VIVOS INC's Losses Widen Amid R&D Spend, Cash Influx from Equity

TL;DR

**RDGL is burning cash faster than it's raising it, making it a speculative bet on future FDA approvals and commercialization.**

AI Summary

VIVOS INC (RDGL) reported a net loss of $1,480,209 for the six months ended June 30, 2025, a significant increase from the $1,061,997 net loss in the same period of 2024. Revenue, net, increased to $41,748 for the six months ended June 30, 2025, up from $18,000 in 2024, but was overshadowed by a substantial rise in Cost of Goods Sold to $85,583 from $16,780, resulting in a gross loss of $43,835. Operating expenses surged to $1,494,470 from $1,100,659, driven primarily by professional fees, including stock-based compensation, which rose to $946,723 from $683,452. The company's cash position improved to $2,660,590 as of June 30, 2025, from $2,212,548 at December 31, 2024, largely due to $1,507,750 in financing activities, including the issuance of 12,500,000 shares of common stock for $1,500,000. VIVOS INC continues to operate with a going concern doubt, requiring approximately $3 million annually to maintain current operations and an estimated $9 million over the next 36 months for FDA approval processes and clinical trials for its RadioGel/IsoPet product.

Why It Matters

VIVOS INC's continued significant net losses and reliance on equity financing raise red flags for investors, indicating a high-risk, pre-revenue stage company. The competitive landscape in radiation oncology medical devices is intense, and VIVOS INC's ability to secure FDA approval for human trials and commercialize its Precision Radionuclide Therapy (RadioGel/IsoPet) is critical for its survival. Employees face uncertainty given the going concern doubt, while potential customers (veterinarians and eventually human oncologists) await a proven, regulatory-approved product. The broader market will watch if this novel Y-90 based therapy can disrupt existing cancer treatments, but substantial capital and regulatory hurdles remain.

Risk Assessment

Risk Level: high — VIVOS INC reported a net loss of $1,480,209 for the six months ended June 30, 2025, and explicitly states a 'significant doubt about the Company's ability to continue as a going concern.' The company requires approximately $3 million annually to maintain current operating activities and an estimated $9 million over the next 36 months for development, far exceeding its current cash of $2,660,590.

Analyst Insight

Investors should approach RDGL with extreme caution, recognizing it as a highly speculative investment. Monitor progress on FDA approvals for human clinical trials and subsequent commercialization efforts, as these are critical milestones. Given the substantial capital requirements and recurring losses, consider this a long-term, high-risk play with potential for significant dilution.

Financial Highlights

debt To Equity

N/A

revenue

$41,748

operating Margin

N/A

total Assets

N/A

total Debt

N/A

net Income

-$1,480,209

eps

N/A

gross Margin

-105.0%

cash Position

$2,660,590

revenue Growth

+131.9%

Revenue Breakdown

Key Numbers

• $1.48M — Net Loss (Increased from $1.06M in prior year, indicating widening losses.)
• $41.7K — Revenue, Net (Increased from $18K, but remains very low for a public company.)
• $2.66M — Cash on Hand (Increased from $2.21M, but insufficient for future operations.)
• $3M — Annual Funding Required (Highlights the significant cash burn and going concern risk.)
• $9M — 36-Month Capital Need (Required for FDA approval and clinical trials, far exceeding current cash.)
• 453,804,006 — Common Shares Outstanding (Increased from 440,873,806, indicating significant dilution.)
• $1.5M — Proceeds from Common Stock (Raised during the six months ended June 30, 2025, through Regulation A+ Offerings.)
• $85.5K — Cost of Goods Sold (Increased significantly from $16.7K, contributing to gross loss.)
• $946.7K — Professional Fees (Major component of operating expenses, up from $683.4K.)
• $86.8M — Accumulated Deficit (Reflects historical losses and ongoing unprofitability.)

Key Players & Entities

• VIVOS INC (company) — registrant
• SEC (regulator) — Securities and Exchange Commission
• FDA (regulator) — United States Food and Drug Administration
• RadioGel (company) — yttrium-90 based precision radionuclide therapy device
• IsoPet (company) — trademarked name for veterinary use of RadioGel
• $1,480,209 (dollar_amount) — net loss for six months ended June 30, 2025
• $41,748 (dollar_amount) — revenue, net for six months ended June 30, 2025
• $2,660,590 (dollar_amount) — cash on hand as of June 30, 2025
• $3 million (dollar_amount) — annual funding required for operating activities
• $9 million (dollar_amount) — additional capital required over next 36 months

FAQ

Risk Factors

• Going Concern and Funding Needs [high — financial]: The company has a substantial accumulated deficit of $86.8M and incurred a net loss of $1.48M for the six months ended June 30, 2025. VIVOS INC requires approximately $3 million annually and an estimated $9 million over the next 36 months for FDA approval and clinical trials, far exceeding its current cash position of $2.66M.
• Gross Loss Due to High COGS [high — operational]: Cost of Goods Sold increased dramatically to $85,583 from $16,780, resulting in a gross loss of $43,835 for the six months ended June 30, 2025. This indicates significant inefficiencies or cost pressures in production relative to revenue.
• High Operating Expenses [high — operational]: Operating expenses surged to $1,494,470 from $1,100,659, driven by professional fees, including stock-based compensation, which rose to $946,723 from $683,452. These high costs contribute significantly to the net loss.
• Dilution from Stock Issuance [medium — financial]: The company issued 12,500,000 shares of common stock for $1,500,000, increasing the total shares outstanding to 453,804,006 from 440,873,806. This significant dilution impacts existing shareholders.
• FDA Approval Dependency [high — regulatory]: The company's future success is heavily dependent on obtaining FDA approval for its RadioGel/IsoPet product. This process requires substantial capital ($9M over 36 months) and is subject to regulatory uncertainties and timelines.

Industry Context

VIVOS INC operates in the highly regulated medical device sector, specifically focusing on radiopharmaceutical products. This industry is characterized by long development cycles, significant R&D investment, and stringent regulatory hurdles, particularly FDA approval. Competition can be intense, with established players and emerging biotechs vying for market share.

Regulatory Implications

The company's primary regulatory challenge is securing FDA approval for its RadioGel/IsoPet product. This process is lengthy, costly (estimated $9M over 36 months), and carries inherent risks of denial or delays, which could severely impact the company's financial viability.

What Investors Should Do

1. Monitor cash burn and future financing rounds.
2. Evaluate progress on FDA approval and clinical trials.
3. Assess the sustainability of operating expenses.

Key Dates

• 2025-06-30: Six months ended June 30, 2025 financial reporting period — Reported increased revenue but also a significantly wider net loss, highlighting ongoing operational challenges and high expenses.
• 2025-06-30: Cash position as of June 30, 2025 — Cash increased to $2.66M, primarily due to financing activities, but remains insufficient for projected operational and regulatory needs.
• 2025-01-01: Start of six months ended June 30, 2025 period — Operations during this period led to a net loss of $1.48M and a gross loss, underscoring the need for substantial future funding.

Glossary

Accumulated Deficit

The cumulative net losses of a company since its inception that have not been offset by net income. (VIVOS INC has an accumulated deficit of $86.8M, indicating a history of unprofitability and a significant need for future capital.)

Cost of Goods Sold (COGS)

The direct costs attributable to the production or purchase of the goods sold by a company. (A sharp increase in COGS to $85,583 resulted in a gross loss, a critical concern for VIVOS INC's profitability.)

Stock-Based Compensation

Compensation provided to employees in the form of stock options or shares, recognized as an expense. (A significant portion of VIVOS INC's operating expenses, totaling $946,723, was related to professional fees including stock-based compensation.)

Going Concern

A business's ability to continue operating for the foreseeable future without the threat of liquidation. (VIVOS INC explicitly states a going concern doubt, requiring substantial funding to meet operational and FDA approval needs.)

Regulation A+ Offering

A type of U.S. securities exemption that allows companies to raise capital from the public. (VIVOS INC raised $1.5M through this type of offering, contributing to its cash position but also increasing share count.)

Year-Over-Year Comparison

For the six months ended June 30, 2025, VIVOS INC reported a net loss of $1.48M, a significant increase from $1.06M in the prior year. While revenue more than doubled to $41.7K from $18K, this was overshadowed by a dramatic rise in Cost of Goods Sold, leading to a gross loss. Operating expenses also climbed substantially, driven by professional fees. The company's cash position improved due to financing activities, but the overall financial picture remains challenging, with ongoing going concern risks.

Key Financial Figures

• $9.0 million — believes it will require approximately $9.0 million in additional capital to: (i) fund the

Filing Documents

• form10-q.htm (10-Q) — 1415KB
• ex31-1.htm (EX-31.1) — 18KB
• ex31-2.htm (EX-31.2) — 19KB
• ex32-1.htm (EX-32.1) — 10KB
• 0001641172-25-023437.txt ( ) — 5744KB
• rdgl-20250630.xsd (EX-101.SCH) — 29KB
• rdgl-20250630_cal.xml (EX-101.CAL) — 30KB
• rdgl-20250630_def.xml (EX-101.DEF) — 149KB
• rdgl-20250630_lab.xml (EX-101.LAB) — 290KB
• rdgl-20250630_pre.xml (EX-101.PRE) — 211KB
• form10-q_htm.xml (XML) — 1141KB

– FINANCIAL INFORMATION

PART I – FINANCIAL INFORMATION Item 1.

Financial Statements

Financial Statements 1 Condensed Balance Sheets as of June 30, 2025 (unaudited) and December 31, 2024 1 Condensed Statements of Operations for the Six and Three Months ended June 30, 2025 and 2024 (unaudited) 2 Condensed Statement of Changes in Stockholders' Equity for the Six Months ended June 30, 2025 and 2024 (unaudited) 3 Condensed Statements of Cash Flow for the Six Months ended June 30, 2025 and 2024 (unaudited) 4 Notes to Condensed Financial Statements (unaudited) 5 Item 2.

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

Management's Discussion and Analysis of Financial Condition and Results of Operations 19 Item 3.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 29 Item 4.

Controls and Procedures

Controls and Procedures 30

– OTHER INFORMATION

PART II – OTHER INFORMATION Item 1.

Legal Proceedings

Legal Proceedings 31 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 31 Item 6. Exhibits 31

SIGNATURES

SIGNATURES 32 i PART I – FINANCIAL INFORMATION VIVOS INC BALANCE SHEETS JUNE 30, 2025 (UNAUDITED) AND DECEMBER 31, 2024 JUNE 30, DECEMBER 31, 2025 2024 (UNAUDITED) ASSETS Current Assets: Cash $ 2,660,590 $ 2,212,548 Accounts receivable 13,270 10,326 Inventory 62,961 - Prepaid expenses 38,735 10,582 Total Current Assets 2,775,556 2,233,456 TOTAL ASSETS $ 2,775,556 $ 2,233,456 LIABILITIES AND STOCKHOLDERS' EQUITY LIABILITIES Current Liabilities: Accounts payable and accrued expenses $ 96,458 $ 86,209 Total Current Liabilities 96,458 86,209 Total Liabilities 96,458 86,209 Commitments and contingencies - - STOCKHOLDERS' EQUITY Preferred stock, par value, $ 0.001 , 20,000,000 shares authorized, Series A Convertible Preferred, 5,000,000 shares authorized, 2,071,007 shares issued and outstanding, respectively 2,071 2,071 Additional paid in capital - Series A Convertible preferred stock 8,842,458 8,842,458 Series B Convertible Preferred, 5,000,000 shares authorized, 363 shares issued and outstanding, respectively - - Additional paid in capital - Series B Convertible preferred stock 4,538 4,538 Series C Convertible Preferred, 5,000,000 shares authorized, 385,302 shares issued and outstanding, respectively 385 385 Preferred stock, value 385 385 Additional paid in capital - Series C Convertible preferred stock 500,507 500,507 Additional paid in capital 500,507 500,507 Common stock, par value, $ 0.001 , 950,000,000 shares authorized, 453,804,006 and 440,873,806 issued and outstanding, respectively 453,804 440,874 Additional paid in capital - common stock 79,716,773 77,719,143 Subscriptions receivable - ( 1,500 ) Accumulated deficit ( 86,841,438 ) ( 85,361,229 ) Total Stockholders' Equity 2,679,098 2,147,247 TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 2,775,556 $ 2,233,456 The accompanying notes are an integral part of these u

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