Kiromic BioPharma, Inc. is advancing its Deltacel-01 immunotherapy, showing promising early results in solid tumors, while simultaneously navigating significant financial constraints. The company's third-quarter 2024 SEC filing reveals both clinical progress and ongoing financial challenges. The Deltacel-01 trial has entered the dose-expansion phase, demonstrating encouraging survival benefits without dose-limiting toxicities. However, Kiromic BioPharma acknowledges substantial doubt about its ability to continue as a going concern due to limited cash reserves.
Deltacel-01 Clinical Trial Update
The Phase 1 clinical trial of Deltacel-01 has shown a 6-month median Progression Free Survival (PFS) among the six patients treated. One patient experienced a PFS of 10 months. The trial's progress has led to the activation of four additional testing sites, including Virginia Oncology Associates and the University of Arizona Cancer Center. In August 2024, the FDA granted Fast-Track Designation to Deltacel, potentially accelerating the approval process through benefits such as Accelerated Approval, Rolling Review, and Priority Review.
Pipeline Expansion and IND Submissions
Kiromic BioPharma is also developing Isocel and Procel, with plans to submit new IND applications in the second half of 2025 and 2026, respectively. These submissions are contingent upon securing sufficient financing. The company is also working on a novel and virus-independent engineering method for its product candidates, which is expected to result in new IND applications.
Financial Overview and Strategic Initiatives
Kiromic BioPharma's financial report indicates increased operating expenses and net losses for the third quarter of 2024. Total operating expenses rose to $6.60 million, a 19% increase compared to the same period in 2023. The net loss for the quarter was $7.44 million, up 77% from $4.19 million in 2023. The company's financial challenges are compounded by ongoing legal proceedings and the need to secure additional funding to support its research and development activities.
To address its financial situation, Kiromic BioPharma has undertaken several strategic initiatives, including converting senior secured convertible promissory notes into preferred stock and entering into a Standby Equity Purchase Agreement (SEPA) with YA II PN, Ltd. The company is also exploring cost reduction actions, including potential workforce reductions and delaying research and development expenditures. Management is actively seeking short-term financing to continue operations and fund liquidity needs through the end of the year.
Challenges and Risks
Kiromic BioPharma faces significant challenges, including the risk of clinical trial discontinuation, slow or delayed IND applications, and difficulties in patient enrollment. The company's principal stockholder also exerts substantial influence over corporate actions. Furthermore, Kiromic BioPharma is cooperating with requests for information from the SEC and the U.S. Department of Justice regarding ongoing investigations.
