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    Amendment: SEC Form S-3/A filed by Celcuity Inc.

    11/26/24 4:06:01 PM ET
    $CELC
    Medical Specialities
    Health Care
    Get the next $CELC alert in real time by email
    S-3/A 1 forms-3a.htm

     

    As filed with the Securities and Exchange Commission on November 26, 2024

     

    Registration No. 333-281887

     

     

     

    UNITED STATES

    SECURITIES AND EXCHANGE COMMISSION

    Washington, D.C. 20549

     

    Amendment No. 1

    to

    Form S-3

     

    REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933

     

    CELCUITY INC.

    (Exact name of registrant as specified in its charter)

     

    Delaware   82-2863566
    (State or other jurisdiction   (I.R.S. Employer
    of incorporation or organization)   Identification Number)

     

    16305 36th Avenue N., Suite 100

    Minneapolis, MN 55446
    (763) 392-0123
    (Address, including zip code, and telephone number, including area code, of principal executive offices)

     

    Brian F. Sullivan
    Chief Executive Officer
    16305 36th Avenue N., Suite 100

    Minneapolis, MN 55446
    (763) 392-0123
    (Name, address, including zip code, and telephone number, including area code, of agent for service)

     

    Please send copies of all communications to:

    Brent Eilefson

    General Counsel

    16305 36th Avenue N., Suite 100

    Minneapolis, MN 55446

    (763) 392-0123

     

    Jonathan R. Zimmerman

    Griffin D. Foster
    Faegre Drinker Biddle & Reath LLP
    2200 Wells Fargo Center

    90 South Seventh Street

    Minneapolis, Minnesota 55402
    (612) 766-7000

     

    Approximate date of commencement of proposed sale to the public: From time to time after the effectiveness of the 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, other than securities offered only in connection with dividend or interest reinvestment plans, 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, please 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.

     

    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 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.

     

     

     

     

     

     

    EXPLANATORY NOTE

     

    Celcuity Inc. is filing this Pre-Effective Amendment No. 1 (“Amendment No. 1”) to its Registration Statement on Form S-3 (333-281887), originally filed on August 30, 2024 (the “Registration Statement”), solely to file an updated auditor consent as Exhibit 23.2. This Amendment No. 1 consists only of the facing page, this explanatory note, Part II of the Registration Statement, the signature page to the Registration Statement, and the exhibit being filed with this Amendment No. 1. The remainder of the Registration Statement, including the prospectus, is unchanged and has been omitted.

     

     

     

     

    PART II

    INFORMATION NOT REQUIRED IN PROSPECTUS

     

    Item 14. Other Expenses of Issuance and Distribution.

     

    The following table sets forth the various expenses in connection with the sale and distribution of the securities being registered. All amounts shown are estimates, except the SEC registration fee. The registrant has agreed to pay these costs and expenses.

     

    Securities and Exchange Commission registration fee  $49,862 
    FINRA corporate filing fees   * 
    Printing and engraving expenses   * 
    Legal fees and expenses   * 
    Accounting fees and expenses   * 
    Transfer Agent and Registrar fees   * 
    Miscellaneous   * 
    Total  $* 

     

    * Estimated expenses not presently known. The applicable prospectus supplement will set forth the estimated aggregate amount of expenses payable in respect of any offering of securities.

     

    Item 15. Indemnification of Directors and Officers.

     

    Section 102(b)(7) of the Delaware General Corporation Law, or DGCL, provides that a Delaware corporation, in its certificate of incorporation, may limit the personal liability of a director or officer to the corporation or its stockholders for monetary damages for breach of fiduciary duties as a director or officer, except for liability for any:

     

      ● breach of the director’s or officer’s duty of loyalty to the corporation or its stockholders;
         
      ● act or omission not in good faith or which involve intentional misconduct or a knowing violation of law;
         
      ● a director for any unlawful payment of dividends or redemption of shares;
         
      ● transaction from which the director or officer derived an improper personal benefit; or
         
      ● an officer in any action by or in the right of the corporation.

     

    Section 145(a) of the DGCL provides, in general, that a Delaware corporation may indemnify 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 (other than 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 or other enterprise. The indemnity may include expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by the person in connection with such action, so long as the person acted in good faith and in a manner he or she reasonably believed was in or not opposed to the corporation’s best interests, and, with respect to any criminal action or proceeding, had no reasonable cause to believe his or her conduct was unlawful.

     

    Section 145(b) of the DGCL provides, in general, that a Delaware corporation may indemnify 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 obtain a judgment in its favor because 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 or other enterprise. The indemnity may include expenses (including attorneys’ fees) actually and reasonably incurred by the person in connection with the defense or settlement of such action, so long as the person acted in good faith and in a manner the person reasonably believed was in or not opposed to the corporation’s best interests, except that no indemnification shall be permitted without judicial approval if a court has determined that the person is to be liable to the corporation with respect to such claim. Section 145(c) of the DGCL provides that, if a present or former director or officer has been successful in defense of any action referred to in Sections 145(a) and (b) of the DGCL, the corporation must indemnify such officer or director against the expenses (including attorneys’ fees) he or she actually and reasonably incurred in connection with such action.

     

    Section 145(g) of the DGCL provides, in general, that a corporation may purchase and maintain insurance on behalf of any person who 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 or other enterprise against any liability asserted against and incurred by such person, in any such capacity, or arising out of his or her status as such, whether or not the corporation could indemnify the person against such liability under Section 145 of the DGCL.

     

    II-1

     

     

    Our certificate of incorporation, as amended, and our bylaws provide for the limitation of liability and indemnification of our directors and officers to the fullest extent permitted under the DGCL.

     

    We have also entered into separate indemnification agreements with our directors and officers in addition to the indemnification provided for in our certificate of incorporation, as amended, and our bylaws. These indemnification agreements provide, among other things, that we will indemnify our directors and officers for certain expenses, including damages, judgments, fines, penalties, settlements and costs and attorneys’ fees and disbursements, incurred by a director or officer in any claim, action or proceeding arising in his or her capacity as a director or officer of the Company or in connection with service at our request for another corporation or entity. The indemnification agreements also provide for procedures that will apply in the event that a director or officer makes a claim for indemnification.

     

    We also maintain a directors’ and officers’ insurance policy pursuant to which our directors and officers are insured against liability for actions taken in their capacities as directors and officers.

     

    Item 16. Exhibits.

     

    The following is a list of exhibits filed as part of this registration statement.

     

    Exhibit   Description
    1.1 **   Form of Underwriting Agreement
    3.1   Certificate of Incorporation of the Company, as amended, including the Certificate of Designations of Preferences, Rights, and Limitations of Series A Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the SEC on October 9, 2024).
    3.3   Bylaws of the Company (incorporated by reference to Exhibit 3.2 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on November 13, 2017).
    4.3   Specimen Certificate representing shares of common stock of Celcuity Inc. (incorporated by reference to Exhibit 4.1 to the Company’s Registration Statement on Form S-1/A filed with the SEC on September 12, 2017).
    4.4   Description of Registered Securities (incorporated by reference to Exhibit 4.2 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 27, 2024).
    4.5 **   Form of Preferred Stock Certificate
    4.6 **   Form of Common Stock Warrant Agreement and Warrant Certificate
    4.7 **   Form of Preferred Stock Warrant Agreement and Warrant Certificate
    4.8 **   Form of Debt Securities Warrant Agreement and Warrant Certificate
    4.9 **   Form of Unit Agreement
    4.10   Form of Indenture (incorporated by reference to Exhibit 4.10 to the Company’s Registration Statement on Form S-3 filed with the SEC on August 30, 2024).
    5.1   Opinion of Fredrikson & Byron, P.A. relating to the Securities (incorporated by reference to Exhibit 5.1 to the Company’s Registration Statement on Form S-3 filed with the SEC on August 30, 2024).
    23.1   Consent of Fredrikson & Byron, P.A. (included in Exhibit 5.1) (incorporated by reference to Exhibit 23.1 to the Company’s Registration Statement on Form S-3 filed with the SEC on August 30, 2024).
    23.2 *   Consent of Boulay PLLP
    24.1   Power of attorney (included on the signature page to the Company’s Registration Statement on Form S-3 filed with the SEC on August 30, 2024).
    25.1   Statement of Eligibility of Trustee Under Debt Indenture (to be filed separately pursuant to Section 305(b)(2) of the Trust Indenture Act of 1939)
    107   Filing Fee Table (incorporated by reference to Exhibit 107 to the Company’s Registration Statement on Form S-3 filed with the SEC on August 30, 2024).

     

    * Filed herewith
    ** To be filed by amendment or incorporated by reference in connection with the offering of the securities.

     

    II-2

     

     

    Item 17. Undertakings.

     

    (a) The undersigned registrant hereby undertakes:

     

    (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 of 1933;

     

    (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 a 20 percent 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 the registration statement or any material change to such information in the registration statement.

     

    Provided, however, that the undertakings set forth in paragraphs (a)(1)(i), (a)(1)(ii) and (a)(1)(iii) of this section 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 Securities Exchange Act of 1934 that are incorporated by reference in the registration statements or is contained in a form of prospectus filed pursuant to Rule 424(b) that is a part of the registration statement.

     

    (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.

     

    (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.

     

    (5) That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser:

     

    (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

     

    (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.

     

    II-3

     

     

    (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: (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.

     

    (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 benefit 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 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 whether such indemnification by it is against public policy as expressed in the Securities Act of 1933, and will be governed by the final adjudication of such issue.

     

    (j) If and when applicable, the undersigned registrant, hereby undertakes to file an application for the purpose of determining the eligibility of the trustee to act under subsection (a) of Section 310 of the Trust Indenture Act in accordance with the rules and regulations prescribed by the Commission under Section 305(b)(2) of the Act.

     

    II-4

     

     

    SIGNATURES

     

    Pursuant to the requirements of the Securities Act of 1933, the registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form S-3 and has duly caused this registration statement on Form S-3 to be signed on its behalf by the undersigned, thereunto duly authorized, in Minneapolis, Minnesota, on November 26, 2024.

     

      CELCUITY INC.
         
      By: /s/ Brian F. Sullivan
        Brian F. Sullivan
       

    Chairman and Chief Executive Officer

    (Principal Executive Officer)

     

    Pursuant to the requirements of the Securities Act of 1933, this registration statement has been signed by the following persons in the capacities and on the dates indicated:

     

    Signature   Title   Date
             
    /s/ Brian F. Sullivan   Chairman and Chief Executive Officer (Principal Executive Officer)   November 26, 2024
    Brian F. Sullivan        
             
    /s/ Vicky Hahne   Chief Financial Officer (Principal Financial and Accounting Officer)   November 26, 2024
    Vicky Hahne        
             
    *   Chief Science Officer, Vice President and Secretary, and Director   November 26, 2024
    Lance G. Laing        
             
    *   Director   November 26, 2024
    Richard E. Buller        
             
    *   Director   November 26, 2024
    David F. Dalvey        
             
    *   Director   November 26, 2024
    Leo T. Furcht        
             
    *   Director   November 26, 2024
    Richard J. Nigon        
             
    *   Director   November 26, 2024
    Polly Murphy        

     

    *By: /s/ Vicky Hahne  
     

    Vicky Hahne

    Attorney-in-Fact

     

     

    II-5

     

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    Detailed Results from PIK3CA Wild-Type Cohort of Phase 3 VIKTORIA-1 Trial Presented at 2025 ESMO Congress Demonstrate Potential for Gedatolisib Regimens to be Practice Changing for Patients with HR+/HER2- Advanced Breast Cancer

    Clinical benefit of the gedatolisib regimens was consistent across patient subgroups Hyperglycemia was reported in only 9.2% of patients treated with gedatolisib + palbociclib + fulvestrant ("gedatolisib triplet") and in 11.5% of patients treated with gedatolisib + fulvestrant ("gedatolisib doublet")Study treatment discontinuation due to treatment related adverse events was reported in 2.3% of patients treated with the gedatolisib triplet and 3.1% of patients with the gedatolisib doubletManagement to host webcast and conference call October 20, 2025, at 8:00 a.m. ET MINNEAPOLIS, Oct. 18, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing

    10/18/25 4:30:00 AM ET
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    Celcuity Inc. Schedules Release of Second Quarter 2025 Financial Results and Webcast/Conference Call

    MINNEAPOLIS, Aug. 07, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it will release its financial results for the second quarter 2025 after the market closes on Thursday, August 14, 2025. Management will host a webcast/teleconference the same day at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update. Webcast and Conference Call InformationTo participate in the teleconference, domestic callers should dial 1-800-717-1738 and international callers should dial 1-646-307-1865. A live webcast presentation can also be accessed using this weblink:

    8/7/25 7:05:00 AM ET
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    $CELC
    Large Ownership Changes

    This live feed shows all institutional transactions in real time.

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    Amendment: SEC Form SC 13G/A filed by Celcuity Inc.

    SC 13G/A - Celcuity Inc. (0001603454) (Subject)

    11/14/24 5:46:12 PM ET
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    Amendment: SEC Form SC 13G/A filed by Celcuity Inc.

    SC 13G/A - Celcuity Inc. (0001603454) (Subject)

    11/14/24 5:46:16 PM ET
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    SEC Form SC 13G filed by Celcuity Inc.

    SC 13G - Celcuity Inc. (0001603454) (Subject)

    11/14/24 4:26:12 PM ET
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    Leadership Updates

    Live Leadership Updates

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    Amid NCI Budget Fears, Emerging Oncology Stocks Gain Attention

    Equity Insider News CommentaryIssued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, July 8, 2025 /PRNewswire/ -- Equity Insider News Commentary – As cancer rates climb and drug costs continue to soar, pressure is mounting on the private sector to drive innovation. Now, cancer experts are alarmed over a "gut wrenching" plan from the U.S. government to cut nearly 40% of National Cancer Institute funding, even as the price of oncology treatments pushes new limits—raising urgent concerns about access and affordability. In this shifting landscape, investors are turning their attention to a new wave of biotechs and specialty care providers developing breakthrough therapies and smarter care mo

    7/8/25 10:25:00 AM ET
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    Biotechnology: Pharmaceutical Preparations
    Biotechnology: Biological Products (No Diagnostic Substances)

    Celcuity Appoints Eldon Mayer as Chief Commercial Officer

    MINNEAPOLIS, Feb. 20, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the appointment of Eldon Mayer as Chief Commercial Officer. Mr. Mayer joins Celcuity with over 30 years of biopharmaceutical commercial experience in companies ranging from early-stage biotechs to full scale pharmaceutical companies across many therapeutic areas, including oncology. "Eldon is an exceptional leader with a proven track record of building commercial organizations from the ground up to support the launch of a biotech company's first drug. His significant commercial experience at multiple bio

    2/20/24 7:05:00 AM ET
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    Celcuity Appoints Polly Murphy, D.V.M., Ph.D., to Board of Directors

    Seasoned executive brings over two decades of pharmaceutical business development and commercial strategy experience to Celcuity's Board of DirectorsMINNEAPOLIS, MN / ACCESSWIRE / September 14, 2022 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company focused on development of targeted therapies for a number of different cancers, today announced the appointment of Polly Murphy, D.V.M., Ph.D. to its Board of Directors."We are delighted to welcome Dr. Murphy to our Board and look forward to leveraging her business development expertise and broad industry experience as we continue to advance our pipeline," said Brian Sullivan, CEO and Co-Founder of Celcuity.Dr. Murphy joins Cel

    9/14/22 9:00:00 AM ET
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