Oncternal Therapeutics, Inc. (ONCT): Business Model Canvas [11-2024 Updated]

Oncternal Therapeutics, Inc. (ONCT) is at the forefront of cancer treatment innovation, leveraging a robust business model canvas that outlines its strategic approach to developing groundbreaking therapies. This model highlights key partnerships, essential activities, and unique value propositions that position the company for success in the competitive biotech landscape. Discover how ONCT's commitment to research and development, along with its focus on personalized medicine, is shaping the future of oncology.

Oncternal Therapeutics, Inc. (ONCT) - Business Model: Key Partnerships

Collaborations with academic institutions

Oncternal Therapeutics has established partnerships with various academic institutions, notably with the Regents of the University of California. This collaboration includes a license agreement for the development and commercialization of ROR1-related antibodies and therapies. The agreement has specific financial terms, including an upfront license fee of $0.5 million, annual maintenance fees, and milestone payments that can total between $20.1 million and $24.5 million per product, based on development and regulatory achievements. Additionally, the agreement stipulates low single-digit royalties on net sales of licensed products.

Licensing agreements for product candidates

Oncternal Therapeutics has entered into several licensing agreements that are crucial for its product candidates. For example, under the license agreement with SPH USA, the company has granted exclusive rights to develop and commercialize its product candidates in Greater China. This agreement requires SPH USA to cover all development costs and pay Oncternal low single-digit royalties on net sales. Furthermore, Oncternal has received NIH grant funding, totaling up to $4.1 million for preclinical activities related to ONCT-534 and ONCT-216.

Partnerships with clinical trial sites

Oncternal collaborates with multiple clinical trial sites to facilitate the development of its therapies. These sites conduct research and development activities on behalf of Oncternal, which includes overseeing clinical trials for ONCT-534 and ONCT-808. The company incurs costs associated with these trials as part of its research and development expenses, which amounted to approximately $19.1 million for the nine months ended September 30, 2024.

Strategic alliances with biotech firms

Oncternal Therapeutics has also formed strategic alliances with other biotech firms to enhance its operational capabilities. These alliances include collaborations for research and development purposes, where shared resources and expertise are leveraged to advance clinical programs. In the context of its ongoing operations, Oncternal has been exploring strategic alternatives, including potential partnerships, to maximize the value of its assets.

Partnership Type	Partner	Financial Terms	Purpose
Academic Collaboration	Regents of UC	Upfront fee: $0.5M; Milestones: $20.1M-$24.5M; Royalties: Low single-digit on sales	Development of ROR1-related therapies
Licensing Agreement	SPH USA	Low single-digit royalties on net sales; SPH USA covers development costs	Commercialization in Greater China
NIH Grant	National Institutes of Health	Up to $4.1M for preclinical activities	Support for ONCT-534 and ONCT-216
Clinical Trials	Various Clinical Sites	Costs included in R&D expenses	Conduct clinical trials for product candidates
Strategic Alliance	Biotech Firms	Not publicly disclosed	Enhance R&D capabilities and explore asset value maximization

Oncternal Therapeutics, Inc. (ONCT) - Business Model: Key Activities

Research and development of therapeutics

Oncternal Therapeutics focuses heavily on the research and development of novel oncology therapies. The company's research and development expenses for the nine months ended September 30, 2024, totaled $19.1 million, down from $23.1 million in the same period of 2023, reflecting a decrease of $4.0 million.

Key product candidates include:

• ONCT-534, with expenses of $6.4 million for the nine months ended September 30, 2024, up from $3.4 million the previous year.
• ONCT-808, which incurred costs of $3.7 million for the nine months ended September 30, 2024, consistent with the prior year.
• Zilovertamab, with expenses dropping to $0.6 million from $6.3 million.
• ONCT-216, which cost $0.3 million.

Clinical trials for product candidates

Oncternal's clinical trials are crucial for validating their product candidates. As of September 30, 2024, the company announced the discontinuation of clinical trials for ONCT-534 and ONCT-808, which previously required substantial funding for trial management. The Phase 1/2 study for ONCT-534, initiated in 2023, was discontinued in the latter part of 2024.

Regulatory compliance and submissions

Regulatory compliance is an ongoing key activity for Oncternal as it navigates the complex landscape of drug approval. The company has received $1.9 million in grant revenue for the nine months ended September 30, 2024, compared to $0.5 million in the same period of 2023, reflecting increased NIH grant activities. The focus remains on adhering to FDA guidelines and ensuring all necessary regulatory submissions are timely and complete.

Financial management and fundraising

Financial management is vital for Oncternal, especially as it seeks to fund its ongoing operations. The company reported a net loss of $25.4 million for the nine months ended September 30, 2024, compared to $30.3 million in 2023. Cash and cash equivalents at the end of the reporting period were $14.6 million, down from $14.9 million in the previous year.

The company has historically raised funds through various means, including:

• Gross proceeds of $136.3 million from common stock issuance.
• Gross proceeds of $49.0 million from convertible preferred stock.
• Receipt of $14.5 million in grant payments.
• Cash proceeds of $18.3 million from the merger with GTx, Inc..

As of September 30, 2024, Oncternal had no debt, but there are substantial doubts about its ability to continue as a going concern without raising additional funding or making operational adjustments.

Oncternal Therapeutics, Inc. (ONCT) - Business Model: Key Resources

Intellectual property portfolio

As of September 30, 2024, Oncternal Therapeutics holds an extensive intellectual property portfolio including multiple patents related to its drug candidates, particularly ONCT-534, ONCT-808, and zilovertamab. The company has secured various patents that cover the composition, methods of use, and manufacturing processes for these therapeutics. This portfolio is critical for protecting the company’s innovations and ensuring competitive advantage in the biotechnology sector.

Experienced R&D team

Oncternal Therapeutics has assembled a highly skilled research and development team, which is essential for advancing its clinical candidates. The R&D expenses for the nine months ended September 30, 2024, totaled approximately $19.1 million, a decrease from $23.1 million in the same period the previous year. The team focuses on developing innovative treatments for hematological malignancies and solid tumors, leveraging their expertise in CAR T-cell therapy and monoclonal antibody development.

Financial capital from stock issuance

Oncternal has raised significant capital through stock issuances, which is vital for funding its operations and R&D activities. Since its inception, the company has generated gross proceeds of approximately $136.3 million from common stock issuance and $49.0 million from convertible preferred stock. As of September 30, 2024, Oncternal reported cash, cash equivalents, and short-term investments amounting to $14.6 million, with no outstanding debt.

Type of Financial Instrument	Amount Raised (in millions)	Use of Funds
Common Stock Issuance	$136.3	Operations and R&D funding
Convertible Preferred Stock	$49.0	Operations and strategic initiatives
NIH Grants	$14.5	Support for preclinical activities
GTx Merger Cash Proceeds	$18.3	Operational expansion

Facilities for clinical trials and manufacturing

Oncternal Therapeutics operates state-of-the-art facilities for conducting clinical trials and manufacturing its product candidates. These facilities are equipped to handle the complexities of developing biologic therapies, ensuring compliance with regulatory standards. The company has allocated significant resources towards its R&D facilities, which play a crucial role in the advancement of its clinical programs. As of September 30, 2024, total liabilities were reported at $6.5 million, reflecting the investment in these critical infrastructures.

Oncternal Therapeutics, Inc. (ONCT) - Business Model: Value Propositions

Innovative therapies targeting cancer

Oncternal Therapeutics, Inc. focuses on developing innovative oncology therapies aimed at treating various types of cancer. Their product pipeline includes ONCT-534, ONCT-808, and zilovertamab, which are designed to address critical unmet medical needs in oncology.

Potentially first-in-class products

Among Oncternal's offerings, ONCT-808 is positioned as a potentially first-in-class CAR T therapy targeting Receptor Tyrosine Kinase-Like Orphan Receptor 1 (ROR1). This innovative approach aims to provide effective treatment options for patients with relapsed or refractory cancers, particularly those resistant to existing therapies.

Personalized treatment options through CAR T therapy

ONCT-808 represents a significant advancement in personalized treatment options, utilizing a CAR T cell therapy platform. This therapy has demonstrated activity in preclinical models against multiple hematological malignancies and solid tumors, emphasizing its potential to tailor cancer treatment to individual patient needs, improving overall outcomes.

Strong preclinical and clinical data supporting efficacy

As of September 30, 2024, Oncternal has reported substantial preclinical and clinical data supporting the efficacy of its product candidates. Research and development expenses for ONCT-534 reached $6.4 million in the third quarter of 2024, reflecting ongoing efforts to advance its clinical studies. Additionally, total research and development expenses for the nine months ended September 30, 2024, were $19.1 million, compared to $23.1 million for the same period in 2023.

Product Candidate	Research & Development Expenses (Q3 2024)	Research & Development Expenses (Q3 2023)	Clinical Status
ONCT-534	$2.8 million	$1.3 million	Phase 1/2 initiation
ONCT-808	$1.0 million	$1.7 million	Discontinued
Zilovertamab	$0.2 million	$2.1 million	Completed clinical activities
ONCT-216	$0.03 million	N/A	Ongoing nonclinical research

Furthermore, Oncternal has secured grant revenues totaling $1.9 million for the nine months ended September 30, 2024, reflecting funding support for its research initiatives. As of September 30, 2024, the company had cash and cash equivalents of $13.1 million, indicating available resources to continue its R&D efforts.

Oncternal Therapeutics, Inc. (ONCT) - Business Model: Customer Relationships

Engagement with healthcare professionals

Oncternal Therapeutics focuses on building strong relationships with healthcare professionals (HCPs) to facilitate clinical trial recruitment and product development. As of September 30, 2024, the company had engaged in various outreach initiatives, including educational webinars and targeted marketing campaigns aimed at oncologists and hematologists, who are key stakeholders in the therapeutic areas they address.

Transparency in clinical trial results

Oncternal emphasizes transparency regarding its clinical trial results to maintain credibility with HCPs and the public. In 2024, the company reported grant revenue of $1.9 million, which reflects its commitment to advancing research through collaborations and NIH grants. They have publicly disclosed the results of their Phase 1/2 studies, providing detailed data on the efficacy and safety of their investigational products such as ONCT-534 and ONCT-808.

Support services for patients during trials

Oncternal offers comprehensive support services for patients participating in clinical trials. This includes access to patient navigators who assist with understanding trial protocols and managing side effects. As of September 30, 2024, the company reported a net loss of $25.4 million, which included investments in patient support programs. These initiatives are designed to enhance patient retention and compliance, crucial for the success of their clinical trials.

Building trust through effective communication

Effective communication is central to Oncternal's strategy for building trust with both HCPs and patients. The company regularly updates stakeholders on trial progress and outcomes through newsletters, dedicated online portals, and direct outreach. They reported a decrease in general and administrative expenses to $9.1 million for the nine months ended September 30, 2024, down from $9.5 million in the previous year, indicating a focus on optimizing communication strategies.

Aspect	Details	Financial Impact (2024)
Engagement with HCPs	Educational webinars, outreach initiatives	Part of R&D expenses of $19.1 million
Transparency in Trials	Public disclosure of clinical trial results	Grant revenue of $1.9 million
Support Services	Patient navigators, side effect management	Contributed to net loss of $25.4 million
Communication	Regular updates via newsletters, online portals	General and administrative expenses of $9.1 million

Oncternal Therapeutics, Inc. (ONCT) - Business Model: Channels

Direct outreach to oncologists and healthcare providers

Oncternal Therapeutics focuses on establishing direct relationships with oncologists and healthcare providers to promote its clinical programs and products. This outreach is integral to building trust and facilitating discussions about their investigational therapies, including ONCT-534 and ONCT-808. As of September 30, 2024, the company has incurred substantial expenses in its research and development efforts, amounting to $19.1 million for the nine months ended September 30, 2024.

Participation in medical conferences and seminars

Oncternal actively participates in medical conferences and seminars to showcase its research findings and engage with the oncology community. In the first three quarters of 2024, the company has allocated resources to attend and present at various oncology-focused events, enhancing visibility and networking opportunities. The general and administrative expenses for the nine months ended September 30, 2024 were $9.1 million.

Online presence through corporate website

The corporate website serves as a key channel for Oncternal to communicate its value proposition and product information to stakeholders. The website provides updates on clinical trials, research findings, and investor relations, contributing to transparency and accessibility. As of September 30, 2024, the company had cash, cash equivalents, and short-term investments of $14.6 million.

Collaboration with patient advocacy groups

Oncternal collaborates with patient advocacy groups to support outreach efforts and enhance awareness of its therapies. These partnerships enable the company to connect with patients directly and gather insights into patient needs and experiences. Grant revenue from the National Institutes of Health (NIH) was reported at $1.9 million for the nine months ended September 30, 2024, reflecting the company's commitment to research and development.

Channel	Key Activities	Financial Impact
Direct Outreach	Building relationships with oncologists	R&D expenses: $19.1 million (2024)
Medical Conferences	Presenting research and networking	G&A expenses: $9.1 million (2024)
Online Presence	Providing information and updates	Cash, cash equivalents: $14.6 million (2024)
Patient Advocacy	Collaborating for outreach and support	Grant revenue: $1.9 million (2024)

Oncternal Therapeutics, Inc. (ONCT) - Business Model: Customer Segments

Patients with specific cancer types

Oncternal Therapeutics focuses on patients suffering from various cancer types, particularly those with hematological malignancies and solid tumors. Their primary investigational therapies target patients with chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), and aggressive B-cell lymphomas. The company has emphasized the need for treatments specifically for patients who are relapsed or refractory to existing therapies, including androgen receptor pathway inhibitors.

Oncologists and healthcare providers

Oncternal Therapeutics aims to engage oncologists and healthcare providers who are involved in administering cancer treatments. These professionals are critical as they are responsible for prescribing therapies such as ONCT-534, ONCT-808, and zilovertamab. The company’s approach includes providing detailed information about the efficacy and safety profiles of its investigational products to facilitate informed treatment decisions.

Institutional investors and biotech analysts

Institutional investors and biotech analysts represent a significant customer segment for Oncternal Therapeutics. The company has raised substantial capital through the issuance of common stock, totaling approximately $136.3 million since its inception. They also raised $49.0 million from convertible preferred stock and received $14.5 million in grant payments. As of September 30, 2024, the company reported an accumulated deficit of $223.2 million, indicating the ongoing need for investment to fund their operations and research activities.

Research institutions and regulatory agencies

Oncternal Therapeutics collaborates with research institutions and regulatory agencies to advance its drug development process. The company has received significant funding from the National Institutes of Health (NIH), with grant revenue increasing to $1.9 million for the nine months ended September 30, 2024, compared to $0.5 million in the same period of the previous year. This funding supports their ongoing research and development efforts, which are essential for obtaining regulatory approvals for their product candidates.

Customer Segment	Description	Relevant Financial Data
Patients with specific cancer types	Focus on hematological malignancies and solid tumors; target patients who are relapsed or refractory to current therapies.	Investigational therapies include ONCT-534 and ONCT-808, both targeting specific cancer types.
Oncologists and healthcare providers	Engagement with professionals who prescribe cancer treatments and monitor patient outcomes.	Sales and marketing efforts aimed at educating healthcare providers on product efficacy.
Institutional investors and biotech analysts	Key stakeholders in funding and evaluating the company's financial health and product pipeline.	Raised $136.3 million from common stock; $49.0 million from convertible preferred stock; accumulated deficit of $223.2 million as of September 30, 2024.
Research institutions and regulatory agencies	Collaboration for drug development and compliance with regulatory standards.	NIH grant revenue $1.9 million for the nine months ended September 30, 2024; increased from $0.5 million in the previous year.

Oncternal Therapeutics, Inc. (ONCT) - Business Model: Cost Structure

High R&D expenses for drug development

Oncternal Therapeutics has incurred significant research and development (R&D) expenses, which are critical for its drug development efforts. For the nine months ended September 30, 2024, total R&D expenses amounted to $19.1 million, compared to $23.1 million for the same period in 2023, reflecting a decrease of $4.0 million. This decline was primarily due to a $2.5 million decrease in direct product candidate expenses and a $1.5 million decrease in unallocated R&D expenses.

R&D Expenses Breakdown (in thousands)	2024	2023	Increase/(Decrease)
ONCT-534	$6,446	$3,448	$2,998
ONCT-808	$3,679	$3,719	($40)
Zilovertamab	$611	$6,336	($5,725)
ONCT-216	$288	($41)	$329
Unallocated R&D Expenses	$8,095	$9,621	($1,526)
Total R&D Expenses	$19,119	$23,083	($3,964)

Administrative costs associated with public company operations

General and administrative (G&A) expenses for Oncternal Therapeutics also contribute significantly to the overall cost structure. For the nine months ended September 30, 2024, G&A expenses totaled $9.1 million, down from $9.5 million in the same period of 2023, a reduction of $0.4 million. This reduction was primarily due to lower corporate insurance costs, which were partially offset by increased legal expenses related to intellectual property.

G&A Expenses (in thousands)	2024	2023	Increase/(Decrease)
General & Administrative Expenses	$9,068	$9,483	($415)

Clinical trial costs and patient recruitment

Clinical trial costs are a substantial part of Oncternal's R&D expenses. The company has made investments in patient recruitment and trial management for its various studies. The direct expenses for ONCT-534 increased by $3.0 million for the nine months ended September 30, 2024, largely due to increased manufacturing and clinical activities. However, the costs associated with ONCT-808 decreased significantly as the study was discontinued in the latter part of the third quarter of 2024.

Legal and compliance costs related to regulatory submissions

Legal and compliance costs are another key component of Oncternal's cost structure. These costs arise from the need to meet regulatory requirements and to navigate the complexities of the biopharmaceutical landscape. As of September 30, 2024, the company has incurred $36,000 in legal expenses associated with patent costs. The ongoing legal and compliance obligations are expected to fluctuate based on the company's strategic direction and operational decisions.

Oncternal Therapeutics, Inc. (ONCT) - Business Model: Revenue Streams

Potential product sales upon commercialization

As of September 30, 2024, Oncternal Therapeutics has not yet commercialized any products. The success of future revenue streams will depend on the commercialization of product candidates such as ONCT-534, ONCT-808, and zilovertamab. The company has incurred significant net losses totaling $25.4 million for the nine months ended September 30, 2024, and has an accumulated deficit of $223.2 million. Future revenue generation will hinge on successful clinical trials and subsequent product approvals.

Grant funding from research institutions

Oncternal Therapeutics has received grant revenue amounting to $1.9 million for the nine months ended September 30, 2024, compared to $0.5 million for the same period in 2023. This increase of $1.4 million was primarily due to the timing of National Institutes of Health (NIH) grant activities. The company has also received $14.5 million in subaward grant payments from UC San Diego since its inception.

Licensing revenues from partnerships

Oncternal has established licensing agreements that involve payment obligations contingent upon achieving specified development, regulatory, and commercial milestones. For example, under a license agreement with the Regents of the University of California, the company paid an upfront license fee of $0.5 million and is subject to milestone payments ranging from $20.1 million to $24.5 million per product. The potential for licensing revenues remains contingent on product development progress.

Possible royalties from product sales in collaboration agreements

Oncternal's licensing agreements also include provisions for low single-digit royalties on net sales of products developed under these agreements. Milestone payments could aggregate to $75.0 million based on tiered revenue levels. The company has obligations to make royalty payments in connection with future product sales, although specific future revenue from these royalties remains uncertain as of September 30, 2024.

Revenue Stream	2024 Amount (in millions)	2023 Amount (in millions)	Notes
Grant Funding	1.9	0.5	Increase due to NIH activities
Licensing Revenues	Contingent on future milestones	Contingent on future milestones	Potential milestone payments of $20.1M to $24.5M per product
Royalties from Product Sales	Low single-digit percentages	Low single-digit percentages	Based on future sales of licensed products

Updated on 16 Nov 2024

Resources:

1. Oncternal Therapeutics, Inc. (ONCT) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of Oncternal Therapeutics, Inc. (ONCT)' financial performance, including balance sheets, income statements, and cash flow statements.
2. SEC Filings – View Oncternal Therapeutics, Inc. (ONCT)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.