Galera Reports Third Quarter 2021 Financial Results and Recent Corporate Updates
November 10 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 third quarter ended September 30, 2021
and provided recent corporate updates.
“We are well-positioned financially to continue
advancing our dismutase mimetic candidate rucosopasem (GC4711) in
combination with stereotactic body radiation therapy (SBRT) in our
randomized Phase 2 GRECO trials, with the goal of increasing the
anti-cancer effectiveness of SBRT in patients with lung and
pancreatic cancer,” said Mel Sorensen, M.D., Galera's President and
CEO. “We have already observed improved tumor outcomes and survival
when combining one of our dismutase mimetics with SBRT in our
randomized, placebo-controlled, proof-of-concept trial in patients
with locally advanced pancreatic cancer, reported in September. We
look forward to reporting initial data evaluating rucosopasem in
lung cancer in the first half of next year.”
Dr. Sorensen continued: “Following the recent
announcement of topline results of the Phase 3 ROMAN trial, we are
continuing to analyze the data and evaluating next steps for
avasopasem. While ROMAN did not achieve statistical significance in
the primary endpoint of reducing SOM incidence, avasopasem was
generally well tolerated and more than halved the number of days
patients experienced this severe side effect resulting from
radiation therapy.”
Recent Corporate Updates
Anti-Cancer Programs:
Locally Advanced Pancreatic Cancer (LAPC)
- The Company reported final data
from the Phase 1/2 pilot trial of avasopasem in combination with
SBRT in patients with unresectable or borderline resectable LAPC.
In this proof-of-concept trial, relative improvements were observed
in overall survival, progression-free survival, local tumor control
and time to distant metastases. 46% of patients in the active arm
were alive at last follow-up (11 out of 24) compared to 33% in the
placebo arm (6 out of 18).
- Enrollment is ongoing in the Phase
2b, 160-patient randomized, multicenter, placebo-controlled GRECO-2
trial of rucosopasem, Galera’s second dismutase mimetic product
candidate, in combination with SBRT in patients with LAPC. The
primary endpoint of the trial is overall survival.
Non-Small Cell Lung Cancer (NSCLC)
- Enrollment is ongoing in the Phase
1/2 GRECO-1 trial of rucosopasem in combination with SBRT in
patients with NSCLC. The Company expects to report initial data
from this trial in the first half of 2022.
Radiotherapy-Induced Toxicity Programs:
Severe Oral Mucositis (SOM)
- The Company reported topline data
from the Phase 3 ROMAN trial of avasopasem for the reduction of SOM
in patients with locally advanced head and neck cancer (HNC)
undergoing standard-of-care radiotherapy. The Company announced
that the trial did not meet its primary endpoint of reduction in
the incidence of SOM. Consistent with the Phase 2b trial, the data
showed relative reduction across all key SOM endpoints, including
more than halving the median duration of SOM.
- The Company expects to report
topline data from the Phase 2a EUSOM multicenter trial of
avasopasem in Europe in patients with HNC undergoing
standard-of-care radiotherapy in the fourth quarter of 2021.
Esophagitis
- Enrollment is ongoing 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.
Third Quarter 2021 Financial Highlights
- Research and development expenses
were $14.8 million in the third quarter of 2021, compared to $12.1
million for the same period in 2020. The increase was primarily
attributable to rucosopasem development costs and an increase in
contractor and consultant expense associated with the avasopasem
SOM program.
- General and administrative expenses
were $5.5 million in the third quarter of 2021, compared to $3.9
million for the same period in 2020. The increase was primarily
attributable to employee-related costs from increased headcount and
share-based compensation expense, increased expenses related to
preparation for potential commercialization of avasopasem, and
increased insurance expense and professional fees.
- Galera reported a net loss of
$(22.6) million, or $(0.86) per share, for the third quarter of
2021, compared to a net loss of $(17.1) million, or $(0.69) per
share, for the same period in 2020.
- As of September 30, 2021, Galera
had cash, cash equivalents and short-term investments of $88.7
million. Galera expects that its existing cash, cash equivalents
and short-term investments will enable Galera to fund its operating
expenses and capital expenditure requirements into 2023, assuming
limited future development and commercial activities for avasopasem
during this period. These assumptions may change as a result of
many factors currently unknown to the Company, including without
limitation the results of further analyses of data from the ROMAN
trial and potential next steps for the Company’s
radiotherapy-induced toxicity programs.
About Galera TherapeuticsGalera
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 technology consists of
selective small molecule dismutase mimetics that are in late-stage
development in patients with cancer. Avasopasem manganese (GC4419,
also referred to as avasopasem) is in development for
radiotherapy-induced toxicities, including SOM in patients with
head and neck cancer and esophagitis in patients with lung cancer.
Avasopasem has been granted FDA Fast Track and Breakthrough Therapy
designations for the reduction of SOM induced by radiotherapy, with
or without systemic therapy. Galera’s second dismutase mimetic
product candidate, rucosopasem manganese (GC4711, also referred to
as rucosopasem), is in clinical-stage development to augment the
anti-cancer efficacy of stereotactic body radiation therapy in
patients with non-small cell lung cancer and locally advanced
pancreatic cancer. Galera is headquartered in Malvern, PA. For more
information, please visit www.galeratx.com.
Forward-Looking StatementsThis
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 the continued advancement of our product
pipeline; the potential safety and efficacy of Galera’s product
candidates and their regulatory and clinical development, including
the interpretation of the safety and efficacy results from the
Phase 3 ROMAN trial, expectations surrounding the progress of the
Phase 2b trial of GC4711 in patients with LAPC, the expectations
surrounding the progress of the Phase 1/2 trial of GC4711 in
patients with NSCLC and the timing of the release of initial data
therefrom, the timing of reporting topline data from the Phase 2a
EUSOM multi-center trial of avasopasem in Europe in patients with
HNC undergoing standard-of-care radiotherapy, the expectations
surrounding the progress of the Phase 2a AESOP trial of avasopasem
evaluating its ability to reduce the incidence of esophagitis
induced by radiotherapy in patients with lung cancer and the timing
of the release of topline data therefrom; the Company’s ability to
achieve its goal of transforming radiotherapy in cancer treatment
with its selective dismutase mimetics; the potential of GC4711 to
augment the anti-cancer efficacy of SBRT in patients with NSCLC and
LAPC; and the Company’s ability to fund its operating expenses and
capital expenditure requirements into 2023. 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 September 30, |
|
|
Nine Months Ended September 30, |
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
14,813 |
|
|
$ |
12,133 |
|
|
$ |
43,203 |
|
|
$ |
40,225 |
|
General and administrative |
5,487 |
|
|
3,945 |
|
|
15,667 |
|
|
11,384 |
|
Loss from operations |
(20,300 |
) |
|
(16,078 |
) |
|
(58,870 |
) |
|
(51,609 |
) |
Other income (expense), net |
(2,326 |
) |
|
(1,000 |
) |
|
(4,857 |
) |
|
(2,543 |
) |
Net loss |
$ |
(22,626 |
) |
|
$ |
(17,078 |
) |
|
$ |
(63,727 |
) |
|
$ |
(54,152 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share of common stock, basic and diluted |
$ |
(0.86 |
) |
|
$ |
(0.69 |
) |
|
$ |
(2.49 |
) |
|
$ |
(2.18 |
) |
Weighted average common shares outstanding, basic and diluted |
26,304,920 |
|
|
24,874,805 |
|
|
25,569,545 |
|
|
24,840,822 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Galera Therapeutics,
Inc.Selected Consolidated Balance Sheet
Data(unaudited, in thousands)
|
September 30, |
|
|
December 31, |
|
2021 |
|
|
2020 |
|
|
|
|
|
Cash, cash equivalents, and short-term investments |
$ |
88,705 |
|
|
$ |
72,776 |
Total assets |
98,765 |
|
|
84,098 |
Total current liabilities |
15,724 |
|
|
13,968 |
Total liabilities |
141,932 |
|
|
77,980 |
Total stockholders' equity
(deficit) |
(43,167 |
) |
|
6,118 |
|
|
|
|
|
Investor Contacts:Christopher DegnanGalera
Therapeutics, Inc.610-725-1500cdegnan@galeratx.com
William WindhamSolebury
Trout646-378-2946wwindham@soleburytrout.com
Media Contact:Zara LockshinSolebury
Trout330-417-6250zlockshin@soleburytrout.com
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