Galera Therapeutics Reports Third Quarter 2020 Financial Results and Provides Business Updates
November 10 2020 - 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, 2020,
and provided business updates.
“We continue to make great strides advancing the clinical
development of our small molecule superoxide dismutase mimetics’
ability to address radiation toxicities and augment the anti-cancer
efficacy of radiation,” said Mel Sorensen, M.D., President and CEO
of Galera. “We are delighted with the encouraging data from our
placebo-controlled trial of GC4419 in combination with stereotactic
body radiation therapy (SBRT) for patients with locally advanced
pancreatic cancer (LAPC), which were presented during a
late-breaker session at the American Society for Radiation Oncology
(ASTRO) 2020 Annual Meeting. The findings are the first clinical
evidence supporting our extensive preclinical science that showed
synergy of our dismutase mimetics with SBRT. In this first trial
with the addition of a dismutase mimetic to SBRT in patients, we
observed better tumor responses, saw more patients succeed in going
to surgical resection, and are particularly pleased by the initial
signal in survival. With these promising early activity results in
hand, coupled with the preliminary safety findings of the
combination, we look forward to continuing to advance the potential
of our dismutase mimetics to enhance the anti-cancer efficacy of
SBRT and improve outcomes for cancer patients. We have initiated
the GRECO-1 Phase 1/2 trial of GC4711 with SBRT in non-small cell
lung cancer (NSCLC), and also anticipate initiating a Phase 2b
trial of GC4711 with SBRT in pancreatic cancer (GRECO-2) in the
first half of 2021. Our most advanced program, the ROMAN Phase 3
trial, continues to enroll well and we look forward to reporting
topline results in the second half of 2021.”
Third Quarter 2020 and Recent Corporate
Highlights
- In October, presented interim efficacy and safety data from the
randomized, double-blind, multicenter, placebo-controlled pilot
Phase 1/2 clinical trial of avasopasem manganese (GC4419) in
combination with SBRT in patients with LAPC at ASTRO. In the
analysis of the intent-to-treat population, multiple endpoints to
date show a positive trend in favor of improved anti-cancer
efficacy with avasopasem compared to placebo. While many of the
patients are early in their follow-up post treatment, addition of
the dismutase mimetic to SBRT appears to improve overall survival
(OS) versus placebo (HR=0.4, 95% CI: 0.12-1.11; median OS not yet
reached for avasopasem vs. 38.7 weeks for placebo; p=0.06). Best
overall response within the SBRT field was partial response,
according to modified RECIST criteria, or better in 33% of
avasopasem patients versus 17% of placebo patients. Five patients
in the avasopasem arm and two in the placebo arm were surgically
resected. Among the resected avasopasem patients, all five achieved
clear margins (R0), compared to only one of the two in the placebo
arm. Progression-free survival hazard ratio as of the cut-off date
also appears to favor the avasopasem arm (HR=0.6, 95% CI:
0.23-1.56; p=0.29). Toxicity was comparable across both treatment
arms, with no significant differences in overall or Grade 3 GI
toxicity post-SBRT. The data presented included all patients
followed for a minimum of three months and 19 for more than one
year, with data through August 24, 2020. The Company plans to
provide an update on this trial with at least one year of follow-up
on all patients in the second half of 2021.
- In October, announced that the first patient had been dosed in
the Phase 1/2 GRECO-1 trial of GC4711 in combination with SBRT in
patients with central or large peripheral NSCLC tumors. GC4711 is
Galera’s second highly selective small molecule superoxide
dismutase mimetic candidate and is being developed specifically for
use in combination with SBRT. Following a safety run-in cohort, up
to 66 NSCLC patients with locally advanced disease will receive
GC4711 with SBRT or placebo with SBRT over five consecutive
weekdays in a first stage of the randomized, double-blind,
placebo-controlled Phase 2 portion of the GRECO-1 trial. A second
stage is planned to add a checkpoint inhibitor to the SBRT
combination. The GRECO-1 trial is supported in part by a recently
awarded Small Business Innovation Research grant (4R44CA206795-02)
from the National Cancer Institute of the National Institutes of
Health. The Company anticipates reporting topline data from the
first stage of this trial in the first half of 2022.
- In October, hosted a virtual Key Opinion Leader (KOL) event
featuring Sarah Hoffe, M.D., Section Head of GI Radiation Oncology
and Senior Member at Moffitt Cancer Center. Dr. Hoffe provided an
overview of the management of patients with localized pancreatic
cancer, including the current clinical treatment paradigm and the
use of SBRT.
- In September, announced the first patient had been dosed in a
pilot Phase 2 clinical trial of avasopasem to evaluate its ability
to improve 28-day mortality in hospitalized patients who are
critically ill with COVID-19. The Company anticipates reporting
topline data from this trial in the first half of 2021.
- Continued enrollment in multiple clinical trials of avasopasem
for radiation-induced toxicities, including the Phase 3 ROMAN trial
to assess its ability to reduce the incidence and severity of
severe oral mucositis induced by radiotherapy in patients with
locally advanced head and neck cancer (HNC), the Phase 2a EUSOM
multi-center trial in Europe assessing the safety of avasopasem in
patients with HNC undergoing standard-of-care radiotherapy, as well
as the AESOP Phase 2a trial to assess its ability to reduce the
incidence of esophagitis induced by radiotherapy in patients with
lung cancer. The Company remains on track to announce topline data
from the ROMAN trial in the second half of 2021.
Third Quarter 2020
Financial Highlights
- Research and development expenses were $12.1 million in the
third quarter of 2020, compared to $11.0 million for the same
period in 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
trial for the treatment of esophagitis in patients with lung cancer
and the Phase 2a multi-center trial in Europe assessing the safety
of avasopasem in patients with HNC. In addition, employee-related
costs also increased due to increased headcount and share-based
compensation expense. The increases were partially offset by
decreased avasopasem preclinical spend and decreased GC4711
development expenses.
- General and administrative expenses were $3.9 million in the
third quarter of 2020, compared to $1.8 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 $(17.1) million, or $(0.69) per
share, for the third quarter of 2020, compared to a net loss of
$(13.4) million, or $(51.43) per share, for the same period in
2019.
- As of September 30, 2020, Galera had cash, cash equivalents and
short-term investments of $89.2 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.
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), 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
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 clinical 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, 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 Quarterly Report on Form 10-Q
for the quarterly period ended September 30, 2020 filed with the
U.S. Securities and Exchange Commission (SEC), Annual Report on
Form 10-K for the year ended December 31, 2019 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, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
12,133 |
|
|
$ |
11,040 |
|
|
$ |
40,225 |
|
|
$ |
29,057 |
|
General and administrative |
|
3,945 |
|
|
|
1,816 |
|
|
|
11,384 |
|
|
|
5,466 |
|
Loss from
operations |
|
(16,078 |
) |
|
|
(12,856 |
) |
|
|
(51,609 |
) |
|
|
(34,523 |
) |
Other income (expense), net |
|
(1,000 |
) |
|
|
(495 |
) |
|
|
(2,543 |
) |
|
|
(735 |
) |
Net
Loss |
|
(17,078 |
) |
|
|
(13,351 |
) |
|
|
(54,152 |
) |
|
|
(35,258 |
) |
Accretion of redeemable convertible preferred stock to redemption
value |
|
- |
|
|
|
(2,108 |
) |
|
|
- |
|
|
|
(6,178 |
) |
Net loss
attributable to common stockholders |
$ |
(17,078 |
) |
|
$ |
(15,459 |
) |
|
$ |
(54,152 |
) |
|
$ |
(41,436 |
) |
|
|
|
|
|
|
|
|
Net loss per share of common stock, basic and diluted |
$ |
(0.69 |
) |
|
$ |
(51.43 |
) |
|
$ |
(2.18 |
) |
|
$ |
(137.85 |
) |
Weighed average common shares outstanding, basic and diluted |
|
24,874,805 |
|
|
|
300,597 |
|
|
|
24,840,822 |
|
|
|
300,597 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Galera
Therapeutics, Inc. |
Selected
Consolidated Balance Sheet Data |
(unaudited,
in thousands) |
|
|
|
|
|
September
30, |
|
December
31, |
|
2020 |
|
2019 |
|
|
|
|
Cash, cash equivalents, and short-term investments |
$ |
89,151 |
|
$ |
112,290 |
Total
assets |
|
98,075 |
|
|
123,376 |
Total
current liabilities |
|
10,503 |
|
|
9,694 |
Total
liabilities |
|
73,380 |
|
|
53,768 |
Total
stockholders' equity |
|
24,695 |
|
|
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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