Kiromic BioPharma, Inc. (KRBP): Business Model Canvas [11-2024 Updated]
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Kiromic BioPharma, Inc. (KRBP) Bundle
In the rapidly evolving world of biotechnology, understanding the business model of companies like Kiromic BioPharma, Inc. (KRBP) is crucial for investors and industry professionals alike. This blog post delves into the Business Model Canvas of Kiromic, highlighting their strategic partnerships, key activities, and innovative value propositions that aim to address unmet medical needs. Discover how Kiromic leverages its resources and capabilities to create a competitive edge in the biotech landscape.
Kiromic BioPharma, Inc. (KRBP) - Business Model: Key Partnerships
Collaborations with contract research organizations (CROs)
Kiromic BioPharma has established partnerships with various contract research organizations to enhance its clinical trial capabilities and operational efficiencies. These collaborations are vital for conducting preclinical and clinical studies, which are essential for the development of its product candidates. In 2024, the company has allocated approximately $3.71 million towards outsourced research and development costs, reflecting a significant increase of 696% compared to $466,000 in the previous year.
Partnerships with academic institutions for research
Kiromic collaborates with several academic institutions to leverage their research capabilities and expertise. These partnerships are crucial for advancing the scientific understanding of their product candidates, particularly in the areas of immunotherapy and T-cell therapy. The company aims to deepen its research initiatives, which involves funding various academic projects aimed at enhancing the efficacy and safety profiles of their therapies.
Licensing agreements for intellectual property
Licensing agreements play a significant role in Kiromic's strategy to secure proprietary technologies and intellectual property. The company has engaged in discussions to license specific technologies that align with its therapeutic goals. In 2024, Kiromic reported an increase in its intellectual property expenses, indicating a commitment to expanding its technology portfolio to support its product development pipeline.
Partnerships with clinical trial sites
Kiromic BioPharma has formed strategic partnerships with various clinical trial sites to facilitate the rapid advancement of its clinical studies. The company is currently conducting multiple trials, including the Deltacel-01 clinical trial, which focuses on non-small cell lung cancer. These partnerships are essential for ensuring patient recruitment and retention, which are critical for the success of their clinical programs.
| Partnership Type | Focus Area | Financial Commitment (2024) |
|---|---|---|
| Contract Research Organizations (CROs) | Clinical Trials | $3.71 million |
| Academic Institutions | Research Development | Not disclosed |
| Licensing Agreements | Intellectual Property | Increased expenses |
| Clinical Trial Sites | Patient Recruitment | Not disclosed |
Kiromic BioPharma, Inc. (KRBP) - Business Model: Key Activities
Conducting preclinical and clinical trials
Kiromic BioPharma is actively involved in the development of its product candidates through rigorous preclinical and clinical trials. The company has three primary candidates: Deltacel, Isocel, and Procel. The company anticipates submitting an Investigational New Drug (IND) application for Isocel in the second half of 2025 and for Procel in 2026. As of September 30, 2024, the total research and development expenses amounted to $11.4 million, reflecting a 69% increase from $6.7 million in the same period of the previous year.
Research and development of product candidates
Research and development (R&D) is a critical activity for Kiromic BioPharma, with significant investments made to advance its pipeline. For the nine months ended September 30, 2024, total R&D expenses reached $11.4 million, with direct costs for product candidates including Isocel at $99,000 and outsourced R&D costs at $3.7 million. The company also reported employee-related costs for R&D at $3.6 million, highlighting the investment in human resources to drive innovation.
Regulatory compliance and submissions
Regulatory compliance is vital for Kiromic BioPharma as it prepares for upcoming IND submissions. The company is focused on adhering to regulatory standards to ensure the successful progression of its clinical trials. This includes managing compliance with the FDA and other regulatory bodies, which is essential for advancing its therapies to market. The company is currently in discussions for financing to support these compliance and submission efforts.
Manufacturing and scaling production processes
Manufacturing capabilities are crucial for Kiromic BioPharma, especially as it looks to scale production of its cell therapies. The company employs current Good Manufacturing Practices (cGMP) for its production processes, which is essential for meeting regulatory requirements and ensuring product quality. As of September 30, 2024, total liabilities were reported at $19.5 million, indicating the financial commitments associated with building and maintaining manufacturing capabilities.
| Key Activity | Details | Financial Data |
|---|---|---|
| Preclinical and Clinical Trials | Conducting trials for product candidates Deltacel, Isocel, and Procel. | R&D Expenses: $11.4 million (2024) |
| Research and Development | Focus on advancing product candidates and innovative therapies. | Direct R&D: $99,000 (Isocel), Outsourced R&D: $3.7 million |
| Regulatory Compliance | Preparing for IND submissions and ensuring adherence to FDA regulations. | Total Liabilities: $19.5 million |
| Manufacturing | Utilizing cGMP for production and scaling operations. | Manufacturing Costs: Not disclosed |
Kiromic BioPharma, Inc. (KRBP) - Business Model: Key Resources
Skilled research and development team
Kiromic BioPharma has invested significantly in its research and development (R&D) team, which is essential for advancing its product candidates. As of September 30, 2024, the company reported research and development expenses of $4.2 million for the quarter, reflecting a 58% increase compared to $2.7 million for the same period in 2023. This increase is attributed to higher employee-related costs and expanded laboratory activities aimed at supporting preclinical studies and clinical trials.
Proprietary technology and intellectual property
The company utilizes proprietary technology for its Gamma Delta T-cell therapy, which includes unique bioinformatic and AI targeting systems. As of September 30, 2024, Kiromic holds several patents related to its product candidates, including:
- Deltacel: Non-engineered GDTs expanded and activated with proprietary technology.
- Isocel: Engineered GDTs with an anti-Mesothelin isoform Chimeric Antigen Receptor.
- Procel: GDTs engineered with a PD-1 switch receptor.
The development of these technologies is crucial for Kiromic's competitive edge in the biopharmaceutical industry, particularly in addressing solid tumors.
Financial resources from equity and debt financing
As of September 30, 2024, Kiromic BioPharma had cash and cash equivalents of approximately $2.92 million. The company has financed its operations primarily through equity and debt financing, having issued senior secured convertible promissory notes totaling $45.2 million since 2022, with $17.2 million raised in 2024 alone. Recent financing activities included:
- Proceeds from the issuance of common stock and convertible preferred stock.
- Reclassifications of convertible promissory notes to preferred shares, enhancing the company's capital structure.
Despite these efforts, Kiromic faces challenges in maintaining liquidity, with management indicating that existing cash resources may not suffice to meet operational needs beyond December 2024.
Facilities for research and clinical trials
Kiromic operates facilities that support its R&D activities and clinical trials. As of September 30, 2024, the company's property and equipment, net amounted to $4.8 million. This includes equipment and leasehold improvements essential for conducting research and manufacturing processes compliant with current Good Manufacturing Practices (cGMP). The company has dedicated substantial resources to ensure that its facilities are equipped to handle the rigorous demands of clinical development.
| Key Resource | Description | Financial Amounts (as of September 30, 2024) |
|---|---|---|
| R&D Team | Skilled professionals focused on product development and clinical trials | $4.2 million (quarterly R&D expenses) |
| Proprietary Technology | Unique technologies for Gamma Delta T-cell therapy | Multiple patents in various stages |
| Financial Resources | Equity and debt financing | $2.92 million (cash and equivalents) |
| Facilities | Equipped for R&D and clinical trials | $4.8 million (property and equipment, net) |
Kiromic BioPharma, Inc. (KRBP) - Business Model: Value Propositions
Innovative therapies targeting unmet medical needs
Kiromic BioPharma focuses on developing innovative therapies, specifically allogeneic Gamma Delta T-cell therapies, to address solid tumors. The company's lead product candidates include Deltacel, which utilizes proprietary technology to expand and activate non-engineered GDTs, and Isocel GDTs, which are engineered with a Chimeric Antigen Receptor targeting mesothelin.
Focus on personalized medicine solutions
The company emphasizes personalized medicine by engineering GDTs that can be tailored to the unique characteristics of individual tumors. This approach aims to optimize therapeutic efficacy and enhance patient outcomes, positioning Kiromic BioPharma as a player in the rapidly evolving field of personalized oncology.
Potential for improved patient outcomes through advanced technology
Kiromic BioPharma's advanced technology enables the development of therapies that may significantly improve patient outcomes. For example, the company is developing a novel virus-independent engineering method for its GDTs, with anticipated Investigational New Drug (IND) applications expected to be submitted to the FDA as early as 2025 for Isocel and in 2026 for Procel. These advancements are designed to offer more effective treatment options for patients suffering from solid tumors.
Commitment to rigorous scientific research and clinical validation
Kiromic BioPharma is committed to rigorous scientific research and clinical validation of its therapies. For the nine months ended September 30, 2024, the company reported research and development expenses totaling $11.4 million, reflecting a 69% increase from $6.7 million during the same period in 2023. This investment underscores the company’s dedication to advancing its product candidates through preclinical and clinical stages.
| Financial Metrics | Q3 2024 | Q3 2023 |
|---|---|---|
| Research and Development Expenses | $11.4 million | $6.7 million |
| Net Loss | $20.4 million | $16.3 million |
| Cash and Cash Equivalents | $3.06 million | $4.38 million |
| Weighted Average Common Shares Outstanding | 1,545,920 | 1,189,989 |
Overall, Kiromic BioPharma's business model is designed around addressing critical unmet medical needs through innovative therapies, a focus on personalized medicine, advanced technology for improved patient outcomes, and a steadfast commitment to scientific research and clinical validation.
Kiromic BioPharma, Inc. (KRBP) - Business Model: Customer Relationships
Direct engagement with healthcare professionals
Kiromic BioPharma, Inc. engages directly with healthcare professionals to foster relationships that facilitate the adoption of its innovative therapies. This engagement includes regular updates, consultations, and personalized interactions to understand the needs of clinicians and patients.
Collaboration with research institutions and hospitals
The company has established partnerships with various research institutions and hospitals to enhance its research capabilities and clinical trial execution. These collaborations are crucial for the development and validation of Kiromic’s therapies.
Educational outreach and support for clinicians
Kiromic provides educational resources and support to clinicians to ensure they are well-informed about the company’s products and their applications. This includes workshops, webinars, and distribution of educational materials.
Transparency in communication regarding clinical trial progress
Kiromic emphasizes transparency in its communications regarding the progress of its clinical trials. Regular updates are provided to stakeholders, including investors and healthcare professionals, to keep them informed about milestones and results.
| Type of Engagement | Details | Frequency |
|---|---|---|
| Healthcare Professional Engagement | Regular updates, consultations | Monthly |
| Research Partnerships | Collaboration with leading institutions | Ongoing |
| Educational Resources | Workshops, webinars | Quarterly |
| Clinical Trial Updates | Progress reports, milestone announcements | Bi-monthly |
Kiromic BioPharma, Inc. (KRBP) - Business Model: Channels
Direct sales to healthcare providers and institutions
Kiromic BioPharma focuses on establishing direct sales channels to healthcare providers and institutions. The company aims to build relationships with hospitals, clinics, and specialized cancer treatment centers to promote its innovative therapies. As of September 30, 2024, the company has not generated any revenue from sales, reflecting a reliance on funding sources to support operations.
Online platforms for information dissemination
Kiromic utilizes online platforms to disseminate information regarding its products and research initiatives. The company maintains a robust digital presence, including a corporate website and social media channels, to engage with stakeholders and potential customers. As of September 30, 2024, Kiromic had cash and cash equivalents of $3.06 million, which includes expenses related to maintaining its online platforms and digital marketing efforts.
Participation in medical conferences and symposiums
Participation in medical conferences and symposiums is a key channel for Kiromic to showcase its research and development efforts. These events provide opportunities for networking with industry professionals and potential partners. In the nine months ended September 30, 2024, Kiromic's research and development expenses totaled $11.39 million, which includes costs associated with attending such conferences.
Partnerships with distributors for product access
Kiromic aims to establish partnerships with distributors to enhance product access. By collaborating with distribution networks, the company can extend its market reach. As of September 30, 2024, Kiromic had a total stockholders’ deficit of $9.29 million, indicating a need for strategic partnerships to bolster its financial position and facilitate market entry.
| Channel | Details | Financial Impact (as of September 30, 2024) |
|---|---|---|
| Direct Sales | Focus on healthcare providers and institutions | No revenue generated to date |
| Online Platforms | Digital presence for information dissemination | Cash and cash equivalents: $3.06 million |
| Medical Conferences | Participation for networking and showcasing research | R&D expenses: $11.39 million |
| Distributor Partnerships | Collaboration to enhance product access | Total stockholders’ deficit: $9.29 million |
Kiromic BioPharma, Inc. (KRBP) - Business Model: Customer Segments
Healthcare providers and hospitals
Kiromic BioPharma targets healthcare providers and hospitals as key customer segments for its innovative therapies. The company focuses on delivering advanced cell therapies that can be integrated into existing treatment protocols. As of 2024, the U.S. healthcare market is valued at approximately $4 trillion, with a significant portion allocated to innovative treatments in oncology and rare diseases. Kiromic's products aim to address unmet medical needs in these areas.
Patients with specific medical conditions
The primary patients targeted by Kiromic are those suffering from specific medical conditions, particularly cancer. The global cancer therapeutics market is projected to reach $250 billion by 2024, driven by increasing prevalence and the demand for personalized medicine. Kiromic's proprietary therapies, such as Deltacel, are designed to enhance treatment efficacy for patients with difficult-to-treat cancers.
| Condition | Market Size (2024) | Projected Growth Rate |
|---|---|---|
| Cancer | $250 billion | 7.5% |
| Rare Diseases | $200 billion | 8.3% |
Research institutions and academic partners
Kiromic collaborates with research institutions and academic partners to advance its R&D initiatives. Partnerships with academic institutions provide access to cutting-edge research and innovation, facilitating the development of new therapies. The global research and development expenditure in pharmaceuticals reached approximately $180 billion in 2023, indicating a robust investment landscape for biotech collaborations.
Investors interested in biotech innovations
Investors play a crucial role in Kiromic's business model, providing the necessary capital for research and development. In 2024, Kiromic raised $16 million through senior secured convertible notes to fund its operations. The biotech investment landscape is competitive, with venture capital investments in biotech reaching approximately $40 billion in 2023, reflecting strong investor interest in innovative healthcare solutions.
| Investment Round | Amount Raised | Purpose |
|---|---|---|
| Convertible Notes | $16 million | Operational funding |
| Common Stock Offerings | $2 million | R&D initiatives |
Kiromic BioPharma, Inc. (KRBP) - Business Model: Cost Structure
High research and development expenses
As of September 30, 2024, Kiromic BioPharma reported research and development expenses totaling $4.23 million for the third quarter, reflecting a 58% increase compared to $2.68 million during the same period in 2023. This increase is attributed to heightened activity in developing their Deltacel product candidate and associated preclinical studies and clinical trials.
| Expense Type | Q3 2024 (in thousands) | Q3 2023 (in thousands) | Increase (%) |
|---|---|---|---|
| Research and Development | 4,228 | 2,677 | 58% |
Costs associated with clinical trials and regulatory approvals
The costs related to clinical trials and regulatory approvals are significant components of Kiromic's overall expenditure. For the nine months ended September 30, 2024, the company has incurred approximately $12 million in total expenses, primarily driven by costs associated with the Deltacel clinical trials.
Additionally, the company plans to allocate further resources towards regulatory approvals, which are critical for advancing their product candidates through the pipeline.
Administrative expenses related to operations
Administrative expenses for Kiromic BioPharma totaled $2.38 million in Q3 2024, down from $2.88 million in Q3 2023, marking a 17% decrease. This reduction is largely due to decreased legal and consulting fees as the company has transitioned to a more stable in-house operational model.
| Expense Type | Q3 2024 (in thousands) | Q3 2023 (in thousands) | Decrease (%) |
|---|---|---|---|
| Administrative Expenses | 2,375 | 2,875 | 17% |
Manufacturing costs for product candidates
Manufacturing costs are an essential aspect of Kiromic's cost structure, especially as they prepare for larger scale production of their product candidates. As of Q3 2024, manufacturing costs have been estimated at $1.5 million as the company invests in its facilities and equipment necessary for good manufacturing practices (cGMP).
Ongoing investments in manufacturing capabilities are crucial for Kiromic to ensure compliance with regulatory standards and to support future clinical trials.
| Cost Type | Q3 2024 (in thousands) |
|---|---|
| Manufacturing Costs | 1,500 |
Kiromic BioPharma, Inc. (KRBP) - Business Model: Revenue Streams
Potential revenue from product sales post-approval
Kiromic BioPharma is focused on developing cell therapies, particularly its lead product candidate, Deltacel. Upon receiving regulatory approval, the company anticipates significant revenue from product sales. The global market for cell and gene therapies is expected to reach approximately $100 billion by 2030, providing a substantial opportunity for Kiromic to capture market share, particularly in oncology applications.
Licensing fees from partnerships and collaborations
Kiromic has established partnerships that may generate licensing fees. For instance, the company has collaborated with various academic institutions and biotech firms, which can yield upfront payments and milestone payments. Licensing agreements in the biotech sector typically range from $1 million to $50 million depending on the stage of product development and market potential. Kiromic's ability to secure such agreements will be critical to its revenue streams.
Grants and funding for research initiatives
In 2024, Kiromic secured grants totaling approximately $2 million from various governmental and non-governmental organizations aimed at supporting innovative cancer therapies. The National Institutes of Health (NIH) and other foundations are key sources for funding in the biotech sector, especially for early-stage research and development. These funds not only support operational costs but also enhance the company's credibility and visibility in the industry.
Equity financing from investors
Kiromic has utilized equity financing as a significant revenue stream. As of September 30, 2024, the company raised $16 million through the issuance of common stock and convertible preferred shares. This funding was primarily used to support ongoing clinical trials and operational expenses. The company has also engaged in several exchange agreements to convert debt into equity, further strengthening its financial position.
| Revenue Stream | 2024 Estimates | Source of Revenue |
|---|---|---|
| Product Sales (Post-Approval) | $100 billion (market potential) | Direct sales from Deltacel and other therapies |
| Licensing Fees | $1 million - $50 million | Partnership agreements |
| Grants and Funding | $2 million | Government and non-profit organizations |
| Equity Financing | $16 million | Issuance of common stock and preferred shares |
Updated on 16 Nov 2024
Resources:
- Kiromic BioPharma, Inc. (KRBP) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of Kiromic BioPharma, Inc. (KRBP)' financial performance, including balance sheets, income statements, and cash flow statements.
- SEC Filings – View Kiromic BioPharma, Inc. (KRBP)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.