0001654954-21-011792.txt : 20211108 0001654954-21-011792.hdr.sgml : 20211108 20211108171642 ACCESSION NUMBER: 0001654954-21-011792 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 16 CONFORMED PERIOD OF REPORT: 20211108 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20211108 DATE AS OF CHANGE: 20211108 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Celcuity Inc. CENTRAL INDEX KEY: 0001603454 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-MEDICAL LABORATORIES [8071] IRS NUMBER: 000000000 STATE OF INCORPORATION: DE FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38207 FILM NUMBER: 211388926 BUSINESS ADDRESS: STREET 1: 16305 36TH AVENUE N STREET 2: SUITE 100 CITY: MINNEAPOLIS STATE: MN ZIP: 55446 BUSINESS PHONE: 763-392-0767 MAIL ADDRESS: STREET 1: 16305 36TH AVENUE N STREET 2: SUITE 100 CITY: MINNEAPOLIS STATE: MN ZIP: 55446 FORMER COMPANY: FORMER CONFORMED NAME: Celcuity LLC DATE OF NAME CHANGE: 20140324 8-K 1 celc_8k.htm PRIMARY DOCUMENT celc_8k.htm

 

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): November 8, 2021

 

Celcuity Inc.

(Exact name of Registrant as Specified in its Charter)

 

Delaware

 

001-38207

 

82-2863566

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

16305 36th Avenue North; Suite 100
Minneapolis, Minnesota 55446

(Address of Principal Executive Offices and Zip Code)

 

(763) 392-0767

(Registrant’s telephone number, including area code)

 

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading Symbol(s)

 

Name of each exchange on which registered

Common Stock, $0.001 par value per share

 

CELC

 

The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒

 

 

 

 

Item 2.02. Results of Operations and Financial Condition.

 

On November 8, 2021, Celcuity Inc. (the “Company”) issued a press release regarding the Company’s financial results for the third quarter ended September 30, 2021. 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 the 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 by reference 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

   

Exhibit

Number

 

 

Description

 

 

99.1

 

Press release dated November 8, 2021

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

2

 

 

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.

 

 

CELCUITY INC.

 

 

  

 

 

Date: November 8, 2021

By:

/s/ Brian F. Sullivan

 

 

 

Brian F. Sullivan

 

 

 

Chairman and Chief Executive Officer

 

 

 

3

 

 EX-99.1 2 celc_ex991.htm ADDITIONAL EXHIBITS celc_ex991.htm

EXHIBIT 99.1

 

 

Celcuity Inc. Reports Third Quarter 2021 Financial Results and Provides Corporate Update

 

 

-

On track to obtain FDA feedback and initiate a Phase 3 study for gedatolisib during the first half of 2022

 

 

 

 

-

 Will present updated Phase 1b data during a Spotlight Poster Discussion Session at the 2021 San Antonio Breast Cancer Symposium in December 2021

 

 

 

 

-

Entered into clinical trial collaboration with University of Rochester Wilmot Cancer Center and Puma Biotechnology to evaluate new therapeutic option for metastatic breast cancer patients with brain metastases

 

 

 

 

-

Management to host webcast and conference call today, November 8, 2021, at 4:30 p.m. ET / 1:30 p.m. PT

 

MINNEAPOLIS, November 8, 2021 — Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing an integrated therapeutic and companion diagnostic strategy for treating patients with cancer, today announced financial results for the third quarter ended September 30, 2021 and summarized recent business progress.

 

“We made great progress advancing our gedatolisib program this past quarter. We initiated preparation for a Phase 3 clinical trial evaluating gedatolisib in combination with Ibrance and Faslodex in patients with ER+/HER2- advanced or metastatic breast cancer that we expect to activate in the first half of 2022,” said Brian Sullivan, CEO and co-founder of Celcuity. “Site identification and feasibility activities are underway. We are excited to have the opportunity to present updated results from our Phase 1b clinical trial in patients with ER+/HER2- advanced breast cancer at the San Antonio Breast Cancer Symposium in December. Finally, we are pleased to have entered into another clinical trial collaboration to evaluate CELsignia® selected patients with advanced breast cancer. The collaboration with University of Rochester Wilmot Cancer Center and Puma represents an important opportunity to identify a potential new treatment for patients with breast cancer that has metastasized to the brain.”

 

Third Quarter 2021 Business Highlights and Other Recent Developments

 

·

 Completed transfer of regulatory, clinical trial, and safety reporting responsibilities for gedatolisib from Pfizer to Celcuity ahead of schedule.

 

 

·

 Updated data from Celcuity’s ongoing Phase 1b clinical trial for patients with ER+/HER2- advanced breast cancer will be presented at the San Antonio Breast Cancer Symposium during a Spotlight Poster Discussion Session on December 10, 2021. Rachel M. Layman, MD, an oncologist at the University of Texas MD Anderson Cancer Center who was a principal investigator for the clinical trial, will be the presenting author.

 

 
1

 

  

·

 Celcuity entered into a clinical trial collaboration agreement with the University of Rochester Wilmot Cancer Center and Puma Biotechnology in October 2021. This single arm Phase 2 trial will evaluate the efficacy and safety of Puma's pan-HER inhibitor, NERLYNX® (neratinib), and capecitabine, a chemotherapy, in patients selected with Celcuity's CELsignia HER2 Activity Test who have metastatic HER2-negative breast cancer that has progressed on prior treatments. Based on estimates of patient enrollment rates, Celcuity expects to obtain interim results 12 to 15 months after initiation of the trial followed by the final results 12 to 15 months later. Enrollment is planned to begin by mid-2022.

 

 

·

 Enrollment in the FACT-1 and FACT-2 trials that are evaluating CELsignia selected patients who have early-stage ER+/HER2- breast cancer was negatively impacted by COVID-19 related delays during the third quarter. Hospitalizations of patients with COVID-19 increased dramatically during this period which led hospitals to reduce clinical trial related activities. Interim results are now expected to be available in the second half of 2022.

 

Third Quarter 2021 Financial Results

 

Unless otherwise stated, all comparisons are for the third quarter ended September 30, 2021, compared to the third quarter ended September 30, 2020. The following discussion should be read in conjunction with our unaudited condensed consolidated financial statements and related notes on Form 10-Q for the third quarter ended September 30, 2021.

 

Total operating expenses were $5.6 million for the third quarter of 2021, compared to $2.5 million for the third quarter of 2020.

 

Research and development (R&D) expenses were $5.0 million for the third quarter of 2021, compared to $2.0 million for the third quarter of 2020. The increase in R&D expenses during the third quarter of 2021 compared to the prior year primarily resulted from costs associated with the development of gedatolisib. Employee related expenses, including consulting fees, accounted for $1.1 million of the increase. The remaining increase of $1.9 million in expenses is related to clinical trials, patent legal fees, and costs associated with the transfer of the gedatolisib-related activities from Pfizer to Celcuity.

 

General and administrative (G&A) expenses were $0.6 million for the third quarter of 2021, compared to $0.5 million for the third quarter of 2020. The increase in the third quarter of 2021 arose primarily from non-cash stock-based compensation.

 

Net loss for the third quarter of 2021 was $6.0 million, or $0.41 loss per share, compared to a net loss of $2.5 million for the third quarter of 2020, or $0.24 loss per share. The Non-GAAP adjusted net loss for the third quarter of 2021 was $5.1 million compared to a non-GAAP adjusted net loss of $2.0 million for the third quarter of 2020. Non-GAAP adjusted net loss excludes stock-based compensation expense, issuance of common stock and non-cash interest. 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 (GAAP) in the United States to non-GAAP financial measures, please see the financial tables at the end of this press release.

 

Net cash used in operating activities for the third quarter of 2021 was $4.0 million, compared to $1.6 million for the third quarter of 2020.

 

At September 30, 2021, Celcuity had cash and cash equivalents of $90.4 million, compared to cash and cash equivalents of $11.6 million at December 31, 2020.

 

 
2

 

 

Anticipated Milestones

 

Celcuity expects to achieve the following potential milestones over the next twelve months:

 

 

·

 Obtain formal feedback from the FDA on the design of its proposed Phase 3 clinical trial by early 2022.

 

 

 

 

·

 Initiate a Phase 3 clinical trial to evaluate gedatolisib in combination with Ibrance and Faslodex in patients with ER+/HER2- advanced breast cancer in the first half of 2022, subject to the FDA feedback.

 

 

 

 

·

 Provide an update on lifecycle development priorities for gedatolisib in the first half of 2022.

 

 

 

 

·

 Obtain interim results from the FACT-1 and FACT-2 trials in the second half of 2022.

 

Webcast and Conference Call Information

 

The Celcuity management team will host a webcast/conference call at 4:30 p.m. ET today to discuss the third quarter financial results and provide a corporate update. To participate in the teleconference, domestic callers should dial (877) 407-0784 and international callers should dial (201) 689-8560. A live webcast presentation can also be accessed using this weblink: https://78449.themediaframe.com/dataconf/productusers/vvdb/mediaframe/46959/indexl.html. A replay of the webcast will be available on the Celcuity website following the live event.

  

About Celcuity

 

Celcuity is a clinical-stage biotechnology company seeking to extend the lives of cancer patients by pursuing an integrated therapeutic and companion diagnostic and strategy. Its CELsignia companion diagnostic platform is uniquely able to analyze live patient tumor cells to identify new groups of cancer patients likely to benefit from already approved targeted therapies. Its therapeutic efforts are focused on in-licensing and developing molecularly targeted therapies that address the same cancer driver its companion diagnostics can identify. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com.

 

 
3

 

 

Forward-Looking Statements

 

This press release contains statements that constitute "forward-looking statements" that involve risks and uncertainties including, but not limited to, expectations with respect to receiving FDA feedback, plans to provide further details about clinical trial design, plans to commence clinical trials, and clinical trial results and any new treatment paradigms that may result therefrom. In some cases, you can identify forward-looking statements by terminology such as "may," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "potential," "intends" or "continue," and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of Celcuity, which include, but are not limited to, the unknown impact of the COVID-19 pandemic on Celcuity's business and those other risks set forth in the Risk Factors section in Celcuity's Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission on February 16, 2021 and in Exhibit 99.4 to Celcuity's Current Report on Form 8-K filed with the Securities and Exchange Commission on April 8, 2021. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Celcuity undertakes no obligation to update these statements for revisions or changes after the date of this press release, except as required by law.

 

Contacts:

 

Celcuity Inc.

Brian Sullivan, bsullivan@celcuity.com

Vicky Hahne, vhahne@celcuity.com

 

Westwicke ICR
Robert Uhl, robert.uhl@westwicke.com
(619) 228-5886

 

 
4

 

 

Celcuity Inc.

Condensed Balance Sheets

 

 

 

September 30, 2021

 

 

December 31, 2020

 

 

 

(unaudited)

 

 

 

Assets

 

 

 

 

 

 

Current Assets:

 

 

 

 

 

 

Cash and cash equivalents

 

 $ 90,366,812

 

 

 $ 11,637,911

 

Deposits

 

 

 22,009

 

 

 

 22,009

 

Deferred transaction costs

 

 

 -

 

 

 

 -

 

Payroll tax receivable

 

 

 356,309

 

 

 

 190,000

 

Prepaid assets

 

 

 437,351

 

 

 

 317,040

 

Total current assets

 

 

 91,182,481

 

 

 

 12,166,960

 

 

 

 

 

 

 

 

 

 

Property and equipment, net

 

 

 365,533

 

 

 

 558,876

 

Operating lease right-of-use assets

 

 

 289,586

 

 

 

 230,911

 

Total Assets

 

 $ 91,837,600

 

 

 $ 12,956,747

 

 

 

 

 

 

 

 

 

 

Liabilities and Stockholders' Equity:

 

 

 

 

 

 

 

 

Current Liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

 $ 1,746,425

 

 

 $ 217,377

 

Finance lease liabilities

 

 

 5,840

 

 

 

 5,810

 

Operating lease liabilities

 

 

 190,458

 

 

 

 187,518

 

Accrued expenses

 

 

 879,851

 

 

 

 774,612

 

Total current liabilities

 

 

 2,822,574

 

 

 

 1,185,317

 

Finance lease liabilities

 

 

 3,916

 

 

 

 8,299

 

Operating lease liabilities

 

 

 108,915

 

 

 

 60,861

 

Note payable, non-current

 

 

 14,427,809

 

 

 

 -

 

Total Liabilities

 

 

 17,363,214

 

 

 

 1,254,477

 

Total Stockholders' Equity

 

 

 74,474,386

 

 

 

 11,702,270

 

Total Liabilities and Stockholders' Equity

 

 $ 91,837,600

 

 

 $ 12,956,747

 

 

 
5

 

 

Celcuity Inc.

Condensed Statements of Operations

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 $ 4,960,515

 

 

 $ 1,962,610

 

 

 $ 20,266,965

 

 

 $ 5,576,250

 

General and administrative

 

 

 639,271

 

 

 

 517,465

 

 

 

 1,768,058

 

 

 

 1,428,578

 

Total operating expenses

 

 

 5,599,786

 

 

 

 2,480,075

 

 

 

 22,035,023

 

 

 

 7,004,828

 

Loss from operations

 

 

 (5,599,786 )

 

 

 (2,480,075 )

 

 

 (22,035,023 )

 

 

 (7,004,828 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income (expense)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

 (433,072 )

 

 

 (28 )

 

 

 (824,283 )

 

 

 (93 )

Interest income

 

 

 5,612

 

 

 

 5,805

 

 

 

 7,803

 

 

 

 81,639

 

Loss on sale of fixed assets

 

 

 -

 

 

 

 -

 

 

 

 (263 )

 

 

 -

 

Other income (expense), net

 

 

 (427,460 )

 

 

 5,777

 

 

 

 (816,743 )

 

 

 81,546

 

Net loss before income taxes

 

 

 (6,027,246 )

 

 

 (2,474,298 )

 

 

 (22,851,766 )

 

 

 (6,923,282 )

Income tax benefits

 

 

 -

 

 

 

 -

 

 

 

 -

 

 

 

 -

 

Net loss

 

 $ (6,027,246 )

 

 $ (2,474,298 )

 

 $ (22,851,766 )

 

 $ (6,923,282 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share, basic and diluted

 

 $ (0.41 )

 

 $ (0.24 )

 

 $ (1.78 )

 

 $ (0.67 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding, basic and diluted

 

 

 14,877,619

 

 

 

 10,273,567

 

 

 

 12,867,484

 

 

 

 10,262,636

 

 

 
6

 

 

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, issuance of common stock and non-cash interest 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.
 

 
7

 

 

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)

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended
September 30,

 

 

Nine Months Ended
September 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GAAP net loss

 

 $ (6,027,246 )

 

 $ (2,474,298 )

 

 $ (22,851,766 )

 

 $ (6,923,282 )

Adjustments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development (1)

 

 

 434,597

 

 

 

 254,537

 

 

 

 1,017,855

 

 

 

 813,099

 

General and administrative (2)

 

 

 265,319

 

 

 

 194,410

 

 

 

 671,476

 

 

 

 523,690

 

Issuance of common stock, licensing agreement (3)

 

 

 -

 

 

 

 -

 

 

 

 5,000,000

 

 

 

 -

 

Non-cash interest expense (4)

 

 

 194,741

 

 

 

 -

 

 

 

 369,709

 

 

 

 -

 

Non-GAAP adjusted net loss

 

 $ (5,132,589 )

 

 $ (2,025,351 )

 

 $ (15,792,726 )

 

 $ (5,586,493 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GAAP net loss per share - basic and diluted

 

 $ (0.41 )

 

 $ (0.24 )

 

 $ (1.78 )

 

 $ (0.67 )

Adjustment to net loss (as detailed above)

 

 

 0.06

 

 

 

 0.04

 

 

 

 0.55

 

 

 

 0.13

 

Non-GAAP adjusted net loss per share

 

 $ (0.35 )

 

 $ (0.20 )

 

 $ (1.23 )

 

 $ (0.54 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding, basic and diluted

 

 

 14,877,619

 

 

 

 10,273,567

 

 

 

 12,867,484

 

 

 

 10,262,636

 

 

(1) To reflect a non-cash charge to operating expense for Research and Development stock-based compensation.

(2) To reflect a non-cash charge to operating expense for General and Administrative stock-based compensation.

(3) To reflect a non-cash charge to operating expense for the Issuance of common stock related to a licensing agreement.

(4) To reflect a non-cash charge to other expense for amortization of debt issuance and discount costs and PIK interest related to the issuance of a note payable.

 

 
8

 

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DE 001-38207 82-2863566 16305 36th Avenue North Suite 100 Minneapolis MN 55446 763 392-0767 false false false false Common Stock, $0.001 par value per share CELC NASDAQ true true XML 10 R1.htm IDEA: XBRL DOCUMENT v3.21.2
Cover
Nov. 08, 2021
Cover [Abstract]  
Entity Registrant Name Celcuity Inc.
Entity Central Index Key 0001603454
Document Type 8-K
Amendment Flag false
Entity Emerging Growth Company true
Document Period End Date Nov. 08, 2021
Entity Ex Transition Period true
Entity Incorporation State Country Code DE
Entity File Number 001-38207
Entity Tax Identification Number 82-2863566
Entity Address Address Line 1 16305 36th Avenue North
Entity Address Address Line 2 Suite 100
Entity Address City Or Town Minneapolis
Entity Address State Or Province MN
Entity Address Postal Zip Code 55446
City Area Code 763
Local Phone Number 392-0767
Written Communications false
Soliciting Material false
Pre Commencement Tender Offer false
Pre Commencement Issuer Tender Offer false
Security 12b Title Common Stock, $0.001 par value per share
Trading Symbol CELC
Security Exchange Name NASDAQ
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