Form 8-K
8-K — Celcuity Inc.
Accession: 0001193125-26-411297
Filed: 2026-10-02
Period: 2026-10-01
CIK: 0001603454
SIC: 8071 (SERVICES-MEDICAL LABORATORIES)
Item: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers
Item: Regulation FD Disclosure
Item: Financial Statements and Exhibits
Documents
8-K — celc-20261001.htm (Primary)
EX-99.1 (celc-ex99_1.htm)
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8-K
8-K (Primary)
Filename: celc-20261001.htm · Sequence: 1
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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): October 1, 2026
Celcuity Inc.
(Exact name of Registrant as Specified in its Charter)
Delaware
001-38207
No. 82-2863566
(State or Other Jurisdiction
of Incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
2800 Campus Drive, Suite 140
Minneapolis, Minnesota 55441
(Address of Principal Executive Offices and Zip Code)
(763) 392-0123
(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 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On October 1, 2026, the Board of Directors (the “Board”) of Celcuity Inc. (the “Company”), upon the recommendation of the Nominating and Corporate Governance Committee of the Board, voted to increase the size of the Board from eight members to nine members and to appoint David W. Gryska as a new director to fill the resulting vacancy, effective immediately, for a term extending through the date of the Company’s 2027 Annual Meeting of Stockholders (the “2027 Annual Meeting”) and the election of his successor, or his earlier death, resignation or removal. The Board determined that Mr. Gryska qualifies as an independent director pursuant to the listing standards of The Nasdaq Stock Market LLC and the rules of the U.S. Securities and Exchange Commission. The Board also appointed Mr. Gryska to serve as a member of the Audit Committee and Compensation Committee of the Board.
Mr. Gryska will receive pro-rated compensation for his service in accordance with the Company’s non-employee director compensation program, which currently provides for an annual cash retainer of $70,000, payable quarterly, and an annual equity award with a fair market value of $100,000, payable in the form of restricted stock units, stock options, or a combination of both, at the director’s election.
Upon appointment to the Board, the Company granted Mr. Gryska a pro-rated annual grant of 893 restricted stock units under the Company’s 2026 Stock Incentive Plan, which will vest as to all shares upon the earlier of (i) the 2027 Annual Meeting or (ii) April 30, 2027.
There are no arrangements or understandings between Mr. Gryska and any other persons pursuant to which Mr. Gryska was selected as a director of the Company. There are no relationships or related transactions between Mr. Gryska or any member of his immediate family and the Company that would be required to be reported under Item 404(a) of Regulation S-K.
Item 7.01 Regulation FD Disclosure.
On October 2, 2026, the Company issued a press release announcing Mr. Gryska's appointment to the Board and the Audit Committee and Compensation Committee of the Board. A copy of this press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference.
The information in this Item 7.01, including the accompanying exhibit, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. The information in this Item 7.01 shall not be incorporated into any filing pursuant to the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
99.1
Press release dated October 2, 2026
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: October 2, 2026
CELCUITY INC.
By
/s/ Brian F. Sullivan
Brian F. Sullivan
Chief Executive Officer
EX-99.1
EX-99.1
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EX-99.1
Exhibit 99.1
Celcuity Appoints David Gryska To Its Board Of Directors
Mr. Gryska brings decades of strategic and financial leadership experience to Celcuity’s Board
MINNEAPOLIS, October 2, 2026 — Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications, today announced the appointment of David W. Gryska to its Board of Directors. Mr. Gryska is a seasoned executive who brings over 35 years of strategic and financial leadership experience in the life sciences industry to Celcuity, including advising early-stage biotechnology companies.
“On the heels of our first FDA approval for REVTORPYK™, we are pleased to welcome David to our Board of Directors as we transition into a commercial-stage company,” said Brian Sullivan, Chief Executive Officer and co-founder of Celcuity. “David's extensive experience as a Chief Financial Officer and board member of a number of pharmaceutical companies, through periods of significant clinical development and commercial growth makes him an outstanding addition to our Board. We are confident he will provide valuable expertise as we execute the launch of REVTORPYK, advance our clinical development programs, and continue building the capabilities needed to support long-term growth.”
Prior to his retirement, Mr. Gryska served as Executive Vice President and Chief Financial Officer of Incyte Corporation; and Senior Vice President and Chief Financial Officer of Celgene Corporation. Mr. Gryska also served as Senior Vice President and Chief Financial Officer as well as Vice President of Finance and Chief Financial Officer at Scios, Inc.. Earlier in his career, Mr. Gryska served as a partner at Ernst & Young LLP in California.
Throughout the past 25 years, Mr. Gryska has served on the Boards of eight public biotechnology companies and currently serves on the Board of Directors of Definium Therapeutics. He previously served on the Boards of Directors of Seagen Inc. for more than 15 years, Forte Biosciences, Aerie Pharmaceuticals, and GW Pharmaceuticals. Mr. Gryska holds a B.A. in Accounting and Finance from Loyola University and an MBA from Golden Gate University.
“Celcuity is entering an exciting new chapter, with the company poised for significant growth over the next few years following the FDA approval and commercial launch of REVTORPYK in advanced breast cancer,” said Mr. Gryska. “I look forward to supporting Brian and Celcuity’s experienced leadership team as we build on this momentum, advance gedatolisib in additional solid tumor indications, and work to bring meaningful benefits to more patients.”
About Celcuity
Celcuity is a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications. The company's first FDA-approved product is REVTORPYK (gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluated gedatolisib in combination with fulvestrant, with or without palbociclib, for the treatment of patients with HR+/HER2- ABC. Data from this trial is the basis for FDA approval of REVTORPYK for use in adult patients with HR+/HER2- ABC without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. Results for the PIK3CA mutant cohort of the VIKTORIA-1 study have been released. Our Phase 3 clinical trial, VIKTORIA-2, is an ongoing trial incorporating two independent studies, Study 1 and Study 2, in two separate cohorts of patients with ABC who are treatment-naive in the advanced setting. Study 1 is evaluating gedatolisib in combination with palbociclib and fulvestrant as first-line treatment for patients with endocrine-resistant HR+/HER2- ABC. Study 2 is evaluating gedatolisib in combination with palbociclib and letrozole as first-line treatment for patients with endocrine-sensitive HR+/HER2- ABC. A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration-resistant prostate cancer, is ongoing. More detailed information about Celcuity’s active clinical trials can be found at ClinicalTrials.gov. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com. Follow us on LinkedIn and X.
Forward Looking Statements
This press release contains statements that constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements relating to REVTORPYK and the potential therapeutic benefits of gedatolisib; the size, design and timing of the Company’s clinical trials; the Company’s interpretation of clinical trial data; the status and timing of the submission, and the FDA’s review, of the Company’s supplemental New Drug Application (“sNDA”) for REVTORPYK, and for making comparable filings with other regulatory authorities outside the U.S.; the market opportunity for REVTORPYK; the Company’s expectations regarding the timing of and its ability to commercialize REVTORPYK; the Company’s strategy, marketing and commercialization plans, including the benefits of strategic decisions regarding studies and trials; other expectations with respect to gedatolisib, including subcutaneous formulations to support potential future indications for gedatolisib regimens; the Company’s anticipated use of cash; and the strength of its balance sheet. Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” "confidence," "encouraged," “potential,” “plan,” “targets,” “likely,” “may,” “will,” “would,” “should” and “could,” and similar expressions or words identify forward-looking statements. The forward-looking statements included in this press release are based on management's current expectations and beliefs which are subject to a number of risks, uncertainties and factors, including that the Company’s topline clinical results are based on an ongoing analysis of efficacy and safety data and such data may change following a more comprehensive review of the data related to the clinical trial; unforeseen delays in the Company’s clinical trials or the submission, and FDA’s review of, its sNDA for REVTORPYK; the Company’s ability to obtain regulatory approval of its sNDA and maintain regulatory approvals to commercialize REVTORPYK in the U.S. and obtain regulatory approval of gedatolisib outside the U.S., and the market acceptance of REVTORPYK; the development of therapies and tools competitive with gedatolisib; and the Company’s ability to access capital upon favorable terms. In addition, all forward-looking statements are subject to other risks detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as such risks may be updated in its subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by these cautionary statements, and the Company undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
Contacts:
For Investors:
Brian Sullivan, bsullivan@celcuity.com
Vicky Hahne, vhahne@celcuity.com
(763) 392-0123
Jodi Sievers, jsievers@celcuity.com
(415) 494-9924
For Media:
Sam Brown LLC
Laura Morgan, lauramorgan@sambrown.com
(951) 333-9110
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