AXIM Biotechnologies, Inc.

What they do

AXIM develops rapid lateral flow immunoassays and reagents, primarily for point-of-care diagnostics. Its current products are two FDA-cleared 510(k) tests for dry eye disease acquired from Advanced Tear Diagnostics in 2021, plus an internally developed third assay. The company also has SARS-CoV-2 neutralizing antibody tests but is not actively commercializing them. Legacy operations in cannabinoid-based pharmaceuticals were divested in May 2020.

Revenue drivers

• Eye Health diagnostics — Revenue comes from sales of two FDA-cleared 510(k) dry eye disease tests (Lactoferrin and IgE) and a third internal assay. This is the primary product focus; annual revenue has been minimal, totaling $39,518 in 2023 according to one XBRL tag.
• SARS-CoV-2 neutralizing antibody tests — The company maintains these assays but has not actively commercialized them, stating it will only do so if a future opportunity arises. No material revenue from this line has been reported.
• Legacy cannabinoid products — Historically the core business, but the related intellectual property was divested in May 2020. No ongoing revenue from this segment.

Recent performance

For the year ended December 31, 2023, AXIM reported revenue of $39,518 and a net loss of $8.1 million, according to one XBRL tag. Operating cash flow was negative $1.0 million in 2023, an improvement from negative $2.0 million in 2022. In the first half of 2024, quarterly revenue was $52,979 in Q1 and $17,479 in Q2, with the company reporting a net loss. As of June 30, 2024, total assets were $3.7 million, total liabilities were $13.3 million, and shareholders' equity was negative $9.5 million. Cash and equivalents stood at only $6,044.

Strategy

Management is focusing on the eye health diagnostics business, leveraging the two FDA-cleared 510(k) tests acquired in 2021 and an internally developed third assay. The company intends to obtain financing through shareholder loans, private placements, or registered offerings, and may take on debt. It has no formal agreements ensuring such funding. G&A expenses for 2024 are estimated at approximately $3.5 million, including $250,000 in audit and accounting costs. R&D spending will depend on available capital.

Risks

• Going concern and liquidity — As of December 31, 2023, AXIM had cash of $156,457 and a working capital deficit of $5.8 million; management states it can provide no assurance it can satisfy cash requirements for the next twelve months.
• Dependence on related-party funding — The company relies on shareholder loans and related parties for continued funding, which may be highly dilutive to existing shareholders and may not be available on reasonable terms.
• Minimal revenue and early-stage operations — Revenue has been negligible (under $40,000 annually in recent years), and the company has an accumulated deficit of $72.2 million as of December 31, 2023.
• Regulatory and commercialization risk — The eye health products require ongoing regulatory compliance and market acceptance; the company must compete with larger diagnostic companies, and its 510(k) clearances do not guarantee commercial success.

Outlook

Management expects G&A expenses of approximately $3.5 million in 2024 and states that R&D spending will vary based on available capital. The company plans to fund operations through shareholder loans, private placements, or registered offerings, but cautions that it may exhaust these sources. No specific revenue or profitability guidance is provided, and management expresses uncertainty about the ability to continue as a going concern.