VIVOS INC
For the period ended Sep 30, 2024. Filed Nov 13, 2024.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2024 · Filed Nov 13, 2024
RDGLStored price and day change unavailable
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-06-30; filed 2024-08-13.
0001493152-24-031540
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-11-13.
0001493152-24-045032
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 64 previous paragraphs and 64 current paragraphs.
44 unchanged; 19 reworded; 1 added; 1 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 8 previous and 8 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (1)
Current report
Comparison of the Nine Months Ended September 30, 2024 and 2023
Removed paragraphs (1)
Previous report
Comparison of the Six Months Ended June 30, 2024 and 2023
Reworded paragraphs (19)
Previous wording
Vivos Inc. (the “Company”) was incorporated under the laws of Delaware on December 23, 1994 as Savage Mountain Sports Corporation (“SMSC”). On September 6, 2006, the Company changed its name to Advanced Medical Isotope Corporation, and on December 28, 2017, the Company began operating as Vivos Inc. The Company has authorized capital of 950,000,000 shares of common stock, $0.001 par value per share, and 20,000,000 shares of preferred stock, $0.001 par value per share.
Current wording
Vivos Inc. (the “Company”) was incorporated under the laws of Delaware on December 23, 1994 as Savage Mountain Sports Corporation (“SMSC”). On September 6, 2006, the Company changed its name to Advanced Medical Isotope Corporation, and on December 28, 2017, the Company began operating as Vivos Inc. The Company has authorized capital of 950,000,000 shares of common stock, $0.001 par value per share (“Common Stock”), and 20,000,000 shares of preferred stock, $0.001 par value per share (“Preferred Stock”).
Previous wording
In November 2019, the Securities and Exchange Commission (the “SEC”) qualified the Company’s offering of its common stock, par value $0.001 per share (“Common Stock”), under Regulation A of Section 3(6) of the Securities Act of 1933, as amended (the “Securities Act”)(“Regulation A”), which offering was and amended from time to time thereafter (the “2019 Regulation A+ Offering”). In September 2021, the SEC qualified the Company’s offering of Common Stock under Regulation A, which offering was amended from time to time thereafter (together with the 2019 Regulation A+ Offering, the “Prior Regulation A+ Offerings”). During the year ended December 31, 2023, $1,179,245 was raised through the sale of 16,132,000 shares of common stock and the private placement of 18,797,000 warrants. During the period January 1, 2024 through May 10, 2024, the Company raised $834,000 through the issuance of 13,000,000 shares of common stock and the private placement of 2,000,000 warrants. During the six months ended June 30, 2024, the Company raised $839,000 through the issuance of 13,000,000 shares of common stock and 7,000,000 warrants. The Company’s Prior Regulation A Offerings undertaken pursuant to Regulation A+ have raised approximately $6,000,000 from the sale of shares of common stock.
Current wording
In November 2019, the Securities and Exchange Commission (the “SEC”) qualified the Company’s offering of its Common Stock under Regulation A of Section 3(6) of the Securities Act of 1933, as amended (the “Securities Act”)(“Regulation A”), which offering was and amended from time to time thereafter (the “2019 Regulation A+ Offering”). In September 2021, the SEC qualified the Company’s offering of Common Stock under Regulation A, which offering was amended from time to time thereafter (together with the 2019 Regulation A+ Offering, the “Prior Regulation A+ Offerings”). During the year ended December 31, 2023, $1,179,245 was raised through the sale of 16,132,000 shares of Common Stock and the private placement of 18,797,000 warrants. During the period January 1, 2024 through May 10, 2024, the Company raised $834,000 through the issuance of 13,000,000 shares of Common Stock and the private placement of 2,000,000 warrants. During the nine months ended September 30, 2024, the Company raised $839,000 through the issuance of 13,000,000 shares of Common Stock and 7,000,000 warrants. The Company’s Prior Regulation A Offerings undertaken pursuant to Regulation A+ have raised approximately $6,000,000 from the sale of shares of Common Stock.
Previous wording
Research and development of the Company’s precision radionuclide therapy product line has been funded with proceeds from the sale of equity and debt securities, including from the Prior Regulation A+ Offerings. The Company requires additional funding of approximately 2.5 million annually to maintain operating activities. Over the next 36 months, the Company believes it will cost approximately $8.0 to $9.0 million to: (1) fund the FDA approval process to conduct human clinical trials; (2) conduct Phase I, pilot, clinical trials; (3) activate several regional clinics to administer IsoPet® across the county; (4) create an independent production center within the current production site to create a template for future international manufacturing; and (5) initiate regulatory approval processes outside of the United States. The proceeds raised from the Prior Regulation A+ Offerings were used to fund this development and proceeds from the July 2024 Regulation A+ Offering will used to continue such development efforts.
Current wording
Research and development of the Company’s precision radionuclide therapy product line has been funded with proceeds from the sale of equity and debt securities, including from the Prior Regulation A+ Offerings. The Company requires additional funding of approximately $2.5 million annually to maintain operating activities. Over the next 36 months, the Company believes it will cost approximately $8.0 to $9.0 million to: (1) fund the FDA approval process to conduct human clinical trials; (2) conduct Phase I, pilot, clinical trials; (3) activate several regional clinics to administer IsoPet® across the county; (4) create an independent production center within the current production site to create a template for future international manufacturing; and (5) initiate regulatory approval processes outside of the United States. The proceeds raised from the Prior Regulation A+ Offerings were used to fund this development and proceeds from the July 2024 Regulation A+ Offering will used to continue such development efforts.
Previous wording
The Company’s headquarters are in Southeast Washington., The initial focus of the animal therapy market has been the Northwestern sector of the United States. The Company has initiated marketing efforts to the animal therapy market in other regions of the United States, attempting to increase the exposure to our product and increase revenue opportunities.
Current wording
The Company’s headquarters are in the State of Washington., The initial focus of the animal therapy market has been the Northwestern sector of the U.S. The Company has initiated marketing efforts to the animal therapy market in other regions of the U.S., attempting to increase the exposure to our product and increase revenue opportunities.
Previous wording
As of June 30, 2024, the Company has $1,724,417 cash on hand. There are currently commitments to vendors for products and services purchased. To continue the development of the Company’s products, the current level of cash may not be enough to cover the fixed and variable obligations of the Company. The Company has focused on operating on minimum overhead, including using a virtual office for the last several years and experienced industry consultants available on an as needed basis.. This has helped stretch the investment dollars on activities that enhance our objectives.
Current wording
As of September 30, 2024, the Company had $1,218,160 cash on hand. There are currently commitments to vendors for products and services purchased. To continue the development of the Company’s products, the current level of cash will be insufficient to cover the fixed and variable obligations of the Company. The Company has focused on operating on minimum overhead, including using a virtual office for the last several years and retaining experienced industry consultants available on an as needed basis. This has helped focus the capital received from the Company’s Regulation A+ Offerings on activities that enhance our objectives.
Previous wording
There is no guarantee that the Company will be able to raise additional funds or to do so at an advantageous price.
Current wording
No assurances can be given that the Company will be able to raise additional funds or to do so on terms advantageous to the Company or its stockholders.
Previous wording
The following table sets forth information from our statements of operations for the six months ended June 30, 2024 and 2023:
Current wording
The following table sets forth information from our statements of operations for the nine months ended September 30, 2024 and 2023:
Previous wording
Revenue was $18,000 and $12,500 for the six months ended June 30, 2024 and 2023, respectively. All revenue recognized in the six months ended June 30, 2024 and 2023 relate to consulting income with respect to the IsoPet® therapies.
Current wording
Revenue was $23,000 and $19,500 for the nine months ended September 30, 2024 and 2023, respectively. All revenue recognized in the nine months ended September 30, 2024 and 2023 relate to consulting income with respect to the IsoPet® therapies.
Previous wording
Operating expense for the six months ended June 30, 2024 and 2023, respectively consists of the following:
Current wording
Operating expense for the nine months ended September 30, 2024 and 2023, respectively consists of the following:
Previous wording
Operating expenses for the six months ended June 30, 2024 and 2023 was $1,100,659 and $1,158,687, respectively. The decrease in operating expense from 2023 to 2024 can be attributed to a decrease in professional fees from $692,963 for the six months ended June 30, 2023 to $683,452 for the six months ended June 30, 2024, partially attributable to the stock based compensation expense related to the restricted stock units; a decrease in general and administrative expense from $101,475 for the six months ended June 30, 2023 to $78,345 for the six months ended June 30, 2024; a decrease in research and development expense from $219,728 for the six months ended June 30, 2023 to $157,109 for the six months ended June 30, 2024 as the Company ramped up the development of their products in 2023 to include studies that are required to continue to have their products accepted by the FDA, and completed some of those studies for the 2024 period; and an increase in payroll expense related to the CEOs employment contract and bonus, to $181,753 for the six months ended June 30, 2024 from $144,521 for the six months ended June 30, 2023.
Current wording
Operating expense for the nine months ended September 30, 2024 and 2023 was $1,944,885 and $1,853,319, respectively. The increase in operating expense from 2023 to 2024 can be attributed to an increase in professional fees from $1,205,819 for the nine months ended September 30, 2023 to $1,310,604 for the nine months ended September 30, 2024, partially attributable to the stock based compensation expense related to the restricted stock units; an increase in general and administrative expense from $132,831 for the nine months ended September 30, 2023 to $143,468 for the nine months ended September 30, 2024; a decrease in research and development expense from $300,586 for the nine months ended September 30, 2023 to $223,660 for the nine months ended September 30, 2024 as the Company ramped up the development of their products in 2023 to include studies that are required to continue to have their products accepted by the FDA, and completed some of those studies for the 2024 period; and an increase in payroll expense related to the CEO’s employment contract and bonus, to $267,153 for the nine months ended September 30, 2024 from $214,083 for the nine months ended September 30, 2023.
Previous wording
Non-operating income (expense) for the six months ended June 30, 2024 and 2023 consists of the following:
Current wording
Non-operating income (expense) for the nine months ended September 30, 2024 and 2023 consists of the following:
Previous wording
Non-operating income (expense) for the six months ended June 30, 2024 and 2023 related to interest earned on the Company’s cash accounts.
Current wording
Non-operating income (expense) for the nine months ended September 30, 2024 and 2023 related to interest earned on the Company’s cash accounts.
Previous wording
Our net loss for the six months ended June 30, 2024 and 2023 was $(1,061,997) and $(1,150,844), respectively.
Current wording
Our net loss for the nine months ended September 30, 2024 and 2023 was $(1,887,260) and $(1,818,534), respectively.
Previous wording
Revenue was $13,500 and $6,500 for the three months ended June 30, 2024 and 2023, respectively. All revenue recognized in the three months ended June 30, 2024 and 2023 relate to consulting income with respect to the IsoPet® therapies.
Current wording
Revenue was $5,000 and $7,000 for the three months ended September 30, 2024 and 2023, respectively. All revenue recognized in the three months ended September 30, 2024 and 2023 relate to consulting income with respect to the IsoPet® therapies.
Previous wording
Operating expense for the three months ended June 30, 2024 and 2023 was $525,029 and $911,905, respectively. The decrease in operating expense from 2023 to 2024 can be attributed to a decrease in professional fees from $608,747 for the three months ended June 30, 2023 to $279,814 for the three months ended June 30, 2024, attributable to the stock based compensation expense related to the restricted stock units; a decrease in general and administrative expense from $57,792 for the three months ended June 30, 2023 to $54,925 for the three months ended June 30, 2024; a decrease in research and development expense from $173,353 for the three months ended June 30, 2023 to $99,662 for the three months ended June 30, 2024 as the Company ramped up the development of their products in 2023 to include studies that are required to continue to have their products accepted by the FDA, and completed some of those studies for the 2024 period; and an increase in payroll expense related to the CEOs employment contract and bonus to $90,628 for the three months ended June 30, 2024 from $72,013 for the three months ended June 30, 2023.
Current wording
Operating expense for the three months ended September 30, 2024 and 2023 was $844,226 and $694,633, respectively. The increase in operating expense from 2023 to 2024 can be attributed to an increase in professional fees from $512,856 for the three months ended September 30, 2023 to $627,152 for the three months ended September 30, 2024, attributable to the stock based compensation expense related to the restricted stock units; an increase in general and administrative expense from $31,357 for the three months ended September 30, 2023 to $65,123 for the three months ended September 30, 2024 related to attendance at various conferences and a marketing campaign commenced in this quarter; a decrease in research and development expense from $80,858 for the three months ended September 30, 2023 to $66,551 for the three months ended September 30, 2024 as the Company ramped up the development of their products in 2023 to include studies that are required to continue to have their products accepted by the FDA, and completed some of those studies for the 2024 period; and an increase in payroll expense related to the CEO’s employment contract and bonus to $85,400 for the three months ended September 30, 2024 from $69,562 for the three months ended September 30, 2023.
Previous wording
Our net loss for the three months ended June 30, 2024 and 2023 was $(503,458) and $(902,526), respectively.
Current wording
Our net loss for the three months ended September 30, 2024 and 2023 was $(825,263) and $(667,690), respectively.
Previous wording
At June 30, 2024, the Company had working capital of $1,603,105, as compared to working capital of $1,365,120 at December 31, 2023. During the six months ended June 30, 2024 and 2023, the Company experienced negative cash flow from operations of $706,870 and $607,963 and had no cash from investing activities. In both 2024 and 2023, there were no investing activities, and in 2024 and 2023, the Company raised $839,000 and $650,665 from the sales of common stock and warrants as part of our Reg A+. As of June 30, 2024, the Company did not have any commitments for capital expenditures.
Current wording
At September 30, 2024, the Company had working capital of $1,195,505, as compared to working capital of $1,365,120 at December 31, 2023. During the nine months ended September 30, 2024 and 2023, the Company experienced negative cash flow from operations of $1,213,127 and $829,886 and had no cash from investing activities. In both 2024 and 2023, there were no investing activities, and in 2024 and 2023, the Company raised $839,000 and $650,665 from the sales of Common Stock and warrants as part of our Regulation A+ Offerings. We also received $10,000 in September 2023 from advances from our CEO that was repaid in October 2023.As of September 30, 2024, the Company did not have any commitments for capital expenditures.
Previous wording
Cash used in operating activities increased from $607,963 for the six months ended June 30, 2023 to $706,870 for the six months ended June 30, 2024. Cash used in operating activities was primarily a result of the Company’s non-cash items, such as loss from operations, stock-based compensation, as well as the changes in accounts receivable, prepaid expense and accounts payable in 2024 compared to only having net changes from current assets and liabilities and stock-based compensation in 2023.
Current wording
Cash used in operating activities increased from $829,886 for the nine months ended September 30, 2023 to $1,213,127 for the nine months ended September 30, 2024. Cash used in operating activities was primarily a result of the Company’s non-cash items, such as loss from operations, stock-based compensation, as well as the changes in accounts receivable, prepaid expense and accounts payable in 2024 compared to only having net changes from current assets and liabilities and stock-based compensation in 2023.
Previous wording
The Company has generated material operating losses since inception. The Company had a net loss of $1,061,997 and $1,150,844 for the six months ended June 30, 2024 and 2023, respectively. The Company expects to continue to experience net operating losses for the foreseeable future. Historically, the Company has relied upon investor funds to maintain its operations and develop the Company’s business. The Company anticipates raising additional capital within the next twelve months for working capital as well as business expansion, although the Company can provide no assurance that additional capital will be available on terms acceptable to the Company, if at all. If the Company is unable to obtain additional financing to meet its working capital requirements, it may have to curtail its business or cease all operations.
Current wording
The Company has generated material operating losses since inception. The Company had a net loss of $1,887,260 and $1,818,534 for the nine months ended September 30, 2024 and 2023, respectively. The Company expects to continue to experience net operating losses for the foreseeable future. Historically, the Company has relied upon investor funds to maintain its operations and develop the Company’s business. The Company anticipates raising additional capital within the next twelve months for working capital as well as business expansion, although no assurances can be given that such additional capital will be available on terms acceptable to the Company, if at all. If the Company is unable to obtain additional financing to meet its working capital requirements, it may have to curtail its business or cease all operations.