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Galera Reports Second Quarter 2023 Financial Results and Recent Corporate Updates Company received Complete Response Letter from FDA for avasopasem and intends to request Type A meeting with FDA to discuss potential next

Key Takeaway: Galera Reports Second Quarter 2023 Financial Results and Recent Corporate Updates Company received Complete Response Letter from FDA for avasopasem and intends to request Type A meeting with FDA to discuss potential next Cash runway extended into Q2 2024 in connection with redu

Full Press Release Details

Galera Reports Second Quarter 2023 Financial Results and Recent Corporate Updates
Company received Complete Response Letter from FDA for avasopasem and intends to request Type A meeting with FDA to discuss potential next
Cash runway extended into Q2 2024 in connection with reduction in workforce
FDA granted orphan drug designation to rucosopasem for the treatment of pancreatic cancer
Enrollment in GRECO trials with rucosopasem remains ongoing
MALVERN, Pa. August 14, 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 second quarter ended June 30, 2023, and provided
recent corporate updates.
Following the FDA s decision on the avasopasem NDA, we have taken decisive steps to extend our cash runway as we
seek a Type A meeting with the FDA to discuss the potential path forward for approval, said Mel Sorensen, M.D., Galera s President and CEO. In parallel, enrollment continues in the ongoing GRECO trials of rucosopasem, our
anti-cancer candidate, as we investigate the novel compound s potential to enhance stereotactic body (high daily dose) radiotherapy and extend the lives of patients with deadly cancers.
Radiotherapy-Induced Severe Oral Mucositis (SOM)
Cisplatin-Related Chronic Kidney Disease
Locally Advanced Pancreatic Cancer (LAPC)
Non-Small Cell Lung Cancer (NSCLC)
General Corporate Updates
Second 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) is being developed for radiation-induced 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 was granted Orphan Drug Designation by the FDA 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; the Company s intention to request and hold a Type A meeting with the FDA in order to understand the FDA s
rationale for its decision and discuss next steps to support an NDA resubmission seeking approval of avasopasem; the Company s ability to resubmit the NDA; the Company s plans to take actions, and the potential for those actions, to extend
its cash runway; the Company s intention to pursue strategic alternatives; 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 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 expected financial and
operational impacts of Galera s recent reduction in force; Galera s ability to fund its operating expenses and capital expenditures into the second quarter of 2024; 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; 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; 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; 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; 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 June 30, Six Months Ended June 30,
2023 2022 2023 2022
Operating expenses:
Research and development $ 7,561 $ 6,636 $ 14,833 $ 14,743
General and administrative 9,246 5,293 15,855 10,340
Loss from operations (16,807 ) (11,929 ) (30,688 ) (25,083 )
Other income (expense), net (3,905 ) (2,629 ) (7,734 ) (4,918 )
Net loss $ (20,712 ) $ (14,558 ) $ (38,422 ) $ (30,001 )
Net loss per share of common stock, basic and diluted $ (0.48 ) $ (0.54 ) $ (0.98 ) $ (1.12 )
Weighted average common shares outstanding, basic and diluted 42,916,962 26,821,303 39,077,876 26,785,540
Galera Therapeutics, Inc.
Selected Consolidated Balance Sheet Data
(unaudited, in thousands)
June 30, 2023 December 31, 2022
Cash, cash equivalents, and short-term investments $ 38,755 $ 31,597
Total assets 48,276 44,036
Total current liabilities 13,622 13,379
Total liabilities 163,275 153,217
Total stockholders deficit (114,999 ) (109,181 )
Galera Therapeutics, Inc.
Solebury Strategic Communications
Solebury Strategic Communications
Last updated: Aug 14, 2023