Attached files
file | filename |
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8-K - CURRENT REPORT - Celcuity Inc. | celc-20211231.htm |
EX-99.4 - SUPPLEMENTAL RISK FACTORS - Celcuity Inc. | celc_ex994.htm |
EX-99.3 - SUPPLEMENTAL BUSINESS DESCRIPTION - Celcuity Inc. | celc_ex993.htm |
EX-99.2 - PRESS RELEASE DATED APRIL 5, 2021 REGARDING THE LOAN AGREEMENT AND OTHER BUSINES - Celcuity Inc. | celc_ex992.htm |
EX-4.2 - FORM OF WARRANT - Celcuity Inc. | celc_ex42.htm |
EX-4.1 - EQUITY GRANT AGREEMENT, DATED APRIL 5, 2021 BETWEEN THE COMPANY AND PFIZER, INC - Celcuity Inc. | celc_ex41.htm |
Exhibit 99.1
Celcuity Announces Worldwide Licensing Agreement with Pfizer to
Develop and Commercialize Gedatolisib, a First-in-Class PI3K/mTOR
Inhibitor for Breast Cancer
-Preliminary
data from 103 patients in the expansion portion of a Phase 1b
clinical trial demonstrated the drug was well tolerated and
anti-tumor activity was noted
-
Unique opportunity to leverage our CELsignia platform to advance
development
of a
first-in-class targeted therapy
-
Management to host conference call/webcast today, April 8, 2021, at
5:00 p.m. ET
MINNEAPOLIS
- April 8, 2021 - Celcuity
Inc. (Nasdaq:CELC), a clinical-stage
biotechnology company pursuing an integrated companion diagnostic
and therapeutic strategy for treating patients with cancer, today
announced it has entered into a global licensing agreement with
Pfizer Inc. (NYSE:PFE) granting Celcuity exclusive rights to
Pfizer’s gedatolisib, a Phase 1b pan-PI3K/mTOR inhibitor.
Gedatolisib is in clinical development for the treatment of
patients with ER+/HER2-negative advanced or metastatic breast
cancer.
Under
the terms of the licensing agreement, Pfizer provided Celcuity with
a world-wide license to develop and commercialize gedatolisib.
Celcuity paid an upfront license fee of $5 million of cash and $5
million of Celcuity’s common stock as upfront payment. Pfizer
is eligible to receive up to $330 million of development and
sales-based milestone payments and tiered royalties on potential
sales.
Additional financial terms of the agreement were not
disclosed.
“We
are excited about the opportunity to utilize our CELsignia platform
to support the development of a potential first-in-class targeted
therapy like gedatolisib,” said Brian Sullivan, CEO and
co-founder of Celcuity. “In light of the important role the
PI3K/mTOR pathway plays in driving tumor growth when patients
become resistant to endocrine therapies, we believe gedatolisib is
a highly promising drug candidate to improve outcomes for patients
with breast cancer. Supporting development of a potential
first-in-class therapy for breast cancer, such as gedatolisib, with
our CELsignia platform is a natural extension of our strategy to
develop CELsignia CDx for other breast cancer therapies. We believe
developing targeted therapies that benefit from the CELsignia
platform while also offering companion diagnostics that enable new
drug indications, creates a synergistic advantage for each
program.”
Approximately
70%-80% of breast cancers in the United States express the estrogen
receptor and are thus likely dependent on estrogen signaling to
promote tumor growth. Patients with estrogen receptor-positive
(ER+)/HER2- metastatic tumors typically receive endocrine
therapies, such as tamoxifen, letrozole, or fulvestrant. Most women
with ER+/HER2- metastatic breast cancer ultimately develop
resistance to these endocrine therapies. One new strategy to treat
metastatic ER+/HER2- breast cancer involves blocking pathways
enabling partial and complete endocrine resistance by combining
gedatolisib and a cyclin-dependent kinases 4 and 6 (CDK 4/6)
inhibitor with existing endocrine therapy.
To
evaluate the efficacy and safety of this new treatment strategy,
gedatolisib is currently being evaluated in combination with
palbociclib, an oral CDK 4/6 inhibitor, and either letrozole or
fulvestrant in the expansion portion of a Phase 1b clinical trial
in patients with ER+/HER2-negative advanced or metastatic breast
cancer. A total of 103 patients were enrolled in one of four
different arms according to their prior treatment history for
metastatic breast cancer. A preliminary analysis of the objective
response rates as of a January 11, 2021 data cut-off demonstrated
that gedatolisib combined with palbociclib and an endocrine therapy
achieved superior objective response rates relative to historical
control data. Gedatolisib was also generally well tolerated, with
the majority of treatment related adverse events (TRAE) being Grade
1 or 2. The most common Grade 3 or 4 TRAE’s were neutrophil
count decrease and stomatitis.
Added
Art DeCillis, M.D., Celcuity’s Chief Medical Officer,
“In light of the data reported as of the January 11, 2021
data cut-off, we intend to initiate, subject to feedback from the
FDA, a Phase 2/3 clinical trial evaluating gedatolisib in
combination with palbociclib and an endocrine therapy in patients
with ER+/HER2- advanced or metastatic breast cancer in the first
half of 2022.”
Webcast Presentation and Conference Call Information
The
Celcuity management team will host a webcast/conference call today,
April 8, 2021, at 5:00 p.m. ET to discuss the gedatolisib license
agreement. To participate in the call, dial 1-877-407-8035. A
live webcast presentation can also be accessed using this weblink
at: https://www.webcaster4.com/Webcast/Page/2678/40570
or via Celcuity’s website at https://celcuity.com/home/investors/events-webcasts/.
A replay of the webcast will be available on the Celcuity website
for a limited time following the event.
About Celcuity
Celcuity
is a clinical-stage biotechnology company seeking to extend the
lives of cancer patients by pursuing an integrated companion
diagnostic and therapeutic strategy. Our CELsignia companion
diagnostic platform is uniquely able to analyze live patient tumor
cells to identify new groups of cancer patients likely to benefit
from targeted therapies. This enables a CELsignia CDx to support
advancement of new indications for already approved targeted
therapies. Our therapeutic efforts are focused on in-licensing and
developing molecularly targeted therapies that address the same
cancer driver our companion diagnostics can identify. By pursuing
an integrated companion diagnostic and therapeutic strategy, we
believe we are uniquely positioned to achieve our goal of helping
cancer patients receive the therapeutic best suited to treat their
cancer driver. 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." 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 in this press release
include, without limitation, expectations with respect to the
results from the B2151009 Phase 1b clinical trial, the timing of
launching a Phase 2/3 clinical trial, the future payments that may
be owed to Pfizer under the license agreement, the expected
benefits of gedatolisib, and other statements regarding the future
of Celcuity’s business and results of operations. .
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. 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
Westwicke
ICR
Robert Uhl, robert.uhl@westwicke.com
(619)
228-5886