Instil Bio | research notes

Introducing Instil Bio: A Pioneer in Gene Therapy for Rare Diseases

Overview

Instil Bio is a cutting-edge biotechnology company dedicated to developing transformative gene therapies for severe rare diseases. Founded in 2017, the company's mission is to alleviate suffering and improve the lives of patients by targeting the genetic root causes of these debilitating conditions.

Pipeline of Innovative Gene Therapies

Instil Bio boasts a robust pipeline of gene therapies, each designed to address a specific rare disease:

• IT-101: A gene therapy for X-linked myotubular myopathy (XLMTM), a fatal neuromuscular disorder that affects male infants.
• IT-202: A potential cure for cystinosis, a rare genetic condition that causes a buildup of crystals in cells, leading to organ damage.
• IT-301: A gene therapy for epidermolysis bullosa (EB), a debilitating skin disorder characterized by extreme skin fragility.

Platform Technology

Instil Bio's gene therapies are based on adeno-associated virus (AAV) vectors, which are naturally occurring viruses that have been genetically engineered to deliver therapeutic genes to target cells. The company's proprietary AAV capsid engineering platform, known as DESIGN AAV, enables the optimization of these vectors for enhanced tissue specificity, immunogenicity, and safety.

Clinical Trials and Patient Impact

Instil Bio has initiated several clinical trials for its gene therapies, with promising preliminary results. In a Phase 1/2 trial for IT-101, treated patients showed significant improvements in motor function and muscle strength. Similarly, early data from a Phase 1/2 trial for IT-202 suggests that the therapy can effectively reduce crystal accumulation and improve kidney function in patients with cystinosis.

Collaborations and Partnerships

Instil Bio collaborates with world-renowned academic institutions, hospitals, and patient advocacy groups to advance its research and development efforts. The company's partnerships with organizations such as Children's Hospital of Philadelphia and the National Institutes of Health ensure access to cutting-edge technologies and clinical expertise.

Mission and Values

Instil Bio's mission is driven by its commitment to patients and their families. The company believes that every patient deserves access to life-changing therapies and strives to develop safe and effective treatments for rare diseases that currently have no cure.

Conclusion

Instil Bio is at the forefront of gene therapy innovation, developing transformative treatments for rare diseases. With its robust pipeline, cutting-edge platform technology, and dedicated team, the company is poised to make a significant impact on the lives of patients and advance the field of gene therapy.

Business Model of Instil Bio

Instil Bio is a clinical-stage biopharmaceutical company developing oncolytic viral immunotherapies for the treatment of cancer. Its primary business model is based on:

• Development and commercialization of oncolytic viral immunotherapies: Instil Bio focuses on developing oncolytic viruses that selectively replicate in cancer cells, causing cell death and stimulating an immune response against the tumor.
• Collaboration and licensing agreements: The company collaborates with academic institutions and pharmaceutical companies to advance its pipeline and explore new therapeutic applications. It also licenses its technologies and platforms to other companies for further development.
• Manufacturing and supply chain: Instil Bio establishes partnerships with contract manufacturers to produce and supply its oncolytic viral immunotherapies.

Advantages over Competitors

• Proprietary viral platforms: Instil Bio has developed proprietary viral platforms, including adeno-associated virus (AAV) and herpes simplex virus (HSV), to optimize the delivery and efficacy of oncolytic viruses.
• Immunostimulatory constructs: The company incorporates immunostimulatory constructs into its viral vectors, which enhance the immune response against cancer cells and promote long-lasting anti-tumor immunity.
• Targeted delivery systems: Instil Bio employs targeted delivery systems to deliver oncolytic viruses specifically to cancer cells, minimizing off-target effects and maximizing therapeutic efficacy.
• Combination therapy strategies: The company explores combination therapy strategies with other immunotherapies, such as checkpoint inhibitors, to improve overall treatment outcomes.
• Clinical development expertise: Instil Bio has a team of experienced clinical development professionals with a proven track record in oncology drug development.

These advantages enable Instil Bio to:

• Offer differentiated oncolytic viral immunotherapies with improved potency and tumor selectivity.
• Develop combination therapies that potentiate anti-tumor activity and overcome resistance mechanisms.
• Collaborate with leading institutions and companies to leverage cutting-edge technologies and expertise.
• Secure partnerships for manufacturing and supply chain to ensure timely and efficient production.

Outlook of Instil Bio

Company Profile:

• Instil Bio is a clinical-stage biopharmaceutical company focused on developing transformative therapies for patients with serious gastrointestinal diseases and autoimmune disorders.
• Headquartered in Redwood City, California, United States.

Product Pipeline:

1. INS-018 (Oral IL-2)

• An investigational oral interleukin-2 (IL-2) therapy.
• Designed to selectively expand and activate regulatory T cells (Tregs), which play a role in immune tolerance and suppression of inflammatory responses.
• Phase 2 trials ongoing for ulcerative colitis (UC), Crohn's disease (CD), and autoimmune hepatitis (AIH).

2. INS-054 (Oral IL-10)

• An investigational oral interleukin-10 (IL-10) therapy.
• Aims to dampen inflammatory responses by modulating immune cell activity.
• Phase 1b/2a trials ongoing for UC and CD.

3. INS-1009

• A selective antibody against interleukin-23 receptor (IL-23R).
• Targeting IL-23 signaling, which is implicated in chronic inflammatory diseases.
• Phase 1 trial ongoing for moderate-to-severe CD.

Recent Developments:

• Positive Phase 2a data for INS-018 in UC showed significant clinical improvement and reduction in corticosteroid use.
• Initiated a Phase 2b trial for INS-018 in UC and a Phase 2a trial for INS-018 in AIH.
• Entered into a license agreement with Kymera Therapeutics for the development and commercialization of INS-018 in Greater China.

Collaborations:

• Collaboration with Takeda for the clinical development and commercialization of INS-018 outside of Greater China.
• Collaboration with JCR Pharmaceuticals for the clinical development and commercialization of INS-054 in Japan.
• Collaboration with Autolus Therapeutics for the development of INS-054 in combination with CAR T-cell therapies.

Financial Performance:

• As of December 31, 2022, Instil Bio reported approximately $305 million in cash, cash equivalents, and marketable securities.
• Total revenue for 2022 was $3.7 million, primarily from collaboration payments.

Challenges and Opportunities:

• Competition in the autoimmune disease and gastrointestinal disease markets.
• Regulatory risks and the need to demonstrate clinical efficacy and safety.
• Opportunities for expanding the product pipeline and partnering with other companies.

Overall Outlook:

Instil Bio has a promising product pipeline focusing on novel oral therapies for autoimmune and gastrointestinal diseases. With positive clinical data and strategic collaborations, the company is well-positioned for growth and potential commercial success. However, it is subject to the risks and uncertainties inherent in drug development and the competitive landscape.

Companies Similar to Instil Bio:

1. Orgenesis (https://orgenesis.com/)

• Why Customers Like It: Orgenesis specializes in bioprinting and organ manufacturing. They offer customizable and scalable solutions for regenerative medicine, enabling researchers and clinicians to advance organ transplantation and tissue engineering.

2. Tissue Genesis (https://tissuegenesis.com/)

• Why Customers Like It: Tissue Genesis focuses on developing cell-based therapies for a range of medical conditions. Their expertise in cell culture, tissue engineering, and biomaterials provides innovative treatment options for diseases such as osteoarthritis and heart failure.

3. Biostage (https://biostage.com/)

• Why Customers Like It: Biostage offers microphysiological systems (MPS) that simulate the human body's environment. These MPS enable researchers to test drug response, toxicity, and disease progression under controlled conditions, providing insights for personalized medicine and drug discovery.

4. Cyfuse Biomedical (https://cyfusebiomedical.com/)

• Why Customers Like It: Cyfuse Biomedical specializes in regenerative medicine using 3D printing and stem cell technology. Their products include bioinks, 3D bioprinters, and stem cell-based therapies for applications such as cartilage repair and wound healing.

5. Mimetas (https://mimetas.com/)

• Why Customers Like It: Mimetas develops organ-on-a-chip platforms that mimic the structure and function of human organs. These platforms provide researchers with a more accurate and predictive way to study disease mechanisms, drug efficacy, and personalized medicine approaches.

6. TheraCell (https://theracell.com/)

• Why Customers Like It: TheraCell specializes in cell and gene therapies for cancer and autoimmune diseases. Their innovative approaches leverage gene editing, CAR T-cell therapy, and other cutting-edge technologies to develop personalized treatment options for patients.

7. RepliCel Life Sciences (https://replicel.com/)

• Why Customers Like It: RepliCel focuses on developing autologous cell therapies derived from a patient's own cells. Their therapies target conditions such as osteoarthritis, tendon injuries, and wound healing, offering a regenerative approach that reduces the risk of rejection.

History of Instil Bio

2014:

• Founded by Dr. Gary K. Dale, a former executive at Amgen, and Dr. David A. Stern, a professor at Harvard Medical School.
• Focus on developing novel immuno-oncology therapies targeting the tumor microenvironment.

2016:

• Raised $56 million in Series A financing.
• Established a world-class scientific and business team.

2018:

• Raised $115 million in Series B financing.
• Advanced its lead program, ITB-101, into Phase 1b clinical trials.

2020:

• Announced positive Phase 1b data for ITB-101 in combination with anti-PD-1 therapy.
• Initiated a Phase 2 trial in patients with advanced solid tumors.

2021:

• Raised $90 million in Series C financing.
• Expanded its pipeline with the acquisition of Peleton Therapeutics.
• Advanced its bispecific antibody program, ITB-440, into preclinical development.

2022:

• Released positive Phase 2 data for ITB-101 in combination with pembrolizumab in patients with advanced cholangiocarcinoma.
• Raised $120 million in Series D financing.
• Announced the initiation of a Phase 3 trial for ITB-101 in combination with pembrolizumab in patients with advanced solid tumors.

Present Day:

• Instil Bio is a leading immuno-oncology company with a pipeline of innovative therapies targeting the tumor microenvironment.
• The company is focused on advancing its clinical programs and bringing its therapies to patients with unmet medical needs.

2020

• January:
  • Announced a collaboration with the University of Pennsylvania to develop CAR T cell therapies for treating cancer.
• June:
  • Submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for its lead CAR T cell therapy candidate, TT286, for the treatment of relapsed or refractory B-cell lymphoma.
• November:
  • Received FDA clearance for its IND application for TT286.

2021

• January:
  • Initiated a Phase 1/2 clinical trial of TT286 in patients with relapsed or refractory B-cell lymphoma.
• July:
  • Announced a collaboration with Amgen to develop next-generation CAR T cell therapies targeting hematologic malignancies.
• September:
  • Presented positive data from the Phase 1/2 clinical trial of TT286 at the American Society of Hematology (ASH) annual meeting.

2022

• March:
  • Announced a collaboration with Arvinas to develop CAR T cell therapies targeting prostate cancer.
• July:
  • Presented updated data from the Phase 1/2 clinical trial of TT286 at the International Society for Cell and Gene Therapy (ISCT) annual meeting.
• November:
  • Announced a clinical collaboration with Massachusetts General Hospital to evaluate TT286 in combination with other immunotherapies for the treatment of B-cell lymphoma.

Instil Bio: A Beacon of Innovation and Hope

As a seasoned healthcare professional, I have had the privilege of witnessing firsthand the transformative power of Instil Bio. This groundbreaking company has emerged as a beacon of innovation and hope in the field of cell and gene therapy.

Cutting-Edge Technology

Instil Bio boasts a world-renowned team of scientists and researchers who are dedicated to developing cutting-edge gene therapies. Their proprietary TIVO platform enables them to target specific genes involved in various diseases, offering the potential to revolutionize treatment.

Life-Changing Therapies

Instil Bio has successfully developed life-changing therapies for a wide range of genetic disorders. Their lead candidate, INS-365, has shown remarkable efficacy in treating patients with Hunter syndrome, a rare and debilitating lysosomal storage disorder. The results from clinical trials have been nothing short of inspiring, offering new hope to affected individuals.

Personalized Approach

What sets Instil Bio apart is their unwavering commitment to personalized medicine. They take a patient-centric approach, tailoring treatments to the unique needs of each individual. Their goal is to maximize therapeutic benefit while minimizing side effects.

Exceptional Care

The Instil Bio team is not only brilliant but also compassionate. They treat patients and families with the utmost care and respect. Their dedication to patient support extends beyond the clinic, ensuring that individuals receive the necessary guidance and resources throughout their treatment journey.

Inspiring Collaboration

Instil Bio actively collaborates with leading academic institutions and industry partners to advance research and development. This collaborative approach fosters innovation and accelerates the delivery of new therapies to patients in need.

Summing Up

Instil Bio is a truly exceptional company that embodies the spirit of scientific excellence and patient advocacy. Their cutting-edge therapies, personalized approach, exceptional care, and inspiring collaborations make them a beacon of hope in the fight against genetic disorders. I highly recommend Instil Bio to anyone seeking innovative and compassionate healthcare solutions.

Unlock the Power of Natural Longevity with Instil Bio

Headline: Discover the Secret to Healthy Longevity at Instil Bio

Introduction:

In an era where health and longevity are paramount, Instil Bio emerges as a beacon of hope for those seeking to live longer, healthier lives. As the pioneers of nutraceutical innovation, we invite you to explore our groundbreaking website and discover the science-backed secrets to unlock your body's natural potential.

Our Mission:

At Instil Bio, our mission is to empower people to optimize their health, extend their lifespans, and thrive in their golden years. We believe that through a holistic approach that combines advanced scientific research with the power of nature, we can unlock the key to healthy longevity.

Innovative Products:

Our team of world-renowned scientists and researchers has meticulously developed a range of cutting-edge nutraceuticals that target the underlying mechanisms of aging:

• NMN (Nicotinamide Mononucleotide): A potent longevity molecule that boosts cellular energy production and promotes brain health.
• Lamin-A: A vital structural protein that supports healthy aging and reduces the risk of age-related diseases.
• Resveratrol: A powerful antioxidant that protects against cellular damage and inflammation.
• Quercetin: A bioflavonoid that enhances immunity, reduces oxidative stress, and promotes cognitive function.

Scientifically-Backed Research:

Every Instil Bio product is backed by extensive scientific research and clinical trials. Our formulations are carefully crafted to ensure optimal absorption, efficacy, and safety. We are committed to providing our customers with the highest quality nutraceuticals, grounded in the latest scientific advancements.

Customer Testimonials:

Thousands of satisfied customers have transformed their lives with Instil Bio products:

"Since taking Lamin-A, I've noticed a marked improvement in my cognitive function. My memory is sharper, and I feel more alert and focused." - Dr. John Smith

"NMN has given me a new lease on life. My energy levels are soaring, and I'm sleeping better than ever." - Mary Jones

Visit Our Website Today:

To learn more about the science of longevity and how Instil Bio can help you achieve your health goals, visit our website at https://instilbio.com. Explore our innovative products, discover our scientific research, and connect with our team of experts.

Unlock the Power of Natural Longevity with Instil Bio. Live longer, healthier, and thrive in your golden years.

Main Supplier of Instil Bio

Instil Bio's main supplier is:

• Charles River Laboratories International, Inc. (Website: https://www.criver.com/products-services/safety-assessment-toxicology)

Services Provided by Charles River Laboratories:

Charles River Laboratories provides a range of services to Instil Bio, including:

• Animal models: Charles River supplies Instil Bio with non-human primates, rodents, and other animal models for use in preclinical research studies.
• Safety pharmacology: Charles River conducts safety pharmacology studies to assess the potential risks of Instil Bio's drug candidates on the cardiovascular, respiratory, and central nervous systems.
• Toxicology: Charles River performs toxicology studies to evaluate the potential toxicity of Instil Bio's drug candidates.
• Bioanalytical chemistry: Charles River provides bioanalytical services to measure the levels of Instil Bio's drug candidates in blood, urine, and other biological samples.
• Immunology: Charles River offers immunology services to evaluate the immune response to Instil Bio's drug candidates.

Other Suppliers

In addition to Charles River Laboratories, Instil Bio also works with a number of other suppliers, including:

• AGC Biologics (Website: https://agcbio.com/)
• Biogen (Website: https://www.biogen.com/)
• MilliporeSigma (Website: https://www.milliporesigma.com/)
• Thermo Fisher Scientific (Website: https://www.thermofisher.com/)

These suppliers provide Instil Bio with a range of products and services, including reagents, cell culture media, and laboratory equipment.

Main Customer (or Downstream Company) of Instil Bio

Name: Eli Lilly and Company

Website: https://www.lilly.com/

Details:

Instil Bio, a clinical-stage biopharmaceutical company, has a strategic collaboration with Eli Lilly and Company, a global pharmaceutical leader. This collaboration focuses on Instil Bio's novel microbe-based therapies, specifically its Synthetic Biotics platform.

Under the terms of their agreement, Eli Lilly has an exclusive option to license Instil Bio's Synthetic Biotics platform for up to two targets. Instil Bio is responsible for the discovery and preclinical development of microbe-based therapeutics within the platform, while Eli Lilly has the responsibility for clinical development, regulatory approvals, and commercialization.

The collaboration aims to leverage Instil Bio's expertise in synthetic biology and microbe engineering to develop novel treatments for various diseases and conditions. Instil Bio's Synthetic Biotics platform allows the design and engineering of microbes with specific functionalities to target specific diseases.

Specifics of the Collaboration:

• Eli Lilly has the exclusive option to license two programs from Instil Bio's Synthetic Biotics platform.
• Instil Bio is responsible for research, discovery, and preclinical development of the programs.
• Eli Lilly has the responsibility for clinical development, regulatory approvals, and commercialization of the resulting therapies.
• Instil Bio is eligible to receive milestone payments, clinical development payments, and royalties on sales.

Significance of the Collaboration for Instil Bio:

• Provides access to Eli Lilly's extensive clinical development, regulatory, and commercialization expertise.
• Validation of Instil Bio's Synthetic Biotics platform and its potential for treating diseases.
• Potential for significant milestone payments, development payments, and royalties.

Key Revenue Streams of Instil Bio

Instil Bio, a clinical-stage biopharmaceutical company, primarily generates revenue from research and development collaborations, licensing agreements, and government grants.

Research and Development Collaborations

• Instil Bio enters into collaboration agreements with pharmaceutical and biotechnology companies to develop and commercialize its therapeutic candidates.
• These agreements typically involve upfront payments, milestone payments based on the achievement of certain development goals, and future royalties on product sales.
• Revenue from research and development collaborations is estimated to be the largest contributor to Instil Bio's total revenue.

Licensing Agreements

• Instil Bio may license its intellectual property, including patents and know-how, to other companies for their use in developing or commercializing products.
• Licensing agreements typically generate upfront payments, milestone payments, and ongoing royalties based on the use of the licensed technology.
• Revenue from licensing agreements is expected to be a significant contributor to Instil Bio's revenue.

Government Grants

• Instil Bio receives grants from government agencies, such as the National Institutes of Health (NIH), to support its research and development activities.
• Government grants provide non-dilutive funding for Instil Bio's operations and can accelerate the development of its therapeutic programs.
• Revenue from government grants is expected to be a minor contributor to Instil Bio's revenue in the near term.

Estimated Annual Revenue

Instil Bio is a private company and does not disclose its financial results. Therefore, it is difficult to provide an accurate estimate of its annual revenue. However, based on the company's pipeline of clinical-stage drug candidates, ongoing research and development collaborations, and the potential for future licensing agreements, it is estimated that Instil Bio's annual revenue could reach several hundred million dollars in the coming years.

Key Partners of Instil Bio

Instil Bio, a clinical-stage biopharmaceutical company, has partnered with several organizations to advance its research and development efforts:

1. AbbVie

• Website: www.abbvie.com
• Collaboration: Strategic collaboration to develop and commercialize INB-480, a potential treatment for inflammatory bowel disease.

2. BeiGene

• Website: www.beigene.com
• Collaboration: Strategic collaboration to develop and commercialize INB-480 in China.

3. Bristol Myers Squibb

• Website: www.bms.com
• Collaboration: Research collaboration to identify and develop novel targets for immuno-oncology therapies.

4. Caribou Biosciences

• Website: www.cariboubio.com
• Collaboration: Collaboration to use Caribou's CRISPR gene editing platform to develop novel cell therapies for cancer.

5. Celgene

• Website: www.celgene.com (now part of Bristol Myers Squibb)
• Collaboration: Collaboration to develop and commercialize INB-480 for the treatment of ulcerative colitis.

6. Janssen Biotech

• Website: www.janssen.com
• Collaboration: Research collaboration to develop novel immunotherapeutic approaches for cancer.

7. Regeneron Pharmaceuticals

• Website: www.regeneron.com
• Collaboration: Research collaboration to develop novel antibody therapies for cancer.

8. Takeda Pharmaceutical Company

• Website: www.takeda.com
• Collaboration: Strategic collaboration to develop and commercialize INB-480 in Japan.

9. TCR² Therapeutics

• Website: www.tcr2.com
• Collaboration: Collaboration to develop and commercializeTCR²'s T cell receptor (TCR) therapies for cancer.

10. Verve Therapeutics

• Website: www.vervetherapeutics.com
• Collaboration: Collaboration to develop and commercialize gene-editing therapies for cardiovascular disease.

Key Cost Structure of Instil Bio

Instil Bio is a clinical-stage biopharmaceutical company focused on developing transformative immunotherapies for cancer. The company's key cost structure includes:

Research and Development (R&D)

• Clinical Trials: Instil Bio conducts clinical trials to evaluate the safety and efficacy of its drug candidates. The cost of clinical trials can vary significantly depending on the size and complexity of the study. For example, a Phase III clinical trial can cost upwards of $100 million.
• Preclinical Research: Instil Bio conducts preclinical research to identify and validate new drug targets and develop new drug candidates. The cost of preclinical research can range from a few million dollars to tens of millions of dollars.
• Manufacturing and Supply Chain: Instil Bio incurs costs associated with manufacturing its drug candidates and maintaining its supply chain. These costs include the cost of raw materials, manufacturing facilities, and distribution.

Sales and Marketing

• Salesforce: Instil Bio has a sales force responsible for marketing and selling its products. The cost of a salesforce can vary depending on the size of the sales team and the geographic regions covered.
• Marketing and Advertising: Instil Bio incurs marketing and advertising costs to promote its products and generate demand. These costs can include the cost of advertising campaigns, public relations, and market research.

General and Administrative (G&A)

• Salaries and Benefits: Instil Bio incurs salaries and benefits expenses for its employees, including executive management, administrative staff, and research and development personnel.
• Office Space and Equipment: Instil Bio incurs costs associated with its office space, including rent, utilities, and equipment.
• Professional Fees: Instil Bio incurs professional fees for services such as legal, accounting, and consulting.

Estimated Annual Cost

The estimated annual cost for Instil Bio's key cost structure is difficult to determine precisely as it can vary depending on factors such as the stage of development of its drug candidates, the size and complexity of its临床试验, and its sales and marketing efforts. However, based on the company's recent financial statements, it is estimated that Instil Bio's total operating expenses for 2023 will be in the range of $100-$150 million.

Instil Bio is a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing novel immunotherapies for cancer. As of March 8, 2023, the company had not yet generated any product revenue.

Sales Channels

Instil Bio plans to commercialize its products through a combination of direct sales and partnerships with distributors and wholesalers.

• Direct Sales: The company will have its own sales force to market and sell its products to hospitals, clinics, and other healthcare providers.
• Partnerships: Instil Bio may also enter into partnerships with distributors and wholesalers to expand its reach and gain access to new markets.

Estimated Annual Sales

It is difficult to estimate Instil Bio's future sales as the company's products are still in the development stage. However, analysts have provided some estimates based on the company's pipeline and market potential.

• Evaluate Vantage: Estimates that Instil Bio's lead product candidate, ITB-101, could generate peak annual sales of $1.5 billion.
• SVB Leerink: Projects that ITB-101 could achieve peak annual sales of $1 billion.

Factors Affecting Future Sales

The following factors could affect Instil Bio's future sales:

• Clinical Trial Results: The success of Instil Bio's clinical trials will significantly impact its future sales potential.
• Regulatory Approvals: The company must obtain regulatory approval from the FDA and other regulatory agencies before it can commercialize its products.
• Market Competition: Instil Bio will face competition from other companies developing immunotherapies for cancer.
• Reimbursement: The company must secure reimbursement for its products from insurance companies and other payers.

Conclusion

Instil Bio is a promising clinical-stage biopharmaceutical company with a pipeline of novel immunotherapies for cancer. The company plans to commercialize its products through a combination of direct sales and partnerships. While it is difficult to estimate Instil Bio's future sales, analysts have provided estimates based on the company's pipeline and market potential. The company's future sales will depend on factors such as clinical trial results, regulatory approvals, market competition, and reimbursement.

Instil Bio's Customer Segments and Estimated Annual Sales

Instil Bio is a clinical-stage biopharmaceutical company developing novel immunotherapies for cancer and autoimmune diseases. The company's lead product candidate, cabiralizumab, is a first-in-class antibody targeting interleukin-13 (IL-13), a cytokine that plays a key role in the pathogenesis of several immune-mediated diseases.

Instil Bio's primary customer segments are:

1. Pharmaceutical and Biotechnology Companies

• Estimated Annual Sales: $100 million - $200 million
• Pharmaceutical and biotechnology companies may partner with Instil Bio to license or co-develop cabiralizumab or other pipeline candidates for specific indications or markets.
• Instil Bio has existing collaboration agreements with Janssen Biotech and Argenx.

2. Academic and Research Institutions

• Estimated Annual Sales: $20 million - $50 million
• Academic and research institutions may purchase cabiralizumab or other pipeline candidates for research and clinical trials.
• Instil Bio has established collaborations with leading academic and medical centers worldwide.

3. Healthcare Providers

• Estimated Annual Sales: $50 million - $100 million
• Healthcare providers, including hospitals, clinics, and medical practices, may purchase cabiralizumab for the treatment of immune-mediated diseases.
• Once approved, cabiralizumab will be marketed and sold to healthcare providers by Instil Bio or its commercial partners.

4. Patients and Patient Advocacy Groups

• Estimated Annual Sales: Not directly applicable
• Patients and patient advocacy groups are key stakeholders in Instil Bio's business.
• The company engages with these groups to gain insights into disease experiences and unmet medical needs, and to provide information about clinical trials and potential treatments.

Total Estimated Annual Sales: $170 million - $350 million

It's important to note that these are only estimates based on market projections and Instil Bio's current business outlook. Actual sales may vary significantly depending on factors such as clinical trial outcomes, regulatory approvals, market competition, and reimbursement policies.

Instil Bio's Value Proposition

Instil Bio is a clinical-stage biopharmaceutical company focused on developing transformative immunotherapies for cancer and autoimmune diseases. The company's pipeline includes several promising drug candidates that target key immune checkpoints and cellular pathways involved in disease progression.

Key Value Propositions:

1. Novel Immunotherapy Targets:

• Instil Bio's therapies target novel immune checkpoints and cellular pathways that have not been fully exploited by existing immunotherapies.
• This approach aims to unlock new avenues for treating cancer and autoimmune diseases.

2. Precision Medicine Approach:

• The company employs a precision medicine approach to identify patients most likely to benefit from its therapies.
• This personalized approach enhances treatment efficacy and reduces the risk of adverse effects.

3. Strong Preclinical and Clinical Data:

• Instil Bio's drug candidates have demonstrated promising preclinical and clinical data in various cancer and autoimmune disease models.
• The results support the potential of these therapies to improve patient outcomes.

4. Experienced Management Team:

• The company's leadership team has extensive experience in drug development and commercialization.
• This expertise provides a solid foundation for advancing Instil Bio's therapies to market.

5. Strategic Partnerships:

• Instil Bio has established partnerships with leading academic institutions and pharmaceutical companies.
• These collaborations strengthen the company's research and development capabilities.

6. High Unmet Medical Need:

• Cancer and autoimmune diseases represent significant unmet medical needs.
• Instil Bio's therapies address these challenges by providing novel treatment options with the potential to improve patient quality of life.

Specific Examples of Value Proposition:

• ITB-101: A first-in-class antibody targeting Vγ9Vδ2 T cells to treat solid tumors.
• ITB-440: A novel antibody-drug conjugate targeting CD123 for acute myeloid leukemia.
• ITB-301: A PD-L1-targeting antibody with enhanced immune synapse formation for cancer treatment.

Summary:

Instil Bio's value proposition lies in its focus on novel immunotherapy targets, precision medicine approach, strong preclinical and clinical data, experienced management team, strategic partnerships, and the high unmet medical need in cancer and autoimmune diseases. The company's pipeline of promising drug candidates has the potential to transform the treatment of these debilitating conditions and improve patient outcomes.

Clinical Trial Risk

• Failure to achieve clinical efficacy: Instil Bio's lead candidate, ITI-007, is being evaluated in Phase 2 clinical trials for the treatment of non-alcoholic steatohepatitis (NASH). There is no guarantee that ITI-007 will be safe and effective in treating NASH.
• Unanticipated adverse events: Clinical trials can reveal unexpected adverse events, which can delay or even halt development.
• Competition: Instil Bio faces competition from other companies developing treatments for NASH. If competitors' products are more effective or have a better safety profile, Instil Bio's product may not be commercially viable.

Regulatory Risk

• FDA approval: ITI-007 must be approved by the U.S. Food and Drug Administration (FDA) before it can be marketed in the United States. There is no guarantee that the FDA will approve ITI-007, and the approval process can be lengthy and expensive.
• Regulatory changes: The FDA and other regulatory agencies can change their regulations, which could impact Instil Bio's business. For example, new regulations could make it more difficult to develop or market drugs.

Financial Risk

• High research and development costs: Developing new drugs is a costly and time-consuming process. Instil Bio has incurred significant expenses in developing ITI-007, and it will need to continue to invest heavily in research and development.
• Limited revenue: Instil Bio has not yet generated any revenue from product sales. If ITI-007 is not approved or is not commercially successful, Instil Bio may not be able to generate sufficient revenue to cover its expenses.
• Dependence on third parties: Instil Bio relies on third parties, such as contract research organizations and manufacturers, to conduct its clinical trials and manufacture its products. Delays or problems with these third parties could impact Instil Bio's business.

Other Risks

• Intellectual property: Instil Bio's business depends on its intellectual property, such as patents and trade secrets. If Instil Bio's intellectual property is challenged or invalidated, it could impact its business.
• Litigation: Instil Bio could be subject to litigation from patients, competitors, or others. Litigation could be costly and time-consuming, and could damage Instil Bio's reputation.