INmune Bio, Inc. (INMB): Business Model Canvas [10-2024 Updated]

Discover how INmune Bio, Inc. (INMB) is revolutionizing cancer treatment with its innovative business model. By leveraging key partnerships, cutting-edge technology, and a focused approach to patient care, INmune Bio is poised to make significant strides in the field of immunotherapy. Explore the essential elements of their Business Model Canvas and see how they plan to enhance the lives of cancer patients through groundbreaking therapies.

INmune Bio, Inc. (INMB) - Business Model: Key Partnerships

Collaborations with clinical trial sites

INmune Bio has established partnerships with multiple clinical trial sites to facilitate the execution of its studies. For instance, the company is currently conducting a Phase 2 study of XPro1595, which focuses on treatment-resistant depression. The financial support for this study includes a grant of up to $2.9 million awarded by the National Institutes of Health (NIH).

Agreements with contract manufacturers for cGMP stem cells

INmune Bio relies on contract manufacturers to produce cells under current Good Manufacturing Practices (cGMP). This is crucial for ensuring that their therapeutic products meet regulatory standards. The company has incurred significant costs related to manufacturing, which are part of their broader research and development expenses, amounting to approximately $25.8 million for the nine months ended September 30, 2024.

Partnerships with academic institutions for research and trials

Collaborations with academic institutions are a vital component of INmune Bio's strategy for research and trials. They have licensing agreements, such as the one with the University of Pittsburgh, which involves annual maintenance fees starting at $25,000 and a royalty of 2.5% on net sales once commercialization begins.

Relationships with biopharma companies for therapeutic development

INmune Bio has formed strategic alliances with biopharma companies like Xencor, Inc., which allows them to leverage proprietary technologies for developing new therapies. Under their agreement, INmune Bio pays a 5% royalty on net sales of licensed products, contributing to the financial framework of their collaborative efforts.

Partnership Type	Details	Financial Implications
Clinical Trial Sites	Collaboration for Phase 2 study of XPro1595	NIH grant of up to $2.9 million
Contract Manufacturers	cGMP production of stem cells	Research and development expenses of $25.8 million (9M 2024)
Academic Institutions	University of Pittsburgh licensing agreement	$25,000 annual fee; 2.5% royalty on net sales
Biopharma Companies	Strategic alliance with Xencor	5% royalty on net sales of licensed products

INmune Bio, Inc. (INMB) - Business Model: Key Activities

Conducting clinical trials for cancer therapies

INmune Bio is actively involved in conducting clinical trials aimed at developing therapies for various cancers. For the nine months ended September 30, 2024, the company reported an increase in clinical trial-related expenses, primarily due to advancements in its Alzheimer’s clinical program, which incurred approximately $10.3 million in research and development costs.

Manufacturing proprietary cell lines and stem cells

As part of its operational strategy, INmune Bio manufactures proprietary cell lines and stem cells. During the nine months ended September 30, 2024, the company recognized revenues of $14,000 from the sale of mesenchymal stem cells, a decrease from $127,000 in the same period of the previous year. This indicates a focus on developing these proprietary technologies but also highlights challenges in revenue generation.

Research and development of immunotherapies

Research and development (R&D) is a critical activity for INmune Bio, with R&D expenses amounting to approximately $25.8 million for the nine months ended September 30, 2024, compared to $14.3 million for the same period in 2023. This increase reflects the company’s commitment to advancing its drug candidates, including those targeting innate immune dysfunction associated with cancer and other diseases.

Regulatory compliance and quality assurance

Regulatory compliance and quality assurance are essential for INmune Bio as it navigates the complex landscape of biotechnology. The company’s operational expenses totaled approximately $33.2 million for the nine months ended September 30, 2024, up from $21.5 million in the previous year. This increase includes costs related to ensuring compliance with regulatory standards necessary for clinical trials and product development.

Key Activity	Details	Financial Impact (2024)
Clinical Trials	Conducting trials for cancer therapies.	$10.3 million in increased costs due to trial advancements.
Manufacturing	Producing proprietary cell lines and stem cells.	Revenue of $14,000 from stem cell sales.
R&D	Development of immunotherapies targeting innate immune dysfunction.	$25.8 million in R&D expenses.
Regulatory Compliance	Ensuring adherence to regulatory standards.	Total operating expenses of $33.2 million.

INmune Bio, Inc. (INMB) - Business Model: Key Resources

Proprietary INKmune cell therapy technology

The INKmune technology is a proprietary cell therapy aimed at enhancing the activity of natural killer (NK) cells to eliminate minimal residual disease in patients with cancer. This platform is designed to prime the immune system to recognize and attack cancer cells more effectively. As of September 30, 2024, the company has invested significantly in developing this platform, with research and development expenses related to INKmune totaling approximately $3.5 million for the nine months ended September 30, 2024.

Access to clinical trial sites and patient populations

INmune Bio has established a network of clinical trial sites across the United States, Australia, and the United Kingdom, facilitating access to diverse patient populations for its trials. The company has reported significant costs associated with these trials, particularly for the Alzheimer’s disease program, which incurred approximately $7.6 million in external costs during the third quarter of 2024. This access is critical for advancing their clinical programs, including those targeting metastatic castration-resistant prostate cancer and treatment-resistant depression.

Skilled personnel in research and manufacturing

INmune Bio employs a dedicated team of skilled professionals in research and development, clinical operations, and manufacturing. The company reported total operating expenses of approximately $33.2 million for the nine months ended September 30, 2024, with a substantial portion allocated to salaries and stock-based compensation. As of the end of September 2024, the company had approximately 6.3 million stock options granted, reflecting a strong incentive structure aimed at retaining top talent.

Partnerships for supply chain and technology development

INmune Bio has formed strategic partnerships to bolster its supply chain and enhance its technology development capabilities. These collaborations include agreements with contract research organizations (CROs) for clinical trial management and manufacturing support. The company has also received grants, such as a $2.9 million award from the National Institutes of Health (NIH) for research support. These partnerships are essential for optimizing operational efficiency and accelerating the development of INmune's product candidates.

Key Resource	Description	Financial Impact (2024)
Proprietary Technology	INKmune cell therapy technology	$3.5 million in R&D expenses
Clinical Trial Access	Network of sites in US, Australia, UK	$7.6 million in external costs for Alzheimer’s program
Skilled Personnel	R&D and clinical operations team	$33.2 million total operating expenses
Partnerships	Strategic collaborations and grants	$2.9 million NIH grant

INmune Bio, Inc. (INMB) - Business Model: Value Propositions

Innovative immunotherapy targeting cancer

INmune Bio focuses on developing innovative immunotherapies, particularly through its proprietary platforms. The company aims to enhance the body's immune response against cancer, specifically targeting residual disease that persists after chemotherapy. Their lead product candidate, INKmune, is designed to activate and enhance the functionality of Natural Killer (NK) cells, which play a critical role in the body’s ability to combat tumors.

Enhancing patients' NK cell functionality

INKmune is engineered to prime NK cells, making them more effective at identifying and destroying cancer cells. The significance of this approach is underscored by the fact that NK cells are a crucial component of the innate immune system, and their dysfunction can lead to poor patient outcomes in cancer therapy. The enhancement of NK cell functionality is pivotal in addressing minimal residual disease, which is a major challenge in cancer treatment.

Focus on residual disease post-chemotherapy

INmune Bio has a strategic emphasis on treating residual disease following chemotherapy. This focus is critical as studies indicate that up to 90% of cancer patients experience residual disease post-treatment, which can lead to relapse. By targeting this residual disease, INmune Bio differentiates itself from competitors that primarily focus on initial tumor reduction without addressing potential recurrences.

Potential to treat multiple cancers and diseases

INmune Bio's innovative therapies have the potential to treat a variety of cancers and diseases. The company’s research and development efforts are directed towards multiple indications, including hematologic malignancies and solid tumors. This multi-faceted approach not only broadens the market potential but also positions INmune Bio as a versatile player in the immunotherapy landscape.

Product Candidate	Indication	Phase	2024 R&D Expense (in thousands)
INKmune	High Risk MDS/AML & Prostate Cancer	Clinical Trials	$3,468
DN-TNF	Alzheimer’s Disease	Clinical Trials	$18,759
Preclinical Programs	Various	Preclinical	$518

As of September 30, 2024, INmune Bio reported a net loss of $32.9 million, primarily driven by research and development expenses totaling $25.8 million for the nine months ended September 30, 2024. This investment reflects the company's commitment to advancing its innovative therapies targeting residual disease and enhancing NK cell functionality.

In summary, INmune Bio’s value propositions are centered around its innovative immunotherapy solutions that aim to improve patient outcomes by effectively targeting residual cancer cells, enhancing immune functionality, and addressing a broad range of diseases. These propositions not only fulfill critical patient needs but also strategically differentiate INmune Bio in the competitive landscape of cancer immunotherapy.

INmune Bio, Inc. (INMB) - Business Model: Customer Relationships

Direct communication with clinical trial participants

INmune Bio engages in direct communication with clinical trial participants to ensure they are informed and involved in the process. This includes regular updates on trial progress and personalized interactions to address participant concerns. The Phase I/II trial for INKmune in patients with metastatic castration-resistant prostate cancer includes ongoing communication regarding biomarker data and treatment responses.

Ongoing updates and transparency about trial results

Transparency is critical in maintaining trust with trial participants and stakeholders. INmune Bio commits to providing ongoing updates about trial results, including efficacy metrics and safety data. For instance, the company plans to report top-line data six months post-trial completion, focusing on immunologic and tumor response variables.

Education and support for patients and healthcare providers

INmune Bio prioritizes education for both patients and healthcare providers. The company aims to disseminate detailed information about its therapies, including the mechanisms of action and potential benefits. This educational outreach is essential for fostering an informed patient base and ensuring healthcare providers are well-equipped to discuss treatment options with their patients.

Building trust through safety and efficacy data

Trust is built through the rigorous presentation of safety and efficacy data. INmune Bio emphasizes the importance of sharing comprehensive trial results, including any adverse events and overall treatment outcomes. The company’s strategy includes leveraging data from completed trials to reassure stakeholders about the safety profiles of its therapies.

Aspect	Details
Clinical Trial Participant Communication	Direct, personalized updates and support throughout the trial process
Trial Results Transparency	Regular updates on trial progress and outcomes, including top-line data reports
Educational Outreach	Information sessions for patients and healthcare providers about treatment options
Trust Building	Sharing comprehensive safety and efficacy data from clinical trials

INmune Bio, Inc. (INMB) - Business Model: Channels

Clinical trial networks for patient recruitment

INmune Bio, Inc. leverages various clinical trial networks to facilitate patient recruitment for its ongoing studies. As of September 30, 2024, the company reported a significant increase in research and development expenses, totaling approximately $25.8 million for the nine months ended September 30, 2024, compared to $14.3 million for the same period in the previous year. This increase is largely attributed to advancements in clinical trial enrollments, particularly for its Alzheimer’s program.

Academic publications and industry conferences for dissemination

INmune Bio actively participates in academic publications and industry conferences to disseminate research findings and engage with the scientific community. The company has been focusing on the publication of results related to its product platforms, including DN-TNF and INKmune. This strategy not only enhances visibility but also establishes credibility within the industry, thereby aiding in future collaborations and partnerships.

Online platforms for information sharing and engagement

The company utilizes various online platforms for sharing information and engaging with stakeholders. As of September 30, 2024, INmune Bio had a cash balance of approximately $33.6 million, which it is utilizing to enhance its digital presence and outreach efforts. This includes updating its website and engaging potential investors through social media channels, thereby improving communication and transparency with the public and investors alike.

Collaborations with healthcare providers for therapy administration

INmune Bio collaborates with healthcare providers to facilitate the administration of its therapies. The company’s ongoing clinical trials often involve partnerships with hospitals and clinics that assist in treatment delivery and patient monitoring. As of September 30, 2024, INmune Bio's research and development expenses reflected a substantial commitment to these collaborations, with approximately $10.1 million incurred in the third quarter of 2024 alone.

Channel Type	Description	Financial Impact (Q3 2024)
Clinical Trial Networks	Facilitates patient recruitment for clinical trials.	$25.8 million R&D expenses
Academic Publications	Engagement with scientific community through research dissemination.	Ongoing costs included in R&D expenses
Online Platforms	Utilizes digital channels for information sharing.	$33.6 million cash balance for outreach efforts
Healthcare Provider Collaborations	Partnerships for therapy administration in clinical trials.	$10.1 million incurred in Q3 2024

INmune Bio, Inc. (INMB) - Business Model: Customer Segments

Cancer patients seeking innovative treatments

INmune Bio focuses on patients diagnosed with various types of cancer, particularly those who are seeking cutting-edge therapies. The company's product, INKmune, is designed to enhance the innate immune response against tumors. With the global cancer therapeutics market projected to reach approximately $260 billion by 2026, INmune Bio aims to capture a portion of this expanding market by offering innovative treatment options tailored to the needs of cancer patients.

Healthcare providers and oncologists

Healthcare providers, including oncologists, are critical customer segments for INmune Bio. These professionals are instrumental in prescribing new therapies to patients and are essential for clinical trial recruitment. The company collaborates with healthcare providers to ensure that its products meet clinical needs and to facilitate patient access to these innovative treatments. As of September 30, 2024, INmune Bio reported engaging with various healthcare systems and institutions to establish relationships for product trials and future commercialization.

Academic and research institutions

INmune Bio partners with academic and research institutions to advance its research initiatives and clinical trials. Collaborations with these organizations are crucial for conducting clinical studies, sharing knowledge, and leveraging external expertise. The company has received funding from the National Institutes of Health for specific projects, highlighting its commitment to academic partnerships. For instance, the company was awarded a grant of up to $2.9 million to support a Phase 2 study of XPro1595 in patients with treatment-resistant depression.

Biopharmaceutical companies interested in partnerships

INmune Bio actively seeks partnerships with biopharmaceutical companies for collaborative research and development efforts. These partnerships can provide additional resources, expertise, and market access. The company’s focus on leveraging its innovative technology platforms attracts interest from larger pharmaceutical firms looking for strategic alliances. As of September 30, 2024, INmune Bio's financial statements indicate ongoing efforts to secure partnerships that can enhance its product development pipeline and expand its market reach.

Customer Segment	Key Characteristics	Market Size	Engagement Strategies
Cancer Patients	Seeking innovative therapies	$260 billion (global cancer therapeutics market by 2026)	Clinical trials, educational outreach
Healthcare Providers	Oncologists, healthcare professionals	Expanding network of oncology specialists	Collaborations, direct engagement
Academic Institutions	Research-focused, clinical trial partners	Significant funding opportunities	Grants, joint research initiatives
Biopharmaceutical Companies	Potential partners for R&D	Large market with strategic collaborations	Partnership agreements, co-development projects

INmune Bio, Inc. (INMB) - Business Model: Cost Structure

Research and Development Expenses for Clinical Trials

Research and development (R&D) expenses for INmune Bio, Inc. amounted to approximately $25.8 million for the nine months ended September 30, 2024, compared to $14.3 million for the same period in 2023. The increase in R&D expenses is primarily attributed to advancements in clinical programs, including $10.3 million related to the Alzheimer's clinical program and $1.8 million for INKmune clinical programs.

For the three months ended September 30, 2024, R&D expenses were approximately $10.1 million, up from $6.0 million in the same quarter of 2023. This increase includes approximately $3.8 million due to advancements in enrollment for clinical trials.

Expense Category	Q3 2024 (in thousands)	Q3 2023 (in thousands)	Change (in thousands)
Research and Development	10,067	5,985	4,082
Total R&D Nine Months	25,813	14,266	11,547

Manufacturing Costs for Cell Therapies

Manufacturing costs associated with cell therapies are significant for INmune Bio, primarily encompassing the costs of production, testing, and related supplies. The exact manufacturing costs are not detailed in the financial statements; however, it is noted that the company incurs substantial expenses in the development and manufacturing of drugs for clinical trials.

Regulatory Compliance and Quality Assurance Costs

Regulatory compliance and quality assurance costs are integral to INmune Bio's operations, particularly as it seeks to advance its product candidates through clinical trials and obtain regulatory approvals. While specific figures for these costs are not disclosed, they are included in the broader category of R&D expenses, which increased significantly in 2024 due to heightened regulatory activities.

Administrative and Operational Expenses

Administrative expenses for INmune Bio amounted to approximately $7.4 million for the nine months ended September 30, 2024, slightly up from $7.2 million in 2023. The company reported $2.2 million in administrative expenses for Q3 2024 compared to $2.6 million in Q3 2023.

Key components of administrative expenses include payroll and personnel costs, professional fees, and general operating expenses. The decrease in administrative expenses in Q3 2024 was primarily due to lower consulting costs.

Expense Type	Q3 2024 (in thousands)	Q3 2023 (in thousands)	Total Nine Months 2024 (in thousands)	Total Nine Months 2023 (in thousands)
General and Administrative	2,219	2,586	7,369	7,223

INmune Bio, Inc. (INMB) - Business Model: Revenue Streams

Funding from grants and research institutions

INmune Bio has been awarded a grant of up to $2.9 million from the National Institutes of Health (NIH) to support a Phase 2 study of XPro1595 in patients with treatment-resistant depression. As of September 30, 2024, the company has not yet received any proceeds from this grant.

Potential revenue from partnerships with biopharma companies

The company has entered into various licensing agreements and collaborations that could provide future revenue streams. For instance, under their licensing agreement with Immune Ventures, the company is committed to pay royalties of 1% of net sales during the life of each patent granted. Additionally, they are required to pay milestone payments, including $25,000 upon initiation of each Phase I trial and $250,000 upon initiation of each Phase II trial.

Future revenue from successful product commercialization

As of now, INmune Bio has not yet commercialized any products. The company's revenue for the nine months ended September 30, 2024, was $14,000, a decrease from $127,000 in the same period of 2023. The revenue primarily came from sales of Mesenchymal stem cells. The timeline for product commercialization is uncertain, with expectations that no products will be commercially available for at least several years.

Licensing fees for proprietary technologies

INmune Bio has established licensing agreements that include provisions for annual maintenance fees and royalties based on sales of products utilizing licensed technology. For example, under the PITT Agreement with the University of Pittsburgh, the company will incur annual maintenance fees of $25,000 beginning June 26, 2025, until the first commercial sale. Upon commercialization, the company is required to pay royalties equal to 2.5% of net sales each quarter.

Revenue Stream	Details	Amount
NIH Grant	Support for Phase 2 study of XPro1595	$2.9 million (unreceived)
Royalties from Immune Ventures	1% of net sales	N/A
Milestone Payments (Immune Ventures)	Upon Phase I and II trial initiation	$25,000 (Phase I), $250,000 (Phase II)
PITT Agreement Maintenance Fee	Annual fee starting June 2025	$25,000
PITT Agreement Royalties	2.5% of net sales	N/A
Sales from Mesenchymal Stem Cells	Revenue for nine months ended September 30, 2024	$14,000

Article updated on 8 Nov 2024

Resources:

1. INmune Bio, Inc. (INMB) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of INmune Bio, Inc. (INMB)' financial performance, including balance sheets, income statements, and cash flow statements.
2. SEC Filings – View INmune Bio, Inc. (INMB)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.