Kiromic Biopharma Inc Stock Price, News & Analysis

Kiromic BioPharma (NASDAQ: KRBP) has submitted an Investigational New Drug (IND) application to the FDA for its Phase 1 clinical trial of KB-GDT-01, known as Deltacel, aimed at treating non-small cell lung cancer (NSCLC) in combination with anti-tumor therapy. Deltacel is an allogeneic, non-viral, off-the-shelf Gamma Delta T-cell therapy, targeting solid tumors that account for 90% of all cancers. This submission marks a significant advancement in the company's efforts to provide new treatment options for lung cancer patients, which is the leading cause of cancer-related deaths in the U.S.

Kiromic BioPharma, Inc. (NASDAQ: KRBP) announced a 1-for-30 reverse stock split effective March 10, 2023, at 4:01 p.m. Eastern Time. The split aims to comply with Nasdaq's minimum bid price requirement and enhance stock attractiveness for institutional investors. Following the split, approximately 966,758 shares will be outstanding, with no fractional shares issued. The action was approved by stockholders on March 7, 2023. The common stock will begin trading on a split-adjusted basis on March 13, 2023. Kiromic is focused on developing cell therapies through its DIAMOND® AI platform for immune-oncology applications.

Kiromic BioPharma (NASDAQ: KRBP) has announced favorable safety results from a preclinical study of its cell therapy Deltacel™. The histopathology evaluation revealed no adverse findings following the administration of Deltacel™, either alone or with a non-biological anti-tumor therapy in mice. This finding completes the necessary dataset for the pharmacology report needed for its IND application. The company plans to submit the IND to the U.S. FDA in Q1 2023 and expects to initiate clinical trials in Q2 2023, focusing on treating non-small cell lung cancer.

Kiromic BioPharma (NASDAQ: KRBP) recently updated stockholders, emphasizing critical upcoming proposals to secure funding and advance its therapeutic candidate, Deltacel™. A Special Meeting is scheduled for March 7, 2023, where stockholders can vote on three key proposals, including a reverse stock split and issuance of common stock to investors. Notably, the company aims to submit an IND application for Deltacel™ by the end of Q1 2023 and initiate clinical trials in the following months. Recent preclinical studies showed promising results, confirming Deltacel™’s safety and efficacy.

Kiromic BioPharma, Inc. (NASDAQ: KRBP) has settled litigation with Sabby Capital Management and entered a Standby Equity Purchase Agreement (SEPA) with YA II PN, LTD, allowing it to sell up to $8 million in stock over 24 months, conditional on a registration statement's effectiveness. The SEPA allows for a potential $10 million in financing, with $2 million already secured from a new investor through a secured convertible note convertible at $0.35 per share. These agreements are aimed at enhancing liquidity and funding ongoing clinical initiatives.

Kiromic BioPharma (NASDAQ: KRBP) announced it received positive FDA feedback on October 4, 2022, regarding its Deltacel™ development strategy for Non-Small Cell Lung Cancer (NSCLC). The company plans to leverage this guidance for an IND submission and aims to launch a clinical trial in Q1 2023. In line with this focus, Kiromic streamlined operations, reducing its workforce by 29% to enhance efficiency. Deltacel™ is positioned as a next-gen cell therapy that utilizes allogeneic, non-viral Gamma Delta T-cells, potentially mitigating supply-chain issues associated with viral approaches.

Kiromic BioPharma (NASDAQ: KRBP) has appointed Dr. Leonardo Mirandola as Chief Scientific Officer, effective immediately. Dr. Mirandola, previously the Vice President of Research & Development since September 2021, aims to lead the company towards achieving critical clinical milestones in oncology cell therapy. Under his guidance, Kiromic expects to advance its Deltacel™ therapy towards clinical trials by year-end. Dr. Mirandola is a recognized expert in molecular immunology, holding over 100 publications and nine patent-pending technologies, and is crucial for the company's growth in cell therapy innovation.

Kiromic BioPharma (NASDAQ: KRBP) announced the completion of its expanded cGMP manufacturing facility in Houston, a critical step for activating the Deltacel™ clinical trial by year-end. This milestone meets FDA requirements following a clinical hold issued in June 2021. The 34,000-square-foot facility features advanced labs to support the development of cell therapies targeting solid tumors. CEO Pietro Bersani emphasized that this expansion aims to enhance availability and reduce costs of promising oncology treatments.

Kiromic BioPharma (NASDAQ: KRBP) is set to submit its first IND application for Deltacel/KB-GDT™ in the second half of 2022, aiming for clinical trial activation by year-end. This marks a strategic pivot towards allogeneic, non-engineered therapies. The company plans to expand its pipeline with three additional IND filings in 2023, totaling five GDT clinical trials. The shift follows a recent research agreement to enhance preclinical data generation for these therapies, potentially addressing the growing cancer cell therapy market projected to exceed $33 billion by 2027.