Trudhesa dihydroergotamine (DHE) nasal spray maker Impel Pharmaceuticals (formerly Impel Neuropharma) has filed a document with the US Securities and Exchange Commission stating that it “has concluded that there is substantial doubt about the Company’s ability to continue as a going concern.” Earlier this year, Impel announced that it needed to “streamline” and would halt development of INP105 intranasal olanzapine for the treatment of agitation in autism spectrum disorder in addition to cutting 16% of its staff.
In March 2022, the company announced that it had secured $100 million from Oaktree Capital Management, half of which was in the form of senior secured debt. That funding was intended to support commercialization of Trudhesa, which was approved by the FDA for the treatment of migraine in September 2021.
The Form NT 10-Q says that the company is now unable to maintain the amount of unrestricted cash and cash equivalents required under the senior credit agreement with Oaktree and is in breach of that agreement. If Impel is unable to negotiate bridge financing with Oaktree and others, the company said, it may need to sell assets or file for Chapter 11 bankruptcy.
Read the Impel Pharmaceuticals Form NT 10-Q.
