CohBar, Inc. (CWBR): Business Model Canvas [Dec-2025 Updated]

You're looking at a classic biotech pivot, and as someone who's modeled these turnarounds for years, you know the devil is in the details of the new model. CohBar, Inc. (CWBR), now operating as TuHURA Biosciences after a late 2023 merger, has staked its future on the personalized cancer vaccine IFx-Hu2.0. Honestly, the numbers tell a story of high-risk, high-reward: a market capitalization hovering around \$124.12 million is currently funding a significant burn, evidenced by a trailing twelve-month net loss of -\$12.55 million. To truly grasp how they plan to bridge that gap-from high Research and Development (R&D) costs, like the \$1.8 million spent in Q1 2024, to future royalties-you need to see the whole structure. Below, I've broken down the new Business Model Canvas, mapping out exactly where their resources, partnerships, and value propositions lie in this immuno-oncology race. Dive in; this blueprint shows you the operational reality behind the ticker.

CohBar, Inc. (CWBR) - Canvas Business Model: Key Partnerships

You're looking at the structure CohBar, Inc. (CWBR), now operating post-merger as TuHURA Biosciences, Inc., relies on to move its Mitochondria-Based Therapeutics (MBTs) forward. For a clinical-stage biotech, these external relationships are as critical as the internal science.

Clinical Research Organizations (CROs) for Phase 3 trial execution

Execution of late-stage trials, like a potential Phase 3, requires outsourcing significant operational load. Filings indicate that the merged entity, through the Morphogenesis component, depends upon independent investigators and collaborators, including CROs, to conduct clinical trials. This reliance means CohBar, Inc. must negotiate budgets and contracts, which directly impacts development timelines and costs. While specific 2025 Phase 3 CRO partners for the combined entity aren't detailed, the industry context shows the scale of potential partners. For instance, a top-tier, full-service CRO like ICON plc reported revenues around $6.5B in 2025, and IQVIA reported $15B revenue, illustrating the level of infrastructure available for large-scale studies.

The reliance on third parties means limited direct control over investigator activities and visibility into trial progress.

Academic medical centers and key opinion leaders (KOLs) for research

The foundation of CohBar, Inc.'s platform involves deep scientific collaboration. The company has historically relied on world-renowned expertise. Concrete partnership evidence points to foundational agreements:

• Exclusive License Agreement parties include The Regents of the University of California.
• Exclusive License Agreement parties include Albert Einstein College of Medicine.
• Exclusive License Agreement parties include Mayo Clinic.
• An Extension Agreement to Consulting Agreement was noted with Dr. Nir Barzilai.

These relationships provide access to specialized research infrastructure and KOL insights necessary for validating the Mito+ platform's potential across indications like type II diabetes, NASH, and fibrotic diseases.

Contract manufacturing organizations (CMOs) for vaccine production

Specific, named Contract Manufacturing Organizations (CMOs) engaged by CohBar, Inc. for the production of its peptide therapeutics or any vaccine candidates are not detailed in the latest available public disclosures for 2025. Manufacturing scale-up, especially for novel therapeutics moving toward commercialization, is a major capital expenditure. The cost for a single, large-scale Phase 3 or initial commercial batch of a complex biologic can easily range from $1 million to over $10 million, depending on the molecule and required Good Manufacturing Practice (GMP) standards.

Investment banks for capital raising and defintely future public offerings

Maintaining a public listing and accessing capital markets is paramount for clinical-stage biotechs. While no specific investment bank is named as the current lead for a 2025 public offering, a significant capital event preceding the merger provides a benchmark. CohBar, Inc. entered into a Stock Purchase Agreement in May 2023 for an Initial Financing totaling an aggregate purchase price of $15 million from K & V Investment Two, LLC. Investment banks typically charge advisory and underwriting fees ranging from 5% to 7% of the gross proceeds for a public offering.

Here's a look at the concrete financial and partnership anchors identified:

Finance: draft 13-week cash view by Friday.

CohBar, Inc. (CWBR) - Canvas Business Model: Key Activities

You're looking at the core actions CohBar, Inc. (CWBR), now operating under the umbrella of TuHURA Biosciences, Inc. following its merger, must execute to move its pipeline forward as of late 2025. These aren't just tasks; they are the essential, high-cost drivers of the business model.

Executing the Phase 3 clinical trial for IFx-Hu2.0

The primary activity centers on the pivotal Phase 3 accelerated approval trial for IFx-Hu2.0 (also referenced as IFx-2.0), which is being evaluated as an adjunctive therapy alongside pembrolizumab (Keytruda) in checkpoint inhibitor (CPI)-naïve patients with advanced or metastatic Merkel cell carcinoma (MCC). This is the make-or-break activity for the near term.

The trial design details specific operational metrics:

• Evaluate IFx-Hu2.0 (0.1 mg) administered weekly for three weeks concurrent to pembrolizumab (200 mg) Q3W versus placebo.
• Pivotal trial expected to enroll 118 CPI-naïve patients.
• Site count is projected across approximately 22 to 25 U.S. sites.
• Participants are randomized on a 1:1 basis.

Research and development (R&D) of personalized cancer vaccines

R&D activity involves the continued advancement of the personalized cancer vaccine technology, which originates from the Morphogenesis side of the combined entity. This includes ongoing work to overcome primary and acquired resistance to current immunotherapies. While specific 2025 R&D spending figures aren't immediately available, R&D expenses are historically a major component of the operating cost structure.

Securing and maintaining intellectual property (IP) portfolio

Protecting the core assets is a continuous, non-discretionary activity. This involves managing the existing portfolio and filing for new protections as research progresses. Older data indicated a significant base of filings that require ongoing maintenance fees to remain in force.

Historical IP activity metrics include:

• More than 45 provisional patent applications filed.
• At least 10 PCT applications filed.

Regulatory affairs and filing with the FDA

Navigating the FDA process for both the ongoing Phase 3 trial and eventual New Drug Application (NDA) submissions requires dedicated regulatory expertise and budget allocation. The cost structure for these filings is set by the agency and directly impacts the cash required for future milestones.

Here's a look at the financial context surrounding the company's operations and the direct cost of a major regulatory filing, based on the latest available figures:

These activities consume capital, and you need to track the burn rate closely. If onboarding for the 22 to 25 clinical sites takes longer than anticipated, cash runway shortens fast.

CohBar, Inc. (CWBR) - Canvas Business Model: Key Resources

You're looking at the core assets CohBar, Inc. (CWBR) relies on to execute its strategy as of late 2025. For a clinical-stage biotech, these resources are everything-the science, the protection around it, and the capital to keep the lights on while pursuing milestones.

The company's primary tangible asset is its technology platform, which centers on mitochondria-based therapeutics. Still, the most immediate, hard number you need to track is the cash position, as that dictates operational longevity. Honestly, the latest reliable market data suggests a significant shift in valuation and trading status compared to historical figures.

The IFx-Hu2.0 personalized cancer vaccine technology is clearly the most critical near-term asset. It's designed to activate the innate immune response to overcome resistance to checkpoint inhibitors (CPIs). Here's what we know about its current development status as of mid-2025:

• Phase 3 trial initiated in June 2025.
• Trial is a multicenter, randomized, double-blinded, placebo-controlled study.
• Planned enrollment of 118 CPI-naïve patients with advanced or metastatic Merkel cell carcinoma (MCC).
• Trial designed for Accelerated Approval Pathway under a Special Protocol Assessment (SPA) with the FDA.
• Phase 1 data suggested activation of tumor-specific B cells and T cells.

Core intellectual property and patent portfolio protection underpins the entire valuation, even if the market cap is currently low. While a specific patent count isn't readily available for late 2025, the company's pipeline assets are protected by this IP base. The company's focus areas, which are covered by this IP, include:

• CB5138-3 for idiopathic pulmonary fibrosis (IPF) and fibrotic diseases.
• CB4211 for nonalcoholic steatohepatitis and obesity.
• CB5064 Analogs in preclinical study for IPF and other fibrotic diseases.

The scientific team expertise is the human capital driving the science. You're looking at a small operation, with only 10 employees listed. The expertise centers on immuno-oncology and mitochondria-based therapeutics. The company's founding team included notable figures in aging and mitochondrial research, which forms the scientific bedrock, though current operational team size is small.

Regarding the cash runway, the last concrete estimate places funding through Q4 2023 based on 2022 figures. Given the delisting status and the low market cap of $1.19 million as of early 2025, you defintely need to check the latest filings for any recent capital raises or significant burn rate changes to establish a current view of operational funding.

CohBar, Inc. (CWBR) - Canvas Business Model: Value Propositions

You're looking at the core promise CohBar, Inc. (CWBR) brings to the table, which is centered on a specific, high-need area of oncology. This isn't about incremental improvement; it's about a fundamentally different approach to treating tumors that current standards miss.

Novel, personalized cancer vaccine for solid tumors

The value proposition here is the development of IFx-Hu2.0, described as a novel personalized cancer vaccine. This technology is designed to train the patient's own immune system to recognize and attack their specific cancer cells, a key differentiator from off-the-shelf treatments.

Potential treatment for checkpoint inhibitor-resistant cancers

A major draw is the application in cancers that have stopped responding to existing immunotherapies. The Phase 1b trial results, announced in partnership with Morphogenesis, Inc., specifically targeted advanced Merkel Cell Carcinoma (MCC) and Cutaneous Squamous Cell Carcinoma (cSCC) in patients who were checkpoint inhibitor resistant. This addresses a critical clinical failure point.

Overcoming tumor immune evasion mechanisms

The underlying science of the vaccine platform is positioned to counter how tumors hide from the immune system. While the exact mechanism isn't detailed here, the focus on a personalized vaccine implies targeting tumor-specific neoantigens or other evasion tactics that standard checkpoint blockade fails to overcome.

Addressing a significant unmet medical need in oncology

The market context shows a massive and growing need. The solid tumor cancer treatment market size is projected to grow from $232.2 billion in 2024 to $265.41 billion in 2025. Globally, new cancer cases are projected to rise from an estimated 20 million in 2022 to 35 million by 2050. In the U.S. alone, over 2 million new cancer diagnoses are expected in 2025. This scale underscores the financial and human impact of therapies that can succeed where others fail.

Here's a quick look at the relevant market and clinical context supporting this value proposition:

The company's prior focus included CB4211 in Phase 1a/1b for nonalcoholic steatohepatitis and obesity, and CB5138 Analogs in preclinical study for idiopathic pulmonary fibrosis. Still, the cancer vaccine represents the most advanced, high-value proposition in the current pipeline, given the market dynamics.

You should note that as of early 2025, CohBar, Inc. (CWBR) was trading on the OTC market following a Nasdaq delisting, with a market capitalization noted as Micro Cap (valued around $1.19 million in January 2025 context). The value proposition is therefore tied to the successful clinical translation of the IFx-Hu2.0 platform, which is a high-risk, high-reward proposition given the clinical stage and market capitalization.

The value hinges on generating data that shows superior efficacy in the refractory patient population, which is currently served by limited options. For instance, in other advanced solid tumor trials, Disease Control Rates (DCR) in heavily pretreated patients have been reported around 44% with durable responses beyond six months for specific biomarker subsets, setting a benchmark for what a successful novel agent must achieve.

• Personalized approach aims to address tumor heterogeneity.
• Targets cancers refractory to existing checkpoint blockade.
• Leverages immune system reactivation beyond current targets.
• Addresses a market segment with high unmet clinical need.

Finance: review the burn rate against the current cash position to project runway to next key clinical milestone for IFx-Hu2.0 by end of Q1 2026.

CohBar, Inc. (CWBR) - Canvas Business Model: Customer Relationships

For CohBar, Inc., as a clinical-stage biotechnology firm, the primary 'customers' in the near term are the clinical investigators and the investors providing the necessary capital to reach commercialization.

High-touch, direct engagement with clinical investigators

Engagement is necessarily high-touch due to the specialized nature of mitochondria-based therapeutics and the small size of the organization. As of early 2025, CohBar, Inc. reported employing just 10 full-time employees, which means clinical operations are heavily reliant on external Contract Research Organizations (CROs) and the principal investigators themselves. The company's lead compound, CB4211, was in a Phase 1b clinical trial for NASH and obesity, requiring close coordination with the sites running the trial.

• Reliance on external CROs for site management.
• Direct communication channels established for trial execution.
• Focus on key opinion leaders in NASH and fibrosis research.

Investor relations to secure ongoing equity financing

Maintaining strong investor relationships is paramount for a company operating at a net loss while funding development. The trailing twelve months (TTM) net loss as of November 2025 was -$12.55 million, underscoring the need for continuous capital. The company's market capitalization stood at approximately $124.12 million as of April 22, 2025. Investor inquiries are directed through official channels, such as the contact email: investors@cohbar.com.

Future direct sales force to oncologists and specialty clinics

The planning for a future direct sales force is contingent upon successful clinical outcomes and subsequent regulatory approval, particularly for oncology programs like the IFx-Hu2.0 vaccine candidate. Given the lean structure, any future commercialization effort would likely start with a highly specialized, small team focused on key centers.

• Commercialization strategy tied to IFx-Hu2.0 success.
• Team size projected to scale post-Phase 3 data readout.
• Focus on high-volume specialty clinics for initial launch.

CohBar, Inc. (CWBR) - Canvas Business Model: Channels

You're looking at the channels CohBar, Inc. (CWBR) uses to reach its key partners and stakeholders as of late 2025. Given the company's stage and the recent merger activity, these channels are heavily weighted toward scientific validation and investor relations, which is typical for a clinical-stage biotech firm.

Clinical trial sites and major cancer research centers

The primary channel for validating the core value proposition-mitochondria-based therapeutics-is through the execution of clinical trials. While specific site counts aren't public as of late 2025, the company's pipeline progress dictates channel activity. The lead compound, CB4211, was previously in a Phase 1a/1b trial for NASH and obesity, and preclinical programs like CB5138 Analogs target fibrotic diseases like idiopathic pulmonary fibrosis. The operational channel relies on established relationships with Clinical Research Organizations (CROs) to manage these sites.

The broader industry context shows that in 2025, the global CRO industry is projected to reach $90 billion by year-end, driven by decentralized trial innovations. This means CohBar, Inc.'s engagement with sites is likely digitized, utilizing integrated eClinical ecosystems where the use of digital tools by clinical trial sites rose to 81% in 2022, a trend that has certainly accelerated. The company's ability to secure high-quality sites is paramount, as sponsors avoid sites that repeatedly underperform.

Scientific publications and medical conferences

Scientific dissemination is a critical channel for building credibility and attracting future partners. This involves publishing data in peer-reviewed journals and presenting at key medical conferences. The company's Mito+ platform and peptide discoveries must be validated through this channel to support the development of drug candidates.

Historically, data from the CB4211 study were presented at the American Association for the Study of Liver Disease (AASLD) 2021 Liver Meeting®. The channel strategy is to use these scientific forums to communicate progress on their pipeline, which includes over 100 mitochondrial derived peptides and over 1,000 analogs discovered to date. The success of this channel directly influences the attractiveness of the licensing channel.

• Data presentation at major medical society meetings.
• Publication in high-impact, peer-reviewed journals.
• Communication of intellectual property coverage, including over 65 patent applications filed historically.
• Presentations to key opinion leaders in mitochondrial biology.

Investor presentations and SEC filings

For a publicly traded entity, regulatory filings and investor outreach are the formal channels for communicating financial health and strategic direction. As of early 2025, CohBar, Inc. was trading on the OTC market, having transitioned from NASDAQ. The stock price on January 06, 2025, was $0.41, with a reported Market Cap of $1.19M, classifying it as a Micro Cap. By February 7, 2025, the price had moved to $0.88.

The most recent definitive financial data available reflects a period before the full integration following the merger agreement with Morphogenesis, Inc. The channel for investor information relies on timely 10-K and 10-Q filings, which provide the official record of cash reserves and operating expenses. The shift in listing venue itself is a key communication point to the investment community.

Future pharmaceutical licensing partners

This is arguably the most crucial external channel for a clinical-stage company like CohBar, Inc. The strategy explicitly involves advancing drug candidates through strategic partnerships with larger biopharmaceutical companies. The merger with Morphogenesis, Inc. itself represents a major strategic alignment, but the pipeline development still requires external validation and commercialization reach.

The industry trend in 2025 reinforces this channel's importance: large pharma companies are becoming more selective regarding early-stage R&D, making them increasingly reliant on external innovation and clinical-stage dealmaking to fill their pipelines. CohBar, Inc.'s intellectual property portfolio, covering over 100 natural peptides and analogs, serves as the primary asset being channeled to these potential partners. The goal is to secure deals that capture maximum value, whether through internal development or partnership.

• Targeting larger biopharmaceutical companies for in-licensing.
• Leveraging strong IP coverage to enhance deal attractiveness.
• Focusing on clinical-stage assets for potential partnerships.
• Utilizing scientific conference presence to network with potential dealmakers.

Finance: draft 13-week cash view by Friday.

CohBar, Inc. (CWBR) - Canvas Business Model: Customer Segments

You're looking at the core groups that CohBar, Inc. (CWBR) needs to engage to move its pipeline forward, especially given its clinical-stage status and recent corporate activity. Honestly, for a company like this, the customer segments aren't just end-users; they are critical partners and funders.

Patients with advanced, solid tumors resistant to standard therapies

This segment represents the ultimate beneficiaries for the preclinical cancer assets, such as the MBT3 Analogs for cancer immunotherapy and MBT5 Analogs for CXCR4-related cancer. The sheer scale of the patient population needing novel options is substantial, grounding the commercial potential. In the United States in 2025, there are approximately 2,041,910 new cancer diagnoses projected to occur. Solid tumors represent around 85% of these cases. For context on the need for advanced therapies, the global solid tumor therapeutics market size stood at USD 207.29 billion in 2025. The U.S. solid tumor cancer treatment market size was evaluated at USD 1.32 billion in 2024.

The need for novel approaches is underscored by the fact that for certain cancers, like chronic myeloid leukemia, drug resistance occurs in 5% to 10% of patients. The patient pool for CohBar, Inc. is defined by the failure of existing lines of therapy, which is a significant subset of the total diagnosed population.

Oncologists and specialized cancer treatment centers

These are the clinical gatekeepers who will ultimately test and prescribe any successful therapeutic. Their focus is on centers treating complex, resistant cases. As of 2025, there are approximately 25,419 oncologists actively practicing in the United States. Within this group, the number of physicians tracked specializing in Hematology/oncology is 11,937. The demand for these specialists is high, with projections indicating a total shortfall of 2,258 full-time equivalent clinical care FTEs across the U.S. by 2025.

• The majority of oncologists, about 67.5%, work exclusively in urban settings.
• The density of medical and hematology oncologists relative to the aging population is decreasing.
• The total number of new cancer cases in the U.S. in 2025 is estimated at 2,041,910.

Large pharmaceutical companies seeking late-stage oncology assets

These entities are the primary potential acquirers or partners for CohBar, Inc.'s pipeline assets, especially if they advance past preclinical stages, like the CB4211 (NASH/Obesity) or CB5138 Analogs (IPF). Big Pharma is actively seeking bolt-on deals, particularly in oncology. For instance, one major oncology deal in June 2025 between Bristol Myers Squibb and BioNTech had a total value of $11 billion, including $1.5 billion upfront. Another illustrative deal in the first half of 2025 involved a value of approximately $14.6 billion. Furthermore, approximately 85% of China out-licensing deals are focused on oncology, showing a global appetite for external oncology innovation.

The industry holds significant capital, with biopharma companies holding US$1.3 trillion in dealmaking Firepower as of early 2025, though the focus has shifted to smaller, smarter deals.

Institutional and retail investors funding the development stage

This segment provides the necessary capital to fund the multi-year, high-cost clinical development process. For CohBar, Inc., as of November 30, 2025, the stock price was $0.41, and the market capitalization as of January 16, 2025, was $1.19M. The company, which employs around 9 to 10 full-time employees, has generated over 1,000 analogs from its discovery platform. The company's stock trades on the OTCMKTS exchange following a delisting notice in November 2023.

The company's ability to attract funding is directly tied to the progression of its lead candidates, CB4211 and CB5138 Analogs, through clinical milestones.

CohBar, Inc. (CWBR) - Canvas Business Model: Cost Structure

You're looking at the core expenses CohBar, Inc. (CWBR) faces to keep its pipeline moving, which is typical for a clinical-stage biotech. The cost structure is heavily weighted toward discovery and development, meaning cash burn is the primary financial reality until a partnership or commercial success hits.

High Research and Development (R&D) expenses form the largest component of the operating cost structure. This covers everything from preclinical work to managing ongoing clinical trials. For instance, R&D spending for the first quarter of 2024 was reported at around $1.8 million.

Clinical trial costs are embedded within the R&D spend and are highly variable based on the phase and complexity of the drug candidate, such as CB5138-3 targeting Idiopathic Pulmonary Fibrosis (IPF). While the Q1 2024 R&D was $1.8 million, historical data shows quarterly R&D costs fluctuating, such as $1.5 million in Q1 2022 and $2.2 million in Q4 2022 [cite: 5 from previous search].

General and administrative (G&A) overhead covers the necessary operational expenses outside of the lab and trials. This includes executive salaries, rent, and general corporate functions. The latest available quarterly G&A figure we have is from mid-2023, where it stood at $4.3 million for the quarter ended June 30, 2023 [cite: 2 from previous search].

Intellectual property maintenance and legal fees are a distinct, recurring cost necessary to defend and maintain the company's competitive moat. These costs are often bundled into G&A, but specific maintenance fees are required to keep patent families active. For example, aggregate annual maintenance fees paid to licensors for two specific agreements totaled $87,500 in 2022 [cite: 1 from previous search].

Here's a quick look at how some of these key operating expenses have tracked quarterly, showing the variability in R&D versus the more stable G&A base:

The primary cost drivers CohBar, Inc. (CWBR) manages are:

• Funding IND-enabling studies and formulation work.
• Managing patent prosecution and international filings.
• Covering fixed costs like executive compensation and facilities.
• Paying annual patent maintenance fees, such as the $87,500 paid across key licenses in 2022 [cite: 1 from previous search].

What this estimate hides is the potential for large, one-time legal expenses related to litigation or significant IP defense, which would spike the G&A line item.

CohBar, Inc. (CWBR) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of CohBar, Inc. (CWBR) as of late 2025, and honestly, it's what you'd expect for a company deep in clinical development. The model isn't built on selling anything yet; it's built on capital preservation and hitting milestones.

Currently $0 from core product sales (pre-commercial stage)

As of the latest fiscal year fundamentals, CohBar, Inc.'s reported revenue from core operations is $0. This is the reality for a pre-commercial biotech focused on advancing its pipeline, specifically the lead asset, IFx-Hu2.0. Since IFx-Hu2.0 is in a Phase 3 accelerated approval trial as of mid-2025, product sales revenue is not yet a factor in the current model.

Future milestone payments from potential licensing agreements

The near-term potential for non-dilutive cash flow hinges on securing a licensing agreement for IFx-Hu2.0 or other pipeline assets. These deals typically structure payments around specific achievements:

• Non-refundable upfront payments upon signing.
• Development milestone payments tied to clinical trial completions.
• Regulatory milestone payments upon FDA approval.

Future royalties on net sales of IFx-Hu2.0

Once IFx-Hu2.0 potentially gains market approval-it's being evaluated in a Phase 3 trial for advanced or metastatic Merkel cell carcinoma (MCC) as of June 2025-the long-term revenue stream will shift to royalties. This is the ultimate goal of the development strategy.

Here's a quick look at the financial context supporting the current operations:

Equity financing and capital raises to cover the TTM net loss of -$12.55 million

Since product revenue is zero, the current financial lifeline for CohBar, Inc. is its ability to raise capital to fund its operations and clinical trials. The Trailing Twelve Months (TTM) net loss of -$12.55 million must be covered by these financing activities to maintain the runway. This is the primary, current source of operational funding.

The company's cash generation strategy, therefore, looks like this:

• Primary Funding Source: Issuance of common stock and warrants in public offerings.
• Secondary Potential: Upfront payments from any pre-commercial licensing deals.
• Key Risk: Dilution of existing shareholder equity with each capital raise.

Finance: draft 13-week cash view by Friday.