Full Press Release Details
Galera Therapeutics Reports Third Quarter 2019 Financial Results and Provides Business Update
- Completed Initial Public Offering of Common Stock That Raised Approximately $58 Million in Net Proceeds -
- Progressed Pivotal Clinical Trial of GC4419 in Head & Neck Cancer with Topline Data Expected in 1H 2021 -
MALVERN, Penn., December 10, 2019 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, 2019, and
highlighted recent corporate accomplishments.
2019 has been a momentous year for Galera, culminating in the closing of our IPO last month,
said Mel Sorensen, M.D., President and CEO of Galera. We look forward to continuing to advance our clinical development of GC4419 and GC4711, which we believe could change the management of radiation therapy by both protecting normal tissue
and improving the effectiveness of radiation.
Third Quarter 2019 and Recent Corporate Highlights
Third Quarter Financial Highlights
About Galera Therapeutics
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 GC4419 (avasopasem
manganese), a potent and highly selective small molecule dismutase mimetic being developed for the reduction of severe oral mucositis (SOM). GC4419 is being studied in the Phase 3 ROMAN trial for its ability to reduce the incidence, severity and
duration of SOM in patients with locally advanced head and neck cancer, its lead indication. The FDA granted Fast Track and Breakthrough Therapy designations to GC4419 for the reduction of the duration, incidence and severity of SOM induced by
radiotherapy. 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 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 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 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
(unaudited, in thousands except share and per share data)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 11,040 | $ | 4,162 | $ | 29,057 | $ | 11,551 | ||||||||
| General and administrative | 1,816 | 1,245 | 5,466 | 3,846 | ||||||||||||
| Loss from operations | (12,856 | ) | (5,407 | ) | (34,523 | ) | (15,397 | ) | ||||||||
| Other income (expense) | (495 | ) | 106 | (735 | ) | 143 | ||||||||||
| Loss before income tax benefit | (13,351 | ) | (5,301 | ) | (35,258 | ) | (15,254 | ) | ||||||||
| Income tax benefit | 52 | 141 | ||||||||||||||
| Net loss | (13,351 | ) | (5,249 | ) | (35,258 | ) | (15,113 | ) | ||||||||
| Accretion of redeemable convertible preferred stock to redemption value | (2,108 | ) | (1,468 | ) | (6,178 | ) | (3,879 | ) | ||||||||
| Net loss attributable to common stockholders | $ | (15,459 | ) | $ | (6,717 | ) | $ | (41,436 | ) | $ | (18,992 | ) | ||||
| Net loss per share of common stock, basic and diluted | $ | (51.43 | ) | $ | (22.35 | ) | $ | (137.85 | ) | $ | (63.18 | ) | ||||
| Weighed average common shares outstanding, basis and diluted | 300,597 | 300,597 | 300,597 | 300,597 |
Galera Therapeutics, Inc.
Selected Consolidated Balance Sheet Data
(unaudited, in thousands)
| September 30, 2019 | December 31, 2018 | |||||||
| Cash, cash equivalents, and short-term investments | $ | 67,945 | $ | 81,517 | ||||
| Total assets | 79,758 | 88,056 | ||||||
| Total current liabilities | 9,083 | 6,444 | ||||||
| Total liabilities | 52,298 | 26,974 | ||||||
| Redeemable convertible preferred stock | 172,080 | 165,902 | ||||||
| Total stockholders deficit | (144,620 | ) | (104,820 | ) |
Galera Therapeutics, Inc.