Galera Therapeutics Reports Second Quarter 2020 Financial Results and Provides Business Updates
August 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 second quarter ended June 30, 2020, and
provided business updates.
“During the second quarter, we continued to advance the
development of our small molecule superoxide dismutase mimetics in
clinical trials evaluating their ability to address radiation
toxicities and augment the anti-cancer efficacy of radiation,” said
Mel Sorensen, M.D., President and CEO of Galera. “We were pleased
to announce the completion of enrollment in our randomized,
blinded, placebo-controlled, adaptive Phase 1b/2a trial of
avasopasem manganese (GC4419) in combination with stereotactic body
radiation therapy (SBRT) for patients with locally advanced
pancreatic cancer (LAPC). We expect to report topline data from
that trial as well as initiate a Phase 1b/2a trial of GC4711 with
SBRT in non-small cell lung cancer in the second half of this year.
We also remain on track to complete enrollment of the Phase 3 ROMAN
trial of avasopasem in the first half of next year and to report
topline data from the ROMAN trial in the second half of 2021.”
Second Quarter 2020 and Recent Corporate
Highlights
- In July, announced the completion of patient enrollment in the
randomized, blinded, placebo-controlled, adaptive Phase 1b/2a
clinical trial of avasopasem in combination with SBRT in patients
with LAPC. Topline data from this trial are expected in the second
half of this year.
- In June, dosed the first patient in a Phase 2a multi-center
trial in Europe assessing the safety of avasopasem in patients with
head and neck cancer (HNC) undergoing standard-of-care
radiotherapy.
- Continued enrollment in the Phase 2a clinical trial of
avasopasem to evaluate its ability to reduce the incidence of
radiation-induced esophagitis in patients with lung
cancer.
- In May, presented new data at the American Society of Clinical
Oncology (ASCO) 2020 Virtual Scientific Program, which demonstrated
statistically significant reductions by avasopasem on markers of
chronic kidney disease due to concurrent cisplatin chemoradiation
in a retrospective analysis of the completed Phase 2b trial for the
reduction of severe oral mucositis in patients with HNC. As a
result, the assessment of these markers has been incorporated into
the ROMAN Phase 3 trial.
- In May, entered into an amendment to the royalty purchase
agreement with Blackstone Life Sciences (Blackstone), which adds
$37.5 million in additional funding to the existing $80 million
royalty financing commitment that Blackstone (formerly Clarus
Ventures) made in 2018. Under the updated agreement terms, Galera
agreed to pay Blackstone up to a high single-digit percentage of
future commercial royalties from the sales of avasopasem and GC4711
until the total royalty amount achieves an unchanged fixed
single-digit multiple of the aggregate financing sum received, upon
which the royalty terminates. As partial consideration for the
amendment, Galera issued two warrants to Blackstone to purchase an
aggregate of 550,661 shares of its common stock at an exercise
price of $13.62 per share, each of which will become exercisable
upon the receipt by Galera of the applicable specified milestone
payment.
- In April, announced the appointment of Linda B. West to its
Board of Directors. Ms. West most recently served as Vice President
for DuPont Corporate Planning & Analyses, where she led the
execution of transformational transactions.
Second Quarter 2020 Financial
Highlights
- Research and development expenses were $13.8 million in the
second quarter of 2020, compared to $9.5 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, and costs associated with
manufacturing scale-up activities. Employee-related costs also
increased due to increased headcount and share-based compensation
expense.
- General and administrative expenses were $3.9 million in the
second 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 $(18.7) million, or $(0.75) per
share, for the second quarter of 2020, compared to a net loss of
$(11.6) million, or $(45.30) per share, for the same period in
2019.
- As of June 30, 2020, Galera had cash, cash equivalents and
short-term investments of $104.4 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 for 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 a Phase 2a
multi-center trial in Europe assessing the safety of avasopasem in
patients with HNC undergoing standard-of-care radiotherapy, a Phase
2a trial for its ability to reduce the incidence of esophagitis
induced by radiotherapy in patients with lung cancer and in a
randomized Phase 1/2 trial in combination with stereotactic body
radiation therapy (SBRT) in patients with locally advanced
pancreatic cancer. The FDA granted Fast Track and Breakthrough
Therapy designations to avasopasem for the reduction of SOM induced
by radiotherapy. Galera is developing a second product candidate,
GC4711, specifically for use in combination with SBRT, which
successfully completed Phase 1 trials in healthy volunteers. 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, 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 June
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.
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Galera Therapeutics, Inc. |
Consolidated Statements of Operations |
(unaudited, in thousands except share and per share
data) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
13,839 |
|
|
$ |
9,515 |
|
|
$ |
28,092 |
|
|
$ |
18,017 |
|
General and administrative |
|
|
3,874 |
|
|
|
1,756 |
|
|
|
7,439 |
|
|
|
3,650 |
|
Loss from operations |
|
|
(17,713 |
) |
|
|
(11,271 |
) |
|
|
(35,531 |
) |
|
|
(21,667 |
) |
Other income (expense), net |
|
|
(944 |
) |
|
|
(287 |
) |
|
|
(1,543 |
) |
|
|
(240 |
) |
Net Loss |
|
|
(18,657 |
) |
|
|
(11,558 |
) |
|
|
(37,074 |
) |
|
|
(21,907 |
) |
Accretion of redeemable convertible preferred stock to redemption
value |
|
|
- |
|
|
|
(2,060 |
) |
|
|
- |
|
|
|
(4,071 |
) |
Net loss attributable to common stockholders |
|
$ |
(18,657 |
) |
|
$ |
(13,618 |
) |
|
$ |
(37,074 |
) |
|
$ |
(25,978 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share of common stock, basic and diluted |
|
$ |
(0.75 |
) |
|
$ |
(45.30 |
) |
|
$ |
(1.49 |
) |
|
$ |
(86.42 |
) |
Weighed average common shares outstanding, basic and diluted |
|
|
24,832,264 |
|
|
|
300,597 |
|
|
|
24,823,644 |
|
|
|
300,597 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Galera Therapeutics, Inc. |
Selected Consolidated Balance Sheet Data |
(unaudited, in thousands) |
|
|
|
|
|
June 30, |
|
December 31, |
|
2020 |
|
2019 |
|
|
|
|
Cash, cash equivalents, and short-term investments |
$ |
104,409 |
|
$ |
112,290 |
Total assets |
|
114,295 |
|
|
123,376 |
Total current liabilities |
|
12,402 |
|
|
9,694 |
Total liabilities |
|
74,058 |
|
|
53,768 |
Total stockholders' equity |
|
40,237 |
|
|
69,608 |
|
|
|
|
|
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Investor Contacts:Christopher DegnanGalera
Therapeutics, Inc.610-725-1500cdegnan@galeratx.com
Jennifer PorcelliSolebury
Trout646-378-2962jporcelli@soleburytrout.com
Media Contact:Gina Cestari6
Degrees917-797-7904gcestari@6degreespr.com
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