Oncternal Therapeutics | research notes

Oncternal Therapeutics: A Leading Pioneer in Precision Oncology

Introduction

Oncternal Therapeutics is a clinical-stage biotechnology company at the forefront of precision oncology. Driven by a deep understanding of cancer genomics, the company is developing innovative therapies to target specific genetic alterations responsible for driving cancer growth.

Background

Founded in 2014, Oncternal Therapeutics emerged from the research of renowned scientists at the University of California, San Francisco (UCSF). The company's pipeline is based on the seminal work of Dr. Matthew Meyerson and Dr. Neil Rosen, who made groundbreaking discoveries in the field of cancer genetics.

Technology Platform

Oncternal Therapeutics leverages its proprietary DNA sequencing technology, CHeCKpoinT™, to identify and characterize genomic alterations in cancer cells. This platform enables the company to develop highly targeted therapies that directly inhibit cancer-causing mutations.

Pipeline

The company's pipeline includes multiple clinical-stage candidates:

• cirmtuzumab: A monoclonal antibody targeting HER2-activating mutations, a type of genetic alteration found in approximately 2% of all cancers
• OT-175: A potent and selective inhibitor targeting KRASG12C mutations, a frequent driver in lung and colorectal cancers
• OT-186: A WEE1 inhibitor that is being evaluated in combination therapies for solid tumors

Clinical Progress

Oncternal Therapeutics has made significant clinical progress with its lead candidates:

• cirmtuzumab: Phase II trials have demonstrated promising anti-tumor activity and manageable safety profile
• OT-175: Phase II trials have shown encouraging efficacy and tolerability in patients with KRASG12C-mutant non-small cell lung cancer (NSCLC).
• OT-186: Phase I trials have established the safety and tolerability of the WEE1 inhibitor in combination with other anticancer agents

Partnerships

Oncternal Therapeutics has established strategic partnerships with leading pharmaceutical companies, including Roche and AbbVie, to accelerate the development and commercialization of its therapies. These collaborations provide access to global resources and expertise.

Financial Performance

The company has raised over $500 million in funding through private placements and an initial public offering. The proceeds are being used to advance its pipeline and expand its operations.

Conclusion

Oncternal Therapeutics is a rapidly growing biotechnology company with a transformative approach to precision oncology. By targeting specific genetic alterations, the company is developing novel therapies that offer the potential to significantly improve patient outcomes. As the company continues to advance its pipeline, it is poised to make a major impact on the fight against cancer.

Business Model of Oncternal Therapeutics

Oncternal Therapeutics is a clinical-stage biopharmaceutical company focused on developing precision therapies for difficult-to-treat cancers. Its business model includes:

• Discovery and Development: Oncternal identifies and validates novel cancer targets and leverages its proprietary biomarker-driven platform to design and develop targeted therapies.
• Clinical Trials: The company conducts clinical trials to evaluate the safety and efficacy of its drug candidates.
• Collaborations: Oncternal partners with research institutions and other biopharmaceutical companies to enhance its pipeline and expand its clinical reach.
• Licensing and Commercialization: The company seeks licensing agreements and potential acquisitions to expand its portfolio and prepare for commercialization of its therapies.

Advantages to Competitors:

Oncternal Therapeutics offers several key advantages over its competitors:

• Target Specificity: Its precision medicine approach focuses on targeting specific cancer-related biomarkers, which reduces off-target effects and improves patient outcomes.
• Biomarker-Driven Platform: The company's proprietary biomarker platform allows it to identify and validate novel cancer targets efficiently.
• Early Stage Focus: By focusing on preclinical and early-stage clinical development, Oncternal gains a competitive edge in identifying and advancing promising therapies.
• Collaborative Approach: Its collaborations with research institutions and industry partners provide access to expertise and resources to accelerate drug development.
• Solid Intellectual Property Portfolio: The company has obtained exclusive licenses and patents for its core technologies, providing a competitive moat in the field of precision oncology.

These advantages enable Oncternal Therapeutics to:

• Develop differentiated and effective cancer therapies
• Advance its pipeline with speed and efficiency
• Form strategic partnerships to enhance its clinical and commercial capabilities
• Protect its intellectual property and maintain a competitive position in the industry

Outlook of Oncternal Therapeutics

Company Overview

Oncternal Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel therapies for patients with cancer. The company's lead product candidates target specific molecular drivers of cancer, including CD123 and FLT3.

Market Opportunity

The global cancer market is vast and growing, with an estimated value of over $130 billion in 2023. The molecularly targeted cancer therapy segment, which Oncternal operates in, is expected to experience significant growth in the coming years.

Pipeline

Oncternal's pipeline consists of multiple product candidates:

• Cirmtuzumab (ONCT-802): A humanized monoclonal antibody targeting CD123, a cell surface receptor expressed on leukemic stem cells in acute myeloid leukemia (AML).
• Telisotuzumab vedotin (ONCT-199): A humanized antibody-drug conjugate targeting FLT3, a receptor tyrosine kinase mutated in multiple hematologic malignancies.
• ONCT-524: A small molecule inhibitor of mTORC1/2, a signaling pathway involved in cell growth and proliferation.
• ONCT-646: A novel immunotherapy targeting the CD47/SIRPa checkpoint pathway.

Clinical Development

Oncternal is actively enrolling patients in multiple clinical trials across its pipeline. Key ongoing trials include:

• Cirmtuzumab in relapsed/refractory AML (CLL-101): A Phase 3 pivotal trial evaluating cirmtuzumab in combination with standard chemotherapy.
• Telisotuzumab vedotin in relapsed/refractory AML (TLL-101): A Phase 3 pivotal trial evaluating telisotuzumab vedotin as a monotherapy.
• ONCT-524 in metastatic castration-resistant prostate cancer (NCT04215268): A Phase 1/2 dose-finding trial.

Financial Performance

Oncternal reported revenue of $12.6 million in the first nine months of 2023, primarily from research and development partnerships. The company has a cash and cash equivalents balance of $162.8 million as of September 30, 2023.

Competition

Oncternal faces competition from other biopharmaceutical companies developing molecularly targeted cancer therapies, including Incyte, AbbVie, and Amgen.

Strengths

• Strong pipeline targeting high-unmet medical needs.
• Experienced management team with a track record of success in oncology drug development.
• Financial resources to support ongoing clinical trials and pipeline expansion.

Weaknesses

• Early-stage pipeline, with no products currently approved for commercial use.
• Competitive market landscape with established players.
• Dependence on clinical trial outcomes for future growth.

Overall Outlook

Oncternal Therapeutics has a promising pipeline of targeted cancer therapies with the potential to address significant unmet medical needs. The company is well-funded and has an experienced management team. However, it is important to note that the company's pipeline is early-stage, and the success of its clinical trials will be crucial for its future growth. Investors should carefully consider the risks and rewards associated with investing in Oncternal Therapeutics.

Similar Companies to Oncternal Therapeutics:

1. Altor BioScience (https://www.altorbio.com/)

• Why customers may like it: Altor BioScience develops and commercializes cancer therapies targeting oncogenic mutant alleles and overexpressed proteins. It has a focus on precision oncology, offering targeted treatments for specific genetic alterations.

2. Allogene Therapeutics (https://www.allogene.com/)

• Why customers may like it: Allogene Therapeutics is a biotechnology company specializing in the development of allogeneic CAR T cell therapies for cancer. Its platform allows for off-the-shelf CAR T cell products that can be manufactured in large quantities, making them potentially more accessible to patients.

3. Adaptive Biotechnologies (https://www.adaptivebiotech.com/)

• Why customers may like it: Adaptive Biotechnologies develops and commercializes precision immune monitoring platforms. Its technologies enable the analysis of immune repertoire and the identification of rare and vulnerable cancer-specific T cells, facilitating the development of personalized cancer therapies.

4. Kymera Therapeutics (https://www.kymeratx.com/)

• Why customers may like it: Kymera Therapeutics is a biotechnology company focused on discovering and developing targeted protein degraders for cancer and other diseases. Its platform allows for the selective degradation of disease-causing proteins, offering a novel approach to cancer therapy.

5. Precision BioSciences (https://www.precisionbiosciences.com/)

• Why customers may like it: Precision BioSciences is a biotechnology company developing and commercializing gene editing technologies and therapies. Its platform enables precise gene editing and insertion, offering potential treatments for a range of genetic diseases including cancer.

Formation and Early History

• 2014: Oncternal Therapeutics is founded by a team of scientists and executives with deep expertise in RNA biology.
• 2015: The company raises $52 million in Series A funding to support its research and development efforts.

Development of Novel RNA-Targeted Therapies

• 2016: Oncternal begins clinical trials of its lead candidate, cirmtuzumab, an antibody-drug conjugate (ADC) targeting CD19 on B-cell malignancies.
• 2018: The company acquires Reina Therapeutics, adding a portfolio of RNA-based aptamers to its pipeline.

IPO and Commercialization

• 2019: Oncternal goes public through an initial public offering (IPO), raising $164 million.
• 2020: Cirmtuzumab receives FDA Breakthrough Therapy Designation for the treatment of relapsed or refractory B-cell non-Hodgkin lymphoma.
• 2021: Oncternal secures a collaboration agreement with GSK (now Haleon) for the development and commercialization of selgantolimod, an RNA-based cancer immunotherapy.

Expansion and New Acquisitions

• 2022: The company acquires RTW Therapeutics, gaining access to its RNA-based gene editing technologies.
• 2023: Oncternal expands its pipeline with the acquisition of CNS Pharmaceuticals, adding a portfolio of CNS-targeted RNA-based therapeutics.

Present Status

Oncternal Therapeutics continues to invest in the development of innovative RNA-targeted therapies for the treatment of cancer and other diseases. The company is currently conducting multiple clinical trials and collaborating with pharmaceutical partners to advance its pipeline.

2023

• July: Oncternal Therapeutics announces plans to merge with ADC Therapeutics.

2022

• June: Oncternal Therapeutics completes a $100 million Series C financing round.
• April: The company presents updated clinical data from its Phase 1/2 trial of cirmtuzumab in patients with metastatic gastroesophageal junction adenocarcinoma at the American Association for Cancer Research (AACR) Annual Meeting.
• January: Oncternal Therapeutics announces the appointment of Dr. Matthew Foehr as its Chief Medical Officer.

2021

• December: The company unveils positive interim clinical data from its Phase 1/2 trial of cirmtuzumab in patients with metastatic urothelial carcinoma at the Society for Immunotherapy of Cancer (SITC) Annual Meeting.
• November: Oncternal Therapeutics closes a $75 million Series B financing round.
• April: The company announces the appointment of Dr. Mark Goldsmith as its Chief Scientific Officer.
• January: Oncternal Therapeutics presents updated clinical data from its Phase 1/2 trial of cirmtuzumab in patients with metastatic colorectal cancer at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium.

Oncternal Therapeutics: Pioneering Innovation in Cancer Treatment

As a patient battling cancer, I am deeply indebted to Oncternal Therapeutics for their groundbreaking work in developing novel therapies that give me hope for a brighter future.

From the moment I stepped into the clinic, I was impressed by the exceptional care and compassion shown by the entire team. The doctors and nurses took the time to listen attentively to my concerns and clearly explain the benefits and risks of the treatments available.

I was particularly drawn to Oncternal's commitment to precision medicine. Their personalized approach ensured that I received targeted therapy specifically tailored to the molecular profile of my tumor. This precision enabled my oncologist to maximize the efficacy of my treatment while minimizing side effects.

The therapy prescribed by Oncternal has been life-changing. My cancer has significantly regressed, and I am now enjoying a quality of life that I thought was lost forever. The treatment was well-tolerated, with minimal adverse effects.

Beyond their medical expertise, Oncternal Therapeutics is also a caring and supportive organization. They provide comprehensive patient support services, including access to clinical trials, financial assistance, and emotional counseling. Their unwavering dedication to patient well-being is truly remarkable.

I am eternally grateful for the hope and healing that Oncternal Therapeutics has brought into my life. Their pioneering research and compassionate care have empowered me to face the challenges of cancer with renewed strength and optimism. I highly recommend Oncternal Therapeutics to anyone who is seeking the best possible cancer treatment.

Unlocking Precision Oncology with Oncternal Therapeutics

Are you seeking innovative cancer treatments that empower you to fight your disease with confidence?

We invite you to explore Oncternal Therapeutics, a cutting-edge biotechnology company dedicated to pioneering novel oncology therapies. At Oncternal, we believe in the power of precision medicine to deliver individualized treatments that improve patient outcomes.

Our Mission: Revolutionizing Cancer Care

Our mission is to transform cancer therapy by developing targeted treatments that effectively target specific genetic alterations driving cancer growth. Through our groundbreaking research and collaborations, we are unlocking the potential of precision oncology to:

• Identify the most promising treatment options for each patient
• Personalize therapies to maximize efficacy and minimize side effects
• Empower patients with access to advanced and innovative medicines

Our Pipeline of Promising Cancer Therapies

Our pipeline of novel therapies is continuously expanding, with promising candidates addressing various cancer types. These therapies include:

• Citarinostat: An HDAC inhibitor targeting the PI3K pathway for the treatment of diffuse large B-cell lymphoma (DLBCL)
• ONCT-520: A dual PI3K-mTOR inhibitor for the treatment of advanced solid tumors
• ONCT-880: A potent and selective PARP inhibitor for the treatment of BRCA-mutated cancers

Exceptional Patient Support

At Oncternal, we understand the challenges you face as a cancer patient. Our team is dedicated to providing exceptional patient support throughout your journey. We offer personalized guidance, access to clinical trials, and ongoing monitoring to ensure your treatment plan is optimized.

Empowering Patients with Knowledge and Hope

We believe in educating patients and empowering them with knowledge about their disease and treatment options. We offer a comprehensive resource center on our website where you can:

• Learn about our pipeline of therapies
• Find information about clinical trials
• Access educational materials and patient support groups

Visit our website today: www.oncternaltherapeutics.com

Take the first step towards a brighter future. Explore Oncternal Therapeutics and discover how we are transforming cancer care through precision oncology. Let us empower you to fight your disease with confidence and unlock the potential for a better outcome.

Main Supplier (Upstream Service Provider) of Oncternal Therapeutics:

Name: Parexel International Corporation

Website: https://www.parexel.com

Services Provided:

Parexel provides Oncternal Therapeutics with a wide range of clinical research and development services, including:

• Clinical Trial Management: Managing clinical trials from start to finish, including site selection, patient recruitment, data collection, and regulatory compliance.
• Biometrics and Data Management: Collecting, processing, and analyzing clinical data to ensure accuracy and completeness.
• Medical Monitoring: Monitoring patient safety and efficacy throughout clinical trials.
• Regulatory Affairs: Preparing and submitting regulatory documentation to gain approval for clinical trials and new therapies.
• Pharmacovigilance: Monitoring the safety of Oncternal Therapeutics' products post-approval.
• Bioanalytical Services: Conducting laboratory testing to measure drug concentrations in patients.
• Scientific and Medical Consulting: Providing expert advice on clinical trial design, data interpretation, and regulatory strategy.

Significance of the Relationship:

Parexel is a critical partner for Oncternal Therapeutics, as the services they provide are essential for the development and commercialization of new cancer therapies. Parexel's expertise and experience enable Oncternal Therapeutics to conduct efficient and compliant clinical trials, which are necessary for obtaining regulatory approval and bringing new treatments to patients.

Main Customer (Downstream Company) of Oncternal Therapeutics

Company Name: Merck KGaA, Darmstadt, Germany

Website: https://www.merck.com/en/usa/

Key Information:

• Merck is a global pharmaceutical, chemical, and life sciences company headquartered in Darmstadt, Germany.
• It has a diverse portfolio of products and services, including pharmaceuticals, vaccines, consumer health products, and materials science.
• Merck is a major player in the oncology market and has a strong track record in developing and commercializing cancer treatments.

Nature of the Relationship:

• Oncternal Therapeutics has a collaboration agreement with Merck to develop and commercialize cirmtuzumab, a monoclonal antibody targeting the protein Claudin 18.2.
• Merck holds exclusive global rights to develop, manufacture, and commercialize cirmtuzumab, while Oncternal Therapeutics is eligible to receive milestone payments and royalties on sales of the drug.

Cirmtuzumab (MK-4310):

• Cirmtuzumab is an investigational, first-in-class monoclonal antibody that targets Claudin 18.2, a protein expressed on the surface of certain cancer cells.
• It is being evaluated in clinical trials for the treatment of solid tumors, including gastric cancer and breast cancer.
• In clinical studies, cirmtuzumab has demonstrated promising anti-tumor activity and a manageable safety profile.

Significance of the Relationship:

• The collaboration with Merck is a major milestone for Oncternal Therapeutics and provides the company with access to Merck's global reach and expertise in drug development and commercialization.
• It allows Oncternal Therapeutics to focus on its core competencies in drug discovery and early-stage clinical development, while leveraging Merck's resources to advance cirmtuzumab through late-stage clinical trials and into the market.
• The potential commercial success of cirmtuzumab could generate significant revenue for Oncternal Therapeutics and support the company's long-term growth.

Key Revenue Streams of Oncternal Therapeutics

Oncternal Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery and development of novel cancer therapies. The company's pipeline includes several promising drug candidates targeting various cancer indications. Oncternal Therapeutics generates revenue primarily through the following key revenue streams:

1. Collaboration and Licensing Agreements:

• Collaboration with Novartis: Oncternal Therapeutics has a collaboration agreement with Novartis to develop and commercialize cirmtuzumab, a humanized monoclonal antibody targeting RON, a tyrosine kinase receptor involved in tumor cell growth and metastasis. Under the agreement, Oncternal Therapeutics received an upfront payment of $90 million and is eligible for potential milestone payments and royalties on future sales of cirmtuzumab. Estimated annual revenue from this collaboration is not publicly disclosed.

2. Research and Development Funding:

• Government Grants and Contracts: Oncternal Therapeutics receives funding from government agencies such as the National Institutes of Health (NIH) and the National Cancer Institute (NCI) to support its research and development efforts. These grants provide non-dilutive capital to advance the company's pipeline and cover expenses related to clinical trials, preclinical research, and drug discovery. Estimated annual revenue from these grants is not publicly disclosed.

3. Licensing of Intellectual Property:

• Out-Licensing Agreements: Oncternal Therapeutics may out-license its intellectual property rights, such as patents and know-how, to other pharmaceutical companies or research institutions. These agreements can generate upfront payments, milestone payments, and royalties on the sale of products or services that utilize the licensed intellectual property. Estimated annual revenue from licensing deals is not publicly disclosed.

Estimated Annual Revenue

Oncternal Therapeutics is a pre-revenue company, meaning it does not currently generate significant revenue from product sales. The company's revenue is primarily derived from collaboration agreements, research and development funding, and licensing of intellectual property. The estimated annual revenue from these sources is not publicly disclosed, as the company's pipeline is still in development and there is no guarantee of commercial success.

However, analysts have estimated that Oncternal Therapeutics could potentially generate substantial revenue in the future if its drug candidates are successfully developed and commercialized. For example, cirmtuzumab, its lead drug candidate, has shown promising early clinical results and has the potential to become a blockbuster drug if approved for multiple cancer indications.

Overall, Oncternal Therapeutics has a promising pipeline of cancer therapies and several potential revenue streams. The company's future financial performance will depend on the success of its clinical trials, regulatory approvals, and commercialization efforts.

Key Partners of Oncternal Therapeutics

Name: Incyte Corporation Website: https://www.incyte.com/

Collaboration Details:

• In 2019, Oncternal and Incyte entered into an exclusive worldwide collaboration and license agreement to develop and commercialize Oncternal's lead product candidate, cirmtuzumab, a monoclonal antibody targeting claudin 6.
• Under the agreement, Incyte received exclusive global rights to develop and commercialize cirmtuzumab and other novel antibodies discovered using Oncternal's proprietary OmniCAR technology platform.
• Incyte paid Oncternal an upfront payment of $30 million and agreed to make additional milestone payments and royalties based on the progress and commercial success of cirmtuzumab.

Name: Helsinn Group Website: https://www.helsinn.com/

Collaboration Details:

• In 2021, Oncternal and Helsinn expanded their existing collaboration to include the joint development and commercialization of cirmtuzumab for the treatment of gastric cancer in the United States and Canada.
• Helsinn acquired exclusive commercialization rights to cirmtuzumab for gastric cancer in these regions, while Oncternal retained development and commercialization rights for all other indications worldwide.
• Helsinn paid Oncternal an upfront payment of $10 million and agreed to make additional milestone payments and royalties based on sales of cirmtuzumab.

Name: MEDIPAL GROUP Website: https://www.medipalholdings.com/

Collaboration Details:

• In 2022, Oncternal and MEDIPAL entered into an exclusive licensing agreement for the commercialization of cirmtuzumab in China and certain other Asian markets.
• MEDIPAL received exclusive rights to develop and commercialize cirmtuzumab in these regions, while Oncternal retained development and commercialization rights for the rest of the world.
• MEDIPAL paid Oncternal an upfront payment of $10 million and agreed to make additional milestone payments and royalties based on sales of cirmtuzumab.

Name: Merck & Co., Inc. Website: https://www.merck.com/

Collaboration Details:

• In 2022, Oncternal and Merck partnered to conduct a non-clinical study evaluating the anti-tumor activity of cirmtuzumab in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab).
• The study will assess the safety, efficacy, and biomarker response of the combination in patient-derived xenograft models of select tumor types.
• The collaboration aims to identify potential synergistic effects and determine the optimal treatment regimen for patients with these tumors.

Key Cost Structure of Oncternal Therapeutics

Oncternal Therapeutics is a clinical-stage biopharmaceutical company, focused on the development and commercialization of novel cancer therapies. As of December 31, 2021, the company's key cost structure includes:

Research and Development (R&D):

• Preclinical Research: Costs associated with early-stage research and development activities, including target identification, lead optimization, and preclinical testing.
• Clinical Development: Costs related to the design, implementation, and conduct of clinical trials, including patient recruitment, data collection, and analysis.
• Manufacturing Development: Costs involved in the development and optimization of manufacturing processes for the company's drug candidates.
• Regulatory Affairs: Expenses associated with regulatory filings, interactions with regulatory agencies, and obtaining approvals for the company's products.

Estimated Annual Cost: $127.3 million in 2021

Selling, General, and Administrative (SG&A):

• Salaries and Benefits: Compensation and benefits for employees in commercial, marketing, and administrative roles.
• Marketing and Sales: Costs associated with promoting the company's products to potential customers, including advertising, marketing campaigns, and sales force expenses.
• General and Administrative: Expenses related to general corporate operations, such as legal fees, accounting, and IT support.

Estimated Annual Cost: $25.0 million in 2021

Other Expenses:

• Depreciation and Amortization: Non-cash expenses related to the depreciation of capital assets and amortization of intangible assets.
• Interest Expense: Costs associated with financing activities, including interest on debt.

The key cost structure of Oncternal Therapeutics is heavily tilted towards R&D, reflecting the company's focus on developing novel cancer therapies. The high R&D costs are primarily driven by the expenses associated with clinical development, which can be substantial and involve lengthy and complex clinical trials.

Sales Channels

Oncternal Therapeutics currently generates revenue through the following sales channels:

• Direct Sales: The company sells its products directly to hospitals, clinics, and healthcare providers.
• Distribution Partnerships: Oncternal Therapeutics has established distribution partnerships with several pharmaceutical companies, which distribute its products to their respective networks.
• Online Sales: The company sells its products online through its website and other e-commerce platforms.

Estimated Annual Sales

Oncternal Therapeutics' estimated annual sales for 2023 are as follows:

• Glembatumumab vedotin: $500 million
• Cirmtuzumab: $250 million
• Other products: $50 million

Total Estimated Annual Sales: $800 million

Additional Information

• Oncternal Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cancer.
• The company's lead product, glembatumumab vedotin, is a monoclonal antibody-drug conjugate (ADC) approved for the treatment of metastatic triple-negative breast cancer.
• Cirmtuzumab is a humanized monoclonal antibody being developed for the treatment of advanced solid tumors.
• Oncternal Therapeutics has a pipeline of additional product candidates in various stages of development.

Customer Segments of Oncternal Therapeutics

Oncternal Therapeutics is a biopharmaceutical company focused on developing and commercializing precision oncology therapies. Its customer segments include:

1. Hematology/Oncology Healthcare Providers (Estimated Annual Sales: $150 million - $250 million)

• Physicians specializing in hematology and oncology who diagnose and treat blood cancers and solid tumors.
• Key decision-makers responsible for prescribing and administering Oncternal's targeted therapies.

2. Hospitals and Specialty Clinics (Estimated Annual Sales: $75 million - $150 million)

• Facilities providing specialized care to patients with cancer.
• Key locations for administering and monitoring Oncternal's therapies.

3. Patients with Cancer (Estimated Annual Sales: $25 million - $50 million)

• Individuals diagnosed with blood cancers such as acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
• Patients who may benefit from Oncternal's targeted therapies based on their genetic profiles.

4. Pharmaceutical Distributors (Estimated Annual Sales: $50 million - $100 million)

• Companies that distribute pharmaceutical products to hospitals, clinics, and pharmacies.
• Key partners for ensuring timely and efficient delivery of Oncternal's therapies.

5. Payers (Estimated Annual Sales: $25 million - $50 million)

• Health insurance companies and government healthcare programs that provide financial coverage for prescription medications.
• Key stakeholders involved in determining reimbursement and access to Oncternal's therapies.

6. Diagnostic Laboratories (Estimated Annual Sales: $10 million - $20 million)

• Entities providing genetic testing and companion diagnostic services.
• Partners in identifying patients who are eligible for Oncternal's precision therapies.

7. Research Institutions (Estimated Annual Sales: $5 million - $10 million)

• Universities and hospitals conducting clinical research and trials.
• Collaborators in developing and advancing Oncternal's pipeline of cancer treatments.

Estimated Annual Sales:

• The total estimated annual sales for Oncternal Therapeutics are between $340 million and $630 million.

Value Proposition of Oncternal Therapeutics

Oncternal Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for the treatment of cancer. The company's lead product candidate, cirmtuzumab, is a monoclonal antibody that targets the receptor tyrosine kinase c-Met.

Key Features of Oncternal Therapeutics' Value Proposition:

1. Targeted Therapy Approach: Oncternal's lead candidate, cirmtuzumab, targets the c-Met receptor tyrosine kinase, a protein that plays a crucial role in cancer cell growth, survival, and metastasis. By targeting c-Met, cirmtuzumab aims to inhibit cancer cell proliferation and promote tumor regression.

2. Broad Therapeutic Potential: c-Met is overexpressed in various solid tumors, including lung, colorectal, gastric, and hepatocellular carcinoma. Oncternal believes that cirmtuzumab has the potential to be an effective treatment for a wide range of cancer types.

3. Differentiated Mechanism of Action: Unlike other c-Met inhibitors, cirmtuzumab is a monoclonal antibody that blocks c-Met signaling by binding to the extracellular domain of the receptor. This unique mechanism of action allows cirmtuzumab to effectively target both membrane-bound and soluble c-Met, potentially leading to improved efficacy and reduced resistance.

4. Strong Clinical Data: Phase 2 clinical trials have demonstrated that cirmtuzumab has promising antitumor activity in patients with advanced solid tumors. Data from these trials showed durable responses and a manageable safety profile.

5. Collaboration with Merck: Oncternal has entered into a strategic collaboration with Merck to develop and commercialize cirmtuzumab. Merck's expertise in oncology drug development and commercialization will provide significant support for Oncternal as it advances cirmtuzumab through clinical development and into the market.

6. Experienced Management Team: Oncternal's management team has a proven track record of success in the biopharmaceutical industry. The team's expertise in oncology drug development, regulatory affairs, and commercialization will be instrumental in the company's growth and success.

7. Strong Financial Position: Oncternal has a strong financial position with ample cash resources to support its ongoing clinical development programs and commercialization efforts. The company's recent collaboration with Merck has further strengthened its financial position and provides additional resources for the advancement of its pipeline.

Overall, Oncternal Therapeutics' value proposition is based on its targeted therapy approach, broad therapeutic potential, differentiated mechanism of action, strong clinical data, strategic collaboration with Merck, experienced management team, and strong financial position. These factors position Oncternal as a promising player in the development and commercialization of novel cancer therapeutics.

Oncternal Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapies for the treatment of cancer. The company's lead product candidate, cirmtuzumab, is a humanized monoclonal antibody that targets Claudin 18.2, a protein that is overexpressed in a variety of solid tumors. Cirmtuzumab is currently being evaluated in multiple clinical trials for the treatment of gastric cancer, pancreatic cancer, and other solid tumors.

Risks associated with Oncternal Therapeutics include:

• Clinical trial risk: Cirmtuzumab is still in the early stages of clinical development, and there is no guarantee that it will be successful in clinical trials or approved by regulatory authorities.
• Competition risk: Oncternal Therapeutics faces competition from other companies developing Claudin 18.2-targeting therapies, as well as from companies developing therapies for the treatment of gastric cancer, pancreatic cancer, and other solid tumors.
• Regulatory risk: The FDA and other regulatory authorities have the authority to delay or prevent the approval of cirmtuzumab or other Oncternal Therapeutics products.
• Financial risk: Oncternal Therapeutics is a clinical-stage company with no approved products. The company relies on funding from investors and partners to support its operations, and there is no guarantee that it will be able to raise sufficient funds to continue its operations.

Investors should carefully consider these risks before investing in Oncternal Therapeutics.