Full Press Release Details
Celcuity Inc. Reports First Quarter 2021 Financial Results and
Provides Corporate Update
Entered into worldwide licensing agreement with Pfizer to develop
and commercialize gedatolisib, a first-in-class PI3K/mTOR
inhibitor, in clinical development for breast cancer
Announced encouraging preliminary data from a Phase 1b trial of
gedatolisib plus Ibrance and endocrine therapy for patients
with ER+/HER2- metastatic breast cancer, in which gedatolisib
showed a potentially differentiated safety and tolerability
Secured additional financing to strengthen cash position and
provide funding for expanded clinical development
Entered into clinical trial collaboration agreements with leading
cancer research centers, Novartis, Pfizer, and Puma to evaluate the
efficacy of targeted therapies in patients selected with
Celcuity's CELsignia Multi-Pathway Activity Test
Management to host webcast and conference call today, May 10, at
4:30 p.m. ET / 1:30 p.m. PT
MINNEAPOLIS, May 10, 2021 Celcuity Inc. (Nasdaq:
CELC), a clinical-stage biotechnology company pursuing an
integrated companion diagnostic (CDx) and therapeutic strategy for
treating patients with cancer, today announced financial results
for the first quarter ended March 31, 2021 and summarized recent
took a transformational strategic step in April when we entered
into a global licensing agreement with Pfizer to obtain exclusive
rights to develop and commercialize gedatolisib, a pan-PI3K/mTOR
inhibitor, in clinical development to treat patients with
ER+/HER2-negative advanced or metastatic breast cancer, said
Brian Sullivan, CEO and co-founder of Celcuity. 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 the first half of 2022. We
have a highly experienced drug development team and the financial
resources in place to advance the gedatolisib program and are
excited by the opportunity to utilize our CELsignia cellular
analysis platform to support the development of a potential
first-in-class targeted cancer therapy like
First Quarter 2021 Business Highlights and Other Recent
Celcuity entered a collaboration with Sarah Cannon Research
Institute and Pfizer Inc. to conduct an open-label Phase 2 clinical
trial. This trial will evaluate the efficacy and safety of two
Pfizer targeted therapies, VIZIMPRO , a pan-HER
inhibitor, and XALKORI , a c-Met
inhibitor, in patients with previously treated metastatic
HER2-negative breast cancer selected with Celcuity's
CELsignia Multi-Pathway Activity Test. Celcuity believes there is
significant clinical interest in finding new diagnostic tests and
targeted therapies for patients with metastatic HER2-negative
breast cancer whose disease progressed on prior therapies. Patient
enrollment is expected to begin in the second or third quarter of
2021 with interim results in the second half of 2022.
approximately $43.0 million of gross proceeds from financings in
the first quarter of 2021 and April 2021.
Celcuity completed a successful follow-on public offering that
raised gross proceeds of approximately $27.6 million.
Celcuity entered into a debt financing agreement with Innovatus
Life Sciences Lending Fund I, LP to provide up to $25.0 million in
term loans with the first tranche of $15.0 million funded at
closing. Celcuity will be able to draw on two additional tranches
of $5.0 million each upon the achievement of certain clinical trial
and financing milestones.
In March, Celcuity entered into a clinical trial
collaboration with MD Anderson, Novartis, and Puma Biotechnology to
evaluate the efficacy and safety of Novartis' targeted
in patients with metastatic
HER2-negative breast cancer selected by Celcuity's CELsignia
Multi-Pathway Activity Test. This is Celcuity's second
clinical trial to treat patients diagnosed with hyperactive HER2
and c-Met signaling breast cancers with matching targeted therapies
and Celcuity now has five clinical trial collaborations in
entered a worldwide licensing agreement with Pfizer for the
exclusive right to develop and commercialize gedatolisib.
Gedatolisib is in Phase 1b clinical development for the treatment
of patients with ER+/HER2-negative advanced or metastatic breast
cancer. Celcuity announced preliminary data for the 103 patients
enrolled in the expansion portion of the ongoing Phase 1b clinical
trial evaluating gedatolisib, plus Ibrance and endocrine therapy.
As of the January 11, 2021 data cut-off, 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.
Celcuity plans to meet with the FDA later this year to discuss its
clinical development plans for gedatolisib.
presented results of studies evaluating gedatolisib, inavolisib (a
PI3K-a inhibitor), and
navitoclax (a BCL inhibitor) in breast and ovarian patient tumors
in two posters at the American Association for Cancer Research
(AACR) Annual Meeting. The results showed that gedatolisib
inhibited nine times more signaling test activity in tumors with
hyperactive RAS network signaling, on average, than inavolisib,
when evaluated at equal concentrations with the CELsignia test.
Gedatolisib at one-fifth the concentration of inavolisib (30 nM vs.
150 nM), inhibited five times more signaling activity as quantified
by the CELsignia test. Data also showed that synergistic
cooperation between PI3K/mTOR and BCL signaling was detected,
suggesting potential patient benefit of combining gedatolisib with
First Quarter 2021 Financial Results
otherwise stated, all comparisons are for the first quarter ended
March 31, 2021, compared to the first quarter ended March 31,
operating expenses were $2.79 million for the first quarter of