Full Press Release Details
Galera Reports First Quarter 2023 Financial Results and Recent Corporate
granted FDA priority review for radiotherapy-induced severe oral mucositis (SOM);
PDUFA target date of August 9, 2023
Company raised $30 million in gross proceeds from registered direct offering
Company expanded commercial team and appointed leading biopharmaceutical executives with decades
of experience successfully launching and commercializing new oncology products
MALVERN, Pa. May 11, 2023 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 first quarter ended March 31, 2023, and provided recent
Galera has made tremendous progress since the start of the year, securing Priority Review designation for our avasopasem NDA,
raising $30 million in a registered direct offering, and expanding our commercial leadership team, said Mel Sorensen, M.D., Galera s President and CEO. In February, the FDA granted priority review and assigned a PDUFA date of
August 9, 2023, to the NDA for avasopasem for the reduction of radiotherapy-induced severe oral mucositis in patients with head and neck cancer. In preparation for the potential U.S. commercial launch of avasopasem in 2023, we built out our
commercial leadership team, appointing leading life sciences executives with demonstrated success launching and commercializing market-leading oncology therapies. We look forward to bringing avasopasem to market as potentially the first FDA approved
drug for radiotherapy-induced SOM in patients with head and neck cancer.
Recent Corporate Updates
Radiotherapy-Induced Toxicity Programs:
Oral Mucositis (SOM)
Anti-Cancer Programs:
Locally Advanced Pancreatic Cancer (LAPC)
Non-Small Cell Lung Cancer (NSCLC)
General Corporate Updates
First Quarter 2023 Financial Highlights
About Galera Therapeutics
Galera Therapeutics, Inc. is a
clinical-stage biopharmaceutical company focused on developing and commercializing 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, or GC4419) is being developed for radiation-induced toxicities. A New Drug Application (NDA) for avasopasem is currently under priority review by the U.S. Food and Drug Administration (FDA) with a
Prescription Drug User Fee (PDUFA) target date of August 9, 2023, for radiotherapy-induced severe oral mucositis in patients with head and neck cancer undergoing
standard-of-care treatment. The Company s second product candidate, rucosopasem manganese (rucosopasem, or GC4711), 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. 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; the potential to obtain approval by the U.S. Food and Drug Administration for avasopasem for the treatment of
radiotherapy-induced severe oral mucositis (SOM) in patients with locally advanced head and neck cancer at any time, including the anticipated PDUFA target date of August 9, 2023; the potential for avasopasem to be the first FDA-approved drug to reduce SOM in head and neck cancer patients undergoing standard-of-care treatment; the ability of the Company to
successfully launch and commercialize avasopasem, if approved, and the timing thereof; the Company s intention to pursue a strategy for avasopasem, if approved for the reduction of SOM, to support the use of avasopasem to reduce
radiotherapy-induced esophagitis in patients with lung cancer as a medically accepted indication in published drug compendia; the ability of avasopasem to reduce radiotherapy-induced esophagitis; the expectations surrounding the progress of the
randomized, placebo-controlled Phase 2b GRECO-2 trial of rucosopasem in combination with stereotactic body radiation therapy (SBRT) in patients with LAPC, including the Company s plans to expand target
enrollment, and the timing of completion of enrollment of the trial and topline data readout therefrom; the expectations surrounding the randomized, placebo-controlled Phase 2 stage of the GRECO-1 trial of
rucosopasem in combination with SBRT in patients with NSCLC and the timing of completion of enrollment of the trial and topline data readout therefrom; the Company s ability to fund its operating expenses and capital expenditures into the
fourth quarter of 2023; and the Company 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; substantial
doubt regarding Galera s ability to continue as a going concern; 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 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, 2022 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 March 31, | ||||||||
| 2023 | 2022 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 7,272 | $ | 8,107 | ||||
| General and administrative | 6,609 | 5,047 | ||||||
| Loss from operations | (13,881 | ) | (13,154 | ) | ||||
| Other income (expense), net | (3,829 | ) | (2,289 | ) | ||||
| Net loss | $ | (17,710 | ) | $ | (15,443 | ) | ||
| Net loss per share of common stock, basic and diluted | $ | (0.50 | ) | $ | (0.58 | ) | ||
| Weighed average common shares outstanding, basic and diluted | 35,196,134 | 26,749,379 |
Galera Therapeutics, Inc.
Selected Consolidated Balance Sheet Data
(unaudited, in thousands)
| March 31, 2023 | December 31, 2022 | |||||||
| Cash, cash equivalents, and short-term investments | $ | 47,751 | $ | 31,597 | ||||
| Total assets | 59,714 | 44,036 | ||||||
| Total current liabilities | 13,266 | 13,379 | ||||||
| Total liabilities | 157,327 | 153,217 | ||||||
| Total stockholders deficit | (97,613 | ) | (109,181 | ) |
Galera Therapeutics, Inc.
Solebury Strategic Communications
Solebury Strategic Communications