BUFFALO, New York, Dec. 30, 2019 /PRNewswire/ -- NPXe Limited ("NPXe"), a Phase III pharmaceutical and drug delivery device company developing XENEX™ (xenon gas for inhalation) for neuro- and cardio-protection and improvement in survival for post-cardiac arrest syndrome (PCAS) patients, announced today that it has filed a voluntary petition to reorganize under Chapter 11 of the Bankruptcy Code in the U.S. Bankruptcy Court for the District of Delaware (the Court). NPXe has also filed a motion seeking authorization to pursue an auction and sale process under Section 363 of the U.S. Bankruptcy Code.
"The NPXe Board of Directors have extensively reviewed our strategic options and financial situation and unanimously agree that this structured sale process represents the optimal pathway forward for the Company," said Bill Burns, CEO of NPXe. "Inhaled Xenon gas has a history of safe use in humans, and based on Phase II data, we believe bringing XENEX™ to market represents an essential element for critical care treatment for PCAS patients, a population in which no approved pharmacotherapy exists."
Lincoln International has been retained as NPXe's investment banking advisor, subject to approval of the Court, to manage the sale and auction process. The proposed bidding procedures, if approved by the Court, would allow interested parties to submit binding offers to acquire substantially all of NPXe's assets, which would be purchased free and clear of the Company's indebtedness and liabilities. Interested parties could include both strategic and financial buyers, for whom substantial due diligence materials are available. The Debtors have proposed the following timeline for the sale process, subject to approval by the Court:
- Bids expected to be submitted by February 19, 2020
- Structured auction targeted to commence no later than February 21, 2020
- Sale intended to be concluded by February 26, 2020
NPXe Company Highlights:
- Large Addressable Commercial Market: There are over 286,000 addressable cardiac arrests in North America and the European Union each year. Management estimates the hospital market for PCAS patients in these territories to be roughly $6+ billion. In addition, there are large commercial opportunities to include indications in stroke and traumatic brain injury.
- Positive Late Stage Data: A 110-Patient Phase II trial demonstrated neuro- and cardio-protection with a significant reduction in white matter brain damage and a suggested improvement in survival outcomes.
- Favorable Regulatory Position: NPXe has received Fast Track and Special Protocol Assessment ("SPA") for the Phase III trial. Any statistically significant improvement in good functional outcome or survival would be FDA/EMA approvable. Management believes that, if successful, the product, in combination with Targeted Temperature Management ("TTM"), would become the standard of care.
- High Barriers to Entry: Orphan drug designation, patents and commercial exclusivities.
Additional information about the proposed asset sale, as well as other documents related to the restructuring and reorganization proceedings, is available through NPXe's claims agent, Omni Agent Solutions, Inc. at https://www.omniagentsolutions.com/NeuroproteXeon. NPXe's proposed bankruptcy counsel is Ashby & Geddes, P.A.
NPXe is developing xenon gas for inhalation for the treatment of Post-Cardiac Arrest Syndrome. The Company has a Special Protocol Agreement with the FDA and a Scientific Working Party Agreement with the European Medicines Agency (EMA). Both the FDA and EMA have provided the sought PCAS indication with Orphan Drug status which prolongs the period of market exclusivity post approval. The FDA has also granted the drug Fast Track designation.
Interested parties should contact Brian Bock at firstname.lastname@example.org or Brent Williams at email@example.com for additional information and access to due diligence materials. The Company filed the voluntary Chapter 11 petition in the U.S. Bankruptcy Court for the District of Delaware, Case No. 19-12676 (MFW).
SOURCE NPXe Limited