MALVERN, Pa., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing 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, 2023 and provided recent corporate updates.
"Given the considerable time and investment required for additional clinical trials, we find it prudent to explore strategic options," said Mel Sorensen, M.D., Galera’s President and CEO. “We also made the difficult decision to discontinue our GRECO trials, which we believe is an appropriate step towards cash conservation and maximizing value for our shareholders. We extend our gratitude to all the patients, research teams, and dedicated employees who have contributed to the advances we have made.”
Recent Corporate Updates
Radiotherapy-Induced Severe Oral Mucositis (SOM)
Cisplatin-Related Chronic Kidney Disease (CKD)
Locally Advanced Pancreatic Cancer (LAPC)
Non-Small Cell Lung Cancer (NSCLC)
General Corporate Updates
Third Quarter 2023 Financial Highlights
About Galera Therapeutics
Galera Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing a pipeline of novel, proprietary therapeutic candidates that have the potential to transform radiotherapy in cancer. Galera’s selective dismutase mimetic product candidate avasopasem manganese (avasopasem) is being developed for radiation-induced and cisplatin-related toxicities. The FDA has granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of severe oral mucositis induced by radiotherapy. The Company’s second product candidate, rucosopasem manganese (rucosopasem), is in clinical-stage development to augment the anti-cancer efficacy of stereotactic body radiation therapy in patients with non-small cell lung cancer and locally advanced pancreatic cancer. Rucosopasem has been granted orphan drug designation and orphan medicinal product designation by the FDA and EMA, respectively, for the treatment of pancreatic cancer. Galera is headquartered in Malvern, PA.
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: the expectations surrounding the continued advancement of Galera’s product pipeline; the potential safety and efficacy of Galera’s product candidates and their regulatory and clinical development; Galera’s intention to pursue strategic alternatives and the ability of any such strategic alternative to provide shareholder value; the expected financial and operational impacts of Galera’s decision to discontinue the Phase 2b GRECO-2 trial and the Phase 1/2 GRECO-1 trial; Galera’s ability to fund its operating expenses and capital expenditure requirements into 2025; and Galera’s ability to achieve its goal of transforming radiotherapy in cancer treatment with its selective dismutase mimetics. 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 or maintain 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; 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; environmental, health and safety laws and regulations; Galera’s recent reduction in force undertaken to significantly reduce our ongoing operating expenses may not result in our intended outcomes and may yield unintended consequences and additional costs; Galera may not be able to enter into any desired strategic alternative or partnership on a timely basis, on acceptable terms, or at all; if Galera is unable to secure additional funding or enter into any desired strategic alternative or partnership, it may need to cease operations; risks related to ownership of Galera’s common stock; the possibility of Galera’s common stock being delisted from The Nasdaq Global Market; 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, 2022 and Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2023 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 | |||||||||||||||||||
(unaudited, in thousands except share and per share data) | |||||||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||||||
Operating expenses: | |||||||||||||||||||
Research and development | $ | 6,093 | $ | 8,105 | $ | 20,926 | $ | 22,848 | |||||||||||
General and administrative | 4,994 | 4,853 | 20,849 | 15,193 | |||||||||||||||
Restructuring costs | 2,309 | - | 2,309 | - | |||||||||||||||
Loss from operations | (13,396 | ) | (12,958 | ) | (44,084 | ) | (38,041 | ) | |||||||||||
Other income (expense), net | (1,677 | ) | (3,075 | ) | (9,411 | ) | (7,993 | ) | |||||||||||
Net loss | $ | (15,073 | ) | $ | (16,033 | ) | $ | (53,495 | ) | $ | (46,034 | ) | |||||||
Net loss per share of common stock, basic and diluted | $ | (0.33 | ) | $ | (0.60 | ) | $ | (1.30 | ) | $ | (1.72 | ) | |||||||
Weighted average common shares outstanding, basic and diluted | 45,477,952 | 26,823,546 | 41,234,679 | 26,798,348 | |||||||||||||||
Galera Therapeutics, Inc. | |||||||||||
Selected Consolidated Balance Sheet Data | |||||||||||
(unaudited, in thousands) | |||||||||||
September 30, | December 31, | ||||||||||
2023 | 2022 | ||||||||||
Cash, cash equivalents, and short-term investments | $ | 28,364 | $ | 31,597 | |||||||
Total assets | 37,779 | 44,036 | |||||||||
Total current liabilities | 12,630 | 13,379 | |||||||||
Total liabilities | 164,332 | 153,217 | |||||||||
Total stockholders' deficit | (126,553 | ) | (109,181 | ) |
Investor Contacts:
Christopher Degnan
Galera Therapeutics, Inc.
610-725-1500
This email address is being protected from spambots. You need JavaScript enabled to view it.
William Windham
Solebury Strategic Communications
646-378-2946
This email address is being protected from spambots. You need JavaScript enabled to view it.
Media Contact:
Timothy Biba
Solebury Strategic Communications
646-378-2927
This email address is being protected from spambots. You need JavaScript enabled to view it.
Last Trade: | US$0.04 |
Daily Change: | -0.10 -71.38 |
Daily Volume: | 10,697 |
Market Cap: | US$2.260M |
May 13, 2024 March 28, 2024 October 31, 2023 September 18, 2023 August 14, 2023 |
C4 Therapeutics is pioneering a new class of small-molecule drugs that selectively destroy disease-causing proteins via degradation using the innate machinery of the cell. This targeted protein degradation approach offers advantages over traditional drugs, including the potential to treat a wider range of diseases...
CLICK TO LEARN MOREChimerix is on a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The company is devoted to filling gaps in the treatment paradigm. Chimerix’s most advanced clinical-stage program is in development for H3 K27M-mutant glioma....
CLICK TO LEARN MOREEnd of content
No more pages to load
COPYRIGHT ©2023 HEALTH STOCKS HUB