Artelo Biosciences, Inc. (ARTL): Business Model Canvas [Dec-2025 Updated]

You're looking at the core structure of a clinical-stage pharmaceutical company, Artelo Biosciences, Inc., and right now, its business model is pure science-meets-survival, defintely not product sales. This is a firm betting big on novel therapeutics like ART27.13 for cancer anorexia-cachexia syndrome and ART26.12 for chronic pain, aiming for high-value partnerships down the line. The reality check, based on late 2025 figures, is that with only $1.7 million in cash as of September 30, 2025, and Q3 R&D costs hitting $1.3 million, their immediate key activity is capital generation, proven by the $3.0 million public offering they executed that quarter. Scroll down to see the precise blueprint-the Key Partnerships, the Cost Structure, and the Revenue Streams-that Artelo Biosciences, Inc. is using to fund this critical development phase.

Artelo Biosciences, Inc. (ARTL) - Canvas Business Model: Key Partnerships

You're looking at the partnerships Artelo Biosciences, Inc. (ARTL) relies on to move its pipeline forward, especially given their cash position as of mid-2025. Honestly, these relationships are the engine for their value creation right now.

Large pharmaceutical companies for out-licensing and commercialization deals

Artelo Biosciences, Inc. is actively positioning itself to secure a development partner for its lead asset, ART27.13, which targets cancer anorexia-cachexia syndrome (CACS). Following the positive interim results from the Phase 2 CAReS trial, the company affirmed it is well positioned to sign a deal, noting strong interest from multiple pharmaceutical companies awaiting this data. The immediate strategy, as stated by the President and CEO, Gregory D. Gorgas, is to secure this development partner to efficiently advance ART27.13 through registrational trials, as Artelo Biosciences does not envision internally funding a Phase 3 trial. This focus on out-licensing is critical, especially considering the company's liquidity situation, with cash and investments totaling $2.066 million as of June 30, 2025, and a working capital deficit of $(3.479) million.

The potential market size for an FDA-approved CACS therapy is significant, described as an underserved, multi-billion-dollar potential market. Artelo Biosciences also has a history of intending to license intellectual property from other pharmaceutical and biotechnology companies to build its pipeline.

Academic institutions and clinical investigators for Phase 2 CAReS trial

The clinical investigation for ART27.13 in the Phase 2 CAReS trial involves key academic partners. The interim data was presented by Professor Barry Laird, who is the Chief Investigator in CAReS and is affiliated with Oslo University Hospital - Radium Hospital and the University of Oslo, Norway. This trial is designed to determine estimates of activity for ART27.13 in terms of weight gain, lean body mass, and improvement of anorexia compared to placebo.

The interim results from the CAReS trial showed compelling efficacy for the highest dose group:

• Mean weight gain after 12 weeks: +6.38% versus an average loss of -5.42% on placebo.
• Lean body mass increase at one month: +4.23% versus a loss of -3.15% in the placebo arm.
• The study included patients who had lost at least 5% of body weight.

The Phase 1 portion of the CAReS study involved ART27.13 in cancer patients, where it demonstrated an excellent safety profile.

Contract Research Organizations (CROs) for managing clinical trials globally

While specific Contract Research Organizations (CROs) are not named in the latest updates, the scale of the ongoing clinical work implies reliance on these external management services. The Phase 2 CAReS trial had 15 clinical sites open as of June 20, 2025. Furthermore, the Phase 1 Single Ascending Dose (SAD) study for ART26.12 involved 49 healthy volunteers.

The operational spend reflects this activity; Research and Development (R&D) expenses for the quarter ended June 30, 2025, were $1.9 million.

Regulatory bodies like the FDA and UK's MHRA for clinical guidance

Engagement with regulatory bodies shapes the development timelines and protocols for Artelo Biosciences, Inc.'s candidates. The company has a history of interaction with both the FDA and the UK's MHRA.

Key regulatory milestones and guidance include:

Changes in regulatory requirements or guidance may necessitate amendments to clinical trial protocols or the overall development plan. The company is also advancing ART26.12 toward a Multiple Ascending Dose (MAD) study planned to start in Q4 2025.

Artelo Biosciences, Inc. (ARTL) - Canvas Business Model: Key Activities

You're hiring before product-market fit, so the key activities revolve around proving the science and keeping the lights on. For Artelo Biosciences, Inc. (ARTL), this means intense clinical execution and constant capital management.

Conducting and Advancing Clinical Trials

The core activity is pushing the pipeline through human testing. For ART27.13, the focus was on the Phase 2 Cancer Appetite Recovery Study (CAReS) for cancer-related anorexia. Interim Phase 2 data, which was anticipated in Q3 2025, showed that patients receiving up to $\mathbf{1300}$ micrograms daily on average gained over $\mathbf{6\%}$ in weight compared to placebo participants losing an additional $\mathbf{5\%}$. Furthermore, treated patients showed improvements in lean body mass of $\mathbf{+4.23\%}$ at one month. This drug is being developed as a once-daily, orally administered treatment.

For ART26.12, the Fatty Acid Binding Protein 5 (FABP5) inhibitor, the key activity involved completing the Phase 1 Single Ascending Dose (SAD) study in $\mathbf{49}$ healthy volunteers. This study tested single doses up to $\mathbf{1050}$ milligrams. Following this, the Multiple Ascending Dose (MAD) study protocol was being finalized, with initiation planned for Q4 2025.

Key clinical trial milestones achieved or planned:

• ART27.13 Phase 2 CAReS trial interim data reported in Q3 2025.
• ART26.12 Phase 1 SAD study completed in healthy volunteers.
• ART26.12 MAD study protocol finalization underway for Q4 2025 start.
• ART27.13 Phase 1 trial previously involved over $\mathbf{250}$ participants.

Research and Development of Novel Lipid-Signaling Pathway Therapeutics

Artelo Biosciences, Inc. (ARTL) is fundamentally an R&D engine focused on modulating lipid-signaling pathways. This activity is reflected directly in the operational expenses. Research and development expenses for the quarter ended September 30, 2025, were $\mathbf{\$1.3}$ million, a significant increase from $\mathbf{\$0.3}$ million in the same period of 2024. For context, R&D expenses in the preceding quarter (Q2 2025) were $\mathbf{\$1.9}$ million. The company is also advancing ART12.11, with human clinical studies planned for the second half of 2025.

Securing and Maintaining Intellectual Property (IP) Protection

Protecting the science is crucial for future monetization. A major IP activity involved ART27.13, where the European Patent Office (EPO) issued a Notice of Allowance for the patent application covering the intended commercial formulation. This patent protection is expected to extend through December 2041. The allowed claims cover compositions of ART27.13 dispersed in polyethylene glycol.

Raising Capital Through Public Offerings and Private Placements

Given the clinical stage, continuous financing is a necessary key activity. As of September 30, 2025, Artelo Biosciences, Inc. (ARTL) held $\mathbf{\$1.7}$ million in cash and investments, while reporting a net loss of $\mathbf{\$3.1}$ million for Q3 2025, or $\mathbf{\$3.97}$ per basic and diluted common share. The company executed several financing events in 2025 to support operations and development.

Here's a look at the capital raised through the second half of 2025:

The October 2025 offering involved selling $\mathbf{441,210}$ shares of common stock at $\mathbf{\$4.40}$ per share and pre-funded warrants. The company also entered an ATM agreement in July 2025 allowing for the sale of up to $\mathbf{\$6.5}$ million of common stock. The net proceeds from the October offering are intended for advancing product candidates through development, including clinical studies.

Artelo Biosciences, Inc. (ARTL) - Canvas Business Model: Key Resources

You're looking at the core assets Artelo Biosciences, Inc. (ARTL) relies on to execute its strategy, which centers on modulating lipid-signaling pathways. These aren't just ideas; they are tangible, protected, and quantified resources as of late 2025.

The most critical tangible assets are the wholly owned, proprietary drug candidates, each targeting significant, often underserved, medical needs. Here's a snapshot of the lead programs and their associated intellectual property status, which is the bedrock of future revenue potential.

Intellectual property forms a major protective moat around these assets. Specifically, the composition of matter and use patent for ART12.11, the CBD:TMP cocrystal, is enforceable until December 10, 2038. This patent protection, validated in the US and granted or validated in 19 additional countries as of July 2025, is a key differentiator for this novel CBD pharmaceutical composition.

Beyond the lead candidates, Artelo Biosciences, Inc. possesses an extensive library of selective Fatty Acid Binding Protein (FABP) inhibitors. This library represents significant discovery potential, as ART26.12, the first selective FABP5 inhibitor from this collection to enter clinical trials, has already shown promise. The depth of this library is a resource for future pipeline expansion.

• Extensive library of selective Fatty Acid Binding Protein (FABP) inhibitors.
• ART26.12 is the first candidate from this library to enter clinical trials.
• The library supports development across multiple therapeutic areas, including oncology and inflammatory diseases.

Financially, the company's immediate operational capacity is tied to its liquidity position. You need to know the latest cash on hand to gauge runway and financing needs. Here is the hard number from the Q3 2025 report.

• Cash and investments totaled $1.7 million as of September 30, 2025.
• This figure follows the sale of common stock for gross proceeds of $0.4 million during the quarter ended September 30, 2025, under an At-The-Market Offering Agreement that allows for up to $6.5 million in sales.

The net loss for the quarter ending September 30, 2025, was $3.1 million. Finance: draft 13-week cash view by Friday.

Artelo Biosciences, Inc. (ARTL) - Canvas Business Model: Value Propositions

You're looking at the core value Artelo Biosciences, Inc. (ARTL) brings to the table right now, late in 2025. It's all about novel mechanisms targeting areas where current options just aren't cutting it.

Novel, non-opioid, non-steroidal analgesic for chronic pain (ART26.12)

ART26.12 is positioned as the first orally active Fatty Acid Binding Protein 5 (FABP5) inhibitor evaluated in humans. This novel approach targets the multibillion-dollar pain management market, which exceeded $97 billion globally in 2023 and is projected to hit $159 billion by 2030. The initial Phase 1 Single Ascending Dose (SAD) study involved 49 healthy volunteers, successfully testing single doses up to 1050 milligrams. The next step, a Multiple Ascending Dose (MAD) study protocol, is being finalized, with plans to start in Q4 2025. Initial clinical development is aimed at chemotherapy-induced peripheral neuropathy (CIPN), for which there is currently no FDA-approved treatment.

Here's a quick look at the clinical progression for ART26.12:

First-in-class treatment potential for cancer anorexia-cachexia syndrome (ART27.13)

ART27.13, a peripherally acting cannabinoid receptor agonist, addresses cancer anorexia-cachexia syndrome (CACS), a condition affecting up to 80% of cancer patients and lacking any FDA-approved therapy. The drug has been in seven clinical studies involving over 280 participants. Artelo Biosciences is expecting initial data from the Phase 2 CAReS trial in Q3 2025. Interim Phase 2 results showed compelling efficacy: patients on the top dose achieved an average +6.4% weight gain compared to placebo participants losing an additional 5%. Furthermore, these patients showed a +4.2% increase in lean body mass. The company believes this data positions them well to secure a development partner, avoiding the need to internally fund a Phase 3 trial.

Improved pharmacokinetics and efficacy via proprietary CBD cocrystal (ART12.11)

ART12.11 is Artelo Biosciences' proprietary cannabidiol:tetramethylpyrazine (CBD:TMP) cocrystal. Preclinical studies demonstrated that ART12.11 significantly outperformed standard cannabidiol (CBD) alone in reducing stress-induced depression and anxiety symptoms. A key value driver is its improved oral bioavailability, leading to higher plasma concentrations of CBD and its metabolite compared to conventional CBD formulations. Tablet prototypes have been evaluated, each containing 100mg of CBD, with the potential to increase drug loading. The US composition of matter patent for ART12.11 is enforceable until December 10, 2038, and has been granted or validated in 19 additional countries. For context, the FDA-approved CBD therapy, Epidiolex®, reported net sales over $845 million in 2023.

The advantages of ART12.11 over standard CBD include:

• Superior oral bioavailability demonstrated in studies.
• Robust antidepressant and anxiolytic-like effects in animals.
• Comparable pharmacokinetics to Epidiolex® in canine studies.
• Potential for a solid dosage form, improving stability and adherence.
• Patent protection extending until December 10, 2038.

Addressing large, underserved markets with high unmet medical need

Artelo Biosciences is focused on three main areas, all characterized by significant unmet needs. The company reported a net loss of $3.1 million for the quarter ended September 30, 2025, reflecting the heavy investment required to advance these novel candidates. Cash and investments stood at $1.7 million as of September 30, 2025, following a September 2025 public offering that brought in gross proceeds of $3.0 million to support these clinical objectives.

The pipeline targets these large markets:

• Chronic Pain: Non-opioid, non-steroidal analgesic potential.
• Cancer Supportive Care: CACS, which currently has no FDA-approved treatment.
• Neurological/Mood: Depression and anxiety, addressing limitations of conventional CBD.

Analyst consensus suggests a significant upside, with the average twelve-month price target at $24.00, representing a forecasted upside of 1,287.28% from the current price of $1.73. Finance: draft 13-week cash view by Friday.

Artelo Biosciences, Inc. (ARTL) - Canvas Business Model: Customer Relationships

You're looking at how Artelo Biosciences, Inc. (ARTL) manages its connections with the key groups that drive its clinical and financial success. For a clinical-stage pharma company, these relationships are about scientific validation and securing future funding or partnerships.

Direct, high-touch engagement with potential pharmaceutical partners

Artelo Biosciences, Inc. focuses its direct engagement on securing strategic alliances, which is critical given its clinical-stage status. The company reports that the positive interim Phase 2 data for ART27.13 has attracted meaningful partnering interest from several pharmaceutical companies. Also, partnering interest continues to expand for ART26.12, the lead Fatty Acid Binding Protein 5 (FABP5) inhibitor. This suggests direct, high-touch interactions are centered around data readouts and pipeline progress.

Scientific communication via presentations at medical conferences

Scientific communication is a primary method for engaging the medical and research community, which indirectly influences potential partners and KOLs. Artelo Biosciences, Inc. actively presented data throughout 2025 at several key events:

• Presented interim Phase 2 Cancer Appetite Recovery Study (CAReS) data on ART27.13 at the 2025 Cancer Cachexia Society Conference.
• Presented expanded data on ART26.12 and ART27.13 at the 8th Annual Cannabinoid & Endocannabinoid Drug Development Summit on October 15-16, 2025, in Boston, Massachusetts.
• Presented data on ART12.11 at the International Medical Cannabis Conference (IMCCB-25) in Bern, Switzerland on February 13-14, 2025.
• Presented new data validating ART26.12 in osteoarthritis at the British Pain Society Conference.

Furthermore, the company reinforced its scientific standing with the publication of a peer-reviewed article on the Role of Fatty Acid Binding Proteins in Cancer on November 4, 2025.

Investor relations and transparent financial reporting

Investor relations centers on providing timely and detailed financial updates to maintain confidence, especially during periods of high research and development (R&D) spending. Artelo Biosciences, Inc. reported its Third Quarter 2025 Financial Results on November 12, 2025. The company also provided a stock snapshot as of November 21, 2025, at 16 PM EST, showing a price of $1.67 and a 52-week range of $1.552 - $28.60. You can see the key financial figures from the Q3 2025 report below:

The company actively engaged in capital raising to support operations. During the quarter ended September 30, 2025, Artelo Biosciences, Inc. generated $0.4 million from its At-The-Market Offering Agreement and $3.0 million from a confidentially marketed public offering in September 2025. Separately, the company raised $737,000 from convertible notes.

Relationships with key opinion leaders (KOLs) and clinical researchers

The credibility of the science is often tied directly to the experts involved. Professor Saoirse O'Sullivan, Vice President of Translational Sciences at Artelo Biosciences, Inc., is noted as a presenter of key data, indicating a strong internal scientific leadership that interfaces with the external research community. The company states it is 'led by proven biopharmaceutical executives collaborating with highly respected researchers and technology experts.' The interim Phase 2 results for ART27.13, showing an average +6.4% weight gain versus a -5.4% loss on placebo, and a +4.2% lean body mass increase, are the direct output of these clinical researcher relationships.

Here's a quick look at the clinical data points driving these relationships:

• ART27.13 top dose achieved +6.4% average weight gain (vs. placebo -5.4% loss) in CAReS Phase 2.
• ART26.12 Single Ascending Dose (SAD) study involved 49 healthy volunteers.
• ART26.12 SAD study demonstrated single doses up to 1050 milligrams were safe.

Finance: draft 13-week cash view by Friday.

Artelo Biosciences, Inc. (ARTL) - Canvas Business Model: Channels

You're looking at how Artelo Biosciences, Inc. (ARTL) gets its science and its financing out into the world as of late 2025. It's a mix of traditional pharma outreach and some quite modern capital strategies.

Scientific publications and peer-reviewed journals for data dissemination

Disseminating data through established scientific channels is key for credibility. Artelo Biosciences announced the publication of a peer-reviewed article on the Role of Fatty Acid Binding Proteins in Cancer on November 4, 2025. Also, a comprehensive review detailing the involvement of fatty acid binding proteins in anxiety and mood disorders was published in Neurobiology of Disease. Further, preclinical data supporting ART12.11 in reducing stress-induced depression and anxiety symptoms was announced as published on September 10, 2025.

• Publication in Neurobiology of Disease for FABP inhibitors.
• Peer-reviewed article on FABP in Cancer announced November 4, 2025.
• Preclinical data publication for ART12.11 announced September 10, 2025.

Direct business development outreach to potential pharma acquirers/licensees

The primary channel for monetization right now is attracting partners for late-stage development or acquisition. The interim Phase 2 Cancer Appetite Recovery Study (CAReS) data for ART27.13 has definitely moved the needle here. That data showed the highest dose group achieved an average +6.4% weight gain versus a -5.4% loss in the placebo group, along with a 4.2% increase in lean body mass. This efficacy profile has attracted meaningful partnering interest from several pharmaceutical companies. Also, partnering interest continues to expand for ART26.12, the lead FABP5 inhibitor.

Investor roadshows and digital communications for capital markets

To fund the pipeline, Artelo Biosciences has been very active in capital markets, using both traditional and novel methods. They closed a public offering on October 1, 2025, raising gross proceeds of approximately $2.0 million. This followed a September offering that secured approximately $3.0 million in gross proceeds. The company also executed a significant private placement in August 2025, expecting gross proceeds of about $9.475 million at a price of $10.45 per security. The total cash and investments as of September 30, 2025, stood at $1.7 million. The stock was recently trading around $1.67. Here's a quick look at the capital activity around the Q3 2025 reporting period:

They use digital communications, like the November 2025 Investor Presentation, to keep the market informed.

Clinical trial sites for drug development and patient access

The clinical sites are where the rubber meets the road for Artelo Biosciences, Inc. (ARTL). The Phase 1 Single Ascending Dose (SAD) study for ART26.12 was completed in 49 healthy volunteers. The next step, the Multiple Ascending Dose (MAD) study, is being finalized with protocols for a Q4 2025 start. For ART27.13, the Phase 2 CAReS trial is the key channel for generating efficacy data, showing that 6.4% average weight gain in the top dose group. The operational spend reflects this: Research and Development Expenses increased to $1.3 million for the quarter ended September 30, 2025, up from $0.3 million in Q3 2024.

You need to track the progress of these trials closely; here's the data we have on the clinical channel status:

Finance: draft 13-week cash view by Friday.

Artelo Biosciences, Inc. (ARTL) - Canvas Business Model: Customer Segments

You're looking at the customer segments for Artelo Biosciences, Inc. (ARTL) as of late 2025. This company is focused on modulating lipid-signaling pathways, which means their customer base is segmented by the specific, high-unmet-need conditions their pipeline candidates are targeting. Honestly, the near-term focus is heavily weighted toward securing a partner for their most advanced asset, ART27.13, given their cash position of $1.7 million as of September 30, 2025.

The customer segments fall into two main groups: the ultimate end-users (patients) and the strategic partners (pharma/biotech companies) who will help bring the therapies to those patients.

For the patients, Artelo Biosciences, Inc. is targeting several distinct, underserved populations:

• Patients with cancer anorexia-cachexia syndrome (CACS).
• Patients suffering from chemotherapy-induced peripheral neuropathy (CIPN).
• Patients with chronic pain, including those with conditions like osteoarthritis.
• Patients with anxiety, mood, and dermatologic disorders, such as psoriasis.

The other critical segment is the corporate one. Artelo Biosciences, Inc. is actively seeking to engage with global pharmaceutical and biotech companies seeking late-stage assets, especially for ART27.13, following positive interim Phase 2 data. This partnering strategy is viewed as the most value-accretive path forward, potentially avoiding the need for Artelo Biosciences, Inc. to internally fund a Phase 3 trial.

Here's a breakdown of the key indications and the associated product candidates, which directly defines the patient customer segments and the market opportunity you should be tracking:

You should note that the CACS patient population is quite large; the condition affects up to 80% of patients with advanced cancer. For the corporate segment, the interest from multiple pharmaceutical companies in ART27.13 suggests a strong validation of the data package Artelo Biosciences, Inc. has generated so far.

Also, consider the intellectual property protection for ART27.13, as this directly impacts the value proposition to potential partners: the European Patent Office issued a Notice of Allowance for the intended commercial formulation through 2041. That's a long runway for a potential partner to plan around.

Artelo Biosciences, Inc. (ARTL) - Canvas Business Model: Cost Structure

You're looking at the core expenditures Artelo Biosciences, Inc. (ARTL) faces to keep its clinical pipeline moving forward as of late 2025. These costs are typical for a clinical-stage biopharma company heavily reliant on external funding.

The cost structure is dominated by the clinical and operational spend required to advance its therapeutic candidates.

• Heavy Research and Development (R&D) expenses, which were $1.3 million in Q3 2025.
• General and Administrative (G&A) costs, totaling $1.8 million in Q3 2025.
• Costs associated with intellectual property protection and maintenance, which are factored into the overall operating expenses, including the potential cost of defending intellectual property disputes.
• Capital raising costs, including professional fees associated with efforts that generated gross proceeds of $3.4 million in Q3 2025 through an At-The-Market Offering Agreement and a confidentially marketed public offering.

The increase in operating expenses for the quarter ended September 30, 2025, was primarily the result of increases in professional fees associated with capital raising efforts and increases in research and development expenditures related to clinical programs. Finance: draft 13-week cash view by Friday.

Artelo Biosciences, Inc. (ARTL) - Canvas Business Model: Revenue Streams

You're looking at the revenue side for Artelo Biosciences, Inc. (ARTL) as of late 2025, and honestly, it's what you expect from a company deep in clinical development. The model is almost entirely reliant on external capital right now, not product sales.

Currently $0.000 in product revenue, typical for a clinical-stage biotech. That zero reflects the focus on advancing the pipeline through trials rather than commercialization.

The primary, immediate revenue driver is capital markets activity. You saw proceeds from equity financing, such as the $3.0 million public offering completed in September 2025. That offering consisted of common stock and pre-funded warrants.

Here's a quick look at the capital raised through financing activities reported around the Q3 2025 period to fund the R&D expenses, which were $1.3 million for the quarter:

Future milestones and royalty payments from out-licensing agreements represent the potential, non-dilutive revenue stream. While Artelo Biosciences is actively seeking partners, specific dollar amounts tied to future milestones or royalties aren't locked in yet, but that's definitely the goal for long-term sustainability.

Also critical to the cash runway was the capital raised via the At-The-Market (ATM) offering, which generated $0.4 million in gross proceeds during Q3 2025. This ATM program allows the company to sell shares opportunistically.

To be fair, the financing picture for the first nine months of 2025 shows a broader reliance on capital markets to bridge the gap:

• Total equity raised through various issuances in the first nine months of 2025 was $4.39 million.
• Capital secured via convertible notes totaled $0.74 million for the same nine-month period.
• An additional $0.13 million came from warrant exercises year-to-date.