Sanonia, Black Diamond Fall Victim To Rough Biotech Market


The first quarter hasn't been kind to international biopharmaceutical firms, which have struggled to stay afloat amidst poor trial results and lack of funding. BioSpace takes a look at the fates of Saniona and Black Diamond below.

Saniona Shutters U.S. Operations, Reshuffles Leadership

Saniona, the Swedish biopharmaceutical firm, is shutting down its U.S. operations, resulting in top-to-bottom layoffs, including executive management.

The U.S. closure is expected to bring future annual operating costs down by 75%. All business in the U.S. will be shut down, and associated positions will be terminated. The company said in a statement that employees who will be affected would receive severance pay, healthcare coverage and other separation benefits.

Saniona reported an operating loss of SEK 411.6 million and a net loss of SEK 410.9 million in the year to December 31, 2021.

The U.S. shutdown translates to changes in Saniona's executive leadership. Thomas Feldthus, Saniona's co-founder and previous chief financial officer, will become the chief executive officer while Anita Milland takes on the role of CFO, from being a vice president for finance and administration, effective April 30, 2022. Karin Sandager Nielson, currently the senior VP for in vivo and translational pharmacology, will be named chief scientific officer.

Saniona co-founder and current board member Jørgen Drejer will also become the interim chairman of the board until the scheduled Annual General Meeting on May 25, when the nominating committee proposes his chairmanship to shareholders. Drejer replaces J. Donald deBethizy, who will step down from his role at the AGM.

Other U.S. board members — Robert E. Hoffman and Edward C. Saltzman — will not be seeking reelection, while Drejer, Anna Ljung and Carl Johan Sundberg have expressed intentions for reelection.

Saniona's restructuring effort is in line with a new direction for the company toward its later-stage clinical programs, specifically SAN711 and Tesomet, both of which are positioned for partnering. The company has not revealed any potential partners for either project but said that both carry a significant value that benefits both patients and investors.

"Seeking partnerships for Tesomet and/or SAN711 may, in the current situation, generate more value for shareholders as we transform the company into a more focused and cost-effective organization. We have a strong pipeline of first-in-class ion channel programs including SAN711 with Phase 1 data expected mid-2022, SAN903 completing preclinical development and multiple new candidates emerging targeting both rare and common diseases primarily related to CNS," commented Thomas Feldthus.

Black Diamond Folds Cancer Drug Project, Lays Off Staff

Black Diamond Therapeutics announced that it is reorganizing its workforce and focusing on immediate value-driving projects to extend its cash reserves to the third quarter of 2024.

Some ongoing development projects will be dropped, particularly BDTX-189, the orally bioavailable, irreversible small molecule inhibitor that targets oncogenic driver mutations of EGFR and HER2 kinases. Black Diamond decided to stop the Phase I study because of the "rapid evolution of the treatment landscape in NSCLC harboring either EGFR or HER2 Exon 20 insertion mutations."

Instead, the company will focus on priority programs BDTX-1535 and BDTX-4933. Black Diamond started the Phase I study for BDTX-1535 in the first quarter of 2022, expecting to present clinical data in 2023. The investigational new drug-enabling studies for BDTX-4933 began in the same period, with an IND submission expected in the first half of 2023. Discovery efforts generated from its Mutation-Allostery-Pharmacology (MAP) drug discovery engine will also continue.

"In order to increase our operational efficiency and execute on our mission, we have made the difficult decision to reduce our workforce by approximately 30%. The actions announced today enable us to focus and strengthen our organizational priorities, reduce our operating expenses, and continue to invest in value-generating clinical development activities to bring us to the next inflection points for BDTX-1535 and BDTX-493," noted David Epstein, Ph.D., the president and CEO of Black Diamond Therapeutics.

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