Form 8-K

8-K — Celcuity Inc.

Accession: 0001493152-26-026761

Filed: 2026-06-02

Period: 2026-06-02

CIK: 0001603454

SIC: 8071 (SERVICES-MEDICAL LABORATORIES)

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — form8-k.htm (Primary)

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0001603454

2026-06-02

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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): June 2, 2026

Celcuity

Inc.

(Exact

name of Registrant as Specified in its Charter)

Delaware

001-38207

82-2863566

(State

or Other Jurisdiction

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 ☐

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.

June 2, 2026, Celcuity Inc. (the “Company”) issued a press release announcing detailed efficacy and safety results from its

PIK3CA mutant-type (“MT”) cohort of its 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.

June 2, 2026, the Company announced detailed efficacy and safety results from the PIK3CA MT cohort of the Phase 3 VIKTORIA-1 clinical

trial of gedatolisib, an investigational pan-PI3K/mTORC1/2 inhibitor, in adults with hormone receptor positive (“HR+”), human

epidermal growth factor receptor 2 negative (“HER2-”), PIK3CA MT, locally advanced or metastatic breast cancer (“ABC”),

following progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor. VIKTORIA-1 is the first Phase 3 clinical

trial to compare the efficacy of two PI3K/AKT/mTOR (“PAM”) inhibitors in this patient population.

the trial, the gedatolisib-triplet demonstrated a statistically significant and clinically meaningful improvement in median progression

free survival (“PFS”) among patients, increasing the likelihood of survival without disease progression or death by two times

compared to alpelisib plus fulvestrant (based on a hazard ratio [HR] of 0.50; 95% CI: 0.37-0.68; p<0.0001). The median PFS, as assessed

by blinded independent central review, was nearly two-times longer, 11.1 months versus 5.6 months, compared to alpelisib plus fulvestrant.

The objective response rate (“ORR”) of the gedatolisib-triplet was 48.9% compared to 26.0% with alpelisib plus fulvestrant,

and the median duration of response (“DOR”) for the gedatolisib-triplet was 15.7 months compared to 7.5 months for alpelisib

plus fulvestrant.

For

the gedatolisib-doublet, the median PFS was more than two-times longer, 11.3 months versus 5.6 months, compared to alpelisib plus fulvestrant

(HR=0.51; 95% CI: 0.33-0.79; descriptive p=0.0013). The ORR of the gedatolisib-doublet was 35.7%, and the median DOR was 24.2 months.

The

topline gedatolisib-triplet efficacy data from the VIKTORIA-1 PIK3CA MT cohort established several new milestones in the history

of drug development for HR+/HER2- ABC:

● First

Phase 3 trial to demonstrate superiority of one PAM inhibitor versus another.

● The

median PFS of 11.1 months for the gedatolisib-triplet is the highest reported by any Phase

3 trial for patients with HR+/HER2- ABC receiving a regimen including endocrine therapy as

second-line treatment.

● The

ORR of 48.9% for the gedatolisib-triplet is the highest reported by any Phase 3 clinical

trial for a regimen including endocrine therapy in second-line HR+/HER2- ABC.

The

gedatolisib-triplet and gedatolisib-doublet were generally well tolerated in the trial with mostly low-grade treatment-related adverse

events (“TRAEs”). The most common Grade 3+ TRAEs for the gedatolisib-triplet, the gedatolisib-doublet, and alpelisib plus

fulvestrant groups included neutropenia (58.8%, 0%, and 0.7% of patients, respectively); stomatitis (16.3%, 5.8%, and 5.3% of patients,

respectively); rash (6.5%, 5.8%, and 15.1% of patients, respectively); and hyperglycemia (2.6%, 0%, and 14.5% of patients, respectively).

TRAEs led to the discontinuation of study treatment in 2.6% of patients in the gedatolisib-triplet group, 3.8% in the gedatolisib-doublet

group, and 7.1% in the alpelisib plus fulvestrant group. One Grade 5 TRAE in the gedatolisib-triplet group, which was related to palbociclib,

was reported; no Grade 5 TRAEs were reported in the gedatolisib-doublet group, and two Grade 5 TRAEs were reported in the alpelisib plus

fulvestrant group.

Overall

survival, a key secondary endpoint in VIKTORIA-1, while immature at the time of the analysis, showed promising trends for both the gedatolisib-triplet

and the gedatolisib-doublet.

The

Company intends to submit these data to the U.S. Food and Drug Administration (the “FDA”) as a supplemental New Drug Application

(“sNDA”) and to submit VIKTORIA-1 data to other regulatory authorities following the sNDA submission.

The

Company believes that it is on track to launch gedatolisib commercially, in anticipation of its potential FDA approval in the

third quarter of 2026.

The

FDA has granted Priority Review of Celcuity’s New Drug Application (“NDA”) for gedatolisib in patients with HR+/HER2-

PIK3CA wild-type (“WT”) ABC and assigned a Prescription Drug User Fee Act (“PDUFA”) goal date of July

17, 2026.

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 clinical trial data; the status and

timing of the FDA’s review of our NDA for gedatolisib, including the PDUFA goal date assigned by the FDA; the ability of our data

to support the filing of an sNDA with the FDA and comparable filings with other regulatory authorities; the market opportunity for gedatolisib;

our expectations regarding the timing of and our ability to obtain FDA approval to commercialize gedatolisib; our strategy, marketing

and commercialization plans, including the benefits of strategic decisions regarding studies and trials; other expectations with respect

to gedatolisib including future subcutaneous formulations of gedatolisib; our anticipated use of cash; and the strength of our 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 report are based

on management’s current expectations and beliefs which are subject to a number of risks, uncertainties and factors, including that

our clinical results are based on an ongoing 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 clinical trials or the FDA’s review of our NDA for gedatolisib;

our ability to obtain and maintain regulatory approvals to commercialize gedatolisib, and the market acceptance of gedatolisib; the development

of therapies and tools competitive with gedatolisib; and our ability to access capital upon favorable terms. 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, 2025, and our Quarterly

Report on Form 10-Q for the quarter ended March 31, 2026, 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 June 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:

June 2, 2026

CELCUITY

INC.

By:

/s/

Brian F. Sullivan

Brian

F. Sullivan

Chief

Executive Officer

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit 99.1

Celcuity’s

Gedatolisib Combination Regimens Doubled the Likelihood of Survival without Disease Progression or Death Compared to Alpelisib plus Fulvestrant

in the PIK3CA Mutant Cohort of the Pivotal Phase 3 VIKTORIA-1 Trial

Patients with HR+/HER2- Advanced Breast Cancer

● Gedatolisib

plus fulvestrant and palbociclib (the “gedatolisib-triplet”) reduced the risk

of disease progression or death by 50% vs. alpelisib plus fulvestrant (HR=0.50; 95% CI: 0.37–0.68;

p<0.0001). Median progression-free survival (“PFS”) was 11.1 months with the

gedatolisib triplet versus 5.6 months with alpelisib plus fulvestrant

● Gedatolisib

plus fulvestrant (the “gedatolisib-doublet”) reduced the risk of disease progression

or death by 49% vs. alpelisib plus fulvestrant (HR=0.51; 95% CI: 0.33–0.79; descriptive

p=0.0013). Median PFS was 11.3 months with the gedatolisib-doublet versus 5.6 months with

alpelisib plus fulvestrant

● Gedatolisib

regimens demonstrated robust and durable responses: 48.9% objective response rate (“ORR”)

and median duration of response (“DoR”) of 15.7 months for the gedatolisib-triplet

and 35.7% ORR and median DoR of 24.2 months for the gedatolisib-doublet

● The

safety data and study treatment discontinuation rates for the gedatolisib-triplet and -doublet

were consistent with previously reported data from the PIK3CA wild-type cohort of VIKTORIA-1

MINNEAPOLIS,

June 2, 2026 — Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on the development of targeted

therapies for the treatment of multiple solid tumor indications, today announced detailed efficacy and safety results from the PIK3CA

mutant (“MT”) cohort of the Phase 3 VIKTORIA-1 clinical trial of gedatolisib, an investigational pan-PI3K/mTORC1/2 inhibitor,

in adults with hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”),

PIK3CA mutated, locally advanced or metastatic breast cancer (“ABC”), following progression on, or after, treatment

with a CDK4/6 inhibitor and an aromatase inhibitor. VIKTORIA-1 is the first Phase 3 clinical trial to compare the efficacy of two PI3K/AKT/mTOR

(“PAM”) inhibitors in this patient population.

The

study results will be presented in a late-breaking abstract (“LBA”) oral session at the American Society of Clinical Oncology

(“ASCO”) Annual Meeting today, Tuesday, June 2, 2026, 12:09 p.m. CDT.

The

PAM pathway is a key oncogenic driver of HR+/HER2- breast cancer that requires inhibition of multiple molecular components to comprehensively

blockade excessive PAM signaling in tumors with or without a PAM variant. Gedatolisib is the first multitarget PAM inhibitor to demonstrate

superior efficacy relative to a single-target inhibitor of this pathway. In the PIK3CA MT cohort of the Phase 3 VIKTORIA-1 trial,

the gedatolisib-triplet demonstrated a statistically significant and clinically meaningful improvement in median PFS among patients,

increasing the likelihood of survival without disease progression or death by two times compared to alpelisib plus fulvestrant (based

on a hazard ratio [HR] of 0.50; 95% CI: 0.37-0.68; p<0.0001). The median PFS, as assessed by blinded independent central review (“BICR”),

was nearly two-times longer, 11.1 months versus 5.6 months, compared to alpelisib plus fulvestrant. The ORR of the gedatolisib-triplet

was 48.9% compared to 26.0% with alpelisib plus fulvestrant and the median DOR for the gedatolisib triplet was 15.7 months compared to

7.5 months for alpelisib plus fulvestrant.

For

the gedatolisib-doublet, the median PFS was more than two-times longer, 11.3 months versus 5.6 months, compared to alpelisib plus fulvestrant

(HR=0.51; 95% CI: 0.33-0.79; descriptive p=0.0013). The ORR of the gedatolisib-doublet was 35.7% and the median DOR was 24.2 months.

The

topline gedatolisib-triplet efficacy data from the VIKTORIA-1 PIK3CA MT cohort established several new milestones in the history

of drug development for HR+/HER2- ABC:

● First

Phase 3 trial to demonstrate superiority of one PAM inhibitor versus another.

● The

median PFS of 11.1 months for the gedatolisib-triplet is the highest reported by any Phase

3 trial for patients with HR+/HER2- ABC receiving a regimen including endocrine therapy as

second-line treatment.

● The

objective response rate of 48.9% for the gedatolisib-triplet is the highest reported by any

Phase 3 clinical trial for a regimen including endocrine therapy in second-line HR+/HER2-

ABC.

“Therapies

that target only PI3Kα or AKT typically offer modest benefit for patients with PIK3CA mutant HR+/HER2- advanced breast cancer

whose disease has progressed while on or after treatment with a CDK4/6 inhibitor,” said Sara Hurvitz, MD, Senior Vice President,

Clinical Research Division, Fred Hutchinson Cancer Center, Smith Family Endowed Chair in Women’s Health and Professor and Head,

Division of Hematology and Oncology, University of Washington, Department of Medicine and co-principal investigator for the trial. “By

comprehensively blocking the PI3K/AKT/mTOR, or PAM, pathway, gedatolisib combined with fulvestrant, with or without palbociclib, showed

it can offer these patients two times the likelihood of survival without disease progression or death relative to a single-target inhibitor

of the PAM pathway. With these results, the gedatolisib regimens, if approved, represent a new potential standard of care for patients

with HR+, HER2-negative, PIK3CA mutant advanced breast cancer whose disease progressed on or after treatment with a CDK4/6 inhibitor.”

The

gedatolisib-triplet and -doublet were generally well tolerated in the trial with mostly low-grade treatment-related adverse events (“TRAEs”).

The most common Grade 3+ TRAEs for the gedatolisib-triplet, the gedatolisib-doublet, and alpelisib plus fulvestrant groups included neutropenia

(58.8%, 0%, and 0.7% of patients, respectively); stomatitis (16.3%, 5.8%, and 5.3% of patients, respectively); rash (6.5%, 5.8%, and

15.1% of patients, respectively); and hyperglycemia (2.6%, 0%, and 14.5% of patients, respectively). TRAEs led to the discontinuation

of study treatment in 2.6% of patients in the gedatolisib-triplet group, 3.8% in the gedatolisib-doublet group, and 7.1% in the alpelisib

plus fulvestrant group. 1One Grade 5 TRAE in the gedatolisib-triplet group, which was related to palbociclib, was reported,

no Grade 5 TRAE’s were reported in the gedatolisib-doublet group, and two Grade 5 TRAE’s were reported in the alpelisib plus

fulvestrant group.

“Both

gedatolisib regimens were well-tolerated with few VIKTORIA-1 patients discontinuing treatment due to an adverse event,” said

Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity. “These safety results compare very favorably to those from the patient

group treated with alpelisib and fulvestrant, which we believe reflects the benefit of gedatolisib’s multi-target mechanism of

action, pharmacokinetic profile, and intravenous administration.”

Overall

survival, a key secondary endpoint in VIKTORIA-1, while immature at the time of the analysis, showed promising trends for both the gedatolisib-triplet

and -doublet.

Celcuity

intends to submit these data to the U.S. Food and Drug Administration (“FDA”) as a supplemental New Drug Application (“sNDA”)

and to submit VIKTORIA-1 data to other regulatory authorities following the sNDA submission.

“It

is rare in oncology for a targeted therapy to offer both improved efficacy and better safety results relative to another drug in its

class,” said Brian Sullivan, CEO and co-founder of Celcuity. “This second positive Phase 3 data readout further underscores

the broad potential of multi-target PAM inhibition and increases our excitement about our two Phase 3 trials in the first-line

setting for HR+/HER2- advanced breast cancer. We are on track to launch gedatolisib commercially, in anticipation of its potential FDA

approval in the third quarter of 2026, and we look forward to the possibility of bringing this important therapy to physicians treating

patients with advanced breast cancer.”

The

FDA has granted Priority Review of Celcuity’s New Drug Application (“NDA”) for gedatolisib in patients with HR+/HER2-/PIK3CA

wild-type (“WT”) ABC and assigned a Prescription Drug User Fee Act (“PDUFA”) goal date of July 17, 2026.

About

HR+/HER2- Breast Cancer

Breast

cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 More than two million

breast cancer cases were diagnosed globally in 2022.1 While survival rates are high for those diagnosed with early breast

cancer, only approximately 30% of patients who are diagnosed with or who progress to metastatic disease are expected to live five years

after their diagnosis.2 HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately

70% of all breast cancers.2

Three

interconnected signaling pathways, estrogen, cyclin D1-CDK4/6, and the PAM pathway , are primary oncogenic drivers of HR+/HER2- ABC.3

Therapies inhibiting these pathways are approved and used in various combinations for ABC. Currently approved inhibitors of the PAM pathway

for breast cancer target a single PAM pathway component, such as PI3Kα, AKT, or mTORC1.4,5,6,7 However, resistance to

CDK4/6 inhibitors and current endocrine therapies develops in many patients with advanced disease.8 Optimizing the inhibition

of the PAM pathway is an active area of focus for breast cancer research.

About

the VIKTORIA-1 Phase 3 Trial

VIKTORIA-1

is a Phase 3 open-label, randomized clinical trial to evaluate the efficacy and safety of gedatolisib in combination with fulvestrant,

with or without palbociclib, in adults with HR+/HER2- ABC whose disease progressed on or after prior CDK4/6 therapy in combination with

an aromatase inhibitor. The trial enrolled 701 subjects regardless of PIK3CA status while enabling separate evaluation of subjects

according to their PIK3CA status. Detailed results from the PIK3CA WT cohort of VIKTORIA-1 have been previously reported.

For the PIK3CA MT cohort, 350 subjects who met eligibility criteria and had confirmed PIK3CA mutations were randomly assigned

(3:3:1) to receive a regimen of either the gedatolisib-triplet, alpelisib and fulvestrant, or the gedatolisib-doublet.

About

Gedatolisib

is an investigational, multi-target PAM inhibitor that potently targets all four class I PI3K isoforms, mTORC1, and mTORC2 to induce

comprehensive blockade of the PAM pathway.9,10,11 As a multi-target PAM inhibitor, gedatolisib’s mechanism of action

is highly differentiated from currently approved single-target inhibitors of the PAM pathway.11 Inhibition of only a single

PAM component gives tumors an escape mechanism through cross-activation of the uninhibited targets. Gedatolisib’s comprehensive

PAM pathway inhibition ensures full suppression of PAM activity by eliminating adaptive resistance cross-activation that occurs with

single-target inhibitors. Unlike single-target inhibitors of the PAM pathway, gedatolisib has demonstrated equal potency and comparable

cytotoxicity in PIK3CA-mutant and -wild-type breast tumor cells in nonclinical studies and early clinical data.11,12

About

Celcuity

is a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor

indications. The company’s lead therapeutic candidate is gedatolisib, a kinase inhibitor of the PI3K/AKT/mTOR (“PAM”)

pathway that binds to all class I PI3K isoforms and the mTOR complexes, mTORC1 and mTORC2. By targeting all class I PI3K isoforms and

mTORC1/2, gedatolisib induces comprehensive inhibition of 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.

The company’s Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib

in patients with HR+/HER2- ABC, has reported detailed results for Study 1, which evaluated patients with PIK3CA WT tumors, and

for Study 2, which evaluated patients with PIK3CA MT tumors. Our Phase 3 clinical trial, VIKTORIA-2, is ongoing and incorporates

two independent studies, Study 1 and Study 2, evaluating two separate cohorts of patients with ABC who are treatment-naive in the advanced

setting. Study 1 is evaluating gedatolisib combined with palbociclib and fulvestrant as first-line treatment for patients with endocrine-resistant

HR+/HER2- ABC. Study 2 is evaluating gedatolisib combined 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.

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 the potential therapeutic benefits of gedatolisib; the size, design and

timing of our clinical trials; our interpretation of clinical trial data; the status and timing of the FDA’s review of our NDA

for gedatolisib, including the PDUFA goal date assigned by the FDA; the ability of our data to support the filing of an sNDA with the

FDA and comparable filings with other regulatory authorities; the market opportunity for gedatolisib; our expectations regarding the

timing of and our ability to obtain FDA approval to commercialize gedatolisib; our strategy, marketing and commercialization plans, including

the benefits of strategic decisions regarding studies and trials; and other expectations with respect to gedatolisib including future

subcutaneous formulations of 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 press release are based on management’s current expectations and beliefs which are subject to a number of risks, uncertainties

and factors, including that our clinical results are based on an ongoing 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 clinical trials or the

FDA’s review of our NDA for gedatolisib; our ability to obtain and maintain regulatory approvals to commercialize gedatolisib,

and the market acceptance of gedatolisib; the development of therapies and tools competitive with gedatolisib; and our ability to access

capital upon favorable terms. 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, 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 press release to reflect events or circumstances after the date hereof.

References:

1. Sung

H, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide

for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;10.3322/caac.21660.

2. National

Cancer Institute. Surveillance, Epidemiology and End Results Program (accessed July 2025).

https://seer.cancer.gov/statfacts/html/breast-subtypes.html

3. Alves,

C. L., & Ditzel, H. J. Drugging the PI3K/AKT/mTOR Pathway in ER+ Breast Cancer. Int J

Mol Sci, 2023;24(5),4522. https://doi.org/10.3390/ijms24054522

4. United

States Package Insert, US FDA, ITOVEBI

5. United

States Package Insert, US FDA, PIQRAY

6. United

States Package Insert, US FDA, TRUCAP

7. United

States Package Insert, US FDA, AFINITOR

8. Lloyd

M R, et al. Mechanisms of Resistance to CDK4/6 Blockade in Advanced Hormone Receptor-positive,

HER2-negative Breast Cancer and Emerging Therapeutic Opportunities. Clin Cancer Res. 2022;28(5):821-30

9. Venkatesan,

A. M., et al. Bis(morpholino-1,3,5-triazine) derivatives: potent adenosine 5’-triphosphate

competitive phosphatidylinositol-3-kinase/mammalian target of rapamycin inhibitors: discovery

of compound 26 (PKI-587), a highly efficacious dual inhibitor. J Med Chem, 2010;53(6), 2636-2645.

https://doi.org/10.1021/jm901830p

10. Mallon,

R., et al. Antitumor efficacy of PKI-587, a highly potent dual PI3K/mTOR kinase inhibitor.

Clin Cancer Res, 2011;17(10), 3193-3203. https://doi.org/10.1158/1078-0432.CCR-10-1694

11. Rossetti,

S., et al. Gedatolisib shows superior potency and efficacy versus single-node PI3K/AKT/mTOR

inhibitors in breast cancer models. NPJ Breast Cancer, 2024;10(1), 40. https://doi.org/10.1038/s41523-024-00648-0

12. Layman,

R., et al. Gedatolisib in combination with palbociclib and endocrine therapy in women with

hormone receptor-positive, HER2-negative advanced breast cancer: results from the dose expansion

groups of an open-label, phase 1b study. Lancet Oncol, 2024;25(4), 474-487. https://doi.org/10.1016/S1470-2045(24)00034-2

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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Filename: R1.htm · Sequence: 19

v3.26.1

Cover

Jun. 02, 2026

Cover [Abstract]

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8-K

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false

Document Period End Date

Jun. 02, 2026

Entity File Number

001-38207

Entity Registrant Name

Celcuity

Inc.

Entity Central Index Key

0001603454

Entity Tax Identification Number

82-2863566

Entity Incorporation, State or Country Code

Entity Address, Address Line One

2800

Campus Drive, Suite 140

Entity Address, City or Town

Minneapolis

Entity Address, State or Province

Entity Address, Postal Zip Code

55441

City Area Code

(763)

Local Phone Number

392-0123

Written Communications

false

Soliciting Material

false

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false

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Title of 12(b) Security

Common

Stock, $0.001 par value per share

Trading Symbol

CELC

Security Exchange Name

NASDAQ

Entity Emerging Growth Company

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For the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.

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