Form 8-K

8-K — Celcuity Inc.

Accession: 0001493152-26-020918

Filed: 2026-05-01

Period: 2026-05-01

CIK: 0001603454

SIC: 8071 (SERVICES-MEDICAL LABORATORIES)

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

Documents

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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): May 1, 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)

16305

36th Avenue North, Suite 100

Minneapolis,

Minnesota 55446

(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.

May 1, 2026, Celcuity Inc. (the “Company”) issued a press release announcing positive topline results from the PIK3CA mutant

cohort of the Phase 3 VIKTORIA-1 clinical trial (the “VIKTORIA-1 trial”) evaluating gedatolisib plus fulvestrant, with or

without palbociclib, in patients with hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative

(“HER2-”), PIK3CA mutant locally advanced or metastatic breast cancer (“ABC”), following progression on or after

treatment with a CDK4/6 inhibitor and an aromatase inhibitor. 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 exhibits, 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.

May 1, 2026, the Company issued a press release announcing positive topline results from the PIK3CA mutant cohort of the VIKTORIA-1 trial

evaluating gedatolisib plus fulvestrant, with or without palbociclib, in patients with HR+/HER2- ABC, following progression on or after

treatment with a CDK4/6 inhibitor and an aromatase inhibitor.

The

primary efficacy analysis of gedatolisib combined with fulvestrant and palbociclib demonstrated a statistically significant and clinically

meaningful improvement in progression-free survival (“PFS”) compared to alpelisib, a PI3Kα inhibitor, and fulvestrant.

The secondary endpoint comparing gedatolisib plus fulvestrant versus alpelisib plus fulvestrant, which was not part of the primary efficacy

analysis in the hierarchical order, also demonstrated a statistically significant and clinically meaningful improvement in PFS compared

to alpelisib and fulvestrant. Both gedatolisib regimens were generally well tolerated, with manageable safety profiles, and no new safety

signals.

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 present these data at the 2026 American Society of Clinical Oncology (“ASCO” Annual Meeting.

The Company intends to submit VIKTORIA-1 data to other regulatory authorities following sNDA submission.

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 status

and timing of the FDA’s review of our New Drug Application (“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;

our intent to present data at the 2026 ASCO Annual Meeting; 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 expectations

regarding potential benefits to additional groups of patients whose cancers involve the PI3K/AKT/mTOR pathway; 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 topline 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 report to reflect events or circumstances after the date hereof.

Item

9.01

Financial

Statements and Exhibits.

(d)

Exhibits

99.1

Press release dated May 1, 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:

May 1, 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

Phase 3 VIKTORIA-1 Trial Achieves Primary Endpoint With Clinically Meaningful Improvement in Progression-Free Survival in PIK3CA Mutant

Cohort

− Detailed

data for the gedatolisib triplet and doublet regimens will be presented at a late-breaking

abstract oral session at the 2026 ASCO Annual Meeting

MINNEAPOLIS,

May 1, 2026 — Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies

for oncology, today announced positive topline results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial

evaluating gedatolisib plus fulvestrant with or without palbociclib in patients with hormone receptor positive (“HR+”), human

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

(“ABC”), following progression on or after treatment with a CDK4/6 inhibitor and an aromatase inhibitor. Detailed results

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

Annual Meeting, taking place May 29 – June 2, 2026, in Chicago, Illinois.

The

primary efficacy analysis of gedatolisib combined with fulvestrant and palbociclib (the “gedatolisib triplet”) demonstrated

a statistically significant and clinically meaningful improvement in progression-free survival (“PFS”) compared to alpelisib,

a PI3Kα inhibitor, and fulvestrant. The secondary endpoint comparing gedatolisib plus fulvestrant (the “gedatolisib doublet”)

versus alpelisib plus fulvestrant, which was not part of the primary efficacy analysis in the hierarchical order, also demonstrated a

statistically significant and clinically meaningful improvement in PFS compared to alpelisib and fulvestrant. Both gedatolisib regimens

were generally well tolerated, with manageable safety profiles, and no new safety signals.

Celcuity

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.

“Patients

with PIK3CA mutant HR+/HER2- advanced breast cancer whose disease has progressed while on or after treatment with a CDK4/6 inhibitor

typically derive modest benefit from subsequent therapies that target only PI3Kα or AKT,” said Sara Hurvitz, MD, Senior Vice

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

Head, Division of Hematology and Oncology, University of Washington, School of Medicine and co-principal investigator for the trial.

“VIKTORIA-1 represents the first Phase 3 study to demonstrate that comprehensively blocking the PI3K/AKT/mTOR, or PAM, pathway

can significantly improve outcomes for patients with PIK3CA mutations compared to therapies only targeting a single component

of this pathway.”

HR+/HER2-

breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers.2 Among

this breast cancer subtype, approximately 40% have PIK3CA mutations.

“These

positive topline results demonstrate the potential for gedatolisib to become a transformative new medicine for the treatment of patients

with PIK3CA mutant HR+/HER2-advanced breast cancer,” said Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity. “When

considered alongside previously presented data from the VIKTORIA-1 PIK3CA wild-type cohort, the gedatolisib regimens have now

demonstrated the potential to improve the standard of care in the second-line setting regardless of the PIK3CA status of a patient’s

tumor.”

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.

“We

believe the results from the VIKTORIA-1 study validate our pioneering approach to targeting cancers involving the PI3K/AKT/mTOR pathway.

Researchers have sought for nearly 20 years to develop a drug that blockades this pathway comprehensively without inducing unacceptable

levels of toxicity,” commented Brian Sullivan, Chairman, CEO and co-founder of Celcuity.

Mr.

Sullivan added, “The implications of these results may extend beyond HR+/HER2- advanced breast cancer patients in the second-line

setting, and we are working urgently to explore the development of gedatolisib for additional groups of patients whose cancers involve

the PI3K/AKT/mTOR pathway.”

Presentation

Details

Presenting

Author: Sara Hurvitz, MD, Senior Vice President, Clinical Research Division, Fred Hutchinson Cancer Center, Professor and Head, Division

of Hematology and Oncology, University of Washington, Department of Medicine

Title:

A randomized, open-label, phase 3 study of gedatolisib + fulvestrant ± palbociclib vs standard of care in HR+/HER2−/PIK3CA-mutant

advanced breast cancer (VIKTORIA-1 Study 2)

Abstract:

LBA1008

Session

Type/Title: Oral Abstract Session - Breast Cancer—Metastatic

Date

and Time: June 2, 2026, 9:45 AM-12:45 PM CDT

Late-breaking

abstracts accepted for an Oral Abstract Session at the ASCO Annual Meeting will be published online via the ASCO website on the day of

presentation.

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, 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 Among this breast cancer subtype, approximately 40% have PIK3CA mutations.13

Three

interconnected signaling pathways, estrogen, cyclin D1-CDK4/6 and PI3K/AKT/mTOR (“PAM”), are primary oncogenic drivers of

HR+/HER2- breast cancer.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 clinical trial is fully enrolled. The trial enrolled 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 mutant cohort, 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 pursuing the development of targeted therapies for the treatment of multiple solid tumor indications.

The company’s lead therapeutic candidate is 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, evaluating gedatolisib in

combination with fulvestrant, with or without palbociclib, in patients with HR+/HER2- ABC, has reported detailed results for the PIK3CA

WT cohort and topline results for the PIK3CA mutant cohort. A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus

a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with endocrine treatment resistant HR+/HER2- ABC, is ongoing.

A Phase 1/2 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 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; our intent to present data at the 2026 ASCO Annual Meeting; 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 expectations regarding potential benefits to additional groups of patients whose

cancers involve the PAM pathway; 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 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 topline 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:

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.

National

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

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

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

United

States Package Insert, US FDA, ITOVEBI

United

States Package Insert, US FDA, PIQRAY

United

States Package Insert, US FDA, TRUCAP

United

States Package Insert, US FDA, AFINITOR

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

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

13.

Anderson,

E. et al. A Systematic Review of the Prevalence and Diagnostic Workup of PIK3CA Mutations in HR+/HER2– Metastatic Breast Cancer,

Int J Breast Cancer. 2020 Jun 20;2020:3759179

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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The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

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- Definition

Local phone number for entity.

+ References

No definition available.

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 13e

-Subsection 4c

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14d

-Subsection 2b

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- Definition

Title of a 12(b) registered security.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b

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- Definition

Name of the Exchange on which a security is registered.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

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Trading symbol of an instrument as listed on an exchange.

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No definition available.

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

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