[8-K] Celcuity Inc. Reports Material Event

Rhea-AI Filing Summary

Celcuity’s Form 8-K furnishes topline data from the PIK3CA wild-type cohort of its Phase 3 VIKTORIA-1 trial in HR-positive/HER2-negative metastatic breast cancer. Adding gedatolisib to fulvestrant plus palbociclib cut risk of progression or death by 76 % (HR 0.24; p<0.0001) and extended blinded-review median PFS to 9.3 months vs. 2.0 months. The gedatolisib+fulvestrant doublet reduced risk by 67 % (HR 0.33) with mPFS of 7.4 months. Both hazard ratios and incremental PFS gains are the best reported for second-line HR+/HER2- ABC in any Phase 3 study. Discontinuations and class-related AEs (hyperglycemia, stomatitis) were lower than prior Phase 1b data and other approved regimens, indicating an improved tolerability profile.

Celcuity plans to file a New Drug Application with the FDA in Q4 2025; full data will be presented at a medical meeting in 2025. Topline results from the separate PIK3CA-mutant cohort are expected by year-end 2025.

Positive

• 76 % risk reduction and 7.3-month mPFS gain for gedatolisib triplet represents best Phase 3 efficacy in second-line HR+/HER2- breast cancer.
• Improved tolerability with lower discontinuations and reduced hyperglycemia/stomatitis versus prior trials.
• Company targets NDA filing in Q4 2025, moving asset into regulatory phase.

Negative

• Results are topline; full safety, overall survival and subgroup data not yet disclosed.
• Commercial launch still contingent on FDA approval; Celcuity may require additional financing before revenue generation.
• Regulatory and competitive risks remain, especially versus next-generation CDK4/6 and SERD therapies.

Insights

Oncology Analyst

TL;DR: Strong Phase 3 PFS boost positions gedatolisib as best-in-class for PIK3CA WT HR+/HER2- breast cancer.

The triplet’s HR 0.24 and 7.3-month PFS delta eclipse everolimus, alpelisib and CDK4/6 combinations, setting a new efficacy benchmark. Reduced AE-related discontinuations mitigate historical PI3K pathway toxicity concerns, bolstering approvability. Pending full safety and OS data, the read-out materially de-risks the asset and justifies NDA submission. Regulatory timing (Q4 2025) leaves ~18-month gap before potential revenue, but momentum should attract partnership interest.

Portfolio Manager

TL;DR: Event is clearly positive yet value realisation hinges on FDA review and commercial execution.

The magnitude of benefit and cleaner safety profile materially improve probability-of-approval (>70 % by our estimate). However, cash burn continues and commercial infrastructure is absent; dilution risk remains. Investors should monitor upcoming full dataset presentations and any licensing activity to gauge upside capture versus funding needs.

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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): July 28, 2025

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 7.01 Regulation FD Disclosure.

On July 28, 2025, Celcuity Inc. (the “Company”) issued a press release announcing topline results from its PIK3CA wild-type cohort of Phase 3 VIKTORIA-1 clinical trial. A copy of the 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 8.01 Other Events.

On July 28, 2025, the Company announced positive topline results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib plus fulvestrant with and without palbociclib versus fulvestrant in adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA wild-type, locally advanced or metastatic breast cancer, following progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor.

In the trial, gedatolisib in combination with palbociclib and fulvestrant (the “gedatolisib triplet”) demonstrated a statistically significant and clinically meaningful improvement in progression free survival (“PFS”) among patients, reducing the risk of disease progression or death by 76% compared to fulvestrant (based on a hazard ratio [HR] of 0.24, 95% confidence interval [CI] 0.17-0.35; p<0.0001). The median PFS (“mPFS”), as assessed by blinded independent central review (“BICR”), was 9.3 months with the gedatolisib triplet versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months.

Gedatolisib in combination with fulvestrant (“gedatolisib doublet”) also demonstrated a statistically significant and clinically meaningful improvement in PFS among patients, reducing the risk of disease progression or death by 67% compared to fulvestrant (based on a HR of 0.33, 95% CI 0.24-0.48; p<0.0001). The mPFS, as assessed by BICR, was 7.4 months with the gedatolisib doublet versus 2.0 months with fulvestrant, an incremental improvement of 5.4 months.

The topline efficacy data from the VIKTORIA-1 PIK3CA wild-type cohort established several new milestones in the history of drug development for HR+/HER2- advanced breast cancer (“ABC”):

	●	The hazard ratios for the gedatolisib triplet and doublet are more favorable than have ever been reported by any Phase 3 trial for patients with HR+/HER2- ABC.
	●	The 7.3- and 5.4-months incremental improvements in mPFS for the gedatolisib triplet and gedatolisib doublet over fulvestrant, respectively, are higher than have ever been reported by any Phase 3 trial for patients with HR+/HER2- ABC receiving at least their second line of therapy.
	●	Gedatolisib is the first inhibitor targeting the PI3K/AKT/mTOR pathway to demonstrate positive Phase 3 results in patients with HR+/HER2-/PIK3CA wild-type ABC whose disease progressed on or after treatment with a CDK4/6 inhibitor.

Treatment discontinuation due to a treatment-related adverse event for the gedatolisib triplet and gedatolisib doublet was lower than was observed in Arm D of the Phase 1b trial in patients with ABC, and lower than observed in any Phase 3 trials for currently approved drug combinations in HR+/HER2- ABC. Additionally, the gedatolisib triplet and gedatolisib doublet were better tolerated than was observed in the Phase 1b trial in patients with ABC, including lower rates of hyperglycemia and stomatitis.

Full data from the PIK3CA wild-type cohort of the VIKTORIA-1 clinical trial will be presented at an upcoming medical conference later this year. The Company expects to submit a New Drug Application for gedatolisib to the U.S. Food and Drug Administration in the fourth quarter of 2025. Topline data for the VIKTORIA-1 PIK3CA mutation cohort is expected by the end of 2025.

Forward-Looking Statements

This Current Report on Form 8-K (including the exhibit thereto) contains statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 including statements relating to the potential therapeutic benefits of gedatolisib; the size, design and timing of our clinical trials; our interpretation of topline clinical trial data; the ability of our data to support the filing of an NDA with the FDA; our expectations regarding the timing of and our ability to obtain FDA approval to commercialize gedatolisib; and other expectations with respect to gedatolisib. 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 report are based on management’s current expectations and beliefs which are subject to a number of risks, uncertainties and factors, including that our topline results are based on a preliminary analysis of key 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 our planned NDA for gedatolisib; and our ability to obtain and maintain regulatory approvals to commercialize gedatolisib. In addition, all forward-looking statements are subject to other risks detailed in our Annual Report on Form 10-K for the year ended December 31, 2024, and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, as such risks may be updated in our 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 we undertake no obligation to revise or update this report to reflect events or circumstances after the date hereof.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

99.1		Press release dated July 28, 2025
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: July 28, 2025

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

FAQ

What did Celcuity (CELC) announce in its July 28 2025 8-K?

Positive topline Phase 3 results for gedatolisib combinations in PIK3CA wild-type HR+/HER2- metastatic breast cancer.

How much did gedatolisib improve progression-free survival?

The triplet achieved 9.3 months mPFS vs. 2.0 months for fulvestrant alone (HR 0.24).

When will Celcuity file an NDA for gedatolisib?

The company plans to submit in Q4 2025.

Were safety concerns identified?

Discontinuations and class-related AEs were lower than prior trials, suggesting an improved safety profile.

What catalysts remain for CELC in 2025?

Full Phase 3 data presentation and topline results from the PIK3CA-mutant cohort by year-end 2025.