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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): August 10, 2023
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
August 10, 2023, Celcuity Inc. (the “Company”) issued a press release regarding the Company’s financial results for
the second quarter ended June 30, 2023. 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 referenced 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
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:
August 10, 2023
|
CELCUITY
INC. |
|
|
|
By: |
/s/
Brian F. Sullivan |
|
|
Brian
F. Sullivan |
|
|
Chief
Executive Officer |
Exhibit 99.1
Celcuity
Inc. Reports Second Quarter 2023 Financial Results and Provides Corporate Updates
|
- |
Phase 3 VIKTORIA-1 clinical trial is now recruiting
patients at nearly 200 sites in 20 countries |
|
|
|
|
- |
Presented updated results from Phase 1b study of gedatolisib in treatment-naïve advanced breast
cancer at the ESMO Breast Cancer Annual Congress |
|
- |
Median progression free survival (PFS) was 48.6 months in
treatment-naïve patients with HR+/HER2- advanced breast cancer who were treated with gedatolisib in combination with palbociclib
and letrozole |
|
- |
Management to host webcast and conference call today, August
10, 2023, at 4:30 p.m. ET |
MINNEAPOLIS,
August 10, 2023 — Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies
for oncology, today reported financial results for the second quarter ended June 30, 2023 and provided other recent corporate updates.
“Patient
enrollment in the Phase 3 VIKTORIA-1 trial is progressing in-line with our planned timeline. Nearly 200 sites are now recruiting patients
in 20 countries,” said Brian Sullivan, CEO and Co-Founder of Celcuity. “We are also very encouraged by the updated median
PFS and DOR data we reported for gedatolisib in combination with letrozole and palbociclib in the first-line setting. These results continue
to drive our confidence that gedatolisib can play an important role in improving outcomes for women with HR+/HER2- advanced breast cancer,
regardless of PIK3CA-status.”
Second
Quarter 2023 Business Highlights and Other Recent Developments
● | The
VIKTORIA-1 Phase 3 trial remains on track to provide initial data and analysis of the PIK3CA
wild type patient sub-group in the second half of 2024 and data for the PIK3CA mutated patient
sub-group in the first half of 2025. |
| ○ | The
Phase 3 VIKTORIA-1 clinical trial is now recruiting patients at nearly 200 sites in
20 countries. |
| ○ | VIKTORIA-1
is evaluating gedatolisib in combination with fulvestrant, an endocrine therapy, with and
without palbociclib, a CDK4/6 inhibitor, in adults with HR+/HER2- advanced breast cancer. |
● | In
May 2023, updated results from a Phase 1b trial evaluating gedatolisib, in combination with
palbociclib and the aromatase inhibitor, letrozole, were presented at the 2023 European Society
for Medical Oncology (ESMO) Breast Cancer Annual Congress, with data updated as of March
16, 2023. |
| ○ | For
treatment-naïve patients from Escalation Arm A and Expansion Arm A (n=41), mPFS was
48.6 months, mDOR was 46.9 months, and ORR was 79%. |
| ○ | This
data compares favorably to published data for current first-line standard-of-care treatments
for patients with HR+/HER2- advanced breast cancer. |
● | In
April 2023, Celcuity presented a poster at the American Association for Cancer Research (AACR)
Annual Meeting demonstrating gedatolisib’s superior therapeutic activity relative to
the various PI3K, AKT, and mTOR inhibitors, regardless of the cell lines’ PTEN, PI3K,
or AKT mutational status in endometrial, ovarian and cervical cancer cell lines. |
| |
● | Enrollment
is ongoing in the FACT-1 and FACT-2 trials for CELsignia selected patients who have early-stage
HR+/HER2- breast cancer with interim results expected in the first half of 2024. |
Second
Quarter 2023 Financial Results
Unless
otherwise stated, all comparisons are for the second quarter ended June 30, 2023, compared to the second quarter ended June 30, 2022.
Total
operating expenses were $15.1 million for the second quarter of 2023, compared to $9.6 million for the second quarter of 2022. Net cash
used in operating activities for the second quarter of 2023 was $9.7 million, compared to $11.3 million for the second quarter of 2022.
Research
and development (R&D) expenses were $13.7 million for the second quarter of 2023, compared to $8.4 million for the second quarter
of 2022. Of the approximately $5.4 million increase in research and development expenses, $0.5 million was related to increased employee
and consulting expenses. The remaining $4.9 million increase in research and development expenses was primarily the result of activities
supporting the VIKTORIA-1 pivotal trial.
General
and administrative (G&A) expenses were $1.3 million for the second quarter of 2023, compared to $1.2 million for the second quarter
of 2022.
Net
loss for the second quarter of 2023 was $14.6 million, or $0.66 loss per share, compared to a net loss of $10.0 million, or $0.67 loss
per share, for the second quarter of 2022. Non-GAAP adjusted net loss for the second quarter of 2023 was $12.8 million, or $0.58 loss
per share, compared to non-GAAP adjusted net loss for the second quarter of 2022 of $8.3 million, or $0.55 per share. Non-GAAP adjusted
net loss excludes stock-based compensation expense and non-cash interest expense. 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.
At
June 30, 2023, Celcuity reported cash, cash equivalents and short-term investments of $146.2 million.
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 second quarter financial results and
provide a corporate update. To participate in the teleconference, domestic callers should dial 1-888-886-7786 and international callers
should dial 1-416-764-8658. A live webcast presentation can also be accessed using this weblink: https://viavid.webcasts.com/starthere.jsp?ei=1625068&tp_key=c09a941d3d.
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 focused on development of targeted therapies for treatment of multiple solid tumor indications.
The company’s lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTOR inhibitor. Its mechanism of action and pharmacokinetic
properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR 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- advanced breast cancer is currently enrolling patients. More detailed information about the VIKTORIA-1 study can be found
at ClinicalTrials.gov. The company’s 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. Celcuity is headquartered
in Minneapolis. Further information about Celcuity can be found at Celcuity.com. Follow us on LinkedIn and Twitter.
Forward-Looking
Statements
This
press release contains statements that constitute “forward-looking statements” including, but not limited to, the timing
of initiating and enrolling patients in, and receiving results from, clinical trials, such as Celcuity’s Phase 3 VIKTORIA-1 clinical
trial, the costs and expected results from any ongoing or planned clinical trials, the impact on gedatolisib and Celcuity of preliminary
clinical trial results, any potential benefits resulting from Breakthrough Therapy designation for gedatolisib, and other expectations
with respect to Celcuity’s lead product candidate, gedatolisib and its CELsignia platform. 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 risks, uncertainties, and conditions, many of which
are beyond the control of Celcuity. These include, but are not limited to, those risks set forth in the Risk Factors section in Celcuity’s
Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission on March 23, 2023,
as may be updated by our quarterly reports on Form 10-Q. 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
763-392-0123
ICR
Westwicke
Robert
Uhl, robert.uhl@westwicke.com
(619)
228-5886
Celcuity
Inc.
Condensed
Balance Sheets
| |
June 30, 2023 | | |
December 31, 2022 | |
| |
(unaudited) | | |
| |
Assets | |
| | | |
| | |
Current Assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 32,238,702 | | |
$ | 24,571,557 | |
Investments | |
| 114,005,385 | | |
| 144,015,954 | |
Deposits | |
| 22,009 | | |
| 22,009 | |
Deferred transaction costs | |
| 79,088 | | |
| 33,195 | |
Payroll tax receivable | |
| - | | |
| 203,665 | |
Prepaid assets | |
| 6,461,156 | | |
| 6,344,157 | |
Total current assets | |
| 152,806,340 | | |
| 175,190,537 | |
| |
| | | |
| | |
Property and equipment, net | |
| 210,858 | | |
| 260,294 | |
Operating lease right-of-use assets | |
| 499,993 | | |
| 246,266 | |
Total Assets | |
$ | 153,517,191 | | |
$ | 175,697,097 | |
| |
| | | |
| | |
Liabilities and Stockholders’ Equity: | |
| | | |
| | |
Current Liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 3,019,282 | | |
$ | 2,627,076 | |
Finance lease liabilities | |
| - | | |
| 2,449 | |
Operating lease liabilities | |
| 191,333 | | |
| 191,749 | |
Accrued expenses | |
| 3,871,135 | | |
| 4,060,280 | |
Total current liabilities | |
| 7,081,750 | | |
| 6,881,554 | |
Operating lease liabilities | |
| 317,120 | | |
| 61,002 | |
Note payable, non-current | |
| 35,985,980 | | |
| 34,983,074 | |
Total Liabilities | |
| 43,384,850 | | |
| 41,925,630 | |
Total Stockholders’ Equity | |
| 110,132,341 | | |
| 133,771,467 | |
Total Liabilities and Stockholders’ Equity | |
$ | 153,517,191 | | |
$ | 175,697,097 | |
Celcuity
Inc.
Condensed
Statements of Operations
(unaudited)
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Research and development | |
$ | 13,746,082 | | |
$ | 8,367,687 | | |
$ | 25,024,575 | | |
$ | 15,064,000 | |
General and administrative | |
| 1,309,403 | | |
| 1,233,040 | | |
| 2,578,447 | | |
| 2,044,332 | |
Total operating expenses | |
| 15,055,485 | | |
| 9,600,727 | | |
| 27,603,022 | | |
| 17,108,332 | |
Loss from operations | |
| (15,055,485 | ) | |
| (9,600,727 | ) | |
| (27,603,022 | ) | |
| (17,108,332 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other income (expense) | |
| | | |
| | | |
| | | |
| | |
Interest expense | |
| (1,314,996 | ) | |
| (455,445 | ) | |
| (2,557,008 | ) | |
| (890,446 | ) |
Interest income | |
| 1,782,794 | | |
| 95,646 | | |
| 3,633,926 | | |
| 103,805 | |
Other income (expense), net | |
| 467,798 | | |
| (359,799 | ) | |
| 1,076,918 | | |
| (786,641 | ) |
Net loss before income taxes | |
| (14,587,687 | ) | |
| (9,960,526 | ) | |
| (26,526,104 | ) | |
| (17,894,973 | ) |
Income tax benefits | |
| - | | |
| - | | |
| - | | |
| - | |
Net loss | |
$ | (14,587,687 | ) | |
$ | (9,960,526 | ) | |
$ | (26,526,104 | ) | |
$ | (17,894,973 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per share, basic and diluted | |
$ | (0.66 | ) | |
$ | (0.67 | ) | |
$ | (1.22 | ) | |
$ | (1.20 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average common shares outstanding, basic and diluted | |
| 21,957,140 | | |
| 14,930,538 | | |
| 21,819,772 | | |
| 14,923,900 | |
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 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.
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 June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
GAAP net loss | |
$ | (14,587,687 | ) | |
$ | (9,960,526 | ) | |
$ | (26,526,104 | ) | |
$ | (17,894,973 | ) |
Adjustments: | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation | |
| | | |
| | | |
| | | |
| | |
Research and development (1) | |
| 639,511 | | |
| 810,664 | | |
| 1,293,982 | | |
| 1,261,183 | |
General and administrative (2) | |
| 637,471 | | |
| 708,795 | | |
| 1,256,282 | | |
| 1,014,547 | |
Non-cash interest expense (3) | |
| 507,717 | | |
| 188,439 | | |
| 1,002,906 | | |
| 385,537 | |
Non-GAAP adjusted net loss | |
$ | (12,802,988 | ) | |
$ | (8,252,627 | ) | |
$ | (22,972,934 | ) | |
$ | (15,233,706 | ) |
| |
| | | |
| | | |
| | | |
| | |
GAAP net loss per share - basic and diluted | |
$ | (0.66 | ) | |
$ | (0.67 | ) | |
$ | (1.22 | ) | |
$ | (1.20 | ) |
Adjustment to net loss (as detailed above) | |
| 0.08 | | |
| 0.12 | | |
| 0.17 | | |
| 0.18 | |
Non-GAAP adjusted net loss per share | |
$ | (0.58 | ) | |
$ | (0.55 | ) | |
$ | (1.05 | ) | |
$ | (1.02 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average common shares outstanding, basic and diluted | |
| 21,957,140 | | |
| 14,930,538 | | |
| 21,819,772 | | |
| 14,923,900 | |
(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 other expense for amortization of debt issuance and discount costs and PIK interest related to the issuance
of a note payable.
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