ZIVO Bioscience, Inc. (ZIVO): SWOT Analysis [Nov-2025 Updated]

You're looking at ZIVO Bioscience, Inc. (ZIVO), and the picture is one of high-stakes biotech: a proprietary, scalable algae platform with compelling animal health data, but an immediate, existential liquidity crisis. Honestly, the science is defintely there, but the balance sheet is screaming for attention. As of September 30, 2025, ZIVO reported cash of only $57,222, yet they need an estimated $6.0 million just to operate over the next 12 months. This isn't a growth story yet; it's a race against the clock where a major licensing deal or capital raise is the only thing standing between a game-changing ingredient and a going concern collapse.

ZIVO Bioscience, Inc. (ZIVO) - SWOT Analysis: Strengths

Proprietary, non-GMO algae strain with broad IP protection.

ZIVO's primary strength is its proprietary microalgae culture, which forms the foundation of its entire business model. This non-genetically modified organism (non-GMO) strain is the subject of a comprehensive intellectual property (IP) portfolio, which includes the strain itself, the patented cultivation process, and the specific bioactive molecules derived from it.

This IP strategy is defintely broad, covering both the nutritional and therapeutic applications. For example, a patent application filed in January 2025 and published in June 2025 specifically covers an algal biomass used in poultry feed to reverse the detrimental effects of coccidiosis and necrotic enteritis. The company's IP extends to methods for immune priming and cytokine modulation, which is a big deal for treating inflammation in animals like cows and dogs.

Here's a quick look at the IP focus:

• Patented cultivation process for the proprietary algae culture.
• Patented or patent-pending inventions for production techniques and bioactive molecules.
• IP covers both human and animal health applications.

Algae biomass offers a sustainable, plant-based protein with a bland taste, improving market adoption.

The nutritional profile of ZIVO's dried algal biomass is a significant market advantage, especially its flavor. Unlike many other commercial microalgae strains, the ZIVO product is almost completely odorless and tasteless, or has a mild taste, which dramatically improves its potential for rapid consumer acceptance in food and supplement formulations.

This biomass is a highly potent plant-based protein source. The powdered form contains approximately 45% pure protein and 26% fiber. Plus, it's already cleared for the U.S. market, having completed the FDA's self-affirmed GRAS (Generally Recognized As Safe) process for use as a human food ingredient and dietary supplement.

The sustainability angle is also a huge selling point in the current market. The energy efficiency of ZIVO's cultivation is compelling:

• Energy efficiency is five times higher than soy.
• Energy efficiency is over 100 times higher than grain-fed beef.

Promising pre-clinical data for animal health applications like coccidiosis and avian influenza mitigation.

The therapeutic pipeline, focused on animal health, is showing strong, concrete results. The company's non-antibiotic, immune-modulating compounds have demonstrated efficacy against major poultry diseases, which is critical given the industry's push to reduce antibiotic use.

For coccidiosis, a parasitic disease that cost the global poultry industry an estimated $1.1 billion in 2024 for control measures, a 42-day confirmatory study in August 2024 yielded favorable results. Broiler chickens treated with ZIVO's product in combination with an ionophore or vaccine showed statistically significant improvements in growth performance (Feed Conversion Ratio, FCR) and clinical signs of disease, performing on par with healthy, uninfected control birds. That's a huge win for a non-antibiotic solution.

In the fight against avian influenza (specifically Low Pathogenicity Avian Influenza, LPAI), preliminary data from a December 2024 study showed a reduction in viral titers (viral shedding) in infected birds. More importantly, there was a statistically significant delay in viral transmission to healthy birds exposed to the treated infected group, suggesting the product can limit the spread of the virus.

The company is already advancing commercialization, with a major global animal health company initiating a confirmatory coccidiosis study in June 2025.

Low-cost, scalable cultivation technology avoids complex bioreactors.

ZIVO has cracked the code on cost-efficient production, which is essential for scaling a commodity-like ingredient. They avoid the expensive, complex infrastructure of traditional microalgae production, such as fermentation systems, photo-bioreactors, panels, and tubes.

Instead, they use a low-complexity model: covered, shallow ponds built from inexpensive, readily-available materials. This simple, phototrophic (sunlight-driven) process is much more affordable and can be duplicated easily in warm, temperate regions globally. The algae strain itself is robust and grows aggressively, leading to better-than-average production yields.

This scalable approach is translating directly into commercial capacity. A facility with their partner, Alimenta Algae, is being repurposed and is anticipated to be fully operational in the second or third quarter of 2025, with a projected capacity to produce up to 100,000 kilograms of dried product per year. Critically, ZWorldwide has already committed to purchasing at least 24,000 kilograms per year for a minimum of five years, securing a substantial portion of the initial output.

Here's the quick math on the 2024 revenue, just to ground the current scale:

The current revenue is small, but the strength is the production plan and the locked-in purchase commitment, which points to a clear path for revenue growth starting in late 2025. Finance: track the 2025 Q3/Q4 revenue against the 24,000 kg purchase commitment.

ZIVO Bioscience, Inc. (ZIVO) - SWOT Analysis: Weaknesses

Critical Liquidity Issue with Minimal Cash Position

You are looking at a company with a dangerously thin cash cushion. As of September 30, 2025, ZIVO Bioscience, Inc.'s cash on hand was a mere $57,222. To put that into perspective, this is a dramatic drop from the $1,542,442 the company held just nine months earlier, at the end of December 2024. This kind of burn rate, where operating activities used $(2,173,204) in cash during the first nine months of 2025, means the company is perpetually on the clock to secure new funding. It's a high-stakes, day-to-day liquidity challenge.

Substantial Doubt About Continuing as a Going Concern

The most serious weakness is the formal acknowledgment of 'substantial doubt about the ability to continue as a going concern.' This isn't just a technical term; it's a stark warning that the company's recurring losses and negative cash flows raise fundamental questions about its operational viability over the next year. Management estimates they need at least $6.0 million in additional capital over the next 12 months to fund their operations. Failing to raise this capital means they may have to significantly curtail or even cease business operations.

Minimal Revenue Against a Significant Net Loss

The gap between ZIVO's sales and its operating costs is massive and unsustainable in the near term. For the first nine months of the 2025 fiscal year, the company generated only $119,025 in total revenue. Compare this to the net loss for that same period, which was a staggering $(6,884,474). Here's the quick math: for every dollar of revenue brought in, the company lost approximately $57.84. That's a research and development cost structure far exceeding sales capacity right now.

The financial disparity is clear when you look at the operating results for the first nine months of 2025:

• Total Revenue: $119,025
• Net Loss: $(6,884,474)
• Net Cash Used in Operations: $(2,173,204)

Total Liabilities Significantly Exceed Total Current Assets

The company's balance sheet shows a critical current ratio problem, indicating a major short-term solvency risk. As of September 30, 2025, ZIVO Bioscience's total liabilities stood at $3,846,055. This is a substantial burden, especially when measured against total current assets of just $281,399. This means the company has a negative working capital position, a classic sign of severe financial distress.

The liabilities are growing, too. Total liabilities increased from $2,158,020 at the end of 2024 to $3,846,055 by September 30, 2025, a jump of nearly 78%. A significant portion of this increase is in current liabilities, which rose to $3,614,268.

Persistent Material Weaknesses in Internal Control Over Financial Reporting (ICFR)

Beyond the financial numbers, there is a persistent structural weakness in the company's financial processes. ZIVO Bioscience has previously reported material weaknesses in its internal control over financial reporting (ICFR). These are deficiencies, or a combination of them, that create a reasonable possibility that a material misstatement in the financial statements won't be prevented or detected on a timely basis. The weaknesses identified as of December 31, 2023, were noted as continuing to exist as of June 30, 2024. This continued lack of effective controls is a red flag for investors and can lead to increased audit fees and a higher cost of debt capital. You defintely need to see a clear remediation plan here.

ZIVO Bioscience, Inc. (ZIVO) - SWOT Analysis: Opportunities

Finalizing a licensing deal for coccidiosis treatment with a major global animal health company

The most immediate and material opportunity for ZIVO Bioscience is securing a definitive licensing agreement for its non-antibiotic coccidiosis treatment. You're sitting on a potential breakthrough here, as the global poultry industry has been relying on decades-old compounds for too long. The market is huge, with the global poultry industry spending an estimated $1.1 billion in 2024 on coccidiosis control, a figure projected to grow to $1.5 billion by 2029.

ZIVO's product, which showed positive results in a 42-day study, acts as an immune-modulator and can be used alone or to enhance existing ionophores and vaccines. The company expected to finalize an agreement with a major global animal health company in the first quarter of 2025, with deal terms likely including an upfront payment, commercial milestones, and a sales royalty. Since then, as of mid-2025, ZIVO and a leading partner executed agreements for further validation studies, which is a strong signal that the commercial agreement is the next logical step. That's a clear path to high-margin revenue.

• Targeting a $1.5 billion global coccidiosis control market by 2029.
• Product is non-antibiotic, meeting consumer and industry demand for alternatives.
• Licensing model provides immediate cash (upfront payment) and long-term royalties.

Expanding the platform into high-value human applications like immune modulation and joint health

The proprietary algae platform isn't just for chickens; it has a significant, high-margin future in human health as a functional food ingredient and potential medical food. Your focus on immune modulation and joint health taps directly into multi-billion-dollar markets.

The company's algae-derived product is a powerful natural source of antioxidants, beta-carotene, and lutein, positioning it strongly in the nutraceutical space. As of September 2025, ZIVO was in active discussions with major nutraceutical clients, anticipating commercial commitments that will materially increase human health revenues. The potential medicinal applications, based on the novel polysaccharide molecular complex, are enormous, with the global rheumatoid arthritis market alone being valued at over $25.0 billion.

Global push for antibiotic-free livestock production creates a huge market for their immune-enhancing compounds

The regulatory and consumer shift away from antibiotics in livestock is a massive tailwind, not a gentle breeze. Your non-antibiotic, immune-enhancing compounds are perfectly timed to capture market share in this trend.

The global antibiotic-free meat market is a behemoth, growing from $167.39 billion in 2024 to an estimated $182.39 billion in 2025, representing a compound annual growth rate (CAGR) of 9.0%. This demand for healthier, safer animal products is pushing farmers toward alternatives like probiotics, where the global animal feed probiotics market was valued at $248.3 million in 2024. Your product offers a scientifically validated solution that maintains animal productivity, which is the key metric for adoption.

Honestly, the convergence of regulatory pressure, consumer preference, and your validated science creates an exceptional market opportunity.

Production capacity expansion to up to 100,000 kilograms annually via the Alimenta Algae partnership, expected operational in mid-2025

All the R&D and licensing deals mean nothing without product to sell. The expansion of cultivation capacity through the partnership with Alimenta Algae is a critical step in moving from R&D to commercial-scale revenue.

The repurposing of the facility in Peru is expected to ramp up production to a capacity of up to 100,000 kilograms of dried product per year. This capacity was anticipated to be fully operational in the second or third quarter of 2025. Here's the quick math: the North American distributor, ZWorldwide, has already committed to purchasing a minimum of 24,000 kilograms annually for five years, covering the first 18 months of total supply. Scaling up production is defintely the next major bottleneck to solve for significant revenue growth in 2026.

• Capacity expansion to 100,000 kilograms annually in mid-2025.
• Secured minimum purchase commitment of 24,000 kilograms per year from ZWorldwide.
• Low-cost, low-complexity cultivation model is highly scalable globally.

ZIVO Bioscience, Inc. (ZIVO) - SWOT Analysis: Threats

You're looking at ZIVO Bioscience, Inc. and the immediate threats are starkly financial and regulatory, not just competitive. The company's extremely limited liquidity and reliance on capital markets create an existential risk, while the slow, complex path to regulatory approval for their core product delays any meaningful revenue. Simply put, the biggest threat is running out of cash before the New Dietary Ingredient (NDI) status comes through.

Failure to secure the estimated $6.0 million in funding will force curtailment or cessation of operations.

The most pressing threat is ZIVO's precarious financial position, which management itself has flagged as creating 'substantial doubt about the ability to continue as a going concern.' As of September 30, 2025, the company reported having minimal cash on hand, just $\mathbf{\$57,222}$, against total liabilities of $\mathbf{\$3,846,055}$. This is a critically tight liquidity position.

Management estimates they need at least $\mathbf{\$6.0 \text{ million}}$ over the next 12 months to fund basic operations, which is a massive gap considering their cash burn. For the first nine months of 2025, the net cash used in operating activities was $\mathbf{\$2,173,204}$, meaning they are burning through capital at a rate far exceeding current revenue generation. If they defintely cannot secure this funding, the result is a forced curtailment of research and development, or worse, a complete cessation of operations.

• Cash on Hand (Q3 2025): \$57,222
• Estimated 12-Month Funding Need: \$6.0 million
• Net Cash Used in Operations (9M 2025): \$2,173,204

Regulatory risk and time-to-market delays for New Dietary Ingredient (NDI) status with the FDA.

ZIVO is relying on its proprietary algae-derived compound to enter the lucrative human nutrition market, but this requires New Dietary Ingredient (NDI) status from the U.S. Food and Drug Administration (FDA). The NDI notification process itself requires a submission at least 75 days before marketing, and the FDA's review involves scientific and policy evaluations. Any request for clarification or additional data from the FDA-a common occurrence-can significantly extend this timeline, pushing out the commercial launch and delaying the revenue stream the company desperately needs.

The risk here is one of timing. Given the $\mathbf{\$6.0 \text{ million}}$ funding gap, every month of regulatory delay is another month the company must finance its burn rate through dilutive means or risk insolvency. This regulatory hurdle, while standard, is a major bottleneck for a company with minimal liquidity.

Dilution risk from ongoing financing activities, including the issuance of convertible notes and warrants.

To keep the lights on and fund operations, ZIVO has been consistently using dilutive financing instruments. This is the trade-off for survival, but it severely erodes shareholder value. The number of outstanding shares was $\mathbf{3,888,595}$ as of November 9, 2025, but the potential future dilution is far greater.

Here's the quick math on the overhang: the company has a substantial number of securities that can be converted into common stock, significantly increasing the share count and lowering the value of existing shares.

The $\mathbf{49,341,861}$ shares issuable from warrants alone, at a low weighted average exercise price of $\mathbf{\$0.66}$, represent a massive potential dilution, dramatically overshadowing the current outstanding share count and creating a significant headwind for the stock price.

Intense competition from established biotech and agtech firms in the functional ingredient space.

ZIVO is competing for market share against large, established players, many of whom are already generating substantial revenue and profit. While ZIVO's nine-month revenue for 2025 was just $\mathbf{\$119,025}$, [cite: 2 from step 1] competitors are operating on a completely different scale. The global animal feed market alone was valued at $\mathbf{\$465.65 \text{ billion}}$ in 2024. [cite: 8 from step 1]

For example, Advanced Enzyme Technologies, a competitor in the enzyme and functional ingredient space, reported revenue of approximately $\mathbf{\$23.5 \text{ million}}$ (₹194.81 crore) and a net profit of approximately $\mathbf{\$5.4 \text{ million}}$ (₹44.74 crore) in Q2 of its fiscal year 2026. Another competitor, Fermentalg, which also focuses on microalgae-based solutions, recorded unaudited revenue of $\mathbf{€7.6 \text{ million}}$ (approx. $\mathbf{\$8.2 \text{ million}}$) in the first half of 2025. These larger, profitable, or significantly higher-revenue competitors have the capital, infrastructure, and distribution channels that ZIVO is still trying to build, making the path to market share exceptionally difficult.