Kiromic Biopharma Reports $26.9 Million Net Loss for Fiscal Year 2024

Kiromic Biopharma, Inc. reported a net loss of $26.9 million for the fiscal year ending December 31, 2024, an increase of 28% compared to a net loss of $20.9 million in the previous year. The company's total operating expenses rose to $23.8 million, up from $19.9 million in 2023, primarily driven by a significant increase in clinical trial expenses, which surged by 201% to $8.1 million. This increase was attributed to the activation of the Deltacel-01 clinical trial, which began patient enrollment in December 2023. The company has not generated any revenue from product sales to date and continues to rely on external financing to support its operations.

In terms of operational developments, Kiromic Biopharma is advancing its lead product candidate, Deltacel, which is currently in a Phase 1 clinical trial for patients with advanced non-small cell lung cancer (NSCLC). The trial has received Fast-Track Designation from the FDA, which is expected to expedite its development process. As of January 2025, ten patients have been enrolled in the trial, with the company anticipating the completion of enrollment for the expansion phase by March 2025. The company is also planning to submit Investigational New Drug (IND) applications for its other product candidates, Isocel and Procel, in the second half of 2025 and 2026, respectively.

Kiromic Biopharma's financial position raises concerns about its ability to continue as a going concern. As of December 31, 2024, the company had cash and cash equivalents of $1.8 million, which included $658,000 of restricted cash. Management has indicated that existing cash resources will not be sufficient to meet operating and liquidity needs beyond March 2025 without securing additional financing. The company is currently exploring various funding options, including potential public offerings and private placements, but there is no assurance that such financing will be available or on favorable terms.

The company has also faced legal challenges, including a class action lawsuit related to its public offering in July 2021, which has been settled for $2.3 million, with a net liability of $1.73 million covered by insurance. Additionally, Kiromic is under investigation by the U.S. Securities and Exchange Commission (SEC) regarding past disclosures related to clinical holds on its IND applications. The company has cooperated with the SEC and has reached a settlement that did not impose a civil penalty.

Looking ahead, Kiromic Biopharma's success will depend on the outcomes of its clinical trials, the ability to secure necessary funding, and navigating the regulatory landscape for its innovative therapies. The company remains focused on advancing its product candidates while managing its financial and operational challenges.