CNBX Pivots to Cannabinoid Cancer Drugs, Eyes 2026 Clinical Trials

TL;DR

**CNBX is a speculative bet on cannabinoid cancer drugs, with 2026 clinical trials as the next major catalyst, but significant funding hurdles remain.**

AI Summary

CNBX Pharmaceuticals Inc., a clinical-stage company, reported no meaningful revenue from oil and gas exploration, leading to a business model transition in 2014 to focus on cannabinoid-based cancer treatments. The company's lead product candidates are Cannabics SR for Cancer Anorexia Cachexia Syndrome (CACS) and RCC-33 for Colorectal Cancer (CRC). Cannabics SR showed promising results in a peer-reviewed pilot study for CACS, justifying a larger clinical study. RCC-33 is being developed as a first-in-class therapy to reduce tumor cell activity in CRC patients. CNBX plans to initiate Phase I/II clinical trials for both candidates in 2026, contingent on fundraising. The company's strategy involves drug discovery, intellectual property protection, and navigating regulatory pathways, aiming for commercial agreements with larger pharmaceutical corporations after demonstrating initial feasibility in humans. The company's market value of common stock held by non-affiliates was $251,840 as of February 28, 2025, with 553,962,206 shares outstanding as of November 20, 2025.

Why It Matters

CNBX's shift from mining to cannabinoid-based cancer therapies represents a high-risk, high-reward bet in the competitive biotech sector. For investors, the success of Cannabics SR and RCC-33 in clinical trials could unlock significant value, but failure would be detrimental given the company's current lack of revenue and reliance on future financing. Employees and customers could benefit from novel treatments for CACS and CRC, addressing significant unmet medical needs where current therapies like megestrol have limitations. The broader market will watch to see if cannabinoid-based drugs can gain further FDA approval, potentially validating a new class of therapeutics and intensifying competition with established oncology players.

Risk Assessment

Risk Level: high — The company explicitly states it does not engage in manufacturing, distribution, or sales, and does not foresee doing so in the near future, indicating a complete reliance on future partnerships or acquisitions. Furthermore, the initiation of Phase I/II clinical trials for Cannabics SR and RCC-33 in 2026 is explicitly contingent 'Upon fundraising,' highlighting a critical financial dependency for its core business development.

Analyst Insight

Investors should approach CNBX with extreme caution, recognizing it as a highly speculative, pre-revenue clinical-stage company. Monitor closely for news regarding successful fundraising and the actual commencement of Phase I/II clinical trials in 2026, as these are critical milestones for any potential future value.

Financial Highlights

debt To Equity

Not Disclosed

revenue

$0

operating Margin

Not Disclosed

total Assets

Not Disclosed

total Debt

Not Disclosed

net Income

Not Disclosed

eps

Not Disclosed

gross Margin

Not Disclosed

cash Position

Not Disclosed

revenue Growth

N/A

Key Numbers

• $251,840 — Aggregate market value of Common Stock held by non-affiliates (as of February 28, 2025, based on $0.0076 closing price)
• 553,962,206 — Shares of Common Stock outstanding (as of November 20, 2025)
• 2014 — Year of business model transition (from mining to biotech)
• 2026 — Target year for Phase I/II clinical trials (for Cannabics SR and RCC-33, contingent on fundraising)
• 1:120 — Reverse stock split ratio (effected on May 12, 2022)
• 40-80% — Prevalence of CACS (estimated range from cancer diagnosis to advanced stages)
• 18,239,594 — Shares issued to Cannabics Inc. (to acquire institutional knowledge and R&D technology)
• $150,000 — Working funds tendered by Cannabics Inc. (earmarked for prospective projects)

Key Players & Entities

• CNBX Pharmaceuticals Inc. (company) — registrant
• Cannabics SR (company) — lead product candidate for CACS
• RCC-33 (company) — lead anti-neoplastic drug candidate for Colorectal Cancer
• Dr. Erez Scapa (person) — Expert in Invasive Gastroenterology, Scientific Board of Advisors
• Dr. Dana Ben-Ami Shor (person) — Scientific Board of Advisors
• Dr. Gil Bar-Sela (person) — Rambam Hospital Health Care Campus, conducted pilot study for Cannabics SR
• FDA (regulator) — regulatory pathway for drug candidates
• Nevada (regulator) — State of Incorporation
• Cannabics Inc. (company) — Delaware corporation, largest shareholder
• G.R.I.N Ultra Ltd (company) — wholly owned subsidiary in Israel

FAQ

Risk Factors

• Uncertainty of Cannabinoid Drug Approval [high — regulatory]: The development and commercialization of cannabinoid-based therapeutics face significant regulatory hurdles. The FDA and other global regulatory bodies have not yet established clear pathways for the approval of such drugs, creating uncertainty regarding the timeline and ultimate success of CNBX's product candidates, Cannabics SR and RCC-33.
• Dependence on Future Fundraising [high — financial]: CNBX is a clinical-stage company with no meaningful revenue and relies heavily on future fundraising to finance its operations and clinical trials. The company plans to initiate Phase I/II trials in 2026, contingent on securing additional capital, indicating a substantial financial risk if funding is not obtained.
• Limited Operating History and Track Record [medium — operational]: CNBX transitioned from an oil and gas exploration company to a biotech firm in 2014. This relatively short history in the pharmaceutical sector means the company has a limited track record in drug development, clinical trials, and commercialization, posing operational risks.
• Competition in Cancer Treatment Market [medium — market]: The oncology market is highly competitive, with numerous established pharmaceutical companies and emerging biotechs developing novel therapies. CNBX's success depends on demonstrating the superiority or unique benefits of its cannabinoid-based candidates against existing and pipeline treatments.
• Low Market Capitalization [high — financial]: As of February 28, 2025, the aggregate market value of CNBX's common stock held by non-affiliates was only $251,840. This low market capitalization may limit the company's ability to raise substantial capital through equity offerings and could impact its ability to attract partnerships.
• Intellectual Property Protection [medium — regulatory]: Protecting intellectual property is crucial for a drug development company. CNBX's strategy relies on IP protection, but the evolving landscape of cannabinoid research and patent law presents challenges in securing and maintaining robust patent protection for its novel therapies.
• Reliance on Third-Party Research and Development [low — operational]: While CNBX conducts R&D in a licensed facility in Israel, the company's acquisition of institutional knowledge and R&D technology from Cannabics Inc. (18,239,594 shares issued) suggests a degree of reliance on external expertise and infrastructure, which could pose operational risks if not managed effectively.

Industry Context

CNBX operates in the highly competitive and rapidly evolving oncology drug development sector. The company is focusing on cannabinoid-based therapies, a niche area with growing scientific interest but significant regulatory uncertainty. Key trends include the search for novel mechanisms of action to overcome treatment resistance and improve patient quality of life, particularly for symptom management like CACS. The industry is characterized by long development cycles, high R&D costs, and the need for substantial capital investment.

Regulatory Implications

The development of cannabinoid-based therapeutics faces significant regulatory hurdles, particularly from the FDA. CNBX must navigate complex and evolving guidelines for drug approval, which differ substantially from those for recreational or medicinal cannabis. Failure to secure regulatory approval for Cannabics SR and RCC-33 would severely impact the company's business model and future prospects.

What Investors Should Do

1. Monitor fundraising efforts closely.
2. Track regulatory developments in cannabinoid therapeutics.
3. Evaluate the scientific merit and clinical data from pilot studies.
4. Assess competitive landscape and potential partnerships.

Key Dates

• 2014-04-29: Company began new direction and Board of Directors elected, renamed to Cannabics Pharmaceuticals Inc. — Marks the strategic pivot from oil and gas exploration to a focus on cannabinoid-based cancer treatments.
• 2014-06-03: Company's Board of Directors declared a two-to-one forward stock split. — Adjusted the number of outstanding shares to facilitate marketability and potentially attract investors.
• 2022-05-12: Effected a 1:120 reverse stock split. — Aimed to increase the per-share price of the common stock, potentially making it more attractive to institutional investors and meeting exchange listing requirements.
• 2025-02-28: Aggregate market value of Common Stock held by non-affiliates was $251,840. — Indicates a very low market capitalization, highlighting the company's early stage and potential challenges in raising capital.
• 2025-11-20: 553,962,206 shares of Common Stock outstanding. — Provides the current share count, essential for calculating per-share metrics and understanding equity dilution.
• 2026: Target year for initiation of Phase I/II clinical trials for Cannabics SR and RCC-33. — Represents a critical upcoming milestone in the company's drug development pipeline, contingent on successful fundraising.

Glossary

Clinical Stage Company

A biotechnology or pharmaceutical company that is focused on the research and development of new drugs or treatments, but has not yet received regulatory approval to market its products. (Defines CNBX's current operational status and highlights its reliance on R&D and future clinical trial success.)

Cancer Anorexia Cachexia Syndrome (CACS)

A complex metabolic syndrome associated with underlying illness, characterized by involuntary weight loss, muscle wasting, and loss of appetite, often seen in advanced cancer patients. (Identifies the target indication for CNBX's lead product candidate, Cannabics SR.)

Anti-neoplastic Drug

A drug that inhibits or prevents the growth and spread of cancerous tumors. (Describes the function of CNBX's RCC-33 candidate, indicating its intended use in treating colorectal cancer.)

Phase I/II Clinical Trials

Early-stage clinical trials designed to assess the safety (Phase I) and preliminary efficacy (Phase II) of a new drug candidate in a small group of patients. (Outlines the next critical steps in CNBX's drug development process, requiring significant investment and regulatory oversight.)

Reverse Stock Split

A corporate action in which a company reduces the total number of its outstanding shares by consolidating them, typically to increase the share price. (Explains the 1:120 ratio effected on May 12, 2022, a common strategy for micro-cap companies to improve market perception or meet exchange requirements.)

Non-affiliates

In the context of stock ownership, individuals or entities that do not have a close relationship with the company's management or insiders. (Specifies the group whose stock holdings are used to calculate the public float and market value, relevant for assessing market liquidity and investor base.)

Year-Over-Year Comparison

Information comparing key metrics to the previous year, such as revenue growth, margin changes, and new risks, is not available from the provided text excerpt of the 10-K. The filing focuses on the current period's business description, risk factors, and historical context, without direct year-over-year financial comparisons.

Key Financial Figures

• $0.0076 — ant on the OTC Bulletin Board system of $0.0076. For purposes of this response, the reg
• $0.0001 — 553,962,206 shares of its Common Stock, $0.0001 par value, outstanding. Table of Conte
• $150,000 — earch. Additionally, Cannabics tendered $150,000 to the Company specifically earmarked a

Filing Documents

• cnbx_i10k-083125.htm (10-K) — 798KB
• cnbx_ex3101.htm (EX-31.1) — 11KB
• cnbx_ex3102.htm (EX-31.2) — 11KB
• cnbx_ex3201.htm (EX-32.1) — 4KB
• cnbx_ex3202.htm (EX-32.2) — 4KB
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• 0001683168-25-008736.txt ( ) — 3584KB
• cnbx-20250831.xsd (EX-101.SCH) — 20KB
• cnbx-20250831_cal.xml (EX-101.CAL) — 32KB
• cnbx-20250831_def.xml (EX-101.DEF) — 64KB
• cnbx-20250831_lab.xml (EX-101.LAB) — 232KB
• cnbx-20250831_pre.xml (EX-101.PRE) — 183KB
• cnbx_i10k-083125_htm.xml (XML) — 275KB

Description of Business

Item 1. Description of Business 1

Risk Factors

Item 1A. Risk Factors 25

Unresolved Staff Comments

Item 1B. Unresolved Staff Comments 46

Cybersecurity

Item 1C. Cybersecurity 46

Properties

Item 2. Properties 47

Legal Proceedings

Item 3. Legal Proceedings 47

Mine Safety Disclosures

Item 4. Mine Safety Disclosures 47 PART II

Market For Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

Item 5. Market For Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 48

Selected Financial Data

Item 6. Selected Financial Data 49

Management's Discussion and Analysis of Financial Condition and Results of Operations

Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations 50

Quantitative and Qualitative Disclosures About Market Risk

Item 7A. Quantitative and Qualitative Disclosures About Market Risk 53

Financial Statements and Supplementary Data

Item 8. Financial Statements and Supplementary Data 54

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 55

Controls and Procedures

Item 9A. Controls and Procedures 55

Other Information

Item 9B. Other Information 56 PART III

Directors, Executive Officers, Promoters and Control Persons; Compliance With Section 16(A) of the Exchange Act

Item 10. Directors, Executive Officers, Promoters and Control Persons; Compliance With Section 16(A) of the Exchange Act 57

Executive Compensation

Item 11. Executive Compensation 58

Security Ownership of Certain Beneficial Owners and Management Related Stockholder Matters

Item 12. Security Ownership of Certain Beneficial Owners and Management Related Stockholder Matters 60

Certain Relationships and Related Transactions, and Director Independence

Item 13. Certain Relationships and Related Transactions, and Director Independence 60

Principal Accounting Fees and Services

Item 14. Principal Accounting Fees and Services 60 PART IV

Exhibits

Item 15. Exhibits 61

FORWARD LOOKING STATEMENTS

FORWARD LOOKING STATEMENTS Certain statements made in this Annual Report are "forward-looking statements" (within the meaning of the Private Securities Litigation Reform Act of 1995) regarding the plans and objectives of management for future operations. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. The forward-looking statements made in this Report are based on current expectations that involve numerous risks and uncertainties. The Company's plans and objectives are based, in part, on assumptions involving the growth and expansion of business. Assumptions relating to the foregoing involve judgments with respect to, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the control of the Company. Although the Company believes that its assumptions underlying the forward-looking statements are reasonable, any of the assumptions could prove inaccurate and, therefore, there can be no assurance that the forward-looking statements made in this Report will prove to be accurate. In light of the significant uncertainties inherent in the forward-looking statements made in this Report, the inclusion of such information should not be regarded as a representation by the Company or any other person that the objectives and plans of the Company will be achieved. As used in this Annual Report, the terms "we", "us", "our", "Company", and "CNBX" means CNBX Pharmaceuticals Inc., unless otherwise indicated. ii PART I

Description of Business

Item 1. Description of Business CNBX PHARMACEUTICALS, INC. is based in Bethesda, Maryland, is a clinical stage company dedicated to discovery, development and commercialization of novel cannabinoid-based products and innovative technologies for the treatment of cancer. Our first lead product candidate is a Cannabics SR, the oral capsule developed for the treatment of patients with advanced cancer and cancer anorexia cachexia syndrome (CACS). Our leading anti-neoplastic drug candidate under development for Colorectal Cancer (CRC) is RCC-33. Historically we were previously an exploration stage mining company which transitioned into a bio-tech company in 2014. Our corporate address is #3 Bethesda Metro Center, Suite 700, Bethesda, Maryland, 20814; Telephone (877) 424-2429. The Company was previously engaged in the oil and gas exploration business. On April 29th, 2014, the Company began a new direction and the majority of the Shareholders of the Company elected the Board of Directors and renamed the Company Cannabics Pharmaceuticals Inc. The Company's R&D has been conducted in a Government licensed lab facility in Israel with the focus of development of cannabinoid-based therapies, medications and administration routes for treatment of cancer. History: Cannabics Pharmaceuticals Inc. was incorporated on September 15, 2004, under the laws of the State of Nevada, as Thrust Energy Corp., for the purpose of acquiring undivided working interests in small oil and gas exploration properties and non-operating interests in both producing and exploration projects throughout the United On September 30, 2010, we increased our authorized capital to 900 million shares of common stock (par value $0.0001) and 100 million shares of preferred stock (par value $0.0001) and effected a 20-for-1 reverse split of our issued and outstanding common stock. As a result of the reverse split, our issued and outstanding common stock was reduced from 13,604,000 shares to 6

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