Kiromic BioPharma, Inc. (OTCQB: KRBP) is a clinical-stage biotherapeutics company at the forefront of developing novel allogeneic cell therapies to tackle solid tumors. With a unique, end-to-end approach combining proprietary technologies in bioinformatics, AI-driven target discovery, and on-site cGMP manufacturing, Kiromic is poised to redefine the landscape of cancer immunotherapy.
Business Overview and History
Kiromic BioPharma, Inc. was formed under the Texas Business Organizations Code in December 2012 as a clinical stage, fully integrated biotherapeutics company. The company maintains offices in Houston, Texas and has not generated any revenue to date. Kiromic's core focus is on developing allogeneic Gamma Delta T-cell therapies to address solid tumors, leveraging its unique, proprietary end-to-end bioinformatic, AI targeting, and manufacturing technologies.
The company's integrated approach encompasses target discovery and validation, product development, and on-site current Good Manufacturing Practices (cGMP). This comprehensive strategy is designed to create a new framework for the next generation of cell therapies, potentially offering more effective and cost-efficient treatments for solid tumors.
Kiromic's product development strategy centers on both non-engineered and engineered allogeneic Gamma Delta T (GDT) cell technologies. The company is also developing proprietary, virus-free cell engineering methods to create novel therapies for solid tumors. Currently, Kiromic's pipeline features three key product candidates: Deltacel, Isocel, and Procel.
In 2022, Kiromic faced significant challenges when its prior executive management failed to disclose clinical holds placed on Investigational New Drug (IND) applications filed with the FDA in May 2021 for the Isocel and Procel product candidates. This oversight led to an SEC investigation, which the company successfully resolved in December 2024 without the imposition of civil penalties. Kiromic's proactive approach, including self-reporting, prompt remediation, and cooperation with authorities, played a crucial role in the favorable resolution of this issue.
Despite this setback, Kiromic has continued to make progress in advancing its product pipeline. A significant milestone was reached in late 2023 with the initiation of the Deltacel-01 Phase 1 clinical trial, demonstrating the company's resilience and commitment to its mission of developing innovative cancer therapies.
Financial Performance and Liquidity
Kiromic, like many clinical-stage biotechnology companies, has yet to generate significant revenue, reporting no sales for the years ended December 31, 2024 and 2023. The company's net losses for the same periods were $26.90 million and $20.95 million, respectively. This is largely attributable to the substantial investments Kiromic has made in research and development to advance its pipeline, as well as general and administrative expenses to support the growth of the business.
For the year ended December 31, 2024, Kiromic reported higher clinical trial expenses of $8.07 million, up from $2.68 million in 2023, primarily due to the advancement of the Deltacel-1 clinical trial. Research and development expenses remained relatively stable at $6.85 million in 2024 compared to $6.95 million in 2023. General and administrative expenses decreased to $8.85 million in 2024 from $10.31 million in the prior year, mainly due to lower legal and outside consulting fees.
In the most recent quarter (Q3 2024), Kiromic reported a net loss of $6.49 million, with no revenue generated during this period.
As of December 31, 2024, Kiromic had $1.14 million in cash and cash equivalents, which included $658,000 in restricted cash. This represents a decrease from $3.2 million at the end of 2023. The company's working capital position was negative $17.60 million, reflecting the ongoing cash burn associated with its clinical and preclinical activities. Kiromic has been financing its operations primarily through the issuance of convertible promissory notes, preferred stock, and common stock.
The company's financial situation has raised substantial doubt about its ability to continue as a going concern. Kiromic is currently in discussions with financing sources to secure short-term funding to continue operations and meet its liquidity needs through the end of 2025. Management has also explored potential cost-cutting measures, including workforce reductions and the delay of research and development expenditures, to preserve cash. The company's ability to continue as a going concern is heavily dependent on its success in obtaining additional financing.
Deltacel-01 Clinical Trial Updates
Kiromic's lead product candidate, Deltacel, has demonstrated promising results in the ongoing Deltacel-01 Phase 1 clinical trial. As of January 2025, ten patients have been enrolled in the trial, which is evaluating Deltacel in combination with low-dose targeted radiation for the treatment of advanced non-small cell lung cancer (NSCLC).
Highlights from the Deltacel-01 trial include:
- The trial has reported a 6-month median progression-free survival with a median follow-up of over 10 months. - The longest progression-free survival observed is 12 months. - The first patient in the trial reached a 12-month progression-free survival (PFS), with a 27% reduction in tumor size compared to baseline. - The fourth patient exhibited a partial response at the 8-month follow-up, with a 32% decrease in tumor volume. - The sixth patient demonstrated stable disease with no new lesions detected and no signs of disease progression at the 2-month follow-up. - No dose-limiting toxicities have been reported for any of the enrolled patients.
Based on the promising safety and efficacy data, the Deltacel-01 trial's Safety Monitoring Committee unanimously recommended advancing the study to the expansion phase in September 2024. Kiromic expects to complete enrollment in the expansion phase, which will include approximately 9 additional patients, by March 2025.
Additionally, in August 2024, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to Deltacel for the treatment of metastatic NSCLC. This designation is expected to expedite the development and review of the therapy, potentially accelerating the path to approval.
Kiromic believes that, depending on the continued positive response rates from the Phase 1 trial, it may be able to initiate a pivotal Phase 2 study to support a Biologics License Application (BLA) for Deltacel in the second half of 2025.
Isocel and Procel Pipeline Advancement
While Deltacel remains Kiromic's lead program, the company is also advancing its engineered GDT cell therapy candidates, Isocel and Procel, through preclinical development.
Isocel is an allogeneic, engineered GDT cell therapy designed to target a tumor-specific variant of the Mesothelin (Iso-Meso) antigen, which is overexpressed in various solid malignancies. Kiromic plans to submit an Investigational New Drug (IND) application for Isocel in the second half of 2025, pending sufficient financing.
Procel, the company's second engineered candidate, is an allogeneic, engineered GDT cell therapy that targets the PD-L1 antigen and features a PD-1 switch receptor intended to overcome the immunosuppressive tumor microenvironment. Kiromic expects to submit the IND for Procel in 2026, also subject to the availability of adequate funding.
The development of both Isocel and Procel, as well as the continued advancement of Deltacel, will be crucial for Kiromic's long-term success. The company's ability to execute on these pipeline programs will largely depend on its capacity to secure additional financing to support its research and clinical activities.
Risks and Challenges
Kiromic faces several risks and challenges that are common to the biopharmaceutical industry, as well as some unique to its allogeneic cell therapy approach:
1. Clinical Development Risks: The success of Kiromic's product candidates is heavily dependent on the outcomes of its clinical trials. Delays, setbacks, or failures in these trials could significantly impact the company's timeline and financial resources.
2. Regulatory Hurdles: Navigating the complex regulatory landscape for cell therapies, including obtaining necessary approvals from the FDA and other global regulatory bodies, poses a significant challenge for Kiromic.
3. Manufacturing Complexities: The production of allogeneic cell therapies requires specialized expertise and infrastructure, which can be costly and time-consuming to establish and maintain.
4. Financing and Liquidity Concerns: As a clinical-stage company with no approved products and limited revenue, Kiromic's ability to continue as a going concern is heavily dependent on its success in securing additional financing.
5. Competition from Established Players: Kiromic faces competition from larger, well-funded biopharmaceutical companies that are also developing innovative cell therapies for solid tumors.
6. Intellectual Property Challenges: Protecting Kiromic's proprietary technologies and product candidates through a robust intellectual property portfolio is crucial, as the company operates in a highly competitive and fast-paced industry.
7. Legal and Regulatory Scrutiny: In 2021, Kiromic was subject to an internal review by a Special Committee regarding risks associated with its public disclosures, which it voluntarily reported to the SEC. The company subsequently cooperated with requests for information from the SEC. In November 2022, Kiromic received a Grand Jury Subpoena from the U.S. Department of Justice requesting certain information, though the company has not been identified as a target of the investigation.
Despite these challenges, Kiromic's unique approach, experienced management team, and promising clinical data have positioned the company as a potential leader in the allogeneic cell therapy space for solid tumors. The company's ability to navigate these risks and successfully advance its pipeline will be crucial in determining its long-term success.
Conclusion
Kiromic BioPharma is a clinical-stage biotherapeutics company at the forefront of developing innovative allogeneic cell therapies to address the significant unmet need in solid tumor treatments. With its proprietary technologies, integrated platform, and promising clinical data, the company is well-positioned to redefine the landscape of cancer immunotherapy.
However, Kiromic's path forward is not without its challenges, as the company faces clinical, regulatory, manufacturing, and financial hurdles common to the biopharmaceutical industry. The company's ability to secure additional financing and successfully advance its pipeline, particularly its lead candidate Deltacel, will be critical in determining its long-term success.
As Kiromic continues to push the boundaries of what is possible in cell therapy, investors and the broader medical community will keenly watch the company's progress and strategic execution. With its unique approach and unwavering commitment to addressing the needs of cancer patients, Kiromic has the potential to emerge as a trailblazer in the field of solid tumor immunotherapy.