Extract to table

Form 8-K — Current Report Requirements Under Section 13(a) and Section 15(d) of the Exchange Act, as implemented by SEC Regulation S-K and the instructions to Form 8-K, a publicly traded company is required to file a Current Report on Form 8-K to disclose certain specified events within four business days of their occurrence

Warning Letters or clinical holds), the underlying principle — that material regulatory developments must be disclosed promptly — applies with equal force to the present inquiry given Zelvara®'s outsized contribution to Penterra's revenue

Even if the ultimate financial impact is uncertain at the time of filing, the existence of the inquiry and its potential implications must be discussed

If any selective disclosure has already occurred — whether intentionally or inadvertently — Penterra must promptly disclose the information publicly, either by filing or furnishing a Form 8-K under Item 7

SAB 99 emphasizes that a purely quantitative approach to materiality is insufficient and that qualitative factors — including the nature of the item, the circumstances in which the judgment is made, and the effect on compliance with regulatory requirements or contractual obligations — must also be considered

SEC guidance and case law establish that the existence of a material inquiry or investigation must be disclosed regardless of its stage