Form 8-K/A

8-K/A — Celcuity Inc.

Accession: 0001493152-26-033357

Filed: 2026-07-15

Period: 2026-07-14

CIK: 0001603454

SIC: 8071 (SERVICES-MEDICAL LABORATORIES)

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K/A — form8-ka.htm (Primary)

EX-99.1 (ex99-1.htm)

EX-99.2 (ex99-2.htm)

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8-K/A

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0001603454

2026-07-14

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UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

Washington,

D.C. 20549

FORM

8-K/A

(Amendment

No. 1)

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 14, 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. ☐

EXPLANATORY NOTE

This Current Report on Form 8-K/A

(this “Amendment”) is being filed to amend the Current Report on Form 8-K filed by Celcuity Inc. (the “Company”)

with the Securities and Exchange Commission on July 15, 2026 (the “Original Report”). The purpose of filing this Amendment

is to correct a clerical error that resulted in the omission of a slide in the presentation furnished as Exhibit 99.2 to the Original

Report and to make certain conforming edits to the description of the live webcast and conference call. Exhibit 99.2 to this Amendment

hereby supersedes Exhibit 99.2 previously furnished with the Original Report. Except as expressly set forth herein, no other changes have

been made to the Original Report.

Item 7.01 Regulation FD Disclosure.

July 14, 2026, the Company issued a press release announcing U.S. Food and Drug Administration (“FDA”) approval of REVTORPYK™

(gedatolisib) for the treatment of patients with hormone receptor positive (“HR+”), human epidermal growth factor receptor

2 negative (“HER2-”), locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression

on or after treatment with at least one line of endocrine therapy in the metastatic setting. A copy of this press release is furnished

as Exhibit 99.1 to this report and is incorporated herein by reference. The Company hosted a live webcast and conference call

on July 14, 2026, at 4:30 p.m. CT to discuss the FDA approval of REVTORPYK. A copy of the presentation that was provided during

the live webcast is furnished as Exhibit 99.2 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.

July 14, 2026, the Company issued a press release announcing FDA approval of REVTORPYK for the treatment of patients with HR+/HER2-,

locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with

at least one line of endocrine therapy in the metastatic setting. The Company anticipates commercial launch of REVTORPYK in late Q3 2026.

The

Company plans to submit in Q3 2026 a supplemental New Drug Application (“sNDA”) to the FDA for REVTORPYK for the treatment

of HR+/HER2-, PIK3CA mutated, locally advanced or metastatic breast cancer, following at least one line of endocrine therapy based

on results from the mutant cohort of the Phase 3 VIKTORIA-1 trial.

Slide

18 of Exhibit 99.2 to this Current Report on Form 8-K is hereby incorporated by reference into this Item 8.01.

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 relating to 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 sNDA for gedatolisib, and for making comparable filings

with other regulatory authorities outside the U.S.; the market opportunity for gedatolisib; the Company’s expectations regarding

the timing of and its ability to commercialize gedatolisib; 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 report 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 gedatolisib; the Company’s ability to obtain regulatory

approval of its sNDA and maintain regulatory approvals to commercialize gedatolisib, and the market acceptance of gedatolisib; 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 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 14, 2026

99.2

Investor presentation dated July 14, 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:

July 15, 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

Announces FDA Approval of REVTORPYK™ (gedatolisib) for the Treatment of HR+/HER2-, PIK3CA Wild-Type Locally Advanced or Metastatic

Breast Cancer

REVTORPYK

is the first and only FDA-approved therapy

that inhibits all class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2

the Phase 3 VIKTORIA-1 trial, REVTORPYK combined with palbociclib and fulvestrant and REVTORPYK combined with fulvestrant reduced

the risk of disease progression or death by 76% and 67%, respectively, compared to fulvestrant among patients with PIK3CA wild-type

advanced or metastatic breast cancer

Celcuity

to host webcast and conference call today Tuesday, July 14, 2026, at 5:30 p.m. EDT

MINNEAPOLIS,

July 14, 2026 — Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies

for multiple solid tumor indications, today announced that the U.S. Food and Drug Administration (“FDA”) approved REVTORPYK™

(gedatolisib) for the treatment of patients with hormone receptor positive (“HR+”), human epidermal growth factor receptor

2 negative (“HER2-”), locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression

on or after treatment with at least one line of endocrine therapy in the metastatic setting. REVTORPYK is the only inhibitor of class

I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2 to receive FDA approval.

“The

PI3K/AKT/mTOR, or PAM, pathway is one of the most important targets in cancer, but comprehensively inhibiting it has stymied researchers

and drug developers for nearly two decades,” said Brian Sullivan, CEO and co-founder of Celcuity. “REVTORPYK addressed this

20-year challenge by becoming the first pan-PI3K, mTORC1/2 inhibitor approved by the FDA. We are thankful for the opportunity to make

this important new therapy available to patients with HR+/HER2- locally advanced or metastatic breast cancer.”

HR+/HER2-

breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers.1 Among

this breast cancer subtype, approximately 60% have PIK3CA wild-type disease.2

“For

patients with HR+/HER2- locally advanced or metastatic breast cancer, there is an urgent need for new treatment options that can meaningfully

increase the likelihood of survival without disease progression or death,” 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, School of Medicine and co-principal investigator for the VIKTORIA-1 trial. “With

the approval of REVTORPYK, oncologists now have an effective new treatment option for these patients.”

The

approval of REVTORPYK is based on positive clinical results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial,

an open-label, global, randomized clinical trial evaluating the efficacy and safety of REVTORPYK plus fulvestrant, with or without palbociclib,

for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 therapy

and an aromatase inhibitor. In the VIKTORIA-1 trial,

median progression free survival (“PFS”) with the REVTORPYK triplet (REVTORPYK plus palbociclib and fulvestrant) was 9.3

months versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months (HR=0.24; 95% CI: 0.17-0.35; p<0.0001). The objective

response rate (“ORR”) of the REVTORPYK triplet was 32% compared to 1% with fulvestrant and the median duration of response

(“DOR”) was 17.5 months. For the REVTORPYK doublet (REVTORPYK plus fulvestrant), the median PFS was 7.4 months versus 2.0

months with fulvestrant, an incremental improvement of 5.4 months (HR=0.33; 95% CI: 0.24-0.48; p<0.0001). The ORR of the REVTORPYK

doublet was 28% and the median DOR was 12.0 months. The median DOR was not determinable for fulvestrant because there was only one objective

response.

“Today’s

approval of REVTORPYK addresses a significant unmet need for the thousands of patients affected each year by HR+/HER2-, PIK3CA wild-type

locally advanced or metastatic breast cancer whose disease has progressed after endocrine therapy,” said Igor Gorbatchevsky, MD,

Chief Medical Officer of Celcuity. “We are deeply grateful to the patients and their caregivers, investigators and clinical study

teams, and Celcuity team members who made this advancement possible.”

Celcuity

anticipates commercial launch in late Q3 2026. Based on the company’s commitment to ensuring broad, affordable, and unrestricted

patient access to REVTORPYK, we have designed a comprehensive patient support program. To make REVTORPYK available to patients prior

to commercial launch, those who are eligible will be able to enroll in Celcuity’s expanded access program.

Celcuity

plans to submit in Q3 2026 a supplemental New Drug Application (“sNDA”) to the FDA for REVTORPYK for the treatment of HR+/HER2-,

PIK3CA mutated, locally advanced or metastatic breast cancer, following at least one line of endocrine therapy based on results

from the mutant cohort of the Phase 3 VIKTORIA-1 trial. Results for this study were recently presented in a late-breaking abstract oral

session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. Following the sNDA submission, Celcuity intends to submit

VIKTORIA-1 data for marketing authorization of gedatolisib to other regulatory authorities around the world.

REVTORPYK

is also being studied in the ongoing Phase 3 VIKTORIA-2 clinical trial incorporating two independent studies evaluating two separate

patient cohorts with HR+/HER2- locally advanced or metastatic breast cancer who are treatment-naive in the advanced setting.

Webcast

and Conference Call Information

The

Celcuity management team will host a live webcast and conference call on Tuesday, July 14, 2026, at 5:30 p.m. EDT / 4:30 p.m. CDT to

discuss the FDA approval of REVTORPYK. Those who would like to participate may access the live webcast here, or register in advance

for the teleconference here. A replay of the webcast will be available on the Celcuity website.

About

REVTORPYK (gedatolisib)

REVTORPYK

is a kinase inhibitor of class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2, resulting in

downstream inhibition of multiple effectors, including AKT.3.4.5

REVTORPYK

is in development for the first-line treatment of HR+/HER2- locally advanced or metastatic breast cancer and for the second-line treatment

of metastatic castration resistant prostate cancer.

Indication

Statement

REVTORPYK

(gedatolisib) is a kinase inhibitor indicated in combination with fulvestrant, with or without palbociclib, for the treatment of adult

patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic

breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine

therapy in the metastatic setting.

IMPORTANT

SAFETY INFORMATION

WARNINGS

AND PRECAUTIONS

Stomatitis:

REVTORPYK can cause severe stomatitis, including ulcers and oral mucositis. Stomatitis occurred in 72% of patients treated with REVTORPYK

with fulvestrant and palbociclib, including Grade 3 events in 22% of patients. Stomatitis occurred in 58% of patients treated with REVTORPYK

with fulvestrant, including Grade 3 events in 12% of patients. Initiate a steroid-containing, alcohol-free mouthwash prior to starting

treatment with REVTORPYK and continue prophylactically during treatment. Monitor patients for signs and symptoms of stomatitis. Withhold,

reduce dose, or permanently discontinue REVTORPYK based on severity.

Dermatologic

Adverse Reactions: REVTORPYK can cause severe rash. Rash occurred in 30% of patients treated with REVTORPYK in combination with fulvestrant

and palbociclib, including Grade 3 events in 6% of patients. Rash occurred in 40% of patients treated with REVTORPYK with fulvestrant,

including 5% of patients with Grade 3 events. Monitor patients for rash and infectious sequelae. Instruct patients to limit sun exposure

during REVTORPYK treatment. Withhold, reduce dose, or permanently discontinue REVTORPYK based on severity.

Hyperglycemia:

REVTORPYK can cause severe hyperglycemia. Monitor fasting glucose prior to initiating treatment with REVTORPYK and periodically during

treatment. Monitor HbA1c level if clinically indicated. Increased fasting glucose occurred in 46% of patients receiving REVTORPYK in

combination with fulvestrant and palbociclib (Grade 3: 0.9%) and in 57% of patients receiving REVTORPYK in combination with fulvestrant

(Grade 3: 1.8%). The safety of REVTORPYK has not been established in patients with Type 1 or uncontrolled Type 2 diabetes mellitus. Patients

with well-controlled Type 2 diabetes may require intensified antihyperglycemic therapy and close monitoring of fasting glucose. Manage

hyperglycemia with antihyperglycemic medications as clinically indicated. Evaluate fastingblood glucose and HbA1c levels prior to starting

and at regular intervals during treatment. Withhold, reduce dose, or permanently discontinue REVTORPYK based on severity.

Embryo-Fetal

Toxicity: Based on its mechanism of action, REVTORPYK can cause fetal harm when administered to a pregnant woman. Advise pregnant

women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective

contraception during treatment with REVTORPYK and for 2 weeks after the last dose. Advise male patients with female partners of reproductive

potential to use effective contraception during treatment and for 2 weeks after the last dose.

Advise

women not to breastfeed during treatment with REVTORPYK and for 2 weeks after the last dose. When REVTORPYK is used in combination, advise

patients to use effective contraception during treatment and for the longest post-treatment duration recommended in the Prescribing Information

of any of the individual products. Verify the pregnancy status of females of reproductive potential prior to initiating treatment.

ADVERSE

REACTIONS

REVTORPYK

in Combination with Fulvestrant and Palbociclib: The most common (≥20%) adverse reactions, including laboratory abnormalities when

given in combination with fulvestrant and palbociclib were decreased white blood cells, decreased neutrophils, decreased hemoglobin,

decreased lymphocytes, stomatitis, nausea, decreased platelets, increased fasting glucose, fatigue, vomiting, rash, constipation, diarrhea,

increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), musculoskeletal pain, decreased sodium, and increased

eosinophils.

REVTORPYK

in Combination with Fulvestrant: The most common (≥20%) adverse reactions, including laboratory abnormalities when given in combination

with fulvestrant were stomatitis, glucose increased, eosinophils increased, hemoglobin decreased, nausea, rash, ALT increased, fatigue,

musculoskeletal pain, lymphocytes decreased, vomiting, AST increased, pruritus, and diarrhea.

USE

IN SPECIFIC POPULATION

Lactation:

Advise women not to breastfeed during treatment with REVTORPYK and for 2 weeks after the last dose. When used in combination, advise

patients not to breastfeed during treatment and for the longest post-treatment duration recommended in the Prescribing Information of

any of the individual products.

Infertility:

Advise females and males of reproductive potential that REVTORPYK may impair fertility.

Please

see full Prescribing Information, including Patient Information, for REVTORPYK.

You

may report side effects related to Celcuity products to Celcuity Medical Information at 1-877-4-CELCUITY (1-877-423-5284) or to FDA at

1-800-FDA-1088 or www.fda.gov/medwatch.

About

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, evaluating

gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- locally advanced or metastatic breast

cancer (“ABC”), supported FDA approval of REVTORPYK for use in patients without a PIK3CA mutation detected. Results

for the PIK3CA mutant cohort of VIKTORIA-1 have been released. VIKTORIA-2 is an ongoing Phase 3 clinical 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 plus palbociclib plus fulvestrant as first-line treatment for patients with endocrine-resistant HR+/HER2-

ABC. Study 2 is evaluating gedatolisib plus palbociclib plus letrozole as first-line treatment for patients with endocrine- sensitive

HR+/HER2- ABC. 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.

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 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 sNDA for gedatolisib, and for making comparable filings with other regulatory

authorities outside the U.S.; the market opportunity for gedatolisib; the Company’s expectations regarding the timing of and its

ability to commercialize gedatolisib; 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 gedatolisib; the Company’s ability to obtain regulatory approval of

its sNDA and maintain regulatory approvals to commercialize gedatolisib, and the market acceptance of gedatolisib; 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.

References:

National

Cancer Institute. Surveillance, Epidemiology and End Results Program (Accessed July 2025). https://seer.cancer.gov/statfacts/html/breast-subtypes.html

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.

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

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

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

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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v3.26.1

Cover

Jul. 14, 2026

Cover [Abstract]

Document Type

8-K/A

Amendment Flag

true

Amendment Description

This Current Report on Form 8-K/A

(this “Amendment”) is being filed to amend the Current Report on Form 8-K filed by Celcuity Inc. (the “Company”)

with the Securities and Exchange Commission on July 15, 2026 (the “Original Report”). The purpose of filing this Amendment

is to correct a clerical error that resulted in the omission of a slide in the presentation furnished as Exhibit 99.2 to the Original

Report and to make certain conforming edits to the description of the live webcast and conference call. Exhibit 99.2 to this Amendment

hereby supersedes Exhibit 99.2 previously furnished with the Original Report. Except as expressly set forth herein, no other changes have

been made to the Original Report.

Document Period End Date

Jul. 14, 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

Entity Address, Address Line Two

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

Pre-commencement Tender Offer

false

Pre-commencement Issuer Tender Offer

false

Title of 12(b) Security

Common Stock, $0.001 par

value per share

Trading Symbol

CELC

Security Exchange Name

NASDAQ

Entity Emerging Growth Company

false

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