Gamida inks restructuring deal to support off-the-shelf cell therapy

In April 2023, the US Food and Drug Administration (FDA) approved Omisirge, an allogeneic cell therapy for patients with blood cancers who are set to undergo stem cell transplantation.

The news was long awaited for developer Gamida Cell, which twice underwent cost-cutting measures (in January 2022 and March 2023) as the FDA twice delayed the approval process. But nearly a year on, continuous financial struggles have led to Gamida entering into a Restructuring Support Agreement (RSA) with certain funds managed by Highbridge Capital Management.

Under terms of the RSA, Highbridge will convert $75 million of its existing unsecured convertible senior note into equity in the company to support the commercialization of Omisirge.

“The transaction allows Gamida Cell to continue as a going concern and to focus on commercializing Omisirge, as we develop and deepen our relationships with transplant center partners to increase access to Omisirge,” Gamida CEO Abbey Jenkins said on her firm’s Q4 2023 conference call last week.

“Going forward, we will be a leaner, more focused organization and with a more stable financial foundation. Gamida Cell will be positioned to continue delivering this potentially lifesaving cell therapy for patients with hematologic malignancies, including those from diverse backgrounds.”

The RSA comes following several attempts to ensure long-term financial stability and continued supply of Omisirge.

“In Q2 2023, we initiated a strategic restructuring and engaged in an extensive process to pursue strategic alternatives to support the commercialization of Omisirge. Our initial strategic alternatives review process included outreach to numerous potential strategic partners, including large and mid-sized pharmaceutical companies and we engaged in substantial discussions with many of those parties. Despite this effort, we did not identify a partnership that would adequately address our strategic needs by the end of the year,” said Jenkins.

“In January, we redoubled our efforts and announced that we were focused on reaching a transaction that would provide the long-term financial runway necessary for Gamida Cell to commercialize Omisirge, specifically pursuing a merger, acquisition or asset sale. Through that process, we engaged with a number of parties, some as re-engagement and others new. However, these efforts did not yield any actionable alternatives.”

For the full year, Gamida sales equated to $1.8 million from the delivery of six units of Omisirge. Cost of sales – including costs of direct manufacturing and quality in addition to royalty expenses and batch failure costs – was $1.5 million, resulting in 18.5% gross margin for the year.

During the year, 17 transplant centers were onboarded, with a further seven transplant centers added so far in 2024. Transplant center onboarding is a critical step in the process of making Omisirge available to patients, as it is required for transplant center teams to select Omisirge as a donor source.