Exhibit
99.1
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
profile
-
Secured additional financing to strengthen cash position and
provide funding for expanded clinical development
activities
-
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
business progress.
"Celcuity
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
gedatolisib.”
First Quarter 2021 Business Highlights and Other Recent
Developments
●
In January,
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.
●
Celcuity raised
approximately $43.0 million of gross proceeds from financings in
the first quarter of 2021 and April 2021.
o
In late February,
Celcuity completed a successful follow-on public offering that
raised gross proceeds of approximately $27.6 million.
o
In early April,
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
therapy TABRECTA®
and Puma’s
NERLYNX®
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
place.
●
In April, Celcuity
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.
●
In April, Celcuity
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
a BCL inhibitor.
First Quarter 2021 Financial Results
Unless
otherwise stated, all comparisons are for the first quarter ended
March 31, 2021, compared to the first quarter ended March 31,
2020.
Total
operating expenses were $2.79 million for the first quarter of
2021, compared to $2.31 million for the first quarter of
2020.
Research
and development (R&D) expenses were $2.24 million for the first
quarter of 2021, compared to $1.85 million for the first quarter of
2020. The approximately $0.39 million increase during the first
three months of fiscal year 2021, compared to the first three
months of fiscal year 2020, resulted from a $0.06 million increase
in compensation related expenses, which included a decrease of
approximately $0.04 million of non-cash stock-based compensation
expense. In addition, other research and development expenses
increased $0.33 million due to clinical validation and laboratory
studies, and operational and business development
activities.
General
and administrative (G&A) expenses were $0.56 million for the
first quarter of 2021, compared to $0.46 million for the first
quarter of 2020. The approximately $0.09 million increase during
the first three months of fiscal year 2021, compared to the first
three months of fiscal year 2020, resulted primarily from a $0.08
million increase in professional fees associated with being a
public company and director and officer insurance.
Net
loss for the first quarter of 2021 was $2.79 million, or $0.25 per
share, compared to a net loss of $2.25 million, or $0.22 per share,
for the first quarter of 2020. Non-GAAP adjusted net loss for the
first quarter of 2021 was $2.34 million, or $0.21 per share,
compared to non-GAAP adjusted net loss of $1.78 million, or $0.17
per share, for the first quarter of 2020. Non-GAAP adjusted net
loss excludes stock-based compensation expense. Because this item
has 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 first quarter of 2021 was
$2.52 million, compared to $1.83 million for the first quarter of
2020.
At
March 31, 2021, Celcuity had cash and cash equivalents of $34.9
million, compared to cash and cash equivalents of $11.6 million at
December 31, 2020. On April 8, 2021, Celcuity paid an upfront
license fee of $5.0 million in conjunction with the Pfizer
gedatolisib license agreement and received $14.5 million of net
proceeds from a debt financing agreement. Taking into account these
two events subsequent to the end of the first quarter, Celcuity has
approximately $44.0 million of cash-on-hand.
Anticipated Milestones
Celcuity
expects to do the following over the next twelve
months:
■
Announce additional
clinical trial collaborations in the first half of 2021 utilizing
the CELsignia platform.
■
Initiate Phase 2/3
clinical trial for gedatolisib in breast cancer in the first half
of 2022 pending discussions with the FDA regarding the clinical
development pathway.
■
Provide interim
results from the FACT-1 and FACT-2 trials in late 2021 or early
2022.
Webcast and Conference Call Information
The
Celcuity management team will host a webcast/conference call at
4:30 p.m. ET today to discuss the first quarter financial results
and provide a corporate update. To participate in the
teleconference, domestic callers should dial 1-877-407-8035 and
international callers should dial 201-689-8035. A live webcast
presentation can also be accessed using this weblink: https://www.webcaster4.com/Webcast/Page/2678/40988.
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 seeking to extend the
lives of cancer patients by pursuing an integrated companion
diagnostic and therapeutic strategy. Our CELsignia companion
diagnostic (CDx) 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 our CELsignia CDx
platform 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 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 and in Exhibit 99.4 to
Celcuity's Current Report on Form 8-K filed with the Securities and
Exchange Commission on April 8, 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, [email protected]
Vicky
Hahne, [email protected]
Westwicke
ICR
Robert
Uhl, [email protected]
(619)
228-5886
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Celcuity Inc.
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Condensed Balance Sheets
|
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|
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March 31,
2021
|
December 31,
2020
|
|
|
(unaudited)
|
|
|
Assets
|
|
|
|
Current Assets:
|
|
|
|
Cash
and cash equivalents
|
$34,936,902
|
$11,637,911
|
|
Deposits
|
22,009
|
22,009
|
|
Deferred
transaction costs
|
13,719
|
-
|
|
Payroll
tax receivable
|
190,000
|
190,000
|
|
Prepaid
assets
|
551,345
|
317,040
|
|
Total current assets
|
35,713,975
|
12,166,960
|
|
|
|
|
|
Property
and equipment, net
|
466,484
|
558,876
|
|
Operating
lease right-of-use assets
|
186,602
|
230,911
|
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Total Assets
|
$36,367,061
|
$12,956,747
|
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|
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Liabilities and Stockholders' Equity:
|
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|
Current Liabilities:
|
|
|
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Accounts
payable
|
$318,213
|
$217,377
|
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Finance
lease liabilities
|
5,819
|
5,810
|
|
Operating
lease liabilities
|
185,656
|
187,518
|
|
Accrued
expenses
|
660,849
|
774,612
|
|
Total current liabilities
|
1,170,537
|
1,185,317
|
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Finance
lease liabilities
|
6,841
|
8,299
|
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Operating
lease liabilities
|
15,139
|
60,861
|
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Total Liabilities
|
1,192,517
|
1,254,477
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Total Stockholders' Equity
|
35,174,544
|
11,702,270
|
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Total Liabilities and Stockholders' Equity
|
$36,367,061
|
$12,956,747
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Celcuity Inc.
Condensed Statements of Operations
(unaudited)
|
|
Three Months Ended
March 31,
|
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|
|
2021
|
2020
|
|
|
|
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Operating expenses:
|
|
|
|
|
|
|
|
Research
and development
|
$2,236,342
|
$1,847,414
|
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General
and administrative
|
555,428
|
463,399
|
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Total
operating expenses
|
2,791,770
|
2,310,813
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Loss
from operations
|
(2,791,770)
|
(2,310,813)
|
|
|
|
|
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Other
income (expense)
|
|
|
|
Interest
expense
|
(24)
|
(33)
|
|
Interest
income
|
388
|
63,851
|
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Loss
on sale of fixed assets
|
(263)
|
-
|
|
Other
income, net
|
101
|
63,818
|
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Net loss before income taxes
|
(2,791,668)
|
(2,246,995)
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Income
tax benefits
|
-
|
-
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Net loss
|
$(2,791,668)
|
$(2,246,995)
|
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|
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Net
loss per share, basic and diluted
|
$(0.25)
|
$(0.22)
|
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|
|
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Weighted
average common shares outstanding, basic and diluted
|
11,072,097
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10,253,988
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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 from net loss and net
loss per share. Management excludes this item because it does 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
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Three Months Ended March 31,
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2021
|
2020
|
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GAAP
net loss
|
$(2,791,668)
|
$(2,246,995)
|
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Adjustments:
|
|
|
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Stock-based
compensation
|
|
|
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Research and development (1)
|
255,181
|
293,116
|
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General and administrative (2)
|
193,917
|
171,533
|
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Non-GAAP
adjusted net loss
|
$(2,342,570)
|
$(1,782,346)
|
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|
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GAAP
net loss per share - basic and diluted
|
$(0.25)
|
$(0.22)
|
|
Adjustment
to net loss (as detailed above)
|
0.04
|
0.05
|
|
Non-GAAP
adjusted net loss per share
|
$(0.21)
|
$(0.17)
|
|
|
|
|
|
Weighted
average common shares outstanding, basic and diluted
|
11,072,097
|
10,253,988
|
|
|
|
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(1) To
reflect a non-cash charge to operating expense for Research and
Development stock-based compensation.
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(2) To
reflect a non-cash charge to operating expense for General and
Administrative stock-based compensation.
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