8-K
Vivos Therapeutics, Inc. (VVOS)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 OR 15(d) of the
Securities
Exchange Act of 1934
Dateof Report (Date of earliest event reported): May 9, 2023 (May 3, 2023)
VivosTherapeutics, Inc.
(Exactname of registrant as specified in its charter)
| Delaware | 001-39796 | 81-3224056 |
|---|---|---|
| (State or other jurisdiction | (Commission | (I.R.S. Employer |
| of incorporation) | File Number) | Identification No.) |
7921Southpark Plaza, Suite 210
Littleton,Colorado 80120
(Addressof principal executive offices) (Zip Code)
(866)908-4867
(Registrant’stelephone number, including area code)
N/A
(Formername or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common<br> Stock, par value $0.0001 per share | VVOS | The<br> NASDAQ Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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. ☐
Item4.01 Change in Registrant’s Certifying Accountant
On May 3, 2023, the Audit Committee (the “Committee”) of the Board of Directors (the “Board”) of Vivos Therapeutics, Inc. (the “Company”) dismissed Plante & Moran, PLLC (“P&M”), the Company’s independent registered public accounting firm, effective immediately. During the fiscal years ended December 31, 2022 and 2021, P&M’s audit reports on the Company’s financial statements did not contain an adverse opinion or disclaimer of opinion, nor were they qualified or modified as to uncertainty, audit scope or accounting principles, except that P&M’s report for the year ended December 31, 2022 included an explanatory paragraph indicating that there was substantial doubt about the Company’s ability to continue as a going concern. During the fiscal years ended December 31, 2022 and 2021 and the subsequent period through the date of this Current Report on Form 8-K, (i) there were no disagreements between the Company and P&M on any matter of accounting principles or practices, financial statement disclosure or auditing scope or procedures, which disagreements, if not resolved to P&M’s satisfaction, would have caused P&M to make reference in connection with P&M’s report to the subject matter of the disagreement; and (ii) there were no “reportable events” as the term is described in Item 304(a)(1)(v) of Regulation S-K, except for the disclosure of material weaknesses in the Company’s internal controls over financial reporting as disclosed in Part II, Item 9A of the Company’s Form 10-K for the years ended December 31, 2022 and 2021.
The Company provided P&M with a copy of the disclosures that the Company is making in response to Item 4.01 on this Current Report on Form 8-K, and requested that P&M furnish it with a letter addressed to the Securities and Exchange Commission stating whether it agrees with the above statements. The letter from P&M, dated May 9, 2023, is filed as Exhibit 16.1 to this Current Report on Form 8-K.
On May 3, 2023, the Committee approved the engagement of Moss Adams LLP (“Moss Adams”) as the Company’s new independent registered public accounting firm, effective immediately. During the fiscal years ended December 31, 2022 and 2021 and through the date of this Current Report on Form 8-K, neither the Company nor anyone acting on its behalf consulted Moss Adams with respect to (i) the application of accounting principles to a specified transaction, either completed or proposed, nor the type of audit opinion that might be rendered on the Company’s financial statements, and neither a written report was provided to the Company nor oral advice provided that Moss Adams concluded was an important factor considered by the Company in reaching a decision as to any accounting, auditing or financial reporting issue; or (ii) any matter that was the subject of a disagreement or a “reportable event” as described in Items 304(a)(1)(iv) and (v), respectively, of Regulation S-K.
Item8.01 Other Information
On May 9, 2023, the Company issued a press release to announce a broad set of initiatives aimed at improving operational efficiencies, reducing expenses, and positioning the Company to take advantage of current growth opportunities. A copy of such press release is filed as Exhibit 99.1 to this Current Report on Form 8-K.
Item9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description |
|---|---|
| 16.1 | Letter to the Securities and Exchange Commission from Plante & Moran, PLLC |
| 99.1 | Press Release dated May 9, 2023. |
| 104 | Cover<br> Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURE
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 hereunto duly authorized.
| VIVOS THERAPEUTICS, INC. | ||
|---|---|---|
| Dated:<br> May 9, 2023 | By: | /s/ Bradford Amman |
| Name: | Bradford<br> Amman | |
| Title: | Chief<br> Financial Officer |
Exhibit16.1
| Plante & Moran, PLLC<br><br> <br>Suite<br> 600<br><br> <br>8181<br> E. Tufts Avenue<br><br> <br>Denver,<br> CO 80237<br><br> <br>Tel:<br> 303.740.9400<br><br> <br>Fax:<br> 303.740.9009<br><br> <br>plantemoran.com |
|---|
May 9, 2023
Securities and Exchange Commission
100 F Street, N.E.
Washington, DC 20549
Commissioners,
We have read the Item 4.01 included in the Form 8-K of Vivos Therapeutics, Inc., which we understand will be filed with the Securities and Exchange Commission on or soon after May 9, 2023 in regard to its change in auditors. We agree with the statements made regarding our firm. We have no basis to agree or disagree with other statements of the registrant contained therein.
| Sincerely, |
|---|
| /s/<br> Plante & Moran, PLLC |
| Denver,<br> Colorado |
Exhibit99.1
VivosTherapeutics Announces Additional Strategic Initiatives Aimed at Accelerating Anticipated Timeline for Cash Flow Positive Operations
MossAdams LLP also appointed as new independent registered public accounting firm
LITTLETON,CO, May 9, 2023 — Vivos Therapeutics, Inc. (“Vivos”, “the Company”) (NASDAQ:VVOS) today announced it has implemented a broad set of initiatives aimed at improving operational efficiencies, reducing expenses, and positioning Vivos to take advantage of current growth opportunities.
These initiatives touch most aspects of Vivos’ operations and include expense reductions, product suite expansion, and organizational changes that included an approximate 17% reduction of its workforce. These initiatives are in addition to cost saving measures previously announced by Vivos. As a result, Vivos is accelerating its target times for achieving positive cash flow by a full quarter.
Vivos Chairman and Chief Executive Officer, Kirk Huntsman, commented, “Vivos has made major strides in recovering from challenges imposed by the COVID-19 pandemic on the dental industry which lost tens of thousands of qualified dental practice personnel, including many who were trained in the Vivos Method. I am pleased to say that after several quarters of rebuilding, our field support infrastructure for our Vivos Integrated Providers (VIPs) has now reached what we believe is sufficient critical mass, and we are in a position now to throttle back our rebuild efforts and associated higher rate of spending. We have implemented several internal initiatives to focus on the most impactful programs for near-term revenue generation (including our recently acquired POD^®^ devices), improve efficiencies and manage operating expenses (including a tactical reduction in our workforce to streamline our operations). These changes are expected to result in relatively flat revenues sequentially for the transitional first half of 2023, and we anticipate top line revenue growth to accelerate beginning in the third quarter of this year.”
“During our March 2023 earnings call, we shared our goal to achieve positive cash flow by mid-2024. I am pleased to say that with these initiatives implemented, we now anticipate reaching that goal in the first quarter of 2024, a full quarter earlier than originally anticipated. Our goal is to achieve these targets without having to raise any further equity capital, if possible,” Mr. Huntsman concluded.
In addition, Vivos announced that the audit committee of its board of directors has dismissed Plante & Moran, PLLC as Vivos’ independent registered public accounting firm and engaged Moss Adams LLP in that capacity, effective May 3, 2023. Moss Adams will review the Company’s first quarter 2023 financial statements. Due to the timing of this change in independent registered public accounting firm, the Company expects to file for an extension for the timing to file its upcoming Quarterly Report on Form 10-Q for the period ended March 31, 2023.
AboutVivos Therapeutics, Inc.
Vivos Therapeutics, Inc. (NASDAQ: VVOS) is a medical technology company focused on developing and commercializing innovative diagnostic and treatment methods for patients suffering from breathing and sleep issues arising from certain dentofacial abnormalities such as mild-to-moderate obstructive sleep apnea (OSA) and snoring in adults. The Vivos Method represents the first clinically effective nonsurgical, noninvasive, nonpharmaceutical and cost-effective solution for treating mild to moderate OSA. It has proven effective in over 33,000 patients treated worldwide by more than 1,750 trained dentists.
The Vivos Method includes the Vivos Complete Airway Repositioning and/or Expansion (CARE) appliance therapy and associated protocols that alter the size, shape and position of the soft tissues that comprise a patient’s upper airway and/or palate. The Vivos Method opens airway space and may significantly reduce symptoms and conditions associated with mild-to-moderate OSA, such as lowering Apnea Hypopnea Index scores. Vivos also markets and distributes SleepImage diagnostic technology under its VivoScore program for home sleep testing in adults and children. The Vivos Integrated Practice (VIP) program offers dentists training and other value-added services in connection with using The Vivos Method. For more information, visit www.vivos.com.
CautionaryNote Regarding Forward-Looking Statements
This press release and statements of the Company’s management made in connection therewith contain “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) concerning future events, particularly with respect to the public offering described herein. Words such as “may”, “should”, “expects”, “projects,” “intends”, “plans”, “believes”, “anticipates”, “hopes”, “estimates” and variations of such words and similar expressions are intended to identify forward-looking statements. These statements involve known and unknown risks and are based upon several assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond Vivos’ control. Actual results (including, without limitation, the results of the Company’s cost cutting initiatives and the potential impact on the Company’s cash flows and results of operations as described herein) may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to (i) whether the Company’s cost cutting initiatives will have their desired effect, (ii) whether the Company will be able to increase its revenues as anticipated and (iii) the other risk factors described in Vivos’ filings with the Securities and Exchange Commission (“SEC”). Vivos’ filings can be obtained free of charge on the SEC’s website at www.sec.gov. Except to the extent required by law, Vivos expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Vivos’ expectations with respect thereto or any change in events, conditions, or circumstances on which any statement is based.
VivosInvestor Relations Contact:
Julie Gannon
Investor Relations Officer
720-442-8113
jgannon@vivoslife.com