Full Press Release Details
Galera Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results and Recent
- Expanded Lead Product Candidate Avasopasem Manganese into Second Radiation Toxicity Indication -
- Presented Data Demonstrating Avasopasem Manganese Maintained Anti-Cancer
Benefit of Chemoradiotherapy for Head and Neck Cancer While Substantially Reducing
Radiation-Induced Severe Oral Mucositis at 2020 Multidisciplinary Head and Neck Cancers Symposium -
MALVERN, Pennsylvania, March 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 fourth quarter and year ended December 31, 2019, and
highlighted recent corporate accomplishments.
Galera capped off a strong 2019 with the closing of an IPO for total gross proceeds of approximately
$65 million, which positions us for growth and the continued advancement of our pipeline in 2020, said Mel Sorensen, M.D., President and CEO of Galera. We kicked off 2020 by taking a critical step toward broadening our understanding
of the breadth of our lead candidate avasopasem manganese s (GC4419) utility in addressing radiation toxicities with the initiation of a Phase 2a trial in a second radiation toxicity, esophagitis, in patients with lung cancer. We also presented
data showing that avasopasem manganese maintained tumor outcomes, and remain on track to read out data from our ongoing pilot Phase 1b/2a safety and anti-cancer trial in patients with locally advanced pancreatic cancer in the second half of this
year. The Phase 3 ROMAN trial continues to progress, and we look forward to reporting topline data in the first half of next year.
Corporate Highlights
Fourth Quarter 2019 Financial Highlights
Full Year 2019 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), a highly selective small molecule superoxide dismutase (SOD) mimetic initially being
developed for the reduction of radiation-induced severe oral mucositis (SOM). Avasopasem manganese is being studied in the Phase 3 ROMAN trial for its ability to reduce the incidence and severity of SOM induced by radiotherapy in patients with
locally advanced head and neck cancer, its lead indication, and in the Phase 2a trial for its ability to reduce the incidence of esophagitis induced by radiotherapy in patients with lung cancer. The FDA granted Fast Track and Breakthrough Therapy
designations to avasopasem manganese for the reduction of SOM induced by radiotherapy. Galera is developing a second product candidate, GC4711, which successfully completed a Phase 1 trial in healthy volunteers. 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, efficacy, and regulatory and clinical development of Galera s product candidates, plans and timing for the release of data from Galera s clinical trials, 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; 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, 2019, 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, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 13,276 | $ | 7,112 | $ | 42,333 | $ | 18,663 | ||||||||
| General and administrative | 2,892 | 1,746 | 8,358 | 5,592 | ||||||||||||
| Loss from operations | (16,168 | ) | (8,858 | ) | (50,691 | ) | (24,255 | ) | ||||||||
| Other income (expense) | (513 | ) | 213 | (1,248 | ) | 356 | ||||||||||
| Loss before income tax benefit | (16,681 | ) | (8,645 | ) | (51,939 | ) | (23,899 | ) | ||||||||
| Income tax benefit | 9 | 82 | 9 | 223 | ||||||||||||
| Net loss | (16,672 | ) | (8,563 | ) | (51,930 | ) | (23,676 | ) | ||||||||
| Accretion of redeemable convertible preferred stock to redemption value | (998 | ) | (2,031 | ) | (7,176 | ) | (5,910 | ) | ||||||||
| Net loss attributable to common stockholders | $ | (17,670 | ) | $ | (10,594 | ) | $ | (59,106 | ) | $ | (29,586 | ) | ||||
| Net loss per share of common stock, basic and diluted | $ | (1.31 | ) | $ | (35.24 | ) | $ | (16.31 | ) | $ | (98.42 | ) | ||||
| Weighed average common shares outstanding, basis and diluted | 13,489,826 | 300,597 | 3,625,005 | 300,597 |
Galera Therapeutics, Inc.
Selected Consolidated Balance Sheet Data
| December 31, | ||||||||
| 2019 | 2018 | |||||||
| Cash, cash equivalents, and short-term investments | $ | 112,290 | $ | 81,517 | ||||
| Total assets | 123,376 | 88,056 | ||||||
| Total current liabilities | 9,694 | 6,444 | ||||||
| Total liabilities | 53,768 | 26,974 | ||||||
| Redeemable convertible preferred stock | 165,902 | |||||||
| Total stockholders equity (deficit) | 69,608 | (104,820 | ) |
Galera Therapeutics, Inc.