Form 8-K

8-K — Celcuity Inc.

Accession: 0001493152-26-023065

Filed: 2026-05-14

Period: 2026-05-14

CIK: 0001603454

SIC: 8071 (SERVICES-MEDICAL LABORATORIES)

Item: Results of Operations and Financial Condition

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 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. ☐

Item

2.02 Results of Operations and Financial Condition.

May 14, 2026, Celcuity Inc. (the “Company”) issued a press release regarding the Company’s financial results for the

first quarter ended March 31, 2026. A copy of the Company’s press release is furnished as Exhibit 99.1 to this report and is incorporated

herein by reference.

The

information in this Item 2.02, 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 2.02 shall not be incorporated into any filing pursuant to the Securities Act

of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.

Item

9.01 Financial Statements and Exhibits.

(d)

Exhibits

99.1

Press release dated May 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:

May 14, 2026

CELCUITY

INC.

/s/

Brian F. Sullivan

Brian

F. Sullivan

Chief

Executive Officer

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit

99.1

Celcuity

Inc. Reports Release of First Quarter 2026 Financial Results and Provides Corporate Update

–

Phase

3 VIKTORIA-1 trial achieved primary endpoint with clinically meaningful improvement in progression-free survival in PIK3CA mutant

cohort; detailed data for gedatolisib regimens will be presented at the 2026 ASCO Annual Meeting

–

Phase

3 VIKTORIA-2 trial expanded to include a second study evaluating gedatolisib as first-line treatment in patients with endocrine-sensitive

HR+/HER2- advanced breast cancer

–

Development

of a gedatolisib formulation for subcutaneous injection underway; first patent application submitted to the U.S. Patent and Trademark

Office

–

Management

to host webcast and conference call today, May 14, 2026, at 4:30 p.m. EDT

MINNEAPOLIS,

May 14, 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 financial results for the first quarter ended March

31, 2026 and other recent business developments.

“With

positive results in both cohorts of the pivotal VIKTORIA-1 study, we believe gedatolisib regimens have the potential to advance the standard

of care in the second-line setting for a significant number of patients with HR+/HER2- advanced breast cancer, regardless of PIK3CA

status,” said Brian Sullivan, CEO and co-founder of Celcuity. “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 bringing this important therapy to physicians treating

patients with advanced breast cancer.”

Mr.

Sullivan added, “Our positive Phase 3 results, combined with our promising Phase 1b clinical trial results in treatment-naive

late-stage patients, provide a strong scientific rationale to evaluate gedatolisib combinations as first-line therapy. By expanding our

VIKTORIA-2 study to enable evaluation of treatment-naive patients who have endocrine-sensitive breast cancer, we are positioning

gedatolisib regimens to potentially be available for nearly all patients in the first-line setting, irrespective of their endocrine sensitivity

or PIK3CA status.”

First

Quarter 2026 Business Highlights and Other Recent Developments

●

Celcuity

reported positive topline results from the PIK3CA mutant-type (“MT”) cohort of the Phase 3 VIKTORIA-1 clinical

trial evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with hormone receptor positive

(“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”) (“HR+/HER2-”), PIK3CA

MT locally advanced or metastatic breast cancer (“ABC”).

○

The

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

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

alpelisib, a PI3Kα inhibitor, and fulvestrant.

○

The

secondary endpoint comparing gedatolisib in combination with fulvestrant (“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.

○

Both

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

○

Detailed

data for the gedatolisib triplet and doublet regimens will be presented in a late-breaking abstract (“LBA”) oral session

on June 2, 2026, at the American Society of Clinical Oncology (“ASCO”) Annual Meeting in Chicago, Illinois.

○

Celcuity

intends to submit these data to the FDA in the third quarter as a supplemental New Drug Application (“sNDA”) and to submit

VIKTORIA-1 data to other regulatory authorities outside the U.S. following the sNDA submission.

●

The

Phase 3 VIKTORIA-2 clinical trial now includes two studies, Study 1 and Study 2, each with independent statistical analysis plans

that include primary endpoints for their respective intent-to-treat populations. Study 1, which is ongoing, is evaluating the efficacy

and safety of gedatolisib in combination with palbociclib and fulvestrant in approximately 440 patients with endocrine-resistant

HR+/HER2- ABC. Study 2, which was added in conjunction with a VIKTORIA-2 protocol amendment, is evaluating the efficacy and safety

of gedatolisib in combination with palbociclib and letrozole in approximately 740 patients with treatment-naive endocrine-sensitive

HR+/HER2- ABC. Eligible patients include those whose cancer relapsed or progressed 12 months or more after completion of adjuvant

endocrine therapy, or those with de novo metastatic disease without prior endocrine therapy exposure. Approximately 60,000 adults

are newly diagnosed each year in the United States with endocrine-sensitive HR+/HER2- ABC.1

●

support its long-term lifecycle development plan, Celcuity submitted its first patent application to the United States Patent and

Trademark Office (“USPTO”) for a subcutaneous formulation of gedatolisib that would enable a patient to receive gedatolisib

as an injection as an alternative to an infusion. Development of the subcutaneous gedatolisib formulation is ongoing with the goal

of demonstrating clinical equivalence to the current intravenous formulation of gedatolisib. The subcutaneous formulation is aimed

to support potential future indications for gedatolisib regimens that may result in duration of treatment periods greater than several

years.

●

January 2026, the FDA accepted the submission of Celcuity’s New Drug Application (“NDA”) for gedatolisib in HR+/HER2-

PIK3CA wild-type (“WT”) ABC. The FDA granted Priority Review and assigned a Prescription Drug User Fee Act (“PDUFA”)

goal date of July 17, 2026.

First

Quarter 2026 Financial Results

Unless

otherwise stated, all comparisons are for the first quarter ended March 31, 2026, compared to the first quarter ended March 31, 2025.

Net

loss for the first quarter of 2026 was $52.8 million, or $0.97 per share, compared to a net loss of $37.0 million, or $0.86 per share,

for the first quarter of 2025. Non-GAAP adjusted net loss for the first quarter of 2026 was $46.8 million, or $0.86 per share, compared

to non-GAAP adjusted net loss of $34.7 million, or $0.81 per share, for the first quarter of 2025. Non-GAAP adjusted net loss excludes

stock-based compensation expense, non-cash interest expense, and non-cash interest income. Because these items have no impact on Celcuity’s

cash position, management believes non-GAAP adjusted net loss better enables Celcuity to focus on cash used in operations. For a reconciliation

of financial measures calculated in accordance with generally accepted accounting principles in the United States (“GAAP”)

to non-GAAP financial measures, please see the financial tables at the end of this press release.

Total

operating expenses were $50.5 million for the first quarter of 2026, compared to $36.1 million for the first quarter of 2025.

Research

and development (“R&D”) expenses were $33.1 million for the first quarter of 2026, compared to $29.8 million for the

prior year period. The $3.3 million increase in R&D expenses was primarily due to a $3.0 million increase in

employee-related and consulting expenses. The remaining increase was primarily due to a $5.4 million increase in manufacturing and other

costs, partially offset by a $5.1 million decrease in clinical trial costs, which was primarily driven by decreased costs for the VIKTORIA-1

Phase 3 clinical trial.

Selling,

general and administrative (“SG&A”) expenses were $17.4 million for the first quarter of 2026, compared to $6.3 million

for the prior year period. The $11.1 million increase in SG&A expenses was primarily due to an $8.7 million increase

in employee-related and consulting expenses, of which $6.6 million was due to commercial headcount additions and other

launch-related activities, and a $2.4 million increase primarily due to software costs, professional fees and other costs.

Net

cash used in operating activities for the first quarter of 2026 was $55.1 million, compared to $35.9 million for the prior year period.

Cash, cash equivalents and short-term investments were $387.1 million at the end of the first quarter of 2026. We expect cash, cash equivalents,

investments and drawdowns on our debt facility to finance our operations through 2027.

Webcast

and Conference Call Information

participate in the teleconference, domestic callers should dial 1-800-717-1738 and international callers should dial 1-646-307-1865.

live webcast presentation can also be accessed using this weblink: https://viavid.webcasts.com/starthere.jsp?ei=1760785&tp_key=2f73ec65ba.

A replay of the webcast will be available on the Celcuity website following the live event.

About

Celcuity

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

indications. Our 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. Our 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 announced topline results 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 outside the U.S.; 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 subcutaneous formulations to support potential future indications for

gedatolisib regimens; 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, filed with the

Securities and Exchange Commission on March 26, 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 press release to reflect events or circumstances after the date hereof.

References:

Internal estimates using data from National Cancer Institute, SEER, 2024; Pan, H, NEJM, 2017;377:1836-46; Dowsett, M 2009; Salvo, E.

M. et al. 2021

Contacts:

Celcuity

Inc.

Brian

Sullivan, bsullivan@celcuity.com

Vicky

Hahne, vhahne@celcuity.com

(763)

392-0123

Jodi

Sievers, jsievers@celcuity.com

(415)

494-9924

Celcuity

Inc.

Condensed

Balance Sheets

(in

thousands)

March 31,

2026

December 31,

2025

(unaudited)

Assets

Current assets:

Cash and cash equivalents

$ 145,191

$ 165,703

Investments

241,873

275,794

Other current assets

21,865

24,162

Total current assets

408,929

465,659

Property and equipment, net

619

499

Operating lease right-of-use assets

Other non-current assets

603

349

Total assets

$ 410,164

$ 466,558

Liabilities and stockholders’ equity

Current liabilities:

Accounts payable

$ 10,454

$ 6,407

Accrued expenses

22,744

37,691

Operating lease liabilities, current

Total current liabilities

33,211

44,152

Convertible notes

195,566

195,324

Note payable

127,862

126,527

Total liabilities

356,639

366,003

Total stockholders’ equity

53,525

100,555

Total liabilities and stockholders’ equity

$ 410,164

$ 466,558

Celcuity

Inc.

Condensed

Statements of Operations

(unaudited)

(in

thousands, except share and per share amounts)

Three Months Ended March 31,

2026

2025

Operating expenses:

Research and development

(1)

$ 33,063

$ 29,759

Selling, general and administrative

(1)

17,444

6,374

Total operating expenses

50,507

36,133

Loss from operations

(50,507 )

(36,133 )

Other (expense) income:

Interest expense

(6,085 )

(3,183 )

Interest income

3,751

2,319

Other (expense) income, net

(2,334 )

(864 )

Net loss before income taxes

(52,841 )

(36,997 )

Income taxes

—

Net loss

$ (52,841 )

$ (36,997 )

Net loss per share, basic and diluted

$ (0.97 )

$ (0.86 )

Weighted average common shares outstanding, basic and diluted

54,462,826

43,052,757

(1)

Certain

prior period amounts have been reclassified from research and development expenses to selling, general and administrative expenses

to conform to the current period presentation.

Cautionary

Statement Regarding Non-GAAP Financial Measures

This

press release contains references to non-GAAP adjusted net loss and non-GAAP adjusted net loss per share. Management believes these non-GAAP

financial measures are useful supplemental measures for planning, monitoring, and evaluating operational performance as they exclude

stock-based compensation expense, non-cash interest expense, and non-cash interest income from net loss and net loss per share. Management

excludes these items because they do not impact Celcuity’s cash position, which management believes better enables Celcuity to

focus on cash used in operations. However, non-GAAP adjusted net loss and non-GAAP adjusted net loss per share are not recognized measures

under GAAP and do not have a standardized meaning prescribed by GAAP. As a result, management’s method of calculating non-GAAP

adjusted net loss and non-GAAP adjusted net loss per share may differ materially from the method used by other companies. Therefore,

non-GAAP adjusted net loss and non-GAAP adjusted net loss per share may not be comparable to similarly titled measures presented by other

companies. Investors are cautioned that non-GAAP adjusted net loss and non-GAAP adjusted net loss per share should not be construed as

alternatives to net loss, net loss per share or other statements of operations data (which are determined in accordance with GAAP) as

an indicator of Celcuity’s performance or as a measure of liquidity and cash flows.

Celcuity

Inc.

Reconciliation

of GAAP Net Loss to Non-GAAP Adjusted Net Loss and

GAAP

Net Loss Per Share to Non-GAAP Adjusted Net Loss Per Share

(unaudited)

(in

thousands, except share and per share amounts)

Three Months Ended March 31,

2026

2025

GAAP net loss

$ (52,841 )

$ (36,997 )

Adjustments to net loss:

Stock-based compensation

Research and development (1), (2)

2,112

1,164

Selling,

general and administrative (1), (3)

3,213

1,280

Non-cash interest expense (4)

1,577

800

Non-cash interest income (5)

(883 )

(946 )

Non-GAAP adjusted net loss

$ (46,822 )

$ (34,699 )

GAAP net loss per share - basic and diluted

$ (0.97 )

$ (0.86 )

Adjustments to net loss:

Stock-based compensation

Research and development

0.04

0.02

Selling, general and administrative

0.06

0.03

Non-cash interest expense

0.03

0.02

Non-cash interest income

(0.02 )

Non-GAAP adjusted net loss per share - basic and diluted

$ (0.86 )

$ (0.81 )

Weighted average common shares outstanding, basic and diluted

54,462,826

43,052,757

(1)

Certain

prior period amounts have been reclassified from research and development expenses to selling, general and administrative expenses

to conform to the current period presentation.

(2)

reflect a non-cash adjustment to operating expenses for research and development stock-based compensation.

(3)

reflect a non-cash adjustment to operating expenses for selling, general and administrative stock-based compensation.

(4)

reflect a non-cash adjustment to other expense for amortization of debt issuance costs and discount and payment-in-kind interest

related to the issuance of the convertible notes and note payable.

(5)

reflect a non-cash adjustment to other income for accretion on investments and change in accrued interest income.

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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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