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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): November 13, 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
November 13, 2023, Celcuity Inc. (the “Company”) issued a press release regarding the Company’s financial results for
the third quarter ended September 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:
November 13, 2023
|
CELCUITY
INC. |
|
|
|
|
By: |
/s/
Brian F. Sullivan |
|
|
Brian
F. Sullivan |
|
|
Chief
Executive Officer |
Exhibit
99.1
Celcuity
Inc. Reports Third Quarter 2023 Financial Results and Provides Corporate Updates
|
- |
Received
FDA clearance of IND to evaluate gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate
cancer (mCRPC) |
|
|
|
|
- |
Entered
into a clinical trial collaboration and supply agreement with Bayer AG to provide Nubeqa® (darolutamide) for planned
Phase 1b/2 clinical trial |
|
|
|
|
- |
Raised
$50 million in private placement sale of equity |
|
|
|
|
- |
Management
to host webcast and conference call today, November 13, 2023, at 8:00 a.m. ET |
MINNEAPOLIS,
November 13, 2023 — Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies
for oncology, today reported financial results for the third quarter ended September 30, 2023 and provided other recent corporate updates.
“Despite
the important role the PI3K/mTOR pathway plays in tumor types such as breast and prostate cancer, the available therapies that target
this pathway have only reported limited improvements in outcomes for patients. Development of an optimized PI3K/mTOR inhibitor, like
gedatolisib, thus represents, we believe, one of the most important opportunities to improve the standard of care in these cancers. With
our Phase 3 program in HR+/HER2- advanced breast cancer, and our newly initiated Phase 1b/2 program in metastatic castration resistance
prostate cancer, we are hoping to eventually impact over 200,000 patients globally,” said Brian Sullivan, CEO and Co-Founder of
Celcuity. “The equity financing we recently closed further supports these programs and extends our cash runway into mid-2026.”
Third
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 220 sites in 23 countries in North and South America, Europe,
and Asia. |
|
|
|
|
○ |
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. |
● |
The
CELC-G-201 Phase 1b/2 clinical trial evaluating gedatolisib in combination with Nubeqa® (darolutamide) for the treatment
of metastatic castration resistant prostate cancer (mCRPC) is on track to activate trial sites in the first quarter of 2024 and to
report initial data in the first half of 2025. |
|
○ |
The
U.S. Food and Drug Administration (FDA) cleared an Investigational New Drug (IND) submission that enables Celcuity to proceed with
a trial to evaluate gedatolisib in combination with darolutamide in August 2023. |
|
|
|
|
○ |
We
entered into a clinical trial collaboration and supply agreement with Bayer AG in August 2023 to provide Nubeqa® (darolutamide)
at no cost. |
|
|
|
|
○ |
The
Phase 1b/2 trial will enroll up to 54 patients with mCRPC whose disease progressed after treatment with an androgen receptor inhibitor. |
● |
Celcuity
closed a private placement of equity that resulted in net proceeds of approximately $50 million in October 2023. |
Third
Quarter 2023 Financial Results
Unless
otherwise stated, all comparisons are for the third quarter ended September 30, 2023, compared to the third quarter ended September 30,
2022.
Total
operating expenses were $18.9 million for the third quarter of 2023, compared to $10.6 million for the third quarter of 2022. Research
and development (R&D) expenses were $17.5 million for the third quarter of 2023, compared to $9.6 million for the third quarter of
2022. Of the approximately $7.9 million increase in R&D expenses, $7.5 million was due to an increase in expenses related to the
VIKTORIA-1 Phase 3 clinical trial, and $0.4 million was related to increased employee-related expenses.
General
and administrative expenses were $1.4 million for the third quarter of 2023, compared to $1.0 million for the third quarter of 2022.
Employee-related expenses accounted for $0.3 million of the increase. The remaining $0.1 million increase resulted from professional
fees and other expenses associated with being a public company.
Net
loss for the third quarter of 2023 was $18.4 million, or $0.83 loss per share, compared to a net loss of $10.9 million, or $0.75 loss
per share, for the third quarter of 2022. Non-GAAP adjusted net loss for the third quarter of 2023 was $17.3 million, or $0.78 loss per
share, compared to non-GAAP adjusted net loss for the third quarter of 2022 of $9.5 million, or $0.63 loss per share. 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.
Net
cash used in operating activities for the third quarter of 2023 was $12.7 million, compared to $9.3 million for the third quarter of
2022. At September 30, 2023, Celcuity reported cash, cash equivalents and short-term investments of $133.9 million.
Webcast
and Conference Call Information
The
Celcuity management team will host a webcast/conference call at 8:00 a.m. ET today to discuss the third quarter financial results and
provide a corporate update. To participate in the teleconference, domestic callers should dial 1-877-407-0784 or1-201-689-8560. A live
webcast presentation can also be accessed using this weblink: https://viavid.webcasts.com/starthere.jsp?ei=1639042&tp_key=7d2827005c.
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. A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients
with metastatic castration resistant prostate cancer, is expected to be initiated in the first quarter of 2024. 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. 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 adequacy
of Celcuity’s cash on hand to fund research and development expenses and other general corporate expenses, the timing of initiating
and enrolling patients in, and receiving results from, clinical trials, such as Celcuity’s Phase 3 VIKTORIA-1 clinical trial and
Phase 1b/2 CELC-G-201 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.
View
source version of release on GlobeNewswire.com
Contacts:
Celcuity
Inc.
Brian Sullivan, bsullivan@celcuity.com
Vicky Hahne, vhahne@celcuity.com
(763) 392-0123
ICR
Westwicke
Maria Yonkoski, maria.yonkoski@westwicke.com
(203) 682-7167
Celcuity Inc. |
Condensed Balance Sheets |
|
| |
September 30, 2023 | | |
December 31, 2022 | |
| |
(unaudited) | | |
| |
Assets | |
| | | |
| | |
Current Assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 25,759,887 | | |
$ | 24,571,557 | |
Investments | |
| 108,180,417 | | |
| 144,015,954 | |
Other current assets | |
| 7,771,131 | | |
| 6,603,026 | |
Total current assets | |
| 141,711,435 | | |
| 175,190,537 | |
| |
| | | |
| | |
Property and equipment, net | |
| 223,378 | | |
| 260,294 | |
Operating lease right-of-use assets | |
| 449,368 | | |
| 246,266 | |
Total Assets | |
$ | 142,384,181 | | |
$ | 175,697,097 | |
| |
| | | |
| | |
Liabilities and Stockholders’ Equity: | |
| | | |
| | |
Current Liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 5,634,806 | | |
$ | 2,627,076 | |
Finance lease liabilities | |
| - | | |
| 2,449 | |
Operating lease liabilities | |
| 188,100 | | |
| 191,749 | |
Accrued expenses | |
| 6,887,136 | | |
| 4,060,280 | |
Total current liabilities | |
| 12,710,042 | | |
| 6,881,554 | |
Operating lease liabilities | |
| 270,925 | | |
| 61,002 | |
Note payable, non-current | |
| 36,506,774 | | |
| 34,983,074 | |
Total Liabilities | |
| 49,487,741 | | |
| 41,925,630 | |
Total Stockholders’ Equity | |
| 92,896,440 | | |
| 133,771,467 | |
Total Liabilities and Stockholders’ Equity | |
$ | 142,384,181 | | |
$ | 175,697,097 | |
Celcuity Inc. |
Condensed Statements of Operations |
(unaudited) |
|
| |
Three Months Ended
September 30, | | |
Nine Months Ended
September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Research and development | |
$ | 17,488,236 | | |
$ | 9,621,505 | | |
$ | 42,512,811 | | |
$ | 24,685,505 | |
General and administrative | |
| 1,409,801 | | |
| 1,022,050 | | |
| 3,988,248 | | |
| 3,066,382 | |
Total operating expenses | |
| 18,898,037 | | |
| 10,643,555 | | |
| 46,501,059 | | |
| 27,751,887 | |
Loss from operations | |
| (18,898,037 | ) | |
| (10,643,555 | ) | |
| (46,501,059 | ) | |
| (27,751,887 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other income (expense) | |
| | | |
| | | |
| | | |
| | |
Interest expense | |
| (1,372,132 | ) | |
| (537,661 | ) | |
| (3,929,140 | ) | |
| (1,428,108 | ) |
Interest income | |
| 1,865,629 | | |
| 287,495 | | |
| 5,499,555 | | |
| 391,301 | |
Other income (expense), net | |
| 493,497 | | |
| (250,166 | ) | |
| 1,570,415 | | |
| (1,036,807 | ) |
Net loss before income taxes | |
| (18,404,540 | ) | |
| (10,893,721 | ) | |
| (44,930,644 | ) | |
| (28,788,694 | ) |
Income tax benefits | |
| - | | |
| - | | |
| - | | |
| - | |
Net loss | |
$ | (18,404,540 | ) | |
$ | (10,893,721 | ) | |
$ | (44,930,644 | ) | |
$ | (28,788,694 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per share, basic and diluted | |
$ | (0.83 | ) | |
$ | (0.75 | ) | |
$ | (2.05 | ) | |
$ | (1.95 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average common shares outstanding, basic and diluted | |
| 22,117,626 | | |
| 14,938,224 | | |
| 21,920,147 | | |
| 14,928,727 | |
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
| |
Three
Months Ended
September 30, | | |
Nine
Months Ended
September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
GAAP
net loss | |
$ | (18,404,540 | ) | |
$ | (10,893,721 | ) | |
$ | (44,930,644 | ) | |
$ | (28,788,694 | ) |
Adjustments: | |
| | | |
| | | |
| | | |
| | |
Stock-based
compensation | |
| | | |
| | | |
| | | |
| | |
Research
and development (1) | |
| 660,706 | | |
| 676,524 | | |
| 1,954,689 | | |
| 1,937,707 | |
General
and administrative (2) | |
| 447,931 | | |
| 546,530 | | |
| 1,704,213 | | |
| 1,561,077 | |
Non-cash
interest expense (3) | |
| 520,794 | | |
| 210,409 | | |
| 1,523,699 | | |
| 595,947 | |
Non-cash
interest income (4) | |
| (480,520 | ) | |
| - | | |
| (439,331 | ) | |
| - | |
Non-GAAP
adjusted net loss | |
$ | (17,255,629 | ) | |
$ | (9,460,258 | ) | |
$ | (40,187,374 | ) | |
$ | (24,693,964 | ) |
| |
| | | |
| | | |
| | | |
| | |
GAAP
net loss per share - basic and diluted | |
$ | (0.83 | ) | |
$ | (0.75 | ) | |
$ | (2.05 | ) | |
$ | (1.95 | ) |
Adjustment
to net loss (as detailed above) | |
| 0.05 | | |
| 0.10 | | |
| 0.22 | | |
| 0.27 | |
Warrant
modification adjustment (5) | |
| - | | |
| 0.02 | | |
| - | | |
| 0.02 | |
Non-GAAP
adjusted net loss per share | |
$ | (0.78 | ) | |
$ | (0.63 | ) | |
$ | (1.83 | ) | |
$ | (1.66 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted
average common shares outstanding, basic and diluted | |
| 22,117,626 | | |
| 14,938,224 | | |
| 21,920,147 | | |
| 14,928,727 | |
(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.
(4)
To reflect a non-cash adjustment to other income for accretion on investments.
(5)
To reflect an adjustment to basic and diluted net loss per share related to a warrant modification.
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