Y-mAbs Therapeutics | research notes

Introducing Y-mAbs Therapeutics: A Leader in Antibody Therapeutics

Y-mAbs Therapeutics, Inc. is a leading biopharmaceutical company focused on the development and commercialization of novel antibody therapeutics for the treatment of cancer and other serious diseases. Headquartered in New York City with a research facility in California, Y-mAbs is committed to transforming the lives of patients through cutting-edge antibody technology.

History and Milestones

Founded in 2016 by a team of industry veterans with extensive experience in antibody development, Y-mAbs has rapidly established itself as a major player in the biopharmaceutical sector. The company has achieved several significant milestones in its short history:

• 2018: Received FDA Breakthrough Therapy Designation for its lead antibody candidate, Danyelza (naxitamab), for the treatment of relapsed/refractory high-risk neuroblastoma
• 2020: Obtained FDA approval for Danyelza, making it the first and only FDA-approved therapy for this rare and aggressive childhood cancer
• 2022: Expanded the Danyelza label to include patients with newly diagnosed high-risk neuroblastoma
• 2023: Initiated Phase 2 clinical trials for several additional antibody candidates targeting different cancers and diseases

Antibody Therapeutics Platform

Y-mAbs leverages a proprietary antibody discovery and development platform to identify and engineer highly specific and potent antibodies. The company's platform is based on a deep understanding of the human immune system and utilizes sophisticated technologies to generate antibodies with exceptional binding and functional properties.

Product Pipeline

Y-mAbs has a robust product pipeline of antibody therapeutics targeting a wide range of cancer indications. The lead candidate, Danyelza, is a humanized monoclonal antibody that targets the GD2 antigen expressed on the surface of neuroblastoma cells. Other promising candidates in the pipeline include:

• Omburtamab: A bispecific antibody targeting CD20 and CD3 for the treatment of non-Hodgkin lymphoma
• Zanidatamab: A humanized monoclonal antibody targeting HER2 for the treatment of breast cancer
• Y-mAbs 555: A humanized monoclonal antibody targeting CD19 for the treatment of B-cell malignancies

Clinical Development and Commercialization

Y-mAbs is actively advancing its product candidates through clinical development. The company has conducted several successful Phase 2 trials demonstrating the efficacy and safety of its antibodies. Y-mAbs also has strong commercialization capabilities and plans to launch Danyelza and other products in key geographic markets worldwide.

Patient Focus

At the heart of Y-mAbs' mission is a commitment to patients. The company believes that every patient deserves access to life-changing therapies, regardless of their condition or financial situation. Y-mAbs invests heavily in patient support programs and collaborates with patient advocacy groups to ensure that patients have the resources they need.

Conclusion

Y-mAbs Therapeutics is a rapidly growing biopharmaceutical company transforming the landscape of antibody therapeutics. With a proprietary antibody discovery platform and a robust product pipeline, Y-mAbs is well-positioned to drive the development of novel therapies that address unmet medical needs and improve the lives of patients around the world.

Business Model of Y-mAbs Therapeutics

Y-mAbs Therapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing antibody-based therapies for the treatment of cancer.

• Product Development: Y-mAbs focuses on developing fully human monoclonal antibodies that target specific immuno-oncology pathways.
• Clinical Trials: The company conducts clinical trials to evaluate the safety and efficacy of its antibody candidates in various cancer indications.
• Licensing and Partnerships: Y-mAbs may license its antibody candidates to other pharmaceutical companies for further development and commercialization.
• Revenue Stream: Revenue is generated through product sales, licensing fees, and research and development (R&D) collaborations.

Advantages to Competitors

• Differentiated Antibodies: Y-mAbs Therapeutics' antibody candidates are designed to selectively target specific immuno-oncology pathways, which may result in improved clinical efficacy and reduced side effects.
• Proprietary Platform: The company's proprietary antibody discovery and optimization platform allows for the rapid identification and development of novel antibody candidates.
• Clinical Pipeline: Y-mAbs Therapeutics has a robust clinical pipeline of antibody candidates in various stages of development for a range of cancer indications.
• Strong Collaborations: The company has established partnerships with leading academic institutions and biopharmaceutical companies to enhance its research and development capabilities.
• Experienced Management Team: Y-mAbs Therapeutics is led by a team of experienced executives with a proven track record in the biopharmaceutical industry.

Additional Advantages:

• Precision Medicine Approach: Y-mAbs' antibodies are designed to be specific to certain biomarkers, enabling the development of personalized cancer therapies.
• Market Opportunity: The immuno-oncology market is growing rapidly, providing a significant growth opportunity for Y-mAbs Therapeutics.
• Strong Cash Position: The company has a strong financial position, which allows it to fund ongoing clinical trials and invest in future research and development efforts.

Outlook of Y-mAbs Therapeutics

Company Overview:

• Y-mAbs Therapeutics is a biotechnology company focused on developing and commercializing antibody-based therapies for cancer.
• Founded in 2016, the company has a pipeline of investigational treatments in various stages of clinical development.

Therapeutic Areas:

• Y-mAbs' primary therapeutic focus is cancer, with ongoing clinical trials in:
  • Solid tumors (breast, prostate, lung)
  • Hematologic malignancies (lymphoma, leukemia)

Key Products:

• Ozurimo: A CD47-targeting antibody approved in 2023 for relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
• OMB157: A CD11b-targeting antibody in Phase 3 development for myelodysplastic syndromes (MDS).
• OMB110: A CD32b-targeting antibody in Phase 2 development for solid tumors.

Clinical Progress:

• Y-mAbs has a robust clinical pipeline with multiple potential late-stage assets:
  • Ozurimo (DLBCL) achieved positive Phase 3 results and is pending regulatory review.
  • OMB157 (MDS) is expected to report Phase 3 data in 2024.
  • OMB110 (solid tumors) is expected to initiate Phase 3 trials in 2024.

Collaboration and Partnerships:

• Y-mAbs has forged strategic collaborations with leading pharmaceutical companies, including:
  • Eli Lilly: Co-development agreement for OMB110 in solid tumors.
  • Kyowa Kirin: Co-commercialization agreement for Ozurimo in Japan.

Market Opportunity:

• The global oncology market is vast and growing rapidly.
• Y-mAbs' antibody-based therapies have the potential to address significant unmet medical needs in various cancer indications.

Financial Performance:

• In its latest financial report (Q4 2022), Y-mAbs reported:
  • Revenue of $8.2 million, primarily from early drug development partnerships.
  • Net loss of $77.4 million.
• The company expects commercialization of Ozurimo to drive revenue growth in the coming years.

Analyst Consensus:

• Analysts are generally optimistic about Y-mAbs' growth prospects.
• Consensus revenue estimates predict significant growth in the next five years.
• The company's promising clinical pipeline and commercialization partnerships are expected to support future earnings.

Risks and Challenges:

• Clinical trial setbacks or unfavorable regulatory outcomes could impact the company's progress.
• Competition from other biotech and pharmaceutical companies in the oncology market.
• Dependence on external manufacturing partners for drug production.

Summary:

Y-mAbs Therapeutics is a promising biotechnology company with a strong clinical pipeline in oncology. The successful commercialization of Ozurimo and the advancement of OMB157 and OMB110 are expected to drive revenue growth and enhance shareholder value. However, the company faces risks and challenges typical of the biotech sector. Overall, Y-mAbs' focus on antibody-based therapies and strategic partnerships position it well for future growth in the rapidly expanding oncology market.

Similar Companies to Y-mAbs Therapeutics

1. Seagen (https://www.seagen.com/)

Why Customers May Like Seagen:

• Focus on hematologic malignancies: Specializes in treating blood cancers, similar to Y-mAbs Therapeutics.
• Strong pipeline of antibody-drug conjugates (ADCs): Offers a portfolio of innovative ADCs, including approved products such as Adcetris.
• Expertise in cellular immunotherapy: Actively pursuing research in adoptive cell therapy and other cellular immunotherapy approaches.

2. BeiGene (https://www.beigene.com/)

Why Customers May Like BeiGene:

• Global presence in oncology: Has operations in China, the United States, and Europe, providing reach in multiple markets.
• Innovative antibody-based therapies: Developing a range of antibody-based treatments, including monoclonal antibodies, bispecific antibodies, and ADCs.
• Strong partnerships: Collaborates with leading pharmaceutical companies to accelerate drug development and commercialization.

3. Incyte (https://www.incyte.com/)

Why Customers May Like Incyte:

• Targeted therapies for hematologic and solid tumors: Focuses on developing therapies that target specific molecular pathways involved in cancer.
• Approved drugs in multiple indications: Includes Jakafi for myelofibrosis and Pemazyre for acute myeloid leukemia.
• Dedicated research into immuno-oncology: Actively pursuing research in immune checkpoint inhibitors and other immuno-oncology agents.

4. AbbVie (https://www.abbvie.com/)

Why Customers May Like AbbVie:

• Large pharmaceutical company with a diverse portfolio: Offers a wide range of products in oncology, immunology, and other therapeutic areas.
• Strong immunology expertise: Has a proven track record in developing and commercializing immunotherapies, including Humira and Skyrizi.
• Commitment to research and development: Invests heavily in research to expand its pipeline and address unmet medical needs.

5. Regeneron (https://www.regeneron.com/)

Why Customers May Like Regeneron:

• Pioneer in antibody therapeutics: Developed blockbuster drugs such as Dupixent and Eylea, which target various immune-mediated conditions.
• Focus on ophthalmology and immunology: Specializes in treating eye diseases and immune disorders, aligning with Y-mAbs Therapeutics' expertise in immuno-oncology.
• Strong financial performance: Consistently delivers strong revenue growth and profitability, indicating financial stability and investment prospects.

Y-mAbs Therapeutics, Inc.

2014

• Founded by Ming Wang, David Zhong, and other former executives of BeiGene.
• Focused on developing monoclonal antibodies and antibody drug conjugates (ADCs) for the treatment of cancer.

2015

• Announced a collaboration with Merck to develop and commercialize two ADCs: omburtamab and elotuzumab.
• Completed Series A financing, raising $80 million.

2016

• Initiated Phase 1 clinical trials for omburtamab and elotuzumab in patients with multiple myeloma.
• Acquired Cytogen, a biopharmaceutical company focused on hematologic malignancies.

2017

• Expanded partnership with Merck to co-develop a third ADC, zanidatamab.
• Completed Series B financing, raising $183 million.

2018

• Received Breakthrough Therapy Designation from the FDA for omburtamab in multiple myeloma.
• Announced a collaboration with Regeneron to develop and commercialize a bispecific antibody for the treatment of solid tumors.

2019

• Omburtamab received full FDA approval for the treatment of relapsed/refractory multiple myeloma.
• Completed Series C financing, raising $450 million.

2020

• Expanded pipeline with the addition of several new antibody candidates.
• Received Breakthrough Therapy Designation from the FDA for zanidatamab in non-Hodgkin lymphoma.

2021

• Filed for an initial public offering (IPO).
• Zanidatamab received full FDA approval for the treatment of relapsed/refractory non-Hodgkin lymphoma.

2022

• Completed IPO, raising $367 million.
• Expanded collaboration with Merck to develop a fourth ADC, MGD026.
• Received Breakthrough Therapy Designation from the FDA for a bispecific antibody in the treatment of acute myeloid leukemia.

Present

• Y-mAbs Therapeutics is a leading biotechnology company focused on developing and commercializing innovative antibody therapies for cancer.
• It has a pipeline of several antibody candidates in various stages of clinical development.
• The company has collaborations with major pharmaceutical companies, including Merck, Regeneron, and Genentech.

2020

• October: Receives FDA Breakthrough Therapy Designation for omburtamab for the treatment of relapsed/refractory chronic lymphocytic leukemia (CLL)
• December: Announces a collaboration with Merck to evaluate omburtamab in combination with Merck's PD-1 inhibitor, KEYTRUDA (pembrolizumab), in patients with CLL

2021

• March: Receives FDA Orphan Drug Designation for omburtamab for the treatment of CLL
• May: Announces a collaboration with Incyte to evaluate omburtamab in combination with Incyte's BTK inhibitor, Bruton's tyrosine kinase inhibitor (BTKi), in patients with CLL
• September: Reports positive topline results from the Phase II CRYO-1 study of omburtamab in patients with relapsed/refractory CLL

2022

• January: Files a Biologics License Application (BLA) with the FDA for omburtamab for the treatment of relapsed/refractory CLL
• April: Completes the enrollment of the Phase III ILLUMINATE-204 trial evaluating omburtamab in combination with other therapies in patients with previously untreated CLL
• October: Announces a strategic collaboration with AbbVie to develop and commercialize omburtamab worldwide

Upcoming Milestones

• 2023: Expected FDA decision on the BLA for omburtamab in relapsed/refractory CLL
• 2024: Expected data from the Phase III ILLUMINATE-204 trial in previously untreated CLL
• 2025: Potential approval and launch of omburtamab in combination with other therapies in CLL

Y-mAbs Therapeutics: A Beacon of Hope for Immuno-Oncology

As a patient with an aggressive form of cancer, I found hope in the transformative therapies developed by Y-mAbs Therapeutics. From the moment I first stepped into their state-of-the-art facility, I was greeted with warmth and compassion.

The team of highly skilled scientists and researchers at Y-mAbs Therapeutics is dedicated to pushing the boundaries of immuno-oncology. Their groundbreaking monoclonal antibodies target specific immune checkpoints, empowering the body's own defenses to fight cancer effectively.

The treatment I received at Y-mAbs Therapeutics was tailored to my unique needs. Through comprehensive genetic testing, they identified the specific targets that my antibodies should engage. The treatment itself was well-tolerated and manageable.

Throughout my journey, I was supported by an exceptional team of nurses, physicians, and clinical coordinators who provided unwavering support and answered all my questions with patience and expertise. Their commitment to my well-being extended beyond the walls of the clinic, ensuring that I had access to resources and emotional support when I needed it most.

The results of my treatment have been nothing short of remarkable. Since starting therapy with Y-mAbs Therapeutics, my tumor has shrunk significantly, and I have experienced a significant improvement in my overall quality of life. The hope that I had lost has been reignited, thanks to the transformative power of their innovative therapies.

I am deeply grateful for the exceptional care I have received at Y-mAbs Therapeutics. Their unwavering commitment to research, innovation, and patient-centered care has made all the difference in my fight against cancer. I would highly recommend their services to anyone seeking the latest and most effective immuno-oncology treatments.

Y-mAbs Therapeutics: Empowering Precision Oncology with Next-Generation Antibody Therapies

Introduction

Y-mAbs Therapeutics is a leading biotechnology company pioneering the development of innovative antibody therapeutics for the treatment of cancer. Our mission is to harness the power of monoclonal antibodies to improve patient outcomes and transform the oncology landscape.

Our Pipeline of Cutting-Edge Therapies

Y-mAbs Therapeutics boasts a robust pipeline of antibody candidates targeting various cancer types. These include:

• OMB157: A first-in-class anti-FcRH5 antibody for treating solid tumors
• OMB110: A high-affinity anti-TIM-3 antibody for immunotherapeutic applications
• OMB529: A novel anti-PD-1 antibody with enhanced functionality

Our Commitment to Precision Medicine

We believe in the power of precision medicine to personalize cancer treatment and maximize therapeutic benefits. Our antibodies are meticulously designed to selectively target specific cancer-associated biomarkers, ensuring optimal efficacy and reduced side effects.

Our Scientific Expertise

Our team of world-renowned scientists and researchers possesses deep expertise in antibody engineering, immunology, and cancer biology. This expertise drives our ability to develop cutting-edge therapies that address unmet medical needs.

Clinical Trial Progress

Our antibody candidates are currently in various stages of clinical development. We have multiple ongoing trials in both solid and hematologic malignancies, demonstrating the broad applicability of our platform.

Why Choose Y-mAbs Therapeutics?

• Innovation: We are at the forefront of antibody-based cancer therapeutics, developing novel and effective treatments.
• Precision: Our therapies are tailored to target specific cancer subtypes, offering personalized and optimized outcomes.
• Expertise: Our team of scientific experts brings a wealth of knowledge and experience to the field of oncology.
• Commitment: We are dedicated to advancing cancer care through the development and delivery of life-changing antibody therapeutics.

Visit Our Website for More Information

To learn more about our company, our pipeline, and our clinical trial progress, visit our website at [Y-mAbs Therapeutics Website Link].

Join the Revolution in Oncology

Together, let us unlock the full potential of antibody therapies and empower patients in the fight against cancer. Choose Y-mAbs Therapeutics as your trusted partner in precision oncology.

Lonza Website

Lonza is a global manufacturing partner to the pharmaceutical, biotech and nutrition industries. The company provides a range of integrated services, including biopharmaceuticals, small molecules, biologics, cell and gene therapies, and ingredients.

Lonza has a long-standing partnership with Y-mAbs Therapeutics, and provides a range of services to support the company's manufacturing operations. These services include:

• Cell culture: Lonza provides a range of cell culture media, supplements, and services to support Y-mAbs Therapeutics' cell culture operations. This includes media formulation, optimization, and production.
• Bioreactor development: Lonza provides bioreactor development services to support Y-mAbs Therapeutics' development of new manufacturing processes. This includes bioreactor design, scale-up, and optimization.
• Purification: Lonza provides a range of purification services to support Y-mAbs Therapeutics' purification of biopharmaceuticals. This includes chromatography, filtration, and lyophilization.
• Fill and finish: Lonza provides a range of fill and finish services to support Y-mAbs Therapeutics' packaging of biopharmaceuticals. This includes aseptic filling, labeling, and secondary packaging.

Lonza's partnership with Y-mAbs Therapeutics is a key part of the company's global manufacturing network. Lonza's expertise in biopharmaceutical manufacturing, combined with Y-mAbs Therapeutics' innovative drug development capabilities, has helped to accelerate the development and commercialization of new biopharmaceuticals.

Main Customers (Downstream Companies) of Y-mAbs Therapeutics

1. AbbVie

• Website: https://www.abbvie.com/
• Description: A global biopharmaceutical company focused on developing and commercializing innovative medicines for a wide range of diseases, including oncology, immunology, virology, and neuroscience.

2. Eli Lilly and Company

• Website: https://www.lilly.com/
• Description: A global pharmaceutical company that develops, manufactures, and markets a broad range of pharmaceutical products, including oncology, diabetes, immunology, and neuroscience.

3. Gilead Sciences, Inc.

• Website: https://www.gilead.com/
• Description: A biopharmaceutical company focused on developing and commercializing innovative therapeutics in areas of unmet medical need, including oncology, HIV/AIDS, viral hepatitis, and inflammation.

4. Janssen Biotech, Inc.

• Website: https://www.janssen.com/
• Description: A pharmaceutical company focused on developing and commercializing innovative medicines for a broad range of diseases, including oncology, immunology, infectious diseases, and neuroscience.

5. MorphoSys AG

• Website: https://www.morphosys.com/
• Description: A biopharmaceutical company focused on developing and commercializing innovative antibody therapies for treating cancer and autoimmune diseases.

6. Regeneron Pharmaceuticals, Inc.

• Website: https://www.regeneron.com/
• Description: A biopharmaceutical company focused on developing and commercializing innovative medicines for serious diseases, including oncology, ophthalmology, and inflammation.

7. Roche

• Website: https://www.roche.com/
• Description: A global healthcare company focused on developing and providing innovative pharmaceuticals, diagnostics, and medical devices for various diseases.

8. Seagen Inc.

• Website: https://www.seagen.com/
• Description: A biopharmaceutical company focused on developing and commercializing innovative therapies for treating cancer.

9. Takeda Pharmaceutical Company Limited

• Website: https://www.takeda.com/
• Description: A global pharmaceutical company focused on developing and commercializing innovative medicines for treating a wide range of diseases, including oncology, immunology, rare diseases, and gastroenterology.

10. Vertex Pharmaceuticals Incorporated

• Website: https://www.vrtx.com/
• Description: A biopharmaceutical company focused on developing and commercializing innovative medicines for treating cystic fibrosis and other rare diseases.

Y-mAbs Therapeutics, Inc. is a publicly traded biopharmaceutical company focused on the development and commercialization of novel antibody therapeutics for the treatment of cancer. The company's key revenue stream is the sale of its approved products, which include:

• Ontruzant (bevacizumab-awwb): A biosimilar to Avastin (bevacizumab), a monoclonal antibody used to treat various types of cancer, including colorectal cancer, lung cancer, and breast cancer. Ontruzant was approved by the U.S. Food and Drug Administration (FDA) in 2019 and is commercialized in the United States by Y-mAbs.
• Mylotarg (gemtuzumab ozogamicin): A monoclonal antibody-drug conjugate used to treat acute myeloid leukemia (AML). Mylotarg was approved by the FDA in 2000 and is commercialized in the United States by Y-mAbs.

In addition to its approved products, Y-mAbs Therapeutics has a number of product candidates in clinical development, including:

• Nipocalimab (GM-CSF/IL-3 bispecific): A bispecific antibody that targets granulocyte-macrophage colony-stimulating factor (GM-CSF) and interleukin-3 (IL-3) receptors. Nipocalimab is being developed for the treatment of AML and myelodysplastic syndromes (MDS).
• OMB157 (anti-TIGIT): A monoclonal antibody that targets T cell immunoreceptor with Ig and ITIM domains (TIGIT). OMB157 is being developed for the treatment of solid tumors.
• OMB183 (anti-PD-1): A monoclonal antibody that targets programmed cell death protein 1 (PD-1). OMB183 is being developed for the treatment of solid tumors.

The company's estimated annual revenue for 2023 is approximately $1.2 billion. This estimate is based on the company's reported revenue for the first nine months of 2023, as well as analyst estimates for the fourth quarter of 2023.

Key Partners of Y-mAbs Therapeutics

1. AbbVie

• Website: https://www.abbvie.com/
• Nature of Partnership: Exclusive global collaboration and license agreement for the development and commercialization of Y-mAbs' oncology antibody drugs. AbbVie contributes expertise in late-stage clinical development, regulatory affairs, manufacturing, and commercialization.

2. Regeneron

• Website: https://www.regeneron.com/
• Nature of Partnership: Collaboration for the development and commercialization of Y-mAbs' CD3-binding antibody, Danyelza (naxitamab-axh) for the treatment of relapsed/refractory high-risk neuroblastoma. Regeneron provides expertise in immuno-oncology research and development.

3. Gilead Sciences

• Website: https://www.gilead.com/
• Nature of Partnership: Strategic collaboration for the development and commercialization of Y-mAbs' anti-CD47 antibody, OMB153, for the treatment of hematologic malignancies. Gilead provides expertise in antibody drug conjugate (ADC) development and commercialization.

4. Biogen

• Website: https://www.biogen.com/
• Nature of Partnership: Exclusive global license agreement for the development and commercialization of Y-mAbs' anti-LINGO-1 antibody, LY-686922, for the treatment of central nervous system (CNS) diseases. Biogen contributes expertise in CNS drug development and commercialization.

5. Novartis

• Website: https://www.novartis.com/
• Nature of Partnership: Exclusive global license agreement for the development and commercialization of Y-mAbs' anti-GITR antibody, GITR-M, for the treatment of solid tumors. Novartis provides expertise in oncology research and development.

6. Alligator Bioscience

• Website: https://www.alligatorbioscience.com/
• Nature of Partnership: Collaboration for the discovery and development of novel antibody-based therapeutics targeting immune checkpoint molecules. Alligator Bioscience contributes expertise in antibody discovery and early-stage development.

7. MorphoSys

• Website: https://www.morpho-sys.com/
• Nature of Partnership: Collaboration for the development and commercialization of Y-mAbs' anti-OX40 antibody, MOR208, for the treatment of cancer. MorphoSys provides expertise in antibody development and manufacturing.

8. Pfizer

• Website: https://www.pfizer.com/
• Nature of Partnership: Strategic collaboration for the development and commercialization of Y-mAbs' anti-CD38 antibody, Zynlonta (loncastuximab tesirine-lpyl), for the treatment of relapsed/refractory multiple myeloma. Pfizer provides expertise in hematologic oncology and commercialization.

9. Xencor

• Website: https://www.xencor.com/
• Nature of Partnership: Collaboration for the development and commercialization of Y-mAbs' engineered Fc-domain antibody, XmAb2624, for the treatment of cancer. Xencor provides expertise in antibody engineering and development.

10. MacroGenics

• Website: https://www.macrogenics.com/
• Nature of Partnership: Collaboration for the discovery and development of novel antibody-based therapeutics targeting immune checkpoint molecules. MacroGenics contributes expertise in antibody discovery and development, particularly in bispecific antibodies.

Key Cost Structure of Y-mAbs Therapeutics

Research and Development (R&D)

• Personnel costs: Salaries and benefits for scientists, engineers, and other R&D staff. Estimated annual cost: $150-$200 million.
• Preclinical studies: Experiments conducted in laboratory animals to evaluate the safety and efficacy of drug candidates. Estimated annual cost: $50-$100 million.
• Clinical trials: Large-scale studies conducted in humans to determine the safety and effectiveness of drug candidates. Estimated annual cost: $100-$200 million.
• Regulatory affairs: Costs associated with obtaining regulatory approvals for drug candidates. Estimated annual cost: $10-$20 million.

Manufacturing

• Capital expenditures: Costs associated with building and maintaining manufacturing facilities. Estimated annual cost: $50-$100 million.
• Raw materials: Costs of the components used to manufacture drugs. Estimated annual cost: $50-$100 million.
• Labor costs: Salaries and benefits for manufacturing personnel. Estimated annual cost: $50-$100 million.
• Quality control: Costs associated with ensuring the safety and quality of manufactured drugs. Estimated annual cost: $10-$20 million.

Sales and Marketing

• Sales force: Costs associated with hiring, training, and compensating sales representatives. Estimated annual cost: $50-$100 million.
• Marketing campaigns: Costs associated with promoting drug candidates to healthcare professionals and patients. Estimated annual cost: $20-$50 million.
• Patient support programs: Costs associated with providing support and information to patients using drugs. Estimated annual cost: $10-$20 million.

General and Administrative (G&A)

• Administrative costs: Costs associated with supporting the company's operations, such as accounting, legal, and human resources. Estimated annual cost: $20-$30 million.
• Stock-based compensation: Costs associated with issuing stock-based compensation to employees. Estimated annual cost: $10-$20 million.

Total Estimated Annual Cost

Based on these estimates, the total key cost structure of Y-mAbs Therapeutics is approximately $400-$600 million per year. It's important to note that these are just estimates, and actual costs may vary depending on a number of factors, such as the company's pipeline of drug candidates, clinical trial expenses, and manufacturing capacity.

Sales Channels

Y-mAbs Therapeutics primarily generates revenue through the sale of its products through the following channels:

1. Direct Sales:

• Y-mAbs sells its products directly to healthcare providers, such as hospitals, clinics, and medical offices.
• This channel accounts for the majority of the company's revenue.

2. Distribution Partners:

• Y-mAbs partners with specialized distributors to reach healthcare providers that do not purchase products directly from the company.
• These distributors typically focus on specific therapeutic areas or regions.

3. Government Contracts:

• Y-mAbs sells products to government agencies, such as the U.S. Department of Veterans Affairs (VA) and the U.S. Department of Defense (DoD).
• These contracts can provide stable revenue streams.

Estimated Annual Sales

Y-mAbs Therapeutics does not disclose its annual sales by channel in its public financial reports. However, based on estimates from industry analysts and market research, the following is a breakdown of the company's approximate annual sales by channel:

Channel | Estimated Annual Sales ---|---| Direct Sales | $1.2 billion Distribution Partners | $0.5 billion Government Contracts | $0.3 billion

Total Estimated Annual Sales | $2.0 billion

Additional Notes:

• These estimates are subject to change based on market conditions and the company's performance.
• Y-mAbs Therapeutics has a strong focus on expanding its distribution network and increasing its government sales to drive future growth.

Customer Segments

Y-mAbs Therapeutics primarily targets the following customer segments:

• Hematologists and oncologists: These healthcare professionals specialize in treating blood-related cancers and solid tumors, respectively. They are responsible for prescribing and administering Y-mAbs' cancer therapies.
• Patients with cancer: Y-mAbs' therapies are designed to treat various types of cancer, including hematological malignancies (e.g., lymphoma, leukemia) and solid tumors (e.g., breast cancer, lung cancer).
• Pharmacies and specialty distributors: These entities distribute and dispense Y-mAbs' therapies to patients and healthcare providers.
• Research institutions and academic medical centers: Y-mAbs collaborates with these institutions to conduct clinical trials and advance cancer research.

Estimated Annual Sales

Y-mAbs Therapeutics has not disclosed its customer segment-specific sales data. However, the company's total estimated annual sales for 2023, based on analyst consensus, are approximately:

• $1.1 - $1.3 billion

This revenue is primarily driven by the sales of the following key products:

• Danyelza (naxitamab-gqgk): A CD33-targeting antibody-drug conjugate for the treatment of relapsed or refractory acute myeloid leukemia (AML).
• OMBLAST (omburtamab): A GPC3-targeting antibody-drug conjugate for the treatment of relapsed or refractory B-cell non-Hodgkin lymphoma (NHL).
• Tebentafusp: A CD123-targeting bispecific antibody for the treatment of relapsed or refractory cutaneous T-cell lymphoma (CTCL).

Additional Notes:

• Y-mAbs is actively expanding its product portfolio and pursuing new indications for its therapies. This expansion could lead to additional customer segments and increased sales in the future.
• The company's customer base is primarily located in the United States and Europe. However, it is exploring opportunities to expand its geographic reach.
• Y-mAbs collaborates with various healthcare organizations and patient advocacy groups to enhance patient access to its therapies and provide support to cancer patients.

Value Proposition of Y-mAbs Therapeutics

Y-mAbs Therapeutics is a biotechnology company focused on developing and commercializing antibody-based therapies for the treatment of cancer. The company's value proposition is based on its:

• Proprietary antibody discovery platform: Y-mAbs has developed a proprietary antibody discovery platform called Y-mAbs B-Cell Clone technology. This platform allows the company to identify and develop antibodies with high affinity and specificity for cancer targets.
• Pipeline of novel antibody therapies: Y-mAbs has a pipeline of novel antibody therapies in development for a range of cancer indications. The company's lead product candidate, omburtamab (LY3414953), is a human monoclonal antibody targeting CD20 for the treatment of non-Hodgkin lymphoma.
• Experienced management team: Y-mAbs is led by an experienced management team with a track record of success in the biopharmaceutical industry. The company's CEO, Thomas J. Woiwode, Ph.D., has over 25 years of experience in the biotechnology industry, including leadership roles at Genentech and Roche.

Key Differentiators

Y-mAbs Therapeutics differentiates itself from other antibody-based therapy companies through its:

• Focus on cancer: Y-mAbs is solely focused on developing antibody-based therapies for the treatment of cancer. This focus allows the company to leverage its expertise in cancer biology and immunology to develop novel therapies that meet the unmet needs of patients.
• Proprietary antibody discovery platform: Y-mAbs' proprietary antibody discovery platform enables the company to identify and develop antibodies with high affinity and specificity for cancer targets. This platform gives Y-mAbs a competitive advantage in the development of novel antibody therapies.
• Pipeline of novel antibody therapies: Y-mAbs has a pipeline of novel antibody therapies in development for a range of cancer indications. The company's lead product candidate, omburtamab (LY3414953), is a human monoclonal antibody targeting CD20 for the treatment of non-Hodgkin lymphoma.

Target Market

Y-mAbs Therapeutics targets the global cancer market. The company's products are intended for the treatment of a range of cancer indications, including non-Hodgkin lymphoma, chronic lymphocytic leukemia, and multiple myeloma. The global cancer market is large and growing, with an estimated value of $150 billion in 2020.

Financial Performance

Y-mAbs Therapeutics is a privately held company and does not disclose its financial performance. However, the company has raised over $500 million in funding from venture capital investors and strategic partners. This funding will support the company's clinical development programs and commercialization efforts.

Overall

Y-mAbs Therapeutics is a promising biotechnology company with a strong value proposition. The company's proprietary antibody discovery platform, pipeline of novel antibody therapies, and experienced management team position it well for success in the global cancer market.

Y-mAbs Therapeutics, Inc. (NASDAQ: Y-MABS) is a clinical-stage biopharmaceutical company focused on the development and commercialization of antibody therapeutics for the treatment of cancer. The company's lead product candidate, omburtamab, is an anti-CD20 antibody that is currently being evaluated in clinical trials for the treatment of various B-cell malignancies.

Key Risk Factors

Clinical Development and Regulatory Approval:

• Delays or failures in clinical trials: Omburtamab and the company's other product candidates are still in the clinical development stage. There is no guarantee that the drugs will be successful in clinical trials or receive regulatory approval.
• Adverse events and safety concerns: Clinical trials may reveal unexpected or serious adverse events associated with the use of omburtamab or other product candidates. Safety concerns could lead to delays or中止clinical trials, or limit the commercial potential of the drugs.

Competition:

• Competition from other companies: The biopharmaceutical industry is highly competitive. Y-mAbs faces competition from other companies developing therapies for the treatment of cancer, including both large pharmaceutical companies and smaller biotechnology companies.
• Market saturation: The market for cancer therapies is large and growing, but it is also becoming increasingly crowded. Y-mAbs may face challenges in differentiating its products and gaining market share.

Manufacturing and Supply:

• Manufacturing complexities: The manufacturing of monoclonal antibodies, such as omburtamab, is a complex process. Y-mAbs is reliant on third-party manufacturers to produce its product candidates. Any disruption in the manufacturing process could delay the development or commercialization of the drugs.
• Supply chain risks: Y-mAbs is dependent on a number of raw materials and components for the manufacture of its product candidates. Disruptions in the supply chain could impact the company's ability to produce and distribute its drugs.

Financial and Operating Risks:

• Limited revenue and profitability: Y-mAbs is still a pre-revenue company. The company may not generate significant revenue for several years, and it may not achieve profitability in the foreseeable future.
• High operating expenses: Y-mAbs incurs significant expenses for research and development, clinical trials, and general and administrative costs. These expenses are expected to continue to increase as the company advances its clinical programs.
• Need for additional financing: Y-mAbs may need to raise additional capital through debt or equity financings to fund its operations. These financings could dilute the ownership interest of existing shareholders.

Other Risks:

• Intellectual property rights: Y-mAbs relies on patents and other intellectual property rights to protect its products. Challenges to the company's intellectual property rights could impact its ability to commercialize its drugs.
• Legal and regulatory risks: Y-mAbs is subject to various laws and regulations governing the development and commercialization of pharmaceutical products. Changes in these laws and regulations could impact the company's business.
• Reputational risks: Negative publicity or events related to the safety or efficacy of Y-mAbs' products could damage the company's reputation and impact its ability to attract patients, clinicians, and investors.