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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 22, 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 8.01 Other Events.
On
August 22, 2023, the Company issued a press release to announce that it expects to initiate a Phase 1b/2 clinical trial, in the first
quarter of 2024, to evaluate patients with metastatic castration resistant prostate cancer (mCRPC). The trial is expected to evaluate
gedatolisib, the company’s pan-PI3K/mTOR inhibitor, in combination with darolutamide, an androgen receptor inhibitor, in patients
with mCRPC whose disease progressed on their first line of androgen receptor treatment for mCRPC. A copy of the press release is attached
as Exhibit 99.1 to this report and is incorporated herein by reference.
On
August 22, 2023, the Company issued a press release to announce entry into a clinical trial collaboration and supply agreement. A copy
of the Company’s press release is attached as Exhibit 99.2 to this report and is incorporated herein by reference.
This
Form 8-K, and the press releases incorporated herein by reference, contain 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 and Phase 1b/2 CELC-G-201 clinical trial, the scope, protocol, costs and expected results from
ongoing and planned clinical trials, the skills and experience of investigators involved with Celcuity’s Phase 1b/2 CELC-G-201
clinical trial, the impact on gedatolisib and Celcuity of preliminary clinical trial results, the market opportunity for gedatolisib
in the prostate cancer market, and other expectations with respect to Celcuity’s lead product candidate, gedatolisib, and Celcuity’s
CELsignia platform. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,”
“should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,”
“predicts,” “potential,” “intends,” “goal,” 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, delays, disruptions or adverse results in the CELC-G-201 clinical trial, Bayer’s continued
performance under the terms of our clinical trial collaboration and supply agreement, and 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, and our subsequent 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.
Item 9.01 Financial Statements and 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 22, 2023
|
CELCUITY
INC. |
|
|
|
By: |
/s/
Brian F. Sullivan |
|
|
Brian
F. Sullivan
Chief
Executive Officer
|
Exhibit
99.1
Celcuity
Announces Plan to Conduct Phase 1b/2 Clinical Trial in
Metastatic
Castration Resistant Prostate Cancer
| - | Received
FDA clearance of IND for gedatolisib in combination with darolutamide |
| - | Virtual
Science Day to be held on September 21, 2023 from 10:00 a.m. – 12:00 p.m. ET |
MINNEAPOLIS,
August 22, 2023 - Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies
for oncology, has been notified by the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) submission has
been reviewed, and Celcuity can proceed with the clinical development of gedatolisib in combination with Nubeqa® (darolutamide),
an approved androgen receptor inhibitor, for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC).
Celcuity’s Phase 1b/2 study (CELC-G-201) will enroll up to 54 participants with mCRPC who progressed after treatment with an androgen
receptor inhibitor as first-line treatment for mCRPC. The Company anticipates initiating this Phase 1b/2 clinical trial in the first
quarter of 2024.
“We
are excited to initiate the clinical development of gedatolisib in prostate cancer,” said Brian Sullivan, Chief Executive Officer
and co-founder of Celcuity. “Gedatolisib’s highly differentiated mechanism of action makes it uniquely suited to address
the complex PI3K/mTOR activity involved in this disease.”
In
the Phase 1b portion of the study, Celcuity expects that 36 participants will be randomly assigned to receive 600 mg darolutamide combined
with either 120 mg gedatolisib in Arm 1 or 180 mg gedatolisib in Arm 2. An additional 12 participants will then be enrolled in the Phase
2 portion of the study at the RP2D level to enable evaluation of 30 participants treated with the RP2D of gedatolisib.
The
primary objectives of the Phase 1b portion of the trial include assessment of the safety and tolerability of gedatolisib in combination
with darolutamide and determination of the recommended Phase 2 dose of gedatolisib. The primary objective of the Phase 2 portion of the
trial is to assess the radiographic progression-free survival (rPFS) at six months of patients who received the RP2D.
“Treatment
options for patients with mCRPC whose disease progressed on or after treatment with an androgen receptor inhibitor are limited, and there
is an urgent need for new drugs to treat this patient population,” said Karim Fizazi, MD, PhD, Professor of Medicine at Institute Gustave Roussy and GETUG President. Professor K. Fizazi,
who is one of the primary principal investigators for this study, further stated:
“Since PI3K/mTOR and androgen receptor signaling are commonly aberrantly activated in mCRPC, combining gedatolisib with the approved
androgen receptor inhibitor darolutamide represents a potentially promising treatment option for these patients.”
Registration
Information for the Virtual Science Day
Celcuity
will host a Virtual Science Day for analysts and investors on Thursday, September 21, 2023, from 10:00 a.m. – 12:00 p.m. ET, featuring
presentations by key opinion leaders and Celcuity’s leadership. During this meeting, Celcuity will provide an in-depth scientific
overview of gedatolisib, the importance of comprehensive, rather than selective, inhibition of the PI3K/mTOR pathway, and review its
clinical development strategy, including a discussion about its Phase 1b/2 study in mCRPC.
A
live chat-based Q&A session will follow the formal presentations. To register for the event, please click here. A replay of
the webcast will be available on the “Events & Presentations” section of Celcuity’s website for a limited time
following the event.
About
Gedatolisib
Gedatolisib
is a potent inhibitor that selectively targets all Class I isoforms of PI3K and mTOR. 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. Inhibiting
all four PI3K isoforms, as gedatolisib does, limits the potential confounding effect of isoform interaction that may occur with isoform-specific
PI3K inhibitors. Inhibiting mTOR also addresses potential resistance mechanisms that can result when PI3K isoforms are targeted in the
absence of mTOR inhibition.
About
Celcuity
Celcuity
is a clinical-stage biotechnology company pursuing development of targeted therapies for oncology. 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 planned to begin enrolling patients 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. 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 and
Phase 1b/2 CELC-G-201 clinical trial, the scope, protocol, costs and expected results from ongoing and planned clinical trials, the skills
and experience of investigators involved with Celcuity’s Phase 1b/2 CELC-G-201 clinical trial, the impact on gedatolisib and Celcuity
of preliminary clinical trial results, the market opportunity for gedatolisib in the prostate cancer market, and other expectations with
respect to Celcuity’s lead product candidate, gedatolisib, and Celcuity’s CELsignia platform. In some cases, you can identify
forward-looking statements by terminology such as “may,” “will,” “should,” “expects,”
“plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,”
“intends,” “goal,” 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, delays, disruptions or adverse results in the CELC-G-201 clinical trial and 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, and our subsequent 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 |
|
Exhibit
99.2
Celcuity
Enters into a Clinical Trial Collaboration and Supply Agreement with Bayer
to
Provide Nubeqa® (darolutamide) for Planned Phase 1b/2 Clinical Trial
MINNEAPOLIS,
August 22, 2023 - Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies
for oncology, today announced that it has entered into a clinical trial collaboration and supply agreement with Bayer AG for Celcuity’s
Phase 1b/2 clinical trial of gedatolisib and Nubeqa® (darolutamide) in patients with metastatic castration resistant prostate
cancer (mCRPC). As part of the supply agreement, Bayer will provide Nubeqa to Celcuity at no cost.
Celcuity
expects to initiate a Phase 1b/2 clinical trial in the first quarter of 2024 to evaluate gedatolisib, the company’s pan-PI3K/mTOR
inhibitor, in combination with darolutamide, an androgen receptor inhibitor, in patients with mCRPC who progressed on their first line
of androgen receptor treatment for mCRPC.
“We
are excited that Bayer is providing darolutamide for this important Phase 1b/2 clinical trial,” said Brian Sullivan, Chief Executive
Officer and co-founder of Celcuity. “Darolutamide is structurally unique to other ARI’s, with an excellent efficacy and differentiated
tolerability profile coupled with minimal drug-drug interactions, making it an ideal combination partner for gedatolisib. Our goal is
to address the significant need for new therapeutic options for patients with metastatic castration resistant prostate cancer.”
About
Gedatolisib
Gedatolisib
is a potent inhibitor that selectively targets all Class I isoforms of PI3K and mTOR. 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. Inhibiting
all four PI3K isoforms, as gedatolisib does, limits the potential confounding effect of isoform interaction that may occur with isoform-specific
PI3K inhibitors. Inhibiting mTOR also addresses potential resistance mechanisms that can result when PI3K isoforms are targeted in the
absence of mTOR inhibition.
About
Celcuity
Celcuity
is a clinical-stage biotechnology company pursuing development of targeted therapies for oncology. 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 planned to begin enrolling patients 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. 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 and
Phase 1b/2 CELC-G-201 clinical trial, the costs and expected results from ongoing and planned clinical trials, the impact on gedatolisib
and Celcuity of preliminary clinical trial results, the market opportunity for gedatolisib in the prostate cancer market, and other expectations
with respect to Celcuity’s lead product candidate, gedatolisib, and Celcuity’s 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,”
“goal,” 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, Bayer’s continued performance
under the terms of our clinical trial collaboration and supply agreement and 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,
and our subsequent 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
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