Galera Reports Fourth Quarter and Full Year 2021 Financial Results and Recent Corporate Updates
March 10 2022 - 6:00AM
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 fourth quarter and year ended December
31, 2021 and provided recent corporate updates.
“In 2021, we were pleased to report positive data from our lead
program evaluating avasopasem for the treatment of severe oral
mucositis, a radiotherapy-induced toxicity, in patients with head
and neck cancer,” said Mel Sorensen, M.D., Galera’s President and
CEO. “The Phase 3 ROMAN trial demonstrated a statistically
significant reduction in the incidence of SOM, the primary
endpoint, and in the number of days patients experienced SOM. This
data is in line with the topline results observed in the Phase 2a
EUSOM trial and our previously completed randomized Phase 2b trial,
reinforcing avasopasem’s potentially transformative clinical
benefit for patients undergoing radiotherapy for head and neck
cancer. With this robust package of data in hand, we are preparing
to meet with the FDA to discuss the potential NDA submission.
Concurrently, we remain on track to report data from our Phase 2a
AESOP trial evaluating avasopasem in esophagitis in the first half
of this year.”
Dr. Sorensen continued: “We also continue to progress our Phase
1/2 GRECO-1 and Phase 2b GRECO-2 clinical trials evaluating our
second product candidate, rucosopasem, in increasing the
anti-cancer efficacy of higher daily doses of radiotherapy in
patients with non-small cell lung cancer and locally advanced
pancreatic cancer, respectively. We look forward to reporting
initial data from our GRECO-1 trial in the first half of this
year.”
Recent Corporate Updates
Radiotherapy-Induced Toxicity Programs:
Severe Oral Mucositis (SOM)
- On December 14, 2021, the Company announced corrected topline
efficacy results from the Phase 3 ROMAN trial of avasopasem for the
reduction of SOM in patients with locally advanced head and neck
cancer (HNC). The Company had previously announced topline results
from the ROMAN trial on October 19, 2021. Upon further analysis
following the October announcement, an error by the contract
research organization was identified in the statistical program.
Correction of this error resulted in improved p-values for the
primary and secondary endpoints. The corrected results demonstrated
efficacy across multiple SOM endpoints with a statistically
significant reduction on the primary endpoint of incidence of SOM
and the secondary endpoint of number of days of SOM, more than
halving the median number of days a patient experienced SOM.
Avasopasem appeared to be generally well tolerated compared to
placebo. The Company announced that it plans to meet with the U.S.
Food and Drug Administration (FDA) in 2022 to discuss a potential
New Drug Application (NDA) submission.
- On December 14, 2021, the Company also reported topline data
from the Phase 2a EUSOM multicenter trial of avasopasem in Europe
in patients with HNC undergoing standard-of-care radiotherapy.
Avasopasem appeared to be generally well tolerated and the
incidence and number of days of SOM was in line with the avasopasem
data reported in the Phase 3 ROMAN trial.
Esophagitis
- The Company expects to report topline data from the Phase 2a
AESOP trial of avasopasem evaluating its ability to reduce the
incidence of esophagitis induced by radiotherapy in patients with
lung cancer in the first half of 2022.
Anti-Cancer Programs:
Locally Advanced Pancreatic Cancer (LAPC)
- 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 stereotactic body radiation therapy (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.
Fourth Quarter 2021 Financial Highlights
- Research and development expenses were $9.2 million in the
fourth quarter of 2021, compared to $14.6 million for the same
period in 2020. The decrease was primarily attributable to a
decrease in avasopasem development costs, partially offset by an
increase in rucosopasem development costs.
- General and administrative expenses were $5.3 million in the
fourth quarter of 2021, compared to $4.3 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 insurance expense and
professional fees.
- Galera reported a net loss of $(16.8) million, or $(0.64) per
share, for the fourth quarter of 2021, compared to a net loss of
$(20.1) million, or $(0.80) per share, for the same period in
2020.
- As of December 31, 2021, Galera had cash, cash equivalents and
short-term investments of $71.2 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 the second half of 2023.
Full Year 2021 Financial Highlights
- Research and development expenses were $52.4 million for the
year ended December 31, 2021, compared to $54.8 million for the
year ended December 31, 2020. The decrease was primarily
attributable to a decrease in avasopasem development costs,
partially offset by an increase in rucosopasem development
costs.
- General and administrative expenses were $21.0 million for the
year ended December 31, 2021, compared to $15.7 million for the
year ended December 31, 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 $(80.5) million, or $(3.12) per
share, for the year ended December 31, 2021, compared to a net loss
of $(74.2) million, or $(2.98) per share, for the year ended
December 31, 2020.
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 selective dismutase mimetic
product candidate avasopasem manganese (GC4419, also referred to as
avasopasem) is being evaluated for radiotherapy-induced toxicities.
The Company’s second 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: the expectations
surrounding the continued advancement of Galera’s 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 of avasopasem for the reduction of SOM in patients with
locally advanced HNC and the Phase 2a EUSOM multi-center trial of
avasopasem in Europe in patients with HNC undergoing
standard-of-care radiotherapy; the timing of the meeting with the
FDA to discuss the potential submission of an NDA for avasopasem;
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
expectations surrounding the progress of the Phase 2b trial of
rucosopasem in patients with LAPC; the expectations surrounding the
progress of the Phase 1/2 trial of rucosopasem in patients with
NSCLC and the timing of the release of initial 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 the
second half of 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, 2021
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.
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Galera Therapeutics, Inc. |
Consolidated Statements of Operations |
(in thousands, except share and per share
data) |
|
|
|
|
|
|
|
|
|
|
|
Three Months EndedDecember 31, |
|
Year EndedDecember 31, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
9,215 |
|
|
$ |
14,620 |
|
|
$ |
52,417 |
|
|
$ |
54,845 |
|
General and administrative |
|
|
5,284 |
|
|
|
4,323 |
|
|
|
20,951 |
|
|
|
15,708 |
|
Loss from operations |
|
|
(14,499 |
) |
|
|
(18,943 |
) |
|
|
(73,368 |
) |
|
|
(70,553 |
) |
Other income (expense), net |
|
|
(2,307 |
) |
|
|
(1,138 |
) |
|
|
(7,166 |
) |
|
|
(3,681 |
) |
Loss before income tax benefit |
|
|
(16,806 |
) |
|
|
(20,081 |
) |
|
|
(80,534 |
) |
|
|
(74,234 |
) |
Income tax benefit |
|
|
- |
|
|
|
16 |
|
|
|
- |
|
|
|
16 |
|
Net Loss |
|
$ |
(16,806 |
) |
|
$ |
(20,065 |
) |
|
$ |
(80,534 |
) |
|
$ |
(74,218 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share of common stock, basic and diluted |
|
$ |
(0.64 |
) |
|
$ |
(0.80 |
) |
|
$ |
(3.12 |
) |
|
$ |
(2.98 |
) |
Weighted average common shares outstanding, basic and diluted |
|
|
26,442,028 |
|
|
|
24,955,986 |
|
|
|
25,789,458 |
|
|
|
24,869,770 |
|
Galera Therapeutics, Inc. |
Selected Consolidated Balance Sheet Data |
(in thousands) |
|
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|
|
|
December 31, |
|
December 31, |
|
|
2021 |
|
|
|
2020 |
|
|
|
|
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Cash, cash equivalents, and short-term investments |
$ |
71,217 |
|
|
$ |
72,776 |
|
Total assets |
|
83,311 |
|
|
|
84,098 |
|
Total current liabilities |
|
12,935 |
|
|
|
13,968 |
|
Total liabilities |
|
141,315 |
|
|
|
77,980 |
|
Total stockholders' equity (deficit) |
|
(58,004 |
) |
|
|
6,118 |
|
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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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