FDA grants fast track status to Kiromic’s lung cancer therapy
HOUSTON – Kiromic BioPharma, Inc. (OTCQB: KRBP) announced that its investigational cancer treatment, Deltacel™, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for use in combination with low-dose radiation therapy to treat certain patients with metastatic non-small cell lung cancer (NSCLC). This regulatory milestone is aimed at accelerating the development and review of the therapy for patients who have not responded to standard treatments.
Deltacel™ is currently undergoing a Phase 1 clinical trial, referred to as Deltacel-01, which targets stage 4 NSCLC patients. The study is evaluating the safety and preliminary efficacy of Deltacel™, which is an allogeneic, off-the-shelf Gamma Delta T-cell (GDT) therapy. The trial involves patients receiving intravenous infusions of Deltacel™ along with four courses of low-dose, localized radiation over a 10-day period.
The FDA’s Fast Track program is designed to facilitate the development of drugs that treat serious conditions and fill an unmet medical need, allowing for more frequent communication with the FDA, potential priority review, and a rolling submission of licensing applications. This designation is significant for Kiromic as it underscores the potential of Deltacel™ to address the urgent needs of patients with advanced solid tumors.
Pietro Bersani, Chief Executive Officer of Kiromic BioPharma, expressed encouragement by the FDA’s recognition of their innovative approach and is committed to the clinical development of Deltacel™. The company expects to open a fifth clinical trial site on August 30th following the recent positive data from the ongoing trial, where Deltacel™ has shown a favorable safety profile.
Kiromic BioPharma is a clinical-stage biotherapeutics company that utilizes its proprietary artificial intelligence platform, DIAMOND®, to develop cell therapies focusing on immuno-oncology. The company is developing a multi-indication allogeneic cell therapy platform that exploits the natural potency of Gamma Delta T-cells to target solid tumors.
The information in this article is based on a press release statement by Kiromic BioPharma. It is important to note that the statements in this article are forward-looking and involve risks and uncertainties. The actual results may differ materially from those projected in the forward-looking statements.
In other recent news, Kiromic BioPharma has secured $2M in convertible note financing. This move is a part of the company’s strategic effort to secure additional capital for its operations. In addition to this, Kiromic BioPharma has undertaken significant financial restructuring, converting $7.2 million of its debt into equity and issuing a new senior secured convertible promissory note.
The company has also been making strides in its ongoing efforts to develop effective treatments for serious conditions like non-small cell lung cancer (NSCLC). Promising results have been reported from its Deltacel phase 1 clinical trial for the treatment of stage 4 metastatic NSCLC, with one patient experiencing a 6.6% reduction in tumor size two months post-treatment. Based on these findings, Kiromic plans to apply for FDA Fast Track Designation, which could expedite the review process of the drug.
The company’s financial restructuring and promising clinical trial results are recent developments that highlight Kiromic BioPharma’s commitment to its operations and the development of effective treatments.
InvestingPro Insights
Kiromic BioPharma’s recent Fast Track designation by the FDA for its Deltacel™ therapy marks a pivotal moment for the company. However, it’s equally important for investors to consider the financial health and market performance of Kiromic BioPharma when evaluating its prospects. According to InvestingPro data, Kiromic BioPharma has a market capitalization of just $1.64 million, reflecting the company’s status as a small-cap stock with a potentially higher risk-reward profile.
The company’s financial metrics indicate significant challenges. With an EBITDA of -$20.11 million for the last twelve months as of Q2 2024, and an adjusted operating income of -$22.34 million, Kiromic BioPharma is operating at a loss. Moreover, the stock’s performance has been concerning, with a 1-month price total return of -39.43%, and a staggering 3-month price total return of -60.3%, which aligns with the InvestingPro Tip suggesting the stock has fared poorly over the last month.
InvestingPro Tips highlight several areas of concern for Kiromic BioPharma, including a significant debt burden and the fact that the company is quickly burning through cash. This is particularly relevant as the company continues to fund its clinical trials and research activities. Moreover, the RSI indicates that the stock is in oversold territory, which could signal a potential buying opportunity for contrarian investors, although this comes with a high level of risk given the company’s financial position.
For those interested in a deeper dive into the financials and future outlook of Kiromic BioPharma, InvestingPro offers additional insights. Currently, there are 15 more InvestingPro Tips available at https://www.investing.com/pro/KRBP, which provide a comprehensive analysis of the company’s financial health and stock performance, crucial for making informed investment decisions.
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