Attached files
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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-99.1 - PRESS RELEASE DATED APRIL 5, 2021 REGARDING THE LICENSE AGREEMENT - Celcuity Inc. | celc_ex991.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
99.2
Celcuity Reports Preliminary Data from Phase 1b Trial of
Gedatolisib plus Ibrance® and Endocrine Therapy for Patients
with ER+/HER2- Metastatic Breast Cancer and Provides Corporate
Update
Preliminary Phase 1b Data
- 53
of the 88 evaluable patients (60%) had an objective response
-
- Gedatolisib
showed a potentially differentiated safety and tolerability profile
-
Corporate Update
-
Entered $25 million debt financing agreement with Innovatus Capital
Partners -
-
Proceeds from first $15 million tranche increase cash-on-hand to
$44 million -
- Drug
development capabilities and team broadened and expanded
-
- Conference
call and webcast scheduled for today, April 8 at 5 p.m. Eastern
Time -
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
reported preliminary data for the 103 patients enrolled in the
expansion portion of an ongoing Phase 1b clinical trial evaluating
gedatolisib, a first-in-class PI3K/mTOR inhibitor, plus Ibrance and
endocrine therapy, in ER+/HER2- advanced or metastatic breast
cancer patients. As of the January 11, 2021 data cut-off date,
53 of the 88 evaluable patients (60%) had an objective response.
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 TRAEs related to gedatolisib were
stomatitis and rash.
“We
are very encouraged by this preliminary data for gedatolisib from
our ongoing Phase 1b trial in patients with breast cancer,”
said Brian Sullivan, CEO and Co-Founder of Celcuity. “The
robust response rate and the observed tolerability profile are
particularly compelling given the need for a therapeutic regimen
that can address endocrine therapy resistance. We look forward to
sharing additional data from the study at a future medical
conference in 2021. Developing a therapeutic such as gedatolisib
allows us to more fully leverage our CELsignia cellular analysis
platform.“
Preliminary Phase 1b Data for Gedatolisib:
The
preliminary Phase 1b data set for the 103 patients enrolled
utilized a January 11, 2021 data cut-off. Patients were enrolled in
one of four expansion arms (A, B, C, D), according to their prior
treatment history for metastatic breast cancer. All patients
received gedatolisib in combination with standard doses of
palbociclib and endocrine therapy (either letrozole or
fulvestrant). In Arms A, B, and C, patients received an intravenous
dose of 180 mg of gedatolisib once weekly. In Arm D, patients
received an intravenous dose of 180 mg gedatolisib on a four-week
cycle of three weeks-on, one week-off. The primary endpoint was
objective response as determined using Response Evaluation Criteria
in Solid Tumors v1.0, or RECIST v1.0.
The
preliminary efficacy and safety analysis showed:
●
53 of the 88
evaluable patients (60%) had an objective response.
●
66 of the 88
evaluable patients (75%) had a clinical benefit, defined as either
a confirmed objective response or stable disease for at least 24
weeks.
●
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 TRAEs associated with gedatolisib were stomatitis and
rash. Gedatolisib was discontinued in 10% of patients.
●
22 patients were
continuing to receive gedatolisib in combination with the other
study drugs, 17 of whom have been on study treatment for more than
two years.
In
light of these encouraging results, Celcuity is planning 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.
Corporate Update
Management team expanded in key areas
With
the in-licensing of gedatolisib, Celcuity has broadened and
deepened its management team with experienced pharmaceutical
development and regulatory affairs experts.
Arthur DeCillis, M.D., Chief Medical Officer
Dr.
DeCillis was the Chief Medical Officer for Eleven Biotherapeutics
(now known as Sesen Bio Inc.) and VP Clinical Research for
Exelixis. Prior to that, he served in senior drug development roles
at Novartis and Bristol-Myers Squibb. Arthur has been involved in
the development of several commercialized oncology drugs, including
SPRYCEL® (dasatinib), AFINITOR® (everolimus),
FARYDAK® (panobinostat), and CABOMETYX®
(cabozantinib).
John R. MacDonald, Ph.D., DABT, Senior Vice President of
R&D
Dr.
MacDonald led the preclinical and clinical R&D efforts at MGI
Pharma, an oncology-focused pharmaceutical company until its sales
to Eisai Co. He has over 30 years of experience in all aspects of
pharmaceutical drug development and licensing. Prior to MGI, he
worked for Warner-Lambert (now Pfizer).
Sheri Smith, Head of Clinical Operations (Acting)
Ms.
Smith was the former Senior Director of Clinical Operations at MGI
Pharma, where she was responsible for all clinical operations. For
the past 17 years, she has served as President of Courante
Oncology, a specialty clinical research services company serving
pharmaceutical and medical device companies.
Bernhard Lampert, Ph.D., Head of CMC
Dr.
Lampert has extensive drug development experience in the
pharmaceutical and biotech industries, including ten years in
large, fully integrated pharmaceutical companies, including Gilead
and GSK. He received his Ph.D. in Medicinal Chemistry from the
University of Georgia in 1989.
Marie DeGayner Kuker, Head of Regulatory
Ms.
Kuker has more than 35 years of experience in the pharmaceutical
industry, most recently as head of global regulatory affairs for 3M
Pharmaceuticals and Drug Delivery Systems before founding her
consultancy in 2007. Marie is an appointed Fellow of the Regulatory
Affairs Professionals Society.
Celcuity announces $25 million debt financing agreement with
Innovatus Capital Partners, LLC
Celcuity
has entered into a debt financing agreement with Innovatus Capital
Partners, LLC (Innovatus) to provide Celcuity with up to $25
million in term loans with the first $15 million tranche funded at
closing. Celcuity will be able to draw on two additional tranches
of $5 million each upon the achievement of certain clinical trial
and financing milestones. Celcuity is entitled to make interest
only payments for 36 months or up to 48 months if certain
conditions are met. The loans will mature on the fifth anniversary
of the initial funding date. Innovatus has the right to convert up
to 20% of the outstanding principal amount into shares of Celcuity
common stock until the third anniversary of the loan agreement. The
loan agreement includes customary warrant coverage and is secured
by all of Celcuity’s assets. Armentum Partners LLC acted as
sole advisor to Celcuity on this transaction.
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 and provide a corporate update. To participate in
the call, dial 1-877-407-8035. A live webcast presentation can be accessed using this
weblink: 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 the Phase 1b Gedatolisib Clinical Trial
The B2151009 trial is a multicenter, open-label, on-going Phase 1b
study in patients with ER+/HER2- metastatic breast cancer. Four
dose expansion arms enrolled 103 patients to determine if the
triplet combination of gedatolisib plus palbociclib and letrozole
or gedatolisib plus palbociclib and fulvestrant produced a superior
objective response (OR), compared to historical control data of the
doublet combination (palbociclib plus endocrine therapy). More
information about the trial is available at NCT02684032.
About Gedatolisib
Gedatolisib
is a potent, reversible dual inhibitor that selectively targets
PI3K and mTOR. Gedatolisib was originally developed by Wyeth and
clinical development was continued by Pfizer after it acquired
Wyeth. Celcuity licensed exclusive global rights to gedatolisib
from Pfizer in April 2021. An on-going Phase 1b trial evaluating
patients with ER+/HER2- metastatic breast cancer was initiated in
2016 and subsequently enrolled 138 patients. Patient enrollment for
the four expansion arms of the trial is complete. Based on the
favorable preliminary results reported to date from the Phase 1b
trial, 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.
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.
Innovatus Capital Partners, LLC
Innovatus
Capital Partners, LLC, is an independent adviser and portfolio
management firm with approximately $1.54B in assets under
management. Innovatus adheres to an investment strategy that
identifies disruptive and growth opportunities across multiple
asset categories with a unifying theme of capital preservation,
income generation, and upside optionality. The firm has a dedicated
team of life sciences investment professionals with deep experience
in healthcare, including life sciences. Innovatus and its
principals have significant experience providing debt financing to
medical device, diagnostics, and biotechnology companies that
address unmet medical needs, improve patient outcomes, and reduce
overall healthcare expenditures. Further information can be found
atwww.innovatuscp.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 the results
from the B2151009 Phase 1b clinical trial, the timing of launching
a Phase 2/3 clinical trial, the expected benefits of gedatolisib,
the growth of Celcuity’s management team, 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