UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY
report pursuant to section 13 or 15( d )
of the Securities Exchange Act of 1934
For
the Quarterly Period Ended September 30, 2025
Or
☐
Transition
report pursuant to section 13 or 15( d )
of the Securities Exchange Act of 1934
For
the Transition Period from to
Commission
File Number: 001-39796
Vivos
Therapeutics, Inc.
(Exact
Name of Registrant as Specified in its Charter)
Delaware
81-3224056
(State
or other jurisdiction
of incorporation or organization)
(I.R.S.
Employer
Identification No.)
7921
Southpark Plaza , Suite 210 ,
Littleton ,
CO
80120
(Address
of principal executive offices)
(Zip
Code)
Registrant’s
telephone number, including area code:
(866)
908-4867
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
Trading
symbol(s)
Name
of exchange on which registered
Common
stock, par value $0.0001 per share
VVOS
Nasdaq
Capital Market
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. YES ☒ NO ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). YES ☒ NO ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer”,
“smaller reporting company”, or “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer ☐
Accelerated
filer ☐
Non-accelerated
filer ☒
Smaller
reporting company ☒
Emerging
growth company ☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES ☐ NO ☒
The
registrant had 8,988,106 shares of its common stock, $ 0.0001 par value per share, outstanding as of November 14, 2025.
TABLE
OF CONTENTS
Page
Cautionary Note Regarding Forward-Looking Statements
1
PART
I.
FINANCIAL INFORMATION
3
Item
1.
Condensed Consolidated Financial Statements (Unaudited)
3
Condensed Consolidated Balance Sheets as of September 30, 2025 and December 31, 2024
3
Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2025 and 2024
4
Condensed Consolidated Statements of Stockholder’s Equity for the three and nine months ended September 30, 2025 and 2024
5
Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2025 and 2024
6
Notes to the Condensed Consolidated Financial Statements
7
Item
2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
31
Item
3.
Quantitative and Qualitative Disclosures About Market Risk
43
Item
4.
Controls and Procedures
43
PART
II.
OTHER INFORMATION
44
Item
1.
Legal Proceedings
44
Item
1A.
Risk Factors
45
Item
2.
Unregistered Sales of Equity Securities and Use of Proceeds
49
Item
3.
Defaults Upon Senior Securities
49
Item
4.
Mine Safety Disclosures
49
Item
5.
Other Information
49
Item
6.
Exhibits, Financial Statement Schedules
49
Signatures
50
i
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
Quarterly Report on Form 10-Q (this “Report”) contains “forward-looking statements” (as defined in Section 27A
of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended) that reflect our current
expectations and views of future events. The forward-looking statements are contained principally in the section entitled “Management’s
Discussion and Analysis of Financial Condition and Results of Operations.” Readers are cautioned that known and unknown risks,
uncertainties and other factors, including those over which we may have no control and others listed in this Report and our other public
filings, may cause our actual results, performance or achievements to be materially different from those expressed or implied by the
forward-looking statements.
You
can identify some of these forward-looking statements by words or phrases such as “may,” “will,” “expect,”
“anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,”
“is/are likely to,” “potential,” “continue” or other similar expressions. We have based these forward-looking
statements largely on our current expectations and projections about future events that we believe may affect our financial condition,
results of operations, business strategy and financial needs. These forward-looking statements include statements relating to:
●
our
ability to continue to refine and execute our evolving business plan, including establishing and growing our new sales, marketing
and distribution model where we acquire or create contractual alliances with operators of sleep testing and treatment centers as
a means of driving sales of our appliances, including our June 2025 acquisition of The Sleep Center of Nevada (“SCN”);
●
our
ability to implement and grow our sales, marketing distribution model, which is new and unproven and may not produce the benefits
we anticipate;
●
our
ability to successfully integrate SCN business into our operations;
●
our
ability to service the substantial indebtedness we incurred in connection with financing the SCN acquisition;
●
compliance
with laws, rules and regulations relating to the corporate practice of medicine;
●
the
acceptance and adoption by dentists, sleep specialists, medical doctors and other healthcare professionals of our proprietary oral
appliances as a treatment for dentofacial abnormalities and/or mild to severe obstructive sleep apnea (“OSA”) and snoring
in adults and moderate to severe OSA in children ages 6-17 as per our U.S. Food and Drug Administration (or “FDA”) clearances;
●
our
expectations concerning the effectiveness and duration of treatment using our appliances and protocols (which we refer to as The
Vivos Method) and the potential for side effects including, but not limited to, patient relapse after completion of treatment;
●
the
potential financial benefits to dentists, sleep testing centers, sleep specialists, and other healthcare professionals from treating
patients with The Vivos Method;
●
our
potential profit margin from sales or leasing of our appliances and other treatments and services, including our SleepImage ®
home sleep testing rings;
●
our
ability to formulate, implement and modify as necessary effective sales, marketing and strategic initiatives to drive revenue growth
(including, for example, our recently implemented strategic alliance and/or acquisition model, our SleepImage ® home
sleep apnea test and our other arrangements with sleep clinics and/or durable medical equipment companies
(“DMEs”));
1
●
the
viability of our current intellectual property and our ability to create and protect new intellectual property in the future;
●
acceptance
of our products and services by the medical and dental communities, as well as the marketplace of the products and services that
we market;
●
government
regulations and our ability to obtain applicable regulatory approvals and comply with government regulations including under healthcare
laws and the rules and regulations of the FDA and non-U.S. equivalent regulatory bodies;
●
our
ability to hire and retain key employees and other service providers (including dentists or other healthcare providers);
●
the
emergence of alternative technologies, devices, drugs or other therapies which directly or indirectly impact the marketability of
our products and services;
●
adverse
changes in general market conditions for medical devices and the products and services we offer;
●
our
ability to generate cash flow and profitability and continue as a going concern;
●
our
future financing plans; and
●
our
ability to adapt to changes in market conditions (including volatile and difficult to access capital markets) which could impair
our operations and financial performance.
These
forward-looking statements involve numerous risks and uncertainties. Although we believe that our expectations expressed in these forward-looking
statements are reasonable, our expectations may later be found to be incorrect. Our actual results of operations or the results of other
matters that we anticipate herein could be materially different from our expectations. Important risks and factors that could cause our
actual results to be materially different from our expectations are generally set forth in “Management’s Discussion and Analysis
of Financial Condition and Results of Operations” “Business” and other sections in this Report as well as the “Risk
Factors” section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and our other public filings. You
should thoroughly read this Report and the documents that we refer to with the understanding that our actual future results may be materially
different from and worse than what we expect. We qualify all of our forward-looking statements by these cautionary statements.
The
forward-looking statements made in this Report relate only to events or information as of the date on which the statements are made in
this Report. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether
as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence
of unanticipated events. You should read this Report and the documents that we refer to in this Report and have filed as exhibits to
this Report and our other public filings, completely and with the understanding that our actual future results may be materially different
from what we expect.
2
PART
I – FINANCIAL INFORMATION
Item
1. Financial Statements.
VIVOS
THERAPEUTICS INC.
Unaudited
Condensed Consolidated Balance Sheets
(In
Thousands, Except Per Share Amounts)
September 30,
2025
December 31,
2024
Current assets
Cash and cash equivalents
$ 3,087
$ 6,260
Accounts receivable, net of allowance of $ 495 and $ 390 , respectively
2,134
430
Prepaid expenses and other current assets
565
783
Total current assets
5,786
7,473
Long-term assets
Goodwill
8,450
2,843
Property and equipment, net
5,642
3,350
Operating lease right-of-use asset
3,383
1,032
Intangible assets, net
2,172
370
Deposits and other
211
216
Total assets
$ 25,644
$ 15,284
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable
$ 2,103
$ 1,098
Accrued expenses
2,682
2,234
Current portion of contract liabilities
537
896
Current portion of operating lease liability
734
477
Current portion of financing lease liability
55
-
Current portion of debt
339
-
Other current liabilities
987
273
Total current liabilities
7,437
4,978
Long-term liabilities
Contract liabilities, net of current portion
1
97
Employee retention credit liability
2,904
1,220
Operating lease liability, net of current portion
2,866
1,035
Financing lease liability, net of current portion
125
-
Debt, net of current portion
8,379
-
Other liabilities
1,400
-
Total liabilities
23,112
7,330
Commitments and contingencies (Note 13)
-
-
Stockholders’ equity
Preferred Stock, $ 0.0001 par value per share. Authorized 50,000,000 shares; no shares issued and outstanding
-
-
Common Stock, $ 0.0001 par value per share. Authorized 200,000,000 shares; issued and outstanding 8,266,877 shares as of September 30, 2025 and 5,889,520 shares as of December 31, 2024
1
-
Additional paid-in capital
120,995
112,141
Accumulated deficit
( 118,464 )
( 104,187 )
Total stockholders’ equity
2,532
7,954
Total liabilities and stockholders’ equity
$ 25,644
$ 15,284
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
VIVOS
THERAPEUTICS INC.
Unaudited
Condensed Consolidated Statements of Operations
(In
Thousands, Except Per Share Amounts)
2025
2024
2025
2024
Three Months Ended
September 30,
Nine Months Ended
September 30,
2025
2024
2025
2024
Revenue
Product revenue
$ 2,195
$ 1,958
$ 5,893
$ 5,608
Service revenue
4,588
1,902
7,726
5,725
Total revenue
6,783
3,860
13,619
11,333
Cost of sales (exclusive of depreciation and amortization shown separately below)
2,846
1,526
6,065
4,411
Gross profit
3,937
2,334
7,554
6,922
Operating expenses
General and administrative
7,884
4,487
19,181
13,531
Sales and marketing
403
346
1,018
1,319
Depreciation and amortization
384
146
867
437
Total operating expenses
8,671
4,979
21,066
15,287
Operating loss
( 4,734 )
( 2,645 )
( 13,512 )
( 8,365 )
Non-operating income (expense)
Other expense
( 679 )
( 18 )
( 850 )
( 42 )
Other income
13
47
86
98
Loss before income taxes
( 5,400 )
( 2,616 )
( 14,276 )
( 8,309 )
Net loss
$ ( 5,400 )
$ ( 2,616 )
$ ( 14,276 )
$ ( 8,309 )
Net loss per share (basic and diluted)
$ ( 0.49 )
$ ( 0.40 )
$ ( 1.49 )
$ ( 1.94 )
Weighted average number of shares of Common Stock outstanding (basic and diluted)
10,963,590
6,615,320
9,557,368
4,282,210
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
VIVOS
THERAPEUTICS INC.
Unaudited
Condensed Consolidated Statements of Stockholders’ Equity
(In
Thousands, Except Common Stock Amounts)
Shares
Amount
Capital
Deficit
Total
Nine Months Ended September 30, 2025 and 2024
Additional
Common Stock
Paid-in
Accumulated
Shares
Amount
Capital
Deficit
Total
Balances, December 31, 2023
1,833,877
$ -
$ 93,462
$ ( 93,051 )
$ 411
Issuance of commons stock upon exercise of warrants, net of issuance costs
897,393
-
3,635
-
3,635
Issuance of warrants to consultants for services
-
-
6
-
6
Stock-based compensation expense
-
-
293
-
293
Net loss
-
-
-
( 3,763 )
( 3,763 )
Balances, March 31, 2024
$ 2,731,270
$ -
$ 97,396
$ ( 96,814 )
$ 582
Issuance of common stock and warrants in private placement, net of issuance costs
169,498
-
7,400
-
7,400
Issuance of commons stock upon exercise of warrants, net of issuance costs
496,000
-
-
-
-
Issuance of common stock to consultants for services
4,720
14
14
Issuance of warrants to consultants for services
-
-
11
-
11
Stock-based compensation expense
-
-
270
-
270
Net loss
-
-
-
( 1,930 )
( 1,930 )
Balances, June 30, 2024
3,401,488
$ -
$ 105,091
$ ( 98,744 )
$ 6,347
Issuance of common stock and warrants in private placement, net of issuance costs
1,363,812
-
3,786
-
3,786
Issuance of warrants to consultants for services
-
-
6
-
6
Stock-based compensation expense
-
-
142
-
142
Net loss
-
-
-
( 2,616 )
( 2,616 )
Balances, September 30, 2024
4,765,300
$ -
$ 109,025
$ ( 101,360 )
$ 7,665
Balances, December 31, 2024
5,889,520
$ -
$ 112,141
$ ( 104,187 )
$ 7,954
Stock-based compensation expense
-
-
317
-
317
Net loss
-
-
-
( 3,864 )
( 3,864 )
Balances, March 31, 2025
Balances,
March 31, 2025
$ 5,889,520
$ -
$ 112,458
$ ( 108,051 )
$ 4,407
Balances
$ 5,889,520
$ -
$ 112,458
$ ( 108,051 )
$ 4,407
Issuance of common stock and warrants in private placement, net of issuance costs
828,000
-
3,642
-
3,642
Common stock consideration for acquisition
607,287
-
1,305
-
1,305
Stock-based compensation expense
-
-
242
-
242
Net loss
-
-
-
( 5,013 )
( 5,013 )
Balances, June 30, 2025
7,324,807
$ -
$ 117,647
$ ( 113,064 )
$ 4,583
Balances
7,324,807
$ -
$ 117,647
$ ( 113,064 )
$ 4,583
Issuance of common stock under At-The-Market program, net of issuance costs
762,070
1
2,427
-
2,428
Issuance of common stock upon exercise of warrants, net of issuance costs
180,000
-
866
866
Stock-based compensation expense
-
-
55
-
55
Net loss
-
-
-
( 5,400 )
( 5,400 )
Balances, September 30, 2025
8,266,877
$ 1
$ 120,995
$ ( 118,464 )
$ 2,532
Balances
8,266,877
$ 1
$ 120,995
$ ( 118,464 )
$ 2,532
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5
VIVOS
THERAPEUTICS INC.
Unaudited
Condensed Consolidated Statements of Cash Flows
(In
Thousands)
2025
2024
Nine Months Ended
September 30,
2025
2024
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$ ( 14,276 )
$ ( 8,309 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense
614
705
Paid-in-kind interest expense on promissory note
100
-
Depreciation and amortization
867
437
Fair value of common stock issued for services
-
11
Fair value of warrants issued for services
-
26
Changes in operating assets and liabilities:
Accounts receivable
( 770 )
( 252 )
Operating lease liabilities, net
( 74 )
( 95 )
Prepaid expenses and other current assets
228
( 19 )
Deposits
48
44
Accounts payable
948
( 1,070 )
Accrued expenses
315
( 293 )
Other liabilities
1,004
( 1 )
Contract liability
( 455 )
( 935 )
Net cash used in operating activities
( 11,451 )
( 9,751 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Payment for acquisition, net of excess cash of $ 865
( 5,135 )
-
Acquisitions of property and equipment
( 810 )
( 403 )
Net cash used in investing activities
( 5,945 )
( 403 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of debt
9,225
-
Proceeds from issuance of common stock
2,775
4,296
Proceeds from issuance of warrants
1,699
7,500
Proceeds from issuance of pre-funded warrants
609
3,941
Proceeds from exercise of warrants
866
-
Payments for issuance costs
( 837 )
( 915 )
Reduction of finance lease liability
( 17 )
-
Reduction of debt liability
( 97 )
-
Net cash provided by financing activities
14,223
14,822
Net increase (decrease) in cash and cash equivalents
( 3,173 )
4,668
Cash and cash equivalents at beginning of year
6,260
1,643
Cash and cash equivalents at end of year
$ 3,087
$ 6,311
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
Cash paid for interest
$ -
$ 7
SUPPLEMENTAL DISCLOSURE OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Conversion of promissory note, net of issuance costs
$ 1,100
$ -
Common stock issued as consideration of acquisition
$ 1,305
$ -
Contingent consideration as consideration for acquisition
$ 1,400
$ -
Fair value of warrants issued in private placement
$ -
$ 262
Acquisitions of property and equipment by issuing debt
$ 928
$ -
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
6
VIVOS
THERAPEUTICS INC.
Notes
to Unaudited Condensed Consolidated Financial Statements
For
the Three and Nine Months Ended September 30, 2025 and 2024
NOTE
1 - ORGANIZATION, DESCRIPTION AND SIGNIFICANT ACCOUNTING POLICIES
Organization
BioModeling
Solutions, Inc. (“BioModeling”) was organized on March 20, 2007 as an Oregon limited liability company, and subsequently
incorporated in 2013. On August 16, 2016, BioModeling entered into a share exchange agreement (the “SEA”) with First Vivos,
Inc. (“First Vivos”), and Vivos Therapeutics, Inc. (“Vivos”), a Wyoming corporation established on July 7, 2016
to facilitate the SEA transaction. Vivos was formerly named Corrective BioTechnologies, Inc. until its name changed on September 6, 2016
to Vivos Biotechnologies and on March 2, 2018 to Vivos Therapeutics, Inc. and had no substantial pre-combination business activities.
First Vivos was incorporated in Texas on November 10, 2015. Pursuant to the SEA, all of the outstanding shares of common stock and warrants
of BioModeling and all of the shares of common stock of First Vivos were exchanged for newly issued shares of common stock and warrants
of Vivos, the legal acquirer. The transaction was accounted for as a reverse acquisition and recapitalization, with BioModeling as the
acquirer for financial reporting and accounting purposes. Upon the consummation of the merger, the historical financial statements of
BioModeling became the Company’s historical financial statements and recorded at their historical carrying amounts.
On
August 12, 2020, Vivos reincorporated from Wyoming to become a domestic Delaware corporation under Delaware General Corporate Law. Accordingly,
as used herein, the term “the Company,” “we,” “us.” “our” and similar terminology refer
to Vivos Therapeutics, Inc., a Delaware corporation and its consolidated subsidiaries. As used herein, the term “Common Stock”
refers to the common stock, $ 0.0001 par value per share, of Vivos Therapeutics, Inc., a Delaware corporation.
On
June 10, 2025, we acquired all of the operating assets (the “Acquisition”) of R.D. Prabhu-Lata K. Shete MDs, LTD., a Nevada
professional corporation d/b/a The Sleep Center of Nevada (“SCN”) in consideration for a (i) cash payment equal to $ 6.0 million,
(ii) 607,287 shares of restricted common stock in the Company, par value $ 0.0001 per share (the “Common Stock”), equal to
$ 1.5 million based on the volume-weighted average price (“VWAP”) of the Common Stock for the 30 days immediately preceding
the Acquisition and (iii) the assumption of certain specific trade accounts payable and liabilities related to specific SCN contracts
assigned to the Company in connection with the Acquisition. See Note 3 for further information.
Description
of Business
We
are a medical technology and services company that features a comprehensive suite of proprietary oral appliances and therapeutic
treatments. Our products include non-surgically treat certain maxillofacial and developmental abnormalities of the mouth and jaws
that are closely associated with breathing and sleep disorders such as, mild to severe obstructive sleep apnea (“OSA”)
and snoring in adults. We offer three separate clinical pathways or programs to providers: (i) Guided Growth and Development, (ii)
Lifeline and (iii) Complete Airway Repositioning and Expansion (“C.A.R.E.”). Each program features certain oral
appliances coupled with specific therapeutic treatments, and each clinical pathway is intended to address the specific needs of a
diverse patient population with different patient journeys. For example, the Guided Growth and Development program features the
Vivos pediatric tooth positioner and PE x appliances along with CO 2 laser treatments and other adjunctive
therapies designed for treating palatal growth and expansion in pediatric patients as they grow. The mid-range priced Lifeline
program features a selection of mandibular advancement devices (“MADs”) such as the Versa and Vida Sleep which are U.S.
Food and Drug Administration (“FDA”) 510(k) cleared for mild-to-moderate OSA in adults, along with the patented Vida
appliance, which is FDA 510(k) cleared as unspecified classification for the alleviation of Temporomandibular Joint Dysfunction
(“TMD”) symptoms, bruxism, migraine headaches, and nasal dilation.
7
Our
flagship C.A.R.E. program, which is part of The Vivos Method, features our patented DNA, mRNA and mmRNA appliances, which are also FDA
510(k) cleared for mild-to-severe OSA and snoring in adults. The Vivos Method may also include adjunctive myofunctional, chiropractic/physical
therapy, and laser treatments that, when properly used with the C.A.R.E. appliances, constitute a powerful non-invasive and cost-effective
means of reducing or eliminating OSA symptoms. In a small subset of a study, the data has actually shown that The Vivos Method can reverse
OSA symptoms in a large portion (up to 80 %) of patients. The primary competitive advantage of The Vivos Method over other OSA therapies
is that The Vivos Method’s typical course of treatment is limited in most cases to 12 to 15 months, and it is possible not to need
lifetime intervention, unlike CPAP and neuro-stimulation implants. Additionally, out of approximately 60,000 patients treated to date
worldwide with our entire current suite of products, there have been very few instances of relapse.
Although
not our current focus due to the pivot in the business model, we have historically offered a suite of diagnostic and support products
and services to dental and medical providers and distributors who service patients with OSA or related conditions. Such products and
services include (i) VivoScore home sleep screenings and tests (powered by SleepImage ® technology), (ii) Treatment Navigator
(a concierge service to assist a provider in educating and supporting the doctors as they navigate insurance coverage, diagnostic indications
and treatment options), (iii) Billing Intelligence Services (which optimizes medical and dental reimbursement), (v) advanced training
and continuing education courses at our Vivos Institute in Denver, Colorado, and (iv) MyoCorrect, a service through which Vivos-trained
providers can provide orofacial myofunctional therapy (“OMT”) to patients via a telemedicine platform. Some of these services
including home sleep screenings, treatment navigator services and MyoCorrect are being provided to patients directly under the new sales,
marketing and distribution model described below. With this shift in focus, we shifted our Medical Integration Division (MID”)
to pursue strategic alliances and acquisitions of sleep centers to provide better options using Vivos products for patients who have
been diagnosed with OSA.
Legacy
Business Model
Our
business model has historically been to teach, train, and support dentists, medical doctors, and distributors in the use of our products
and services. Dentists who use our products and services typically enroll in a variety of live or online training and educational programs
offered through our Vivos Institute; a 18,000 sq. ft. facility located near the Denver International Airport. Dentists are able to select
the specific program or clinical pathway that they want to focus on, such as Guided Growth and Development or Lifeline or both. They
could also enroll in our Vivos Integrated Provider (“VIP”) program for the complete set training, educational, and support
services available in all three clinical pathway programs. Dentists enrolled in the VIP program are referred to as “VIPs.”
We historically charged up front enrollment fees to educate and train new VIPs. We also charged for the ancillary support services listed
above and view each product and service as a revenue center. We refer to the VIP-focused business model herein as our “legacy”
or “historic” business model.
New
Sales, Marketing and Distribution Model
Over
the course of 2024 and during 2025, we worked to pivot our business strategy and began to steadily decrease our prior dependence
on dentists to sell our products and our dependence on VIP enrollment revenue. This new business strategy is focused on contractual alliances
with and outright acquisitions of sleep specialty providers, sleep centers and others and is based on a profit-sharing model between
us and the provider which aligns our revenue generation more directly to sales of our novel appliances.
In
June 2024, we entered into our first contractual alliance with Rebis Health, a sleep center operator in Colorado. Revenues from this
arrangement have not developed as we had expected for many reasons beyond our control, but we learned important lessons which have led
to changes to this model.
In
June 2025, we acquired all assets, including operating assets such as sleep testing, diagnostics, and treatment centers, of SCN. The
Acquisition marked a milestone in the pivot to our sales, marketing distribution model for our innovative OSA appliances. Under the new
model, SCN will provide sleep disorder patients with the opportunity to be candidates for our advanced, proprietary and FDA-cleared CARE
oral medical devices, oral appliances and additional adjunctive therapies and methods. Under customary agreements designed to comply
with applicable corporate practice of medicine law, our operation of SCN allows us to manage and capture both diagnostic and consulting
revenues, representing new higher margin revenue streams for us, as well as potential Vivos appliance and related product and service
revenue from SCN.
8
We
are exploring and seeking to implement additional acquisitions of, or collaborations with, medical sleep and similar healthcare practices
to expand our business model in an effort to grow our revenues.
We
refer to this new model herein alternatively as our new sales, marketing and distribution model or our strategic alliance and/or acquisition
model.
Basis
of Presentation and Consolidation
The
Company’s unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting
principles (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found
in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting
Standards Board (“FASB”).
In
the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments, consisting
of normal recurring adjustments, which are necessary to present fairly the Company’s financial position, results of operations,
and cash flows. The condensed consolidated balance sheet at December 31, 2024 has been derived from audited financial statements at that
date. The interim results of operations are not necessarily indicative of the results that may occur for the full fiscal year. Certain
information and footnote disclosure normally included in the financial statements prepared in accordance with GAAP have been condensed
or omitted pursuant to instructions, rules, and regulations prescribed by the United States Securities and Exchange Commission (“SEC”).
The
Company believes that the disclosures provided herein are adequate to make the information presented not misleading when these unaudited
condensed consolidated financial statements are read in conjunction with the December 31, 2024 audited consolidated financial statements
contained in the Company’s 2024 Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on March
31, 2025.
Emerging
Growth Company Status
The
Company is an “emerging growth company” (an “EGC”), as defined in Section 2(a) of the Securities Act, as modified
by the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), and as a result, we may take advantage of certain exemptions
from various reporting requirements that are applicable to other public companies that are not EGCs. These include, but are not limited
to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley
Act”), reduced disclosure obligations regarding executive compensation, and exemptions from the requirements of holding a nonbinding
advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved.
Further,
Section 102(b)(1) of the JOBS Act exempts EGCs from being required to comply with new or revised financial accounting standards until
private companies (that is, those that have not had a Securities Act registration statement declared effective or do not have a class
of securities registered under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) are required to comply
with the new or revised financial accounting standards. The JOBS Act provides that a company can elect to opt out of the extended transition
period and comply with the requirements that apply to non-EGC but any such election to opt out is irrevocable. We currently expect to
retain our status as an EGC until December 31, 2025, and will do a full assessment during our fourth quarter to identify the
required updates to our disclosures going forward.
Revenue
Recognition
Prior
to the 2024-2025 pivot in business model as described above, we generated revenue from the sale of products and services and a significant
majority of our revenues was generated from enrolling dentists as either (i) Guided Growth and Development VIPs; (ii) Lifeline VIPs;
(iii) combined Guided Growth and Development and Lifeline VIPs; or Premier Vivos Integrated Providers (“Premier VIPs”). Prior
to the second quarter of 2023, the majority of VIP enrollments were Premier VIPs. The other, lower priced enrollments were piloted in
fiscal quarters prior to second quarter of 2023, and on a limited basis. They were officially adopted during the second quarter of 2023.
For each VIP program, revenue is recognized when control of the products or services is transferred to customers (i.e., VIP dentists
ordering such products or services for their patients) in a manner that reflects the consideration we expect to be entitled to in exchange
for those products and services. We will continue to recognize some legacy VIP-related revenue even as we seek to grow revenues via our
new sales, marketing and distribution strategy.
9
Following
the guidance of ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”) and the applicable provisions of
ASC Topic 842 , Leases (“ASC 842”), we determine revenue recognition through the following five-step model,
which entails:
1)
identification
of the promised goods or services in the contract;
2)
determination
of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the
contract;
3)
measurement
of the transaction price, including the constraint on variable consideration;
4)
allocation
of the transaction price to the performance obligations; and
5)
recognition
of revenue when, or as the Company satisfies each performance obligation.
Service
Revenue
VIP
Enrollment Revenue
As
part of our legacy business model based on VIP enrollment revenue and related appliance sales, we reviewed our VIP enrollment contracts
from a revenue recognition perspective using the 5-step method outlined above. While we have pivoted our marketing and distribution model
over the last year, we still recognize legacy VIP enrollment revenue and will continue to do so through 2026. Unearned revenue reported
on the balance sheet as contract liability represents the portion of fees paid by VIP customers for services that have not yet been performed
as of the reporting date and are recorded as the service is rendered. We recognize this revenue as performance obligations are met.
VIP
enrollment fees historically included multiple performance obligations which varied on a contract-by-contract basis. The performance
obligations included with enrollments may include sleep apnea rings, a six- or twelve-month BIS subscription, a marketing package, lab
credits and the right to sell our appliances. We allocate the transaction price of a VIP enrollment contract to each performance obligation
under such contract using the relative standalone selling price method. The relative standalone price method is based on the proportion
of the standalone selling price of each performance obligation to the sum of the total standalone selling prices of all the performance
obligations in the contract.
The
right to sell is similar to a license of intellectual property because without it the VIP cannot purchase appliances from us. The right
to sell performance obligation includes the Vivos training and enrollment materials which prepare dentists for treating their patients
using The Vivos Method.
Because
the right to sell was never sold outside of VIP contracts, and VIP contracts were sold for varying prices, we believe that the appropriate
treatment was to estimate the standalone selling price of this performance obligation using the residual method. As such, the observable
prices of other performance obligations under a VIP contract were deducted from the contract price, with the residual being allocated
to the right to sell performance obligation.
In
our legacy VIP model, we used significant judgements in revenue recognition, including an estimation of customer life over which we recognize
the right to sell. This included different determinations with respect to different levels of VIP subscriptions to ascertain the revenue
allocated to the right to sell for various types of VIPs. Revenue is recognized in accordance with each individual performance obligation
unless it becomes remote the VIP will continue as a VIP, at which time the remainder of revenue is accelerated and recognized in the
following month. Those VIPs who completed our training typically remained active for a much longer period, and revenue from the right
to sell for those VIPs is recognized over the estimated period of which those VIPs will remain active. Because of various factors occurring
year to year, we have estimated customer life for each year a contract is initiated. Estimated customer lives have been calculated separately
for each year and were estimated between 14 months and 27 months for the years 2020 through 2024, depending upon the length of time customers
stayed active each year. Year to date revenue for the right to sell is being recognized over the requisite period depending upon when
the VIP enrolled. The right to sell is recognized on a sum of the years’ digits method over the estimated customer life for each
year as this approximates the rate of decline in VIPs purchasing behaviors we have observed and will be fully recognized by year end
2026.
10
Other
Service Revenue
BIS
is an additional service provided on a monthly subscription basis, which includes our AireO2 medical billing and practice management
software. Revenue for these services is recognized monthly during the month the services are rendered.
We
also offer our VIPs the ability to provide MyoCorrect to the VIP’s patients as part of treatment with The Vivos Method. The program
includes packages of treatment sessions that are sold to the VIPs and resold to their patients. Revenue for MyoCorrect services is recognized
over the 12-month performance period as therapy sessions occur.
As
we shift to our new strategic acquisition and alliance business model, we expect to derive a greater portion of our revenues from product
sales to patients who are referred by sleep and airway medicine centers in select markets with established patient bases who are diagnosed
with OSA or other sleep related breathing disorders. Although we will continue to sell our products and services to trained and qualified
VIP dentists, we eventually expect the revenue from our new strategic alliance and acquisitions business model to constitute the vast
majority of service revenue for us.
Allocation
of Revenue to Performance Obligations
We
identify all goods and services that are delivered separately under a sales arrangement and allocate revenue to each performance obligation
based on relative fair values. These fair values approximate the prices for the relevant performance obligation that would be charged
if those services were sold separately and are recognized over the relevant service period of each performance obligation. After allocation
to the performance obligations, any remainder is allocated to the right to sell under the residual method and is recognized over the
estimated customer life. In general, revenues are separated between durable medical equipment (product revenue) and education and training
services (service revenue).
Treatment
of Discounts and Promotions
Under
our legacy VIP model, from time to time, we offered various discounts to VIPs relating to their participation in the VIP program. These
include the following:
1)
Discount
for cash paid in full
2)
Conference
or trade show incentives, such as subscription enrollment into the SleepImage ® home sleep test program, or a free
trial period for the SleepImage ® lease program
3)
Negotiated
concessions on annual enrollment fee
4)
Credits/rebates
to be used towards future product orders such as lab rebates
The
amount of the discount is determined up front prior to the sale. Accordingly, measurement is determined before the sale occurs and revenue
is recognized based on the terms agreed upon between us and the customer over the performance period. In rare circumstances, a discount
has been given after the sale during a conference which is offering a discount to full price. In this situation, revenue is measured
and the change in transaction price is allocated over the remaining performance obligation.
The
amount of consideration can vary by customer due to promotions and discounts authorized to incentivize a sale. Prior to the sale, the
customer and us agree upon the amount of consideration that the customer will pay in exchange for the we provide. The net consideration
that the customer has agreed to pay is the expected value that is recognized as revenue over the service period. At the end of each reporting
period, we update the transaction price to represent the circumstances present at the end of the reporting period and any changes in
circumstances during the reporting period.
11
Product
Revenue
In
addition to revenue from services, we also generate revenue from sales of our line of oral devices and preformed pediatric tooth positioners
(known as appliances or systems) to our customers, the VIP dentists or OSA patients directly in the case of our strategic alliance model.
These include the DNA appliance ® , mRNA appliance ® , the mmRNA appliance, the Versa, the Vida, the Vida Sleep
and others. We expanded our product offerings in the first quarter of 2023 via the acquisition of certain U.S. and international patents,
product rights, and other miscellaneous intellectual property from Advanced Facialdontics, LLC, a New York limited liability company
(“AFD”). Our appliances are similar to a retainer that is worn in the mouth after braces are removed. Each appliance is unique
and is fitted to the patient.
VIP
Model
Under
our legacy VIP model, revenue from appliance sales is recognized when the control of a product is transferred to the VIP in an amount
that reflects the consideration it expects to be entitled to in exchange for those products. The VIP in turn charges the VIP’s
patient and or patient’s insurance a fee for the appliance and for his or her professional services in measuring, fitting, and
installing the appliance and educating the patient as to its use. We contract with VIPs for the sale of the appliance, and we are not
involved in the sale of the products and services from the VIP to the VIP’s patient. In the case of sales to sleep centers through
our distribution alliances, revenue from appliance sales is recognized when the control of a product is transferred to the patient.
We
utilize our network of certified VIPs throughout the United States and in some non-U.S. jurisdictions (notably Canada and Australia)
to sell the appliances to their customers as well as in two dental centers that we operate. We utilize third party contract manufacturers
or labs to produce our patient-customized, patented appliances and our preformed pediatric tooth positioners. The manufacturer designated
by us produces the appliance in strict adherence to our patents, design files, treatments, processes and procedures and under the direction
and specific instructions from us, ships the appliance to the healthcare provider who ordered the appliance from us. All of our contract
manufacturers are required to follow our master design files in the production of appliances, or the lab will be in violation of the
FDA’s rules and regulations. We have performed an analysis and concluded we are the principal in the transaction since we have
control of the product, and we are reporting revenue gross. Under our legacy model, we billed the VIP the contracted price for the appliance
which is recorded as product revenue. Product revenue is recognized once the appliance ships to the VIP under our direction.
Historically,
in support of the VIPs using our appliances for their patients, we utilized a team of trained technicians to measure, order and fit each
appliance. Revenue is recognized differently for Company owned centers and distribution alliances with third party sleep centers than
it does for revenue from VIPs. Upon scheduling the patient (which is our customer in this case), the center takes a deposit and reviews
the patient’s insurance coverage. We recognize revenue in the centers after the appliance is received from the manufacturer and
once the appliance is fitted and provided to the patient.
We
also historically offered certain dentists (known as Clinical Advisors) discounts to standard VIP pricing. This was done to help encourage
Clinical Advisors, who help the VIPs with technical aspects of our products, to purchase our products for their own practices. In addition,
from time to time, we offered credits to incentivize VIPs to adopt our products and increase case volume within their practices. These
incentives are recorded as a liability at issuance and are deducted from the related product sale at the time the credit is used.
New
Sales, Marketing and Distribution Model
Under
our new sales, marketing and distribution strategy, we train and employ providers to treat OSA patients directly, which allows us to
introduce and offer our oral appliances and therapeutic treatments to the patient rather than to the VIP dentist, who in turn offers
our appliances or treatments.
In
the case of an acquisition like SCN, this new model also allows us to capture product sales at the point in time when shipment of the
related products occurs as well as OSA diagnostic and treatment revenue. In the case of contractual alliances, through varying arrangements,
we capture revenue from appliance sales as principal in the transaction, and depending on the agreement, pay a fee or split gross profit
or net income with the sleep medical provider affiliate,
12
Use
of Estimates
The
preparation of financial statements and related disclosures in conformity with U.S. GAAP requires us to make judgments, assumptions,
and estimates that affect the amounts reported in its consolidated financial statements and accompanying notes. We base our estimates
and assumptions on existing facts, historical experience, and various other factors that we believe are reasonable under the circumstances,
to determine the carrying values of assets and liabilities that are not readily apparent from other sources. Our significant accounting
estimates include, but are not necessarily limited to, assessing collectability on accounts receivable, determining customer life and
breakage related to recognizing revenue for VIP contracts, impairment of goodwill and long-lived assets; valuation assumptions for assets
acquired in asset acquisitions and business combinations; valuation assumptions for stock options, warrants, warrant liabilities and
equity instruments issued for goods or services; deferred income taxes and the related valuation allowances; and the evaluation and measurement
of contingencies. We believe we have made appropriate accounting estimates based on the facts and circumstances available as of the reporting
date. To the extent there are material differences between our estimates and the actual results, our future consolidated results of operations
will be affected.
Accounts
Receivable, Net
Accounts
receivable represent amounts due from customers in the ordinary course of business and are recorded at the invoiced amount and do not
bear interest. Accounts receivables are stated at the net amount expected to be collected, using an expected credit loss methodology
to determine the allowance for expected credit losses. We evaluate the collectability of its accounts receivable and determine the appropriate
allowance for expected credit losses based on a combination of factors, including the aging of the receivables, historical collection
trends, and charge-offs. When we are aware of a customer’s inability to meet its financial obligation, we may individually evaluate
the related receivable to determine the allowance for expected credit losses. We use specific criteria to determine uncollectible receivables
to be charged off, including bankruptcy filings, the referral of customer accounts to outside parties for collection, and the length
that accounts remain past due.
Loss
and Gain Contingencies
We
are subject to the possibility of various loss contingencies arising in the ordinary course of business. An estimated loss contingency
is accrued when it is probable that an asset has been impaired, or a liability has been incurred, and the amount of loss can be reasonably
estimated. If some amount within a range of loss appears to be a better estimate than any other amount within the range, we accrue that
amount. Alternatively, when no amount within a range of loss appears to be a better estimate than any other amount, we accrue the lowest
amount in the range. If we determine that a loss is reasonably possible and the range of the loss is estimable, then we disclose the
range of the possible loss. If we cannot estimate the range of loss, we will disclose the reason why it cannot estimate the range of
loss. We regularly evaluate current information available to us to determine whether an accrual is required, an accrual should be adjusted
and if a range of possible loss should be disclosed. Legal fees related to contingencies are charged to general and administrative expense
as incurred. Contingencies that may result in gains are not recognized until realization is assured, which typically requires collection
in cash.
Share-Based
Compensation
We
measure the cost of employee and director services received in exchange for all equity awards granted, including stock options, based
on the fair market value of the award as of the grant date. We compute the fair value of stock options using the Black-Scholes-Merton
(“BSM”) option pricing model. We estimate the expected term using the simplified method which is the average of the vesting
term and the contractual term of the respective options. We determine the expected price volatility based on the trading history of our
Common Stock. Industry peers consist of several public companies in the bio-tech industry similar to us in size, stage of life cycle
and financial leverage. We intends to continue to consistently apply this process using the same or similar public companies until a
sufficient amount of historical information regarding the volatility of our own stock price becomes available, or unless circumstances
change such that the identified companies are no longer similar to us, in which case, more suitable companies whose share prices are
publicly available would be utilized in the calculation. We recognize the cost of the equity awards over the period that services are
provided to earn the award, usually the vesting period. For awards granted which contain a graded vesting schedule, and the only condition
for vesting is a service condition, compensation cost is recognized as an expense on a straight-line basis over the requisite service
period as if the award were, in substance, a single award. We recognize the impact of forfeitures and cancellations in the period that
the forfeiture or cancellation occurs, rather than estimating the number of awards that are not expected to vest in accounting for stock-based
compensation.
13
Leases
Operating
leases are included in operating lease right-of-use (“ROU”) assets, accrued expenses, and operating lease liability - current
and non-current portion in our balance sheets. ROU assets represent our right to use an underlying asset for the lease term and lease
liabilities represent our obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized
at the lease commencement date based on the present value of lease payments over the lease term. In determining the present value of
lease payments, we use our incremental borrowing rate based on the information available at the lease commencement date as the rate implicit
in the lease is not readily determinable. The determination of our incremental borrowing rate requires management judgment based on information
available at lease commencement. The operating lease ROU assets also include adjustments for prepayments, accrued lease payments and
exclude lease incentives. Our lease terms may include options to extend or terminate the lease when it is reasonably certain that we
will exercise such options. Operating lease cost is recognized on a straight-line basis over the expected lease term. Lease agreements
entered into after the adoption of ASC 842 that include lease and non-lease components are accounted for as a single lease component.
Lease agreements with a noncancelable term of less than 12 months are not recorded on our balance sheets.
Income
Taxes
We
account for income taxes in accordance with Accounting Standards Codification (“ASC”) 740, Income Taxes, under which deferred
income taxes are recognized based on the estimated future tax effects of differences between the financial statement and tax bases of
assets and liabilities given the provisions of enacted tax laws. Deferred income tax provisions and benefits are based on changes to
the assets or liabilities from year to year. In providing for deferred taxes, we consider tax regulations of the jurisdictions in which
we operate, estimates of future taxable income, and available tax planning strategies. If tax regulations, operating results, or the
ability to implement tax-planning strategies vary, adjustments to the carrying value of deferred tax assets and liabilities may be required.
A valuation allowance is recorded when it is more likely than not that a deferred tax asset will not be realized. The recorded valuation
allowance is based on significant estimates and judgments and if the facts and circumstances change, the valuation allowance could materially
change. In accounting for uncertainty in income taxes, we recognize the financial statement benefit of a tax position only after determining
that the relevant tax authority would more likely than not sustain the position following an audit. For tax positions meeting the more
likely than not threshold, the amount recognized in the financial statements is the largest benefit that has a greater than 50 percent
likelihood of being realized upon ultimate settlement with the relevant tax authority. We recognize interest and penalties accrued on
any unrecognized tax benefits as a component of income tax expense.
Basic
and Diluted Net Loss Per Share
Basic
net loss per common share is computed by dividing the net loss applicable to common stockholders by the weighted average number of common
shares outstanding for each period presented. Diluted net loss per common share is computed by giving effect to all potential shares
of Common Stock, including stock options, convertible debt, Preferred Stock, and warrants, to the extent the same are dilutive.
Warrant Accounting
We
account for our warrants and financial instruments as either equity or liabilities based upon the characteristics and provisions of each
instrument, in accordance with ASC 815, Derivatives and Hedging and ASC 480, Distinguishing Liabilities from Equity . Warrants
classified as equity are recorded at fair value as of the date of issuance on our consolidated balance sheets and no further adjustments
to their valuation are made. Warrants classified as liabilities and other financial instruments that require separate accounting as liabilities
are recorded on our consolidated balance sheets at their fair value on the date of issuance and will be revalued on each subsequent balance
sheet date until such instruments are exercised or expire, with any changes in the fair value between reporting periods recorded as other
income or expense. Management estimates the fair value of these liabilities using the Black-Scholes model and assumptions that are based
on the individual characteristics of the warrants or instruments on the valuation date, as well as assumptions, expected volatility,
expected life, yield, and risk-free interest rate.
14
Segment
Information
Operating
segments are defined as components of an enterprise about which separate financial information is available that is evaluated regularly
by a company’s chief operating decision maker (“CODM”), or a decision-making group, in deciding how to allocate resources
and in assessing financial performance. As of September 30, 2025, our CODM is the Company’s Chief Executive Officer, and we concluded
that we have one reportable segment. Refer to Note 16, “Segment Information”, for additional disclosures regarding segment
information.
Accounting
Pronouncements
Presented
below is a discussion of new accounting standards including deadlines for adoption under our current designation as an
EGC.
Recent
Accounting Pronouncements Yet to be Adopted
In
November 2024, the FASB issued ASU No. 2024-03, Disaggregation of Income Statement Expenses (“ASU 2024-03”). The standard’s
purpose is “to improve the disclosures about a public business entity’s expenses and address requests from investors for
more detailed information about the types of expenses (including purchases of inventory, employee compensation, depreciation, amortization,
and depletion) in commonly presented expense captions (such as cost of sales, SG&A, and research and development).” Public
companies will be required to disclose in the notes to financial statements specified information about certain costs and expenses at
each interim and annual reporting period. Specifically, they will be required to:
1.
Disclose
the amounts of (a) purchases of inventory; (b) employee compensation; (c) depreciation; (d) intangible asset amortization; and (e)
depreciation, depletion, and amortization recognized as part of oil- and gas-producing activities (or other amounts of depletion
expense) included in each relevant expense caption.
2.
Include
certain amounts that are already required to be disclosed under current generally accepted accounting principles (GAAP) in the same
disclosure as the other disaggregation requirements.
3.
Disclose
a qualitative description of the amounts remaining in relevant expense captions that are not separately disaggregated quantitatively.
4.
Disclose
the total amount of selling expenses and, in annual reporting periods, an entity’s definition of selling expenses.
The
amendments in the ASU are effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning
after December 15, 2027. Early adoption is permitted. We are currently evaluating the effect of this new guidance on our consolidated
financial statements and disclosures.
We
have reviewed and considered all other recent accounting pronouncements that have not yet been adopted and believe there are none that
could potentially have a material impact on our business practices, financial condition, results of operations, or disclosures.
NOTE
2 - LIQUIDITY AND ABILITY TO CONTINUE AS A GOING CONCERN
The
financial statements have been prepared in conformity with generally accepted accounting principles, which contemplate continuation of
the Company as a going concern. We have incurred losses since inception, including $ 5.4 and $ 2.6 million for the three months ended September
30, 2025 and 2024, respectively, and $ 14.3 and $ 8.3 million for the nine months ended September 30, 2025 and 2024, respectively, resulting
in an accumulated deficit of approximately $ 118.5 million as of September 30, 2025.
15
Net
cash used in operating activities amounted to approximately $ 11.5 and $ 9.8 million for the nine months ended September 30, 2025 and 2024,
respectively. As of September 30, 2025, we had total liabilities of approximately $ 23.1 million.
As
of September 30, 2025, we had approximately $ 3.1 million in cash and cash equivalents, which will not be sufficient to fund operations
and strategic objectives over the next twelve months from the date of the issuance of these financial statements. Without additional
financing, these factors raise substantial doubt regarding the Company’s ability to continue as a going concern.
We
have implemented cost savings measures that have reduced cash used in operations. However, even though we have worked to refine our business
model, our sales did not grow during either of our fiscal years ended 2023 or 2024, nor the nine months of 2025 as anticipated. As such,
we have raised equity capital in the period ended September 30, 2025 and during the fiscal years ended December 31, 2023 and 2024. We
were required to obtain additional financing to satisfy our cash needs (including the Acquisition, as discussed in Note 3) and increase
our stockholders’ equity for Nasdaq compliance purposes as we seek to increase revenue with a view towards ultimately achieving
positive cash flow operations. See Notes 8 and 10 for further information on our financing activity.
Until
we have attained positive cash flow, our management is reviewing all options to obtain additional financing to fund our operations. To
finance the Acquisition, we incurred senior secured debt and issued equity securities to an existing significant investor to sustain
operations for the closing of the Acquisition and to integrate SCN operations into ours as we seek ramp revenues and achieve positive
cash flows, if ever. We originally expected our Strategic Alliance Agreement (“SAA”) with Rebis Health in Colorado entered
into in June 2024 to increase patient volume, drive top line revenue and lower customer acquisition costs and overhead. However, due
to ongoing delays at Rebis Health that have been beyond our control, we are currently re-evaluating and lowering our revenue expectations
under the SAA and are seeking to make other acquisitions or enter into other strategic alliances (such as the Acquisition). There can
be no assurances that adequate additional funding will be available on favorable terms, or at all. If such funds are not available in
the future, or if the Acquisition of SCN, the SAA or similar alliances or acquisitions do not result in the patient volume, appliance
sales and financial results within the timeframes we expect, we may be required to delay, significantly modify or terminate some or all
of our operations, all of which could have a material adverse effect on us and our stockholders.
We
do not have any off-balance sheet arrangements, as defined by applicable regulations of the SEC, that are reasonably likely to have a
current or future material effect on our financial condition, results of operations, liquidity, capital expenditures or capital resources.
NOTE
3 – BUSINESS COMBINATION
On
June 10, 2025 (“Closing Date”), we acquired the net operating assets of SCN pursuant to an Asset Purchase Agreement (the
“SCN Purchase Agreement”). We agreed to purchase the net operating assets and liabilities related to SCN’s sleep testing,
diagnostics, and treatment centers (the “Acquisition”). With seven operating locations, SCN is a leader in delivering and
promoting sleep wellness and health through its proprietary, non-invasive treatments for obstructive sleep apnea (“OSA”)
and is the largest operator of medical sleep centers in the state of Nevada. The Acquisition represents our first major acquisition of
a sleep testing center and associated medical sleep practice. We funded the consideration for the Acquisition at closing by issuing a
senior, non-convertible, secured term note (the “Note”) to Streeterville Capital, LLC (the “Lender”) in the principal
amount of $ 8.3 million. We also entered into a securities purchase agreement with V-Co Investors 2 LLC, a Wyoming limited liability company
and an affiliate of a significant investor in our company (“V-Co 2”), for a private placement of our equity instruments in
consideration for total gross proceeds of $ 3.65 million to support ourselves in connection with the Acquisition and for general working
capital purposes.
16
Total
consideration for SCN aggregated $ 8.7 million consisting of $ 6.0 million in cash consideration, 607,287 shares of unregistered common
stock with a fair value of $ 1.3 million, and contingent “earn out” consideration with an estimated fair value of $ 1.4 million
payable upon the achievement of a financial milestone as specified in the Purchase Agreement. The Company has elected, as an accounting
policy, to determine the fair value of equity securities issued in business combinations using the average market price of the Company’s
common stock on the acquisition closing date. Management believes this method appropriately reflects the fair value of the consideration
transferred and this policy election will be applied consistently to all future business combinations. The fair value of the earn-out
was determined using a Monte Carlo simulation of potential outcomes. The earn-out is payable in the form of restricted common stock equal
to $ 1.5 million based on the volume-weighted average price of the Common Stock for the 30 days immediately preceding the date on which
such financial milestone is achieved, as determined in accordance with U.S. generally accepted accounting principles. If the financial
milestone is not achieved, the contingent consideration will not be paid. The fair value estimates of the net tangible and identifiable
intangible assets acquired and liabilities assumed were based on the preliminary valuation of their fair values on the Closing Date.
Goodwill recorded from this transaction is attributable to SCN’s technical expertise and strategic operations, which are highly
complementary to the Company’s existing business. Identifiable intangible assets of $ 1.9 million consist primarily of $ 0.4 million
of tradenames to be amortized over 4 years and $ 1.5 million of referral relationships to be amortized over 8 years. The fair value of
the acquired accounts receivable of $ 0.9 million consists of gross contractual receivables of $ 5.1 million offset by amounts not expected
to be collected of $ 4.2 million. The goodwill of $ 5.6 million created by the transaction is deductible for income tax purposes, subject
to certain limitations. The accounting for business combinations requires estimates and judgments regarding expectations for future cash
flows of the acquired business, and the allocations of those cash flows to identifiable tangible and intangible assets, in determining
the assets acquired and liabilities assumed. The fair values assigned to tangible and intangible assets acquired and liabilities assumed
are based on management’s best estimates and assumptions, as well as other information compiled by management, including valuations
that utilize customary valuation procedures and techniques.
The
following table summarizes the estimated fair values of the consideration, the tangible and identifiable intangible assets acquired,
and liabilities assumed (in thousands):
SCHEDULE
OF ESTIMATED FAIR VALUE OF TANGIBLE AND IDENTIFIABLE INTANGIBLE ASSETS ACQUIRED AND LIABILITIES ASSUMED
Total purchase consideration:
Cash consideration
$ 6,000
Fair value of common stock consideration
1,304
Fair value of contingent equity consideration
1,400
Total fair value of consideration transferred
$ 8,704
Identifiable assets acquired and liabilities assumed:
Cash
$ 864
Accounts receivable
934
Prepaid expenses and other assets
51
Property and equipment
1,322
Operating lease right-of-use assets
2,378
Intangible assets
1,900
Operating lease liabilities
( 1,990 )
Liabilities assumed
( 2,362 )
Total identifiable assets acquired and liabilities assumed
$ 3,097
Goodwill
5,607
Net assets acquired and liabilities assumed
$ 8,704
The
initial allocation of the purchase price is based upon a preliminary valuation, and accordingly, our estimates and assumptions are subject
to change as we obtain additional information during the measurement period. We anticipate finalizing the purchase price allocation within
12 months from the acquisition date. Transaction costs incurred of approximately $ 0.6 million were related to the acquisition.
17
The
following table reflects our unaudited pro forma operating results for the three and nine months ended September 30, 2025 and 2024, respectively,
which give effect to the acquisition of the SCN as if it had occurred effective January 1, 2024. The pro forma results are not necessarily
indicative of the operating results that would have occurred had the acquisition been effective as of the date indicated, nor are they
intended to be indicative of results that may occur in the future. The pro forma information does not include the effects of any synergies
related to the SCN acquisition or transactions between the entities prior to acquisition. Pro forma earnings during the periods presented
were adjusted to include the following adjustments:
●
Amortization
of definite-lived intangible assets recognized at fair value that exceed one year as if acquired January 1, 2024;
●
Interest
expense (including amortization of debt issuance costs) on the Note entered into with the Lender in connection with the acquisition
as if the Note was obtained on January 1, 2024. The interest rate assumed for purposes of preparing this pro forma financial information
was 9.0 % which is the stated fixed rate throughout the term of the Note; and
●
Given
our history of net losses and full valuation allowances, our management estimated an annual effective income tax rate of 0.0 %. Accordingly,
no income tax adjustments have been recorded resulting from any pro forma adjustments.
SCHEDULE
OF PRO FORMA INFORMATION
2025
2024
2025
2024
Three Months Ended
September 30,
Nine Months Ended
September 30,
2025
2024
2025
2024
(unaudited)
Net Revenue
$ 6,783
$ 5,785
$ 17,271
$ 16,840
Net Loss
$ ( 5,472 )
$ ( 2,883 )
$ ( 15,447 )
$ ( 8,571 )
Revenue
and net income attributable to SCN were $ 2.2
million and less than $ 0.1
million for the three months ending September 30, 2025, and $ 2.8 million and $ 0.1 million for the nine months ending September
30, 2025.
NOTE
4 - REVENUE, CONTRACT ASSETS AND CONTRACT LIABILITIES
Net
Revenue
For
the three and nine months ended September 30, 2025 and 2024, the components of revenue from contracts with customers and the related
timing of revenue recognition is set forth in the table below (in thousands):
SCHEDULE OF REVENUE FROM CONTRACT WITH CUSTOMERS
2025
2024
2025
2024
Three Months Ended
September 30,
Nine Months Ended
September 30,
2025
2024
2025
2024
Product revenue
Appliances
1,405
1,583
3,805
4,498
Guides
790
375
2,088
1,110
Total product revenue
2,195 (1)
1,958 (1)
5,893 (1)
5,608 (1)
Service revenue
VIP
82 (2)
926 (2)
435 (2)
3,007 (2)
Billing intelligence services
184
206
556
644
Sleep testing services
2,560
329
3,727
954
Myofunctional therapy services
205
147
516
472
Treatment centers
1,321
-
1,563
-
Sponsorship/seminar/other
236
294
929
648
Total service revenue
4,588
1,902
7,726
5,725
Total revenue
$ 6,783
$ 3,860
$ 13,619
$ 11,333
(1)
Product
revenue from the sale of appliances, pediatric tooth positioners and Lifeline products is typically fixed at the inception of the
contract and is recognized at the point in time when shipment of the related products occurs.
(2)
Service
revenue from the sale of VIP enrollments, billing services and therapy is typically fixed at the inception of the contract and is
recognized ratably over time as the services are performed and the performance obligations completed.
18
Changes
in Contract Liabilities
The
key components of changes in contract liabilities related to our legacy model for the three and nine months ended September 30, 2025
and 2024 are as follows (in thousands):
SCHEDULE OF CHANGES IN CONTRACT LIABILITIES
2025
2024
Beginning balance, January 1
$ 993
$ 2,427
New contracts, net of cancellations
23
1,466
Revenue recognized
( 422 )
( 962 )
Ending balance, March 31
$ 594
$ 2,931
New contracts, net of cancellations
189
411
Revenue recognized
( 298 )
( 1,195 )
Ending balance, June 30
$ 485
$ 2,147
New contracts, net of cancellations
327
275
Revenue recognized
( 274 )
( 931 )
Ending balance, September 30
$ 538
$ 1,491
The
current portion of deferred revenue from our legacy VIP model is approximately $ 0.5
million, which is expected to be entirely recognized before December 31, 2026, following which there will be no deferred VIP revenue as discussed in Note 1. Additionally, revenue
from breakage on contract liabilities was approximately $ 0
and $ 0.5
million for the three months ended September 30, 2025 and 2024, respectively, and approximately $ 0.1
and $ 1.5
million for the nine months ended September 30, 2025 and 2024, respectively.
Changes
in Accounts Receivable
Our
VIP customers (i.e., the dentists under our legacy model) are billed based on fees agreed upon in each customer contract. Receivables
from customers were $ 0.4 million at December 31, 2024 and $ 2.1 million at September 30, 2025. An allowance is maintained for accounts
receivable which is generally based on a combination of factors, including the aging of the receivables, historical collection trends,
and charge-offs. Adjustments to the allowance are recorded in bad debt expense under general and administrative expenses in the consolidated
statement of operations. An allowance of $ 0.5 and $ 0.4 million existed as of September 30, 2025 and December 31, 2024.
NOTE
5 - PROPERTY AND EQUIPMENT, NET
As
of September 30, 2025 and December 31, 2024, property and equipment consist of the following (in thousands):
SCHEDULE OF PROPERTY AND EQUIPMENT
September 30,
2025
December 31,
2024
Furniture and equipment
$ 2,727
$ 1,349
Leasehold improvements
3,024
2,479
Construction in progress
-
1,857
Molds and other
2,922
523
Gross property and equipment
8,673
6,208
Less accumulated depreciation
( 3,031 )
( 2,858 )
Net Property and equipment
$ 5,642
$ 3,350
19
Leasehold
improvements relate to the Vivos Institute (a 15,000 square foot facility where we provide advanced post-graduate education and certification
to dentists, dental teams, and other healthcare professionals in a live and hands-on setting), the two Company-owned dental centers in
Colorado, and the recently acquired SCN. Refer to Note 3, “Business Combination”, for additional disclosures regarding the
SCN Acquisition. Total depreciation and amortization expense was $ 0.4 million and $ 0.1 million for the three months ended September 30,
2025 and 2024, respectively, and $ 0.9 million and $ 0.4 million for the nine months ended September 30, 2025 and 2024, respectively.
NOTE
6 - GOODWILL AND INTANGIBLE ASSETS
Goodwill
Goodwill
of $ 8.5 million as of September 30, 2025 and $ 2.8 million as of December 31, 2024, consist of the following acquisitions (in thousands):
SCHEDULE OF GOODWILL
Acquisitions
September 30,
2025
December 31,
2024
The Sleep Center of Nevada
$ 5,607
$ -
BioModeling
2,619
2,619
Empowered Dental
52
52
Lyon Dental
172
172
Total goodwill
$ 8,450
$ 2,843
Intangible
Assets
As
of September 30, 2025 and December 31, 2024, identifiable intangible assets were as follows (in thousands):
SCHEDULE OF IDENTIFIABLE INTANGIBLES
September 30,
2025
December 31,
2024
Patents and developed technology
$ 3,803
$ 2,302
Trade name
730
330
Other
27
27
Total intangible assets
4,560
2,659
Less accumulated amortization
( 2,388 )
( 2,289 )
Net intangible assets
$ 2,172
$ 370
20
Amortization
expense of identifiable intangible assets was less than $ 0.1 million for the three and nine months ended September 30, 2025 and 2024.
The estimated future amortization of identifiable intangible assets is as follows (in thousands):
SCHEDULE OF ESTIMATED FUTURE AMORTIZATION OF IDENTIFIABLE ASSETS
Nine Months Ending September 30,
2025 (remaining three months)
95
2026
279
2027
274
2028
274
2029
274
Thereafter
976
Total
$ 2,172
NOTE
7 – OTHER FINANCIAL INFORMATION
Accrued
Expenses
As
of September 30, 2025 and December 31, 2024, accrued expenses consist of the following (in thousands):
SCHEDULE OF ACCRUED EXPENSES
September 30,
2025
December 31,
2024
Accrued payroll
$ 1,233
$ 1,001
Accrued legal and other
488
752
Accrued interest
234
-
Accrued sales tax
727
481
Total accrued liabilities
$ 2,682
$ 2,234
NOTE
8 – DEBT AND OTHER LIABILITIES
Debt
We
had the following outstanding Note Payable balance as of September 30, 2025:
SCHEDULE
OF OUTSTANDING NOTE PAYABLE BALANCE
Principal amount
$ 8,225
Less: Unamortized debt issuance costs and original issue discount
( 338 )
Total notes payable
$ 7,887
On
June 9, 2025, we entered into a note purchase agreement the Lender secured by the assets of Airway Integrated Management Company,
LLC, a Colorado limited liability company and a wholly-owned subsidiary of the Company (“AIM”), pursuant to which we
agreed to issue and sell to the Lender the Note in an aggregate initial principal amount of $ 8.3
million, which is payable on or before the date that is 18 months from the issuance date. The initial principal amount includes an
original issue discount of $ 0.7
million and $ 50
thousand that we agreed to pay to the Lender to cover the Lender’s legal fees, accounting costs, due diligence, monitoring and
other transaction costs. The net proceeds from the Note were $ 7.5
million.
Interest
on the Note accrues at a rate of 9 % per annum and is payable on the maturity date. The Company may prepay all or a portion of the Note
at any time.
A
monitoring fee of 10 % of the outstanding balance will be charged starting on the 120-day anniversary of the issuance of the Note (October
7, 2025) to cover Lender’s accounting, legal and other costs incurred in monitoring. The foregoing fee shall automatically be added
to the outstanding balance on the applicable date without any further action by either party.
21
Beginning
on the sixth month anniversary of the issuance, the Lender shall have the right to redeem up to $ 0.6 million of the Note plus any interest
accrued thereunder each month by providing written notice delivered to us; provided, however, that if the Lender does not exercise any
monthly redemption amount in its corresponding month then such monthly redemption amount shall be available for the Lender to redeem
in any further month in addition to such future month’s monthly redemption amount. Upon receipt of any monthly redemption notice,
we shall pay the applicable monthly redemption amount in cash to the Lender within three (3) trading days of the Company’s receipt
of such monthly redemption notice.
The
Note includes customary event of default provisions, subject to certain cure periods, and provides for a default interest rate equal
to the lesser of twenty-two percent (22%) or the maximum rate permitted under applicable law. Upon the occurrence of an event of default,
interest would accrue on the outstanding balance of the Note beginning on the date the applicable event of default occurred.
Interest
expense recognized on the condensed consolidated statement of operations was $ 0.5 million for the three months ended September 30, 2025,
and $ 0.6 million for the nine months ended September 30, 2025.
Other
Liabilities
As
of September 30, 2025 and December 31, 2024, other liabilities consist of the following (in thousands):
SCHEDULE
OF OTHER LIABILITIES
September 30,
2025
December 31,
2024
Contingent consideration on acquisition of SCN
$ 1,400
$ -
Total
$ 1,400
$ -
NOTE
9 – PREFERRED STOCK
As
of September 30, 2025, our Board of Directors continues to have the authority to designate up to 50,000,000 shares of Preferred Stock
in various series that provide for liquidation preferences, and voting, dividend, conversion, and redemption rights as determined at
the discretion of the Board of Directors.
NOTE
10 – COMMON STOCK
We
are authorized to issue 200,000,000 shares of Common Stock. Holders of Common Stock are entitled to one vote for each share held . Our
Board of Directors may declare dividends payable to the holders of Common Stock.
February
2024 Warrant Inducement Transaction
On
February 14, 2024, we entered into a warrant inducement letter agreement (the “Inducement Agreement”) with the same institutional
investor in the November 2023 Private Placement pursuant to which the investor agreed to exercise for cash the entirety of the Series
B Warrant at an exercise price of $ 4.02 per share (with such exercise price being established for purposes of compliance with the listing
rules of the Nasdaq Stock Market), resulting in gross proceeds to us of approximately $ 4.0 million. Pursuant to the Inducement Agreement,
in consideration for the immediate exercise of the Series B Warrant in full, we agreed to issue to the investor, in a new private placement
transaction (the “Inducement Transaction”): (i) a 5 -year, Series B-1 Common Stock Purchase Warrant to purchase 735,296 shares
of our Common Stock at an exercise price of $ 5.05 per share, and (ii) an 18 -month, Series B-2 common stock purchase warrant to purchase
735,296 shares of our Common Stock at an exercise price of $ 5.05 per share (collectively, the “Inducement Warrants” and such
aggregate 1,470,592 shares of our Common Stock underlying the Inducement Warrants, the “Inducement Warrant Shares”). The
Inducement Warrants are identical to each other, other than their dates of expiration, and are substantially identical to the Series
B Warrant. Issuance costs associated with the February inducement were approximately $ 0.3 million.
22
June
2024 Private Placement
On
June 10, 2024 we entered into a securities purchase agreement (the “June 2024 SPA”) with V-CO Investors LLC, a Wyoming limited
liability company (“V-CO”). V-CO is an affiliate of New Seneca Partners Inc., a Michigan corporation (“Seneca”)
and an independent private equity firm. Pursuant to the SPA, we sold to V-CO in a private placement offering (the “2024 Private
Placement”): (i) 169,498 shares (the “June 2024 SPA Shares”) of our Common Stock, (ii) a pre-funded warrant to purchase
3,050,768 shares of Common Stock (the “June 2024 SPA Pre-Funded Warrant”, with the shares of Common Stock underlying the
June 2024 Pre-Funded Warrant being referred to as the “June 2024 SPA PFW Shares”), and (iii) a Common Stock Purchase Warrant
to purchase up to 3,220,266 shares of Common Stock (the “June 2024 SPA Common Stock Purchase Warrant, and together with the June
2024 Pre-Funded Warrant, the “June 2024 SPA Warrants”, and with the shares of Common Stock underlying the June 2024 SPA Common
Stock Purchase Warrant being referred to as the “June 2024 SPA Warrant Shares”).
V-CO
paid a purchase price of $ 2.329
for each June 2024 SPA Share and June 2024 SPA Pre-Funded Warrant Share and associated June 2024 SPA Common Stock Purchase Warrant,
with such price being established for purposes of compliance with the listing rules of the Nasdaq Stock Market LLC
(“Nasdaq”). The 2024 Private Placement closed on September 10, 2024. We received gross proceeds of $ 7.5
million from the 2024 Private Placement. We used the net proceeds from the 2024 Private Placement for general working capital and
general corporate purposes. No placement agent was used in connection with the 2024 Private Placement. The June 2024 SPA Common
Stock Purchase Warrant has a 5 five-year term, an exercise price of $ 2.204
per share and became exercisable immediately as of the date of issuance. The June 2024 SPA Pre-Funded Warrant has a term ending on
the complete exercise of the June 2024 SPA Pre-Funded Warrant, an exercise price of $ 0.0001
per share and became exercisable immediately as of the date of issuance. The June 2024 SPA Warrants also contain customary
stock-based (but not price-based) anti-dilution protection as well as beneficial ownership limitations that may be waived at the
option of each holder upon 61 days’ notice to the Company.
The
June 2024 SPA provides that for a period of three (3) years from the closing of the 2024 Private Placement, Seneca shall be entitled
to (i) receive notice of any regular or special meeting of our Board of Directors at the time such notice is provided to such members
of the Board of Directors, (ii) receive copies of any materials delivered to our directors in connection with such meetings and (iii)
allow one Seneca representative (who shall be an officer or employee of Seneca) to attend and participate (but not vote) in all such
meetings of the Board of Directors. The June 2024 SPA also includes standard representations, warranties, indemnifications, and covenants
of the Company and V-CO.
The
terms of the June 2024 SPA required us to file a registration statement on Form S-3 or other appropriate form (the “June 2024 Resale
Registration Statement”) registering the June 2024 SPA Shares, the June 2024 SPA PFW Shares and the June 2024 SPA Warrant Shares
(collectively, the “June 2024 Registerable Securities”) for resale. Such June 2024 Resale Registration Statement was filed
with the SEC on July 30, 2024 and was declared on August 7, 2024. Pursuant to the June 2024 SPA, we must also use commercially reasonable
efforts to keep the June 2024 Resale Registration Statement continuously effective (including by filing a post-effective amendment to
the Resale Registration Statement or a new registration statement if the June 2024 Resale Registration Statement expires) for a period
of three (3) years after the date of effectiveness of the June 2024 Resale Registration Statement or for such shorter period as such
securities no longer constitute June 2024 Registrable Securities, subject to certain limitations specified in the June 2024 SPA.
September
2024 Registered Direct Offering
On
September 18, 2024, we entered into a securities purchase agreement (the “September 2024 Purchase Agreement”) with certain
institutional investors in connection with a registered direct offering (the “September 2024 Offering”), priced at-the-market
under Nasdaq rules, to purchase 1,363,812 shares (the “September 2024 Shares”) of our Common Stock at a purchase price of
$ 3.15 per Share. No common stock purchase warrants were offered or issued to investors in the September 2024 Offering. The September
2024 Offering closed on September 20, 2024. H.C. Wainwright & Co., LLC, pursuant to an engagement agreement with us, dated May 2,
2024 and amended on August 2, 2024 (as amended, the “Engagement Agreement”), acted as the exclusive placement agent (the
“Placement Agent”) for the September 2024 Offering. Pursuant to the Engagement Agreement, we have paid the Placement Agent
(i) a cash fee equal to 7.0% of the aggregate gross proceeds of the September 2024 Offering, and (ii) a management fee of 1.0% of the
aggregate gross proceeds of the Offering. We have also agreed to reimburse the Placement Agent for certain expenses and legal fees . In
addition, we issued to the Placement Agent, or its designees warrants (the “September 2024 Placement Agent Warrants”) to
purchase up to 95,467 shares of Common Stock (or 7 % of the number of September 2024 Shares sold in the September 2024 Offering) at an
exercise price of $ 3.9375 per share of Common Stock, exercisable beginning upon issuance until five years from the commencement of sales
in the September 2024 Offering.
23
The
gross proceeds to us from the September 2024 Offering were approximately $ 4.3 million, before deducting the Placement Agent’s fees
and other offering expenses payable by us. We used the net proceeds from the offering for working capital and general corporate purposes.
The
September 2024 Shares were issued pursuant to an effective shelf registration statement on Form S-3 that was filed with the SEC (File
No. 333-262554) on February 7, 2022 and declared effective on February 14, 2022. A prospectus supplement relating to the September 2024
Offering has been filed with the SEC. The September 2024 Purchase Agreement contains customary representations, warranties and agreements
of the Company and the investors and customary indemnification rights and obligations of the parties. Pursuant to the terms of the September
2024 Purchase Agreement, we agreed to certain restrictions on the issuance and sale of our shares of Common Stock and securities convertible
into shares of Common Stock for a period of 30 days following the closing of the September 2024 Offering. We also agreed not to effect
or agree to effect any Variable Rate Transaction (as defined in the September 2024 Purchase Agreement) until one year following the closing
of the September 2024 Offering, subject to certain exceptions.
December
2024 Registered Direct Offering
On
December 22, 2024, we entered into a securities purchase agreement (the “December 2024 SPA”) with certain institutional investors
in connection with a registered direct offering, priced at-the-market under Nasdaq rules, to purchase 709,220 shares of Common Stock
and, in a concurrent private placement (collectively, with the registered direct offering, the “December 2024 Offering”),
warrants (the “December 2024 Warrants”) to purchase up to 709,220 shares of Common Stock (the shares of Common Stock issuable
upon exercise of the December 2024 Warrants, the “December 2024 Warrant Shares”). The combined purchase price per share for
the December 2024 Warrants is $ 4.935 . The December 2024 Warrants are immediately exercisable upon issuance, will expire two years following
the issuance date and have an exercise price of $ 4.81 per share. On January 22, 2025, we filed a registration statement with the SEC
on Form S-1 (File No. 333-284399) under the Securities Act of 1933, as amended (the “Securities Act”), covering the resale
of the December 2024 Warrants. Such registration statement was subsequently declared effective on January 30, 2025.
Pursuant
to the HCW Engagement Agreement dated May 2, 2024, as amended on August 2, 2024 and December 22, 2024 with us, HCW acted as the Placement
Agent for the December 2024 Offering. Pursuant to the HCW Engagement Agreement, we have (i) paid the Placement Agent a cash fee equal
to 7.0% of the aggregate gross proceeds of the December 2024 Offering, (ii) paid the Placement Agent a management fee of 1.0% of the
aggregate gross proceeds of the December 2024 Offering, and (iii) reimbursed the Placement Agent for certain expenses and legal fees.
In addition, upon the exercise of any December 2024 Warrants for cash, we have agreed to (i) pay the Placement Agent a cash fee equal
to 7.0% of the aggregate exercise price paid in cash, (ii) pay the Placement Agent a management fee of 1.0% of the aggregate exercise
price paid in cash and (iii) issue to the Placement Agent or its designees warrants to purchase shares of Common Stock representing 7%
of the shares of Common Stock underlying the December 2024 Purchase Warrants that have been exercised .
We
also issued to the Placement Agent or its warrants (the “December 2024 PA Warrants”) to purchase up to 95,467 shares of Common
Stock (or 7 % of the number of shares sold in the December 2024 Offering) at an exercise price of $ 6.1688 per share of Common Stock, exercisable
beginning upon issuance until two years following the issuance date. We registered the Common Stock underlying the December 2024 PA Warrants
for public resale pursuant to the registration statement on S-1 (File No. 333-284399) filed on January 22, 2025 and declared defective
on January 30, 2025.
The
gross proceeds from the December 2024 Offering were approximately $ 3.5 million, before deducting the Placement Agent’s fees and
other offering expenses payable by us of approximately $ 0.5 million.
24
June
2025 Private Placement
On
June 9, 2025, we entered into a Securities Purchase Agreement (the “June 2025 PIPE SPA”) with V-Co 2. V-Co 2 is an affiliate
of Seneca. Pursuant to the June 2025 PIPE SPA, the Company sold to V-Co 2 in a private placement offering (the “June 2025 PIPE
Offering”): (i) 828,000 shares (the “June 2025 PIPE Shares”) of Common Stock, (ii) a pre-funded warrant to purchase
725,258 shares of Common Stock (the “June 2025 Pre-Funded Warrant”, with the shares of Common Stock underlying the Pre-Funded
Warrant being referred to as the “June 2025 PFW Shares”), and (iii) a Common Stock Purchase Warrant to purchase up to 2,329,886
shares of Common Stock (the “June 2025 Common Stock Purchase Warrant, and together with the Pre-Funded Warrant, the “June
2025 Warrants”, and with the shares of Common Stock underlying the Common Stock Purchase Warrant being referred to as the “June
2025 Warrant Shares”).
V-Co
2 paid a purchase price of $ 2.42 for each June 2025 PIPE Share and June 2025 Pre-Funded Warrant Share and associated June 2025 Common
Stock Purchase Warrant, with such price being established for purposes of compliance with the listing rules of Nasdaq. The June 2025
PIPE Offering closed on June 9, 2025. We received $ 2.7 million in cash proceeds upon the closing of the June 2025 PIPE Offering. Additionally,
the $ 1.1 million bridge note entered into by us and V-Co 2 on May 20, 2025, the terms of which were previously reported on Current Report
on Form 8-K filed on May 23, 2025, automatically converted into the June 2025 PIPE Offering, which we received total gross proceeds of
$ 3.7 million upon conversion of the bridge note. The gross proceeds exclude an original issue discount of $ 0.1 million paid by us in
connection with issuing the bridge note. We intended to use the net proceeds from the June 2025 PIPE Offering to support ourselves in
connection with the Acquisition and for general working capital purposes. No placement agent was used in connection with the June 2025
PIPE Offering.
The
June 2025 Common Stock Purchase Warrant has a term ending on or before June 9, 2029 , an exercise price of $ 2.23 per share and became
exercisable immediately as of the date of issuance. The June 2025 Pre-Funded Warrant has a term ending on the complete exercise of the
June 2025 Pre-Funded Warrant, an exercise price of $ 0.0001 per share and became exercisable immediately as of the date of issuance. The
June 2025 Warrants also contain customary stock-based (but not price-based) anti-dilution protection as well as beneficial ownership
limitations preventing Seneca or its affiliates from exercising the June 2025 Warrants if such exercise would result in Seneca or its
affiliates from owning in excess of 19.99 % of the then outstanding Common Stock.
We
agreed to file a registration statement under the Securities Act covering the resale of the June 2025 Warrants with 45 calendar days
following the closing of the June 2025 SPA and to use commercially reasonable effort to cause the registration statement to be declared
effective by the SEC within 90 days of the closing of the June 2025 SPA. Subsequently, pursuant to an amendment to the June 2025 PIPE
SPA, dated July 24, 2025, we and V-Co 2 agreed to extend the respective date for which we must file the registration statement and cause
such registration statement to be declared effective by 30 days.
SCN
Acquisition
On
June 10, 2025, we acquired all of the operating assets of the SCN in consideration for a (i) cash payment equal to $ 6.0 million, (ii)
607,287 shares of restricted Common Stock, equal to $ 1.5 million based on the VWAP of the Common Stock for the 30 days immediately preceding
the Acquisition and (iii) the assumption of certain specific trade accounts payable and liabilities related to specific SCN contracts
assigned to us as part of the acquisition of SCN. Pending the achievement of an agreed to financial milestone, we will pay to Prabhu
Rachakonda, M.D., SCN’s principal owner (“Dr. Prabhu”) a contingent “earn out” consideration in the form
of restricted Common Stock equal to $ 1.5 million based on the VWAP of the Common Stock for the 30 days following the date on which such
financial milestone is achieved, as determined in accordance with U.S. generally accepted accounting principles. See Note 3 for further
information.
25
“At-the-Market”
Equity Offering
As
previously reported on a Current Report on From 8-K filed on February 14, 2025 (the “February 8-K”), on February 14,
2025, pursuant to a prospectus supplement to the Company’s previously filed shelf registration statement on Form S-3 (File No.
333-262554) (the “Prior Shelf Registration”), the Company entered into an At The Market Offering Agreement (the
“ATM Sales Agreement”) with H.C. Wainwright & Co., LLC, as agent (“Wainwright”), pursuant to which the
Company may offer and sell shares of Common Stock from time to time through Wainwright. The Company did not sell any shares of
Common Stock under the Prior Shelf Registration pursuant to the ATM Sales Agreement.
On
September 12, 2025, the Company filed a prospectus supplement (the “ATM Pro Supp”) Securities and Exchange Commission (the
“SEC”) pursuant to which the Company may continue, under the ATM Sales Agreement, to sell, from time to time, up to an aggregate
sales price of $ 5,830,572 of its Common Stock (the “Shares”), through Wainwright as sales agent. Wainwright will be entitled
to compensation at a fixed commission rate of 3.0 % of the gross proceeds of each sale of Shares. In connection with
the sale of our Shares on our behalf, Wainwright will be deemed to be an “underwriter” within the meaning
of the Securities Act and the compensation of Wainwright will be deemed to be underwriting commissions or discounts. We have also agreed
to provide indemnification and contribution to Wainwright with respect to certain liabilities, including liabilities under the Securities
Act.
The
offer and sale of the Shares have been and will be made pursuant to a shelf registration statement on Form S-3 (File No.
333-284834), as amended (the “New Shelf Registration”), initially filed by the Company with the SEC on February 11, 2025 and declared effective by the SEC on
September 10, 2025, as supplemented by the ATM Pro Supp filed with the SEC pursuant to Rule 424(b) under the Securities Act of 1933,
as amended (the “Securities Act”).
During
the three and nine months ended September 30, 2025, the Company sold 762,070
Shares at an average price of $ 3.29
per share through the ATM Sales Agreement, resulting in proceeds of $ 2.4
million net of commissions. Under the ATM Offering, $ 3.3
million of common stock remain available for future sales as of September 30, 2025; however, the Company is not obligated to make
any sales under this program.
NOTE
11 – STOCK OPTIONS AND WARRANTS
Stock
Options
In
2017, our shareholders approved the adoption of a stock and option award plan (the “2017 Plan”), under which shares were
reserved for future issuance for Common Stock options, restricted stock awards and other equity awards. The 2017 Plan permits grants
of equity awards to employees, directors, consultants and other independent contractors. Our shareholders have approved a total reserve
of 53,333 shares of Common Stock for issuance under the 2017 Plan.
On
September 22, 2023, our stockholders approved an amendment and restatement of the 2019 Plan to increase the number shares or our Common
Stock available for issuance thereunder by 80,000 shares of Common Stock such that, after amendment and restatement of the 2019 Plan,
126,667 shares of Common Stock are available for issuance under the 2019 Plan. As of September 30, 2025, awards (in the form of options)
for an aggregate of 174,380 shares of Common Stock have been issued under our 2019 Plan. A total of 287 shares remaining for issuance
were retired with the approval and adoption of the 2024 Omnibus Plan (as further described below).
On
November 26, 2024, our shareholders approved and adopted the Vivos Therapeutics, Inc. 2024 Omnibus Equity Incentive Plan (or the “2024
Omnibus Plan”). The 2024 Omnibus Plan automatically replaced and superseded the 2019 Plan. Under the 2024 Omnibus Plan, a total
of 1,600,000 shares are available for future use. No awards are to be granted under the 2019 Plan or any other prior plan on or after
the effective date of the 2024 Omnibus Plan and after the 2024 Omnibus Plan became effective any unused shares left in the 2019 Plan
are to be retired. We anticipate that the 1,600,000 shares will allow the 2024 Omnibus Plan to operate for several years, although this
could change based on other factors, including but not limited to merger and acquisition activity. The purpose of the 2024 Omnibus Plan
is to promote the success and enhance the value of the Company by linking the personal interest of the participants to those of our stockholders
by providing the participants with an incentive for outstanding performance. Any non-employee director, officer, employee or consultant
of the Company or its subsidiaries or affiliates will be eligible to participate in the 2024 Omnibus Plan. As of September 30, 2025,
we had five non-employee directors, two officers, 260 employees and three consultants, although we expect that, based on our current
usage, awards will be generally limited to approximately five non-employee directors, two officers, ten employees, and three consultants.
The 2024 Omnibus Plan provides for the grant of options to purchase shares of our Common Stock, including stock options intended to qualify
as incentive stock options (“ISOs”) under Section 422 of the Code and nonqualified stock options that are not intended to
so qualify (“NQSOs”), stock appreciation rights (“SARs”), restricted stock awards, and other equity-based or
equity-related awards including restricted stock units and performance units (each, an “Award”). As of September 30, 2025,
awards (in the form of options) for an aggregate of 1,110,487 shares of Common Stock have been issued under our 2024 Omnibus Plan.
26
During
the nine months ended September 30, 2025, the Company granted no stock options. For the same period ended September 30, 2024, the
Company granted stock options to purchase 105,000 shares
of Common Stock at a weighted average price of $ 2.38 per
share. During the nine months ended September 30, 2025, the Company granted Restricted Stock Units (“RSU”) for 90,000 shares,
of which 60,000 were
valued at $ 6.00 and 30,000 were
valued at $ 4.72 . No RSU’s
were granted during the nine months ended September 30, 2024.
The
following table summarizes all stock options as of September 30, 2025 (shares in thousands):
SCHEDULE
OF STOCK OPTIONS
2025
Shares
Price
(1)
Term
(2)
Outstanding, at December 31, 2024
1,238
$ 8.80
8.5
Granted
-
-
Forfeited
( 13 )
-
Exercised
-
-
Outstanding, at September 30
1,225 (3)
$ 7.04
7.8
Exercisable, at September 30
163 (4)
29.28
2.5
(1)
Represents
the weighted average exercise price.
(2)
Represents
the weighted average remaining contractual term until the stock options expire.
(3)
As
of September 30, 2025, the aggregate intrinsic value of stock options outstanding was $ 0 .
(4)
As
of September 30, 2025, the aggregate intrinsic value of exercisable stock options was $ 0 .
There
were no stock options granted for the three and nine months ended September 30, 2025. For the three months ended September 30, 2025 and
2024, the Company recognized approximately $ 0.1 million of share-based compensation expense. For the nine months ended September 30, 2025
and 2024, the Company recognized approximately $ 0.6 million and $ 0.7 million of share-based compensation expense relating to the vesting
of stock options, respectively. Unrecognized expense relating to these awards as of September 30, 2025 was approximately $ 2.8 million,
which will be recognized over the weighted average remaining term of 7.8 years.
27
Warrants
The
following table sets forth activity with respect to the Company’s warrants to purchase Common Stock for the nine months ended September
30, 2025 (shares in thousands):
SCHEDULE OF WARRANT OUTSTANDING
2025
Shares
Price
(1)
Term
(2)
Outstanding, at December 31, 2024
9,658
$ 3.22
3.9
Grants of warrants:
Private placement
3,055
Warrant inducement
-
Exercised
( 180 )
Forfeited
( 735 )
Outstanding, at June 30
11,798 (3)
$ 2.69
3.6
Exercisable, at June 30
11,745 (4)
$ 2.60
3.5
(1)
Represents
the weighted average exercise price.
(2)
Represents
the weighted average remaining contractual term until the warrants expire.
(3)
As
of September 30, 2025, the aggregate intrinsic value of warrants outstanding was $ 0 million.
(4)
As
of September 30, 2025, the aggregate intrinsic value of warrants exercisable was $ 0 million.
No
warrants were granted for the three months ended September
30, 2025. For t he nine months ended September 30, 2025,
the valuation assumptions for warrants issued were estimated on the measurement date using the BSM option-pricing model with the following
weighted-average assumptions:
2025
Measurement date closing price of Common Stock (1)
$ 2.14
Contractual term (years) (2)
4.0
Risk-free interest rate
4.0 %
Volatility
148 %
Dividend yield
0 %
(1)
Weighted
average grant price.
(2)
The
valuation of warrants is based on the expected term.
NOTE
12 - INCOME TAXES
Income
tax expense during interim periods is based on applying an estimated annual effective income tax rate to year-to-date income, plus any
significant unusual or infrequently occurring items which are recorded in the interim period. The provision for income taxes for the
three and nine months ended September 30, 2025 and 2024 differs from the amount that would be provided by applying the statutory U.S.
federal income tax rate of 21 % to pre-tax income primarily due to permanent differences, state taxes and change in valuation allowance.
A full valuation allowance was in effect, which resulted in the Company’s zero tax expense.
Management
assesses the available positive and negative evidence to estimate if sufficient future taxable income will be generated to use the existing
deferred tax assets. A significant piece of objective negative evidence evaluated was the cumulative loss incurred since inception. Such
objective evidence limits the ability to consider other subjective evidence such as the Company’s projections for future growth.
On the basis of this evaluation, a full valuation allowance has been recorded at September 30, 2025 and December 31, 2024 to record the
deferred tax asset that is not likely to be realized.
The
computation of the annual estimated effective tax rate at each interim period requires certain estimates and significant judgement including,
but not limited to, the expected operating income for the year, projections of the proportion of income earned and taxed in various jurisdictions,
permanent and temporary differences, and the likelihood of recovering deferred tax assets generated in the current year. The accounting
estimates used to compute the provision for income taxes may change as new events occur, more experience is obtained, additional information
becomes known or as the tax environment changes.
NOTE
13 - COMMITMENTS AND CONTINGENCIES
Other
than the earn-out related to the SCN acquisition (see Note 3), there were no new material commitments or contingencies entered into during
the three and nine months ended September 30, 2025 and 2024.
28
NOTE
14 - NET LOSS PER SHARE OF COMMON STOCK
Basic
and diluted net loss per share of Common Stock (“EPS”) is computed by dividing (i) net loss (the “Numerator”),
by (ii) the weighted average number of shares of Common Stock outstanding during the period (the “Denominator”).
The
calculation of diluted EPS is also required to include the dilutive effect, if any, of stock options, unvested restricted stock awards,
convertible debt and Preferred Stock, and other Common Stock equivalents such as pre-funded warrants computed using the treasury stock
method, in order to compute the weighted average number of shares outstanding. As of September 30, 2025 and 2024, all Common Stock equivalents
were antidilutive.
Presented
below are the calculations of the Numerators and the Denominators for basic and diluted EPS (dollars in thousands, except per share amounts):
SCHEDULE OF COMPUTATION OF ANTI-DILUTIVE WEIGHTED-AVERAGE SHARES OUTSTANDING
2025
2024
2025
2024
For the Three Months Ended
September 30,
For The Nine Months Ended
September 30,
2025
2024
2025
2024
Calculation of Numerator:
Net loss
$ ( 5,400 )
( 2,616 )
$ ( 14,276 )
( 8,309 )
Loss applicable to common stockholders
$ ( 5,400 )
$ ( 2,616 )
$ ( 14,276 )
$ ( 8,309 )
Calculation of Denominator:
Weighted average number of shares of Common Stock outstanding
10,963,590
6,615,320
9,557,368
4,282,210
Net loss per share of Common Stock (basic and diluted)
$ ( 0.49 )
$ ( 0.40 )
$ ( 1.49 )
$ ( 1.94 )
As
of September 30, 2025 and 2024, the following potential Common Stock equivalents were excluded from the computation of diluted net loss
per share of Common Stock since the impact of inclusion was antidilutive (in thousands):
SCHEDULE OF OUTSTANDING COMMON STOCK SECURITIES NOT INCLUDED IN THE COMPUTATION OF DILUTED NET LOSS PER SHARE
September 30,
2025
September 30,
2024
Common stock warrants
11,798
9,244
Common stock options
1,225
228
Total
13,023
9,472
NOTE
15 - FINANCIAL INSTRUMENTS AND SIGNIFICANT CONCENTRATIONS
Fair
Value Measurements
Fair
value is defined as the price that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction
between market participants on the measurement date. When determining fair value, we consider the principal or most advantageous market
in which it transacts and considers assumptions that market participants would use when pricing the asset or liability. We apply the
following fair value hierarchy, which prioritizes the inputs used to measure fair value into three levels and bases the categorization
within the hierarchy upon the lowest level of input that is available and significant to the measurement of fair value:
Level
1 - Quoted prices in active markets for identical assets or liabilities accessible to the reporting entity at the measurement date
Level
2 - Other than quoted prices included in Level 1 that are observable for the asset and liability, either directly or indirectly through
market collaboration, for substantially the full term of the asset or liability
Level
3 - Unobservable inputs for the asset or liability used to measure fair value to the extent that observable inputs are not available,
thereby allowing for situations in which there is little, if any market activity for the asset or liability at measurement date
29
As
of September 30, 2025 and 2024, the fair value of our cash and cash equivalents, accounts receivable, accounts payable, and other accrued
liabilities approximated their carrying values due to the short-term nature of these instruments.
Recurring
Fair Value Measurements
For
the three and nine months ended September 30, 2025 and 2024, we did not have any assets and liabilities classified as Level 1, Level
2 or Level 3. Level 3 techniques were used in the non-recurring measurement of assets and liabilities acquired in the SCN acquisition
(see Note 3).
Our
policy is to recognize asset or liability transfers among Level 1, Level 2 and Level 3 as of the actual date of the events or change
in circumstances that caused the transfer. During the three and nine months ended September 30, 2025 and 2024 we had no transfers of
assets or liabilities between levels of the fair value hierarchy.
Significant
Concentrations
Credit
Risk
We
maintain our cash and cash equivalents primarily in depository and money market accounts within three large financial institutions in
the United States. Cash balances deposited at these major financial banking institutions exceed the insured limits. We have not experienced
any losses on our bank deposits and believe these deposits do not expose us to any significant credit risk. If we were unable to access
cash and cash equivalents as needed, the financial position and ability to operate the business could be adversely affected. As of September
30, 2025, we had cash and cash equivalents with five financial institutions in the United States with an aggregate balance of $ 3.1 million.
Generally,
credit risk with respect to accounts receivable is diversified due to the number of entities comprising our customer base and their dispersion
across different geographies and industries. We perform ongoing credit evaluations on certain customers and generally do not require
collateral on accounts receivable. No single customer represented more than 10% of our sales or accounts receivable as of September 30,
2025. We maintain reserves for potential bad debts.
Supplier
Concentration
As
previously disclosed, we rely on third-party suppliers and contract manufacturers for the raw materials and components used in our appliances
and to manufacture and assemble our products. As of September 30, 2025, we had five suppliers that accounted for approximately 57 % of
our total purchases during the year. We expect to maintain existing relationships with these vendors.
NOTE
16 – SEGMENT INFORMATION
We
operate our business as one operating segment. An operating segment is defined as a component of an enterprise for which separate discrete
financial information is available and evaluated regularly by a CODM in deciding how to allocate resources and in assessing performance.
Our CODM is our Chief Executive Officer and Chair of the Board of Directors. Reportable segment information is consistent with how management
reviews the business, makes investing and resource allocation decisions and assesses operating performance. Our segment revenues are
derived from the sales of our products, services, the Vivos Method, to sleep centers and VIP providers in the U.S., Canada, Australia
and in select countries in Europe and Asia.
Our
CODM uses consolidated revenue, gross profit, gross margin and operating loss as the measure of profit or loss. Our CODM assesses performance
for the segment and allocates resources and monitors budget versus actual results using consolidated revenue, gross profit, gross margin
and operating loss, as disclosed in the statement of operations. The monitoring of budget versus actual results are used in establishing
management’s compensation. The measure of segment assets is reported on the balance sheet as total consolidated assets. Revenue
and long-lived tangible assets are all located in the U.S.
NOTE
17 – SUBSEQUENT EVENTS
Ortho-Tain
Litigation Settlement
As
previously disclosed, on June 5, 2020, we filed suit against Ortho-Tain, Inc. (“Ortho-Tain”) in the United States
District Court for the District of Colorado seeking relief from certain false, threatening, and defamatory statements to our
business affiliate, Benco Dental (“Benco”). As of the date of this Report, the parties are engaging in mediation and
settlement discussions, although no assurances can be given that a final settlement will be reached.
New
Shelf Registration Statement and At The Market Offering
On
October 24, 2025, the Company filed a prospectus supplement to update the maximum amount of Shares which the Company may
under the New Shelf Registration pursuant to General Instruction I.B.6 of Form S-3. As a result of these limitations and the then
current market value of the Common Stock held by non-affiliates of the Company, and in accordance with the terms of the ATM Sales
Agreement, we may offer and sell Shares having an aggregate offering price of up to $ 3,583,686
from time to time through Wainwright, which does not include the Shares having an aggregate sales price of
approximately $ 4,605,773
that were sold pursuant to the Prior Shelf Registration to date.
During
October and November 2025, the Company sold 681,337
Shares at an average price of $ 3.20
per share through its ATM Sales Agreement, resulting in proceeds of $ 2.1
million net of commissions. Under the ATM Sales Agreement, $ 4.7
million of Shares remain available for future sales as of the date of this filing; however, the Company is not obligated to make any
sales under this program.
Increase in Size of 2024 Omnibus Plan
On
November 4, 2025, the Company conducted its 2025 annual meeting of stockholders (the “Annual Meeting”). At the
Annual Meeting, the Company’s stockholders approved and adopted an amendment to the 2024 Omnibus Plan to increase the number of
shares of our Common Stock authorized to be issued pursuant to the 2024 Omnibus Plan from 1,600,000
shares to 4,100,000
shares in the aggregate.
30
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The
following discussion and analysis of our financial condition and results of operations should be read in conjunction with our financial
statements and the related notes to those statements included elsewhere in this Quarterly Report on Form 10-Q. In addition to historical
financial information, the following discussion and analysis contains forward-looking statements that involve risks, uncertainties, and
assumptions. Some of the numbers included herein have been rounded for the convenience of presentation. Our actual results may differ
materially from those anticipated in these forward-looking statements as a result of many factors. See “Cautionary Note Regarding
Forward-Looking Statements.”
Overview
We
are a revenue stage medical technology company focused on the development and commercialization of innovative treatment alternatives
for patients with dentofacial abnormalities and/or patients diagnosed with mild to severe obstructive sleep apnea (“OSA”)
and snoring in adults. We believe our technologies and conventions represent a significant improvement in the treatment of mild to severe
OSA versus other treatments such as continuous positive airway pressure (“CPAP”) or palliative oral appliance therapies.
Our alternative treatments are part of what we call The Vivos Method .
The
Vivos Method is an advanced therapeutic protocol, which often combines the use of customized oral appliance specifications and proprietary
clinical treatments which we developed and is prescribed by specially trained dentists in cooperation with their medical colleagues.
Published studies have shown that using our customized appliances and clinical treatments led to significantly lower Apnea Hypopnea Index
scores and have improved other conditions associated with OSA. Approximately 60,000 patients have been treated to date worldwide with
our entire current suite of products by more than 2,000 trained dentists.
In
June 2024, as our initial entry into our new sales, marketing and distribution model, we entered into our first contractual alliance
with Rebis Health, a sleep center operator in Colorado. Revenues from this arrangement have not developed as we had expected for many
reasons beyond our control, but we learned important lessons which have led to changes to this model.
In
an important milestone in our business model pivot we undertook during 2024 and 2025, on June 10, 2025, we acquired the net operating
assets of R.D. Prabhu-Lata K. Shete MDs, LTD., a Nevada professional corporation d/b/a The Sleep Center of Nevada (“SCN”)
pursuant to an Asset Purchase Agreement dated April 15, 2025 (the “SCN Purchase Agreement”) whereby we agreed to purchase
the net operating assets and liabilities related to SCN’s sleep testing, diagnostics, and treatment centers (the “Acquisition”)
from SCN’s shareholders Prabhu Rachakonda, M.D. (“Dr. Prabhu”) and Lata K. Shete, M.D.
31
With
seven operating locations, two of which are currently onboarded to provide Vivos diagnostic and treatment services, SCN delivers and promotes sleep wellness and health through its proprietary, non-invasive treatments for OSA
and is the largest operator of medical sleep centers in the State of Nevada. The Acquisition represents our first major acquisition of
a sleep testing center and associated medical sleep practice. We funded the consideration for the Acquisition at closing by issuing a
senior, non-convertible, secured term note to Streeterville Capital, LLC (the “Lender”) in the principal amount of $8.3 million.
We also entered into a securities purchase agreement with V-Co Investors 2 LLC, a Wyoming limited liability company and affiliate of
an existing significant investor in our company (“V-Co 2”), for a private placement of common stock and warrants in consideration
for total gross proceeds of $3.7 million to support ourselves in connection with the Acquisition and for general working capital purposes.
Please refer to “ Material Items, Trends and Risks Impacting Our Business - Pivot in Our Sales, Marketing and Distribution Model and Decreased Emphasis on VIP Enrollments” and “Material Items, Trends and Risks Impacting Our Business – SCN Integration Update”
below for a further discussion of the Acquisition and our progress on integrating SCN into our business.
Total
consideration for SCN equaled to a sum of $8.7 million consisting of $6.0 million in cash consideration, 607,287 shares of Vivos common
stock with a fair value of $1.3 million, and contingent “earn out” consideration with a fair value of $1.4 million payable
upon the achievement of a financial milestone as specified in the SCN Purchase Agreement.
See
Note 1 to the accompanying financial statements for additional background information on our company and our legacy VIP and current alliance/acquisition
sales, marketing and distribution models.
Material
Items, Trends and Risks Impacting Our Business
We
believe that the following items and trends may be useful in better understanding our results of operations.
Pivot in Our Sales, Marketing and Distribution Model and Decreased Emphasis on VIP Enrollments . Enrolling dental practices as
VIPs has historically been the first step in our ability to generate new revenue. However, as a result of our strategic pivot away
from growing our VIP model and toward contractual alliances with, or the acquisition and operation of, medical and dental sleep
medicine centers, we have reduced our sales personnel in connection with our VIP business model and generally ceased recruitment of
new VIP dentists. As a result, revenue from VIP enrollments has declined substantially, although we will continue to recognize some
VIP enrollment revenue going forward in accordance with ASC 606. VIP enrollment revenue is expected to cease by the end of 2026. While we will
continue to provide technical and product support to our existing VIP customer base, we are now fully engaged in maximizing the SCN
opportunity through refocused training facilities, programs and personnel aimed at supporting the dentists, staff members,
nurse practitioners, physician assistants, and medical doctors who work at our Sleep and Airway Medicine
Centers as part of our new strategic model.
As
part of our pivot to the new strategic alliance and acquisition model, on April 15, 2025, we entered into the SCN Purchase Agreement
with the Seller, pursuant to which we agreed to purchase, among other things, the operating assets related to SCN’s sleep testing,
diagnostics, and treatment centers. By operating Sleep and Airway Medicine Centers (as we do through SCN), we generate product
revenue though the sale of our appliances and oral guides as well as revenue from providing services to patients under the administration
arrangement described below. Because of our acquisition of SCN, we generated service revenue which we call “treatment center”
revenue, consisting of $1.3 million and $1.5 million for the three and nine months ended September 30, 2025 respectively. Treatment center
revenue is expected to entirely replace our reliance on VIP subscription revenue, and we expect to grow treatment center revenue over
time as more patients are provided services through our Sleep and Airway Medicine Centers. See Note 4 to the accompanying unaudited financial
statements for further information on the composition of our revenues.
The below provides a summary of the Acquisition and the contractual arrangements we had entered with
SCN in connection with the Acquisition:
On
June 10, 2025, we completed the Acquisition, and we acquired all of the operating assets of the Seller in consideration for a (i)
cash payment equal to $6.0 million, (ii) 607,287 shares of restricted common stock our company equal to $1.5 million based on the
volume-weighted average price (“VWAP”) of our common stock for the 30 days immediately preceding the Acquisition and
(iii) the assumption of certain specific trade accounts payable and liabilities related to specific SCN contracts assigned to us as
part of the Acquisition. Pending the achievement of an agreed upon financial milestone, we will pay to Dr. Prabhu a contingent
“earn out” consideration in the form of Vivos restricted common stock equal to $1.5 million based on the VWAP of the
Vivos common stock for the 30 days following the date on which such financial milestone is achieved, as determined in accordance
with U.S. generally accepted accounting principles.
32
As
of June 10, 2025, but effective as of June 2, 2025, pursuant to the SCN Purchase Agreement, our wholly-owned subsidiary AIM, entered
into Practice Administration Agreements (“PAAs”) respectively with SCN (the “SCN PAA”) and the Sleep Center of
Nevada, Rachakonda & Associates, PLLC, a newly formed Nevada professional limited liability company owned and controlled by Dr. Prabhu
(“SCN PLLC” and the practice management agreement with SCN PLLC, the “SCN PLLC PAA”). SCN PLLC was formed for
the purpose of integrating the medical practices of SCN with the Company in connection with the Acquisition. The principal purpose of
the PAAs is to allow AIM to manage the SCN practice in compliance with applicable federal and Nevada laws, rules and regulations relating
to the corporate practice of medicine (the “CPM Laws”). AIM intends to conduct an orderly transition of the operation of
the SCN practice to SCN PLLC.
Pursuant
to the PAAs, AIM provides management, administrative, and non-clinical services to SCN and SCN PLLC, in consideration for monthly
administration fees (the “Administration Fees”) of $0.2 million from SCN and $0.1 million from SCN PLLC. The Administration
Fees may be adjusted by AIM prospectively after quarterly reviews. Both the PAAs have a term of fifteen years and subject both SCN and
SCN PLLC, along with Dr. Prabhu, to an exclusivity provision during the term and for a period of one-year after termination, whereby
neither SCN nor SCN PLLC shall operate, participate in, or be connected with any other entity providing similar services within Nevada,
except for operating its own medical practice without a third-party provider providing covered programs. In connection with the PAAs,
Dr. Prabhu, as an equity owner of and on behalf of SCN and SCN PLLC, has entered into management and succession agreements with AIM for
continued operation of their respective medical practices upon occurrence of certain events as described therein and for Dr. Prabhu to
comply with the CPM Laws.
Pursuant
to the SCN Purchase Agreement, SCN had entered into a physician employment agreement (the “Physician Employment Agreement”)
with Dr. Prabhu. Under the Physician Employment Agreement, Dr. Prabhu shall perform his duties as a physician in SCN (or SCN affiliated
companies) and comply with all CPM Laws. The Physician Employment Agreement provides an annual compensation of $400,000 and bonus incentives,
payable in cash, should SCN achieve certain annual revenue targets in a calendar year. The Physician Employment Agreement also affords
Dr. Prabhu a board observation right, whereby Dr. Prabhu is entitled to receive advanced notices and attend our board of directors meetings.
Below
is a summary of financing arrangements we entered into to fund the Acquisition and our working capital:
Senior
Secured Loan . On June 9, 2025, concurrently with the Acquisition, we entered into a Note Purchase Agreement (the “Note Purchase
Agreement”) with Streeterville Capital, LLC, a Utah limited liability company (“Lender”), pursuant to which we issued
and sold to Lender a Secured Promissory Note (the “Note”) in the original principal amount of $8.3 million (the “Principal
Amount”, and the financing as described herein, the “Note Financing”). The Principal Amount includes an original issue
discount of $0.7 million. We also agreed to pay $50 thousand to the Lender to cover its legal fees, accounting costs, due diligence,
monitoring, and other transaction costs, each of which was added to the Principal Amount, resulting in a purchase price of for the Note
and gross proceeds to the Company of $7.5 million received by the Company. The Note is not convertible into shares of Common Stock or
otherwise.
The
Note accrues interest at a rate of nine percent (9%) per annum and has a maturity date of eighteen (18) months from the issuance of the
Note, unless earlier prepaid, redeemed or accelerated in accordance with its terms prior to such date. We used the net proceeds from
the Note Financing for funding the cash portion of the Acquisition purchase price and to support ourselves in connection with the Acquisition.
No placement agent was used in connection with the Note Financing.
The
Note is secured by all of the tangible and intangible assets of AIM pursuant to that certain Security Agreement, dated June 9, 2025,
between AIM and the Lender (the “Security Agreement”). We have also pledged the entirety of AIM’s membership interests
to the Lender as collateral for the Loan pursuant to that certain Pledge Agreement dated June 9, 2025, between us and the Lender (“Pledge
Agreement”) and caused AIM to enter into the Guaranty Agreement, dated June 9, 2025, in favor of the Lender (“Guaranty Agreement”)
to respectively secure our performance and provide a guarantee of our obligations to the Lender under the Note and the other transaction
documents.
33
Commencing
six (6) months after the date of issuance of the Note and at any time thereafter until the Note is paid in full, the Lender will have
the right to redeem up to $0.6 million of the Principal Amount under the Note per calendar month. We must pay the redeemed amount in
cash within three (3) trading days of receiving a redemption notice. We may prepay all or any portion of the outstanding balance of the
Note. If we elect to prepay the Note in part within one hundred twenty (120) days from the issuance of Note, we will be required to pay
to the Lender an amount in cash equal to one hundred and seven percent (107%) of the portion (the “Prepayment Premium”) of
the outstanding balance we elect to prepay. Notwithstanding the foregoing, the Prepayment Premium shall not apply to any outstanding
balance of the Note that we elect to prepay on or after the one hundred twenty (120) days after the issuance of the Note.
Additionally,
since the Note remained outstanding on the one hundred twenty (120) days from the anniversary of the issuance, in October 2025 we
incurred a one-time monitoring fee equal to $ 1,4 95,000,
which is the difference between (i) the outstanding balance of the Note divided by 0.85 (as minuend), and (ii) the outstanding balance of
the Note (as subtrahend), which fee was added to the Principal Amount.
The
Note provides for customary events of default (each as defined in the Note, an “Event of Default”), including, among other
things, the event of nonpayment of principal, interest, fees or other amounts, a representation or warranty proving to have been incorrect
when made, failure to perform or observe covenants as specified in the Note, failure to obtain prior written consent from the Lender
on a fundamental transaction (including consolidations, mergers, and certain changes in control of the Company) undertaken by us, and
the occurrence of a bankruptcy, insolvency or similar event affecting us. Upon the occurrence of certain Events of Default related to
the occurrence of a bankruptcy, insolvency or similar event affecting us, the outstanding Principal Amount of the Note will become automatically
due and payable. Additionally, upon the occurrence of any Events of Default, interest shall begin accruing on the outstanding balance
of the Note from the date of the Event of Default equal to the lesser of twenty-two percent (22%) per annum and the maximum rate allowable
under law.
Private
Placement Financing. On June 9, 2025, in connection with the Acquisition, we entered into a Securities Purchase Agreement (the “PIPE
SPA”) with V-Co Investors 2 LLC, a Wyoming limited liability company (“V-Co 2”). V-Co 2 is an affiliate of New Seneca
Partners Inc., a Michigan corporation (“Seneca”), a leading independent private equity firm and an existing significant investor
in our company.
Pursuant
to the PIPE SPA, we sold to V-Co 2 in a private placement offering (the “PIPE Offering”): (i) 828,000 shares (the “PIPE
Shares”) of our common stock, (ii) a pre-funded warrant to purchase 725,258 shares of our common stock (the “Pre-Funded Warrant”,
with the shares of common stock underlying the Pre-Funded Warrant being referred to as the “PFW Shares”), and (iii) a Common
Stock Purchase Warrant to purchase up to 2,329,886 shares of our common stock (the “Common Stock Purchase Warrant, and together
with the Pre-Funded Warrant, the “Warrants”, and with the shares of Common Stock underlying the Common Stock Purchase Warrant
being referred to as the “Warrant Shares”).
V-Co
2 paid a purchase price of $2.42 for each PIPE Share and Pre-Funded Warrant Share and associated Common Stock Purchase Warrant, with
such price being established for purposes of compliance with the listing rules of the Nasdaq Stock Market LLC. The PIPE Offering closed
on June 9, 2025. We received $2.7 million in cash proceeds upon the closing of the PIPE Offering. Additionally, the $1.1 million bridge
note entered into by the Company and V-Co 2 on May 20, 2025, the terms of which were previously reported on Current Report on Form 8-K
filed on May 23, 2025, automatically converted into the PIPE Offering, for total gross proceeds of $3.7 million upon conversion of the
bridge note. The gross proceeds exclude an original issue discount of $0.1 million paid by us in connection with issuing the bridge note.
We are using the net proceeds from the PIPE Offering to support the integration of SCN into our business and for general working capital
purposes. No placement agent was used in connection with the PIPE Offering.
The
Common Stock Purchase Warrant has a term ending on or before June 9, 2029, an exercise price of $2.23 per share and became exercisable
immediately as of the date of issuance. The Pre-Funded Warrant has a term ending on the complete exercise of the Pre-Funded Warrant,
an exercise price of $0.0001 per share and became exercisable immediately as of the date of issuance. The Warrants also contain customary
stock-based (but not price-based) anti-dilution protection as well as beneficial ownership limitations preventing Seneca or its affiliates
from exercising Warrants if such exercise would result in Seneca or its affiliates from owning in excess of 19.99% of our then outstanding
common stock.
34
The
terms of the PIPE SPA requires us to file a registration statement on Form S-3 or other appropriate form (the “Resale Registration
Statement”) registering the PIPE Shares, the PFW Shares and the Warrant Shares (collectively, the “Registerable Securities”)
for resale no later than 45 days of the closing of the PIPE Offering and to use commercially reasonable best efforts to cause the Resale
Registration Statement to be effective within 90 days of the closing of the PIPE Offering. Subsequently, on July 24, 2025, we and V-Co
2 agreed to extend the respective date for which we file the registration statement and cause such registration statement to be declared
effective by 30 days pursuant to an amendment to the June 2025 PIPE SPA. As of the date of this Report, we have yet to file the Resale Registration Statement, and V-Co 2 has not required
us to. We must also use our commercially reasonable efforts to keep
the Resale Registration Statement continuously effective (including by filing a post-effective amendment to the Resale Registration Statement
or a new registration statement if the Resale Registration Statement expires) for a period of three (3) years after the date of effectiveness
of the Resale Registration Statement or for such shorter period as such securities no longer constitute Registrable Securities, subject
to certain limitations specified in the PIPE SPA. The PIPE SPA further provides that we shall pay V-Co 2 in the amount equal to $50,000
for the fees and expenses of V-Co 2’s counsel incurred in connection with the PIPE Offering. The PIPE SPA also includes standard
representations, warranties, indemnifications, and covenants of the Company and V-Co 2.
SCN
Integration Update. Our operational planning for the integration of SCN began in April 2025, when we signed the definitive
agreement to purchase SCN. We believe these two months of advance planning has benefited the process of integrating SCN into our
business, as our operations team has been able to execute our plan on schedule and under budget with respect to two of SCN’s
seven locations in the greater Las Vegas area. Also, because of this effort, we recognized a small amount of SCN revenue during our
fiscal second quarter (for the period beginning with the June 10, 2025 Acquisition closing date through June 30, 2025). For the
three months ended September 30, 2025 (the first full quarter of SCN operations), we recognized Sleep Testing Service revenue from SCN of $2.2
million and treatment center revenue of $1.3 million. The goal is to continue to increase diagnostic sleep testing revenue
from SCN and related Vivos treatment center revenue in the fourth quarter of 2025 and into 2026 and beyond.
As
we had anticipated during the initial stage of SCN integration, patient demand is exceeding our capacity to process and treat patients
under our model which includes offering SCN patients Vivos treatment options. Our goal is to ramp up our systems and operations by strategically
deploying additional personnel and resources to meet this demand. We currently expect that some of SCN’s locations, including the
two already integrated, to be primary treatment hubs with larger patient capacities, with the remaining being referral centers (which
could be relocated facilities) requiring less time and effort to integrate.
Our
operational plan is driven by our deployment of our Sleep Optimization (SO) teams, each consisting of one nurse practitioner (or physician’s
assistant), two specially trained dentists, six dental assistants, six administrative support personnel, and one treatment navigator.
These SO teams can be dedicated to high demand locations or spread across multiple locations as circumstances dictate. In third quarter, we had
1.5 SO teams deployed across two SCN locations and expect to have two additional SO teams deployed by the end of 2025.
We anticipate an initial ramp of 30 to 60 days for SO teams to become fully functional, and up to five months or longer before net revenue
collections match revenue generating activity (such as OSA diagnostic services or OSA treatment case starts). A fourth SO team is planned
for deployment sometime in the first quarter of 2026, giving us an expected total of 4.5 SO teams operating by the end of the first quarter
of 2026. Based on the current volume of OSA patient demand, we believe the current markets served by SCN could support up to eight SO
teams, and potentially more if certain planned growth initiatives meet expectations. Such initiatives include, but are not limited to,
the expansion of diagnostic and treatment services, the establishment and rollout of a pediatric OSA program, and the collaboration with
certain specialty medical groups who treat patients with comorbid OSA but who lack the ability to test, evaluate and treat such patients
within their existing practice environments.
Based
on our experience to date, we believe our limiting constraints for near-term revenue growth at SCN are (1) physical space to see an
optimal number of patients; (2) provider and staff recruiting, training, and onboarding; and (3) customary issues with third party
provider credentialing. At the SCN locations we have onboarded, we are currently fully booked for appointments for several weeks,
and we are processing what we believe is less than 40% of patients attempting to get appointments for treatment. We expect the
current expansion at one facility and relocation of a second facility, coupled with the additional deployments of the two new SO
teams by year-end 2025, will help reduce the backlog of patients seeking treatment. However, we do not believe we will be able to
fully meet current demand until additional SO teams are fully deployed during 2026.
35
Our
initial average case revenue and acceptance rate for Vivos treatment at SCN to date suggest that each SO team could potentially generate
collections in excess of $500,000 per month, net of adjustments, with contribution margins above 50%. In addition to current Vivos diagnostic
and treatment options, we expect to be able to offer SCN patients additional diagnostic and treatment services that could generate additional
high-margin revenue. It will take time for each SO team to reach full capacity, if at all, so the above figures should be viewed as our
current best estimates based on our limited operating experience and actual performance to date, rather than projections of our future
performance. That said, we continue to gather additional data that will allow us to refine our model and optimize operations, and results
of operations, in future periods.
Importantly,
we expect to apply the lessons learned from our SCN integration activities to future sleep center or medical practice acquisitions
or management collaborations we are currently exploring and hope to consummate in the future as described below. These lessons
include our experience with the time needed to train medical providers in the use of Vivos diagnostic and treatment devices, and the
challenges associated with validating issuance coverage. Further, we have noticed trends in our SCN operations that provide us with insights into how we can optimize such operations. For example, after a patient
elects to proceed with treatment following a diagnosis of OSA, there is typically a delay between the recognition of diagnostic revenue and the subsequent
recognition of treatment revenue related to the use of our appliances. Based on our relatively limited experience to date, this lag generally ranges from approximately one month to four and a half
months following treatment acceptance. The timing difference is primarily attributable to the completion of prerequisite clinical
procedures and the production lead time required to manufacture and fit the appliance.
We expect to fund costs associated with our SCN integration activities with net proceeds from our June 2025 debt
and equity financings, potential future financings, and ultimately cash from operations.
Revised
OSA Provider Management Model. In addition to growth through acquisitions of medical sleep providers like SCN, we are actively
developing a revised strategic alliance or management model that we are implementing in situations where the sleep center or medical
practice owners are not interested in being purchased by us, but are interested in making the full range of our OSA treatment
options available to their patients. Our plan is to accomplish this type of collaboration through the creation and pro-rata funding
of a new management services entity that is jointly owned by the sleep center owners and our company, but where our company retains
a supermajority controlling interest. The revised management model incorporates our experience with Rebis Health in Colorado, our
first sleep provider collaboration arrangement which we entered into in 2024, and which has not yet performed to our expectations.
Under the revised model, through the co-owned management company, we will have more operational control to help ensure that our
business model is being properly implemented.
We
believe this revised management model can provide financial upside for our company with limited capital expenditures, and with what we
believe are manageable risks. At the same time, this revised management model creates the potential for economic upside for sleep center
or medical practice collaborators who are currently not interested in an outright sale to our company. Moreover, we believe the overall
quality of care and service to the OSA patients of our medical provider collaborators can improve by having more treatment options available.
The revised management model, as in the previous model, is designed to be compliant with current state and federal healthcare, anti-kickback,
and corporate practice of medicine and dentistry regulations.
On
July 14, 2025, we entered into our first management agreement under this revised approach with MISleep Solution LLC to provide our
full suite of Vivos treatments and services to OSA patients at a joint location in Auburn Hills, Michigan (which is near Detroit).
Consistent with our new model, our company owns a supermajority equity stake in the management services company, with the sleep
doctors having minority ownership interests. The facility to support these operations is currently under construction, with an
estimated opening date in early December 2025. We are currently in the process of hiring, training, and onboarding one complete SO
team that we expect to deploy as soon as the physical facility is ready for occupancy. Based on our internal analysis and
experience, we expect the economics of our Detroit SO team to be similar to the economics described above for our SO teams at SCN,
except that net profit distributions from the management services entity will be paid out on a pro-rata basis (with our company
receiving the supermajority share). As of this time, we have no direct operating history in the Detroit, Michigan market or with
this new model. However, we believe that the overall benefit to our company that this model derives with limited risks (as opposed
to outright acquisitions) and generally low equipment and facility capital expenditures relative to the potential revenue
opportunity. This model also obviates the need for us to finance the purchase and other costs associated with our acquisition
model.
Potential
Provider Acquisition or Management Pipeline. We are currently in active discussions with a number of potential acquisition
targets and strategic sleep center affiliations to follow our SCN acquisition and Detroit-area management agreement. Every prospect
must meet a rigorous set of criteria and standards in order to be considered by our mergers and acquisitions team for acquisition or
management. One such acquisition target is currently under an exclusive letter of intent with us. Our pipeline of additional
potential acquisition and management opportunities with sleep centers and medical sleep specialists continues to expand. This
is happening largely through word of mouth and very little expenditure in terms of marketing efforts to the more than 2,600 American
Academy of Sleep Medicine accredited sleep testing centers nationwide. We believe this pipeline of potential acquisition and
management activity, together with the experience gained from previous endeavors, will be a key driver of future accretive growth
for us.
36
Distribution
Agreements. During 2023, we entered into distribution collaborations with third parties to expand access of our products to potential
patients. We hope that these strategic initiatives will lead to revenue growth opportunities for us in 2025 and beyond, and our ability
to capitalize on these initiatives is expected to be a material aspect of our sales and marketing program going forward.
For
example, in October 2023, we announced an exclusive distribution agreement with NOUM DMCC, a Dubai-based company focused on
diagnostic testing and treatment product distribution for healthcare providers and hospital networks treating obstructive sleep
apnea patients throughout the Middle East-North Africa region. With regulatory approvals pending, there was no revenue from this
collaboration in 2024 and no material revenue thus far in 2025.
Trade
Policy/Tarriff Risks. Certain of our products or components are manufactured outside the United States. Most products imported into
the United States are subject to duty and restrictive quotas on the amount of products that can be imported from certain countries into
the United States each year. Because of the duty rates and quotas, changes in U.S. trade policy as reflected in the imposition of tariffs,
trade legislation, trade preference programs and trade agreements have the potential to materially impact our sourcing strategy and the
competitiveness of our contract manufacturers. During 2025, the U.S. has imposed (and in some cases retracted) significant tariffs on a global scale, creating uncertainty
and price fluctuations. We seek to manage this risk by continually monitoring U.S. trade policy, analyzing the impact
of changes in such policy and adjusting its manufacturing and sourcing strategy accordingly.
Inflation .
The U.S. has been experiencing a period of inflation which has increased (and may continue to increase) our and our suppliers’
costs as well as the end cost of our products to consumers. To date, we have been able to manage inflation risk without a material adverse
impact on our business or results of operations. However, inflationary pressures (including increases in the price of raw material components
of our appliances) made it necessary for us to adjust our standard pricing for our appliance products in 2022 and will be revisited in
2026. The full impact of such price adjustments on sales or demand for our products is not fully known at this time and may require us
to adjust other aspects of our business as we seek to grow revenue and, ultimately, achieve profitability and positive cash flow from
operations.
An
additional inflation-related risk is the Federal Reserve’s response to inflation, which as of the date of this Report, has been
to maintain elevated interest rates. Such actions have, in times past, created unintended consequences for housing starts, overall manufacturing,
the capital markets, and the banking sector. An uncertain Federal Reserve response to inflation could, as a result, have an impact on our revenue,
earnings and access to capital.
Supply
Chain. From time to time, we may experience supply chain challenges due to forces beyond our control. For example, the Suez Canal
blockage earlier in 2021 caused some delay in shipments of SleepImage ® rings from China. Overall, however, as our appliances
are made in the U.S., we have not experienced significant supply chain issues as a result of COVID-19 or otherwise, although this may
change in future periods.
War
in Ukraine and Middle East Hostilities. In addition, worldwide supply chain constraints and economic and capital markets
uncertainty arising out of Russia’s invasion of Ukraine in February 2022 and conflicts and continuing tensions in the Middle
East since October of 2023 have disrupted commercial and capital markets and emerged as new barriers to long-term economic recovery.
If an economic recession or depression commences and is sustained as a result of such regional armed conflicts, it could have a
material adverse effect on our business as demand for our products could decrease. Capital markets uncertainty, with public stock
price decreases and volatility, could make it more difficult for us to raise capital when needed.
Potential
Nasdaq Delisting . As previously reported, we were previously subject to a Nasdaq Stock Market (“Nasdaq”) listing deficiencies
related to Nasdaq’s $2,500,000 minimum stockholders’ equity requirement (the “Minimum Stockholders’ Equity Requirement”).
On
May 16, 2024, we received a written notice from Nasdaq indicating that, as of March 31, 2024, we failed to comply with the Equity Requirement.
On June 25, 2024, we reported in a Current Report on Form 8-K that it believed it had stockholders’ equity of at least $2.5 million
as of the date of the filing of such report as a result of our closing of a $7.5 million equity private placement on June 10, 2024. On
June 27, 2024, we met with the Nasdaq Hearing Panel (the “Hearing Panel”) to discuss our past, current, and anticipated future
compliance with the Equity Requirement, and requested the continued listing of its securities on Nasdaq. On July 5, 2024, we were notified
that the Panel had granted our request for continued listing on Nasdaq, subject to our filing of the Form 10-Q for the quarter ended
June 30, 2024, with the Securities and Exchange Commission by August 15, 2024, evidencing our compliance with the Equity Requirement.
We made such filing in a timely manner.
37
We
are working diligently to ensure our continued compliance with the Equity Requirement, including exploring additional equity capital
financings to stay above the minimum threshold of the Equity Requirement. We anticipate that our new strategic marketing and distribution
alliance model will also positively impact our revenue growth and stockholders’ equity in upcoming fiscal quarters. However, there
is a risk that we will be unable to raise sufficient capital or generate sufficient revenue or operating results to maintain compliance
with the Equity Requirement. If we fail to achieve ongoing compliance and our common stock is delisted by Nasdaq, such delisting would
likely have a material adverse effect on our stock price, the ability of our stockholders to buy or sell their common stock, our ability
to raise capital and on our reputation, all of which could make it significantly more difficult to operate.
Key
Components of Consolidated Statements of Operations
Net
revenue
Legacy VIP Model .
Under our legacy VIP model, we recognize revenue when we satisfy our performance obligations over time as our customers receive the benefit
of the promised goods and services, which generally occurs over a short period of time. Performance obligations with respect to appliance
sales are typically satisfied by shipping or delivering products to our VIPs or to any sleep clinic, through our new marketing and distribution
model, in the case of enrollment or service revenue, upon our satisfaction of performance obligations associated with VIP enrollments.
Revenue consists of the gross sales price, net of estimated allowances, discounts, and personal rebates that are accounted for as a reduction
from the gross sale price.
New
Treatment Center Distribution Model . The quarter ended September 30, 2025 represented the first full quarter of revenues generated
from SCN and our agreements related to the Acquisition , leading to a significant increase of year over year revenue. Under this
new model, VIP enrollment revenue has been substituted with a new revenue stream we call “treatment center” revenue, consisting
of Vivos treatment protocols including head and neck exams, cone beam tomography, laser and myofunctional therapy, and Vivos appliances
of approximately $1.3 million in the quarter.
Cost
of sales. Cost of goods sold primarily consists of direct costs attributable to the purchase from third party suppliers and related
products as well as direct payroll costs. It also includes freight costs, fulfillment, distribution, and warehousing costs related to products sold.
Sales
and marketing. Sales and marketing costs primarily consist of personnel costs for employees engaged in sales and marketing activities,
commissions, advertising and marketing costs, website enhancements, and conferences for our sales and marketing staff.
General
and administrative expenses. General and administrative (“G&A”) expenses consist primarily of personnel costs
for our administrative, human resources, finance and accounting employees, and executives. General and administrative expenses also include
contract labor and consulting costs, travel - related expenses, legal, auditing and other professional fees, rent and facilities
costs, repairs and maintenance, and general corporate expenses.
Depreciation
and amortization expense. Depreciation and amortization expense is comprised of depreciation expense related to property and
equipment, amortization expense related to leasehold improvements, and amortization expense related to identifiable intangible assets.
Other
income. Other income relates to interest income and the excess warrant fair value and change in fair value of warrant liability.
38
Results
of Operations
Comparison
of the three and nine months ended September 30, 2025 and 2024
Our
consolidated statements of operations for the three and nine months ended September 30, 2025 and 2024 (which includes incremental revenue
recognized from the operations of SCN from June 10, 2025 to September 30, 2025) are presented below (dollars in thousands):
Three Months Ended
September 30,
Nine Months Ended
September 30,
2025
2024
Change
2025
2024
Change
Revenue (see Note 4 for further detail on composition of revenue)
Product revenue
$ 2,195
$ 1,958
$ 237
$ 5,893
$ 5,608
$ 285
Service revenue
4,588
1,902
2,686
7,726
5,725
2,001
Total revenue
6,783
3,860
2,923
13,619
11,333
2,286
Cost of sales (exclusive of depreciation and amortization shown separately below)
2,846
1,526
1,320
6,065
4,411
1,654
Gross profit
3,937
2,334
1,603
7,554
6,922
632
Gross profit %
58 %
60 %
55 %
61 %
Operating expenses
General and administrative
7,884
4,487
3,397
19,181
13,531
5,650
Sales and marketing
403
346
57
1,018
1,319
(301 )
Depreciation and amortization
384
146
238
867
437
430
Operating loss
(4,734 )
(2,645 )
(2,089 )
(13,512 )
(8,365 )
(5,147 )
Non-operating income (expense)
Other expense
(679 )
(18 )
(661 )
(850 )
(42 )
(808 )
Other income
13
47
(34 )
86
98
(12 )
Net loss
$ (5,400 )
$ (2,616 )
$ (2,784 )
$ (14,276 )
$ (8,309 )
$ (5,967 )
Comparison
of the three months ended September 30, 2025 and 2024
Revenue
Revenue
increased by approximately $2.9 million, or 76%, to approximately $6.8 million for the three months ended September 30, 2025
compared to $3.9 million for the three months ended September 30, 2024. The increase in total revenue during the third quarter of
2025 was impacted by an increase of approximately $2.7 million in service revenue and approximately $0.2 million in product revenue.
The increase in service revenue is attributable to $2.2 million in sleep testing services primarily generated by SCN and $1.3
million generated from SCN treatment centers (providing the services described under “Key Components of Consolidated
Statements of Operations” above) launched at two SCN locations, which was offset by a decrease of $0.8 million in VIP revenue
from our legacy business model. VIP revenue in the third quarter of 2025 was impacted by no breakage in contracts, when compared to
the same period in 2024. Breakage of contracts accelerated revenue recognition on several contracts for VIPs in 2024 who did not
complete their training during the first 90 days of their enrollment. Approximately $0.5 million in revenue was attributable to
breakage during the three months ended September 30, 2024. Over the last year, our reliance on VIP enrollment revenue has diminished
significantly as such revenues have decreased.
For
the three months ended September 30, 2025, we sold 4,370 oral appliance arches for a total of approximately $2.2 million,
representing a 12% increase in revenue from the three months ended September 30, 2024, when we sold 1,954 oral appliance arches for
a total of approximately $2.0 million. The decrease in revenue per appliance is directly attributable a higher volume mix of
pediatric and Lifeline sales, which are lower revenue generating products when compared to higher end Vivos C.A.R.E.
appliances.
We have observed a lag time that ranges from approximately one month to four and a half months following treatment acceptance
which is primarily attributable to the completion of prerequisite clinical procedures and the production lead time required to manufacture
and fit the appliance.
Cost
of Sales and Gross Profit
Cost
of sales increased $1.3 million or 87% to approximately $2.8 million for the three months ended September 30, 2025, compared to $1.5
million for the three months ended September 30, 2024. This was primarily attributable to higher costs associated with the integration
of SCN, including $0.5 million related to appliance, pediatric and Lifeline fees, $0.4 million related to SCN operations, $0.3 million
increase in support costs for the treatment centers such as staff compensation and financing fees, and $0.1 million increase in software
and medical reporting services.
For
the three months ended September 30, 2025, gross profit increased by approximately $1.6 million to $3.9 million. This increase was attributable
to the increase in revenue of approximately $2.9 million offset by an increase in cost of sales of $1.3 million. Gross margin decreased
to 58% for the three months ended September 30, 2025, compared to 60% for the three months ended September 30, 2024 due to the higher
increase in cost of sales when compared to revenue.
39
General
and Administrative Expenses
General
and administrative expenses increased by approximately $3.4 million, or 76%, to approximately $7.9 million for the three months
ended September 30, 2025, as compared to $4.5 million for the three months ended September 30, 2024. The primary cause of this
increase was approximately $1.6 million in costs associated with integrating and running SCN’s operations, approximately $0.6 million
related to professional fees, approximately $0.6 million associated with salaries and wages on additional personnel, infrastructure
costs of approximately $0.4 million and travel related expenses of approximately $0.1 million, when compared to the three months ended September 30, 2024.
Sales
and Marketing
Sales
and marketing expenses stayed relatively flat at $0.4 million for the three months ended September 30, 2025, which is attributable to
our one-time focus on the acquisition and commencement of integration of SCN into our operations offset by cost savings.
Depreciation
and Amortization
Depreciation
and amortization expense increased $0.2 million for the three months ended September 30, 2025 due to depreciation on assets acquired
from SCN and being placed into service.
Other
Income/(Expense)
Other
(Expense) increased $0.7 million due to interest expense on a note during the three months ended September 30, 2025.
Comparison
of the nine months ended September 30, 2025 and 2024
Revenue
Revenue
increased approximately $2.3 million, or 20%, to approximately $13.6 million for the nine months ended September 30, 2025 compared
to $11.3 million for the nine months ended September 30, 2024. The increase in total revenue was impacted by an increase of
approximately $2.0 million in service revenue and approximately $0.3 million in product revenue. The increase in services revenue is
attributable to $2.8 million in sleep testing services primarily generated by SCN and $1.6 million generated from treatment centers
(providing the services described under “Key Components of Consolidated Statements of Operations” above) launched at two
SCN locations, which was offset by a decrease of $2.6 million in VIP revenue from our legacy business model. VIP revenue in the
first nine months of 2025 was impacted by lower breakage in contracts, when compared to the same period in 2024. Breakage of
contracts accelerated revenue recognition on several contracts for VIPs in 2024 who did not complete their training during the first
90 days of their enrollment. Approximately $1.5 million in revenue was attributable to breakage during the nine months ended
September 30, 2024. Additionally, there was approximately a $0.3 million increase in sponsorship and seminar revenue. Over the last
year, our reliance on VIP enrollment revenue has diminished significantly as such revenues have decreased.
For
the nine months ended September 30, 2025, we sold 12,222 oral appliance arches for a total of approximately $5.9 million,
representing a 5% increase in revenue from the nine months ended September 30, 2024, when we sold 5,993 oral appliance arches for a
total of approximately $5.6 million. The decrease in revenue per appliance is directly attributable to an increase in pediatric and
Lifeline sales at a lower average price than higher end CARE devices. Refer to “ Material Items, Trends and Risks Impacting
Our Business ” section above for events that impacted our product sales.
We have observed a lag time that ranges from approximately one month to four and a half months following treatment acceptance
which is primarily attributable to the completion of prerequisite clinical procedures and the production lead time required to manufacture
and fit the appliance.
Cost
of Sales and Gross Profit
Cost
of sales increased $1.7 million or 37% to approximately $6.1 million for the nine months ended September 30, 2025, compared to $4.4 million
for the nine months ended September 30, 2024. This was primarily attributable to higher costs associated with the integration of SCN,
including $0.6 million related to appliance and pediatric and Lifeline fees, $0.5 million related to SCN operations, $0.2 million increase
in support costs for the treatment centers such as staff compensation and financing fees, and $0.4 million increase in software and medical
reporting services, when compared to the nine months ended September 30, 2024.
40
For
the nine months ended September 30, 2025, gross profit increased by approximately $0.6 million to $7.6 million. This increase was attributable
to the increase in revenue of approximately $2.3 million offset by an increase in cost of sales of $1.7 million. Gross margin decreased
to 55% for the nine months ended September 30, 2025, compared to 61% for the nine months ended September 30, 2024 due to the higher increase
in cost of sales when compared to revenue.
General
and Administrative Expenses
General
and administrative expenses increased by approximately $5.7 million or 42% to approximately $19.2 million for the nine months ended
September 30, 2025, as compared to $13.5 million for the nine months ended September 30, 2024. The primary cause of this increase
was approximately $2.0 million in costs associated with integrating and running SCN’s operations, approximately $1.6 million
related to professional fees, approximately $1.1 million associated with salaries and wages on additional personnel, infrastructure
costs of approximately $0.6 million and equipment, repairs and maintenance of approximately $0.2 million, when compared to the nine
months ended September 30, 2024.
Sales
and Marketing
Sales
and marketing expenses decreased by $0.3 million to $1.0 million for the nine months ended September 30, 2025, compared to $1.3 million
for the nine months ended September 30, 2024. This decrease was primarily driven by our decrease in sales and marketing campaigns, resulting
in lower commissions paid to our employees for digital media services and reduction in use of marketing supplies.
Depreciation
and Amortization
Depreciation
and amortization expense increased $0.4 million to approximately $0.9 million for the nine months ended September 30, 2025 from $0.4
million for the nine months ended September 30, 2024. Depreciation and amortization increased during the period due to depreciation on
the assets acquired from SCN and being placed into service.
Other
Income /(Expense)
Other
(Expense) increased $0.8 million due to interest expense on a note during the nine months ended September 30, 2025.
Liquidity
and Capital Resources
The
accompanying unaudited financial statements have been prepared in conformity with generally accepted accounting principles, which
contemplate continuation of the Company as a going concern. We have incurred losses since inception, including $5.4 and $2.6 million
for the three months ended September 30, 2025 and 2024, respectively, and $14.3 and $8.3 million for the nine months ended September
30, 2025 and 2024, respectively, and accumulated deficit of approximately $118.5 million as of September 30, 2025.
Net
cash used in operating activities amounted to approximately $11.5 and $9.8 million for the nine months ended September 30, 2025 and 2024,
respectively. As of September 30, 2025, we had total liabilities of approximately $23.1 million.
As
of September 30, 2025, we had approximately $3.1 million in cash and cash equivalents, which will not be sufficient to fund
operations and strategic objectives over the next twelve months from the date of the issuance of the accompanying unaudited
financial statements. Without additional financing, these factors raise substantial doubt regarding the Company’s ability to
continue as a going concern.
41
We
have implemented cost savings measures in our legacy business that have reduced cash used in operations. However, even though we
have worked to refine our business model, our sales did not grow during our fiscal year ended 2024, and is only beginning to
increase during the nine months of 2025. Revenue from our first contractual alliance with Rebis Health have not developed as we had
expected for many reasons beyond our control, but we learned important lessons which have led to improvements to our alliance model.
We expected a short-term drop in sales and an increase in costs as we executed on our business model pivot. This trend began to shift materially in the quarter ended September 30, 2025 as we experienced our first full quarter
of SCN operations and resulting in increases in revenue.
As
such, we have funded our operations through equity raises in the period ended September 30, 2025 and fiscal year ended December 31, 2023
and 2024. We were required to obtain additional financing to satisfy our cash needs, including to fund the SCN acquisition, and increase
our stockholders’ equity for Nasdaq compliance purposes as we seek to increase revenue with a view towards ultimately achieving
positive cash flow from operations. For a discussion of the financings to fund the SCN acquisition, please refer to the section “M aterial
Items, Trends and Risks Impacting Our Business - Pivot in Our Sales, Marketing and Distribution Model and Decreased Emphasis on VIP Enrollments.”
Until
we attain positive cash flow, our management is reviewing all options to obtain additional financing to fund our operations. We financed
the SCN acquisition from the issuance of senior secured debt and equity securities. As reflected in our increase in revenue during the
three months ended September 30, 2025, we expect the SCN acquisition will ultimately allow our company to achieve positive cash flows;
however, there is a risk this may not occur. We originally expected the Strategic Alliance Agreement (“SAA”) with Rebis Health
entered into in June 2024 to increase patient volume, drive top line revenue and lower customer acquisition costs and overhead. However,
due to ongoing delays at Rebis Health that are beyond our control, we are currently re-evaluating expectations under this SAA. As such,
we seek to acquire other sleep centers in transactions similar to the SCN acquisition or enter into other strategic alliances with improved
terms. There can be no assurances that adequate additional funding will be available on favorable terms, or at all. If such funds are
not available in the future, or the SAA or similar alliances or acquisitions do not result in the patient volume, appliance sales and
financial results within the timeframes we expect, we may be required to delay, significantly modify or terminate some or all of our
operations, all of which could have a material adverse effect on us and our stockholders.
We
do not have any off-balance sheet arrangements, as defined by applicable regulations of the SEC, that are reasonably likely to have a
current or future material effect on our financial condition, results of operations, liquidity, capital expenditures or capital resources.
Cash
Flows
The
following table presents a summary of our cash flow for the three and nine months ended September 30, 2025 and 2024 (in thousands):
2025
2024
Net cash provided by (used in):
Operating activities
$ (11,451 )
$ (9,751 )
Investing activities
(5,945 )
(403 )
Financing activities
14,223
14,822
Net
cash used in operating activities of approximately $11.5 million for the nine months ended September 30, 2025 an increase of approximately
$1.7 million compared to net cash used in operating activities of approximately $9.8 million for the nine months ended September 30,
2024. This increase is due primarily to a $6.0 million increase in net loss for the nine months ended September 30, 2025 and decrease
in contract liabilities of approximately $0.5 million, offset by an increase in depreciation and amortization of approximately $0.4 million,
an increase of approximately $2.0 million in accounts payable, an increase of approximately $1.0 million in other liabilities, and an
increase of approximately $0.6 million in interest expense on a promissory note.
For
the nine months ended September 30, 2025, net cash used in investing activities consisted of approximately $5.1 million for payment of
a business acquisition and capital expenditures of $0.8 million related to the development of software for internal use,
and assets placed in service in 2025 related to the integration of SCN. This compares to net cash used in investing activities for the
nine months ended September 30, 2024 of $0.4 million due to capital expenditures for internally developed software.
42
Net
cash provided by financing activities of $14.2 million for the nine months ended September 30, 2025, is attributable to proceeds of approximately
$9.2 million from the issuance of debt, approximately $1.7 million for the issuance of warrants, approximately $0.6 million form the
issuance of pre-funded warrants, approximately $2.8 million from the issuance of common stock, and approximately $0.9 million form the exercise of warrants. This compares to net cash used in
investing financing for the nine months ended September 30, 2024 of $14.8 million attributable to proceeds from the issuance of Common
Stock, net of approximately $0.9 million of professional fees and other issuance costs, in our February 2024 warrant inducement transaction
and the June and September 2024 private placements.
Critical
Accounting Policies Involving Management Estimates and Assumptions
Our
critical accounting policies and estimates are described in “ Management’s Discussion and Analysis of Financial Condition
and Results of Operations—Critical Accounting Policies and Estimates ” in our Annual Report on Form 10-K for the fiscal
year ended December 31, 2024. We have reviewed and determined that those critical accounting policies and estimates remain our critical
accounting policies and estimates as of and for the three and nine months ended September 30, 2025.
Recent
Accounting Pronouncements
From
time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board or other standard setting bodies that
are adopted by us as of the specified effective date. Unless otherwise discussed in Note 1 to the accompanying condensed consolidated
financial statements included in this Report, we believe that the impact of recently issued standards that are not yet effective could
have a material impact on our financial position or results of operations upon adoption. For additional information on recently issued
accounting standards and our plans for adoption of those standards, please refer to the section titled Recent Accounting Pronouncements
under Note 1 to the accompanying condensed consolidated financial statements included in this Report.
Item
3. Quantitative and Qualitative Disclosures About Market Risk
Not
applicable to smaller reporting companies.
Item
4. Controls and Procedures.
Evaluation
of Disclosure Controls and Procedures
Our
disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e)) are designed to ensure that information required to
be disclosed by us in reports we file or submit under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized
and reported within the appropriate time periods, and that such information is accumulated and communicated to our Chief Executive Officer
and Chief Financial Officer, as appropriate, to allow timely discussions regarding required disclosure. We, under the supervision of
and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, have evaluated the effectiveness
of our disclosure controls and procedures. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded
that the design and operation of our disclosure controls and procedures were effective, at the reasonable assurance level, as of the
end of the period covered by this Report.
Management’s
evaluation of disclosure controls and procedures excluded the internal controls of The Sleep Center of Nevada, which we acquired on June
10, 2025. The Sleep Center of Nevada represents approximately 28% of our consolidated total assets as of and for the period ended September
30, 2025 and 20% and 33% of our consolidated revenues for the three and nine months ended September 30, 2025. We are in the process of
integrating The Sleep Center of Nevada into our disclosure controls and procedures and internal control framework.
Changes
in Internal Control over Financial Reporting
There
were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act)
that occurred during the quarter ended September 30, 2025 that have materially affected, or are reasonably likely to materially affect,
our internal control over financial reporting.
As
noted above, we are in the process of integrating The Sleep Center of Nevada and expect to complete this integration within one year
of the acquisition date.
43
PART
II – OTHER INFORMATION
Item
1. Legal Proceedings.
From
time to time, we may become involved in various lawsuits and legal proceedings which arise in the ordinary course of business. Below
is a description of our outstanding pending litigation matters. Litigation is subject to inherent uncertainties and an adverse result
in the below described or other matters may arise from time to time that may harm our business.
On
June 5, 2020, we filed suit against Ortho-Tain, Inc. (“Ortho-Tain”) in the United States District Court for the District
of Colorado seeking relief from certain false, threatening, and defamatory statements to our business affiliate, Benco Dental (“Benco”).
We believe such statements have interfered with our business relationship and contract with Benco, causing harm to our reputation, loss
of goodwill, and unspecified monetary damages. On February 12, 2021, we amended our complaint to add claims for false advertising and
unfair business practices, as well as additional variants of the original claims to address Ortho-Tain’s alleged false advertising
campaign against us in the fall of 2020. Our amended complaint seeks permanent injunctive relief to prevent what we believe are defamatory
statements and interference with our business relationships by Ortho-Tain.
We
further seek declaratory relief to refute the defendant’s false allegations, as well as monetary damages. Prior to filing the suit,
we worked collaboratively with legal counsel at Benco to address and resolve this matter. Such efforts were unsuccessful. On February
26, 2021, Ortho-Tain, Inc. filed a motion to dismiss the amended complaint. We opposed the motion. On June 21, 2022, the Tenth Circuit
entered an order and judgment. Pursuant to such order, the appeal was terminated, and the case was remanded to the U.S. District Court
for the District of Colorado for further proceedings. On July 13, 2022, the Clerk of Court for the Tenth Circuit transferred jurisdiction
back to the District of Colorado. On February 14, 2024, the District Court of Colorado issued an order denying Ortho-Tain’s motion
to dismiss after analyzing the issue of litigation privilege under the standard ordered by the Tenth Circuit. In response, Ortho-Tain
filed a notice of appeal of the District Court of Colorado order on February 14, 2024. The appeal has been docketed in the Tenth Circuit,
and the record has been completed. On March 5, 2024, we filed a motion to dismiss the appeal for lack of jurisdiction. Ortho-Tain filed
its response to the motion to dismiss on March 19, 2024. Our reply in support of the motion to dismiss was filed on March 26, 2024. On
March 20, 2024, the Court ordered that our motion to dismiss for lack of jurisdiction would be referred to the panel of judges to be
assigned to the appeal, and that no ruling on the motion to dismiss would be issued at that time. Ortho-Tain filed its opening brief
on April 29, 2024. We filed an Answer Brief on May 29, 2024. Ortho-Tain filed its response brief on June 20, 2024. On October 31, 2024,
the Tenth Circuit ordered additional briefing on two discrete issues and that briefing was filed on November 21, 2024. Oral Argument
occurred on March 18, 2025, and on July 8, 2025 the parties are awaiting a ruling. Tenth Circuit issued its opinion dismissing the appeal
in its entirety for lack of jurisdiction. Ortho-Tain then filed a petition for rehearing on July 22, 2025, which was denied by the Tenth
Circuit on August 4, 2025.
On
July 22, 2020, Ortho-Tain, Inc. filed a complaint in the United States District Court for the Northern District of Illinois against the
Company, our Chairman and Chief Executive Officer, R. Kirk Huntsman, Benco Dental Supply Co., Dr. Brian Kraft, Dr. Ben Miraglia, and
Dr. Mark Musso (the “Illinois Ortho-Tain Case”). The complaint in the Illinois Ortho-Tain Case addresses the same events
as the suit we filed against Ortho-Tain in June 2020 as described above. The complaint in the Illinois Ortho-Tain Case alleges violation
of the Lanham Act and an alleged civil conspiracy among the defendants to violate the Lanham Act by an alleged false designation of origin
related to a presentation given by Dr. Brian Kraft at an event sponsored by us and Benco Dental.
44
Ortho-Tain
also alleges that the actions of the defendants diverted sales from Ortho-Tain, deprived Ortho-Tain of advertising value and resulted
in a loss of goodwill to Ortho-Tain. Ortho-Tain further alleges two separate breach of contract actions against Dr. Brian Kraft and Mr.
Huntsman. Ortho-Tain’s allegation of breach of contract against Mr. Huntsman, relates to a Non-Disclosure Agreement entered into
in October 2013 with Mr. Huntsman’s prior entity, Xenith Practices, LLC, which Non-Disclosure Agreement expired pursuant to its
terms in October 2016. We continue to evaluate the allegations, although we believe the allegations lack merit and further believe Ortho-Tain
will be unable to establish actionable damages.
On
September 9, 2020, we moved to dismiss the claims against it in the Illinois Ortho-Tain Case. On October 23, 2020, we filed a motion
requesting, in the alternative, that if the case is not dismissed, it be transferred to the Colorado action described above or stayed.
On May 14, 2021, the United States District Judge entered an order granting our motion to stay this case pending the outcome of a substantially
similar, first-filed suit by us is pending in the United States District Court. In light of the stay, the District Court denied, without
prejudice, our pending motion to dismiss. On March 2, 2023, the District Court lifted the stay.
The
Defendants renewed their motions to dismiss. On August 23, 2024, the District Court of Colorado issued its order partially granting the
motions to dismiss, including dismissing Defendants Benco Dental Supply Co. and Dr. Mark Musso. Ortho-Tain subsequently sought leave
to amend its Complaint to try and address the deficiencies identified by the District Court of Colorado in its August 23, 2024 order.
The Defendants opposed the Motion for Leave to Amend, and, on October 9, 2024, the District Court of Colorado held a hearing to address
the Motion for Leave to Amend. The District Court of Colorado denied Plaintiff’s Motion for Leave to File an Amended Complaint
without Prejudice.
The
Parties submitted a Joint Discovery Plan to the District Court on October 21, 2024. On October 22, 2024, the District Court ordered the
parties to exchange Rule 26(a)(1) initial disclosures by November 22, 2024 and Initial Written Discovery to Be Issued by the same date,
which the parties completed. The parties are continuing with discovery and have provided additional status reports to the District Court
on January 6, 2025, February 24, April 7, May 5, June 11, July 9, August 6, 2025, August 26, 2025, and September 16, 2025. On October
23, 2025, the parties attended a mediation in an effort to resolve their disputes and agreed upon principal terms of a confidential settlement.
The parties are working to finalize negotiation of a definitive settlement agreement, which would fully resolve the suit we filed against
Ortho-Tain in Colorado and the Illinois Ortho-Tain Case.
Item
1A. Risk Factors
We
are voluntarily providing in this Item 1A. updated risk factors associated with SCN, the Acquisition and related matters.
In
2024 and 2025, we worked to pivot our sales, marketing distribution model, including via the acquisition of the Sleep Center of Nevada
(the “Acquisition”). However, this new model is unproven and may not produce the benefits we anticipate. This makes it difficult
to evaluate our future prospects and may increase the risk of your investment.
In
June 2025, we acquired all assets, including operating assets such as sleep testing, diagnostics, and treatment centers, of SCN. The
Acquisition marked the completion in a pivot to our sales, marketing distribution model for our innovative OSA appliances. Under the
new model, SCN will provide sleep disorder patients with the opportunity to be candidates for our advanced, proprietary and FDA-cleared
CARE oral medical devices, oral appliances and additional adjunctive therapies and methods. Under customary agreements designed to comply
with applicable corporate practice of medicine law, our operation of SCN allows us to manage and capture both diagnostic and consulting
revenues, representing new higher margin revenue streams for us, as well as potential Vivos appliance sales revenue from SCN. We are
exploring and seeking to implement additional acquisitions of, or collaborations with, medical sleep and similar healthcare practices
to expand our business model in an effort to grow our revenues.
45
We
are placing significant emphasis on establishing and growing this new model as means of increasing our revenue. However, this new model
is unproven, and we have limited operating history associated with this new model. Our prior collaboration with Rebis Health in Colorado
entered into in 2024 has not met our expectations and differed materially from the SCN acquisition in that we did not have adequate control
over patient processing, systems and protocols, dentist hiring and management, staff hiring and management, patient education, hours
of operation, or medical provider training and education. As a result, the Rebis Health collaboration has not benefited us as we had
anticipated. There is therefore a lack of information for you to evaluate our future prospects utilizing this new model.
Moreover, there
is a material risk that this new model will not increase our revenues or gross margins in the manner we anticipate. For example, we have faced challenges in fully integrating SCN’s operations into our own and meeting market
demand due to matters such as (i) difficulties in identifying and training healthcare providers in the products and services we offer
and (ii) obtaining insurance reimbursement for such products and services. Our ability to address these and similar challenges could lead
to slower increases, or even reductions, in our revenues.
In addition, we may
be unable to find additional sleep medical providers to incorporate into our business, and even if we do, the is a risk we may not derive
the benefits from additional acquisition that we intend to. Our inability to implement and scale this marketing and distribution model
would materially harm our business and operating results and likely cause our stock price to suffer.
Additionally,
if the benefits of the Acquisition or similar acquisitions or collaborations we may undertake do not meet the expectations of our shareholders,
the market price of our securities may decline. Fluctuations, including declines, in the price of our common stock could contribute to
the loss of all or part of your investment. Certain factors, including, but not limited to, the factors listed below could have a material
adverse effect on the price of our common stock:
●
actual
or anticipated fluctuations in financial results post-Acquisition or following the execution of similar transactions;
●
changes
in the market’s expectations about our operating results post-Acquisition or following the execution of similar transactions;
●
announcements
of technological innovation, or new products, by our competition; and
●
the
success of our competitors.
As
such, no assurances can be given that the Acquisition or similar transactions will benefit our operating results or stock price.
We
have incurred substantial indebtedness in connection with financing the SCN acquisition, the cost of servicing that debt could adversely
affect our business, financial condition, and results of operation, and we may not be able in the future to service that debt.
Concurrently
with the SCN Acquisition, we entered into a Note Purchase Agreement with Streeterville Capital, LLC, a Utah limited liability company
(“Lender”), pursuant to which we issued and sold to Lender a Secured Promissory Note in the original principal amount of
$8,250,000 (the “Note”). The Note is secured by our wholly-owned subsidiary AIM, which manages SCN in accordance with the
corporate practice of medicine. The Company has also pledged the entirety of AIM’s membership interests to the Lender as collateral
for the Loan pursuant and caused AIM to provide a guarantee of our obligations to the Lender under the Note and the other transaction
documents.
Our
ability to make scheduled payments under the Note or any alternative debt financing arrangements we may enter into in connection with
our growth strategy to acquire additional medical sleep practices will depend on our financial and operating performance, which will
be affected by economic, financial, competitive, business, and other factors, some or all of which are beyond our control. The indebtedness
we incurred in connection with the Acquisition will require us to dedicate a portion of our cash flow to servicing this debt, thereby
reducing the availability of cash to fund other business initiatives. There can be no assurance that our business, inclusive of SCN,
will generate sufficient cash flow from operations to service our indebtedness or to fund our other liquidity needs. If we are unable
to meet our debt obligations or fund our other liquidity needs, we may need to restructure or refinance all or a portion of our indebtedness
on or before maturity or sell certain of our assets. There can be no assurance that we will be able to restructure or refinance any of
our indebtedness on commercially reasonable terms, if at all, which could cause us to default on our debt obligations and impair our
liquidity. Any refinancing of our indebtedness could be at higher interest rates and may require us to comply with more onerous covenants,
which could further restrict our business operations. If we are unable to generate or borrow sufficient cash to make payments on our
indebtedness, our business, financial condition, and results of operations could be adversely affected.
46
Integrating
SCN’s operations may be more difficult, costly, or time-consuming than expected.
The
ongoing integration of Vivos and SCN could result in the disruption of our ongoing business, and inconsistencies in standards, controls,
procedures, policies and insurance coverage that adversely affect our ability to maintain relationships with patients and employees or achieve the anticipated
benefits of the Acquisition. As with any acquisition, there also may be disruptions that cause us to lose patients or cause patients
to elect alternative form of sleep treatment. We may also face other unintended consequences from the Acquisition (including adverse
effects on our business reputation, supply chain issues, and similar matters) that that could have a material adverse effect on our results
of operations, financial condition and stock price.
If
our contractual arrangements between AIM and our physicians at SCN are found to constitute the improper rendering of medical services
or fee splitting under applicable state laws, our business, financial condition and our ability to operate in those states could be adversely
impacted.
Our
contractual relationships between AIM and our physicians at SCN (and similar arrangements we may enter into in the future in connection
with other sleep provider acquisitions) may implicate certain state laws that generally prohibit non-professional entities from providing
licensed medical services or exercising control over medical practitioners or other healthcare professionals (such activities generally
referred to as the “corporate practice of medicine”, and laws, rules and regulations relating to the corporate practice of
medicine, the “ CPM Laws” ) or engaging in certain practices such as fee-splitting with such licensed professionals.
The interpretation and enforcement of CPM Laws vary significantly from state to state. There can be no assurance that CPM Laws will be
interpreted in a manner consistent with our practices or that other laws or regulations will not be enacted in the future that could
have a material and adverse effect on our business, financial condition and results of operations. Regulatory authorities, state boards
of medicine, state attorneys general and other parties may assert that, despite the agreements through which we operate, we are engaged
in the provision of medical services and/or that our arrangements with our medical practitioners constitute unlawful fee-splitting. If
a jurisdiction’s prohibition on the corporate practice of medicine or fee-splitting is interpreted in a manner that is inconsistent
with our practices, we would be required to restructure or terminate our arrangements with our medical practitioner at SCN to bring our
activities into compliance with such CPM Laws. A determination of non-compliance, or the termination of or failure to successfully restructure
these relationships could result in disciplinary action, penalties, damages, fines, and/or a loss of revenue, any of which could have
a material and adverse effect on our business, financial condition and results of operations. State corporate practice and fee-splitting
prohibitions also often impose penalties our medical practitioners for aiding in the improper rendering of professional services, which
could discourage medical practitioners and other healthcare professionals from providing clinical services at SCN or other sleep centers
we may operate in the future.
As
a result of our business model pivot which includes the acquisition of sleep centers like SCN, we may become a party to lawsuits, demands,
claims, qui tam suits, governmental investigations and audits and other legal matters, any of which could result in, among other things,
substantial financial and other penalties, damage to our reputation or adverse effects on our ability to conduct business.
As
a result of our 2025 business model pivot, which includes acquisitions of sleep medical providers like SCN as a means of driving sales
of our OSA treatments, our business has (subject to compliance with CPM laws as described above) become more associated with diagnosing
and treating OSA patients. Given the nature of this business, we may in the future be subject to investigations and audits by governmental
agencies, private civil qui tam complaints and other lawsuits, demands, claims, legal proceedings and/or other actions alleging
our, or the medical practices we manage, failure to comply with applicable rules, regulations, laws or the practice of medicine.
For
example, we and sleep medical providers we manage (like SCN) could become subject to audits from the government concerning the billing
of patients. If, following the conclusion of any audit, the government were to require refunds and/or modifications to our business practices,
and such amounts or changes are significant, it could have a material adverse effect on our business, results of operations, financial
condition and cash flows. In addition, any allegation against us, our medical providers we manage or related personnel, representatives,
third party vendors, or operations in such matters or matters that involve patients suffering adverse health outcomes, may, among other
things harm our reputation, stock price, and adversely affect our relationships and/or contracts related to our business, among other
things.
47
Responding
to subpoenas, investigations and other lawsuits, claims and legal proceedings, as well as defending ourselves in such matters, would
require management’s attention and cause us to incur significant legal expense. Negative developments, findings or terms and conditions
that we might agree to accept as part of a negotiated resolution of pending or future legal or regulatory matters, or have been forced
upon us, could result in, among other things, harm to our or our medical providers’ reputation, substantial financial penalties
or awards against us, substantial payments made by us, required changes to our business practices, impacts on our various relationships
and/or contracts related to our business, exclusion from future participation in Medicare, Medicaid and other healthcare programs and,
in certain cases, criminal penalties, any of which could have a material adverse effect on us.
Changes
in the structure of and payment rates under private insurance, Medicare, Medicaid or other non-Medicare government-based programs or
payment rates related to our business could have a material adverse effect on our business, results of operations, financial condition
and cash flows.
Sleep
center providers like SCN or other medical sleep providers we may acquire and manage or do business with rely on various forms of insurance
held by patients for payment for products and services. These include private insurance, Medicare, Medicaid and other government programs.
As such, the business of the medical sleep providers we manage and our business and results of operations could be adversely impacted
by matters related to insurance coverage including, without limitation:
●
The
risk that reimbursement rates are reduced by private insurance carriers or government insurance providers;
●
The
risk that changes in insurance policies or regulatory mandates could limit the ability to either be paid for covered services or
bill for treatments or services or otherwise impact reimbursement;
●
The
risk that interpretations of existing regulations, manual provisions and/or guidance, or the implementation or enforcement of new
interpretations, will be inconsistent with how we and the medical sleep providers we manage have interpreted regulations, manual
provisions and/or guidance;
●
The
risk that data and related reporting requirements are implemented that result in decreased reimbursement, increased technology and
operational costs, or reputational harm;
●
The
risk that increases in our operating costs will outpace any Medicare or other rate increases we receive;
●
The
risk of federal budget sequestration cuts or other disruptions in federal government operations and funding; and
●
The
risk of ensuring that the sleep medical providers we manage remain compliant with applicable requirements, including marketing and
education requirements and restrictions, as well as contractual terms with associated insurance plans.
If
we are faced with these or similar risks, we could face material adverse consequences on our business, results of operations, financial
condition and cash flows.
Our
business and the medical practices we manage are labor intensive. Our inability to recruit qualified talent and manage labor costs or
shortages result could result significant increases in our operating costs, decreases in productivity, and disruptions in our business
operations.
Our
business and the business of the medical practices we manage is labor intensive. This is particularly true with respect to the Sleep
Optimization (SO) teams we are putting in place at SCN, each consisting of one nurse practitioner (or physician’s assistant), two
specially trained dentists, six dental assistants, six administrative support personnel, and one treatment navigator. Labor requirements
also exist, albeit to a lesser extent, for contractual alliances with medical sleep providers we may enter into. We face increased labor
costs and the risk of difficulties in hiring skilled clinical personnel. The healthcare labor market for the talent we require is challenging
and experiences volatility, uncertainty and labor supply shortages. We may be unable to achieve the financial results we desire from
the SCN acquisition, the acquisition of other medical sleep providers or our contractual alliances due to variations in labor-related
costs and the productivity our personnel.
48
We
have incurred and, as we seek to scale our business, expect to continue to incur increased labor costs, including through elevated compensation
levels to our personnel, the ultimate extent of which will depend on the needs at SCN or other medical sleep providers we acquire as
well as macroeconomic conditions and ancillary impacts on the labor market, among other things.
We
compete for qualified talent with hospitals and other healthcare providers. Furthermore, changes in certification requirements could
adversely impact our ability to maintain sufficient staff levels, including to the extent our personnel are not able to meet new requirements.
In addition, if we experience a higher than normal turnover rate for our skilled clinical personnel, our operations and ability to meet
patient demand may be negatively impacted, which could adversely affect our business, results of operations, financial condition and
cash flows.
Also,
political or other efforts at the national or local level could result in actions or proposals that increase the likelihood of success
of union organizing activities at the facilities we manage. If a significant portion of our personnel were to become unionized, we could
experience, among other things, potential additional work stoppages or other business disruptions; adverse impacts to our financial results
due to the costs of bargaining or implementing a grievance procedure and processing grievances, decreases in our operational flexibility
and efficiency, or negative impacts on our employee culture. Any of these events or circumstances, including our responses to such events
or circumstances, could have a material adverse effect on our employee relations, treatment growth, productivity, business, results of
operations, financial condition, cash flows and reputation.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds
Not
applicable.
Item
3. Default Upon Senior Securities
None.
Item
4. Mine Safety Disclosures
Not
applicable.
Item
5. Other Information
None.
Item
6. Exhibits, Financial Statement Schedules.
The
following documents are filed as exhibits to this Quarterly Report on Form 10-Q.
Exhibit
No.
Exhibit
Description
3.1
Certificate of Incorporation of Vivos Therapeutics, Inc. filed with Delaware Secretary of State on August 12, 2020. (1)
3.2
Amended and Restated Bylaws of Vivos Therapeutics, Inc. (1)
3.3
Certificate of Conversion filed with Delaware Secretary of State on August 12, 2020. (1)
3.4
Certificate of Amendment to the Certificate of Incorporation of Vivos Therapeutics, Inc., dated October 25, 2023. (2)
31.1*
Certification of the Chief Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. (*)
31.2*
Certification of the Chief Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. (*)
32.1**
Certification of the Chief Executive Officer pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. (*)#
32.2**
Certification of the Chief Financial Officer pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. (*)#
101.INS*
Inline
XBRL Instance Document
101.SCH*
Inline
XBRL Taxonomy Extension Schema
101.CAL*
Inline
XBRL Taxonomy Extension Calculation Linkbase
101.DEF*
Inline
XBRL Taxonomy Extension Definition Linkbase
101.LAB*
Inline
XBRL Taxonomy Extension Label Linkbase
101.PRE*
Inline
XBRL Taxonomy Extension Presentation Linkbase
104
Cover
Page Interactive Data File (embedded within the Inline XBRL document)
*
Filed
herewith.
**
Furnished
herewith.
(1)
Incorporated
by reference to the Company’s Registration Statement on Form S-1, filed with the SEC on October 9, 2020.
(2)
Incorporated
by reference to the Company’s Current Report on Form 8-K, filed with the SEC on October 27, 2023.
49
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
Vivos
Therapeutics, Inc.
Date:
November 19, 2025
By:
/s/
R. Kirk Huntsman
R.
Kirk Huntsman
Chairman
of the Board and Chief Executive Officer
(principal
executive officer)
Date:
November 19, 2025
By:
/s/
Bradford Amman
Bradford
Amman
Chief
Financial Officer and Secretary
(principal
accounting officer)
50
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.