Galera Reports First Quarter 2021 Financial Results and Recent Accomplishments
May 11 2021 - 7:00AM
Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage
biopharmaceutical company focused on developing and commercializing
a pipeline of novel, proprietary therapeutics that have the
potential to transform radiotherapy in cancer, today announced
financial results for the first quarter ended March 31, 2021, and
highlighted recent corporate accomplishments.
“Galera is off to a strong start in 2021, as we continue to
progress our clinical oncology programs in radiation-induced severe
oral mucositis (SOM), locally advanced pancreatic cancer (LAPC) and
non-small cell lung cancer (NSCLC) with our dismutase mimetics,”
said Mel Sorensen, M.D., President and CEO of Galera. “We recently
reported updated data from our placebo-controlled Phase 1/2 pilot
trial, in which a near doubling of median overall survival was
observed in patients with pancreatic cancer. Building on the
positive results from this trial, we anticipate initiating a Phase
2b trial in the first half of 2021 in patients with LAPC, with
overall survival as the primary endpoint. Importantly, we look
forward to announcing topline data in the pivotal Phase 3 trial in
SOM and potential regulatory approval and commercialization of
avasopasem, our lead dismutase mimetic product candidate.”
Recent Corporate Highlights
Severe Oral Mucositis (SOM)
- Continued enrollment in the pivotal Phase 3 ROMAN trial of
avasopasem for the treatment of SOM in patients with locally
advanced head and neck cancer (HNC) undergoing standard-of-care
radiotherapy. The Company remains on track to report topline data
in the second half of 2021.
- The Company expects to report topline data from the Phase 2a
EUSOM multi-center trial of avasopasem in Europe in patients with
HNC undergoing standard-of-care radiotherapy in the second half of
2021.
Locally Advanced Pancreatic Cancer (LAPC)
- Reported updated data from the placebo-controlled Phase 1/2
pilot trial of Galera’s dismutase mimetic in patients with LAPC who
are also undergoing stereotactic body radiation therapy (SBRT). As
of the data analysis, median overall survival (OS) in the treatment
arm (20.1 months) was nearly twice as long as observed in the
placebo arm (10.9 months); 29% of patients in the treatment arm
achieved a partial response compared to 11% of patients in the
placebo arm; and positive results were also observed in local tumor
control, time to metastases and progression-free survival. The
Company expects to report final results from the trial with at
least one year of follow-up on all patients in the second half of
2021.
Non-Small Cell Lung Cancer (NSCLC)
- Continued enrollment in the Phase 1/2 GRECO-1 trial of GC4711,
Galera’s second dismutase mimetic product candidate, in combination
with SBRT in patients with NSCLC. The Company remains on track to
report initial data in the first half of 2022.
Esophagitis
- Continued enrollment in the Phase 2a AESOP trial of avasopasem
evaluating its ability to reduce the incidence of esophagitis
induced by radiotherapy in patients with lung cancer. The Company
expects to report topline data in the first half of 2022.
First Quarter 2021 Financial Highlights
- Research and development expenses were $12.4 million in the
first quarter of 2021, compared to $14.3 million for the same
period in 2020. The decrease was primarily attributable to
avasopasem development costs, due to decreased expenses related to
the ROMAN trial and a decrease in preclinical expenses.
- General and administrative expenses were $5.1 million in the
first quarter of 2021, compared to $3.6 million for the same period
in 2020. The increase was primarily attributable to
employee-related costs from increased headcount and share-based
compensation expense, and increased expenses related to
pre-commercial activities for avasopasem.
- Galera reported a net loss of $(18.7) million, or $(0.75) per
share, for the first quarter of 2021, compared to a net loss of
$(18.4) million, or $(0.74) per share, for the same period in
2020.
- As of March 31, 2021, Galera had cash, cash equivalents and
short-term investments of $57.5 million. Galera expects that its
existing cash, cash equivalents and short-term investments,
together with the expected payments from Blackstone in the amount
of $57.5 million upon the achievement of certain clinical
enrollment milestones in the ROMAN trial and the anti-cancer
program in combination with SBRT under the amended royalty
agreement, will enable Galera to fund its operating expenses and
capital expenditure requirements into the second half of 2022. The
Company expects to achieve these clinical enrollment milestones in
the first half of 2021.
About Galera Therapeutics
Galera Therapeutics, Inc. is a clinical-stage biopharmaceutical
company focused on developing and commercializing a pipeline of
novel, proprietary therapeutic candidates that have the potential
to transform radiotherapy in cancer. Galera’s lead product
candidate is avasopasem manganese (GC4419, also referred to as
avasopasem), a selective small molecule dismutase mimetic initially
being developed for the reduction of radiation-induced severe oral
mucositis (SOM). Avasopasem is being studied in the Phase 3 ROMAN
trial to assess its ability to reduce the incidence and severity of
SOM induced by radiotherapy in patients with locally advanced head
and neck cancer (HNC), its lead indication. It is also being
studied in the EUSOM Phase 2a multi-center trial in Europe
assessing the safety of avasopasem in patients with HNC undergoing
standard-of-care radiotherapy, the AESOP Phase 2a trial to assess
its ability to reduce the incidence of esophagitis induced by
radiotherapy in patients with lung cancer, and a Phase 2 trial in
hospitalized patients who are critically ill with COVID-19. A pilot
Phase 1/2 trial of avasopasem in combination with stereotactic body
radiation therapy (SBRT) in patients with locally advanced
pancreatic cancer (LAPC) has completed enrollment and reported
updated results, with follow-up ongoing. The FDA granted Fast Track
and Breakthrough Therapy designations to avasopasem for the
reduction of SOM induced by radiotherapy, with or without systemic
therapy. Galera’s second dismutase mimetic product candidate,
GC4711, is being developed specifically to augment the anti-cancer
efficacy of SBRT, and is currently being studied in the GRECO-1
Phase 1/2 trial in combination with SBRT in patients with non-small
cell lung cancer. Galera also intends to initiate the GRECO-2 Phase
2b trial of GC4711 in combination with SBRT in patients with LAPC.
Galera is headquartered in Malvern, PA. For more information,
please visit www.galeratx.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. All statements contained in this press release that do not
relate to matters of historical fact should be considered
forward-looking statements, including without limitation statements
regarding: expectations surrounding our growth and the continued
advancement of our product pipeline, including plans for the
commercial launch of avasopasem; the potential, safety, efficacy,
and regulatory and clinical development of Galera’s product
candidates; plans and timing for the commencement of and the
release of data from Galera’s clinical trials; expected payments
from Blackstone; and the sufficiency of Galera’s cash, cash
equivalents and short-term investments. These forward-looking
statements are based on management’s current expectations. These
statements are neither promises nor guarantees, but involve known
and unknown risks, uncertainties and other important factors that
may cause Galera’s actual results, performance or achievements to
be materially different from any future results, performance or
achievements expressed or implied by the forward-looking
statements, including, but not limited to, the following: Galera’s
limited operating history; anticipating continued losses for the
foreseeable future; needing substantial funding and the ability to
raise capital; Galera’s dependence on avasopasem manganese
(GC4419); uncertainties inherent in the conduct of clinical trials;
difficulties or delays enrolling patients in clinical trials; the
FDA’s acceptance of data from clinical trials outside the United
States; undesirable side effects from Galera’s product candidates;
risks relating to the regulatory approval process; failure to
capitalize on more profitable product candidates or indications;
ability to receive or maintain Breakthrough Therapy Designation or
Fast Track Designation for product candidates; failure to obtain
regulatory approval of product candidates in the United States or
other jurisdictions; ongoing regulatory obligations and continued
regulatory review; risks related to commercialization; risks
related to competition; ability to retain key employees and manage
growth; risks related to intellectual property; inability to
maintain collaborations or the failure of these collaborations;
Galera’s reliance on third parties; the possibility of system
failures or security breaches; liability related to the privacy of
health information obtained from clinical trials and product
liability lawsuits; unfavorable pricing regulations, third-party
reimbursement practices or healthcare reform initiatives;
environmental, health and safety laws and regulations; the impact
of the COVID-19 pandemic on Galera’s business and operations,
including preclinical studies and clinical trials, and general
economic conditions; risks related to ownership of Galera’s common
stock; and significant costs as a result of operating as a public
company. These and other important factors discussed under the
caption “Risk Factors” in Galera’s Annual Report on Form 10-K for
the year ended December 31, 2020 filed with the U.S. Securities and
Exchange Commission (SEC) and Galera’s other filings with the SEC
could cause actual results to differ materially from those
indicated by the forward-looking statements made in this press
release. Any forward-looking statements speak only as of the date
of this press release and are based on information available to
Galera as of the date of this release, and Galera assumes no
obligation to, and does not intend to, update any forward-looking
statements, whether as a result of new information, future events
or otherwise.
Galera
Therapeutics, Inc. |
Consolidated
Statements of Operations |
(unaudited,
in thousands except share and per share data) |
|
|
|
|
|
Three Months Ended March 31, |
|
|
2021 |
|
|
|
2020 |
|
Operating
expenses: |
|
|
|
Research and development |
$ |
12,423 |
|
|
$ |
14,252 |
|
General and administrative |
|
5,058 |
|
|
|
3,566 |
|
Loss from
operations |
|
(17,481 |
) |
|
|
(17,818 |
) |
Other income (expense), net |
|
(1,234 |
) |
|
|
(599 |
) |
Net
loss |
$ |
(18,715 |
) |
|
$ |
(18,417 |
) |
|
|
|
|
Net loss per share of common stock, basic and diluted |
$ |
(0.75 |
) |
|
$ |
(0.74 |
) |
Weighed average common shares outstanding, basic and diluted |
|
24,988,198 |
|
|
|
24,815,024 |
|
Galera
Therapeutics, Inc. |
Selected
Consolidated Balance Sheet Data |
(unaudited,
in thousands) |
|
|
|
|
|
March
31, |
|
December
31, |
|
2021 |
|
2020 |
|
|
|
|
Cash, cash
equivalents, and short-term investments |
$ |
57,520 |
|
|
$ |
72,776 |
Total
assets |
|
70,486 |
|
|
|
84,098 |
Total
current liabilities |
|
15,855 |
|
|
|
13,968 |
Total
liabilities |
|
81,059 |
|
|
|
77,980 |
Total
stockholders' equity (deficit) |
|
(10,573 |
) |
|
|
6,118 |
Investor Contacts:Christopher DegnanGalera
Therapeutics, Inc.610-725-1500cdegnan@galeratx.com
William WindhamSolebury
Trout646-378-2946wwindham@soleburytrout.com
Media Contact:Zara LockshinSolebury
Trout646-378-2960zlockshin@soleburytrout.com
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