Purple Biotech Ltd. (PPBT): Business Model Canvas [Dec-2025 Updated]

You're digging into the mechanics of a clinical-stage oncology play, and honestly, the map for Purple Biotech Ltd. is exactly what you'd expect: a high-stakes R&D engine where all the value is locked up in pipeline milestones, not product sales-they reported $0 in trailing revenue. As of September 30, 2025, they were running on $10.5 million in cash, funding the push for CM24 in pancreatic cancer and NT219, with Q3 2025 R&D costs hitting $0.6 million. This Business Model Canvas breaks down how they manage that burn, leaning heavily on key partnerships like the one with Bristol Myers Squibb and protecting their core CAPTN-3 intellectual property while they chase that crucial next data readout.

Purple Biotech Ltd. (PPBT) - Canvas Business Model: Key Partnerships

You're looking at the critical external relationships Purple Biotech Ltd. relies on to push its pipeline forward, especially as they manage cash flow toward key 2026 milestones. These aren't just names on a slide; they represent shared risk and validation from established players and academic centers.

Clinical collaboration with Bristol Myers Squibb for CM24 Phase 2 trial

The partnership involving CM24, a humanized monoclonal antibody blocking the CEACAM1 immune checkpoint protein, is anchored by its combination use with Bristol Myers Squibb's immune checkpoint inhibitor, Nivolumab, alongside standard chemotherapy in second-line metastatic pancreatic ductal adenocarcinoma (PDAC) patients. The final Phase 2 data, presented at the AACR Annual Meeting 2025, showed compelling efficacy signals in biomarker-enriched subgroups.

Here's a look at the efficacy demonstrated in that Phase 2 study:

Purple Biotech Ltd. is planning the next step, a biomarker-driven Phase 2b study for CM24, which is scheduled to start in the second half of 2025.

Academic collaboration with the University of Colorado for NT219 Phase 2 study

The development of NT219, a dual inhibitor targeting IRS1/2 and STAT3 pathways to overcome tumor resistance, involves an investigator-initiated Phase 2 study at the University of Colorado Anschutz Medical Campus. This study is led by Dr. Antonio Jimeno.

The trial evaluates NT219 in combination with standard-of-care treatments for recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN).

• The study structure follows a Simon 2-stage design.
• Initial enrollment targets 10 subjects per arm.
• The study may expand to a total of 29 patients per arm.
• One cohort combines NT219 with pembrolizumab (Keytruda).
• The other cohort combines NT219 with cetuximab (Erbitux).
• The market for SCCHN treatment is projected to reach $5 billion by 2030.

Contract Research Organizations (CROs) for managing global clinical trials

While specific CRO names aren't public, the execution of these multi-site trials, like the NT219 Phase 2 study, necessitates external management for global clinical trial logistics, monitoring, and data handling. The financial structure supporting these operations is tied to the company's overall cash position. As of September 30, 2025, Purple Biotech Ltd. had $10.5 million in cash and cash equivalents and short-term deposits. This provided an anticipated cash runway extending into the first half of 2027. The net loss for the three months ended September 30, 2025, was $1.3 million.

Manufacturing partners for producing tri-specific antibodies (e.g., IM1240)

Purple Biotech Ltd. announced a significant manufacturing milestone for IM1240, the first tri-specific antibody from its CAPTN-3 platform, which targets the tumor-associated antigen 5T4. This achievement validates the scalability of the platform via a high-efficiency manufacturing and purification process that achieved commercially viable yield. The technology is designed to engage both T cells and NK cells.

The CAPTN-3 platform development timeline involves external manufacturing expertise:

• IM1240 targets the 5T4 antigen.
• IM1305, the second candidate, targets the TROP2 TAA.
• The company plans to submit an Investigational New Drug (IND) application for IM1240 in 2026.
• The cash runway into the first half of 2027 is intended to support these preclinical and IND-enabling studies.

The successful production of IM1240 at high yield and purity was noted as a significant challenge mastered by the team, suggesting established, though perhaps not exclusively internal, high-level biomanufacturing capabilities.

Purple Biotech Ltd. (PPBT) - Canvas Business Model: Key Activities

You're looking at the core engine driving Purple Biotech Ltd.'s value right now, which is all about executing clinical milestones and de-risking the pipeline assets. Honestly, the Key Activities section is where you see the cash being spent to generate the next data points that will change the valuation.

Research and development (R&D) of the CAPTN-3 antibody platform

The R&D focus is heavily weighted on advancing the CAPTN-3 tri-specific antibody platform. This platform is designed to create conditionally activated antibodies that engage both T cells and NK cells locally within the tumor microenvironment. As of the third quarter of 2025, Purple Biotech Ltd. had nominated IM1305, targeting TROP2, as the second development candidate from this platform, following the lead candidate, IM1240 (targeting 5T4). This platform development is a major activity, even as the financial reporting shows a shift in spending priorities.

Here's the quick math on the recent R&D spend:

What this estimate hides is the capital expenditure required for the manufacturing milestone achieved for IM1240 in October 2025, which validates the scalability of the complex tri-specific antibody production.

Executing and managing Phase 2b clinical trials for CM24 in PDAC

Managing the transition from the proof-of-concept Phase 2 trial for CM24 in pancreatic ductal adenocarcinoma (PDAC) into the next stage is a critical activity. The final data from the Phase 2 study, presented at AACR 2025, provided the strong biomarker signals needed to justify the next step. The activity here is centered on patient selection based on these findings.

Key efficacy numbers from the Phase 2 data driving this activity include:

• 90% reduction in risk of death in the high tumor CEACAM1 and low PD-L1 CPS subgroup.
• 78% reduction in risk of death in a defined serum or tumor CEACAM1 subgroup.
• Objective Response Rate of 37.5% in biomarker-enriched subgroups versus 0% in the control group.
• The initial Phase 2 study involved a biomarker-enriched subgroup of 31 patients.

Purple Biotech Ltd. plans to initiate the biomarker-driven Phase 2b study for CM24 in second-line PDAC in the second half of 2025. This trial may also test CM24 in other indications, potentially including gastric and/or biliary tract cancer.

Advancing NT219 Phase 2 combination studies in head and neck cancer

The execution of the NT219 Phase 2 trial in recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) is a major operational focus for late 2025. This investigator-initiated study, in collaboration with the University of Colorado Anschutz Medical Campus, began in the first half of 2025. The activity involves managing two distinct single-arm cohorts, testing NT219 in combination with standard-of-care agents.

The structure of this Phase 2 trial dictates specific enrollment activities:

• Initial enrollment is set at 10 patients per arm.
• The Simon 2-stage design allows for expansion up to a total of 29 patients per arm based on early signals.
• The SCCHN market is projected to reach $5 billion by 2030.
• The trial aims to improve upon current standard-of-care response rates, such as pembrolizumab at 20% and cetuximab at 15-20%.

Securing and maintaining Intellectual Property (IP) for novel assets

Protecting the innovation is a continuous, non-financial activity that underpins future revenue streams. For NT219, Purple Biotech Ltd. secured enhanced patent protection across major markets, including the US, Europe, China, and Japan, as noted in early 2025 updates. More recently, in September 2025, the company received an intention to grant a European Patent specifically covering NT219 combinations with immunotherapies or MEK inhibitors to overcome tumor resistance.

IND-enabling studies and regulatory filings for new candidates like IM1240

For the CAPTN-3 lead candidate, IM1240, the key activity is moving from preclinical data generation to regulatory submission readiness. Following the achievement of a manufacturing milestone for IM1240 in October 2025, the next steps are clearly defined for 2026.

The regulatory pathway activities planned include:

• Conducting non-GLP and GLP toxicology studies for IM1240.
• Submitting the Investigational New Drug (IND) application in 2026.
• Initiating a Phase 1 study for IM1240 in 2026.

Finance: draft 13-week cash view by Friday.

Purple Biotech Ltd. (PPBT) - Canvas Business Model: Key Resources

You're looking at the core assets that power Purple Biotech Ltd.'s strategy as of late 2025. These aren't just ideas; they are tangible scientific and financial foundations supporting their push in oncology.

Core Intellectual Property (IP) around the CAPTN-3 tri-specific platform represents a major resource. This is a preclinical platform of conditionally activated tri-specific antibodies designed to engage both T cells and NK cells to create a strong, localized immune response inside the tumor microenvironment. The lead candidate, IM1240, targets the tumor-associated antigen 5T4. Purple Biotech Ltd. achieved a manufacturing milestone for IM1240 in October 2025 and plans to submit an Investigational New Drug (IND) application for its first candidate in 2026. Furthermore, the platform's versatility is shown by the initiation of development for a second CAPTN-3 tri-specific antibody targeting TROP2.

The company's expertise is deeply rooted in its scientific team. They focus on developing first-in-class therapies specifically designed to overcome tumor immune evasion and drug resistance. This specialized knowledge is critical for maximizing the potential of their pipeline assets.

The financial bedrock supporting these efforts is the cash position. As of September 30, 2025, Purple Biotech Ltd. held $10.5 million in cash and cash equivalents. Honestly, this cash position is projected to support operations into the first half of 2027, which gives them runway to hit near-term milestones, though more funding will definitely be needed for later-stage trials.

Here's a quick look at the key clinical-stage pipeline assets that form the value proposition:

• CM24: Anti-CEACAM1 mAb.
• NT219: Small molecule dual inhibitor.
• IM1240: Lead CAPTN-3 tri-specific antibody targeting 5T4.

To give you a clearer picture of the clinical assets and their latest reported status, check out this table:

The scientific and clinical expertise is the human capital that translates IP into potential product candidates. This team's deep understanding of the tumor microenvironment and drug resistance pathways is what allows them to design assets like the conditionally activated CAPTN-3 platform to specifically address these hard-to-treat areas. Finance: draft 13-week cash view by Friday.

Purple Biotech Ltd. (PPBT) - Canvas Business Model: Value Propositions

You're looking at the core value Purple Biotech Ltd. (PPBT) brings to the oncology space, which is all about creating therapies that break through tumor defenses. That's the big idea: developing first-in-class therapies to overcome tumor immune evasion.

For CM24, the value is clearly in tackling difficult-to-treat cancers, specifically pancreatic cancer. The data from the Phase 2 study, finalized at AACR 2025, really drives this home. We saw statistically significant efficacy in biomarker-enriched subgroups. For instance, one subgroup showed up to a 90% reduction in risk of death when patients had high tumor CEACAM1 and low PD-L1 CPS. Also, the Objective Response Rate (ORR) hit 37.5% in biomarker-enriched patients, compared to 0% in the control group. Even without biomarkers, the ORR was 25% versus 6.7% for the control arm. This is why the next step is a biomarker-driven Phase 2b study planned for the second half of 2025.

Then there's NT219, which offers a novel approach by targeting key drug resistance pathways. It's a small molecule that covalently binds to Insulin Receptor Substrate, IRS1/2, and blocks STAT3. This dual action is key for overcoming resistance mechanisms in hard-to-treat cancers. A Phase 1 dose escalation study concluded, showing anti-tumor activity when combined with cetuximab in second-line recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) patients. Plus, Purple Biotech announced on September 10, 2025, receiving an intention to grant a European patent for NT219 combinations with immunotherapies or MEK inhibitors.

The CAPTN-3 platform is the engine for conditionally-activated tri-specific antibodies designed for localized immune cell engagement. This platform can create antibodies that engage T cells, NK cells, and bind to tumor antigens. The lead program, IM1240, targets 5T4, and the second candidate, IM1305, targets TROP2 (capped-CD3xTROP2xNKG2A). Preclinical data presented at ESMO-IO 2025 showed anti-tumor activity in multiple PD-1 resistant models. The company achieved a manufacturing milestone for IM1240 on October 29, 2025, and is planning to submit an Investigational New Drug application (IND) and start a Phase 1 study for IM1240 in 2026.

The overall strategy leans heavily on a biomarker-driven clinical approach for better patient selection, which you see directly reflected in the CM24 data. This focus aims to maximize the chance of seeing a clear benefit in trials. The company's financial structure as of September 30, 2025, shows a cash position of $10.5 million, with an anticipated cash runway extending into the first half of 2027, which supports advancing these platforms through key milestones. Research and Development Expenses for Q3 2025 were $0.6 million, a decrease of 56.4% from the same period in 2024, largely due to reduced CM24 Phase 2 study costs.

Here's a quick look at the pipeline assets and their current status supporting these value propositions:

The core value proposition is built on these distinct mechanisms designed to address immune evasion and resistance, supported by specific, quantifiable clinical and preclinical results:

• Developing first-in-class therapies to overcome tumor immune evasion.
• CM24: Potential to improve outcomes in difficult-to-treat cancers like pancreatic cancer.
• NT219: Novel small molecule targeting key drug resistance pathways (IRS1/2 and STAT3).
• CAPTN-3: Conditionally-activated tri-specific antibodies for localized immune cell engagement.
• Biomarker-driven clinical strategy for better patient selection.

Purple Biotech Ltd. (PPBT) - Canvas Business Model: Customer Relationships

The Customer Relationships for Purple Biotech Ltd. (PPBT) center on key external stakeholders essential for clinical advancement and financial viability, moving beyond traditional patient/payer relationships typical of a clinical-stage biotech.

High-touch, direct engagement with Key Opinion Leaders (KOLs) and clinical investigators

Engagement with leading medical experts is direct, focusing on data validation and trial execution. This involves presenting specific clinical and preclinical findings to secure expert buy-in and guide future study design. For instance, in collaboration with Mt. Sinai Principal Investigator Dr. Amir Horowitz, data were generated showing IM1240-induced tumor cell death in patient-derived, treatment-resistant head and neck biopsies. Furthermore, the Phase 2 study for NT219 in recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) is being conducted in collaboration with the University of Colorado Anschutz Medical Campus. The company also planned to present new preclinical data from its CAPTN-3 platform at the European Society of Medical Oncology Immuno-Oncology (ESMO-IO) 2025 Annual Congress, held from December 10-12, 2025, in London, United Kingdom.

Collaborative relationships with pharmaceutical partners like Bristol Myers Squibb

Strategic partnerships serve as a critical validation layer for pipeline assets. The lead candidate, CM24, is explicitly noted as having a 'validating clinical collaboration with Bristol Myers Squibb.' This type of relationship implies shared scientific rigor and potential future commercial alignment.

Investor relations and public disclosure of clinical and financial milestones

Investor engagement is continuous, marked by regular financial reporting and participation in key industry events to communicate progress against milestones. As of September 30, 2025, Purple Biotech Ltd. reported cash and cash equivalents and short-term deposits of $10.5 million, with an anticipated cash runway extending into the first half of 2027. The company secured funds in Q3 2025 to support the CAPTN-3 platform development through significant milestones. The relationship with the investment community was actively managed through events like the fireside chat and 1x1 investor meeting at the H.C. Wainwright 27th Annual Global Investment Conference, held September 8-10, 2025. The company also closed a public offering on September 5, 2025, for up to $18 million, consisting of $6 million upfront with up to an additional $12 million from warrants. The Net Loss for the nine months ended September 30, 2025, was $2.84 million, an improvement from $6.83 million a year ago. The Operating Loss for Q3 2025 was $1.4 million, a decrease of 35.8% year-over-year.

Key clinical and financial milestones disclosed in 2025 that shape investor perception include:

Regulatory engagement with the FDA and other health authorities

Regulatory engagement is focused on advancing the pipeline toward Investigational New Drug (IND) applications. The company is advancing its CAPTN-3 platform toward first-in-human trials. Specifically, Purple Biotech Ltd. plans to conduct non-GLP and GLP toxicology studies, submit an Investigational New Drug application (IND), and initiate a Phase 1 study for IM1240 in 2026. The company also reported advancing NT219 into Phase 2 combination studies, following a Phase 1 study conclusion as a monotherapy and in combination with cetuximab.

The company's R&D expenses reflected a shift in focus, decreasing by 56.4% year-over-year in Q3 2025 to $0.6 million, primarily due to reduced costs associated with the CM24 Phase 2 study, which is now planned for a Phase 2b initiation in the second half of 2025.

• NT219 Phase 2 study in R/M SCCHN is ongoing.
• CM24 Phase 2b study planned for initiation in the second half of 2025.
• IND submission for CAPTN-3's first candidate (IM1240) planned for 2026.

Purple Biotech Ltd. (PPBT) - Canvas Business Model: Channels

Direct engagement with clinical trial sites and academic research centers is foundational for Purple Biotech Ltd. as a clinical-stage company. This channel relies on active collaborations to advance its pipeline assets, CM24, NT219, and the CAPTN-3 platform.

• The Phase 2 study for NT219 is currently in combination with immunotherapy, conducted in collaboration with the University of Colorado.
• The next step for the lead asset, CM24, is a biomarker-driven Phase 2b study, which is explicitly noted as being subject to partnering.
• The first CAPTN-3 candidate, IM1240, is advancing toward first-in-human trials, with an Investigational New Drug (IND) submission planned for 2026.

Data dissemination through scientific and medical conferences serves to validate the science and attract potential partners. Purple Biotech Ltd. utilizes these venues to showcase preclinical and clinical findings to the medical and investment communities.

Scientific communication is critical for de-risking the pipeline. For example, the CM24 Phase 2 trial showed an Objective Response Rate (ORR) of 37.5% in biomarker-enriched subgroups.

Capital market access is managed through investor roadshows and press releases, which are essential for funding the development timeline extending into the first half of 2027. The September 2025 public offering was a key event for this channel.

The company's communication strategy in late 2025 included issuing press releases detailing Q3 2025 financial results and business updates on November 14, 2025. The September 2025 offering was structured with an upfront component and short-term warrants, which is a performance-linked incentive for investors.

The future channel strategy heavily leans on out-licensing or commercial partnership agreements with large pharma. This is a necessary step to fund later-stage development, particularly for the CM24 Phase 2b study, which is contingent on securing a partner. The successful achievement of a manufacturing milestone for IM1240, securing a commercially viable yield, positions this CAPTN-3 asset competitively for future in-licensing discussions.

Purple Biotech Ltd. (PPBT) - Canvas Business Model: Customer Segments

You're looking at the core groups Purple Biotech Ltd. (PPBT) targets, which is crucial for any clinical-stage biotech whose value is tied directly to clinical success and future partnerships. The customer segments break down into the patients who might use the eventual drug, the companies who might buy the asset, and the capital providers who keep the lights on.

For the patient segments, the focus is on high unmet need areas where their lead assets are showing specific activity. For instance, the CM24 asset targets advanced/metastatic pancreatic ductal adenocarcinoma (PDAC). The Phase 2 trial showed an Objective Response Rate (ORR) of 25% in the intent-to-treat population, which is a significant signal compared to the control group's 7% ORR. More compellingly, in biomarker-enriched subgroups, the ORR reached 37.5%. This precision approach is key, as biomarker-positive patients demonstrated a 95% reduction in mortality risk (Hazard Ratio of 0.05). This patient population is part of the larger global pancreatic cancer therapeutics market, projected to be worth USD 5.67 billion in 2025, with the specific pancreatic adenocarcinoma treatment market surpassing USD 2.92 billion in 2025.

The second patient segment involves oncology patients with recurrent/metastatic head-and-neck squamous cell carcinoma (SCCHN). The NT219 asset is aimed here, with a Phase 2 study initiated in Q2 2025. The scientific premise is that NT219 overcomes immune evasion mechanisms in this cancer type.

Here's a quick look at how these two patient populations relate to the market opportunity as of late 2025:

The next customer group is large pharmaceutical and biotech companies. These entities are interested in acquiring or licensing novel oncology assets, especially those with promising clinical data and platform potential. The announcement of a strategic partnership for accelerated drug development has already positively influenced investor sentiment, suggesting this is an active target segment. The pipeline offers multiple points of interest for these partners:

• CM24: Anti-CEACAM1 mAb with positive Phase 2 data in PDAC.
• NT219: Small molecule dual inhibitor targeting IRS1/2 and STAT3.
• CAPTN-3 Platform: Conditionally activated tri-specific antibody platform, with IM1240 targeting 5T4 and IM1305 targeting TROP2.

Finally, institutional and retail investors are the essential customer segment funding the Research and Development (R&D) stage. As of September 30, 2025, Purple Biotech Ltd. reported a cash position of $10.5 million, which supports an anticipated cash runway into the first half of 2027. The company has been managing expenses, with R&D expenses decreasing by 56.4% year-over-year for the three months ended September 30, 2025. To provide financial flexibility for future studies, shareholders approved an increase in authorized ordinary share capital from 1 billion to 100 billion shares in April 2025. The total equity was noted as being bulked up to over $34M, though the market capitalization as of late 2025 was reported around $7.82M or $6M.

• Cash and Deposits (as of September 30, 2025): $10.5 million.
• Anticipated Cash Runway: Into the first half of 2027.
• Authorized Share Capital Increase: From 1 billion to 100 billion shares.
• R&D Expense Decrease (YoY Q3 2025): 56.4%.

Finance: draft 13-week cash view by Friday.

Purple Biotech Ltd. (PPBT) - Canvas Business Model: Cost Structure

You're looking at the expenses that keep Purple Biotech Ltd. running as they push their pipeline forward. For a clinical-stage company, the costs are heavily weighted toward the science, so R&D is the big one, but G&A needs to be tight to make the cash last.

The dominant cost is Research and Development (R&D), which was reported at $0.6 million for the three months ended September 30, 2025. This figure represented a 56.4% decrease from the $1.3 million reported in the same period of 2024. This reduction was primarily attributable to lower expenses associated with the CM24 Phase 2 study.

General and Administrative (G&A) expenses were $0.8 million for the third quarter of 2025. This amount was consistent with the $0.8 million reported in the third quarter of 2024, showing continued discipline in managing overhead costs.

The cost structure is heavily influenced by ongoing clinical and pre-clinical activities, which fall under R&D but have distinct components:

• Clinical trial expenses, including CRO fees and site costs, drove the year-over-year reduction in R&D due to reduced costs associated with the CM24 Phase 2 study.
• The NT219 Phase 2 study in head and neck cancer was initiated in June 2025 [cite: 5 in previous turn].
• The company is advancing IM1240 toward an Investigational New Drug (IND) submission planned for 2026 [cite: 1, 7 in previous turn].

Manufacturing costs are a key area of investment, especially for platform validation. The focus here is on proving scalability for the CAPTN-3 platform:

Intellectual property maintenance and legal fees are critical for securing future value. The company has been actively strengthening its IP portfolio:

• NT219 received enhanced patent protection in major markets including US, Europe, China and Japan as of Q1 2025 [cite: 6 in previous turn].
• In September 2025, Purple Biotech Ltd. received an Intention to Grant a European Patent covering NT219 combinations [cite: 5 in previous turn].

Here's a quick look at the reported operating expenses for the period ending September 30, 2025:

The resulting Operating Loss for the quarter was $1.4 million.

Purple Biotech Ltd. (PPBT) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Purple Biotech Ltd. (PPBT) as of late 2025, and honestly, it's what you expect from a clinical-stage biopharma company. The core business isn't generating sales yet.

Currently, Purple Biotech Ltd. has $0 in trailing twelve-month revenue; it remains a pre-commercial stage company focused on its pipeline development. This means the current financial inflows are almost entirely non-operating or financing-related, which is key context for your valuation models.

Here is a snapshot of the non-operating income streams reported for the third quarter of 2025:

The most significant recent cash infusion came from equity financing. On September 5, 2025, Purple Biotech Ltd. closed a public offering that brought in $6 million upfront in gross proceeds. This offering also included short-term warrants, which could potentially yield up to an additional $12 million if fully exercised, though that is contingent on investor action. You need to track those warrants closely; they represent contingent future dilution or cash inflow. The company intends to use these net proceeds for developing its oncology therapeutic candidates and general working capital.

Looking ahead, the entire revenue model shifts to potential value creation through successful clinical progression. This is where the real financial upside is anticipated to materialize. The future revenue streams are entirely dependent on successful partnerships and regulatory outcomes:

• Upfront payments from potential licensing deals.
• Milestone payments tied to clinical trial success or regulatory achievements.
• Royalties on future net sales following commercialization by a partner.
• Product sales revenue, though this is contingent on achieving necessary regulatory approval for its candidates like CAPTN-3 (IM1240 and IM1305).

Finance: draft 13-week cash view by Friday.