D | &nbsp;&nbsp;Director | &nbsp;&nbsp;February 10, 2023 |
| Lucy Lu, M.D. |  |  |

---

## Exhibit 5.1

**Exhibit 5.1**

---

| | |
|:---|:---|
| **McGuireWoods LLP**<br> 201 North Tryon Street<br> Suite 3000<br> Charlotte, NC 28202-2146<br> Phone: 704.343.2000<br> Fax: 704.343.2300<br> www.mcguirewoods.com<br>| ![](tm235864d1_ex5-1img01.jpg) |

---

February 10, 2023

Fortress Biotech, Inc.

1111 Kane Concourse, Suite 301

Bay Harbor Islands, FL 33154

**Fortress Biotech, Inc.**

**<u>Registration Statement on Form S-3</u>**

Ladies and Gentlemen:

We have acted as special counsel to Fortress Biotech, Inc., a Delaware corporation (the "<u>Company</u>"), in connection with the Registration Statement on Form S-3 (the "<u>Registration Statement</u>") being filed by the Company on the date of this opinion letter with the Securities and Exchange Commission (the "<u>SEC</u>") under the Securities Act of 1933, as amended (the "<u>Securities Act</u>"). The Registration Statement relates to the registration of the offer and resale by certain selling stockholders of the Company of 647,000 shares of the Company's Common Stock, par value $0.001 per share (the "<u>Securities</u>").

This opinion letter is being furnished in accordance with the requirements of Item 16 of Form S-3 and Item 601(b)(5)(i) of Regulation S-K promulgated under the Securities Act. Capitalized terms used and not defined herein shall have the meanings assigned to them in the Registration Statement.

The Securities are described in the Registration Statement. The Securities are issuable in exchange for shares of 8% Cumulative Redeemable Perpetual Class B Preferred Stock of Urica Therapeutics, Inc., a Delaware corporation ("<u>Urica</u>"), par value $0.0001 (the "<u>Urica Preferred Stock</u>") pursuant to the terms of the Urica Preferred Stock as set forth in the Certificate of Designation of Rights and Preferences 8% Cumulative Redeemable Perpetual Preferred Stock, dated December 22, 2022 (the "<u>Subject Document</u>").

**<u>Documents Reviewed</u>**

In connection with this opinion letter, we have examined the following documents:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) the Registration Statement, including the exhibits being filed therewith and incorporated by reference therein from previous filings made by the Company with the SEC; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) the prospectus contained in the Registration Statement (the "<u>Prospectus</u>").

In addition, we have examined and relied upon the following:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i) a certificate from the Corporate Secretary of the Company certifying as to (A) true and correct copies of the Amended and Restated Certificate of Incorporation and Second Amended and Restated Bylaws of the Company and (B) the resolutions of the Board of Directors of the Company authorizing (1) the filing of the Registration Statement by the Company; and (2) the Securities issuable by the Company with respect to such Securities;

Fortress Biotech, Inc.

February 10, 2023

Page 2 of 3

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii) a certificate dated February 9, 2023 issued by the Secretary of State of the State of Delaware, attesting to the corporate status of the Company in the State of Delaware; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii) originals, or copies identified to our satisfaction as being true copies, of such other records, documents and instruments as we have deemed necessary for the purposes of this opinion letter.

"<u>Applicable Law</u>" means the Delaware General Corporation Law.

**<u>Assumptions Underlying Our Opinions</u>**

For all purposes of the opinions expressed herein, we have assumed, without independent investigation, the following:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) Factual Matters. To the extent that we have reviewed and relied upon (i) certificates of the Company or authorized representatives thereof, (ii) representations of the Company set forth in the Subject Document (if any) and (iii) certificates and assurances from public officials, all of such certificates, representations and assurances are accurate with regard to factual matters and all official records (including filings with public authorities) are properly indexed and filed and are accurate and complete.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) Signatures. The signatures of individuals who signed the Subject Document are genuine and (other than those of individuals signing on behalf of the Company at or before the date hereof) authorized.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) Authentic and Conforming Documents. All documents submitted to us as originals are authentic, complete and accurate, and all documents submitted to us as copies conform to authentic original documents.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) Organizational Status, Power and Authority and Legal Capacity of Certain Parties. All parties to the Subject Document were, as of the date the Subject Document was executed and delivered, validly existing and in good standing in their respective jurisdictions of formation, except that no such assumption is made as to the Company as of the date hereof. All parties to the Subject Document had, as of the date the Subject Document was executed and delivered, the capacity and full power and authority to execute, deliver and perform the Subject Document and the documents required or permitted to be delivered and performed thereunder. All individuals who signed the Subject Document had, as of the date the Subject Document was executed and delivered, the legal capacity to execute the Subject Document.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e) Authorization, Execution and Delivery of Subject Document. The Subject Document and the documents required or permitted to be delivered thereunder have been duly authorized by all necessary corporate, limited liability company, business trust, partnership or other action on the part of the parties thereto and have been duly executed and delivered by such parties.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f) Subject Document Binding on Certain Parties. The Subject Document and the documents required or permitted to be delivered thereunder were, as of the date the Subject Document was executed and delivered, valid and binding obligations enforceable against the parties thereto in accordance with their terms.

Fortress Biotech, Inc.

February 10, 2023

Page 3 of 3

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(g) Registration. The Registration Statement shall have become effective under the Securities Act automatically upon filing thereof, and such effectiveness shall not have been terminated or rescinded.

**<u>Our Opinions</u>**

Based on and subject to the foregoing and the exclusions, qualifications, limitations and other assumptions set forth in this opinion letter, we are of the opinion that the Securities have been duly authorized and, when issued and delivered in the manner described in the Registration Statement against payment therefor, will be validly issued, fully paid and non-assessable.

Our opinion set forth above is limited to the Applicable Law, and we do not express any opinion concerning any other law.

**<u>Miscellaneous</u>**

The foregoing opinions are being furnished only for the purpose referred to in the first paragraph of this opinion letter. Our opinions are based on statutes, regulations and administrative and judicial interpretations which are subject to change. We undertake no responsibility to update or supplement these opinions subsequent to the effective date of the Registration Statement. Headings in this opinion letter are intended for convenience of reference only and shall not affect its interpretation. We hereby consent to the filing of this opinion as Exhibit 5.1 to the Registration Statement on or about the date hereof, to the incorporation by reference of this opinion of counsel into the Registration Statement and to the reference to our firm in the Prospectus under the caption "Legal Matters." In giving this consent, we do not admit that we are within the category of persons whose consent is required by Section 7 of the Securities Act or the rules and regulations of the SEC promulgated thereunder.

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| |
|:---|
| Very truly yours, |
| /s/ McGuireWoods LLP |
| McGuireWoods LLP |

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## Exhibit 23.2

**Exhibit 23.2**

**<u>Consent of Independent Registered Public Accounting Firm</u>**

Fortress Biotech, Inc.

Bar Harbor Islands, Florida

We hereby consent to the incorporation by reference in the Prospectus constituting a part of this Registration Statement on Form S-3 of our report dated March 31, 2021, relating to the consolidated financial statements as of and for the period ended December 31, 2020 appearing in the Company's Annual Report on Form 10-K for the year ended December 31, 2021.

We also consent to the reference to us under the caption "Experts" in the Prospectus.

/s/ BDO USA, LLP

Boston, Massachusetts

February 10, 2023

## Exhibit 23.3

**Exhibit 23.3**

Consent of Independent Registered Public Accounting Firm

We consent to the use of our report dated March 28, 2022, with respect to the consolidated financial statements of Fortress Biotech, Inc., incorporated herein by reference, and to the reference to our firm under the heading "Experts" in the prospectus.

/s/ KPMG LLP

Short Hills, New Jersey<br> February 10, 2023

## Ex-Filing

**Exhibit 107.1**

**Calculation of Filing Fee Tables**

**Form S-3**

(Form Type)

**Fortress Biotech, Inc.**

(Exact Name of Registrant as Specified in its Charter)

**Table 1: Newly Registered Securities**

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| | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|
| **Security <br> Type** | **Security<br> Class<br> Title** | **Fee<br> Calculation<br> Rule<sup>(1)</sup>** | **Amount<br> Registered<sup>(2)</sup>** | **Maximum<br> Aggregate<br> Offering Price<sup>(1)</sup>** | **Fee Rate** | **Amount of<br> Registration Fee** |
| Equity | Common Stock, par value $0.001 per share | 457(c) | 647000$0.751<sup>(2)</sup> | $485897.00 | .00011020 | $53.55 |
| **Total Offering Amounts** | **Total Offering Amounts** | **Total Offering Amounts** | **Total Offering Amounts** | $485897.00 |  | $53.55 |
| **Total Fee Offsets** | **Total Fee Offsets** | **Total Fee Offsets** | **Total Fee Offsets** |  |  |  |
| **Net Fee Due** | **Net Fee Due** | **Net Fee Due** | **Net Fee Due** |  |  | $53.55 |

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(1) Pursuant to Rule 457(c) under the Securities Act, and solely for the purpose of calculating the registration fee, the proposed maximum offering price per share is the average of the high and low prices reported for the registrant's Common Stock quoted on The Nasdaq Capital Market LLC on February 8, 2023.

(2) Pursuant to Rule 416(a) under the Securities Act, this registration statement also covers an indeterminate number of additional shares as may be issuable as a result of stock splits, stock dividends or similar transactions.