FDA Rejection Leaves Galera Devastated, Forced to Lay Off 70% of Employees

The FDA dealt a crushing blow to Galera Therapeutics Wednesday, rejecting its proposed treatment for radiotherapy-induced severe oral mucositis in patients with head and neck cancer. In the aftermath, Galera shares tanked an incredible 83% in after-hours trading.

The FDA declined to approve Galera’s avasopasem treatment for severe oral mucositis in patients with head and neck cancer, citing an inadequate amount of evidence in support of the drug’s effectiveness and safety. The regulator requested that the company provide results from an additional trial before they consider a resubmission of their application.

With compelling data from the Phase III ROMAN and Phase IIb GT-201 studies, Galera’s candidate avasopasem manganese demonstrated a significant reduction in radiotherapy-induced severe oral mucositis. Topline data from ROMAN were especially promising, providing strong evidence for the drug’s effectiveness against SOM burden.

In a statement, Mel Sorensen, CEO of Galera, expressed deep disappointment upon the FDA’s decision, yet vowed to request a Type A meeting with the agency to better understand the rejection and explore the prospective next steps for its candidate.

Manganese, like a superhero, is here to save the day! It utilizes its incredible powers of selective dismutase along with its ability to convert superoxide into hydrogen peroxide, to protect healthy cells from radiation whilst simultaneously sensitizing cancer cells. This amazing superhero-like power can bring hope to head and neck cancer patients suffering from radiation-related SOM, as it is presently the only therapeutic option available.

On Wednesday, Avasopasem Manganese announced a dramatic restructuring plan that will affect nearly 70% of its workforce. As a part of this plan, the company will cease its commercial readiness efforts and shift its focus towards unlocking a path forward. In order to make this possible, Avasopasem Manganese must first ensure its cash runway is secure enough to continue operations without interruption.

Galera is taking a bold step forward to optimize the potential success of avasopasem manganese and focus its resources on the clinical trials of the second candidate rucosopasem. This promising candidate is being developed to enhance the anti-cancer effects of stereotactic body radiation therapy for two of the most fatal types of cancer –non-small cell lung cancer and advanced pancreatic cancer. Let’s join forces and foster this initiative to bring a brighter future to those affected by cancer.

As of June 30th, Galera’s total cash, cash equivalents, and marketable securities have been estimated to be roughly $38.8 million, ensuring a financial lifeline through the second quarter of 2024.

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