The news about the CRL and lay-offs led to a freefall of Galera’s stock. Image Credit: ArtemisDiana / Shutterstock.

Galera Therapeutics is winding down operations by reducing its workforce by 70% as a cash-reduction measure.

This is due to the US Food and Drug Administration (FDA) issuing a complete response letter (CRL) for avasopasem manganese (avasopasem) for treating radiotherapy-induced severe oral mucositis. In the CRL, the FDA asked for additional safety and efficacy data before Galera files for resubmission.

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The news about the CRL and lay-offs led to a freefall of Galera’s stock. The company’s share price reduced by over 80% in pre-market trading on 10 August, compared to market close on the previous day. Galera’s current market cap is at $96.1m.

Avasopasem is an enzyme mimetic that converts superoxide-free radical molecules to hydrogen peroxide and oxygen, thereby reducing the intensity and duration of severe oral mucositis.

Galera had submitted data from its placebo-controlled Phase III ROMAN trial (NCT03689712) evaluating the efficacy and safety of avasopasem prior to radiation therapy for reducing the severity of radiation-induced oral mucositis in patients with non-metastatic squamous cell carcinoma of the head and neck. Additional data from the placebo-controlled Phase II trial (NCT02508389) was also included in the application.

The company said it plans to request a Type A meeting with the US FDA to gain further insight into the CRL and discuss resubmission for the approval of avasopasem. Additionally, the company is exploring partnerships and licensing agreements for both avasopasem and its other lead drug candidate rucosopasem.

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Galera’s CEO Mel Sorensen stated that the company plans to shift its focus to the Phase IIb placebo-controlled trial (NCT04698915) for rucosopasem in the treatment of locally advanced pancreatic cancer.

The company’s reported cash reserves total $38.8m, as of 30 June. These reserves are expected to fund operations till Q2 2024.