Galera Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Recent Accomplishments
March 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 fourth quarter and year ended December
31, 2020, and highlighted recent corporate accomplishments.
“In 2020, Galera presented positive interim data demonstrating
that our dismutase mimetics have the potential to benefit the
anti-cancer side of the therapeutic index of radiotherapy,” said
Mel Sorensen, M.D., President and CEO of Galera. “This encouraging
interim data from our pilot placebo-controlled Phase 1/2 trial in
patients with pancreatic cancer was presented at ASTRO in late
2020. We look forward to providing the final data readout from this
trial in the second half of 2021 and advancing this regimen with
the initiation of our Phase 2b GRECO-2 trial of GC4711 in
combination with SBRT in patients with LAPC in the first half of
2021.”
Dr. Sorensen continued, “We are excited for the year ahead,
which we believe will be transformative for our company, with the
topline data readout of our Phase 3 ROMAN trial. In anticipation,
we continue our preparations for the commercial launch of
avasopasem manganese.”
Recent Corporate Highlights
Severe Oral Mucositis
(SOM)
- Continued enrollment in the 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 complete enrollment in the first half
of 2021 and report topline data in the second half of 2021.
- Completed enrollment in the Phase 2a EUSOM multi-center trial
in Europe assessing the safety of avasopasem in patients with HNC
undergoing standard-of-care radiotherapy. The Company remains on
track to report topline data in the second half of 2021.
Locally Advanced Pancreatic
Cancer (LAPC)
- Presented positive interim data from the pilot
placebo-controlled Phase 1/2 anti-cancer trial of avasopasem in
combination with SBRT in patients with LAPC at the American Society
for Radiation Oncology (ASTRO) virtual Annual Meeting in late 2020.
Data on all patients through a minimum follow-up of three months
demonstrated better tumor outcomes, including overall survival,
with avasopasem compared to placebo. The Company plans to provide
final data from this trial with at least one year of follow-up data
on all patients in the second half of 2021.
- Remain on track to initiate the Phase 2b GRECO-2 trial of
GC4711, Galera’s second superoxide dismutase mimetic candidate, in
combination with SBRT in patients with LAPC in the first half of
2021. GRECO-2 is a randomized, double-blind, placebo-controlled
trial to evaluate the effect of 100 mg of GC4711 versus placebo in
combination with SBRT on overall survival in patients with LAPC.
The trial is expected to enroll approximately 160 patients.
Non-Small Cell Lung Cancer
(NSCLC)
- Continued enrollment in the Phase 1/2 GRECO-1 trial of GC4711
in combination with SBRT in patients with NSCLC. The Phase 2
portion of GRECO-1 is randomized, double-blind, and
placebo-controlled to evaluate the effect of 100 mg of GC4711
versus placebo. The Company continues to expect 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
remains on track to report topline data in the first half of
2022.
Fourth Quarter 2020 Financial Highlights
- Research and development expenses were $14.6 million in the
fourth quarter of 2020, compared to $13.3 million for the same
period in 2019. The increase was primarily attributable to
avasopasem and GC4711 development costs, as well as higher
employee-related costs due to increased headcount and share-based
compensation expense. The increases were partially offset by
decreased avasopasem and GC4711 preclinical spend.
- General and administrative expenses were $4.3 million in the
fourth quarter of 2020, compared to $2.9 million for the same
period in 2019. The increase was primarily the result of
employee-related costs from increased headcount and share-based
compensation expense, and increased insurance, professional fees
and other operating costs as a result of becoming a public
company.
- Galera reported a net loss of $(20.1) million, or $(0.80) per
share, for the fourth quarter of 2020, compared to a net loss of
$(16.7) million, or $(1.31) per share, for the same period in
2019.
- As of December 31, 2020, Galera had cash, cash equivalents and
short-term investments of $72.8 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. We
expect to achieve these clinical enrollment milestones in the first
half of 2021.
Full Year 2020 Financial Highlights
- Research and development expenses were $54.8 million for the
year ended December 31, 2020, compared to $42.3 million for the
year ended December 31, 2019. The increase was primarily
attributable to avasopasem development costs due to increased
expenses in the Phase 3 ROMAN trial, additional clinical trials
including the Phase 2a AESOP trial and the Phase 2a EUSOM trial,
and manufacturing scale-up activities. In addition,
employee-related costs also increased due to increased headcount
and share-based compensation expense.
- General and administrative expenses were $15.7 million for the
year ended December 31, 2020, compared to $8.4 million for the year
ended December 31, 2019. The increase was primarily the result of
employee-related costs from increased headcount and share-based
compensation expense, and increased insurance, professional fees
and other operating costs as a result of becoming a public
company.
- Galera reported a net loss of $(74.2) million, or $(2.98) per
share, for the year ended December 31, 2020, compared to a net loss
of $(51.9) million, or $(16.31) per share, for the year ended
December 31, 2019.
About Galera Therapeutics
Galera Therapeutics, Inc. is 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. Galera’s lead product candidate
is avasopasem manganese (GC4419, also referred to as avasopasem), a
highly selective small molecule superoxide dismutase (SOD) 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 interim results, with follow-up ongoing. The FDA granted
Fast Track and Breakthrough Therapy designations to avasopasem for
the reduction of SOM induced by radiotherapy. 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 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 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 |
(in
thousands, except share and per share data) |
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
Year Ended December 31, |
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
14,620 |
|
|
$ |
13,276 |
|
|
$ |
54,845 |
|
|
$ |
42,333 |
|
General and administrative |
|
4,323 |
|
|
|
2,892 |
|
|
|
15,708 |
|
|
|
8,358 |
|
Loss from
operations |
|
(18,943 |
) |
|
|
(16,168 |
) |
|
|
(70,553 |
) |
|
|
(50,691 |
) |
Other income (expense), net |
|
(1,138 |
) |
|
|
(513 |
) |
|
|
(3,681 |
) |
|
|
(1,248 |
) |
Loss before
income tax benefit |
|
(20,081 |
) |
|
|
(16,681 |
) |
|
|
(74,234 |
) |
|
|
(51,939 |
) |
Income tax benefit |
|
16 |
|
|
|
9 |
|
|
|
16 |
|
|
|
9 |
|
Net
loss |
|
(20,065 |
) |
|
|
(16,672 |
) |
|
|
(74,218 |
) |
|
|
(51,930 |
) |
Accretion of redeemable convertible preferred stock to redemption
value |
|
- |
|
|
|
(998 |
) |
|
|
- |
|
|
|
(7,176 |
) |
Net loss
attributable to common stockholders |
$ |
(20,065 |
) |
|
$ |
(17,670 |
) |
|
$ |
(74,218 |
) |
|
$ |
(59,106 |
) |
|
|
|
|
|
|
|
|
Net loss per share of common stock, basic and diluted |
$ |
(0.80 |
) |
|
$ |
(1.31 |
) |
|
$ |
(2.98 |
) |
|
$ |
(16.31 |
) |
Weighed average common shares outstanding, basic and diluted |
|
24,955,986 |
|
|
|
13,489,826 |
|
|
|
24,869,770 |
|
|
|
3,625,005 |
|
|
|
|
|
|
|
|
|
Galera
Therapeutics, Inc. |
Selected
Consolidated Balance Sheet Data |
(in
thousands) |
|
|
|
|
|
December 31, |
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
Cash, cash
equivalents, and short-term investments |
$ |
72,776 |
|
|
$ |
112,290 |
|
Total
assets |
|
84,098 |
|
|
|
123,376 |
|
Total
current liabilities |
|
13,968 |
|
|
|
9,694 |
|
Total
liabilities |
|
77,980 |
|
|
|
53,768 |
|
Total
stockholders' equity |
|
6,118 |
|
|
|
69,608 |
|
Investor Contacts:Christopher DegnanGalera
Therapeutics, Inc.610-725-1500cdegnan@galeratx.com
Jennifer PorcelliSolebury
Trout646-378-2962jporcelli@soleburytrout.com
Media Contact:Heather Anderson6
Degrees919-827-5539handerson@6degreespr.com
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