Full Press Release Details
Galera Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Recent
Pivotal Phase 3 ROMAN Trial in Severe Oral Mucositis on Track for Completion of Enrollment in 1H21; Topline Data
Anticipate Final Data Readout from Locally Advanced Pancreatic Cancer (LAPC) Pilot Trial in 2H21
On Track for Initiation of Phase 2b GRECO-2 Trial of GC4711 in Combination with Stereotactic Body
Radiation Therapy (SBRT) for LAPC in 1H21
MALVERN, Pa. March 11, 2021 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.
Severe Oral Mucositis (SOM)
Locally Advanced Pancreatic Cancer (LAPC)
Non-Small Cell Lung Cancer (NSCLC)
Fourth Quarter 2020 Financial Highlights
Full Year 2020 Financial Highlights
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
| 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 |
Galera Therapeutics, Inc.