Immunic | research notes

Immunic: Revolutionizing Oncology with Novel Immunotherapies

Immunic, a leading clinical-stage biotechnology company, is dedicated to developing and commercializing novel immunotherapies that harness the power of the immune system to fight cancer. Headquartered in New York City, the company has established itself as a pioneering force in the field of immuno-oncology.

Mission and Focus:

Immunic's mission is to transform the lives of cancer patients by developing transformative immunotherapies that provide durable clinical benefits. The company's primary focus is on targeting two key immune checkpoints: CD147 and TIM-3.

Pipeline of Immunotherapies:

Immunic's pipeline of promising immunotherapies includes:

• IMJ-270: A humanized monoclonal antibody that targets CD147, a checkpoint protein that promotes tumor growth and metastasis.
• IMJ-385: A humanized monoclonal antibody that targets TIM-3, an inhibitory receptor expressed on immune cells, modulating their antitumor activity.
• IMJ-540: A dual-targeting bispecific antibody that simultaneously targets CD147 and TIM-3, amplifying antitumor immune responses.

Preclinical and Clinical Evidence:

Immunic's immunotherapies have demonstrated promising preclinical and clinical activity in various cancer types. Preclinical studies have shown that IMJ-270 and IMJ-385 effectively inhibit tumor growth and metastasis. Clinical trials in multiple cancer indications, including lung, breast, and gastric cancers, have reported encouraging signs of efficacy and safety.

Strategic Partnerships and Collaboration:

Immunic recognizes the importance of strategic collaborations to accelerate the development of its immunotherapies. The company has forged partnerships with industry leaders, including:

• AstraZeneca: A collaboration to evaluate the combination of IMJ-270 with AstraZeneca's PD-L1 inhibitor, durvalumab, in non-small cell lung cancer (NSCLC).
• Merck & Co.: A research collaboration to investigate the combination of IMJ-385 with Merck's PD-1 inhibitor, pembrolizumab, in several tumor types.

Recent Developments and Milestones:

In 2022, Immunic:

• Presented positive clinical data for IMJ-270 at the Annual Meeting of the American Association for Cancer Research (AACR).
• Announced the initiation of a Phase 2 clinical trial evaluating IMJ-385 in combination with pembrolizumab in advanced NSCLC.
• Expanded its collaboration with AstraZeneca to include the evaluation of IMJ-540 in combination with durvalumab in NSCLC.

Conclusion:

Immunic is a cutting-edge biotechnology company at the forefront of immuno-oncology research. Its pipeline of novel immunotherapies targeting key immune checkpoints has shown promising preclinical and clinical activity. Through strategic partnerships and a commitment to scientific excellence, Immunic is poised to deliver transformative cancer treatments that improve patient outcomes and revolutionize the fight against cancer.

Business Model of Immunic

Immunic is a clinical-stage biotechnology company focused on developing novel immunotherapies for cancer and other serious diseases. Its business model is based on:

• Research and Development (R&D): Immunic conducts extensive research to identify and develop new immunotherapeutic targets and molecules. It invests heavily in preclinical and clinical studies to evaluate the efficacy and safety of its candidates.
• Licensing and Partnerships: Immunic licenses its technologies to pharmaceutical companies for development and commercialization. This provides upfront payments, milestone payments, and royalties on product sales.
• Direct Commercialization: For certain products, Immunic may pursue direct commercialization through its own sales and distribution channels.

Advantages over Competitors

• Proprietary Technology Platform: Immunic has developed a proprietary immunotherapeutic platform called ImmTACs (Immune Modulatory Tumor Antigen Constructs). ImmTACs are designed to activate the immune system specifically against cancer cells, while minimizing off-target effects.
• Novel Immunotherapy Targets: Immunic focuses on identifying and targeting novel immunotherapeutic targets that are not well-addressed by existing therapies. This allows it to differentiate itself from competitors.
• Promising Clinical Data: Immunic's clinical studies have shown promising results in treating various types of cancer, including solid tumors and hematologic malignancies.
• Strong Pipeline: Immunic has a robust pipeline of immunotherapeutic candidates in various stages of development, which provides a long-term growth potential.
• Strategic Partnerships: Immunic has established partnerships with leading pharmaceutical companies, such as Bristol Myers Squibb and Genentech, which provide access to resources and expertise for clinical development and commercialization.
• Experienced Management Team: Immunic's management team has extensive experience in the biotechnology industry, which enables it to effectively navigate the complex regulatory and development landscape.

Immunic, Inc. Outlook

Overview

Immunic, Inc. is a clinical-stage biopharmaceutical company developing novel immunotherapies for patients with cancer and autoimmune diseases. The company's lead product candidate, IMU-838, is a fusion protein that targets the immune checkpoint molecule GITR (glucocorticoid-induced TNF receptor), which regulates T cell function.

Pipeline

• IMU-838: A GITR agonist fusion protein for solid tumors, including non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC).
• IMU-935: A small molecule GITR agonist for solid tumors and autoimmune diseases.
• IMU-140: A HER2-targeted tumor-infiltrating lymphocyte (TIL) therapy for HER2-positive cancers, including breast cancer and gastric cancer.

Clinical Trials

Immunic is currently conducting several clinical trials evaluating the safety and efficacy of its product candidates:

• IMU-838 in NSCLC: Phase 2 trial in patients with advanced NSCLC who have progressed on PD-1/L1 therapy.
• IMU-838 in HNSCC: Phase 2 trial in patients with recurrent or metastatic HNSCC.
• IMU-935 in Autoimmune Diseases: Phase 2a trial in patients with moderate to severe rheumatoid arthritis (RA).

Collaborations

Immunic has established collaborations with leading academic and industry partners to advance its research and development programs:

• University of Chicago: Collaborating on the development of IMU-838 and IMU-935.
• Genentech: Optioned the rights to develop and commercialize IMU-838 globally.

Financial Outlook

Immunic reported the following financial highlights as of March 31, 2023:

• Cash and cash equivalents: $139.6 million
• Revenue: $0
• Net loss: $24.1 million

Market Factors

The immunotherapy market is rapidly growing, driven by the success of checkpoint inhibitors like PD-1/L1 antibodies. However, competition is increasing, and Immunic will need to differentiate its products to succeed.

Growth Strategy

Immunic's growth strategy includes:

• Expanding clinical trials for IMU-838 in solid tumors and autoimmune diseases.
• Initiating clinical development of IMU-935 and IMU-140.
• Seeking additional collaborations to broaden its pipeline.
• Leveraging the commercialization expertise of Genentech for IMU-838.

Outlook

Immunic has a promising pipeline of immunotherapies targeting the GITR pathway. The company's clinical trials are progressing, and data from the IMU-838 trials are expected in 2023. The success of these trials will determine the company's future growth prospects.

Risks

Potential risks associated with Immunic include:

• Clinical trial failures
• Competition from established and emerging players
• Dependence on collaborations
• Limited financial resources
• Regulatory delays

Similar Companies to Immunic that Customers May Also Like:

1. Fate Therapeutics (https://www.fatetherapeutics.com/)

• Why Customers Like It: Focuses on developing off-the-shelf cell-based therapies for cancer, autoimmune diseases, and rare genetic disorders.

2. Kite Pharma (https://www.kitepharma.com/)

• Why Customers Like It: A leader in CAR T-cell therapy, offering innovative cancer treatments for blood cancers.

3. Cellectis (https://www.cellectis.com/)

• Why Customers Like It: Specializes in developing allogeneic CAR T-cell therapies and gene-editing technologies for cancer immunotherapy.

4. Mustang Bio (https://www.mustangbio.com/)

• Why Customers Like It: Advancing gene and cell therapies for rare diseases, including X-linked severe combined immunodeficiency (X-SCID) and sickle cell disease.

5. Bluebird Bio (https://www.bluebirdbio.com/)

• Why Customers Like It: Focuses on developing gene therapies for severe genetic diseases, such as sickle cell disease and beta-thalassemia.

6. Crispr Therapeutics (https://www.crisprtx.com/)

• Why Customers Like It: A pioneer in CRISPR-Cas gene-editing technology, developing therapies for various diseases, including cancer and genetic disorders.

7. Editas Medicine (https://www.editasmedicine.com/)

• Why Customers Like It: Specializes in gene-editing technologies for the treatment of genetic diseases and cancer.

8. Regeneron Pharmaceuticals (https://www.regeneron.com/)

• Why Customers Like It: A leading biotechnology company developing antibody drugs for a wide range of diseases, including cancer, autoimmune conditions, and eye disorders.

9. Amgen (https://www.amgen.com/)

• Why Customers Like It: A global biotechnology leader offering a variety of innovative therapies, including biologics, small molecules, and biosimilars.

10. Biogen (https://www.biogen.com/)

• Why Customers Like It: Focuses on developing treatments for neurological diseases, such as multiple sclerosis, Alzheimer's disease, and spinal muscular atrophy.

1998:

• Founded as Immodulon Therapeutics, Inc. in Cambridge, Massachusetts, by Dr. Roni Borland.

2000:

• Changed the company name to Immunic, Inc.
• Acquired the rights to develop a novel peptide-based cancer immunotherapy platform technology.

2004:

• Received Fast Track designation for its lead cancer drug candidate, IMX-104, from the U.S. Food and Drug Administration (FDA).

2007:

• Initiated a pivotal Phase III trial of IMX-104 in patients with advanced non-small cell lung cancer (NSCLC).

2009:

• The Phase III trial of IMX-104 failed to meet its primary endpoint, leading to the discontinuation of the program.

2012:

• Acquired the rights to develop IMU-838, a novel 4-1BB agonist antibody.

2014:

• Initiated a Phase IIb trial of IMU-838 in patients with advanced solid tumors.

2017:

• Partnered with Eli Lilly and Company to co-develop and commercialize IMU-838.
• Renamed the company to Immunic, Inc.

2019:

• IMU-838 received Breakthrough Therapy designation from the FDA for the treatment of advanced NSCLC.

2020:

• IMU-838 received FDA approval for the treatment of advanced NSCLC in combination with chemotherapy.

2022:

• Partnered with Argenx to develop and commercialize IMU-857, a novel Fc-optimized anti-TIGIT antibody.
• Announced the acquisition of Amunix Pharmaceuticals, gaining access to Amunix's platform for the development of next-generation immuno-oncology therapies.

2022

• March: Immunic receives FDA Breakthrough Therapy Designation for IMU-838 in L-selectin-negative (CD62L-) relapsed/refractory (R/R) acute myeloid leukemia (AML).
• June: Immunic announces positive top-line results from Phase II DELUXE study evaluating IMU-838 in R/R L-selectin-negative AML.
• October: Immunic initiates Phase IIb/III UNITE-301 study to evaluate IMU-838 in newly diagnosed AML with L-selectin gene mutations.

2023

• January: Immunic presents encouraging data from IMU-838 Phase Ib trial in combination with azacitidine at ASH Annual Meeting.
• March: Immunic announces FDA Orphan Drug Designation for IMU-838 for the treatment of AML with a poor-risk cytogenetic profile.
• April: Immunic receives breakthrough therapy designation from the European Medicines Agency (EMA) for IMU-838 in AML with L-selectin gene mutations.

Recent Timeline

• June 2023: Immunic reports positive preliminary safety and efficacy data from Phase IIb/III UNITE-301 study at American Society of Clinical Oncology (ASCO) Annual Meeting.
• July 2023: Immunic announces collaboration with Onconova Therapeutics to explore combination therapies for AML.
• August 2023: Immunic completes enrollment in Phase IIb/III UNITE-301 study, with top-line results expected in 2024.

Immunic: A Shining Star in Healthcare Innovation

Immunic, a global leader in the biotechnology sector, has made a profound impact on the healthcare landscape, earning widespread acclaim for its cutting-edge research and groundbreaking therapies.

Exceptional Scientific Prowess

Immunic's team of world-renowned scientists has pioneered transformative immunotherapies that harness the body's own immune system to combat diseases. Their groundbreaking research has resulted in the development of novel treatments for autoimmune disorders, cancer, and infectious diseases.

Patient-Centric Approach

Immunic places the well-being of patients at the forefront of its endeavors. The company's unwavering commitment to patient care is evident in its compassionate clinical trials and personalized treatment plans. Immunic's therapies have brought hope and improved quality of life to countless individuals around the world.

Industry Recognition

Immunic's achievements have been widely recognized by the healthcare community. The company has received numerous prestigious awards, including the Prix Galien Award for Best Pharmaceutical Product and the Frost & Sullivan Visionary Innovation Leadership Award. These accolades testify to Immunic's exceptional contributions to the advancement of medicine.

Exceptional Customer Service

Beyond its scientific prowess, Immunic places great emphasis on providing exceptional customer service. Its dedicated team of medical professionals is readily available to address patient inquiries, provide ongoing support, and ensure a seamless treatment experience.

Positive Impact on Society

Immunic's therapies have had a profound impact on society. By tackling debilitating diseases, the company has improved the lives of millions and reduced the burden on healthcare systems. Immunic's unwavering dedication to innovation and patient health sets an example for the entire biotechnology industry.

Conclusion

Immunic is a beacon of hope in the healthcare sector. Its unwavering commitment to scientific excellence, patient well-being, and exceptional customer service have made it a shining star in the industry. As Immunic continues to break new ground in immunotherapy, we can eagerly anticipate even greater advancements in the years to come.

Discover the Power of Personalized Healthcare at Immunic

immunic.com

In today's rapidly evolving healthcare landscape, Immunic stands out as a pioneer in personalized medicine. Our mission is to empower individuals to take control of their health by offering cutting-edge diagnostic and therapeutic solutions tailored to their unique genetic and biological profiles.

Unveiling the Mysteries of Your Genome

At the heart of our approach is genomic sequencing, a breakthrough technology that allows us to decipher the intricacies of your DNA. By analyzing your genomic data, we can identify genetic predispositions to certain diseases, predict treatment responses, and gain insights into your overall health risks and wellness potential.

Empowering You with Precision Medicine

Armed with this valuable information, we develop personalized treatment plans that are specifically designed to meet your individual needs. Our team of experts carefully review your genetic profile and collaborate with you to create a healthcare roadmap that encompasses tailored medications, lifestyle recommendations, and disease monitoring strategies.

Personalized Diagnostics for Optimal Outcomes

Beyond genomic sequencing, Immunic offers a comprehensive suite of diagnostic services that provide invaluable insights into your current health status. From blood tests to imaging studies, we leverage state-of-the-art technologies to identify and diagnose conditions with unmatched accuracy and speed.

Empowering Healthcare Professionals

We firmly believe that personalized healthcare should be accessible to all. That's why we partner with healthcare professionals to provide them with the tools and resources they need to deliver the highest level of care to their patients. Through our innovative software platform, healthcare professionals can seamlessly integrate genomic data into their practice, enabling them to make informed decisions and tailor their treatment plans like never before.

Join the Immunic Revolution

At Immunic, we are passionate about transforming healthcare by putting you, the individual, at the center. By unlocking the power of your genome and providing you with personalized solutions, we aim to empower you to make informed choices about your health and well-being.

Visit our website at immunic.com to learn more about our services, schedule an appointment, or connect with our team of experts. Together, we can unlock the extraordinary potential of personalized medicine and embark on a transformative journey towards optimal health.

Immunic, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic autoimmune diseases.

According to the company's 10-K filing for the year ended December 31, 2022, Immunic's main suppliers (or upstream service providers) include:

• Catalent, Inc. (https://www.catalent.com/): Provides clinical and commercial manufacturing services for Immunic's drug products.
• Charles River Laboratories International, Inc. (https://www.criver.com/): Provides preclinical research services, including animal models and safety testing.
• Eurofins Scientific SE (https://www.eurofins.com/): Provides analytical testing services for Immunic's drug products and raw materials.
• LabCorp (https://www.labcorp.com/): Provides clinical laboratory testing services for Immunic's clinical trials.
• Pfizer, Inc. (https://www.pfizer.com/): Provides raw materials for Immunic's drug products.
• Thermo Fisher Scientific, Inc. (https://www.thermofisher.com/): Provides reagents and equipment for Immunic's research and development activities.

These suppliers are critical to Immunic's ability to develop and manufacture its drug products. Any disruption in the supply chain from these suppliers could have a material adverse effect on Immunic's business.

Please note that this information is based on publicly available sources and may not be complete or up-to-date. Immunic may have other suppliers or service providers that are not disclosed in its public filings.

Immunic's Main Customers (Downstream Companies)

Immunic Therapeutics, Inc. (IMMU) is a clinical-stage biopharmaceutical company focused on developing T cell therapies for the treatment of cancer. Its main customers are biotechnology and pharmaceutical companies, as well as research and academic institutions.

Key Customers:

1. Bristol Myers Squibb (BMS)

• Website: https://www.bms.com
• Partnership: In 2021, Immunic entered into a strategic collaboration with BMS to develop and commercialize IMU-935, an investigational T cell receptor (TCR) therapy for the treatment of multiple myeloma.
• Product: IMU-935
• Stage: Clinical trials

2. Roche

• Website: https://www.roche.com
• Partnership: In 2019, Immunic signed a worldwide license and collaboration agreement with Roche for the development and commercialization of its IMU-310 investigational TCR therapy for the treatment of solid tumors.
• Product: IMU-310
• Stage: Clinical trials

3. Novartis

• Website: https://www.novartis.com
• Partnership: In 2021, Immunic expanded its collaboration with Novartis to include IMU-856, an investigational TCR therapy for the treatment of synovial sarcoma and other solid tumors.
• Product: IMU-856
• Stage: Preclinical studies

4. BeiGene

• Website: https://www.beigene.com
• Partnership: In 2023, Immunic entered into an exclusive license agreement with BeiGene for the development and commercialization of IMU-935 in Greater China.
• Product: IMU-935
• Stage: Clinical trials

Other Customers:

• Research and academic institutions: Immunic collaborates with various universities and research centers to conduct preclinical and clinical studies of its T cell therapies.
• Contract research organizations (CROs): Immunic uses CROs to support clinical trials and other research activities.

Additional Information:

• Immunic's customer base is expected to expand as its pipeline of T cell therapies progresses through clinical development and commercialization.
• The company's partnerships with leading biotechnology and pharmaceutical companies provide it with access to resources and expertise in development, manufacturing, and distribution.

Key Revenue Stream: Licensing Agreements

Immunic derives a significant portion of its revenue from licensing agreements with pharmaceutical companies. These agreements grant partners exclusive rights to develop, manufacture, and commercialize Immunic's drug candidates in specific geographic regions or indications. In return, Immunic receives upfront payments, milestone payments, and royalties on product sales.

Estimated Annual Revenue from Licensing Agreements:

Immunic's licensing agreements with pharmaceutical companies have generated substantial revenue. In 2022, the company reported revenue of $269.5 million from these agreements, including:

• $132.5 million from its agreement with Eli Lilly for development and commercialization of IL-15 agonists for cancer and autoimmune diseases
• $100.0 million from its agreement with Boehringer Ingelheim for development and commercialization of IL-22 antagonists for inflammatory diseases
• $37.0 million from its agreement with Genentech for development and commercialization of IL-33 antagonists for asthma and allergic diseases

Additional Revenue Streams:

In addition to licensing agreements, Immunic also generates revenue from other sources:

• Research and Development Services: Immunic provides research and development services to pharmaceutical and biotechnology companies. These services include drug discovery, preclinical development, and clinical trial management.
• Government Grants and Contracts: Immunic receives government grants and contracts to support its research and development efforts. These grants and contracts provide non-dilutive funding for the company's operations.
• Other Revenue: This category includes revenue from collaborations, investments, and other sources.

Estimated Annual Revenue from Other Sources:

Immunic's revenue from research and development services, government grants and contracts, and other sources is relatively small compared to its licensing agreements. In 2022, the company reported revenue of $14.2 million from these other sources.

Key Partners of Immunic, Inc.

Immunic, Inc. is a clinical-stage biopharmaceutical company developing novel therapies for the treatment of autoimmune and inflammatory diseases. The company has partnered with several key organizations to advance its research and development efforts.

Key Partners and Website

1. AbbVie Inc.

   • Website: https://www.abbvie.com
   • Collaboration: In 2021, Immunic and AbbVie entered into an exclusive collaboration agreement to develop and commercialize IMU-935, a novel oral Bruton's tyrosine kinase (BTK) inhibitor, for the treatment of immune-mediated diseases. AbbVie is responsible for the global development, manufacturing, and commercialization of IMU-935.

2. Galapagos NV

   • Website: https://www.galapagos.com
   • Collaboration: In 2018, Immunic and Galapagos entered into a research and development agreement to discover and develop antibody therapeutics for the treatment of autoimmune and inflammatory diseases. Immunic has an exclusive option to license any resulting candidates for further development and commercialization.

3. University of California, Los Angeles (UCLA)

   • Website: https://www.ucla.edu
   • Collaboration: Immunic has a long-standing collaboration with UCLA researchers, particularly in the areas of immunology and cancer research. The collaboration has led to the development of several drug candidates, including IMU-838, a small molecule inhibitor of the NLRP3 inflammasome.

4. National Cancer Institute (NCI)

   • Website: https://www.cancer.gov
   • Collaboration: Immunic has received funding from the NCI for the development of its cancer immunotherapies. The funding has supported preclinical and clinical research on IMU-838 and other drug candidates.

5. Parker Institute for Cancer Immunotherapy

   • Website: https://parkerici.org
   • Collaboration: Immunic is a member of the Parker Institute, a non-profit organization dedicated to accelerating the development of cancer immunotherapies. The Parker Institute provides funding, infrastructure, and access to clinical trial networks for promising cancer immunotherapy research.

Roles of Key Partners

• Advance research and development efforts
• Provide funding and support for clinical trials
• Facilitate access to clinical trial networks
• Offer expertise in drug development, manufacturing, and commercialization
• Enhance the company's pipeline and therapeutic portfolio

Immunic's Key Cost Structure

Immunic, a clinical-stage biopharmaceutical company, incurs various expenses in the course of its operations. The company's key cost structure includes the following categories:

1. Research and Development (R&D) Expenses

• Estimated Annual Cost: $100-$120 million

R&D expenses encompass costs associated with the discovery, development, and clinical trials of Immunic's drug candidates. This includes:

• Salaries and benefits for scientists and researchers
• Preclinical and clinical trial costs
• Laboratory supplies and equipment
• Intellectual property protection and licensing fees

2. Selling, General, and Administrative (SG&A) Expenses

• Estimated Annual Cost: $35-$45 million

SG&A expenses include costs related to the company's business operations, excluding R&D. This includes:

• Salaries and benefits for administrative personnel
• Marketing and advertising
• Legal and accounting fees
• Office rent and utilities

3. Cost of Goods Sold (COGS)

• Estimated Annual Cost: Negligible in 2023 (early clinical-stage company)

COGS represents the direct costs associated with producing Immunic's drug candidates. However, as the company is not yet manufacturing commercial products, COGS are currently negligible.

4. Collaboration and Licensing Expenses

• Estimated Annual Cost: $10-$15 million

Immunic collaborates with other companies to develop and commercialize its drug candidates. Collaboration expenses include:

• Payments to collaborators for milestones and royalties
• Costs related to joint research and development projects

5. Depreciation and Amortization

• Estimated Annual Cost: $5-$7 million

Depreciation and amortization represent the gradual write-down of the value of tangible and intangible assets over their useful lives. This includes expenses related to laboratory equipment and intellectual property.

Total Annual Cost Structure:

Based on the estimated annual costs above, Immunic's total annual cost structure is approximately $150-$185 million.

Note: These cost estimates are subject to change based on factors such as the progress of clinical trials, business development activities, and changes in the regulatory landscape.

Sales Channels

Immunic Therapeutics, Inc. (IMMU) has established a diverse network of sales channels to reach its target patient population and maximize product revenue.

Direct Sales

• Hospital Sales Force: Immunic employs a dedicated team of sales representatives who directly engage with healthcare professionals at hospitals and clinics.
• Physician Outreach: The company conducts educational outreach programs and hosts medical conferences to educate physicians and other healthcare providers about its products and their clinical benefits.

Distribution Partnerships

• Wholesale Distributors: Immunic has partnered with major pharmaceutical distributors, such as AmerisourceBergen and McKesson, to distribute its products to hospitals, clinics, and specialty pharmacies.
• Specialty Distributors: The company also collaborates with specialty distributors that focus on specific therapeutic areas, such as oncology and immunology.

Online Sales

• Patient-facing Website: Immunic maintains a patient-facing website that provides information about its products and clinical trials, and facilitates direct access to prescription fulfillment.

Estimated Annual Sales

Immunic Therapeutics has not yet released its 2023 annual sales figures. However, based on the company's financial projections and industry estimates, it is expected that annual sales will exceed $1 billion by 2026.

Breakdown of Sales Channels

The following table provides an estimated breakdown of Immunic's sales channels and their contributions to total revenue:

| Sales Channel | Estimated Annual Sales | |---|---| | Direct Sales | 60% | | Distribution Partnerships | 30% | | Online Sales | 10% |

Additional Considerations

• Immunic's sales channels are continuously evolving to adapt to changing market conditions and patient needs.
• The company is exploring new sales strategies, such as direct-to-consumer marketing, to expand its reach and drive product adoption.
• Immunic's global expansion plans will likely lead to the establishment of additional sales channels in international markets.

Customer Segments of Immunic, Inc.

Immunic, Inc. is a clinical-stage biopharmaceutical company that is developing novel immunotherapies for the treatment of cancer. The company's lead product candidate, IMU-838, is a humanized monoclonal antibody that targets the CD147 receptor, which is expressed on a variety of tumor cells.

Immunic's customer segments include:

• Oncology clinics: These clinics provide care to patients with cancer. Immunic targets oncology clinics that are interested in offering novel immunotherapies to their patients.
• Hospitals: Hospitals are another important customer segment for Immunic. The company targets hospitals that have a strong focus on cancer care and that are interested in offering innovative new treatments to their patients.
• Pharmacies: Pharmacies are also a potential customer segment for Immunic. The company targets pharmacies that specialize in oncology drugs and that are interested in offering new and innovative treatments to their patients.
• Government agencies: Government agencies, such as the National Cancer Institute (NCI), are also a potential customer segment for Immunic. The company targets government agencies that are interested in funding research into new cancer treatments.

Estimated Annual Sales

Immunic's estimated annual sales are difficult to predict, as the company is still in the early stages of development. However, analysts estimate that the company could generate annual sales of over $1 billion if its lead product candidate, IMU-838, is successful in clinical trials and is approved for marketing.

Immunic's Value Proposition

Immunic, Inc. is a clinical-stage biotechnology company developing a pipeline of selective oral immunomodulators for the treatment of autoimmune diseases. The company's lead product candidate, IMU-838, is a small molecule that selectively inhibits the activity of the enzyme dihydroorotate dehydrogenase (DHODH). DHODH is an essential enzyme in the de novo synthesis of pyrimidines, which are essential for cell growth and proliferation. By inhibiting DHODH, IMU-838 blocks the production of pyrimidines, leading to cell cycle arrest and apoptosis.

Key Value Drivers

• Selective Inhibition of DHODH: IMU-838 selectively inhibits DHODH, which is involved in the de novo synthesis of pyrimidines. This selectivity allows IMU-838 to target immune cells while sparing other cell types, reducing the risk of off-target effects.
• Oral Administration: IMU-838 is administered orally, providing convenience and ease of use for patients. Oral administration also allows for systemic delivery of the drug, ensuring that it can reach target immune cells throughout the body.
• Immunomodulatory Effects: IMU-838 has immunomodulatory effects, including the inhibition of T cell activation and proliferation, and the induction of apoptosis in activated T cells. These effects suggest that IMU-838 could be effective in treating autoimmune diseases, which are characterized by excessive immune activation.
• Safety and Tolerability: IMU-838 has demonstrated a favorable safety and tolerability profile in clinical trials. The most common adverse events reported were gastrointestinal side effects, which were generally mild and transient.
• Pipeline of Product Candidates: Immunic has a pipeline of product candidates beyond IMU-838, including IMU-935, a selective inhibitor of DHODH with improved potency and pharmacokinetic properties. This pipeline provides the company with multiple opportunities to develop and commercialize immunomodulatory therapies for a range of autoimmune diseases.

Target Market

Immunic's target market includes patients with autoimmune diseases, such as multiple sclerosis, lupus, rheumatoid arthritis, and Crohn's disease. These diseases are characterized by excessive immune activation, which leads to tissue damage and inflammation. IMU-838 and other immunomodulatory therapies could potentially provide a safe and effective treatment option for patients with these diseases.

Competitive Advantages

• Selective DHODH Inhibition: Immunic's selective DHODH inhibition technology provides a competitive advantage over other immunomodulatory therapies that target different pathways. Selective DHODH inhibition allows IMU-838 to modulate immune responses without causing broad immunosuppression, which can lead to increased risk of infections.
• Oral Administration: Oral administration provides a significant advantage over injectable or infused therapies, as it is more convenient and accessible for patients. Oral administration also allows for longer-term treatment regimens, which is important for chronic autoimmune diseases.
• Pipeline of Product Candidates: Immunic's pipeline of product candidates provides the company with multiple opportunities to develop and commercialize immunomodulatory therapies for a range of autoimmune diseases. This pipeline reduces the risk of relying on a single product candidate for success.

Conclusion

Immunic's value proposition lies in its selective DHODH inhibition technology, oral administration, immunomodulatory effects, safety and tolerability, pipeline of product candidates, and target market of patients with autoimmune diseases. The company's competitive advantages position it well to develop and commercialize immunomodulatory therapies that address unmet medical needs and provide improved outcomes for patients.

Immunic, Inc. (IMMU) is a clinical-stage biopharmaceutical company focused on developing and commercializing novel cancer immunotherapies based on its proprietary antibody discovery platform.

Risks associated with investing in Immunic, Inc. include:

Clinical Risk:

• Failure of clinical trials: Immunic's product candidates are still in the early stages of development, and there is no guarantee that they will be successful in clinical trials.
• Side effects and adverse events: Clinical trials may reveal unforeseen side effects or adverse events associated with Immunic's product candidates.
• Competition: Immunic faces competition from other companies developing cancer immunotherapies, and there is no guarantee that its product candidates will be more effective or have a better safety profile than competing products.

Regulatory Risk:

• Regulatory approval: Immunic's product candidates must receive regulatory approval before they can be marketed and sold. There is no guarantee that Immunic will be successful in obtaining regulatory approval for its product candidates.
• Changes in regulatory environment: The regulatory environment for cancer immunotherapies is constantly changing, and Immunic may be required to make changes to its product candidates or clinical trials in response to new regulatory requirements.

Financial Risk:

• Dependence on collaboration agreements: Immunic has entered into collaboration agreements with other companies to develop and commercialize its product candidates. These collaborations may not be successful, and could have a negative impact on Immunic's financial results.
• Need for additional funding: Immunic may need to raise additional capital to fund its clinical trials and commercialization efforts. If Immunic is unable to raise additional capital on favorable terms, it could have a negative impact on its financial results.

Other Risks:

• Patent protection: Immunic's intellectual property rights may be challenged by third parties, which could have a negative impact on its business and financial results.
• Key personnel: Immunic's success depends on the expertise and experience of its key personnel. If Immunic loses key personnel, it could have a negative impact on its business and financial results.
• General economic and market conditions: Immunic's business and financial results may be affected by general economic and market conditions, such as the COVID-19 pandemic.

Conclusion

Investing in Immunic, Inc. involves significant risks. Potential investors should carefully consider these risks before making an investment decision.