Vivos Inc. Deepens Losses Amidst Strategic India Expansion

TL;DR

**RDGL is burning cash faster than it can raise it, making its India expansion a high-stakes gamble for a company teetering on the edge.**

AI Summary

VIVOS INC (RDGL) reported a net loss of $1,987,503 for the nine months ended September 30, 2025, an increase from a net loss of $1,887,260 in the same period of 2024. Revenue for the nine months ended September 30, 2025, was $43,627, up from $23,000 in 2024, but gross profit turned into a gross loss of $56,650 from a profit of $2,301. Operating expenses increased to $2,012,678 from $1,944,885 year-over-year. The company's cash position decreased slightly to $2,202,109 as of September 30, 2025, from $2,212,548 at December 31, 2024. Vivos Inc. established Vivos Scientific India LLP on October 1, 2025, to expand human therapies and manufacturing in India. The company continues to face significant doubt about its ability to continue as a going concern, 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.

Why It Matters

Vivos Inc.'s continued net losses and 'going concern' warning are critical for investors, signaling high financial risk despite strategic moves like the Vivos India LLP formation. The company's reliance on equity and debt sales for funding, including $1.5 million raised in the last nine months, indicates a precarious financial state. For employees and customers, the uncertainty around funding could impact job security and product availability, especially for its IsoPet and RadioGel therapies. In the competitive medical device market, Vivos's struggle to secure consistent revenue and profitability, alongside its need for $9 million in additional capital for FDA approvals and clinical trials, puts it at a significant disadvantage against better-capitalized rivals.

Risk Assessment

Risk Level: high — VIVOS INC has suffered recurring losses, with a net loss of $1,987,503 for the nine months ended September 30, 2025, and its cash position of $2,202,109 is insufficient to support its estimated annual operating activities of $3 million. The company's independent registered public accounting firm has expressed substantial doubt about its ability to continue as a going concern, citing limited revenue and accumulated deficits of $87,348,732.

Analyst Insight

Investors should exercise extreme caution and consider this a highly speculative investment. Given the 'going concern' warning and significant capital requirements of $9 million over 36 months for FDA approvals and clinical trials, potential investors should wait for clear evidence of sustained revenue generation and successful capital raises before considering a position.

Financial Highlights

debt To Equity

N/A

revenue

$43,627

operating Margin

N/A

total Assets

N/A

total Debt

N/A

net Income

$(1,987,503)

eps

N/A

gross Margin

-129.8%

cash Position

$2,202,109

revenue Growth

90%

Key Numbers

• $43,627 — Revenues, net (for the nine months ended September 30, 2025, up from $23,000 in 2024)
• $(56,650) — Gross (loss) profit (for the nine months ended September 30, 2025, a decline from $2,301 gross profit in 2024)
• $(1,987,503) — Net loss (for the nine months ended September 30, 2025, an increase from $(1,887,260) in 2024)
• $2,202,109 — Cash (as of September 30, 2025, a slight decrease from $2,212,548 at December 31, 2024)
• $1,500,000 — Proceeds from common stock (raised during the nine months ended September 30, 2025)
• $87,348,732 — Accumulated deficit (as of September 30, 2025, indicating significant historical losses)
• $9.0 million — Additional capital required (over the next 36 months for FDA approval and clinical trials)
• 454,664,957 — Common stock outstanding (as of November 11, 2025, an increase from 440,873,806 at December 31, 2024)

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 RadioGel for veterinary use
• Vivos Scientific India LLP (company) — wholly owned separate legal entity in India
• Board of Directors (person) — approved creation of Vivos Scientific India LLP
• $1,987,503 (dollar_amount) — net loss for nine months ended September 30, 2025
• $2,202,109 (dollar_amount) — cash on hand as of September 30, 2025
• $3 million (dollar_amount) — annual funding required to maintain current operating activities

FAQ

Risk Factors

• Going Concern Uncertainty [high — financial]: Vivos Inc. faces substantial doubt about its ability to continue as a going concern. The company requires approximately $3 million annually for current operations and an estimated $9 million over the next 36 months for FDA approval processes and clinical trials, indicating a significant funding gap.
• Deteriorating Profitability [high — financial]: Despite a revenue increase to $43,627 for the nine months ended September 30, 2025, from $23,000 in 2024, the company experienced a gross loss of $56,650, a sharp decline from a gross profit of $2,301 in the prior year. This indicates significant cost control issues or pricing pressures.
• Increased Operating Expenses [medium — operational]: Operating expenses rose to $2,012,678 for the nine months ended September 30, 2025, from $1,944,885 in the same period of 2024. This increase, coupled with the gross loss, contributed to a wider net loss.
• FDA Approval and Clinical Trials [high — regulatory]: The company estimates needing $9 million over the next 36 months for FDA approval processes and clinical trials. Delays or failures in these critical stages could severely impact future revenue streams and market access.
• Dependence on External Financing [medium — financial]: The company raised $1,500,000 in proceeds from common stock during the nine months ended September 30, 2025. Continued reliance on equity financing may dilute existing shareholders and is subject to market conditions.

Industry Context

Vivos Inc. operates in the highly regulated biotechnology and human therapies sector. This industry is characterized by long development cycles, substantial R&D investment, and stringent regulatory oversight, particularly from bodies like the FDA. Success hinges on innovation, clinical trial outcomes, and securing significant funding to navigate these complex processes.

Regulatory Implications

The company's path to market is heavily dependent on successful FDA approval, which requires substantial investment in clinical trials and adherence to rigorous regulatory standards. Any setbacks or delays in this process pose a significant risk to Vivos Inc.'s future revenue and viability.

What Investors Should Do

1. Monitor cash burn rate and future funding rounds.
2. Evaluate progress on clinical trials and FDA submissions.
3. Analyze the impact of the Indian subsidiary on future revenues and costs.
4. Assess the sustainability of the current business model given the gross loss.

Key Dates

• 2025-10-01: Establishment of Vivos Scientific India LLP — Indicates strategic expansion into India for human therapies and manufacturing, potentially opening new markets and cost efficiencies.
• 2025-09-30: Nine months ended financial reporting — Provides a snapshot of the company's financial performance and position, highlighting increased losses and a declining gross profit.
• 2024-09-30: Nine months ended financial reporting — Provides a comparative period for assessing year-over-year performance changes, showing revenue growth but worsening profitability.
• 2024-12-31: Year-end financial reporting — Serves as the prior year-end benchmark for cash position and other balance sheet items.

Glossary

Going Concern

An assumption that a company will continue to operate for the foreseeable future, typically at least 12 months. If there is substantial doubt, it must be disclosed. (Vivos Inc. faces significant doubt about its ability to continue as a going concern, highlighting a critical financial risk.)

Gross Profit (Loss)

Revenue minus the cost of goods sold. A negative gross profit indicates that the cost of producing goods or services exceeds the revenue generated from them. (Vivos Inc. has shifted from a gross profit to a gross loss, indicating severe issues with its cost of sales relative to its revenue.)

Accumulated Deficit

The cumulative net losses of a company since its inception, minus any accumulated profits. It represents a negative retained earnings balance. (Vivos Inc.'s substantial accumulated deficit of $87,348,732 underscores its history of unprofitability.)

FDA Approval

The process by which the U.S. Food and Drug Administration reviews and approves new drugs, medical devices, or other products to ensure their safety and efficacy. (Significant capital is earmarked for FDA approval processes, a critical and often lengthy hurdle for Vivos Inc.'s products.)

Year-Over-Year Comparison

For the nine months ended September 30, 2025, Vivos Inc. saw revenue more than double to $43,627 compared to $23,000 in the prior year. However, this top-line growth was overshadowed by a significant deterioration in profitability, with the company reporting a gross loss of $56,650, a stark contrast to a gross profit of $2,301 in 2024. Operating expenses also increased, leading to a wider net loss of $1,987,503 from $1,887,260 year-over-year. The company continues to face significant going concern risks, requiring substantial capital for operations and regulatory processes.

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) — 1714KB
• ex31-1.htm (EX-31.1) — 18KB
• ex31-2.htm (EX-31.2) — 19KB
• ex32-1.htm (EX-32.1) — 10KB
• 0001493152-25-021619.txt ( ) — 5691KB
• rdgl-20250930.xsd (EX-101.SCH) — 32KB
• rdgl-20250930_cal.xml (EX-101.CAL) — 30KB
• rdgl-20250930_def.xml (EX-101.DEF) — 160KB
• rdgl-20250930_lab.xml (EX-101.LAB) — 303KB
• rdgl-20250930_pre.xml (EX-101.PRE) — 225KB
• form10-q_htm.xml (XML) — 934KB

Financial Statements

Financial Statements 1 Condensed Balance Sheets as of September 30, 2025 (unaudited) and December 31, 2024 1 Condensed Statements of Operations for the Nine and Three Months ended September 30, 2025 and 2024 (unaudited) 2 Condensed 3 Condensed Statements of Cash Flow for the Nine Months ended September 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 CONDENSED BALANCE SHEETS SEPTEMBER 30, 2025 (UNAUDITED) AND DECEMBER 31, 2024 SEPTEMBER 30, DECEMBER 31, 2025 2024 (UNAUDITED) ASSETS Current Assets: Cash $ 2,202,109 $ 2,212,548 Accounts receivable 4,699 10,326 Inventory 62,734 - Prepaid expenses 25,643 10,582 Total Current Assets 2,295,185 2,233,456 TOTAL ASSETS $ 2,295,185 $ 2,233,456 LIABILITIES AND STOCKHOLDERS' EQUITY LIABILITIES Current Liabilities: Accounts payable and accrued expenses $ 112,693 $ 86,209 Total Current Liabilities 112,693 86,209 Total Liabilities 112,693 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, 454,664,957 and 440,873,806 issued and outstanding, respectively 454,665 440,874 Additional paid in capital - common stock 79,726,600 77,719,143 Subscriptions receivable - ( 1,500 ) Accumulated deficit ( 87,348,732 ) ( 85,361,229 ) Total Stockholders' Equity 2,182,492 2,147,247 TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 2,295,185 $ 2,233,456 The accompanying notes are an integral part of these una

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