Galera Reports First Quarter 2022 Financial Results and Recent Corporate Updates
May 16 2022 - 7:30AM
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, 2022 and
provided recent corporate updates.
“We are excited to announce our plan to submit an NDA for
avasopasem by year end following discussions with the FDA,” said
Mel Sorensen, M.D., Galera’s President and CEO. “Based on the
positive data readout from our Phase 3 ROMAN trial, Galera
continues to execute on its development strategy to advance its
lead program, avasopasem, toward potential commercialization. To
that end, we are delighted to attend the upcoming ASCO Annual
Meeting where our ROMAN data will be highlighted in an oral
presentation. In addition, we recently announced positive topline
data from our Phase 2a AESOP study of avasopasem for
chemoradiotherapy-induced esophagitis in patients with lung cancer.
We are encouraged by these results, which further demonstrate
avasopasem’s ability to reduce radiation toxicity in high-risk
patient populations.”
Recent Corporate Updates
Radiotherapy-Induced Toxicity Programs:
Severe Oral Mucositis (SOM)
- The Company announced plans to submit a New Drug Application
(NDA) for avasopasem, its lead product candidate, for the treatment
of radiotherapy-induced SOM to the U.S. Food and Drug
Administration (FDA) by the end of 2022.
- An abstract on the Phase 3 ROMAN data of avasopasem for SOM was
accepted for an oral presentation on June 3rd at the 2022 American
Society of Clinical Oncology (ASCO) Annual Meeting.
Esophagitis
- The Company reported positive topline data from the Phase 2a
AESOP trial of avasopasem evaluating its ability to reduce the
incidence of severe acute radiation-induced esophagitis in patients
with lung cancer receiving concurrent chemoradiotherapy. Overall,
avasopasem was well tolerated and the incidence of Grade 3
esophagitis was substantially reduced in comparison to literature.
No patients experienced Grade 4 or 5 esophagitis at any point
during the trial.
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.
- A Trials in Progress abstract on GRECO-2 was accepted for
presentation at the upcoming 2022 ASCO Annual Meeting.
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.
First Quarter 2022 Financial Highlights
- Research and development expenses were $8.1 million in the
first quarter of 2022, compared to $12.4 million for the same
period in 2021. 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 $5.0 million in the
first quarter of 2022, consistent with the first quarter of
2021.
- Galera reported a net loss of $(15.4) million, or $(0.58) per
share, for the first quarter of 2022, compared to a net loss of
$(18.7) million, or $(0.75) per share, for the same period in
2021.
- As of March 31, 2022, Galera had cash, cash equivalents and
short-term investments of $60.9 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.
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; the timing of the
submission of an NDA for avasopasem for the treatment of
radiotherapy-induced SOM in patients with locally advanced head and
neck cancer with the FDA; the ability of the results 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 to demonstrate avasopasem’s ability to reduce radiation
toxicity in high-risk patient populations; 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.
Galera
Therapeutics, Inc. |
Consolidated
Statements of Operations |
(unaudited,
in thousands except share and per share data) |
|
|
|
|
|
Three Months Ended March 31, |
|
|
2022 |
|
|
|
2021 |
|
Operating
expenses: |
|
|
|
Research and development |
$ |
8,107 |
|
|
$ |
12,423 |
|
General and administrative |
|
5,047 |
|
|
|
5,058 |
|
Loss from
operations |
|
(13,154 |
) |
|
|
(17,481 |
) |
Other income (expense), net |
|
(2,289 |
) |
|
|
(1,234 |
) |
Net
loss |
$ |
(15,443 |
) |
|
$ |
(18,715 |
) |
|
|
|
|
Net loss per share of common stock, basic and diluted |
$ |
(0.58 |
) |
|
$ |
(0.75 |
) |
Weighed average common shares outstanding, basic and diluted |
|
26,749,379 |
|
|
|
24,988,198 |
|
|
|
|
|
Galera
Therapeutics, Inc. |
Selected
Consolidated Balance Sheet Data |
(unaudited,
in thousands) |
|
|
|
|
|
March
31, |
|
December
31, |
|
|
2022 |
|
|
|
2021 |
|
|
|
|
|
Cash, cash
equivalents, and short-term investments |
$ |
60,947 |
|
|
$ |
71,217 |
|
Total
assets |
|
71,099 |
|
|
|
83,311 |
|
Total
current liabilities |
|
10,931 |
|
|
|
12,935 |
|
Total
liabilities |
|
141,570 |
|
|
|
141,315 |
|
Total
stockholders' deficit |
|
(70,471 |
) |
|
|
(58,004 |
) |
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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