Galera Reports Second Quarter 2021 Financial Results and Recent Accomplishments
August 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 second quarter ended June 30, 2021, and
highlighted recent corporate accomplishments.
“We had a highly productive quarter in the clinic, including
completion of enrollment in our 455-patient pivotal Phase 3 ROMAN
trial of our lead product candidate, avasopasem, for SOM in
patients with head and neck cancer, promising tumor outcome and
survival data in an interim analysis of our 42-patient pancreatic
cancer trial, and initiation of our 160-patient double-blinded
placebo-controlled GRECO-2 pancreatic cancer trial,” said Mel
Sorensen, M.D., President and CEO. “We look forward to reporting
clinical trial results from our key programs later this year. In
parallel, Galera continues to strengthen our cash position and
build our commercial capabilities as we work toward potential FDA
approval of avasopasem in radiotherapy-induced SOM.”
Recent Corporate Highlights
Severe Oral Mucositis (SOM)
- Completed enrollment in the pivotal Phase 3 ROMAN trial of
avasopasem for SOM in patients with locally advanced head and neck
cancer (HNC) undergoing standard-of-care radiotherapy, which
triggered a $37.5 million milestone payment from funds managed by
Blackstone Life Sciences (Blackstone) received in July 2021. The
Company expects to report topline data in the fourth quarter 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 fourth quarter
of 2021.
Locally Advanced Pancreatic Cancer (LAPC)
- Reported updated data from the placebo-controlled 42-patient
trial of Galera’s dismutase mimetic in patients with LAPC who are
undergoing stereotactic body radiation therapy (SBRT). The updated
results include a minimum follow-up of six months on all 42
patients. As of the interim data analysis, median overall survival
in the treatment arm (20.1 months) was nearly twice as long as
observed in the placebo arm (10.9 months); 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 third quarter of 2021.
- Initiated the 160-patient randomized, multicenter,
placebo-controlled GRECO-2 trial of GC4711, Galera’s second
dismutase mimetic product candidate, in combination with SBRT in
patients with LAPC in May 2021, which triggered a $20 million
milestone payment from Blackstone received in June 2021.
Non-Small Cell Lung Cancer (NSCLC)
- Enrollment is ongoing in the Phase 1/2 GRECO-1 trial of GC4711
in combination with SBRT in patients with NSCLC. The Company
expects to report initial data from this trial in the first half of
2022.
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.
Second Quarter 2021 Financial Highlights
- Research and development expenses were $16.0 million in the
second quarter of 2021, compared to $13.8 million for the same
period in 2020. The increase was primarily attributable to
avasopasem development costs due to increased clinical expenses,
primarily related to the ROMAN trial, and an increase in
manufacturing and regulatory activities.
- General and administrative expenses were $5.1 million in the
second 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 pre-commercial
activities for avasopasem, and increased insurance expense and
professional fees.
- Galera reported a net loss of $(22.4) million, or $(0.88) per
share, for the second quarter of 2021, compared to a net loss of
$(18.7) million, or $(0.75) per share, for the same period in
2020.
- As of June 30, 2021, Galera had cash, cash equivalents and
short-term investments of $66.5 million. Galera expects that its
existing cash, cash equivalents and short-term investments,
together with the payment from Blackstone in the amount of $37.5
million received in July 2021, will enable Galera to fund its
operating expenses and capital expenditure requirements for at
least the next twelve months.
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 (avasopasem, or GC4419), a
selective small molecule dismutase mimetic in late-stage
development to reduce the incidence and severity of
radiotherapy-induced severe oral mucositis (SOM) in patients with
head and neck cancer. Avasopasem is also in development for
radiotherapy-induced 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, GC4711, 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 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 the potential,
safety, efficacy, clinical development and regulatory approval of
Galera’s product candidates, including with respect to the updated
results from the LAPC pilot trial; plans and timing for the
commencement of and the release of data from Galera’s clinical
trials, including with respect to the Phase 3 ROMAN trial, the
Phase 2a EUSOM trial, and the LAPC pilot trial, among others; plans
for the commercial launch of avasopasem; 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 or otherwise completing clinical trials; the FDA’s
acceptance of data from clinical trials conducted 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.
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Galera Therapeutics, Inc. |
Consolidated Statements of Operations |
(unaudited, in thousands except share and per share
data) |
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2021 |
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2020 |
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2021 |
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2020 |
Operating expenses: |
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Research and development |
$ |
15,966 |
|
|
$ |
13,839 |
|
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$ |
28,389 |
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$ |
28,092 |
|
General and administrative |
|
5,122 |
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|
3,874 |
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10,180 |
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7,439 |
|
Loss from operations |
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(21,088 |
) |
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(17,713 |
) |
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(38,569 |
) |
|
|
(35,531 |
) |
Other income (expense), net |
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(1,298 |
) |
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(944 |
) |
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(2,532 |
) |
|
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(1,543 |
) |
Net loss |
$ |
(22,386 |
) |
|
$ |
(18,657 |
) |
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$ |
(41,101 |
) |
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$ |
(37,074 |
) |
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Net loss per share of common stock, basic and diluted |
$ |
(0.88 |
) |
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$ |
(0.75 |
) |
|
$ |
(1.63 |
) |
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$ |
(1.49 |
) |
Weighted average common shares outstanding, basic and diluted |
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25,401,046 |
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24,832,264 |
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25,195,763 |
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24,823,644 |
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Galera Therapeutics, Inc. |
Selected Consolidated Balance Sheet Data |
(unaudited, in thousands) |
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June 30, |
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December 31, |
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2021 |
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2020 |
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Cash, cash equivalents, and short-term investments |
$ |
66,527 |
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$ |
72,776 |
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Total assets |
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115,269 |
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84,098 |
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Total current liabilities |
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16,843 |
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13,968 |
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Total liabilities |
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140,786 |
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77,980 |
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Total stockholders' equity (deficit) |
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(25,517 |
) |
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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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