0001603454 false 0001603454 2022-09-12 2022-09-12 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): September 12, 2022

 

Celcuity Inc.

(Exact name of Registrant as Specified in its Charter)

 

Delaware   001-38207   82-2863566

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

16305 36th Avenue North; Suite 100
Minneapolis, Minnesota 55446

(Address of Principal Executive Offices and Zip Code)

 

(763) 392-0767

(Registrant’s telephone number, including area code)

 

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common Stock, $0.001 par value per share   CELC   The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 

 

 
 

 

Item 1.01Entry into a Material Definitive Agreement.

 

On September 13, 2022, Celcuity Inc. (the “Company”) entered into a First Amendment to Representative’s Warrant (the “Warrant Amendment”) with Craig-Hallum Capital Group LLC (“Craig-Hallum”), amending the terms of that certain Representative’s Warrant, dated September 22, 2017 (the “Representative’s Warrant”) issued by the Company to Craig-Hallum in connection with the Company’s initial public offering.

 

Under the terms of the Warrant Amendment, (i) the number of shares of the Company’s common stock issuable upon exercise of the Representative’s Warrant was reduced from 138,000 shares to 70,000 shares, and (ii) the exercise period of the Representative’s Warrant was extended three years to September 19, 2025. There were no other material amendments or modifications to the Representative’s Warrant.

 

The foregoing description of the Warrant Amendment is not complete and is qualified in its entirety by reference to the full text of such agreement, a copy of which is filed herewith as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

Item 3.03Material Modification to the Rights of Security Holders.

 

To the extent required by Item 3.03 of Form 8-K, the disclosure set forth in Item 1.01 of this Current Report on Form 8-K is incorporated by reference in this Item 3.03.

 

Item 5.02Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

 

On September 12, 2022, the Board of Directors (the “Board”) of the Company, voted to increase the size of the Board from six members to seven members and to elect Polly Murphy, D.V.M., Ph.D. as a new director to fill the resulting vacancy. Dr. Murphy joined the Board as an independent director, effective immediately, for a term extending through the date of the Company’s 2023 Annual Meeting of Stockholders (the “2023 Annual Meeting”). Dr. Murphy was not elected to the Board pursuant to any arrangement or understanding between her and any other person. The Board has not appointed Dr. Murphy to any committees as of the date hereof.

 

Upon election to the Board, and consistent with grants to other non-employee directors, the Company granted Dr. Murphy an option, under the Company’s 2017 Stock Incentive Plan (the “Plan”) to purchase 16,300 shares of common stock at an exercise price of $8.31, the closing price of the Company’s common stock on September 12, 2022. The option will vest and become exercisable as to all 16,300 shares upon the earlier of (i) the 2023 Annual Meeting or (ii) April 30, 2023. The Company expects to make grants of similar value each year that Dr. Murphy continues to serve on the Board and intends to enter into an indemnification agreement with Dr. Murphy that is substantially similar to those entered into by other members of the Board.

 

Additionally, the Company granted Dr. Murphy an option, under the Plan, to purchase 10,000 shares of common stock at an exercise price of $8.31, the closing price of the Company’s common stock on September 12, 2022. The options will vest and become exercisable as to 2,500 shares on each of September 12, 2023, 2024, 2025 and 2026.

 

Other than as described above, Dr. Murphy has not been a party to, nor has she had a direct or indirect material interest in, any transactions with the Company during the current fiscal year or prior fiscal years that would be reportable under Item 404(a) of Regulation S-K.

 

A copy of the Company’s press release announcing the election of Dr. Murphy to the Board is attached hereto as Exhibit 99.1.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

10.1   First Amendment to Representative’s Warrant, dated September 13, 2022, between Celcuity Inc. and Craig-Hallum Capital Group LLC.
     
99.1   Press Release of Celcuity Inc. dated September 14, 2022.
     
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 
 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: September 14, 2022

 

  CELCUITY INC.
   
  By /s/ Brian F. Sullivan
    Brian F. Sullivan
    Chief Executive Officer

 

 

 

Exhibit 10.1

 

FIRST AMENDMENT

TO REPRESENTATIVE’S WARRANT

 

This FIRST AMENDMENT TO REPRESENTATIVE’S WARRANT (this “Amendment”) is entered into as of September 13, 2022 (the “Effective Date”) between Celcuity Inc., a Delaware corporation (the “Company”), and Craig-Hallum Capital Group LLC (“Holder”).

 

WHEREAS, in connection with the Company’s initial public offering and that certain Underwriting Agreement, dated September 19, 2017, between the Company and Holder as representative of the several underwriters listed in Schedule I thereto, the Company issued Holder a Representative’s Warrant dated September 22, 2017 (the “Warrant”) to purchase 138,000 shares of the Company’s common stock, par value $0.001 per share (“Common Stock”); and

 

WHEREAS, the Company and Holder desire to amend the terms of the Warrant to reduce the number of shares of Common Stock that Holder may purchase pursuant to exercise of the Warrant from 138,000 shares to 70,000 shares and to extend the period pursuant to which the Warrant may be exercised by three additional years, as set forth herein.

 

NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree as follows.

 

1. Amendment. Effective as of the Effective Date, the Warrant is hereby amended as follows:

 

(a) The first sentence of the first paragraph of the Warrant is deleted in its entirety and replaced with the following:

 

“THIS CERTIFIES THAT, for value received, Craig-Hallum Capital Group LLC, or its registered assigns (herein referred to as the “Purchaser” or “Holder”), is entitled to subscribe for and purchase from Celcuity Inc., a Delaware corporation (herein called the “Company”), seventy thousand (70,000) shares (the “Shares”) of common stock, par value $0.001 per share (the “Common Stock”), of the Company (subject to adjustment as noted below) at an exercise price of $10.45 per Share (the “Warrant Purchase Price”) (subject to adjustment as noted below).”

 

(b) Section 1 is deleted in its entirety and replaced with the following:

 

“The Warrant exercise period (the “Exercise Period”) for this Warrant shall begin the effective date of the Offering and shall end on the eighth (8th) anniversary of the effective date of the Offering. As used herein, the “effective date of the Offering” means September 19, 2017.”

 

2. Representations and Warranties.

 

(a) Each party hereby represents and warrants to the other party that:

 

(i) It has the full right, power, and authority to enter into this Amendment and to perform its obligations hereunder and under the Warrant as amended by this Amendment.

 

(ii) The execution of this Amendment by the individual whose signature is set forth at the end of this Amendment on behalf of such party, and the delivery of this Amendment by such party, have been duly authorized by all necessary action on the part of such party.

 

 
 

 

(iii) This Amendment has been executed and delivered by such party and (assuming due authorization, execution, and delivery by the other party hereto) constitutes the legal, valid, and binding obligation of such party, enforceable against such party in accordance with its terms, except as may be limited by any applicable securities laws.

 

(b) Holder further represents and warrants to the Company that, as of the Effective Date, Holder has not assigned all or any portion of the Warrant, or any of its rights thereunder, to any other party and has not exercised or attempted to exercise any portion of the Warrant.

 

3. Miscellaneous.

 

(a) No other Amendments. Except as expressly provided in this Amendment, all of the terms and provisions of the Warrant are and will remain in full force and effect and are hereby ratified and confirmed by the parties.

 

(b) Severability. The invalidity or unenforceability of any provision of this Amendment shall not affect the validity or enforceability of any other provision of this Amendment, and each other provision of this Amendment shall be severable and enforceable to the extent permitted by law.

 

(c) Binding Effect and Obligation. This Amendment shall be binding upon and inure to the benefit of the Company and to Holder and their respective successors and assigns.

 

(d) Entire Agreement; Governing Law. This Amendment, together with the Warrant, constitutes the entire agreement between the Company and Holder with respect to the subject matter hereof and supersede in their entirety all prior undertakings and agreements of the Company and Holder with respect to the subject matter hereof. This Amendment shall be governed by and construed in accordance with the laws of the State of New York, without reference to conflict of law provisions thereof.

 

(e) Amendment. This Amendment may be amended or modified by, and only by, a written instrument executed by the Company and Holder.

 

(f) Counterparts. This Amendment may be executed and delivered (including via electronic means) in any number of counterparts, each of which shall be deemed an original, but all of which together shall constitute one instrument.

 

[Signature Page Follows]

 

2
 

 

IN WITNESS WHEREOF, the parties have entered into this First Amendment to Warrant as of the Effective Date set forth above.

 

  COMPANY:
   
  CELCUITY INC.
     
  By: /s/ Brian F. Sullivan
  Name: Brian F. Sullivan
  Title: Chief Executive Officer

 

  HOLDER:
   
  CRAIG-HALLUM CAPITAL GROUP LLC
     
  By: /s/ Kevin Harris
  Name: Kevin Harris
  Title: Managing Partner

 

 

 

Exhibit 99.1

 

 

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 Directors

 

MINNEAPOLIS, 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 Celcuity with over 20 years of business development and commercial strategy experience at leading global pharmaceutical companies, including 12 years in leadership positions with increasing responsibility at Pfizer. While at Pfizer she led business development for Worldwide R&D and the global Specialty Care Business Unit, and later Global Marketing and Commercial Development for the Pfizer Oncology Business Unit. Dr. Murphy was also Vice President and Head, Strategy and Business Development for Pfizer China where she was in charge of business and commercial development, as well as strategy and innovation for the company’s biopharmaceutical business in China. Prior to Pfizer, Dr. Murphy held senior leadership positions at several pharmaceutical and academic research entities, including The Scripps Research Institute, Salk Institute, and Aurora Biosciences.

 

Dr. Murphy is currently the Chief Business Officer of UroGen Pharma, where she has served since 2020, and a member of Atea Pharmaceuticals’ Board of Directors. She received a D.V.M. in 1989 and Ph.D. in Veterinary Pathology in 1994 from Iowa State University and an MBA from Nova Southeastern University in 1998.

 

“I am thrilled to be joining Celcuity’s Board of Directors as the company continues to make strides with its lead product candidate, gedatolisib. This is an exciting time for Celcuity, and I look forward to working with the other Board members, Brian, and the management team to advance the development pipeline and the CELsignia platform,” stated Dr. Murphy.

 

About Celcuity

 

Celcuity is a clinical-stage biotechnology company focused on development of targeted therapies for treatment of multiple solid tumor indications. The company’s lead therapeutic candidate is gedatolisib, a potent, reversible dual inhibitor that selectively targets all Class 1 PI3K isoforms and mTOR. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. The company expects to initiate a Phase 3 study evaluating gedatolisib in patients with HR+/HER2- advanced breast cancer and expects to dose the first patient in the next few months. Its CELsignia companion diagnostic platform is uniquely able to analyze live patient tumor cells to identify new groups of cancer patients likely to benefit from already approved targeted therapies. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com. Follow us on LinkedIn and Twitter.

 

 
 

 

Forward-Looking Statements

 

This press release contains statements that constitute “forward-looking statements” including, but not limited to, the timing of initiating and enrolling patients in, and receiving results from, Celcuity’s planned Phase 3 clinical trial (VIKTORIA-1), as well as other expectations with respect to Celcuity’s lead product candidate, gedatolisib and its CELsignia platform. In some cases, you can identify forward-looking statements by terminology such as “may,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “intends” or “continue,” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. Forward-looking statements are subject to numerous risks, uncertainties, and conditions, many of which are beyond the control of Celcuity. These include, but are not limited to, those risks set forth in the Risk Factors section in Celcuity’s Quarterly Report for the period ended March 31, 2022 filed with the Securities and Exchange Commission on May 16, 2022. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Celcuity undertakes no obligation to update these statements for revisions or changes after the date of this press release, except as required by law.

 

Contacts:

 

Celcuity Inc.

Brian Sullivan, bsullivan@celcuity.com

Vicky Hahne, vhahne@celcuity.com

(763) 392-0123

 

ICR Westwicke

Robert Uhl, robert.uhl@westwicke.com

(619) 228-5886