Kiromic BioPharma, Inc. (OTCQB: KRBP) is an allogeneic Gamma Delta T-cell therapy company that is developing innovative, proprietary end-to-end bioinformatic, AI targeting, and manufacturing technologies to address solid tumors. The company's comprehensive approach spans target discovery and validation, product development, and on-site current good manufacturing practices (cGMP), positioning it to leverage a new framework for the next generation of cell therapies.

Business Overview

Kiromic BioPharma is focused on utilizing non-engineered and engineered Gamma Delta T cell (GDT) technologies to develop novel therapies for solid tumors. The company's lead product candidate, Deltacel™️, is an allogeneic, off-the-shelf non-engineered GDT cell-based product currently in a Phase 1 clinical trial. Additionally, the company is developing two engineered GDT product candidates, Procel™️ and Isocel™️, which are in the preclinical development stage.

Deltacel™️ consists of non-engineered GDTs that are expanded, enriched, and activated ex-vivo through a proprietary process, with the goal of treating solid tumors regardless of the specific tumor antigen expression. Procel™️ comprises engineered GDTs that target PD-L1, while Isocel™️ consists of engineered GDTs that target a tumor-specific variant (Isoform) of Mesothelin.

Kiromic BioPharma currently has five clinical programs to study its key product candidates:

1. Deltacel-01: A Phase 1 clinical trial evaluating Deltacel™️ in combination with low-dose targeted radiation for patients with stage 4 non-small cell lung cancer (NSCLC). 2. Isocel combination: A planned Phase 1 clinical trial to evaluate Isocel™️ in combination with low-dose radiation for patients with Mesothelin Isoform 2 positive solid malignancies. 3. Alexis-ISO-1: A planned Phase 1 clinical trial to evaluate Isocel™️ in patients with Mesothelin Isoform 2 positive solid malignancies. 4. Procel combination: A planned Phase 1 clinical trial to evaluate Procel™️ in combination with low-dose radiation for patients with PD-L1 positive solid malignancies. 5. Alexis-PRO-1: A planned Phase 1 clinical trial to evaluate Procel™️ in patients with PD-L1 positive solid malignancies.

Financials

Kiromic BioPharma is a clinical-stage company and has not generated any revenue to date. The company reported an annual net loss of $21,294,000 for the fiscal year ended December 31, 2023, with an annual operating cash flow of -$21,225,300 and an annual free cash flow of -$21,431,900.

For the three months ended March 31, 2024, the company reported a net loss of $6,148,000, with research and development expenses of $3,022,000 and general and administrative expenses of $2,091,000. The company's cash and cash equivalents stood at $3,676,000 as of March 31, 2024.

Liquidity

Kiromic BioPharma's current cash and cash equivalents, combined with verbal, non-contractual commitments for additional financing, are not sufficient to meet the company's operating and liquidity needs beyond July 2024. This condition raises substantial doubt about the company's ability to continue as a going concern.

The company is currently in discussions with financing sources in an attempt to secure short-term financing to continue operations and fund other liquidity needs through the end of the year. Management may also evaluate various cost reduction actions, including possible reductions in the company's workforce and suspending research and development expenditures on one or more product candidates, in order to reduce expenditures and preserve cash. However, the company is limited in its ability to reduce expenditures for known contractual obligations.

Clinical Update

In the second half of 2022, Kiromic BioPharma started the development of Deltacel, its novel, non-engineered GDT cell product. The company submitted the IND application for the Deltacel-01 trial in March 2023 and received authorization from the FDA to proceed with the study in April 2023. The company began the clinical trial activation process during the second quarter of 2023 and has since entered into a clinical trial agreement with Beverly Hills Cancer Center (BHCC) to conduct the Deltacel-01 Phase 1 Study in patients with stage 4 NSCLC.

The first patient in the Deltacel-01 trial received the first dose of Deltacel at BHCC on December 13, 2023. The company has reported no dose-limiting toxicities to date and a favorable preliminary outcome showing stabilization of disease at the 6-week follow-up, and a reduction of the tumor lesion at the two-month follow-up. Such favorable condition persists as of the 4-month follow-up visit. Kiromic BioPharma has since enrolled four additional patients at BHCC between January and April 2024 and expects to enroll one more patient in May 2024.

The company's ability to continue the development of Isocel and Procel and submit the Isocel and Procel INDs by the first half of 2025 is subject to obtaining sufficient financing to support the progression of the development of these additional clinical trial candidates.

Regulatory Pathway and Potential Milestones

Kiromic BioPharma is considering two primary pathways to advance the clinical development of Deltacel:

1. Pursuing Fast Track designation concurrent with the ongoing Deltacel-01 Phase 1 study, which could be followed by a pivotal Phase 2 trial and subsequent submission of a Biologics License Application (BLA). 2. Completing the Phase 1 trial, followed by a seamless Phase 2-3 trial to support a BLA application.

By June 2024, the company anticipates acquiring substantial clinical evidence to support a Fast Track designation application, with an expected FDA response within sixty days of the application. If granted, Fast Track designation would offer benefits such as Accelerated Approval, Rolling Review, and Priority Review, which could accelerate the approval process.

In the mid-term development trajectory of Deltacel, provided there is a continued absence of toxicities and promising preliminary clinical evidence, Kiromic BioPharma may also apply for Breakthrough Therapy Designation (BTD) in 2025, ahead of the conclusion of the Deltacel-01 Phase 1 trial.

Risks and Challenges

Kiromic BioPharma faces several risks and challenges, including:

1. Slow or delayed IND applications and clinical trial enrollment. 2. Patent reinforcement and prosecution. 3. Changes in laws or the regulatory environment affecting the company. 4. Ability to secure sufficient financing to continue operations and fund future development.

The company's current liquidity position and the substantial doubt about its ability to continue as a going concern are significant concerns that the management team is actively working to address through financing discussions and potential cost reduction measures.

Conclusion

Kiromic BioPharma is a promising allogeneic Gamma Delta T-cell therapy company that is leveraging its unique, proprietary end-to-end technologies to develop novel treatments for solid tumors. The company's lead product candidate, Deltacel™️, has shown favorable preliminary results in its ongoing Phase 1 clinical trial, and the company is exploring regulatory pathways to accelerate its development.

However, Kiromic BioPharma faces significant liquidity challenges and substantial doubt about its ability to continue as a going concern. The company's ability to secure additional financing and effectively manage its cash resources will be crucial in determining its long-term success. Investors should closely monitor the company's progress in addressing its liquidity situation and the continued development of its promising pipeline of cell therapy candidates.