Kiromic BioPharma Announces Settlement of Previously Disclosed SEC Investigation

Rhea-AI Summary

Kiromic BioPharma (OTCQB: KRBP) has reached a settlement agreement with the SEC regarding an investigation into the non-disclosure of FDA clinical holds by former management. The investigation concerned IND applications for ALEXIS-PRO-1 (Procel™) and ALEXIS-ISO-1 (Isocel™) filed in May 2021. Due to the company's self-reporting, prompt remediation, and cooperation, the SEC decided not to impose civil penalties, and there are no ongoing obligations related to the settlement.

Positive

• SEC declined to impose civil penalties
• Settlement reached with SEC resolving the investigation
• No ongoing undertakings required from the settlement

Negative

• Previous management failed to disclose FDA clinical holds on IND applications
• Historical regulatory compliance issues with FDA applications

SEC declines to impose civil penalties in light of the Company’s self-reporting, prompt remediation and cooperation

HOUSTON--(BUSINESS WIRE)-- Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) today announced that it has entered into a settlement agreement with the U.S. Securities and Exchange Commission (the “SEC”), resolving the previously disclosed SEC investigation arising from the non-disclosure by Kiromic’s prior executive management of the clinical holds placed on the investigational new drug (“IND”) applications the Company filed with the U.S. Food and Drug Administration (the “FDA”) in May 2021. The IND applications pertained to ALEXIS-PRO-1 (Procel^™) and ALEXIS-ISO-1 (Isocel^™). In light of the Company’s self-reporting, prompt remediation and cooperation, the SEC has determined not to impose a civil penalty on the Company and there are no ongoing undertakings in connection with the settlement.

About Kiromic BioPharma

Kiromic BioPharma, Inc. is a clinical-stage, fully integrated biotherapeutics company developing a multi-indication allogeneic cell therapy platform that exploits the natural potency of Gamma Delta T-cells to target solid tumors. Kiromic is using its proprietary DIAMOND^® artificial intelligence (AI) 2.0 platform to discover novel targets for immuno-oncology. The Company maintains offices in Houston, Texas. To learn more, visit www.kiromic.com and connect with us on Twitter and LinkedIn.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241203898249/en/

Alliance Advisors IR

Tirth T. Patel

tpatel@allianceadvisors.com

212-201-6614

Source: Kiromic BioPharma, Inc.

FAQ

What was the outcome of Kiromic BioPharma's (KRBP) SEC investigation settlement?

The SEC declined to impose civil penalties on Kiromic BioPharma due to the company's self-reporting, prompt remediation, and cooperation, with no ongoing undertakings required.

What triggered the SEC investigation into Kiromic BioPharma (KRBP)?

The SEC investigation was triggered by the non-disclosure of FDA clinical holds placed on IND applications for ALEXIS-PRO-1 and ALEXIS-ISO-1 filed in May 2021 by the company's prior executive management.

Which IND applications were involved in Kiromic BioPharma's (KRBP) SEC settlement?

The IND applications involved were for ALEXIS-PRO-1 (Procel™) and ALEXIS-ISO-1 (Isocel™), which were filed with the FDA in May 2021.