Registration No. 333-[ ]
Nevada | | | 2834 | | | 04-3562325 |
(State or other jurisdiction of incorporation or organization) | | | (Primary SIC Number) | | | (I.R.S. Employer Identification No.) |
| | Robert E. Tritt, Esq. Dentons US LLP 303 Peachtree Street, NE Suite 5300 Atlanta, GA 30308 (404) 527-8130 | | | Brian Lee, Esq. Dentons US LLP 1221 Avenue of the Americas New York, NY New York, NY 10020 (212) 768-6926 | |
Large accelerated filer | | | ☐ | | | Accelerated filer | | | ☐ |
Non-accelerated filer | | | ☒ | | | Smaller reporting company | | | ☒ |
Emerging growth company | | | ☐ | | | | |
• | a base prospectus which covers the offering, issuance and sale by us of up to $100,000,000 of our common stock, warrants, and rights; and |
• | a sales agreement prospectus covering the offering, issuance and sale by us of up to a maximum aggregate offering price of $35,967,000 of our common stock that may be issued and sold under an At The Market Issuance Sales Agreement we have entered into with H.C. Wainwright & Co., LLC on May 11, 2020 as sales agent. As of the date of this prospectus, common stock having a maximum aggregate offering price of $35,967,000 may be offered and sold pursuant to such At The Market Issuance Sales Agreement. |

• | Our Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 30, 2023; |
• | Our Current Reports on Form 8-K filed with the SEC on March 2, 2023 and January 5, 2023; and |
• | The description of our common stock contained in our registration statement on Form 8-A filed with the SEC on September 9, 2003, pursuant to Section 12(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), including any amendments or reports filed for the purpose of updating that description, including Amendment No 1 to Form 8-A filed with the SEC on March 22, 2012. |
• | our early stage of development; |
• | we have incurred significant operating losses since our inception and cannot assure you that we will generate revenue or profit; |
• | our dependence on additional outside capital; |
• | we may be unable to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates; |
• | uncertainties related to our technology and clinical trials; |
• | we may be unable to demonstrate the efficacy and safety of our developmental product candidates in human trials; |
• | we may be unable to improve upon, protect and/or enforce our intellectual property; |
• | we are subject to extensive and costly regulation by the U.S. Food and Drug Administration (FDA) and by foreign regulatory authorities, which must approve our product candidates in development and could restrict the sales and marketing and pricing of such products; |
• | competition and stock price volatility in the biotechnology industry; |
• | limited trading volume for our stock, concentration of ownership of our stock, and other risks detailed herein and from time to time in our SEC reports; and |
• | other risks detailed herein and from time to time in our SEC reports, including our Annual Report on Form 10-K filed with the SEC for the fiscal year ended December 31, 2022, and our subsequent SEC filings. |
• | any merger or consolidation involving the corporation (or any subsidiary of the corporation) and (i) the interested stockholder or (ii) any other entity which is, or after and as a result of the merger or consolidation would be, an affiliate or associate of the interested stockholder; |
• | any sale, transfer, pledge or other disposition of the assets of the corporation (or a subsidiary thereof) involving the interested stockholder or any affiliate or associate of the interested stockholder where the assets transferred (a) have an aggregate market value equal to more than 5% of the aggregate market value of all of the corporation’s assets, determined on a consolidated bases; (b) have an aggregate market value equal to more than 5% of the aggregate market value of all outstanding voting shares of the corporation; or (c) represent more than 10% of the earning power or net income of the corporation, determined on a consolidated basis; |
• | subject to certain exceptions, any transaction that results in the issuance or transfer by the corporation of any stock of the corporation with a market value of 5% or more of the value of the outstanding shares of the corporation; |
• | the adoption of any plan or proposal for the liquidation or dissolution of the corporation under any agreement, arrangement or understanding (whether or not in writing) with the interested stockholder or any affiliate or associate of the interested stockholder; |
• | any transaction involving the corporation that has the effect of increasing the proportionate share of the stock of any class or series of the corporation beneficially owned by the interested stockholder or any affiliate or associate of the interested stockholder; or |
• | the receipt by the interested stockholder or any affiliate or associate of the interested stockholder of the benefit of any loans, advances, guarantees, pledges or other financial benefits provided by or through the corporation. |
• | the title of the warrants; |
• | the designation and terms of the common stock for which the warrants are exercisable; |
• | the designation and terms of the common stock, if any, with which the warrants are to be issued and the number of warrants issued with the common stock; |
• | the price or prices at which the warrants will be issued, if any; |
• | the aggregate number of warrants; |
• | the number of shares of common stock that may be purchased upon exercise of the warrants and the exercise price for the warrants; |
• | any provisions for adjustment of the number or amount of shares of common stock receivable upon exercise of the warrants or the exercise price of the warrants; |
• | any provisions with respect to a holder’s right upon a change in control or similar event; |
• | if applicable, the date on and after which the warrants and the common stock purchasable upon exercise of the warrants will be separately transferable; |
• | any provisions with respect to a holder’s right upon a change in control or similar event; |
• | the dates on which the right to exercise the warrants will commence and expire; |
• | if applicable, the maximum or minimum number of warrants that may be exercised at any time; |
• | information with respect to book-entry procedures, if any; |
• | if applicable, a discussion of material U.S. federal income tax considerations; and |
• | any additional terms of the warrants, including the terms, procedures and limitations relating to the exchange, exercise and settlement of the warrants. |
• | the price, if any, per right; |
• | the exercise price payable for common stock or warrants upon the exercise of the rights; |
• | the number of rights issued or to be issued to each shareholder; |
• | the number and terms of common stock or warrants which may be purchased per right; |
• | the extent to which the rights are transferable; |
• | any other terms of the rights, including the terms, procedures and limitations relating to the exchange and exercise of the rights; |
• | the date on which the holder’s ability to exercise the rights shall commence, and the date on which the rights shall expires; |
• | the extent to which the rights may include an over-subscription privilege with respect to unsubscribed securities; and |
• | if applicable, the material terms of any standby underwriting or purchase arrangement entered into by us in connection with the offering of such rights. |
• | to or through underwriters or dealers; |
• | directly to a limited number of purchasers or to a single purchaser; or |
• | through agents. |
• | the name or names of any underwriters, dealers or agents and the amounts of securities underwritten or purchased by each of them; |
• | the purchase price of the securities and the proceeds we will receive from the sale; |
• | any over-allotment options under which underwriters may purchase additional securities; |
• | any underwriting discounts or commissions or agency fees and other items constituting underwriters’ or agents’ compensation; |
• | the initial public offering price of the securities; |
• | any discounts, commissions or concessions allowed or re-allowed or paid to dealers; and |
• | any securities exchange or market on which the securities may be listed. |

• | 11,557,964 shares issuable upon exercise of outstanding warrants with a weighted average exercise price of $4.37; |
• | 6,545,561 shares issuable upon exercise of outstanding options with a weighted average exercise price of $2.68; |
• | Zero shares reserved for issuance under our 2009 Incentive Compensation Plan and 1,722,006 shares reserved for issuance under our 2019 Omnibus Equity Incentive Plan; and |
• | 503,340 shares issuable upon the conversion of preferred stock. |
• | our early stage of development; |
• | we have incurred significant operating losses since our inception and cannot assure you that we will generate revenue or profit; |
• | our dependence on additional outside capital; |
• | we may be unable to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates; |
• | uncertainties related to our technology and clinical trials; |
• | we may be unable to demonstrate the efficacy and safety of our developmental product candidates in human trials; |
• | we may be unable to improve upon, protect and/or enforce our intellectual property; |
• | we are subject to extensive and costly regulation by the U.S. Food and Drug Administration (FDA) and by foreign regulatory authorities, which must approve our product candidates in development and could restrict the sales and marketing and pricing of such products; |
• | competition and stock price volatility in the biotechnology industry; |
• | limited trading volume for our stock, concentration of ownership of our stock, and other risks detailed herein and from time to time in our SEC reports; and |
• | other risks detailed herein and from time to time in our SEC reports, including our Annual Report on Form 10-K filed with the SEC for the fiscal year ended December 31, 2022, and our subsequent SEC filings. |
Assumed Offering price per share | | | $1.99 |
Net tangible book value per share as of December 31, 2022 | | | $(0.55) |
Increase in net tangible book value per share attributable to the offering | | | $0.58 |
As-adjusted net tangible book value per share after giving effect to the offering | | | $0.03 |
Dilution in net tangible book value per share to new investors | | | $1.96 |
• | 11,557,964 shares issuable upon exercise of outstanding warrants with a weighted average exercise price of $4.37; |
• | 5,745,561 shares issuable upon exercise of outstanding options with a weighted average exercise price of $2.90; |
• | Zero shares reserved for issuance under our 2009 Incentive Compensation Plan and 1,966,279 shares reserved for issuance under our 2019 Omnibus Equity Incentive Plan; and |
• | 503,340 shares issuable upon the conversion of preferred stock. |
• | our Annual Report on Form 10-K for the year ended December 31, 2022 filed on March 30, 2023; |
• | our Current Reports on Form 8-K filed with the SEC on March 2, 2023 and January 5, 2023; and |
• | the description of our Common Stock contained in our registration statement on Form 8-A filed with the SEC on September 9, 2003, including any amendments or reports filed for the purpose of updating such description, including Amendment No 1 to Form 8-A filed with the SEC on March 22, 2012. |
Item 14. | Other Expenses of Issuance and Distribution. |
SEC Registration Fee | | | $3,232 |
FINRA Fee | | | $15,500 |
Accountants’ Fees and Expenses | | | $* |
Legal Fees and Expenses | | | $* |
Transfer Agent Fees and Expenses | | | $* |
Miscellaneous | | | $* |
Total Expenses | | | $* |
* | Except for the SEC registration fee and FINRA filing fee, estimated expenses are not presently known. The foregoing sets forth the general categories of expenses that we anticipate we will incur in connection with the offering of securities under this registration statement. To the extent required, any applicable prospectus supplement will set forth the estimated aggregate amount of expenses payable in respect of any offering of securities under the registration statement. |
Item 15. | Indemnification of Directors and Officers. |
“1. | A corporation may indemnify pursuant to this subsection any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative, except an action by or in the right of the corporation, by reason of the fact that the person is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, against expenses, including attorneys' fees, judgments, fines and amounts paid in settlement actually and reasonably incurred by the person in connection with the action, suit or proceeding if the person: |
(a) | Is not liable pursuant to NRS 78.138; or |
(b) | Acted in good faith and in a manner which 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 the conduct was unlawful. |
2. | A corporation may indemnify pursuant to this subsection any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action or suit by or in the right of the corporation to procure a judgment in its favor by reason of the fact that the person is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, |
(a) | Is not liable pursuant to NRS 78.138; or |
(b) | Acted in good faith and in a manner which he or she reasonably believed to be in or not opposed to the best interests of the corporation. |
3. | Any discretionary indemnification pursuant to this section, unless ordered by a court or advanced pursuant to subsection 2 of NRS 78.751, may be made by the corporation only as authorized in each specific case upon a determination that the indemnification of a director, officer, employee or agent of a corporation is proper under the circumstances. The determination must be made by: |
(a) | The stockholders; |
(b) | The board of directors, by majority vote of a quorum consisting of directors who were not parties to the action, suit or proceeding; or |
(c) | Independent legal counsel, in a written opinion, if: |
(1) | A majority vote of a quorum consisting of directors who were not parties to the action, suit or proceeding so orders; or |
(2) | A quorum consisting of directors who were not parties to the action, suit or proceeding cannot be obtained.” |
1. | A corporation shall indemnify any person who is a director, officer, employee or agent to the extent that the person is successful on the merits or otherwise in defense of: |
(a) | Any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative, including, without limitation, an action by or in the right of the corporation, by reason of the fact that the person is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise; or |
(b) | Any claim, issue or matter therein, against expenses actually and reasonably incurred by the person in connection with defending the action, including, without limitation, attorney's fees. |
2. | Unless otherwise restricted by the articles of incorporation, the bylaws or an agreement made by the corporation, the corporation may pay the expenses of officers and directors incurred in defending a civil or criminal action, suit or proceeding as they are incurred and in advance of the final disposition of the action, suit or proceeding, upon receipt of an undertaking by or on behalf of the director or officer to repay the amount if it is ultimately determined by a court of competent jurisdiction that the director or officer is not entitled to be indemnified by the corporation. The articles of incorporation, the |
3. | The indemnification pursuant to this section and NRS 78.7502 and the advancement of expenses authorized in or ordered by a court pursuant to this section: |
(a) | Does not exclude any other rights to which a person seeking indemnification or advancement of expenses may be entitled under the articles of incorporation or any bylaw, agreement, vote of stockholders or disinterested directors or otherwise, for either an action in the person's official capacity or an action in another capacity while holding office, except that indemnification, unless ordered by a court pursuant to NRS 78.7502 or for the advancement of expenses made pursuant to subsection 2, may not be made to or on behalf of any director or officer finally adjudged by a court of competent jurisdiction, after exhaustion of any appeals taken therefrom, to be liable for intentional misconduct, fraud or a knowing violation of law, and such misconduct, fraud or violation was material to the cause of action. |
(b) | Continues for a person who has ceased to be a director, officer, employee or agent and inures to the benefit of the heirs, executors and administrators of such a person. |
4. | Unless the articles of incorporation, the bylaws or an agreement made by a corporation provide otherwise, if a person is entitled to indemnification or the advancement of expenses from the corporation and any other person, the corporation is the primary obligor with respect to such indemnification or advancement. |
5. | A right to indemnification or to advancement of expenses arising under a provision of the articles of incorporation or any bylaw is not eliminated or impaired by an amendment to such provision after the occurrence of the act or omission that is the subject of the civil, criminal, administrative or investigative action, suit or proceeding for which indemnification or advancement of expenses is sought, unless the provision in effect at the time of such act or omission explicitly authorizes such elimination or impairment after such act or omission has occurred.” |
Item 16. | Exhibits |
Item 17. | Undertakings. |
(1) | To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement: |
(i) | To include any prospectus required by Section 10(a)(3) of the Securities Act; |
(ii) | To reflect in the prospectus any facts or events arising after the effective date of this 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 this 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 Securities and Exchange Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20% change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement; and |
(iii) | To include any material information with respect to the plan of distribution not previously disclosed in this registration statement or any material change to such information in this registration statement; |
(2) | That, for the purpose of determining any liability under the Securities Act, 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; |
(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; |
(4) | That, for the purpose of determining liability under the Securities Act to any purchaser: |
(A) | Each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of this registration statement as of the date the filed prospectus was deemed part of and included in this registration statement; and |
(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 shall be deemed to be part of and included in this 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 this registration statement relating to the securities in this registration statement to which the 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 this registration statement or made in a document incorporated or deemed incorporated by reference into this registration statement or prospectus that is part of this 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 this registration statement or prospectus that was part of this registration statement or made in any such document immediately prior to such effective date; and |
(5) | That, for the purpose of determining liability of the registrant under the Securities Act 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: |
(i) | Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424; |
(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; |
(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 |
(iv) | Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser. |
| | | GALECTIN THERAPEUTICS INC. | ||||
| | | (Registrant) | ||||
| | | | | |||
| | | By: | | | /s/ Joel Lewis | |
| | | Name: | | | Joel Lewis. | |
| | | Title: | | | Chief Executive Officer and President (Principal Executive Officer) | |
Name | | | Title | | | Date |
| | | | | |||
/s/ Joel Lewis | | | Chief Executive Officer and President (Principal Executive Officer) | | | April 14, 2023 |
Joel Lewis | | |||||
| | | | | |||
/s/ Jack W. Callicutt | | | Chief Financial Officer (Principal Financial and Accounting Officer) | | | April 14, 2023 |
Jack W. Callicutt | | |||||
| | | | | |||
/s/ Richard E. Uihlein | | | Chairman and Director | | | April 14, 2023 |
Richard E. Uihlein | | |||||
| | | | | |||
/s/ Gilbert F. Amelio, Ph.D | | | Director | | | April 14, 2023 |
Gilbert F. Amelio, Ph.D. | | |||||
| | | | | |||
/s/ James C. Czirr | | | Director | | | April 14, 2023 |
James C. Czirr | | |||||
| | | | | |||
/s/ Kary Eldred | | | Director | | | April 14, 2023 |
Kary Eldred | | |||||
| | | | | |||
/s/ Kevin D. Freeman | | | Director | | | April 14, 2023 |
Kevin D. Freeman, CFA | |
Name | | | Title | | | Date |
| | | | | |||
/s/ Gilbert S. Omenn | | | Director | | | April 14, 2023 |
Gilbert S. Omenn, M.D., Ph.D. | | |||||
| | | | | |||
/s/ Marc Rubin | | | Director | | | April 14, 2023 |
Marc Rubin, M.D. | | |||||
| | | | | |||
/s/ Elissa J. Schwartz | | | Director | | | April 14, 2023 |
Elissa J. Schwartz, Ph.D. | | |||||
| | | | | |||
/s/ Harold Shlevin | | | Director | | | April 14, 2023 |
Harold Shlevin, Ph.D. | | |||||
| | | | | |||
/s/ Richard A. Zordani | | | Director | | | April 14, 2023 |
Richard A. Zordani | |
Exhibit No. | | | Description |
1.1* | | | Form of Underwriting Agreement |
| | | At The Market Issuance Sales Agreement between Galectin Therapeutics Inc. and H.C. Wainwright & Co., LLC (incorporated by reference to the Company’s Shelf Registration Statement on Form S-3 dated May 11, 2020) | |
| | | Amended and Restated Articles of Incorporation of Galectin Therapeutics Inc. (incorporated by reference to the Company’s Current Report on Form 8-K filed with the Commission on May 30, 2012). | |
| | | Amended and Restated Bylaws of Galectin Therapeutics Inc. (incorporated by reference to the Company’s Current Report on Form 8-K filed with the Commission on September 27, 2016). | |
| | | Certificate of Designation of Preferences, Rights and Limitations of Series A 12% Convertible Preferred Stock of Pro Pharmaceuticals, Inc., as filed with the Secretary of State of the State of Nevada on October 5, 2007. (incorporated by reference to the Company’s Current Report on Form 8-K filed with the Commission on October 9, 2007). | |
| | | Amendment to Certificate of Designation of Preferences, Rights and Limitations of Series A 12% Convertible Preferred Stock of Pro Pharmaceuticals, Inc., as filed with the Secretary of State of the State of Nevada on May 15, 2017. (incorporated by reference to the Company’s Current Report on Form 8-K filed with the Commission on May 19, 2017). | |
| | | Certificate of Designation of Preferences, Rights and Limitation of Series C Super Dividend Convertible Preferred Stock of Pro-Pharmaceuticals, Inc., as filed with the Secretary of State of Nevada on December 30, 2010 (incorporated by reference to the Company’s Current Report on Form 8-K as filed with the Commission on January 6, 2011). | |
| | | Certificate of Change as filed with the Nevada Secretary of State on March 1, 2012 (incorporated by reference to the Company’s Current Report on Form 8-K as filed with the Commission on March 23, 2012). | |
| | | Certificate of Designation of Preferences, Rights and Limitation of Common Stock (Class W), as filed with the Secretary of State of Nevada on February 13, 2017 (incorporated by reference to the Company’s Current Report on Form 8-K as filed with the Commission on February 17, 2017). | |
| | | Amendment to Certificate of Designation of Preferences, Rights and Limitation of Common Stock (Class W), as filed with the Secretary of State of Nevada on May 15, 2017 (incorporated by reference to the Company’s Current Report on Form 8-K as filed with the Commission on May 19, 2017). | |
| | | Amendment to the Amended and Restated Articles of Articles of Incorporation of Galectin Therapeutics Inc. (Incorporated by reference to Exhibit 3.7 of the Company Annual Report on Form 10-K, filed March 30, 2023) | |
| | | Specimen certificate for shares of Common Stock (incorporated by reference to Exhibit 4.1 of the Company’s Form S-1 Registration Statement filed with the Commission on November 19, 2008) | |
| | | Opinion of Dentons US LLP | |
| | | Consent of Cherry Bekaert LLP (independent registered public accounting firm). | |
| | | Consent of Dentons US LLP (included in legal opinion filed as Exhibit 5.1). | |
| | | Power of Attorney** | |
| | | Filing Fee Table |
* | To the extent applicable, to be filed by an amendment or as an exhibit to a document filed under the Securities Exchange Act of 1934, as amended, and incorporated by reference herein. |
† | Filed herewith. |
** | Included on signature page filed herewith. |