Kiromic Biopharma, Inc. SEC 10-K Report

Kiromic Biopharma, Inc., a clinical-stage biotherapeutics company specializing in allogeneic Gamma Delta T-cell therapies for solid tumors, has released its annual 10-K report. The report provides a comprehensive overview of the company's financial performance, business operations, strategic initiatives, and the challenges it faces in the competitive biopharmaceutical industry.

Financial Highlights

• Total Operating Expenses: $23.774 million, increased by 19% from the previous year due to higher clinical trials expenses.
• Loss from Operations: $(23.774) million, reflecting increased operating expenses.
• Net Loss: $(26.898) million, increased by 28% compared to the previous year, primarily due to higher interest expenses and reduced other income.
• Interest Expense: $(3.723) million, increased by 101% due to the issuance of additional convertible promissory notes.
• Net Cash Used in Operating Activities: $(19.458) million, a decrease from the previous year as the company worked towards increasing its cash position.

Business Highlights

• Company Overview: Kiromic BioPharma, Inc. is focused on developing allogeneic Gamma Delta T-cell therapies for solid tumors, utilizing proprietary bioinformatic, AI targeting, and manufacturing technologies.
• Product Candidates: The company has three main product candidates: Deltacel, Isocel, and Procel. Deltacel is in a Phase 1 clinical trial for advanced non-small cell lung cancer, while Isocel and Procel target Mesothelin Isoform 2 and PD-L1, respectively.
• Clinical Trials: Deltacel is in a Phase 1 trial with ten patients enrolled as of January 2025. The trial has shown promising results with no dose-limiting toxicities and a median progression-free survival of six months. The expansion phase began in September 2024.
• Manufacturing Operations: The company operates a 4,000 sq ft manufacturing facility in Houston, Texas, which includes ISO 7 cleanrooms and a Quality Control Laboratory, supporting the production of clinical batches under cGMP conditions.
• Future Outlook: Kiromic BioPharma plans to initiate a pivotal Phase 2 trial for Deltacel in the second half of 2025, with the potential to submit a Biologics License Application by 2027. The company also aims to submit IND applications for Isocel and Procel, contingent on sufficient financing.
• Target Discovery Platform: The Diamond AI platform is used for identifying and prioritizing cancer-specific isoantigens, enhancing the precision of immunotherapy target discovery.
• Regulatory Designations: Deltacel received Fast-Track Designation from the FDA in August 2024, which may expedite its development and review process.
• Competitive Position: The company targets multiple solid malignancies with both non-engineered and engineered allogeneic GDT cells, using a novel low-dose radiation protocol in combination with its cell products.

Strategic Initiatives

• Strategic Focus: Kiromic BioPharma is advancing its product candidates, particularly Deltacel, Isocel, and Procel, through clinical trials. The company is actively seeking to relist on a major stock exchange to increase stock liquidity and is exploring various financing options to support its operations and research programs.
• Capital Management: The company executed Convertible Promissory Notes (CPNs) and Exchange Agreements to strengthen its balance sheet by reclassifying CPNs to preferred shares. As of December 31, 2024, the company had cash and cash equivalents of $1.80 million, including $658 thousand of restricted cash. The company relies on financing activities, including the issuance of convertible notes, to fund its operations.
• Future Outlook: Kiromic BioPharma anticipates the need for significant additional capital funding to continue its operations beyond March 2025. The company plans to seek short-term financing to support its immediate liquidity needs and intends to pursue further capital to develop its platform and conduct clinical trials. The company acknowledges the potential for filing a voluntary petition for relief under the United States Bankruptcy Code if it cannot secure sufficient financing.

Challenges and Risks

• Financial Challenges: The company has incurred net losses since inception and expects to continue incurring losses in the foreseeable future. The focus on research and development, clinical trials, and general administrative expenses contributes to these losses.
• Funding Requirements: The company requires substantial additional funding to develop product candidates and conduct future operations. There is uncertainty about the availability of additional capital on acceptable terms, which could force the company to delay or reduce research programs and commercialization efforts.
• Operational Risks: The company's limited operating history makes it difficult to evaluate business prospects. The company has never commercialized a product and lacks the necessary sales and marketing infrastructure, posing challenges in successfully bringing products to market.
• Regulatory Risks: The FDA and other authorities require extensive data and compliance for product approval. The novel nature of the company's tumor-specific cancer immunotherapy approach adds complexity and uncertainty to the regulatory approval process.
• Market Risks: The company faces intense competition from larger pharmaceutical companies with greater resources. The ability to attract and retain qualified personnel is critical, yet challenging due to competition for talent. Geopolitical uncertainties, such as the conflict in Ukraine and changes in U.S. government policies, could adversely affect business operations.
• Management Strategies: Management is exploring various financing options, including equity offerings and strategic partnerships, to address funding needs. The company is focused on advancing its product candidates through clinical trials and obtaining necessary regulatory approvals, while managing expenses and implementing cost reduction measures where possible.

SEC Filing: Kiromic Biopharma, Inc. [ KRBP ] - 10-K - Feb. 14, 2025