After eliminating workforce, migraine biotech Zosano abandons core — and only — program Endpoints News

It looks like Zosano doesn’t have much left in the tank.

In April, the migraine-focused biotech announced it would cut about a third of its workforce – less than a month after the FDA refused to review the company’s new submission for its migraine treatment patch. known as M207. The agency said the company did not adequately address deficiencies identified in the FDA’s initial 2020 CRL.

At the time, Zosano President and CEO Steven Lo said, “We are in discussions with the FDA to determine if there is a viable option to pursue approval of M207 using clinical data. currently available. In addition, we actively evaluate financial and strategic alternatives in collaboration with external advisors, with the aim of maximizing value.

But now the company has a new update. Zosano announced on Friday that it was suspending the M207 program in what appears to be one of the company’s latest attempts to stay open. The decision comes just over two weeks after the FDA granted the biotech a 12-month extension to resubmit its NDA for the program. Zosano also noted that it has an ongoing feasibility study with an unnamed pharmaceutical partner, which is expected to be completed by the end of the quarter.

Terminal news has contacted Zosano for comment and will update accordingly.

The biotech said that in the weeks after laying off around 40% of its employees, a slight jump in hunger from the roughly 33% announced in March, it had also suspended GMP manufacturing operations at its plant in Fremont, Calif., suspended operations of its third-party CRO and is currently evaluating its “long-lived assets” for “impairment related to those actions.”

As of April 26, the company had approximately $11.4 million in combined cash and cash equivalents.

Christine Matthew

Zosano had used a 35-to-1 reverse stock split on April 8, driving its stock price to more than a dollar a share after it fell below 20 cents apiece. $ZSAN biotechnology stock fell more than 25% in post-trade trading on Friday.

Zosano lost money in 2021, losing $7 million in the fourth quarter and just under $30 million for the full year. The biotech also said in its March 10-K that it will require “substantial additional funding to fund our operations, and we will not be able to continue our business if we are unable to do so.”

At the same time, CEO Steven Lo and CFO Christine Matthews received bonuses under Zosano’s “retention bonus program,” with Lo receiving $178,500 and Matthews receiving $98,333 on March 31.

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