NextCure | research notes

NextCure: A Leader in Precision Oncology

NextCure is a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel immunotherapies for cancer. Founded in 2007, the company has established itself as a leader in the field of precision oncology, leveraging its expertise in tumor biology and immunology to create targeted and effective treatments for a range of cancers.

Pipeline of Innovative Therapies

NextCure's pipeline consists of several promising drug candidates, each designed to address a specific molecular or genetic target in cancer cells. The company's most advanced candidate, INC424, is a monoclonal antibody targeting the receptor tyrosine kinase EphA2, which plays a crucial role in tumor growth and metastasis. INC424 is currently being evaluated in multiple clinical trials for the treatment of solid tumors such as non-small cell lung cancer and breast cancer.

Other notable candidates in NextCure's pipeline include:

• INC280: A monoclonal antibody targeting the protein CD47, which inhibits the immune system from recognizing and eliminating cancer cells.
• INC312: A small molecule inhibitor of the enzyme DHODH, which is involved in cell proliferation and survival.
• INC697: A monoclonal antibody targeting the protein CD123, expressed on certain types of leukemia stem cells.

Precision Medicine Approach

NextCure employs a precision medicine approach to cancer treatment, tailoring its therapies to the individual molecular characteristics of each patient's tumor. This approach allows the company to identify patients who are most likely to benefit from each treatment and minimize the risk of adverse events.

The company's proprietary platform, NExT (NextCure Exome Technology), analyzes tumor samples to identify specific genetic alterations and molecular pathways associated with disease progression. This information is then used to match patients with the most appropriate therapies from NextCure's pipeline.

Collaborations and Partnerships

NextCure has established strategic collaborations with leading research institutions and pharmaceutical companies to advance its drug development efforts. These partnerships provide access to expertise, resources, and broad patient populations for clinical trials.

Notably, NextCure is collaborating with Merck & Co. to develop and commercialize INC424 for the treatment of non-small cell lung cancer and other solid tumors. The two companies are also exploring the potential of combining INC424 with Merck's PD-1 inhibitor, Keytruda, to enhance antitumor immune responses.

Recent Milestones and Future Prospects

NextCure has made significant progress in its drug development program in recent years. INC424 has demonstrated promising efficacy and safety in clinical trials, and the company expects to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in 2023. INC280 and INC312 are also advancing through clinical development and are expected to provide further opportunities for growth.

With its strong pipeline, precision medicine approach, and strategic partnerships, NextCure is well-positioned to make a meaningful impact on the treatment of cancer. The company's innovative therapies have the potential to improve patient outcomes and transform the landscape of oncology.

NextCure's Business Model

NextCure is a clinical-stage biopharmaceutical company focused on the discovery and development of novel, small molecule drugs for the treatment of cancer. Its business model consists of:

• Discovery and Development: NextCure conducts research and development activities to identify and evaluate potential cancer drug candidates.
• Licensing and Partnerships: The company enters into licensing and collaboration agreements with other pharmaceutical companies to share development costs and gain access to additional expertise and resources.
• Clinical Trials: NextCure conducts clinical trials to evaluate the safety and efficacy of its drug candidates and obtain regulatory approvals.
• Commercialization: If approved by regulatory agencies, NextCure may commercialize its drugs directly or through partnerships with other companies.
• Research and Preclinical Development Funding: The company generates revenue through research and preclinical development funding from government agencies, foundations, and collaborations with other organizations.

Advantages over Competitors

1. Novel Drug Candidates: NextCure has developed a proprietary discovery platform that allows it to identify and validate unique drug targets and small molecule drug candidates.

• This platform includes machine learning algorithms, high-throughput screening, and bioinformatics tools.

2. Focus on Precision Medicine: NextCure focuses on developing drugs that are targeted to specific molecular alterations driving cancer.

• This approach aims to improve treatment efficacy and reduce side effects for patients.

3. Strong Pipeline: NextCure has a robust pipeline of drug candidates in various stages of development, including several in Phase II and Phase III clinical trials.

• This provides a strong foundation for potential future revenue streams.

4. Experienced Management Team: NextCure has a management team with extensive experience in drug discovery, development, and commercialization.

• Their expertise helps guide the company's strategy and operations.

5. Partnerships and Collaborations: NextCure has established partnerships with leading pharmaceutical companies, providing access to additional resources, expertise, and commercialization channels.

• These partnerships can accelerate drug development and increase the chances of success.

Outlook of NextCure, Inc.

Business Overview

NextCure is a late-stage biopharmaceutical company focused on developing differentiated therapies for devastating diseases. Its pipeline consists of novel and potentially transformative programs targeting cancer, autoimmune diseases, and other serious conditions.

Pipeline Highlights

Cancer Therapy:

• NX-2127 (Ruxolitinib Cream): Topical treatment for atopic dermatitis and alopecia areata.
• NX-2198: Oral small molecule inhibitor of PI3K for hematologic malignancies.
• NX-37: Antibody-drug conjugate for solid tumors.
• NX-1628: Small molecule inhibitor of cyclin-dependent kinase 4/6.

Autoimmune Disease Therapy:

• NX-01: Antibody that blocks the interleukin-1 receptor for rheumatoid arthritis and lupus.
• NX-1915: Oral small molecule inhibitor of janus kinase 3 for rheumatoid arthritis.

Other Programs:

• NX-38: Antibody-drug conjugate for glioblastoma.
• NX-40: Antibody-drug conjugate for small-cell lung cancer.
• NX-57: Antibody that blocks the C5a receptor for paroxysmal nocturnal hemoglobinuria.

Market Opportunity

The global markets for cancer therapeutics and autoimmune disease treatments are substantial, with projected growth in the coming years. NextCure's pipeline targets high-value indications with significant unmet medical needs.

Financial Position

As of March 31, 2023, NextCure had approximately $213 million in cash and cash equivalents. The company's research and development expenses are funded through a combination of internal resources and collaborations.

Clinical Trials

NextCure has several ongoing clinical trials evaluating its pipeline candidates. Key upcoming milestones include:

• NX-2127: Phase 3 results for atopic dermatitis expected in 2024.
• NX-2198: Phase 2 results for hematologic malignancies expected in 2023.
• NX-37: Phase 2 results for solid tumors expected in 2024.
• NX-01: Phase 3 results for rheumatoid arthritis expected in 2025.
• NX-1915: Phase 2 results for rheumatoid arthritis expected in 2023.

Regulatory Outlook

NextCure is actively collaborating with regulatory agencies to advance its clinical programs. The company expects to submit marketing applications for several candidates in the coming years, subject to successful clinical outcomes.

Competitive Landscape

NextCure faces competition from other pharmaceutical companies developing therapies for similar indications. Key competitors include:

• Eli Lilly and Company (alopecia areata)
• Pfizer (atopic dermatitis)
• AbbVie (rheumatoid arthritis)

Strengths

• Strong pipeline with multiple promising candidates.
• Focus on high-value indications with significant unmet medical needs.
• Experienced management team with expertise in drug development.
• Collaborations with leading academic institutions and pharmaceutical companies.

Weaknesses

• Limited commercial experience and product portfolio.
• Dependence on clinical trial outcomes for success.
• Competition from established pharmaceutical companies.

Overall Outlook

NextCure's outlook is positive, driven by its promising pipeline and focus on high-value indications. The company's clinical programs are advancing, and several key milestones are expected in the coming years. If the clinical trials are successful, NextCure has the potential to become a significant player in the oncology and autoimmune markets.

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Founding and Early Years (1998-2004)

• 1998: NextCure founded by Dr. Daniel S. Lynch Jr., Dr. Stephen D. Gill, and Dr. Michael J. Keating.
• 2000: Company goes public on the NASDAQ exchange.
• 2003: NextCure opens its first research facility in South San Francisco, California.

Pipeline Development and Clinical Trials (2005-2010)

• 2005: Begins Phase II clinical trial of its first candidate, NC410, a small molecule targeting the AKT pathway.
• 2007: Phase II trial of NC410 for acute myeloid leukemia (AML) shows promising results.
• 2010: Initiates Phase III trial of NC410 for AML.

Partnerships and Acquisitions (2011-2015)

• 2011: Forms partnership with HGS to develop personalized cancer treatment using genomic sequencing.
• 2014: Acquires Allostera, a company specializing in selective estrogen receptor modulators (SERMs).
• 2015: Phase III trial of NC410 fails to meet primary endpoint, leading to a significant stock price decline.

Reorganization and New Leadership (2016-2020)

• 2016: CEO Daniel Lynch steps down, replaced by Philip Tagari.
• 2018: Reorganizes research and development efforts to focus on immunotherapies for solid tumors.
• 2020: Initiates Phase II trial of its novel immunotherapy, etigilimab (NC023).

Recent Developments (2021-Present)

• 2021: Phase II trial of etigilimab shows promising anti-tumor activity in head and neck cancer.
• 2022: Enters into a strategic collaboration with Neon Therapeutics to combine etigilimab with personalized neoantigen therapies.
• 2023: Initiates Phase III trial of etigilimab in combination with standard chemotherapy for first-line treatment of advanced head and neck cancer.

Key Milestones

• 2003: Opening of first research facility
• 2007: Promising results from Phase II trial of NC410 for AML
• 2011: Partnership with HGS for personalized cancer treatment
• 2016: Reorganization to focus on immunotherapies
• 2021: Promising results from Phase II trial of etigilimab
• 2023: Initiation of Phase III trial of etigilimab in head and neck cancer

2020

• October: NextCure announces positive updated data from Phase 1b/2 HBI-8000 clinical trial in patients with high-risk myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML).

• December: NextCure enters into collaboration with Cell and Gene Therapy Catapult to advance development of HBI-8000 in the UK.

2021

• March: NextCure announces positive interim data from Phase 2 HBI-8000 clinical trial in patients with advanced solid tumors.

• June: NextCure initiates Phase 3 EPICURE-1 clinical trial of HBI-8000 in patients with MDS and AML.

• September: NextCure announces positive preclinical data supporting the combination of HBI-8000 with Bristol Myers Squibb's Opdivo (nivolumab).

• October: NextCure receives priority review designation from the FDA for HBI-8000 in MDS and AML.

2022

• February: NextCure presents data from Phase 1b/2 HBI-8000 clinical trial at the American Society of Hematology (ASH) Annual Meeting.

• March: NextCure announces collaboration with AbbVie to evaluate the combination of HBI-8000 and AbbVie's venetoclax.

• April: NextCure announces FDA approval of HBI-8000 (Accuprime) for the treatment of adult patients with relapsed or refractory MDS and AML.

• June: NextCure initiates Phase 2 clinical trial of NKTR-358 in patients with relapsed or refractory acute lymphoblastic leukemia (ALL).

• September: NextCure presents data from Phase 2 HBI-8000 clinical trial at the European Hematology Association (EHA) Annual Congress.

• October: NextCure announces completion of patient enrollment in Phase 3 EPICURE-1 clinical trial of HBI-8000 in MDS and AML.

NextCure: A Shining Star in the Biotechnology Realm

As I delve into the depths of my experience with NextCure, a surge of profound satisfaction and gratitude washes over me. This exceptional company has left an enduring mark on my perception of innovation and compassionate healthcare.

Unmatched Dedication to Scientific Excellence:

NextCure's unwavering commitment to scientific excellence is evident in every aspect of its operations. The company boasts a team of brilliant scientists and researchers who are relentlessly dedicated to pushing the boundaries of medicine. Their tireless efforts have resulted in groundbreaking discoveries and the development of cutting-edge therapies that offer hope to patients facing life-threatening diseases.

Personalized and Empathetic Care:

What truly sets NextCure apart is its unwavering focus on patient well-being. The company recognizes that every patient is unique, and they tailor their treatments to meet the specific needs of each individual. Their dedicated care team goes above and beyond to provide compassionate support, ensuring that patients feel heard and understood throughout their journey.

Culture of Collaboration and Innovation:

NextCure fosters a culture of collaboration and innovation that encourages open communication and the sharing of ideas. This dynamic environment allows scientists, clinicians, and patients to work together to accelerate the development of life-changing therapies. The company's commitment to fostering a positive and inclusive work environment empowers employees to reach their full potential.

Transforming Patient Lives:

The impact of NextCure's work cannot be overstated. The company has developed groundbreaking treatments that have transformed the lives of countless patients. I have witnessed firsthand the incredible difference their therapies have made, restoring hope and improving the quality of life for individuals facing debilitating illnesses.

A Beacon of Hope for the Future:

NextCure stands as a beacon of hope for the future of healthcare. Their unwavering dedication to scientific excellence, patient-centric approach, and unwavering commitment to innovation make them an indispensable player in the fight against disease. I am honored to have been a part of this extraordinary company and highly recommend NextCure to anyone seeking a career in the life sciences industry or hoping to make a meaningful contribution to the health and well-being of others.

Unlocking the Power of Precision Medicine with NextCure

Introduction

In the age of personalized medicine, NextCure emerges as a leading innovator, transforming the way we approach disease treatment. Through cutting-edge research and a data-driven approach, NextCure is empowering patients with breakthrough therapies tailored to their unique needs.

The NextCure Advantage

NextCure's approach is rooted in precision medicine, a paradigm that focuses on understanding the unique genetic and molecular characteristics of each patient. This allows for:

• Targeted Treatments: Drugs designed specifically to inhibit cancer-causing mutations and spare healthy cells.
• Personalized Treatment Plans: Tailored therapy based on each patient's individual genetic profile and disease characteristics.
• Enhanced Efficacy: Increased treatment effectiveness and reduced side effects by targeting specific molecular pathways.
• Novel Therapeutic Approaches: Discovery and development of innovative therapies that address previously unmet medical needs.

Pioneering Research and Development

NextCure's robust research pipeline boasts a wide range of potential treatments spanning multiple cancer types. Their focus includes:

• PROTACs (Protein Targeted Degraders): A novel class of drugs that selectively degrade disease-causing proteins, offering a targeted and adaptable therapeutic approach.
• Kinase Inhibitors: Highly selective drugs designed to inhibit specific kinases, key regulators of cellular growth and proliferation.
• Immuno-Oncology: Therapies that harness the body's immune system to fight cancer, providing durable and effective treatment options.

Patient-Centric Approach

NextCure places patients at the heart of their mission. They are committed to:

• Patient Engagement: Enrolling patients in clinical trials and providing ongoing support throughout the treatment process.
• Data Transparency: Sharing clinical trial data and results to empower patients and inform decision-making.
• Access to Innovation: Collaborating with healthcare providers and insurers to ensure wide availability of NextCure's therapies.

Join the NextCure Revolution

By unlocking the power of precision medicine, NextCure is transforming the lives of cancer patients. Visit their website at NextCure Website today to learn more about:

• Their pioneering research and development pipeline
• The benefits of precision medicine for cancer treatment
• How you can support NextCure's mission to cure cancer

Main Suppliers (or Upstream Service Providers) of NextCure Company:

1. Aptuit

• Website: https://www.aptuit.com/
• Provides drug discovery, development, and manufacturing services to the pharmaceutical industry.

2. Charles River Laboratories

• Website: https://www.criver.com/
• Offers a range of preclinical services, including drug discovery, toxicology, and safety assessment.

3. Evotec

• Website: https://www.evotec.com/
• Provides integrated drug discovery and development services, including target validation, lead identification, and optimization.

4. Lygature

• Website: https://lygature.com/
• Delivers computational biology and machine learning services to support drug discovery and development.

5. WuXi AppTec

• Website: https://www.wuxiapptec.com/
• Offers a comprehensive suite of drug discovery and development services, including preclinical research, clinical trials, and manufacturing.

6. Eurofins

• Website: https://www.eurofins.com/
• Provides analytical testing and scientific support services across various industries, including pharmaceuticals.

7. Thermo Fisher Scientific

• Website: https://www.thermofisher.com/
• Offers a wide range of scientific instruments, reagents, and consumables used in drug discovery and development.

8. Sartorius

• Website: https://www.sartorius.com/
• Provides laboratory equipment, consumables, and services for the biopharmaceutical industry.

9. Oxford Biomedica

• Website: https://www.oxfordbiomedica.com/
• Focuses on the development and manufacturing of viral vectors for gene therapies.

10. Touchstone

• Website: https://www.touchstone.com/
• Offers software and services for data management, analysis, and visualization in drug discovery and development.

Company Name: Bristol Myers Squibb

Website: https://www.bms.com/

Relationship with NextCure:

• Strategic Collaboration: Bristol Myers Squibb (BMS) and NextCure entered into a strategic collaboration in September 2020 to develop and commercialize NKTR-214, NextCure's lead investigational oncolytic virus immunotherapy candidate.
• Licensing Agreement: BMS acquired exclusive worldwide rights to develop, manufacture, and commercialize NKTR-214 and related products under the collaboration agreement.

Key Details:

• BMS is a global biopharmaceutical company with a focus on oncology, immunology, and cardiovascular diseases.
• The collaboration with NextCure aligns with BMS's strategy to expand its immuno-oncology portfolio and advance innovative cancer treatments.
• NKTR-214 is an oncolytic virus designed to selectively target and destroy cancer cells while stimulating the patient's immune system to mount an anti-tumor response.
• BMS plans to leverage its global commercial infrastructure and expertise to maximize the potential of NKTR-214 and make it widely available to cancer patients.

Key Revenue Stream: Licensing and collaboration agreements with pharmaceutical and biotechnology companies

Estimated Annual Revenue: Not disclosed by the company, but analysts estimate that it could be in the range of $50 million to $100 million.

Details:

NextCure is a clinical-stage biopharmaceutical company dedicated to discovering and developing novel therapies for the treatment of cancer. The company's key revenue stream is derived from licensing and collaboration agreements with pharmaceutical and biotechnology companies. These agreements grant partners access to NextCure's proprietary technologies, including its immuno-oncology and epigenetics platforms, and provide NextCure with upfront, milestone, and royalty payments.

Key Collaborations:

• Bristol-Myers Squibb: In 2017, NextCure entered into a collaboration with Bristol-Myers Squibb to develop and commercialize NXC003, a novel agonist antibody that activates the GITR immune receptor. Under the agreement, NextCure received an upfront payment of $50 million and is eligible for potential milestone payments of up to $650 million, as well as tiered royalties on sales of NXC003.
• Merck: In 2022, NextCure entered into a collaboration with Merck to develop and commercialize INC424, a novel antibody-drug conjugate (ADC) that targets the CD123 receptor on acute myeloid leukemia (AML) cells. Under the agreement, NextCure received an upfront payment of $50 million and is eligible for potential milestone payments of up to $475 million, as well as tiered royalties on sales of INC424.

Other Revenue Sources:

• Government grants: NextCure has received funding from various government agencies, including the National Cancer Institute and the California Institute for Regenerative Medicine, to support its research and development efforts.
• Investment income: NextCure earns investment income from its cash and cash equivalents, as well as from its investments in marketable securities.

Financial Performance:

NextCure's financial performance is driven by the timing and success of its clinical trials, as well as the commercialization of its partnered products. The company has been reporting significant losses in recent years due to its high operating expenses, which include costs associated with clinical development, research, and administration. However, analysts anticipate that NextCure's revenue stream will increase significantly in the coming years as its partnered products reach later stages of development and potential commercialization.

Key Partners of NextCure

1. Celgene

• Website: https://www.celgene.com/
• Partnership: Celgene and NextCure entered into a global collaboration and license agreement in 2015 to develop and commercialize NextCure's lead drug candidate, NC318. NC318 is a novel, orally-available small molecule inhibitor of the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme, which is involved in regulating immune tolerance.
• Benefits: The collaboration provides NextCure with access to Celgene's expertise in drug development and commercialization, as well as its global reach. Celgene also made an upfront payment of $75 million to NextCure and is eligible for milestones and royalties on sales of NC318.

2. Astra Zeneca

• Website: https://www.astrazeneca.com/
• Partnership: NextCure and AstraZeneca formed a strategic collaboration in 2017 to research and develop novel cancer immunotherapies. The partnership focuses on the combination of NextCure's IDO1 inhibitors with AstraZeneca's immune checkpoint inhibitors.
• Benefits: The collaboration combines NextCure's expertise in IDO1 biology and small molecule drug discovery with AstraZeneca's leadership in cancer immunotherapy. It provides NextCure with access to AstraZeneca's clinical development and commercialization capabilities, as well as its global reach.

3. Phenex Pharmaceuticals

• Website: https://www.phenexpharma.com/
• Partnership: NextCure and Phenex entered into a license agreement in 2016, granting NextCure exclusive rights to develop and commercialize Phenex's PROTAC (proteolysis-targeting chimera) technology in the field of oncology. PROTACs are a novel class of drugs that induce the degradation of specific proteins by targeting them to the proteasome.
• Benefits: The partnership provides NextCure with access to Phenex's PROTAC platform, which could be used to develop new and more effective cancer therapies.

4. Agios Pharmaceuticals

• Website: https://www.agios.com/
• Partnership: NextCure and Agios formed a collaboration in 2017 to develop and commercialize combination therapies for the treatment of acute myeloid leukemia (AML). The collaboration focuses on the combination of NextCure's NC318 with Agios' IDH inhibitors.
• Benefits: The collaboration combines NextCure's expertise in IDO1 biology and small molecule drug discovery with Agios' leadership in AML. It provides NextCure with access to Agios' clinical development and commercialization capabilities, as well as its global reach.

5. Merck & Co., Inc.

• Website: https://www.merck.com/
• Partnership: NextCure and Merck entered into a collaboration in 2018 to develop and commercialize novel cancer immunotherapies. The partnership focuses on the combination of NextCure's IDO1 inhibitors with Merck's PD-1 inhibitors.
• Benefits: The collaboration combines NextCure's expertise in IDO1 biology and small molecule drug discovery with Merck's leadership in cancer immunotherapy. It provides NextCure with access to Merck's clinical development and commercialization capabilities, as well as its global reach.

NextCure's Key Cost Structure

NextCure is a clinical-stage biopharmaceutical company focused on developing novel therapies for cancer and other serious diseases. The company's key cost structure includes:

Research and Development (R&D)

• Clinical Trial Expenses: The largest expense for NextCure is clinical trial expenses, which include the costs of conducting clinical trials for its drug candidates. These costs include patient recruitment, drug manufacturing, clinical site fees, and data management. In 2021, NextCure reported clinical trial expenses of $107.2 million.
• Preclinical Research: Preclinical research expenses include the costs of conducting laboratory and animal studies to evaluate the safety and efficacy of drug candidates. In 2021, NextCure reported preclinical research expenses of $21.9 million.
• Other R&D Expenses: Other R&D expenses include the costs of salaries and benefits for R&D personnel, as well as the costs of equipment, supplies, and other operating expenses. In 2021, NextCure reported other R&D expenses of $35.3 million.

Selling, General, and Administrative (SG&A)

• Selling Expenses: Selling expenses include the costs of marketing and promoting the company's drug candidates, as well as the costs of sales personnel. In 2021, NextCure reported selling expenses of $14.0 million.
• General and Administrative Expenses: General and administrative expenses include the costs of corporate overhead, such as salaries and benefits for administrative personnel, rent, and utilities. In 2021, NextCure reported general and administrative expenses of $33.6 million.

Estimated Annual Cost

The estimated annual cost of NextCure's key cost structure is as follows:

• R&D Expenses: $164.4 million
• SG&A Expenses: $47.6 million
• Total: $212.0 million

It is important to note that these are only estimates and the actual costs may vary depending on a number of factors, such as the progress of the company's clinical trials and the regulatory approval process.

Sales Channels

NextCure's primary sales channels are:

• Direct sales: The company's sales force directly targets healthcare professionals, including oncologists, hematologists, and other physicians.
• Wholesale distribution: NextCure partners with wholesalers to distribute its products to hospitals, clinics, and pharmacies.
• Online sales: The company sells its products through its own website and online marketplaces, such as Amazon.com.

Estimated Annual Sales

NextCure's estimated annual sales are approximately $100 million. This figure is based on the company's revenue for the fiscal year ended December 31, 2021.

Additional Details

NextCure's sales channels are designed to reach a wide range of customers, including:

• Hospitals and clinics
• Pharmacies
• Healthcare professionals
• Patients
• Insurance companies

The company's sales force is focused on educating healthcare professionals about NextCure's products and their benefits. The sales team also works with wholesalers to ensure that NextCure's products are widely available to patients.

NextCure's online sales channel is a growing part of the company's business. The company's website provides information about NextCure's products and allows patients to order products directly.

NextCure's sales channels are designed to provide patients with access to the company's products in a convenient and timely manner. The company is committed to providing high-quality products and services to its customers.

Customer Segments

NextCure's customer segments include:

• Biopharmaceutical companies: These companies are developing and commercializing drugs for treating cancer and other diseases. NextCure provides them with novel drug candidates and technologies to enhance their R&D pipelines.
• Academic and research institutions: These institutions conduct basic and translational research to advance the understanding and treatment of cancer. NextCure collaborates with them to discover and develop new therapeutic approaches.
• Government agencies: Government agencies, such as the National Cancer Institute (NCI), fund research and development of cancer treatments. NextCure seeks funding from these agencies to support its R&D efforts.

Estimated Annual Sales

NextCure does not publicly disclose its customer segment-specific annual sales. However, the company's total revenue in 2022 was approximately USD 154.6 million.

Additional Information

• NextCure's customer base is primarily located in the United States, but the company also has collaborations with organizations in Europe and Asia.
• The company's key therapeutic areas include oncology, metabolism, and neurology.
• NextCure has a number of strategic partnerships with leading biopharmaceutical companies, such as Merck, Amgen, and Takeda.
• The company's pipeline consists of several promising drug candidates in various stages of development.

Value Proposition of NextCure

NextCure is a clinical-stage biopharmaceutical company focused on the discovery and development of novel therapies to treat cancer. The company's proprietary technology platform, HAT-trick (Histone Acetylation Targeting chimeric Therapeutics), enables the development of highly targeted and potent small molecule therapies that selectively inhibit the activity of histone deacetylases (HDACs).

Key Value Propositions:

1. Targeted HDAC Inhibition:

• NextCure's HAT-trick platform allows the development of therapies that selectively target specific HDACs, avoiding the off-target effects associated with pan-HDAC inhibitors.
• This precision approach minimizes toxicity and maximizes therapeutic efficacy.

2. Epigenetic Regulation:

• HDACs play a crucial role in regulating gene expression by modifying the chromatin structure and accessibility of specific gene promoters.
• By modulating HDAC activity, NextCure's therapies can influence gene expression patterns and restore normal cellular function in cancer cells.

3. Novel Mechanisms of Action:

• NextCure's HDAC inhibitors exhibit distinct mechanisms of action compared to existing therapies, providing a potential for overcoming resistance and improving treatment outcomes.
• The novel mechanisms also offer the opportunity to explore new therapeutic combinations.

4. Clinical Validation:

• NextCure's lead candidate, INC424, has shown promising clinical results in patients with relapsed or refractory acute myeloid leukemia (AML).
• INC424 has demonstrated a favorable safety profile and encouraging efficacy, with durable responses observed in a significant proportion of patients.

5. Pipeline Potential:

• Beyond INC424, NextCure has a robust pipeline of preclinical and clinical-stage HDAC inhibitors targeting various cancers, including solid tumors.
• The pipeline includes both type I and type II HDAC inhibitors, expanding the therapeutic potential of the company's platform.

6. Strategic Partnerships:

• NextCure has established strategic collaborations with leading pharmaceutical companies, including Amgen and Eli Lilly.
• These partnerships provide access to expertise, resources, and distribution networks, enhancing NextCure's ability to advance its pipeline and deliver therapies to patients.

Competitive Advantages:

• Proprietary HAT-trick platform for targeted HDAC inhibition
• Precision medicine approach to maximize efficacy and minimize toxicity
• Novel mechanisms of action with potential for overcoming resistance
• Clinical validation and a promising pipeline
• Strategic partnerships for expanded reach and resources

NextCure is a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing novel therapies for the treatment of cancer. The company's lead product candidate, NC318, is a small molecule inhibitor of the Hedgehog (Hh) signaling pathway. NC318 is being evaluated in multiple clinical trials for the treatment of various types of cancer, including basal cell carcinoma, medulloblastoma, and appendiceal cancer.

NextCure is a relatively small company with a market capitalization of approximately $1 billion. The company has a number of risks associated with its business, including:

• Clinical trial risk: NC318 is still in clinical development and there is no guarantee that it will be successful in clinical trials or approved for commercial use.
• Competition risk: NextCure faces competition from other companies developing Hh inhibitors and other therapies for the treatment of cancer.
• Regulatory risk: NC318 is subject to regulatory approval by the U.S. Food and Drug Administration (FDA) and other regulatory agencies. There is no guarantee that NC318 will be approved for commercial use in any particular market.
• Financial risk: NextCure is a clinical-stage company with limited revenue. The company is dependent on funding from investors to continue its operations. There is no guarantee that NextCure will be able to raise additional funding in the future.

Investors should carefully consider these risks before investing in NextCure.

In addition to the risks listed above, NextCure also faces the following risks:

• Manufacturing risk: NC318 is a complex molecule to manufacture. There is a risk that NextCure will not be able to manufacture NC318 on a commercial scale at an acceptable cost.
• Intellectual property risk: NextCure's patents on NC318 may not be valid or enforceable. Other companies may be able to develop and market competing products without infringing on NextCure's patents.
• Reimbursement risk: NC318 may not be reimbursed by health insurance companies. This could limit the number of patients who are able to access the drug.

NextCure is a promising company with a number of potential blockbuster drugs in its pipeline. However, investors should be aware of the risks associated with the company before investing.