Kiromic BioPharma, Inc. (KRBP): SWOT Analysis [Nov-2025 Updated]

You're looking for a clear-eyed view of Kiromic BioPharma, Inc. (KRBP), and honestly, the picture is defintely stark: the company filed for Chapter 7 bankruptcy in April 2025, so the analysis shifts entirely from operational viability to asset valuation. Your primary takeaway should be that the company's value now rests almost entirely on the sale of its intellectual property (IP) and clinical data, not its ability to continue operations, especially after reporting a significant net loss of $26.9 million for the 2024 fiscal year. With the market already pricing in failure-evidenced by the tiny market capitalization of about $7.85K as of November 2025-the only remaining opportunity is the potential residual value from the sale of valuable assets like the DIAMOND® AI 2.0 platform and the promising Deltacel Phase 1 data. We need to map the risks and opportunities of this liquidation process, not a business plan.

Kiromic BioPharma, Inc. (KRBP) - SWOT Analysis: Strengths

Allogeneic (off-the-shelf) Gamma Delta T-cell (GDT) platform is a valuable asset.

Kiromic BioPharma's core strength is its allogeneic (donor-derived, or off-the-shelf) Gamma Delta T-cell (GDT) platform. This approach is a significant advantage over patient-specific (autologous) cell therapies, which are complex to manufacture. The allogeneic model allows for mass production, creating a ready-to-use inventory that drastically cuts down the time a critically ill patient has to wait for treatment. This is a huge logistical and clinical differentiator. The global allogeneic cell therapy market is projected to reach a value of $1.55 billion in 2025, underscoring the commercial potential of this platform.

Proprietary DIAMOND® AI 2.0 target discovery engine for new therapies.

The proprietary DIAMOND® artificial intelligence (AI) 2.0 platform is the engine driving Kiromic BioPharma's pipeline. This AI-driven system uses big data and machine learning to identify novel, cancer-selective targets for immuno-oncology therapies. By leveraging AI, the company can dramatically compress the timeline and cost of drug development, moving from target identification to a viable therapeutic candidate much faster than traditional methods. This technology provides a competitive edge in continually refreshing the product pipeline with new, high-potential candidates like Procel™ and Isocel™.

Deltacel (KB-GDT-01) Phase 1 trial showed favorable 10-month progression-free survival.

The initial clinical data from the Deltacel-01 Phase 1 trial in stage 4 metastatic non-small cell lung cancer (NSCLC) is highly encouraging, especially for a first-in-human study. As of early 2025, one patient reached a 10-month Progression-Free Survival (PFS), meaning their cancer did not grow or spread during that period. Another patient, at the 12-month follow-up visit in January 2025, showed a remarkable 33.33% reduction in tumor volume, achieving a partial response. This level of durable response in late-stage cancer patients who have failed multiple prior treatments is a strong validation of the GDT platform's therapeutic potential.

• Patient 4 PFS: 10 months as of January 2025.
• Patient 1 Tumor Reduction: 33.33% at 12-month follow-up (Partial Response) as of January 2025.
• Average PFS (5 evaluable patients): 4.8 months (range, 2-8) as of August 2024.

FDA Fast Track Designation for Deltacel received in August 2024.

Receiving the U.S. Food and Drug Administration (FDA) Fast Track Designation for Deltacel (KB-GDT-01) in August 2024 is a major regulatory milestone. This designation is for use in combination with low-dose radiation therapy for metastatic NSCLC patients who have progressed on at least two lines of standard-of-care therapy. The Fast Track status allows for more frequent communication with the FDA and a potential for priority review and rolling submission of the Biologics License Application (BLA), which could significantly accelerate Deltacel's path to market. It signals the FDA's recognition of Deltacel's potential to address a serious, unmet medical need.

GDT therapies avoid the complex, costly manufacturing of autologous CAR-T.

The allogeneic nature of Kiromic BioPharma's GDT platform bypasses the logistical and financial bottlenecks of personalized (autologous) Chimeric Antigen Receptor T-cell (CAR-T) therapy. Autologous products require a complex, patient-by-patient manufacturing process that typically takes 1-2 weeks (ex vivo cell manipulation), plus transportation and testing time, creating a long wait for the patient. Allogeneic GDT products, by contrast, are manufactured in large batches from healthy donors and are readily available as off-the-shelf inventory. This scalability dramatically lowers the Cost of Goods Sold (COGS) per dose, making the therapy more accessible and affordable.

Here's the quick math on the manufacturing cost difference:

Kiromic BioPharma, Inc. (KRBP) - SWOT Analysis: Weaknesses

Filed for Chapter 7 Bankruptcy in March 2025, Halting All Operations

The single most critical weakness, and frankly, the terminal event for the company, was the filing of a voluntary petition for relief under Chapter 7 of the U.S. Bankruptcy Code on March 21, 2025. This is a liquidation bankruptcy, not a restructuring, which immediately ceased all corporate operations and clinical development activities.

This action dissolved the Board of Directors and terminated key executives, including the Chief Financial Officer and Chief Operating Officer. For investors and stakeholders, this means the company's value proposition is now limited to the liquidation of its remaining assets, a process overseen by a court-appointed Chapter 7 trustee.

Substantial Doubt About Going Concern Cited in February 2025 10-K

The bankruptcy wasn't a surprise; the financial distress was clearly flagged months earlier. The company's Annual Report on Form 10-K, filed on February 14, 2025, for the fiscal year ended December 31, 2024, explicitly stated there was 'substantial doubt about its ability to continue as a going concern.'

This is the financial analyst's alarm bell. The company's cash and cash equivalents were only $1.80 million as of December 31, 2024, including $658 thousand of restricted cash, which was insufficient to fund operations beyond March 2025 without securing additional capital. Honestly, when a company's own auditors raise this flag, you need to act fast.

Significant Net Loss for Fiscal Year 2024

The company's inability to secure financing stemmed directly from its persistent and growing losses. For the fiscal year ending December 31, 2024, Kiromic BioPharma reported a significant net loss of approximately $26.9 million (specifically, $26.898 million). This loss was a 28% increase from the previous year's net loss of $20.9 million, showing a rapidly accelerating cash burn.

Here's the quick math on the major expense drivers for 2024:

The spike in clinical trials expenses to $8.1 million and a massive 101% increase in interest expense to $3.723 million were clear signs of a company spending heavily on R&D while relying on increasingly expensive debt to stay afloat.

Trading on the OTC Markets as KRBPQ with a Tiny Market Capitalization

The stock's current trading status reflects the complete collapse of the business. Post-bankruptcy, the stock trades on the OTC Markets under the ticker KRBPQ. As of November 2025, the market capitalization is negligible, hovering around $471. To be fair, this is a liquidation situation, so the market cap is essentially the residual value of a defunct company.

This tiny valuation makes the stock illiquid and highly speculative, a classic sign of a company in the final stages of asset disposition. The stock price, for context, had decreased by -99.99% in the year leading up to November 2025.

Past Regulatory Issues: December 2024 SEC Charge and Settlement

Beyond the financial and operational failures, the company had a significant regulatory black mark. On December 3, 2024, the Securities and Exchange Commission (SEC) filed settled charges against Kiromic BioPharma and two former executives for misleading investors.

The core issue was the company's failure to disclose crucial information about the status of its drug candidates:

• The SEC found that Kiromic BioPharma did not disclose that the FDA had placed 'clinical holds' on two of its Investigational New Drug (IND) applications-ALEXIS-PRO-1 and ALEXIS-ISO-1.
• This non-disclosure occurred just weeks before a July 2021 public offering that raised $40 million.
• The company's former CEO and CFO agreed to pay civil penalties of $125,000 and $20,000, respectively, to settle the charges.

While the company itself avoided a civil penalty due to its self-reporting and cooperation, this regulatory failure defintely eroded investor trust and pointed to serious deficiencies in disclosure controls and corporate governance years before the bankruptcy.

Kiromic BioPharma, Inc. (KRBP) - SWOT Analysis: Opportunities

You're looking at a classic biotech liquidation scenario, but the assets themselves hold real, tangible value for an acquirer. The opportunity here isn't in a turnaround-that ship sailed with the Chapter 7 filing in March 2025-it's in the immediate, high-quality intellectual property (IP) and clinical data that a larger, solvent entity can immediately use. This is a fire sale of promising oncology assets, not a complete write-off.

IP and clinical data sale could provide a return to creditors and potentially residual equity value.

The primary financial opportunity was the successful sale of substantially all assets, including the core IP and clinical data, to Immunocell Therapeutics, Inc. The sale was approved by the U.S. Bankruptcy Court on April 14, 2025, for a total consideration dominated by a secured creditor's claim. The transaction value was a $5 million credit bid plus $0.25 million in cash and assumed liabilities. This sale directly addressed the secured debt of the largest creditor, Shannon Ralston, and her subsidiaries. Honestly, that's the only real return here.

For unsecured creditors and common equity holders (KRBP), the opportunity for a meaningful return is virtually nonexistent. In a Chapter 7 liquidation, the secured debt is paid first, and the sale price was largely a credit bid against that debt. The company's market capitalization had already shrunk to just $1.49 million prior to the March 21, 2025, bankruptcy filing, so residual equity value is defintely a long shot, if not zero.

An acquirer can integrate the DIAMOND® AI 2.0 platform into a larger oncology pipeline.

The proprietary DIAMOND® AI 2.0 platform is an artificial intelligence (AI) engine for immuno-oncology target discovery. This technology is a critical, non-dilutive asset for the acquirer, Immunocell Therapeutics, Inc. The platform's value lies in its ability to dramatically compress the time and capital required for preclinical development by identifying novel targets faster than traditional methods. A larger biotech can integrate this AI engine into its existing infrastructure, immediately boosting its research and development (R&D) efficiency and providing a competitive edge in the crowded oncology space. This is a pure technology acquisition.

Deltacel's Phase 1 data, showing tumor volume decrease, offers a clear path for a larger biotech to restart development.

The Deltacel program, an allogeneic (off-the-shelf) Gamma Delta T-cell therapy for non-small cell lung cancer (NSCLC), has generated compelling Phase 1 data that significantly de-risks the asset for a new owner. The clinical results from the Deltacel-01 trial are the most valuable part of the IP package.

• Patient 1: Achieved a 33.33% tumor volume reduction at the 12-month follow-up.
• Patient 4: Showed an approximately 32% decrease in tumor volume at the eight-month follow-up.
• Both patients achieved a partial response (PR) in late-stage metastatic NSCLC.

For a larger company, this data provides a clear path to restart development without the initial costs and risks of preclinical work and early-stage safety trials. The 15-month progression-free survival achieved by the first patient is a significant metric in this patient population, which typically has a much shorter survival rate.

Allogeneic cell therapy market growth allows an acquirer to bypass early-stage risk.

The allogeneic cell therapy market-which uses cells from healthy donors, making them 'off-the-shelf'-is one of the fastest-growing segments in oncology. Acquiring Deltacel's Phase 1 data allows Immunocell Therapeutics, Inc. to bypass the riskiest, most capital-intensive phase of development and jump straight into a de-risked asset in a high-growth market.

• The global allogeneic cell therapy market is projected to be valued at approximately $1.55 billion in 2025.
• Allogeneic platforms are forecast to grow at a Compound Annual Growth Rate (CAGR) of 12.56% through 2030.

This market growth, coupled with the lower manufacturing cost and ready availability of allogeneic products compared to autologous (patient-specific) therapies, makes Deltacel an attractive, ready-made entry point for the new owner.

Cost reduction actions, like delaying R&D expenditures, are now fully realized via Chapter 7 liquidation.

The ultimate cost-reduction action was the Chapter 7 bankruptcy filing on March 21, 2025. This move immediately ceased all operations, terminated all employees and executives, and eliminated all future R&D expenditures and associated overhead. The acquirer, Immunocell Therapeutics, Inc., is now able to acquire the core assets-the IP and clinical data-without inheriting the massive debt, burn rate (last 12-month Free Cash Flow was a negative $19.8 million in Q4 2024), or legacy operational costs of the former entity. The operational clean slate is a major financial advantage for the new owner.

Kiromic BioPharma, Inc. (KRBP) - SWOT Analysis: Threats

You're looking at Kiromic BioPharma, Inc.'s situation, and the hard truth is that the threats have already materialized into a corporate failure. The March 2025 Chapter 7 bankruptcy filing means the company is liquidating, and the remaining value is now a question for the bankruptcy trustee, not the market.

Here's the quick math: with a market cap of $7.85K and a 2024 net loss of $26.9 million, the market has already priced in failure. The only action is monitoring the bankruptcy proceedings for asset sale details.

Liquidation process will likely extinguish all common shareholder value.

The filing for Chapter 7 bankruptcy protection on March 21, 2025, initiated a complete liquidation of the company's assets. In a Chapter 7 scenario, the liquidation proceeds are distributed according to a strict hierarchy of claims, starting with secured creditors, then unsecured creditors, and finally, equity holders. Common shareholders are at the very bottom of this priority ladder.

Given the company's financial distress-evidenced by the massive 2024 net loss of $26.9 million-it is defintely a near certainty that the proceeds from the sale of assets, primarily intellectual property (IP), will be insufficient to satisfy even the senior creditors. This means common shareholders will receive nothing for their investment.

• Filing Date: March 21, 2025.
• Process: Chapter 7 liquidation of all assets.
• Shareholder Risk: Near-total loss of common stock value.

Key talent and institutional knowledge are lost following the Chapter 7 filing.

The immediate and complete loss of the entire executive leadership team and Board of Directors on the day of the bankruptcy filing ensures the immediate halt of all operations and the loss of critical institutional knowledge. The Board of Directors, including Pietro Bersani, Michael Nagel, Mike Catlin, and Pamela Misajon, all resigned effective March 21, 2025.

Also, the company terminated its key operational officers: Brian Hungerford (Chief Financial Officer), Leonardo Mirandola (Chief Operating Officer), and Scott Dahlbeck (Chief of Staff). This means there is no remaining internal team to manage or transition the company's scientific data, manufacturing protocols, or regulatory filings, severely degrading the value of the assets being sold by the appointed trustee.

The Deltacel Phase 1 trial is now paused or terminated, risking data degradation and loss of momentum.

The company's primary asset, the allogeneic, off-the-shelf Gamma Delta T-cell (GDT) therapy Deltacel (KB-GDT-01), was in a Phase 1 clinical trial (Deltacel-01) for non-small cell lung cancer. As recently as January 2025, the company reported encouraging results, including a patient with a 33.33% reduction in tumor volume at the 12-month follow-up.

But, the Chapter 7 filing in March 2025 means all clinical operations have ceased. The trial is effectively terminated, and the proprietary data from the Deltacel-01 study is now static. This cessation creates a massive risk of data degradation, loss of patient follow-up, and obsolescence, dramatically reducing the value of the Deltacel IP for any potential buyer.

Highly competitive allogeneic cell therapy space with larger, better-funded rivals like Allogene Therapeutics.

Even if Kiromic BioPharma had survived, its technology faced an intensely competitive field dominated by significantly better-funded rivals. The financial disparity is stark, illustrating the impossibility of Kiromic continuing its research and development (R&D) efforts.

Here is a direct financial comparison using the latest 2025 data for a key competitor, Allogene Therapeutics:

Allogene Therapeutics has a cash runway into the second half of 2027, giving them years of operational certainty to advance their pivotal Phase 2 trial. Kiromic BioPharma simply ran out of money before it could move beyond early-stage trials, a common but fatal threat in biotech.

The negative perception from the SEC investigation could taint the value of the IP assets for sale.

The company's history of regulatory issues, specifically the December 2024 settlement with the Securities and Exchange Commission (SEC), creates a negative overhang. The SEC charged the company for misleading investors in a July 2021 public offering by failing to disclose that the FDA had placed clinical holds on two of its drug candidates, ALEXIS-PRO-1 and ALEXIS-ISO-1.

While the company itself was not ordered to pay a civil penalty due to its self-reporting and cooperation, the former CEO and CFO were fined $125,000 and $20,000, respectively. This history of disclosure failures can make potential buyers of the Deltacel IP wary, as they must conduct extra due diligence to ensure the IP's regulatory history and supporting data are clean and fully disclosed, potentially leading to a lower sale price in the liquidation process.