KIROMIC BIOPHARMA INC - KRBP STOCK NEWS

Kiromic BioPharma reported significant operational updates and clinical progress in its Q2 2021 results. The company re-submitted two IND applications for ALEXIS product candidates, anticipating first in-human dosing in Q1 2022. With a new Chief Operating and Manufacturing Officer appointed and a successful public offering generating $37.1 million, Kiromic aims to strengthen its financial position. The company noted a cash decrease to $3.1 million and a 109% increase in R&D expenses, while G&A expenses dropped significantly. Net loss narrowed to $8.9 million, demonstrating improved cost management.

Kiromic Biopharma, Inc. (Nasdaq: KRBP) has successfully completed the acquisition of InSilico Solutions, enhancing its capabilities in bioinformatics and artificial intelligence. This strategic move aims to strengthen Kiromic's lead in developing CAR-T cell therapies by employing advanced techniques to identify optimal biomarkers. The acquisition involves a stock-swap operation, retaining InSilico's entire team and assets. This integration is expected to accelerate the development and manufacturing of Kiromic's off-the-shelf allogeneic CAR-T therapies.

Kiromic BioPharma, Inc. (Nasdaq: KRBP) submitted two INDs to the FDA in May 2021 for its off-the-shelf allogeneic CAR-T for solid tumors. The FDA provided feedback regarding reagent tracing, manufacturing flow charts, and Certificates of Analysis (COA). The company has established a taskforce of industry veterans to address these comments. Kiromic plans to tighten the timeline for commencing human clinical trials, targeting delivery in Q3 2021. The company utilizes an AI platform called DIAMOND for target discovery and gene-editing in cancer treatment.

Kiromic BioPharma, Inc. (Nasdaq: KRBP) has successfully closed its public offering of 8,000,000 shares at $5.00 per share, generating gross proceeds of $40 million. The underwriters have an option for an additional 1,200,000 shares for over-allotments. The funds will primarily support clinical trials for ALEXIS-ISO-1 and ALEXIS-PRO-1, GMP facility expansion, and general corporate purposes. ThinkEquity managed the offering, and the registration statement was effective as of June 29, 2021.

Kiromic BioPharma, Inc. (Nasdaq: KRBP) announced a public offering of 8,000,000 shares of common stock priced at $5.00 per share, aiming for gross proceeds of $40 million. The offering includes a 45-day option for underwriters to purchase an additional 1,200,000 shares for over-allotments. The proceeds will primarily fund clinical trials for ALEXIS-ISO-1 and ALEXIS-PRO-1, facility expansion, intellectual property protection, IND applications, and general corporate purposes. The offering is expected to close around July 2, 2021.

Kiromic Biopharma (Nasdaq: KRBP) is recognized as an innovator in immuno-oncology, showcasing its AI-driven cancer targets at the 4th Annual Next-Gen Immuno Oncology Congress. The presentation focuses on artificial intelligence-selected targets, claiming enhanced safety and efficacy over conventional methods. The company plans to advance Mesothelin isoform 2 in human trials for solid tumors by Q3 2021, utilizing a CAR-T therapy with chPD1. Leadership highlights the potential of AI to significantly improve target specificity and affinity, aiming to reduce side effects and elevate treatment effectiveness.

Kiromic has made significant strides in Gamma Delta T (GDT) cell therapy manufacturing, earning recognition as a pioneer in the field. The company will present its allogeneic CAR-T technology at the Gamma Delta T Cell Summit in July 2021, following a successful showcase of its GDT cells at AACR 2021. Kiromic projects the first in-human dosing for solid tumors in Q3 2021, showcasing promising early clinical data. Notable executives have expressed confidence in their innovative technologies and operational readiness as they prepare for Phase 1 clinical trials.

Kiromic BioPharma (Nasdaq: KRBP) is expanding its in-house cGMP manufacturing facility in Houston to support upcoming clinical trials, with therapeutic doses anticipated for first-in-human dosing in Q3 2021. The company appointed Ignacio Núñez as Chief Operating and Manufacturing Officer, who brings 20 years of experience in global operations from prominent firms like General Electric and Novartis. This expansion will add approximately 30,000 square feet for clean rooms, quality control, and storage, crucial for Kiromic's growth in immuno-oncology therapies.

Kiromic Biopharma, Inc. (Nasdaq: KRBP) has submitted a novel Investigational New Drug (IND) application to the FDA for a Phase 1 clinical trial of KB-ISM, a universal CAR-T therapy targeting solid tumors expressing Iso-mesothelin. The trial, titled ALEXIS-ISO-1, will evaluate the safety and efficacy of allogeneic Gamma Delta T-cells expressing a CAR against Isoform 2 of Mesothelin. The trial is set to enroll 30 patients and will last 18 months, with initial data expected by Q4 2021. FDA feedback on the IND submission is anticipated within 30 days.