| Mentioned: | GRTX |
EQNX::TICKER_START (NasdaqGM:GRTX), EQNX::TICKER_END 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 the appointment of Eugene P. Kennedy, M.D., F.A.C.S., as Chief Medical Officer (CMO). Dr. Kennedy is a renowned Johns Hopkins-trained surgical oncologist and former Chief of Pancreatic and Hepatobiliary Surgery at Thomas Jefferson University with over 15 years' experience in clinical development and biopharma leadership. He will succeed Jon T. Holmlund, M.D., who will retire at the end of this year. In the interim, Dr. Kennedy and Dr. Holmlund will work together closely to ensure a smooth and successful transition, with particular focus on the preparation for the Company's submission of an NDA to the U.S. FDA for avasopasem by the end of 2022.
"We are thrilled to welcome Gene to Galera and are immeasurably grateful to Jon for his invaluable leadership and service over the last 10 years," said Mel Sorensen, M.D., Galera's President and CEO. "We believe Gene's extensive clinical trial development, regulatory strategy and oncological medical experience will be instrumental in supporting our team's plan to finalize our NDA submission package for avasopasem by year-end. In addition, as we continue advancing our anti-cancer programs in the clinic, Gene's proven leadership managing various aspects of a biopharma business and his oncology expertise, including in pancreatic cancer, will help Galera build upon and execute our long-term clinical strategy."
"I am honored to join Galera during this pivotal time in the Company's history, and I look forward to working with, and gaining insight from, Jon in the coming months," said Eugene P. Kennedy, M.D., F.A.C.S., Galera's Chief Medical Officer. "I am also eager to collaborate with the entire Galera management team to drive forward our ongoing anti-cancer clinical trials, aim to commercialize avasopasem and lead innovation in the field of radiotherapy treatment for patients with cancer."
Before joining Galera, Dr. Kennedy served as Chief Medical Officer at Innovative Cellular Therapeutics, where he was an integral part of developing the Phase 1 clinical protocol and filing a first-in-human IND for a solid tumor CAR T-cell therapy. Previously, he served as Chief Medical Officer at Lumos Pharma, where he was responsible for clinical development strategy and execution, as well as investor and patient outreach. Prior to Lumos, Dr. Kennedy served as Chief Medical Officer at NewLink Genetics, where he oversaw clinical trials across multiple product candidates and indications. Prior to joining NewLink Genetics, he served as Associate Professor of Surgery at Thomas Jefferson University and held leadership positions as Chief of the Section of Pancreatic and Hepatobiliary Surgery and Co-Director of the Jefferson Pancreas, Biliary, and Related Cancers Center. Dr. Kennedy also has practiced, taught, and held leadership roles at the Johns Hopkins Hospital and Louisiana State University and has authored over 50 peer-reviewed publications. Dr. Kennedy received a bachelor's degree from the University of Virginia and an M.D. from the Medical College of Virginia.
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 (GC4419, also referred to as avasopasem) is being evaluated for radiotherapy-induced toxicities. The Company's second product candidate, rucosopasem manganese (GC4711, also referred to as 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. 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: the impact of Dr. Eugene Kennedy's experience in supporting the Company's plan to finalize its NDA submission package for avasopasem by year-end; 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 timing of the submission of an NDA for avasopasem for the treatment of radiotherapy-induced SOM in patients with locally advanced head and neck cancer with the FDA; 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; 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; 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, 2021 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.
Investor Contacts:
Christopher Degnan
Galera Therapeutics, Inc.
610-725-1500
cdegnan@galeratx.com
William Windham
Solebury Strategic Communications
646-378-2946
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