Full Press Release Details
Galera Therapeutics Reports Third Quarter 2020 Financial Results and Provides Business Updates
Presented Promising Interim Data from Placebo-controlled Pilot Dismutase Mimetic SBRT Combination Trial for Pancreatic Cancer
Announced Planned Phase 2b GC4711 SBRT Combination Trial for Pancreatic Cancer (GRECO-2)
Initiated Randomized Phase 1/2 GC4711 SBRT Combination Trial for NSCLC (GRECO-1)
Remain on Track with Ongoing Phase 3 ROMAN Trial and Other Radiation-Induced Toxicity Trials of Avasopasem
MALVERN, Pennsylvania, November 10, 2020 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
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
Third Quarter 2020 Financial Highlights
About Galera Therapeutics
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, 2020 | December 31, 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 |
Galera Therapeutics, Inc.