Two years ago, Santhera refocused its energies on Duchenne muscular dystrophy prospect vamorolone and lung disease candidate lonodelestat. Now, the biotech has decided its lonodelestat dreams may have to die so vamorolone can fly.
Ushering vamorolone through U.S. and EU approval processes will continue to be the company’s main strategic focus, the company announced Monday in a half-year financial update, which will scoop up all the biotech’s financial and human resources, leaving nothing available for lonodelestat.
The focus on vamorolone has already pushed Santhera’s operating expenses to 30 million Swiss francs ($29.9 million) for the first half of the year, compared with 21.9 million francs for the same period in 2021. As of June 30, 2022, the company had cash and equivalents of 12.7 million francs, barely half the 21.2 million francs it entered the year with, according to the financial update.
With money in short supply, even the future of a “far advanced” phase 2 study for lonodelestat in an acute pulmonary indication will be dependent on securing fresh funding.
“Santhera explores various opportunities via collaboration and/or partnerships to resume the project as quickly as possible,” the company said in its report.
This year has been “fully geared” toward vamorolone, Santhera CEO Dario Eklund said in the release, with the company rewarded for its efforts by seeing a marketing authorization application validated in the EU and the completion of a rolling new drug application submission in the U.S.
Santhera originally acquired the nonhormonal steroid modulator from ReveraGen BioPharma.
“With equally high priority, we are pursuing additional near-term financing, primarily to allow us to fund market entry preparations for vamorolone,” Eklund added. “We are evaluating various non-dilutive options including but not limited to licensing agreements and monetization of assets in addition to debt and royalty financing and, depending on market conditions, may also consider equity-based funding options.”
Based on typical timelines for an FDA priority review, Santhera is hoping for a decision on vamorolone as early as mid-2023, with the drug hitting the U.S. market in the second half of the year. The first patient has also been dosed in a phase 2 study of the drug in Becker muscular dystrophy.
It follows a tough couple years for the Swiss biotech. In 2020, the company underwent a restructuring after a phase 3 DMD asset called idebenone flopped. The company switched focus to vamorolone, also in DMD, cut 50 staffers and saw its chief medical officer pack her bags. The cuts meant $10 million in savings, and the company managed to borrow another $16 million to stay afloat.