Clinical-stage biotech company Yumanity is laying off about 60% of its staff in a corporate restructuring that comes a month after the FDA placed a partial clinical hold on its lead program, a potential treatment for Parkinson’s disease.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The restructuring involves more than cutting staff to conserve cash. Boston-based Yumanity said Thursday that it is now exploring “strategic alternatives” that could include a merger, a licensing deal, or a sale of the company or its assets.
The drug discovery technology of Yumanity is based on yeast. The biotech uses yeast cells to model the protein folding that is characteristic of neurodegenerative disorders. Those models are screened against libraries of molecules to find the ones that can protect cells from the toxic effects of the misfolded proteins characteristic of neurological diseases. The technology was licensed from MIT’s Whitehead Institute for Biomedical Research.
Parkinson’s is characterized by the aggregation of misfolded versions of a protein called alpha synuclein. While several companies are developing drugs to break up these aggregations, Yumanity is taking a different approach. YTX-7739 is a small molecule that penetrates the blood-brain barrier in order to block the activity of stearoyl-CoA desaturase, an enzyme that catalyzes a lipid metabolism reaction. This approach is intended to block the intracellular toxicity associated with the buildup of alpha synuclein, which could allow neurons to function normally.
The second most advanced program in Yumanity’s pipeline, YTX-9184, is chemically distinct from YTX-7739 but is designed block the same enzyme target. That small molecule is in preclinical development as a potential treatment for dementia with Lewy bodies. Two additional programs that address undisclosed targets are in preclinical development under a partnership with Merck.
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Yumanity had advanced its lead asset into early-stage clinical development: a Phase 1 study testing a single ascending dose in healthy volunteers, and a multiple-ascending dose study in healthy volunteers that includes a Phase 1b component evaluating a multiple ascending dose in Parkinson’s patients. Last month, the company disclosed that the FDA placed a partial hold that affects multi-dose tests of the drug. The regulator is allowing the single-dose clinical tests of the drug to proceed. Yumanity did not specify what questions or concerns the FDA raised.
Yumanity’s headcount was 44 full-time employees at the end of 2020, 32 of them in research roles, according to the company’s annual report. As of the end of the third quarter of 2021, the company said its cash position was $43.5 million. In its financial report for that quarter, Yumanity said that it expected its cash to last less than 12 months.
“If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, reduce or eliminate our product development or future commercialization efforts, or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves,” the company said.
Yumanity said Thursday that the layoffs are expected to be completed by April, resulting in a one-time charge of about $400,000 that will be recorded in the current quarter. Included in the strategic alternatives Yumanity listed is serving as a vehicle to take another company public, a move called a reverse merger. Yumanity gained its public stock listing in a 2020 reverse merger with ailing cystic fibrosis drug developer Proteostasis.
Yumanity’s closing stock price Thursday was $1.26, down 28.8% from Wednesday’s close.
Image: Dr_Microbe, Getty Images
