Antibe Therapeutics Inc(Pre-Merger) ATBPF

RE:RE:RE:RE:Good Sign

[Forestview]

Othena, Marky.

As planned, we will be submitting otenaproxesul’s IND (“Investigational New Drug”) application to the U.S. FDA within weeks. In ordinary circumstances, we would then expect to proceed with the adaptive Phase III trial in the upcoming quarter. However, the ongoing rise in COVID-19 infections is increasingly compromising the ability of clinics and hospitals to accommodate large clinical trials, particularly in the U.S. where this trial must take place. With this situation expected to ease later in the year as vaccines take hold, guidance for trial initiation is being adjusted to the second half of 2021. In the interim, and supported by our strong balance sheet, we are taking the opportunity to perform an enhanced version of the previously planned absorption, metabolism and excretion (“AME”) study which is set to begin in Canada this quarter. In addition to providing valuable information for potential partners, this 6-week study (which includes 2 weeks of follow-up monitoring) will further de-risk dose selection for our Phase III program, while also supplying pharmacokinetic data required for drug marketing approval.