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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 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 ~~June~~September 30, 2024


☐	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: 001-40988

Sonendo, Inc.

(Exact Name of Registrant as Specified in its Charter)


Delaware	20-5041718
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)
26061 Merit Circle, Suite 102 Laguna Hills, CA	92653
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code: (949) 766-3636

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 stock, par value $0.001 per share

    SONX

    OTC Markets

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, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “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 ☒

As of ~~August~~November 28, 2024, the registrant had 72418,~~837,868~~049 shares of common stock, $0.001 par value per share, outstanding.

Table of Contents

		Page
	Cautionary Note Regarding Forward-Looking Statements	1
PART I.	FINANCIAL INFORMATION	3
Item 1.	Financial Statements (Unaudited)	3
	Condensed Consolidated Balance Sheets	3
	Condensed Consolidated Statements of Operations and Comprehensive Loss	4
	Condensed Consolidated Statements of Stockholders’ Equity	5
	Condensed Consolidated Statements of Cash Flows	67
	Notes to Condensed Consolidated Financial Statements	78
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	2223
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	3234
Item 4.	Controls and Procedures	3234
PART II.	OTHER INFORMATION	3435
Item 1.	Legal Proceedings	3435
Item 1A.	Risk Factors	3435
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	3537
Item 3.	Defaults Upon Senior Securities	3537
Item 4.	Mine Safety Disclosures	3537
Item 5.	Other Information	3537
Item 6.	Exhibits	3537
Signatures		3840

Cautionary Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that involve risks and uncertainties, including statements based on our current expectations, assumptions, estimates and projections about future events, our business, financial condition, results of operations and prospects, our industry and the regulatory environment in which we operate. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of those terms, or other comparable terms intended to identify statements about the future. The forward-looking statements included herein are subject to risks and uncertainties that could cause actual results to differ materially from those expressed in the forward-looking statements. These risks and uncertainties, all of which are difficult or impossible to predict accurately and many of which are beyond our control, include, but are not limited to those described in Item 1A. Risk Factors of this Quarterly Report on Form 10-Q, Item 1A. Risk Factors of our Annual Report on Form 10-K for fiscal year 2023 and in the filings we make with Securities and Exchange Commission (the “SEC”) from time to time.

•

We are an early-stage company with a history of significant net losses, we expect to continue to incur operating losses for the foreseeable future and we may not be able to achieve or sustain profitability.

•

Our common stock has been delisted from the New York Stock Exchange (“NYSE”) and is currently trading on the OTC Markets Group Inc.’s (“OTC”) OTCQX U.S. tier (the “OTCQX”). If we are unable to comply with the continued listing requirements of the OTCQX, our common stock could be moved to the OTC Pink market, which could further affect our common stock’s market price and liquidity and reduce our ability to raise capital.

•

The market price of our common stock may be volatile and an active trading market may not develop.

•

Our revenue is primarily generated from sales of our GentleWave Console and the accompanying single-use procedure instruments (“PIs”) and we are therefore highly dependent on the success of these offerings.

•

Our future operating results may be difficult to predict and could fall below expectations or any guidance we may provide.

•

The terms of our credit agreement contain operating and financial covenants and place restrictions on our operating and financial flexibility.

•

We need additional funding to finance our planned operations, and may not be able to raise capital when needed.

•

The commercial success of our GentleWave System and the GentleWave Procedure will depend upon the degree of market acceptance of our products by dental practitioners, our ability to maintain strong working relationships with our existing clinicians and dental customers and our ability to increase penetration in existing markets and expand into adjacent markets.

•

We may provide inadequate training, fail to increase our sales and marketing capabilities or fail to develop and maintain broad brand awareness in a cost-effective manner.

•

We may not be able to obtain or maintain adequate levels of third party coverage and reimbursement.

•

We may not be able to achieve or maintain satisfactory pricing and margins for our products.

•

We may not be able to compete successfully.

•

We may be unable to develop or commercialize new products on a timely basis and our products may become obsolete.

•

We have limited experience manufacturing our products in large-scale commercial quantities and we face a number of manufacturing risks that may adversely affect our manufacturing abilities, which could delay, prevent or impair our growth.

•

We depend upon third-party suppliers, including contract manufacturers and single source suppliers, making us vulnerable to supply shortages and price fluctuations that could negatively affect our business, financial condition and results of operations.

•

Any changes in our shipping arrangements or damages or losses sustained from shipping could adversely affect our business, financial condition, results of operations and prospects.

•

Our operating expenses may substantially increase and our business and financial results will be adversely affected if we receive a significant number of warranty claims or our GentleWave Systems require significant amounts of service after sale.

•

We may encounter difficulties in managing our growth, forecasting demand and managing inventory.

•

Our internal computer systems or those used by our contractors or consultants, may fail or suffer security breaches, and such failure could negatively affect our business, financial condition and results of operations.

•

Natural or man-made disasters and other similar events may significantly disrupt our business, including by causing delays in production or an increase in costs, and negatively impact our business, financial condition and results of operations.

•

The sizes of the addressable markets for our GentleWave System have not been established with precision and our potential market opportunity may be smaller than we estimate and may decline.

•

We may incur substantial liabilities and other negative impacts on our business as a result of product liability lawsuits and we may not be able to obtain or maintain insurance to cover these and other risks.

•

Our insurance policies are expensive and protect us only from some business risks, which leaves us exposed to significant uninsured liabilities.

•

Our products and operations are subject to extensive government regulation and oversight in the United States.

•

Our ability to utilize our net operating loss carryforwards and research and development credit carryforwards may be limited.

•

We are highly dependent on our senior management team.

•

Our success depends on our ability to obtain and maintain our intellectual property.

•

Anti-takeover provisions in our Certificate of Incorporation and Bylaws, as well as those under Delaware law could prevent or delay a change in control.

•

The effect of our reverse stock split on the market price and trading of our common stock cannot be predicted with any certainty.

•

The sale of securities by us in any equity or debt financing could result in dilution to our existing stockholders.

•

We are subject to additional risks and costs as a result of being a public company.

•

We maintain cash deposits in excess of federally insured limits. Adverse developments affecting financial institutions, including bank failures, could adversely affect our liquidity and financial performance.

We operate in a very competitive and rapidly changing environment. New risks emerge from time to time and it is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements.

The forward-looking statements included herein are based on current expectations of our management based on available information and are believed to be reasonable. In light of the significant risks and uncertainties inherent in the forward-looking statements included herein, the inclusion of such information should not be regarded as a representation by us or any other person that such results will be achieved. You are cautioned not to place undue reliance on the forward-looking statements included in this Quarterly Report on Form 10-Q, which speak only as of the date of this document. We do not intend, and undertake no obligation, to update or revise these forward-looking statements to reflect events or circumstances after the date of this document or to reflect the occurrence of unanticipated events, except as required by law.

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements (Unaudited)

SONENDO, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except par value and share data)

	June 30,			December 31,
	September 30,			December 31,
	2024			2023
	(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents	$	1513,~~703~~096		$	14,009
Short-term investments		84,~~533~~188			32,773
Accounts receivable, net		4,~~528~~445			4,790
Inventory		11,~~798~~487			11,074
Prepaid expenses and other current assets		~~1,025~~508			1,969
Current assets of discontinued operations		~~927~~1,000			656
Total current assets		4234,~~514~~724			65,271
Property and equipment, net		~~766~~691			461
Operating lease right-of-use assets		2,~~899~~592			2,703
Other assets		124			128
Non-current assets of discontinued operations		—			9,597
Total assets	$	4638,~~303~~131		$	78,160
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	~~931~~686		$	1,142
Accrued compensation		12,~~550~~008			2,413
Other accrued expenses		13,~~874~~202			3,072
Operating lease liabilities		~~983~~884			1,250
Current portion of term loan		10,800			24,900
Other current liabilities		1,~~592~~535			1,844
Current liabilities of discontinued operations		—			700
Total current liabilities		1719,~~730~~115			35,321
Operating lease liabilities, net of current		1,~~765~~570			1,423
Term loan, net of current		86,~~511~~084			12,467
Other liabilities		~~428~~396			530
Total liabilities		2827,~~434~~165			49,741
Commitments and contingencies (Note 9)
Stockholders’ equity:
Preferred stock, $0.001 par value; authorized —10,000,000 shares; issued and outstanding - none		—			—
Common stock, $0.001 par value; authorized — 500,000,000 shares; issued and outstanding— 72,834,586 shares as of June 30, 2024 and 63,547,467 shares as of December 31, 2023		73			64
Common stock, $0.001 par value; authorized — 500,000,000 shares; issued and outstanding— 418,038 shares as of September 30, 2024 and 317,737 shares as of December 31, 2023		84			64
Additional paid-in-capital		~~461~~462,~~938~~555			458,357
Accumulated other comprehensive (loss) gain		(2	)		11
Accumulated other comprehensive income		3			11
Accumulated deficit		(~~444~~451,~~140~~676	)		(430,013	)
Total stockholders’ equity		1710,~~869~~966			28,419
Total liabilities and stockholders’ equity	$	4638,~~303~~131		$	78,160

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

SONENDO, INC.

CONDENSED CONSOLIDATED STATEMENTS OF

OPERATIONS AND COMPREHENSIVE LOSS

(unaudited)

(in thousands, except share and per share amounts)

	Three Months Ended June 30,						Six Months Ended June 30,
	Three Months Ended September 30,						Nine Months Ended September 30,
	2024			2023			2024			2023
Revenue, net	$	8,~~314~~036		$	8,~~763~~163		$	1523,~~361~~397		$	1725,~~441~~604
Cost of sales		54,~~198~~726			97,~~248~~279			1014,~~244~~970			1523,~~948~~227
Gross profit (loss)		3,116			(485	)		5,117			1,493
Gross profit		3,310			884			8,427			2,377
Operating expenses:
Selling and marketing		43,~~072~~642			76,~~693~~954			912,~~216~~858			1522,~~674~~628
General and administrative		4,~~163~~872			67,~~416~~708			913,~~080~~952			1220,~~549~~257
Research and development		1,~~568~~588			2,~~764~~787			35,~~757~~345			58,~~691~~478
Total operating expenses		910,~~803~~102			1617,~~873~~449			2232,~~053~~155			3351,~~914~~363
Operating loss		(6,~~687~~792	)		(1716,~~358~~565	)		(1623,~~936~~728	)		(3248,~~421~~986	)
Other expense, net:
Interest and other expense:
Interest and financing costs, net		(759	)		(739	)		(2,699	)		(1,318	)
Interest expense		(1,010	)		(1,649	)		(4,608	)		(4,778	)
Loss before income tax expense		(7,446	)		(18,097	)		(19,635	)		(33,739	)
Other income		266			765			1,165			2,576
Total interest and other expense		(744	)		(884	)		(3,443	)		(2,202	)
Loss before income tax expense		(7,536	)		(17,449	)		(27,171	)		(51,188	)
Income tax expense		—			—			—			—
Loss from continuing operations, net of tax		(7,~~446~~536	)		(1817,~~097~~449	)		(1927,~~635~~171	)		(3351,~~739~~188	)
Income from discontinued operations, net of tax		81—			~~407~~469			5,508			~~678~~1,147
Net loss	$	(7,~~365~~536	)	$	(1716,~~690~~980	)	$	(1421,~~127~~663	)	$	(3350,~~061~~041	)
Other comprehensive income (net of tax):
Unrealized (loss) gain on short-term investments		(15	)		~~(25~~24	)		(138	)		3155
Comprehensive loss	$	(7,~~366~~531	)	$	(1716,~~715~~956	)	$	(1421,~~140~~671	)	$	(3349,~~030~~986	)
Net loss per share from continuing operations – basic and diluted	$	(015.0877	)	$	(037.1901	)	$	(057.2118	)	$	(0108.3693	)
Net income per share from discontinued operations – basic and diluted	$	—		$	—0.99		$	011.0659		$	02.0144
Net loss per share – basic and diluted	$	(015.0877	)	$	(036.1902	)	$	(045.1559	)	$	(0106.3549	)
Weighted-average shares outstanding – basic and diluted		95477,~~429,233~~857			93471,~~684,289~~427			95475,~~085,847~~188			93469,~~538,676~~934

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

SONENDO, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(unaudited)

(in thousands, except shares amount)

	Common Stock				Additional			Accumulated						Total
					Paid-In			Other			Accumulated			Stockholders’
	Shares		Amount		Capital			Comprehensive Income (Loss)			Deficit			Equity
Balance at December 31, 2023		63317,~~547,467~~737	$	64—	$	458,~~357~~421		$	11		$	(430,013	)	$	28,419
Employee stock plans		~~790~~3,~~524~~953		—		(4	)		—			—			(4	)
Stock-based compensation		—		—		2,890			—			—			2,890
Exercise of pre-funded warrants		630,~~111,882~~559		6—		(6—	)		—			—			—
Unrealized gain on short-term investments		—		—		—			(12	)		—			(12	)
Unrealized loss on short-term investments		—		—		—			(12	)		—			(12	)
Net loss		—		—		—			—			(6,762	)		(6,762	)
Balance at March 31, 2024		70352,~~449,873~~249	$	70—	$	461,~~237~~307		$	(1	)	$	(436,775	)	$	24,531
Employee stock plans		~~291~~1,~~098~~455		1—		—1			—			—			1
Stock-based compensation		—		—		703			—			—			703
Exercise of pre-funded warrants		210,~~093,615~~468		2—		(2—	)		—			—			—
Unrealized loss on short-term investments		—		—		—			(1	)		—			(1	)
Net loss		—		—		—			—			(7,365	)		(7,365	)
Balance at June 30, 2024		72364,~~834,586~~172	$	73—	$	~~461~~462,~~938~~011		$	(2	)	$	(444,140	)	$	17,869
Employee stock plans		433		—		(2	)		—			—			(2	)
Stock-based compensation				—		630			—			—			630
Exercise of pre-funded warrants		53,433		—		—			—			—			—
Unrealized gain on short-term investments		—		—		—			5			—			5
Net loss		—		—		—			—			(7,536	)		(7,536	)
Balance at September 30, 2024		418,038	$	—	$	462,639		$	3		$	(451,676	)	$	10,966

	Common Stock				Additional			Accumulated						Total
					Paid-In			Other			Accumulated			Stockholders’
	Shares		Amount		Capital			Comprehensive Loss			Deficit			Equity
Balance at December 31, 2022		49,974,281	$	50	$	451,060		$	(61	)	$	(369,094	)	$	81,955
Employee stock plans		216,105		—		—			—			—			—
Stock-based compensation		—		—		1,942			—			—			1,942
Exercise of pre-funded warrants		1,062,080		1		—			—			—			1
Unrealized gain on short-term investments		—		—		—			56			—			56
Net loss		—		—		—			—			(15,371	)		(15,371	)
Balance at March 31, 2023		51,252,466	$	51	$	453,002		$	(5	)	$	(384,465	)	$	68,583
Employee stock plans		698,016		1		116			—			—			117
Stock-based compensation		—		—		2,059			—			—			2,059
Exercise of pre-funded warrants		709,202		1		(1	)		—			—			—
Unrealized loss on short-term investments		—		—		—			(25	)		—			(25	)
Net loss		—		—		—			—			(17,690	)		(17,690	)
Balance at June 30, 2023		52,659,684	$	53	$	455,176		$	(30	)	$	(402,155	)	$	53,044

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.


	Common Stock				Additional			Accumulated						Total
					Paid-In			Other			Accumulated			Stockholders’
	Shares		Amount		Capital			Comprehensive Income (Loss)			Deficit			Equity
Balance at December 31, 2022		249,871	$	—	$	451,110		$	(61	)	$	(369,094	)	$	81,955
Employee stock plans		1,080		—		—			—			—			—
Stock-based compensation		—		—		1,942			—			—			1,942
Exercise of pre-funded warrants		5,311		—		1			—			—			1
Unrealized gain on short-term investments		—		—		—			56			—			56
Net loss		—		—		—			—			(15,371	)		(15,371	)
Balance at March 31, 2023		256,262	$	—	$	453,053		$	(5	)	$	(384,465	)	$	68,583
Employee stock plans		3,490		—		117			—			—			117
Stock-based compensation		—		—		2,059			—			—			2,059
Exercise of pre-funded warrants		3,546		—		—			—			—			—
Unrealized loss on short-term investments		—		—		—			(25	)		—			(25	)
Net loss		—		—		—			—			(17,690	)		(17,690	)
Balance at June 30, 2023		263,298	$	—	$	455,229		$	(30	)	$	(402,155	)	$	53,044
Employee stock plans		1,324		—		(92	)		—			—			(92	)
Stock-based compensation		—		—	$	1,784			—			—			1,784
Exercise of pre-funded warrants		234		—		—			—			—			—
Unrealized gain on short-term investments		—		—		—			24			—			24
Net loss		—		—		—			—			(16,980	)		(16,980	)
Balance at September 30, 2023		264,856	$	—	$	456,921		$	(6	)	$	(419,135	)	$	37,780

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

SONENDO, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

(in thousands)

	Six Months Ended June 30,
	Nine Months Ended September 30,
	2024			2023
Cash flows from operating activities:
Net loss	$	(1421,~~127~~663	)	$	(3350,~~061~~041	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation		~~137~~213			~~710~~1,094
Amortization of intangible assets		51			~~331~~498
Amortization of right-of-use lease assets		~~602~~871			~~628~~947
Excess and obsolete inventory provisions		~~241~~341			2,917
Impairment of long-lived assets		161			—3,392
Stock-based compensation		3,593			4,001
Provision for bad debt		(176	)		571
Amortization of debt issuance costs		1,444			297
Stock-based compensation		4,223			5,785
Accretion of available for sale securities, net		(353	)		(1,272	)
Amortization of debt issuance costs		1,717			456
Accretion of available for sale securities, net		(416	)		(1,831	)
Gain on sale of discontinued operations		(5,703	)		—
Changes in operating assets and liabilities:
Accounts receivable, net		554			(510	)
Accounts receivable		812			(373	)
Inventory		(1,~~398~~187	)		~~(616~~1,156	)
Prepaid expenses and other assets		12,~~716~~195			65,~~543~~887
Accounts payable		(~~245~~489	)		(3,~~346~~494	)
Other accrued expenses and other liabilities		(32,~~041~~146	)		(2,~~056~~996	)
Deferred revenue		~~169~~227			(19	)
Accrued compensation		(~~1,208~~749	)		(~~926~~506	)
Net cash used in operating activities		(1721,~~407~~718	)		(2636,~~341~~557	)
Cash flows from investing activities:
Purchases of available-for-sale securities		(24,~~118~~506	)		(3049,~~733~~978	)
Proceeds from maturities of available-for-sale securities		2633,~~698~~498			5281,~~500~~800
Purchases of property and equipment		(161	)		(~~627~~843	)
Proceeds from sale of discontinued operations, net		14,~~204~~208			—
Net cash provided by investing activities		3843,~~623~~039			2130,~~140~~979
Financing activities:
Cash flows from financing activities:
Principal repayments on term loan		(1922,~~500~~200	)		—
Tax paid on vested stock awards under employee stock plan		(43	)		—(92	)
Issuance of stock under employee stock plans		—(3	)		117
Proceeds from exercise of pre-funded warrants		—			1
Principal repayments on finance lease		(1828	)		(1523	)
Net cash provided by (used in) financing activities		(1922,~~522~~234	)		~~103~~3
Net decrease in cash and cash equivalents		~~1,694~~(913	)		(5,~~098~~575	)
Cash and cash equivalents at beginning of period		14,009			17,665
Cash and cash equivalents at end of period	$	1513,~~703~~096		$	12,~~567~~090
Supplemental disclosures of cash flow information:
Cash paid for:
Interest	$	2,~~129~~866		$	24,~~828~~319
Supplemental schedule of non-cash investing and financing activities:
Operating lease right-of-use assets obtained in exchange for lease liabilities	$	858		$	1,792

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

SONENDO, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited)

1. Organization and Basis of Presentation

Description of Business

Sonendo, Inc. (the “Company” or “we” and “our”) was incorporated in June 2006 pursuant to the laws of the State of Delaware under the name Dentatek Corporation. In March 2011, the Company changed its name to Sonendo, Inc. The Company is a medical technology company that has developed and is commercializing the GentleWave System to treat tooth decay. The Company’s principal market is the United States (“U.S.”). The Company’s products include the GentleWave System, which is cleared by the U.S. Food and Drug Administration (the “FDA”) for sale in the U.S. and approved by Health Canada in Canada, along with the system’s sterilized, single-use procedure instruments (“PIs”).

Basis of Presentation

The Company’s financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and pursuant to Form 10-Q and Article 10 of SEC Regulation S-X on a consistent basis with the Company’s annual financial statements and in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, considered necessary for a fair statement of the Company’s financial information. Accordingly, the accompanying unaudited condensed consolidated financial statements do not include all of the information and notes required by GAAP for complete financial statements. The condensed consolidated balance sheet as of December 31, 2023 included herein was derived from the audited financial statements as of that date. The results of operations included in these unaudited condensed consolidated financial statements are not necessarily indicative of the results of operations to be expected for the year, any other interim period, or for any other future annual or interim period. Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed, consolidated, or omitted. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed with the SEC on March 11, 2024.

As discussed in Note 3, “Discontinued Operations”, on March 1, 2024, the Company divested its software segment by selling substantially all assets and liabilities of TDO Software, Inc, its wholly owned subsidiary. The sale met the criteria to be accounted for as a discontinued operation as required by Accounting Standards Codification (“ASC”) 205-20. Accordingly, the financial results of the software business are reported as discontinued operations in the accompanying unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for all periods presented. The Company's Condensed Consolidated Statements of Cash Flows include the financial results of the software business for the ~~six~~nine months ended ~~June~~September 30, 2024 and 2023. All amounts and disclosure included in the Notes to condensed consolidated financial statements reflect only the Company's continuing operations unless otherwise noted.

The accompanying unaudited condensed consolidated financial statements reflect the 1-for-200 reverse split of the Company's common stock that was approved by our Board of Directors and made effective on October 18, 2024. All share and per share information herein that relates to our common stock prior to the effective date has been retroactively restated to reflect the reverse stock split.

Certain line items on the condensed consolidated statements of operations and comprehensive loss and the condensed consolidated statements of cash flows are reclassified in the prior period to conform to current period presentation.

Liquidity and Going Concern

OnAs of September 2730, ~~2022~~2024, the Company ~~completed~~had acash ~~private~~and ~~placement~~cash ~~(the~~equivalents ~~“Private Placement”), issuing an aggregate of approximately 23.0 million shares of its common stock at a purchase price of $0.95 per share~~ and ~~pre~~short-~~funded~~term ~~warrants~~investments ~~to purchase an aggregate~~ of 43$17.3 million ~~shares of common stock at a purchase price of $0.949 per pre-funded warrant. The pre-funded warrants have an exercise price of $0.001 per share of common stock, are immediately exercisable~~ and ~~will remain exercisable until exercised in full. The aggregate net proceeds from the Private Placement, after deducting placement agent fees and other offering expenses, were~~ $5917.08 million. ~~See~~in ~~Note~~principal 6,outstanding ~~Stockholders’~~under ~~Equity,~~its ~~for~~term ~~additional~~loan ~~information~~facility.

AsThe Company has a limited operating history, and the revenue and income potential of ~~June~~the Company’s business and market are unproven. The Company has experienced net losses and negative cash flows from operations since its inception and as of September 30, 2024 had an accumulated deficit of $451.7 million. During the nine months ended September 30, 2024, the Company ~~had~~incurred net losses of $27.2 million, used $21.7 million of cash and cash equivalents in its continuing operations, and ~~short-term~~recognized ~~investments~~a gain of $245.27 million ~~and~~from ~~$20~~sale of discontinued operations.5 ~~million~~The inCompany ~~principal~~will ~~outstanding~~continue ~~under~~to incur significant costs and expenses related to its ~~term~~ongoing ~~loan~~operations ~~facility~~until it gains greater market acceptance of its products and achieves a level of revenues adequate to support its operations.

The Company has a limited operating history, and the revenue and income potential of the Company’s business and market are unproven. The Company has experienced net losses and negative cash flows from operations since its inception and as of June 30, 2024 had an accumulated deficit of $444.1 million. During the six months ended June 30, 2024, the Company incurred net losses of $19.6 million, used $17.4 million of cash and cash equivalents in its continuing operations, and recognized a gain of $5.7 million from sale of discontinued operations. The Company will continue to incur significant costs and expenses related to its ongoing operations until it gains greater market acceptance of its products and achieves a level of revenues adequate to support its operations.8

The accompanying unaudited condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The unaudited condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.

The Company’s ability to continue as a going concern depends on its ability to continue to commercialize its products, achieve and maintain profitable operations, as well as the adherence to conditions of the outstanding term loan as amended in March 2024 (see Note 10). Without additional financing, the Company will have insufficient liquidity to achieve further commercialization of our products and maintain compliance with our loan covenants. Due to these conditions, there is substantial doubt about the Company’s ability to continue as a going concern and, therefore, it may be unable to realize its assets and discharge its liabilities in the normal course of business.

The Company ~~will~~has ~~require~~active ~~additional~~plans ~~financing in order~~ to ~~fund~~mitigate ~~its~~any ~~future~~doubt ~~expected~~as ~~negative cash flows. Due~~ to ~~its failure to comply with~~ the ~~continued listing standards set forth in the NYSE~~Company’s ~~Listed~~ability ~~Company~~to ~~Manual,~~continue ~~our~~as ~~common~~a ~~stock~~going ~~was suspended from trading on the NYSE effective at the opening of business Eastern Standard Time on November 22, 2023~~concern. ~~The Company commenced trading on the OTCQX on the same day. In April 2024~~Specifically, the Company ~~withdrew its request to appeal and the NYSE and our common stock~~ has been ~~delisted~~taking ~~from~~steps ~~the NYSE, which may negatively impact the Company’s stockholders~~ and ~~the~~plans ~~trading~~to ~~price~~further ~~and~~reduce ~~liquidity~~negative ofcash ~~its~~flow ~~common~~through ~~stock.~~additional ~~Over-the-counter~~operating ~~markets~~expense ~~are more limited than the NYSE, and it is likely that there will be significantly less liquidity in the trading of the Company’s common stock~~reductions. The ~~delisting of the~~ Company’s ~~common~~is ~~stock~~also ~~from~~actively ~~the~~exploring ~~NYSE~~financing ~~could~~options, ~~have~~including ~~material~~a ~~adverse~~combination ~~effects~~of ondebt, ~~its business~~equity, ~~financial condition~~ and ~~results~~non-dilutive ~~of operations~~sources. ~~On June 4~~Additionally, ~~2024,~~as ~~the~~detailed ~~Company~~in ~~received~~Note ~~notice from OTC that the Company’s common stock no longer met the Standards for Continued Qualification for the OTCQX per the OTCQX Rules for U.S. Companies section~~ 3~~.2.b.1~~ ~~because~~and ~~the~~Note ~~Company’s stock bid price closed below $0.~~10 ~~for more than 30 consecutive calendar days. The Company has a cure period of 180 calendar days to regain compliance~~, ~~which~~in ~~expires~~March ~~December 2~~2024, ~~2024. If~~ the Company’s ~~bid~~closed ~~price~~on ~~does not stay at or above~~ the ~~$0.10~~sale ~~minimum~~of ~~for~~TDO ~~ten consecutive trading days during the cure period~~Software, ~~then the Company’s common stock will be moved from OTCQX to the OTC Pink market~~Inc. On(“TDO”) ~~June 10, 2024, the Company’s shareholders approved an amendment to the Company’s Amended~~ and ~~Restated~~renegotiated ~~Certificate~~its ofcovenant ~~Incorporation~~requirements towith ~~effect~~its ~~a reverse stock split of the Company’s issued shares of common stock~~lender, atamong aother ~~specific ratio~~terms, ~~ranging~~which ~~from~~resulted ~~1:10~~in ~~to 1:200, at~~ the ~~discretion~~Company ofremitting ~~the~~$15 ~~Company’s~~million ~~board~~ of ~~directors~~principal atpayments ~~any~~on ~~time~~its ~~prior~~outstanding toborrowings. ~~the~~Its ~~Company’s~~plans ~~2025~~are ~~annual~~subject ~~meeting~~to ofinherent ~~stockholders,~~risks ~~with~~and ~~the~~uncertainties ~~exact~~and ~~ratio~~there tocan be ~~determined~~no byassurance ~~the~~that ~~Company’s~~its ~~board~~plans ofcan ~~directors~~be ~~without~~effectively ~~further~~implemented ~~approval or authorization of the Company’s stockholders. The Company’s Board of Directors is evaluating the merits~~ and, ~~timing~~therefore, tothat ~~effect a reverse stock split. The OTCQX Rules also requires~~ the ~~Company~~conditions tocan ~~have~~be aeffectively ~~market capitalization of at least $5 million for at least one of every 30 consecutive calendar days~~mitigated.

The Company ~~has~~will ~~active~~require ~~plans~~additional tofinancing ~~mitigate~~in ~~these~~order ~~conditions.~~to ~~Specifically,~~fund ~~the~~its ~~Company~~future ~~has~~expected ~~been~~negative ~~taking~~cash ~~steps~~flows. ~~and~~Due ~~plans~~to its failure to ~~further~~comply ~~reduce~~with ~~negative~~the ~~cash~~continued ~~flow~~listing ~~through~~standards ~~additional~~set ~~operating~~forth ~~expense~~in ~~reductions.~~the ~~The~~NYSE’s Listed Company isManual, ~~also~~our ~~actively~~common ~~exploring~~stock ~~financing~~was ~~options,~~suspended ~~including~~from atrading ~~combination~~on the NYSE effective at the opening of ~~debt,~~business ~~equity,~~Eastern ~~and~~Standard ~~non-dilutive~~Time ~~sources.~~on ~~Additionally~~November 22, as2023. ~~detailed~~The inCompany ~~Note~~commenced 3trading ~~and~~on ~~Note~~the ~~10,~~OTCQX inon ~~March~~the same day. In April 2024, the Company ~~closed~~withdrew onits ~~the~~request ~~sale~~to ofappeal ~~TDO~~and ~~Software,~~the ~~Inc.~~NYSE ~~(“TDO”)~~ and ~~renegotiated~~our ~~its~~common ~~covenant~~stock ~~requirements~~has ~~with~~been ~~its~~delisted ~~lender,~~from ~~among~~the ~~other terms~~NYSE, which ~~resulted~~may innegatively impact the Company’s ~~remitting~~stockholders ~~$15~~and ~~million~~the oftrading ~~principal~~price ~~payments~~and onliquidity of its ~~outstanding~~common ~~borrowings~~stock. ~~Its~~Over-the-counter ~~plans~~markets are ~~subject~~more tolimited ~~inherent~~than ~~risks~~the NYSE, and ~~uncertainties~~it ~~and~~is likely that there ~~can~~will be nosignificantly ~~assurance~~less ~~that~~liquidity ~~its~~in ~~plans~~the ~~can~~trading beof ~~effectively~~the ~~implemented~~Company’s ~~and,~~common ~~therefore,~~stock. ~~that~~The delisting of the ~~conditions~~Company’s ~~can~~common bestock ~~effectively~~from ~~mitigated~~the NYSE could have material adverse effects on its business, financial condition and results of operations.

On June 4, 2024, the Company received notice from OTC that the Company’s common stock no longer met the Standards for Continued Qualification for the OTCQX per the OTCQX Rules for U.S. Companies section 2.1(A) because the Company’s stock bid price closed below $0.10 for more than 30 consecutive calendar days. The Company had a cure period of 180 calendar days to regain compliance, which expires December 2, 2024. If the Company’s bid price did not stay at or above the $0.10 minimum for ten consecutive trading days during the cure period, then the Company’s common stock would have been moved from OTCQX to the OTC Pink market.

On June 10, 2024, the Company’s shareholders approved an amendment to the Company’s Amended and Restated Certificate of Incorporation to effect a reverse stock split of the Company’s issued shares of common stock, at a specific ratio, ranging from 1:10 to 1:200, at the discretion of the Company’s board of directors at any time prior to the Company’s 2025 annual meeting of stockholders, with the exact ratio to be determined by the Company’s board of directors without further approval or authorization of the Company’s stockholders. In September 2024, the Board approved a 1-for-200 reverse stock split.

On October 16, 2024, the Company filed an amendment to its Amended and Restated Certificate of Incorporation to implement a 1-for-200 reverse stock split of its issued and outstanding common stock, effective as of October 18, 2024. The reverse stock split correspondingly adjusted the per share exercise price of all outstanding options and all shares underlying any of the outstanding warrants by reducing the conversion ratio for each outstanding warrant and increasing the applicable exercise price or conversion price in accordance with the terms of each outstanding warrant and based on the reverse stock split ratio. No fractional shares were issued in connection with the reverse stock split. Stockholders who are entitled to fractional shares will receive a cash payment in lieu of receiving fractional shares (after taking into account and aggregating all shares of the Company’s common stock then held by such stockholder) equal to the fractional share interest multiplied by $5.00 (the per share closing price of the Company’s common stock, on a post-split basis, as last reported on the OTCQX market on November 7, 2024). The reverse stock split was announced by FINRA on its OTC Daily List on November 7,2024 and took effect at the open of trading on November 8, 2024 on the OTCQX. Upon the effectiveness of the reverse stock split, the Company became compliant with OTCQX Rule 2.1(A).

The number of shares of common stock authorized under the Amended and Restated Certificate of Incorporation is unchanged at 500,000,000 shares. The accompanying interim unaudited condensed financial statements reflect the 1-for-200 reverse split of our common stock. All share and per share information data herein that relates to the Company's common stock prior to the effective date has been retroactively restated to reflect the reverse stock split.

On November 7, 2024, the Company received notice from the OTC that the Company’s common stock no longer met the Standards for Continued Qualification for the OTCQX per the OTCQX Rules for U.S. Companies section 2.1(B) because the Company’s market capitalization has stayed below $5 million for the past 30 consecutive calendar days. The Company has a cure period of 90 calendar days to regain compliance. The 90-calendar day grace period expires February 7, 2025 and at that time if the Company’s market

capitalization has not stayed at or above $5 million for ten consecutive trading days then the Company's common stock will be removed from OTCQX and moved to the OTC Pink market.

Effects of the Macroeconomic Environment

The Company’s unaudited condensed consolidated financial statements as of and for the three and ~~six~~nine months ended ~~June~~September 30, 2024 reflect the Company’s estimates of the impact of the macroeconomic environment, including the impact of inflation and higher interest rates. The duration and the scope of these conditions cannot be predicted; therefore, the extent to which these conditions will directly or indirectly impact the Company’s business, results of operations and financial condition, is uncertain. The Company is not aware of any specific event or circumstance that would require an update to its estimates, judgments and assumptions or a revision of the carrying value of the Company’s assets or liabilities as of the date of this filing.

Operating Segments

The Company previously had two operating and reportable segments: Product and Software. Following the divestiture of the software business on March 1, 2024, there were no substantial assets or operations remaining of the software segment. The software segment was reported as discontinued operations as of ~~June~~September 30, 2024, and is presented as such for all periods in this report.

Emerging Growth Company Status

The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. The Company has elected to avail itself of this exemption and, therefore, for new or revised accounting standards applicable to public companies, the Company will be subject to an extended transition period until those standards would otherwise apply to private companies.

this exemption and, therefore, for new or revised accounting standards applicable to public companies, the Company will be subject to an extended transition period until those standards would otherwise apply to private companies.

2. Summary Accounting Policies and Recent Accounting Pronouncements

The accounting policies followed by the Company are set forth in Part II, Item 8, Note 2, Summary of Accounting Policies, of the Notes to Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make informed estimates, judgements and assumptions that affect the reported amounts in the unaudited condensed consolidated financial statements and disclosures in the accompanying notes, including estimates of probable losses and expenses, as of the date of the accompanying unaudited condensed consolidated financial statements. Management considers many factors in selecting appropriate financial accounting policies and in developing the estimates and assumptions that are used in the preparation of these unaudited condensed consolidated financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including the expected business and operational changes, the sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates. Actual results could differ materially from the estimates and assumptions used in the preparation of the accompanying unaudited condensed consolidated financial statements under different assumptions or conditions.

Inventory

Inventory consists of finished products, work-in-process and raw materials and is valued at the lower of cost or net realizable value. Cost may include materials, labor and manufacturing overhead. Cost is determined by the first in, first out inventory method. The carrying value of inventory is reviewed for potential impairment whenever indicators suggest that the cost of inventory exceeds the carrying value and management adjusts the inventory to its net realizable value. The Company also periodically evaluates inventory for estimated losses from excess quantities and obsolescence and writes down the cost of inventory to net realizable value at the time such determinations are made. Net realizable value is determined using the estimated selling price, in the ordinary course of business, less estimated costs of completion and disposal.

Revenue Recognition

Contracts with Customers

The Company recognizes revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods and services. Specifically, the Company applies the following five core principles to recognize revenue: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when, or as, the Company satisfies a performance obligation.

Revenue recorded from continuing operations is generated from sales of the GentleWave Console and related PIs and accessories and services on its GentleWave Console. The Company’s products are sold primarily in the United States and Canada directly to customers through its field sales force.

Performance Obligations

The Company’s performance obligations from continuing operations primarily arise from the manufacture and delivery of the GentleWave System, related PIs and accessories, and to a lesser extent, performance of service contracts on its GentleWave Consoles. Payment terms are typically on open credit terms consistent with industry practice and do not have significant financing components. Consideration may be variable based on volume.

The Company considers the individual deliverables in its product offering as separate performance obligations and assesses whether each promised good or service is distinct. The total contract transaction price is determined based on the consideration expected to be received, based on the stated value in contractual arrangements or the estimated cash to be collected in no-contracted arrangements, and is allocated to the identified performance obligations based upon the relative standalone selling prices of the performance obligations. The stand-alone selling price is based on an observable price offered to other comparable customers. The Company estimates the standalone selling price using the market assessment approach considering market conditions and entity-specific factors including, but not limited to, features and functionality of the products and services, geographies, type of customer and market conditions. The Company regularly reviews and updates standalone selling prices as necessary. The consideration the Company receives in exchange for its goods or services is only recognized when it is probable that a significant reversal will not occur. The consideration to which the Company expects to be entitled includes a stated list price, less various forms of variable consideration. The Company estimates related variable consideration at the point of sale, including discounts, product returns, refunds, and other similar obligations.

receives in exchange for its goods or services is only recognized when it is probable that a significant reversal will not occur. The consideration to which the Company expects to be entitled includes a stated list price, less various forms of variable consideration. The Company estimates related variable consideration at the point of sale, including discounts, product returns, refunds, and other similar obligations.

Revenue is recognized over time when the customer simultaneously receives and consumes the benefits provided by the Company’s performance. Revenue is recognized at a point in time if the criteria for recognizing revenue over time are not met, and the Company has transferred control of the goods to the customer.

Product revenue is recognized at a point in time when the Company has transferred control to the customer, which is generally when title of the goods transfers to the customer. Sales of extended service contracts are recorded as deferred revenue until such time as the standard warranty expires, which is generally up to two years from the date of sale. Service contract revenue is recognized on a straight-line basis over time consistent with the life of the related service contract in proportion to the costs incurred in fulfilling performance obligations under the service contract.

The Company generally does not experience significant returns. IfAs necessary, a provision is recorded for estimated sales returns and allowances and is deducted from gross product revenue to arrive at net product revenue in the period the related revenue is recorded. These estimates are based on historical sales returns and allowances and other known factors. Actual returns and claims in any future period are inherently uncertain and thus may differ from these estimates. If actual or expected future returns and claims are significantly greater or lower than the reserves established, a reduction or increase to revenue will be recorded in the period in which such a determination is made.

All non-income government-assessed taxes (sales and use taxes) collected from the Company’s customers and remitted to governmental agencies are recorded in accrued expenses until they are remitted to the government agency.

The Company has adopted the practical expedient permitting the direct expensing of costs incurred to obtain contracts where the amortization of such costs would occur over one year or less, and it applied to substantially all the Company’s contracts.

Contract liabilities

The Company recognizes a contract liability when a customer pays for goods or services for which the Company has not yet transferred control. The balances of the Company’s contract liabilities are as follows:

	June 30,		December 31,
	September 30,		December 31,
	2024		2023
	(in thousands)
Total contract liabilities - extended service contracts	$	1,~~089~~147	$	920
Less: long-term portion		~~243~~230		302
Contract liabilities – current	$	~~846~~917	$	618

Contract liabilities are included within other current liabilities and other long-term liabilities in the accompanying unaudited condensed consolidated balance sheets. Revenue recognized during each of the three months ended September 30, 2024 and 2023 that was included in the contract liability balance as of June 30, 2024 and 2023 was immaterial. Revenue recognized during the nine months ended September 30, 2024 and 2023 that was included in the contract liability balance as of December 31, 2023 and 2022 was $0.5 million and $0.3 million, respectively.

Disaggregation of revenue

The Company disaggregates revenue from contracts with customers by the timing of when goods and services are transferred, which depicts how the nature, amount, timing and uncertainty of revenue and cash flows are affected.

The following table provides information regarding disaggregated revenues and the timing of when goods and services are transferred:

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Nine Months Ended September 30,

2024

2023

2024

2023

(in thousands)

Product revenue recognized at a point in time

7,~~941~~662

87,~~617~~934

1422,~~671~~333

1725,~~141~~075

Service revenue recognized over time

~~373~~374

~~146~~229

~~690~~1,064

~~300~~529

Total revenue

8,~~314~~036

8,~~763~~163

1523,~~361~~397

1725,~~441~~604

No individual customer accounted for more than 10% of sales for the three and ~~six~~nine months ended ~~June~~September 30, 2024 and 2023.

Allowance for credit losses

At each reporting period the Company recognizes or revises its estimate of expected credit losses for financial assets and other assets within the scope of the current expected credit losses (“CECL”) model under ASC 326, which include its trade receivables. The Company records reserves for accounts receivables as they age, as adjusted based on factors including changes in credit terms, recent collection trend and existence of payment plans. As of September 30, 2024, the allowance for credit losses was approximately $0.3 million.

Warranty Reserve

The Company provides a standard warranty on its GentleWave Systems for a specified period of time. For the ~~six~~nine months ended ~~June~~September 30, 2024 and 2023, GentleWave Systems sold were covered by the warranty for a period of up to two years from the date of sale. Estimated warranty costs are recorded as a liability at the time of delivery with a corresponding provision to cost of sales. Warranty accruals are estimated based on the current product costs, the Company’s historical experience, management’s expectations of future conditions and standard maintenance schedules. The Company evaluates this reserve on a regular basis and makes adjustments as necessary.

10The following table provides a reconciliation of the change in estimated warranty liabilities for the nine months ended September 30, 2024 and 2023:

accruals are estimated based on the current product costs, the Company’s historical experience, management’s expectations of future conditions and standard maintenance schedules. The Company evaluates this reserve on a regular basis and makes adjustments as necessary.


	Three Months Ended September 30,						Nine Months Ended September 30,
	2024			2023			2024			2023
	(in thousands)
Balance at beginning of period	$	754		$	1,579		$	1,269		$	1,930
Provision for warranties issued		177			170			620			570
Changes in estimate of pre-existing warranty		—			—			(112	)		—
Warranty costs incurred		(316	)		(384	)		(1,162	)		(1,135	)
Balance at end of period	$	615		$	1,365		$	615		$	1,365
Current portion							$	574		$	1,228
Non-current portion								41			137
Total							$	615		$	1,365

The following table provides a reconciliation of the change in estimated warranty liabilities for the six months ended June 30, 2024 and 2023:

	Three Months Ended June 30,						Six Months Ended June 30,
	2024			2023			2024			2023
	(in thousands)
Balance at beginning of period	$	1,042		$	1,757		$	1,269		$	1,930
Provision for warranties issued		243			205			443			400
Changes in estimate of pre-existing warranty		(112	)		—			(112	)		—
Warranty costs incurred		(419	)		(383	)		(846	)		(751	)
Balance at end of period	$	754		$	1,579		$	754		$	1,579
Current portion							$	705		$	1,302
Non-current portion								49			277
Total							$	754		$	1,579

The warranty liabilities, current and non-current, are included in other current liabilities and other liabilities, respectively, on the unaudited condensed consolidated balance sheets.

Recent Accounting Pronouncements

Changes to GAAP are established by the Financial Accounting Standards Board (“FASB”) in the form of accounting standards updates (“ASU”). ASUs not listed below were assessed and determined not to be applicable or are expected to have minimal impact on the Company’s unaudited condensed consolidated financial statements.

In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures”, which expands on segment reporting requirements primarily through enhanced disclosures surrounding significant segment expenses. The ASU expands on existing segment reporting requirements to require that a public entity, including entities with a single reportable segment, disclose, on an annual and interim basis, significant segment expenses that are regularly provided to an entity's CODM, a description of other segment items by reportable segment, and any additional measures of a segment's profit or loss used by the CODM when deciding how to allocate resources. The ASU is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. The Company is evaluating the impact of this ASU on its Consolidated Financial Statements.

In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The amendments require disclosure of specific categories in the rate reconciliation and provides additional information for reconciling items that meet a quantitative threshold and further disaggregation of income taxes paid for individually significant jurisdictions. The ASU is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company does not expect the adoption to have a material impact on its Consolidated Financial Statements.

In November 2024, the FASB issued ASU No. 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. The ASU intends to improve income statement expense disclosure requirements, primarily through enhanced disclosure about certain costs and expenses included in income statement expense captions. The amendments are effective for annual reporting periods beginning after December 15, 2026 and interim periods beginning after December 15, 2027. Early adoption is permitted. The Company is evaluating the impact of this ASU on its Consolidated Financial Statements.

3. Discontinued Operations

On March 1, 2024, the Company entered into an Asset Purchase Agreement by and among TDO, Valsoft Corporation Inc., a Quebec corporation, and Aspire USA LLC, a Delaware limited liability company and affiliate of Valsoft (collectively “Valsoft”), pursuant to which TDO agreed to sell to Valsoft substantially all the assets and liabilities relating to the Company’s software segment. As consideration for the transaction, Valsoft agreed to pay TDO approximately $16.0 million, with $15.0 million paid on March 1, 2024 and $1.0 million due approximately 12 months post-closing. In connection with the transaction, Valsoft agreed to make offers of employment to certain employees of the Business on terms that are comparable to those currently in effect for such employees. The Asset Purchase Agreement contains certain representations, warranties and covenants of each of TDO and Valsoft. Each of TDO and the Valsoft has agreed to indemnify the other for certain losses arising out of breaches of representations and covenants and for certain losses arising out of retained liabilities or assumed liabilities relating to the TDO business, as applicable, subject to customary limitations.

11The divestiture met the criteria to be accounted for as a discontinued operation as of March 31, 2024. Accordingly, the operating results of the discontinued operations for the three and nine months ended September 30, 2024 and 2023, respectively, are presented in the Condensed Consolidated Statements of Operations and Comprehensive Loss within income from discontinued operations as follows:

The divestiture met the criteria to be accounted for as a discontinued operation as of March 31, 2024. Accordingly, the operating results of the discontinued operations for the three and six months ended June 30, 2024 and 2023, respectively, are presented in the Condensed Consolidated Statements of Operations and Comprehensive Loss within income from discontinued operations as follows:


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024			2023
	(in thousands)				(in thousands)
Revenue	$	—	$	2,243	$	1,478		$	6,569
Cost of sales		—		681		511			2,056
Gross profit		—		1,562		967			4,513
Operating expenses:
General and administrative		—		398		524			1,254
Selling and marketing		—		197		162			535
Research and development		—		498		476			1,599
Income (loss) from discontinued operations, net of tax		—		469		(195	)		1,125
Other income		—		—		—			22
Gain on sale of discontinued operations, net of tax		—		—		5,703			—
Net income from discontinued operations	$	—	$	469	$	5,508		$	1,147

	Three Months Ended June 30,				Six Months Ended June 30,
	2024		2023		2024			2023
	(in thousands)				(in thousands)
Revenue	$	89	$	2,280	$	1,478		$	4,326
Cost of sales		1		697		511			1,375
Gross profit		88		1,583		967			2,951
Operating expenses:
General and administrative		7		447		524			856
Selling and marketing		—		195		162			338
Research and development		—		534		476			1,101
Income (loss) from discontinued operations, net of tax		81		407		(195	)		656
Other income		—		—		—			22
Gain on sale of discontinued operations, net of tax		—		—		5,703			—
Net income from discontinued operations	$	81	$	407	$	5,508		$	678

Software is licensed via delivery to the customer or via a service arrangement under which cloud-based access is provided on a subscription basis (software-as-a-service). When a fixed up-front license fee is received in exchange for the delivery of software, revenue is recognized at the point in time when the delivery of the software has occurred. When software is licensed on a subscription basis, revenue is recognized over the respective license period.

~~The following table presented assets and liabilities of discontinued operations as of June 30, 2024 and December 31, 2023:~~13

	June 30, 2024		December 31, 2023
	(in thousands)
Current assets:	$	927	$	656
Non-current assets:
Intangible assets, net		—		661
Goodwill		—		8,454
Other		—		482
Total assets of discontinued operations	$	927	$	10,253
Current liabilities:
Accounts payable	$	—	$	34
Accrued expenses		—		194
Accrued compensation		—		345
Operating lease liabilities		—		127
Total liabilities of discontinued operations	$	—	$	700

The following table presented assets and liabilities of discontinued operations as of September 30, 2024 and December 31, 2023:

Depreciation and amortization of long-lived assets, stock-based compensation expense and capital expenditures of discontinued operations were not material for each of the three and six months ended June 30, 2024 and 2023.


	September 30, 2024		December 31, 2023
	(in thousands)
Current assets:	$	1,000	$	656
Non-current assets:
Intangible assets, net		—		661
Goodwill		—		8,454
Other		—		482
Total assets of discontinued operations	$	1,000	$	10,253

Current liabilities:
Accounts payable	$	—	$	34
Accrued expenses		—		194
Accrued compensation		—		345
Operating lease liabilities		—		127
Total liabilities of discontinued operations	$	—	$	700

During the three months ended September 30, 2024, no depreciation and amortization of long-lived assets was recorded in the discontinued operations. During the nine months ended September 30, 2024, $60 thousand expenses of depreciation and amortization of long-lived assets was recorded in the discontinued operations. During the three and nine months ended September 30, 2023, $0.1 million and $0.4 million expenses of depreciation and amortization of long-lived assets was recorded in the discontinued operations.

For each of the three and nine months ended September 30, 2024 and 2023, no capital expenditure was recorded in the discontinued operations.

See Note 7 “Stock based Compensation.” for stock based compensation expense recorded in the discontinued operations for each of the three and nine months ended September 30, 2024 and 2023.

4. Balance Sheet Components

Inventory

Inventory consisted of the following:

	June 30,		December 31,
	September 30,		December 31,
	2024		2023
	(in thousands)
Raw materials	$	65,~~184~~693	$	6,450
Work in process		~~245~~230		278
Finished goods		5,~~369~~564		4,346
Total inventory	$	11,~~798~~487	$	11,074

The balance of the reserve of excess and obsolete inventory was $01.90 million ~~for~~and ~~each~~$0.8 ofmillion ~~the~~as ~~periods~~of ~~ending~~September ~~June~~ 30, 2024 and December 31, 2023, respectively. During the three and nine months ended ~~June~~September 30, 2024, the Company recorded a reserve for excess and obsolete inventory of $0.1 million and $0.3 million, respectively, related to phasing out the legacy GentleWave Console (“Gen3”) and legacy molar and anterior pre-molar procedure instruments. During the nine months ended September 30, 2023, the Company recorded a reserve for excess and obsolete inventory of $1.7 million related to reduced sales volumes of legacy Gen3, and a charge of $1.2 million related to phasing out the legacy molar and anterior pre-molar procedure instruments as the Company moved to the CleanFlow procedure instruments, of which $0.6 million was due to excess and obsolete inventory.

of $0.2 million related to phasing out the legacy GentleWave Console ("Gen3") and legacy molar and anterior pre-molar procedure instruments. During the three months ended June 30, 2023, the Company recorded a reserve for excess and obsolete inventory of $1.7 million related to reduced sales volumes of legacy Gen3, and a charge of $1.2 million related to phasing out the legacy molar and anterior pre-molar procedure instruments as the Company moved to the CleanFlow procedure instruments, of which $0.6 million was due to excess and obsolete inventory.

5. Fair Value of Financial Instruments

The Company applies fair value measurements to record fair value adjustments to certain assets and liabilities and to determine fair value disclosures. The Company’s financial instruments consist principally of cash, cash equivalents, short-term investments, accounts receivable, accounts payable, operating lease liabilities, warrant liabilities and a term loan. Fair value is measured as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. A fair value measurement assumes that the transaction to sell the asset or transfer the liability occurs in the principal market for the asset or liability or, in the absence of a principal market, the most advantageous market. Valuation techniques that are consistent with the market, income or cost approach are used to measure fair value.

The fair value hierarchy prioritizes the inputs to valuation techniques used to measure fair value into three levels:

Level 1 – Observable inputs such as unadjusted quoted prices in active markets that are accessible at the measurement date for identical unrestricted assets or liabilities the Company has the ability to access.

Level 2 – Inputs (other than quoted prices included within Level 1) that are observable for the asset or liability, either directly or indirectly, for substantially the full term of the asset or liability. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active.

Level 3 – Unobservable inputs that are significant to the fair value measurement and reflect the reporting entity’s use of significant management judgment and assumptions when there is little or no market data. Level 3 assets and liabilities include those whose fair value measurements are determined using pricing models, discounted cash flow methodologies or similar valuation techniques and significant management judgment or estimation. These include the Black-Scholes option-pricing model which uses inputs such as expected volatility, risk-free interest rate and expected term to determine fair market valuation.

Assets and liabilities are classified based on the lowest level of input that is significant to the fair value measurements. The Company reviews the fair value hierarchy classification at each reporting date. Changes in the ability to observe valuation inputs may result in a reclassification of levels for certain assets or liabilities within the fair value hierarchy. The Company did not have any transfers of assets and liabilities between the levels of the fair value measurement hierarchy during the periods presented.

The carrying amounts of cash and cash equivalents, accounts receivable, accounts payable, and certain accrued expenses approximate fair value due to the short-term nature of these items. Accordingly, the Company estimates that the recorded amounts approximate fair market value.

The following table provides the assets and liabilities measured at fair value on a recurring basis and indicate the fair value hierarchy of the valuation techniques utilized by the Company to determine such value at ~~June~~September 30, 2024 and December 31, 2023:

	June 30, 2024
	September 30, 2024
	Fair Value		Quoted Prices in Active Markets for Identical Assets(Level 1)		Significant Other Observable Inputs(Level 2)		Significant Unobservable Inputs(Level 3)
	(in thousands)
Assets:
Cash equivalents:
Money market funds	$	911,~~564~~789	$	911,~~564~~789	$	—	$	—
Corporate bonds		1,514		—		1,514		—
U.S. treasury securities		750		750		—		—
U.S. treasury securities		3,741		3,741		—		—
Total cash equivalents at fair value		12,539		12,539		—		—
Total cash equivalents at fair value		14,819		13,305		1,514		—
Short-term investments:
U.S. treasury securities		21,~~976~~487		21,~~976~~487		—		—
Commercial paper and corporate bonds		52,~~557~~701		—		52,~~557~~701		—
Total short-term investments at fair value		84,~~533~~188		21,~~976~~487		52,~~557~~701		—
Total assets at fair value	$	2316,~~352~~727	$	1614,~~281~~026	$	72,~~071~~701	$	—


	September 30, 2024
	Fair Value		Cost Basis		Amounts Recognized in Accumulated Other Comprehensive Loss
					Unrealized Gains		Unrealized Losses
	(in thousands)
Available-for-sale securities:
U.S. treasury securities	$	1,487	$	1,485	$	2	$	—
Commercial paper and corporate bonds		2,701		2,700		1		—
Total available-for-sale securities at fair value	$	4,188	$	4,185	$	3	$	—

	June 30, 2024
	Fair Value		Cost Basis		Amounts Recognized in Accumulated Other Comprehensive Loss
					Unrealized Gains		Unrealized Losses
	(in thousands)
Available-for-sale securities:
U.S. treasury securities	$	2,976	$	2,976	$	—	$	—
Commercial paper and corporate bonds		5,557		5,559		—		(2	)
Total available-for-sale securities at fair value	$	8,533	$	8,535	$	—	$	(2	)


	December 31, 2023
	Fair Value		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
	(in thousands)
Assets:
Cash equivalents:
Money market funds	$	10,761	$	10,761	$	—	$	—
Corporate Bonds		1,827		—		1,827		—
Total cash equivalents at fair value		12,588		10,761		1,827		—
Short-term investments:
U.S. treasury securities		14,826		14,826		—		—
Commercial paper and corporate bonds		13,204		—		13,204		—
U.S. government agency bonds		4,743		—		4,743		—
Total short-term investments at fair value		32,773		14,826		17,947		—
Total assets at fair value	$	45,361	$	25,587	$	19,774	$	—


	December 31, 2023
	Fair Value		Cost Basis		Amounts Recognized in Accumulated Other Comprehensive Loss
					Unrealized Gains		Unrealized Losses
	(in thousands)
Available-for-sale securities:
U.S. Treasury securities	$	14,826	$	14,820	$	6	$	—
Commercial paper and corporate bonds		13,204		13,197		9		(2	)
U.S. government agency bonds		4,743		4,745		—		(2	)
Total available-for-sale securities at fair value	$	32,773	$	32,762	$	15	$	(4	)

Money market funds and U.S. Treasury securities are highly liquid investments and are actively traded. The pricing information on these investment instruments is readily available and can be independently validated as of the measurement date. This approach results in the classification of these securities as Level 1 of the fair value hierarchy.

Commercial paper, U.S. government agency bonds and corporate bonds are measured at fair value using Level 2 inputs. The Company reviews trading activity and pricing for these investments as of each measurement date. When sufficient quoted pricing for identical securities is not available, the Company uses market pricing and other observable market inputs for similar securities obtained from third party data providers. These inputs represent quoted prices for similar assets in active markets or these inputs have been derived from observable market data. This approach results in the classification of these securities as Level 2 of the fair value hierarchy.

6. Stockholders’ Equity

Warrants

InWarrants ~~April 2022, the Company amended its term loan and the warrants previously~~ issued to Perceptive Credit Holdings III, LP (“Perceptive”) and certain of its affiliates toand ~~purchase~~outstanding anat ~~aggregate~~December ~~of 304~~31,~~105~~ ~~shares~~2023 ofincluded ~~its~~95 ~~common~~warrants ~~stock.~~with ~~Such~~exercise ~~warrants~~price ~~were~~of ~~amended~~$2,190 ~~solely~~per toshare ~~reduce~~and ~~the~~1,518 warrants with exercise price of ~~the~~$2,400 per share. Warrants issued and outstanding at September 30, 2024 includes 1,518 warrants towith exercise price of $~~12.00~~2,400 per share. These warrants expire between June 2027 and August 2031.

~~Warrants~~The Company issued pre-funded warrants to certain institutional investors and ~~outstanding~~accredited atinvestors ~~June~~in a previous private placement. As of September 30, 2024, ~~and~~approximately ~~December~~157.2 ~~31,~~thousand ~~2023~~shares ~~included~~have ~~19,179~~been ~~warrants~~issued ~~with~~pursuant ~~exercise~~to ~~price~~the exercise of ~~$10~~pre-funded warrants and 59.953 ~~per~~thousand ~~share~~shares ~~and~~underlying ~~304,105~~the pre-funded warrants ~~with~~remain ~~exercise~~outstanding. ~~price~~The ofpre-funded ~~$12.00~~warrants ~~per~~are ~~share~~classified as equity and are accounted for as a component of additional paid-in ~~each~~capital ~~period~~at the time of issuance. ~~These~~The pre-funded warrants ~~expire~~are ~~between~~included ~~June~~in ~~2024~~the calculation of basic and ~~August~~diluted ~~2031~~loss per share.

1416

On September 27, 2022, the Company completed the Private Placement, issuing an aggregate of approximately 23.0 million shares of its common stock at a purchase price of $0.95 per share and pre-funded warrants to purchase an aggregate of 43.3 million shares of common stock at a purchase price of $0.949 per pre-funded warrant to certain institutional investors and accredited investors (the “Purchasers”). The pre-funded warrants have an exercise price of $0.001 per share of common stock, are immediately exercisable and will remain exercisable until exercised in full. The aggregate net proceeds from the Private Placement, after deducting placement agent fees and other offering expenses, were $59.0 million.

The pre-funded warrants include a provision whereby the exercisability of the warrants may be limited if, upon exercise, the warrant holder or any of its affiliates would beneficially own more than 9.99% of the Company’s common stock. The threshold is subject to the Purchasers’ rights under the pre-funded warrant to increase or decrease such percentage to any other percentage not in excess of 19.99% upon at least 61 days’ prior notice from the Purchasers to the Company. As of June 30, 2024, approximately 8.2 million shares have been issued pursuant to the exercise of pre-funded warrants and 22.8 million shares underlying the pre-funded warrants remain outstanding.

The pre-funded warrants are classified as equity and are accounted for as a component of additional paid-in capital at the time of issuance. The pre-funded warrants are included in the calculation of basic and diluted loss per share. Pursuant to the terms and conditions of the purchase agreements entered into by the Purchasers, the Company was obligated to file a registration statement with the SEC registering the resale by the Purchasers of the shares of common stock issued to them in the Private Placement and the shares of common stock to be issued to them upon exercise of the pre-funded warrants issued to them in the Private Placement within 45 days of the closing of the Private Placement. On November 4, 2022, the Company filed a registration statement on Form S-3 (File No. 333-268174), as required under the purchase agreements, and the registration statement was declared effective by the SEC on November 16, 2022.

7. Stock Based Compensation

Stock-based Compensation Expenses

The following tables present the Company’s stock-based compensation for stock-settled awards by type (i.e., stock options and restricted stock units (“RSUs”)) granted under the Company’s incentive plans, and rights to purchase shares of common stock issued under the Company’s Employee Stock Purchase Plan (“ESPP”) and financial statement lines included in the accompanying unaudited condensed consolidated statement of operations and comprehensive loss for the three and ~~six~~nine months ended ~~June~~September 30:

	Three months ended June 30,				Six months ended June 30,
	Three months ended September 30,				Nine months ended September 30,
	2024		2023		2024		2023
	(in thousands)
Options	$	~~257~~233	$	~~757~~645	$	~~647~~880	$	12,~~588~~233
RSUs		~~446~~397		1,~~229~~094		23,~~946~~343		23,~~295~~389
ESPP		—	7345			—	~~118~~163
Total stock-based compensation expense	$	~~703~~630	$	21,~~059~~784	$	34,~~593~~223	$	45,~~001~~785


	Three months ended September 30,
	2024						2023
	Continuing operations		Discontinued operations		Total		Continuing operations		Discontinued operations		Total
	(in thousands)
Cost of sales	$	14	$	—	$	14	$	44	$	10	$	54
Selling and marketing		47		—		47		550		6		556
General and administrative		539		—		539		1,010		19		1,029
Research and development		30		—		30		136		9		145
Total stock-based compensation expense	$	630	$	—	$	630	$	1,740	$	44	$	1,784

	Nine months ended September 30,
	2024						2023
	Continuing operations		Discontinued operations		Total		Continuing operations		Discontinued operations		Total
	(in thousands)
Cost of sales	$	324	$	79	$	403	$	262	$	31	$	293
Selling and marketing		838		59		897		1,698		18		1,716
General and administrative		2,141		140		2,281		3,156		55		3,211
Research and development	551		91			642		538		27		565
Total stock-based compensation expense	$	3,854	$	369	$	4,223	$	5,654	$	131	$	5,785

	Three months ended June 30,
	2024						2023
	Continuing operations		Discontinued operations		Total		Continuing operations		Discontinued operations		Total
	(in thousands)
Cost of sales	$	8	$	—	$	8	$	79	$	12	$	91
Selling and marketing		68		—		68		589		7		596
General and administrative		601		—		601		1,165		19		1,184
Research and development		26		—		26		178		10		188
Total stock-based compensation expense	$	703	$	—	$	703	$	2,011	$	48	$	2,059
	Six months ended June 30,
	2024						2023
	Continuing operations		Discontinued operations		Total		Continuing operations		Discontinued operations		Total
	(in thousands)
Cost of sales	$	310	$	79	$	389	$	218	$	21	$	239
Selling and marketing		791		59		850		1,148		12		1,160
General and administrative		1,602		140		1,742		2,146		36		2,182
Research and development	521		91			612		402		18		420
Total stock-based compensation expense	$	3,224	$	369	$	3,593	$	3,914	$	87	$	4,001

During the nine months ended September 30, 2024, the Company accelerated vesting of outstanding RSUs granted to certain non-executive employees in the continuing operations and recognized $1.6 million unamortized compensation expenses associated with these RSUs, with approximately $0.3 million expenses recorded in cost of sales, $0.6 million in selling and marketing, $0.2 million in general and administrative and $0.4 million in research and development.

During the ~~six~~nine months ended ~~June~~September 30, 2024, the Company ~~immediately~~accelerated ~~vested~~vesting ~~457,093~~of outstanding RSUs granted to certain non-executive employees in the ~~continuing~~discontinued operations and recognized $10.63 million unamortized compensation expenses associated with these RSUs, ~~with~~as ~~approximately~~presented ~~$0.3 million expenses recorded~~ in ~~cost~~the oftable ~~sales, $0~~above.~~2 million in selling and marketing, $0.6 million in general and administrative and $0.4 million in research and development.~~

~~During~~Compensation ~~the~~cost ~~six~~related ~~months~~to ~~ended~~unvested ~~June~~stock ~~30,~~options ~~2024,~~and ~~the~~RSUs ~~Company~~will ~~immediately~~generally ~~vested~~be ~~132,394~~amortized ~~outstanding~~on ~~RSUs~~a ~~granted~~straight-line tobasis ~~certain~~over ~~non-executive~~the ~~employees~~remaining inaverage ~~the~~service ~~discontinued~~period. ~~operations~~The ~~and~~following ~~recognized~~table ~~$0.3~~presents ~~million~~the unamortized compensation ~~expenses~~cost ~~associated~~and ~~with~~weighted ~~these~~average ~~RSUs,~~service asperiod ~~presented~~of inall ~~the~~unvested ~~table~~outstanding ~~above~~awards as of September 30, 2024.

Compensation cost related to unvested stock options and RSUs will generally be amortized on a straight-line basis over the remaining average service period. The following table presents the unamortized compensation cost and weighted average service period of all unvested outstanding awards as of June 30, 2024.


	Unamortized Compensation Costs		Weighted Average Service Period
	(in thousands)		(years)
Options	$	660		0.75
RSUs		2,978		3.28
Total unamortized compensation cost	$	3,638

	Unamortized Compensation Costs		Weighted Average Service Period
	(in thousands)		(years)
Options	$	1,029		0.59
RSUs		3,869		1.78
Total unamortized compensation cost	$	4,898

Plan Activities

The following table summarizes stock option activity under the Company’s incentive plans:

	Numberof Shares			WeightedAverageExercise Price PerShare		Weighted- Average Remaining Contractual Life		Aggregate Intrinsic Value		~~Aggregate Intrinsic Value~~
						(in years)		(in thousands)		~~(in thousands)~~
Options outstanding, December 31, 2023		211,~~383,641~~786		$	2571.8627	6.3		$	—	$	—
Forfeited/Expired		(~~646~~3,~~470~~670	)	$	~~2.63~~
Options outstanding, June 30, 2024		1,737,171		$	2.94		5.6			$	—
Options outstanding, September 30, 2024		8,116		$	592.24	5.2		$	—
Options vested and exercisable, June 30, 2024		1,597,645		$	2.79		5.5			$	—
Options vested and exercisable, September 30, 2024		7,600		$	559.60	5.1		$	—

There were no options granted during the ~~six~~nine months ended ~~June~~September 30, 2024. The weighted-average grant-date fair value of options granted during the ~~six~~nine months ended ~~June~~September 30, 2023 was $0.83.

The following table summarizes the non-vested stock options that were outstanding as of ~~June~~September 30, 2024 and December 31, 2023:


	Number of Shares		Weighted Average Grant Date Fair Value
Non-vested Options, December 31, 2023		2,217	$	1,045.01
Non-vested Options, September 30, 2024		505	$	1,736.21

	Number of Shares		WeightedAverageGrant Date Fair Value
Non-vested Options, December 31, 2023		461,287	$	5.33
Non-vested Options, June 30, 2024		139,526	$	8.81

The total fair value of shares vested during the nine months ended September 30, 2024 and 2023 was $2.8 million and $2.1 million, respectively.

~~The~~Certain ~~total~~stock ~~fair~~option ~~value~~grants under the 2017 Stock Incentive Plan (the “2017 Plan”) allow the recipient to exercise the options prior to the options becoming fully vested. Under the 2017 Plan, the Company retains the right to repurchase shares of its common shares ~~vested~~that ~~during~~have been issued upon early exercise of options at the ~~six~~original issue price. During the nine months ended ~~June~~September 30, 2024, ~~and~~the ~~2023~~Company did not repurchase any shares. There was $1not a material number of shares of common stock subject to repurchase as of September 30, 2024.6 ~~million~~Cash received for the early exercise of unvested stock options is initially recorded as a liability and $0released to equity over the vesting period.7 ~~million~~There were no early exercised stock options during the nine months ended September 30, ~~respectively~~2024 and 2023.

Certain stock option grants under the 2017 Stock Incentive Plan (the “2017 Plan”) allow the recipient to exercise the options prior to the options becoming fully vested. Under the 2017 Plan, the Company retains the right to repurchase shares of its common shares that have been issued upon early exercise of options at the original issue price. During the six months ended June 30, 2024, the Company did not repurchase any shares. There was not a material number of shares of common stock subject to repurchase as of June 30, 2024. Cash received for the early exercise of unvested stock options is initially recorded as a liability and released to equity over the vesting period. There were no early exercised stock options during the six months ended June 30, 2024 and 2023.

The following table summarizes RSU activity under the Company’s incentive plans:

	Numberof Shares			WeightedAverageGrant Date Fair Value
RSUs outstanding, December 31, 2023		316,~~342,621~~593		$	2517.6003
Granted		~~963~~29,~~941~~194		$	07.0998
Vested		(16,~~117,092~~245	)	$	2570.9364
Forfeited		(~~602~~4,~~168~~120	)	$	2502.4649
RSUs outstanding, June 30, 2024		2,587,302		$	1.55
RSUs outstanding, September 30, 2024		35,422		$	87.71

During the ~~six~~nine months ended ~~June~~September 30, 2024, vested RSUs included a total of ~~589~~2,~~487~~947 aforementioned ~~immediately~~the ~~vested~~accelerated vesting of outstanding RSUs to certain employees.

8. Leases

The Company leases office space under operating leases with expirations ranging from March 2025 to March 2028, some of which include rent escalations or an option to extend the lease for up to three years per renewal. The exercise of lease renewal options is at the sole discretion of the Company.

During the ~~six~~nine months ended ~~June~~September 30, 2024, the Company has not entered into any new leases that would entitle the Company to significant rights or create additional obligations.

The Company determines whether a contract is or contains a lease at the inception of the contract. A contract will be deemed to be or contain a lease if the contract conveys the right to control and direct the use of identified property, plant, or equipment for a period of time in exchange for consideration. The Company generally must also have the right to obtain substantially all of the economic benefits from the use of the property, plant, and equipment.

The Company has elected the practical expedient to not separate its lease component from non-lease component for its real estate leases. The Company has elected the practical expedient not to apply the lease recognition requirements to short-term leases with an initial term of 12 months or less.

The Company uses either its incremental borrowing rate or the implicit rate in the lease agreement as the basis to calculate the present value of future lease payments at lease commencement. The incremental borrowing rate represents the rate the Company would have to pay to borrow funds on a collateralized basis over a similar term and in a similar economic environment.

Future minimum lease payments under these leases are as follows:


	Lease Amounts
	(in thousands)
2024 (remaining three months)	$	202
2025		991
2026		938
2027		480
2028		122
Total future minimum lease payments		2,733
Less: Imputed Interest		(279	)
Present value of operating lease liabilities	$	2,454
Less: Current portion		884
Long-term operating lease liabilities	$	1,570

Weighted average remaining lease term in years		2.84
Weighted average discount rate		8.10	%

	Lease Amounts
	(in thousands)
2024 (remaining six months)	$	532
2025		1,008
2026		938
2027		480
2028		122
Total future minimum lease payments		3,080
Less: Imputed Interest		(332	)
Present value of operating lease liabilities	$	2,748
Less: Current portion		983
Long-term operating lease liabilities	$	1,765
Weighted average remaining lease term in years		2.98
Weighted average discount rate		8.19	%

Variable operating lease expenses consist primarily of real estate taxes and insurance. The components of lease expense and related cash flows were as follows:

	Three Months Ended June 30,				Six Months Ended June 30,
	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
	(in thousands)
Rent expense	$	~~316~~297	$	~~381~~373	$	~~672~~969	$	~~767~~1,140
Variable lease costs		148		3217		149		6481
Total	$	~~317~~345	$	~~413~~390	$	~~673~~1,018	$	~~831~~1,221

	Three Months Ended June 30,				Six Months Ended June 30,
	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
	(in thousands)
Cost of sales	$	5059	$	6867	$	~~130~~189	$	~~138~~205
General and administrative		~~267~~286		~~345~~323		~~543~~829		~~693~~1,016
Total	$	~~317~~345	$	~~413~~390	$	~~673~~1,018	$	~~831~~1,221
Cash paid for operating leases	$	~~328~~310	$	382	$	~~698~~1,008	$	~~758~~1,140

9. Commitments and Contingencies

Contingencies

The Company is subject to claims and assessments from time to time in the ordinary course of business, including without limitation, actions with respect to intellectual property, employment, regulatory, product liability and contractual matters. For example, on January 22, 2024, a former employee whose position was eliminated as part of the Company’s reduction-in-force, filed a complaint against the Company, alleging various violations of California wage and hour laws, including unpaid meal and rest period premiums. In connection with these proceedings or matters, the Company regularly assesses the probability and amount (or range) of possible issues based on the developments in these proceedings or matters. A liability is recorded in the accompanying unaudited condensed consolidated financial statements if it is determined that it is probable that a loss ~~has~~will ~~been~~be incurred, and that the amount (or range) of the loss can be reasonably estimated. The Company’s management does not believe that any such matters, individually or in the aggregate, will have a material adverse effect on the Company’s business, financial condition, results of operations or cash flows.

loss can be reasonably estimated. The Company’s management currently does not believe that any such matters, individually or in the aggregate, will have a material adverse effect on the Company’s business, financial condition, results of operations or cash flows.

10. Term Loan

Perceptive loan

On January 13, 2023, the Company entered into Amendment No. 2 (the “Second Amendment”) to the Amended and Restated Credit Agreement and Guaranty by and among the Company, the Subsidiary Guarantors party thereto, the Lenders party thereto and Perceptive (the “Amended Perceptive Loan Agreement”) to replace the existing benchmark rate from the one-month LIBOR with a one-month Secured Overnight Financing Rate (“SOFR”). All other terms remain unchanged on the original agreement. For the ~~six~~nine months ended ~~June~~September 30, 2024 and 2023, the interest rate for amounts borrowed under the Amended Perceptive Loan Agreement was the greater of the one-month SOFR and 2.00% plus the applicable margin of 9.25%.

On March 1, 2024, the Company entered into Amendment No. 3 (the “Third Amendment”) to the Amended Perceptive Loan Agreement. Pursuant to the Third Amendment, the Company made a one-time $15.0 million principal repayment on March 1, 2024, and made an amortization payment of $1.8 million on the outstanding principal on March 31, 2024 and agreed to make monthly amortization payments on the outstanding principal each in the amount of $0.9 million on each payment date commencing on April 30, 2024. Accordingly, $1.0 million of the unamortized debt issuance costs were expensed in connection with the Third Amendment.

For the ~~six~~nine months ended ~~June~~September 30, 2024 and 2023, the effective interest rate of the Amended Perceptive Loan, was 21.2210% and 17.2339%, respectively. As of ~~June~~September 30, 2024 and December 31, 2023, the fair value of the Amended Perceptive Loan approximates its carrying amount.

Pursuant to the Third Amendment, future principal repayments and the net carrying value of the Perceptive Loan as of ~~June~~September 30, 2024, are as follows:

	Principal
	(in thousands)
Remaining 6 months of 2024	$	5,400
Remaining 3 months of 2024	$	2,700
2025		10,800
2026		4,300
Total principal payment		2017,~~500~~800
Debt discounts		(~~1,189~~916	)
Net carrying value	$	1916,~~311~~884

The Company is permitted to make voluntary prepayments, subject to a scaled prepayment premium that ranges from 7.0% to 1.0% of the aggregate principal amount outstanding on such prepayment date for prepayments made after August 23, 2022 and before August 23, 2025. No prepayment premium is required for payments made after August 23, 2025.

The Amended Perceptive Loan Agreement contains events of default, including, without limitation, upon: (i) failure to make a payment pursuant to the terms of the agreement; (ii) violation of certain covenants; (iii) payment or other defaults on other indebtedness; (iv) material adverse change in the business or change in control; (v) insolvency; (vi) significant judgments; (vii) incorrectness of representations and warranties; (viii) regulatory matters; and (ix) failure by us to maintain a valid and perfected lien on the collateral securing the borrowing. Based on the Amended Perceptive Loan Agreement, the Company has granted a security interest in substantially all of its assets.

The Amended Perceptive Loan Agreement includes financial covenants that require the Company to (i) maintain, at all times, a minimum aggregate balance of $3.0 million in cash in one or more controlled accounts, and (ii) pursuant to the Third Amendment, satisfy certain minimum revenue thresholds, measured for the consecutive 12-month periods ending on each calendar quarter-end until ~~June~~September 30, 2026 as follows:

For 12-month Period Ending	Revenue
	(in thousands)
June 30, 2024	$	35,500
September 30, 2024	$	33,000
December 31, 2024	$	31,500
March 31, 2025	$	31,000
June 30, 2025	$	33,000
September 30, 2025	$	35,935
December 31, 2025	$	40,160
March 31, 2026	$	44,950
June 30, 2026	$	51,500


For 12-month Period Ending	Revenue
	(in thousands)
September 30, 2024	$	33,000
December 31, 2024	$	31,500
March 31, 2025	$	31,000
June 30, 2025	$	33,000
September 30, 2025	$	35,935
December 31, 2025	$	40,160
March 31, 2026	$	44,950
June 30, 2026	$	51,500

Pursuant to the Third Amendment, the lender also waived the covenant requiring the absence of any “going concern” or like qualification or exception or any qualification or exception as to the scope of the audit, solely with respect to the fiscal year ending on December 31, 2023.

Failure to satisfy any covenants would constitute an event of default under the Amended Perceptive Loan Agreement. In the event of an event of default, the lender may terminate its commitments and declare all amounts outstanding under the Amended Perceptive Loan Agreement immediately due and payable, together with accrued interest and all fees and other obligations. The amount of such repayment will include payment of any prepayment premium applicable due to the time of such payment. In addition, upon the occurrence and during the continuance of any event of default, the applicable margin will increase by 3.00% per annum to 12.25%.

Total revenue generated from continuing and discontinued operations for the 12-months period ended ~~June~~September 30, 2024 was $3836.95 million, and the cash and cash equivalents and short term investment balance was $2417.23 million as of ~~June~~September 30, 2024. As such, the Company was in compliance with all financial covenants and conditions under the Amended Perceptive Loan Agreement as of September 30, 2024.

Company was in compliance with all financial covenants and conditions under the Amended Perceptive Loan Agreement as of June 30, 2024.

11. Income Taxes

The Company maintains a full valuation allowance against its net deferred tax assets as of ~~June~~September 30, 2024 based on the current assessment that it is not more likely than not these future benefits will be realized before expiration. No material income tax expense or benefit has been recorded given the valuation allowance position and projected taxable losses in the jurisdictions where the Company files income tax returns. The Company has not experienced any significant increases or decreases to its unrecognized tax benefits since December 31, 2023 and does not expect any within the next 12 months.

The Company monitors changes to the tax laws in the states it conducts business and files corporate income tax returns.

Utilization of the net operating loss carryforwards may be subject to substantial annual limitation due to ownership change limitations that may have occurred or that could occur in the future, as required by Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”), as well as similar state provisions. These ownership changes may limit the amount of net operating loss carryforwards that can be utilized annually to offset future taxable income and tax, respectively. In general, an “ownership change,” as defined by Section 382 of the Code, results from a transaction or series of transactions over a three-year period resulting in an ownership change of more than 50 percentage points of the outstanding stock of a company by certain stockholders or public groups. The Company has not completed an analysis regarding the limitation of net operating loss and R&D credit carryforwards as of ~~June~~September 30, 2024.

The Company is subject to U.S. federal and various states income taxes. The federal returns for tax years 2021 through 2023 remain open to examination and the state returns remain subject to examination for tax years 2020 through 2023. Carryforward attributes that were generated in years where the statute of limitations is closed may still be adjusted upon examination by the Internal Revenue Service or other respective tax authorities. All other state jurisdictions remain open to examination.

In October 2024, the Company was notified that it was selected for examination by the Internal Revenue Service for its federal income tax return for the fiscal year 2022 period. The Company does not expect the results of the audit to have a material impact on its financial results.

12. Segment Information

The Company previously operated and reported its results in two business segments, Product and Software. Software segment assets included goodwill and intangible assets, which were derecognized in connection with the divestiture of the software business on March 1, 2024. Following the divestiture, there were no substantial assets or operations of the software segment.

The software segment was reported as discontinued operations as of ~~June~~September 30, 2024, and is presented as such for all periods in this report. For more information, see Note 3 “Discontinued Operations.”

13. Net Loss Per Share

The following table sets forth the computation of basic and diluted net loss per share attributable to common stockholders for the periods presented:

	Three Months Ended June 30,						Six Months Ended June 30,
	Three Months Ended September 30,						Nine Months Ended September 30,
	2024			2023			2024			2023
	(in thousands, except shares and per share data)						(in thousands, except shares and per share data)
Numerator:
Loss from continuing operations, net of tax	$	(7,~~446~~536	)	$	(1817,~~097~~449	)	$	(1927,~~635~~171	)	$	(3351,~~739~~188	)
Income from discontinued operations, net of tax	81	—		~~407~~	469		~~5508~~	5,508		~~678~~	1,147
Net loss	$	(7,~~365~~536	)	$	(1716,~~690~~980	)	$	(1421,~~127~~663	)	$	(3350,~~061~~041	)
Denominator:
Weighted-average shares outstanding – basic and diluted		95477,~~429,233~~857			93471,~~684,289~~427			95475,~~085,847~~188			93469,~~538,676~~934
Net loss per share – basic and diluted	$	(015.0877	)	$	(036.1902	)	$	(045.1559	)	$	(0106.3549	)

~~The~~For ~~following~~the ~~potentially~~three ~~dilutive~~months ~~securities~~and ~~were~~the ~~excluded~~nine ~~from~~months ended September 30, 2024 and 2023, the ~~computation~~Company ofrecorded ~~diluted~~a net loss, ~~per~~and ~~share~~all ~~calculations~~shares ~~for~~subject ~~the~~to ~~periods~~outstanding ~~presented~~equity ~~because~~awards were excluded from the ~~impact~~calculation of ~~including~~diluted ~~them~~shares for those periods because their impact would behave been anti-dilutive: .

2014. Subsequent Event

	Six Months Ended June 30,
	2024		2023
Stock options		1,737,171		2,767,267
RSUs		2,587,302		5,258,808
Warrants		331,503		331,503
Total		4,655,976		8,357,578

Reverse Stock Split

21On October 16, 2024, the Company filed an amendment to our Amended and Restated Certificate of Incorporation to implement a 1-for-200 reverse stock split of its issued and outstanding common stock, effective as of October 18, 2024. The reverse stock split was announced by FINRA on its OTC Daily List on November 7,2024 and took effect at the open of trading on November 8, 2024 on the OTCQX. The reverse stock split correspondingly adjusted the per share exercise price of all outstanding options and all shares underlying any of the Company’s outstanding warrants by reducing the conversion ratio for each outstanding warrant and increasing the applicable exercise price or conversion price in accordance with the terms of each outstanding warrant and based on the reverse stock split ratio. No fractional shares were issued in connection with the reverse stock split. The number of shares of common stock authorized under the Company’s Amended and Restated Certificate of Incorporation is unchanged at 500,000,000 shares. The accompanying interim unaudited condensed financial statements reflect the 1-for-200 reverse split of the Company’s common stock. All share and per share information data herein that relates to common stock prior to the effective date has been retroactively restated to reflect the reverse stock split.

Biolase Assets Auction

On September 30, 2024, the Company entered into an Asset Purchase Agreement (the “Biolase Asset Purchase Agreement”) with Biolase, Inc., a Delaware corporation (“Biolase”), BL Acquisition Corp., a Delaware corporation (“BL Acquisition”), BL Acquisition II, Inc., a Delaware corporation (“BL Acquisition II”), and Model Dental Office, LLC, a Delaware limited liability company (“MDO” and together with Biolase, BL Acquisition and BL Acquisition II, each a “Seller” and collectively, the “Sellers”), pursuant to which, subject to the terms and conditions set forth in the Biolase Asset Purchase Agreement, the Company was designated as the “stalking horse” bidder in connection with a sale of certain assets of Biolase under Section 363 of Title 11 of the United States Code for a total purchase price of (i) $14 million in cash subject to a downward working capital adjustment, (ii) the assumption of liabilities and (iii) the value of the Delaware Litigation (as defined in the Biolase Asset Purchase Agreement) (the “Purchase Price”).

The Sellers conducted a bankruptcy auction on November 4, 2024. Based on the result of that auction, the Company was not the winning bidder. Accordingly, the Company does not expect to proceed with the transaction described in the Biolase Asset Purchase Agreement except in the unlikely event the winning bidder fails to close. Subject to final Bankruptcy Court approval, the Biolase Asset Purchase Agreement will be terminated upon the sale of the Biolase assets to the prevailing bidder, and the Sellers will be required to pay the Company a break-up fee equal to 3% of the Purchase Price plus a capped expense reimbursement of up to approximately $0.6 million. Additionally, 10% of the Purchase Price that was placed into escrow at the time of signing, will be returned to the Company upon the termination of the Biolase Asset Purchase Agreement. For the three and nine months ended September 30, 2024, the Company incurred $0.9 million of transaction and financing expenses related to the Biolase acquisition, which were recorded in the general and administrative expenses in the condensed consolidated statements of operations and comprehensive loss.

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 unaudited condensed consolidated financial statements and the related notes to those statements included elsewhere in this Quarterly Report on Form 10-Q and the audited consolidated financial statements and notes thereto included in Part II, Item 8 of our Annual Report on Form 10-K for the fiscal year ended December 31, 2023. In addition to historical financial information, the following discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results and timing of selected events may differ materially from those anticipated in these forward-looking statements as a result of many factors, including those discussed in Item 1A. Risk Factors in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 and in the filings we make with the Securities and Exchange Commission (the “SEC”) from time to time. See “Cautionary Note Regarding Forward-Looking Statements.”

Overview

We are a commercial-stage medical technology company focused on saving teeth from tooth decay, the most prevalent chronic disease globally. We have developed and manufacture the GentleWave® System, an innovative technology platform designed to treat tooth decay by cleaning and disinfecting the microscopic spaces within teeth without the need to remove tooth structure. The GentleWave System employs a sterilized, single-use procedure instrument ("“PI"”), to transform root canal therapy (“RCT”), by addressing the limitations of conventional methods.

The clinical benefits of our GentleWave System when compared to conventional methods of RCT include improved clinical outcomes, such as superior cleaning that is independent of root canal complexity and tooth anatomy, high and rapid rates of healing and minimal to no post- operative pain. In addition to the clinical benefits, the GentleWave System can improve the workflow and economics of dental practices. We began scaling commercialization of our current technology in 2017 and are focused on establishing the GentleWave Procedure as the standard of care for RCT.

Our GentleWave System represents an innovative technology platform and approach to RCT. The GentleWave System is a Class II device and has received 510(k) clearance from the FDA for preparing, cleaning, and irrigating teeth indicated for RCT. The key components of our GentleWave System are a sophisticated and mobile console and a pre-packaged, sterilized, single-use PI. The GentleWave System utilizes a proprietary mechanism of action that is designed to combine procedure fluid optimization, broad-spectrum acoustic energy and advanced fluid dynamics to efficiently and effectively reach microscopic spaces within teeth and dissolve and remove tissue and bacteria with minimal or no removal of tooth structure. We have invested significant resources in establishing a broad intellectual property portfolio that protects the GentleWave Procedure and its unique mechanism of action, as well as future capabilities under development. We believe our GentleWave System transforms the patient and dental practitioner experience and addresses many of the limitations of conventional RCT.

In the United States and Canada, our direct sales force markets and sells the GentleWave System to dental practitioners performing a high volume of root canals as part of their practice. Our commercial strategy and sales model involves a focus on driving adoption of our GentleWave System by increasing our installed base of consoles and maximizing recurring PI revenue through increased utilization. We have been and expect to continue to expand the size of our sales and clinician support teams to support our efforts of driving adoption and utilization of the GentleWave System. We plan to pursue marketing authorizations and similar certifications to enable marketing and engage in other market access initiatives over time in attractive international regions in which we see significant potential opportunity.

As of ~~June~~September 30, 2024, we ~~had~~maintained an ~~installed~~active user base of ~~approximately~~more ~~1,155~~than ~~GentleWave~~800 ~~Systems~~customers. We generated revenue of $1523.4 million and incurred a net loss of $1927.62 million from continuing operations for the ~~six~~nine months ended ~~June~~September 30, 2024, compared to revenue of $1725.46 million and a net loss of $3351.72 million for the ~~six~~nine months ended ~~June~~September 30, 2023. As of ~~June~~September 30, 2024, we had cash and cash equivalents and short-term investments of $2417.23 million, an accumulated deficit of $~~444~~451.17 million, and $2017.58 million in principal outstanding under our term loan facility.

We expect to continue to incur net losses for the next several years. We expect to continue to make investments in our sales and marketing organization, including potentially expanding our international marketing programs and expanding direct to clinician digital marketing efforts to help facilitate further adoption among existing accounts and to broaden awareness and adoption of our products to new clinicians. We also expect to continue to make investments in research and development, regulatory affairs and clinical studies to develop future generations of our GentleWave products, support regulatory submissions and demonstrate the clinical efficacy of our new products. Moreover, we will continue to incur expenses as a result of operating as a public company, including legal, accounting, insurance, exchange listing and SEC compliance, investor relations, and other administrative and professional services expenses. As a result of these expenses, we require additional financing to fund our operations and planned growth.

Our ability to continue as a going concern depends on our ability to successfully secure additional financing, continue to commercialize our products, achieve and maintain profitable operations, as well as the adherence to conditions of outstanding term loans (see Note 10 to the Condensed Consolidated Financial Statements). Without additional financing, we will have insufficient liquidity to achieve further commercialization of our products and maintain compliance with our loan covenants. There is a material ~~uncertainty that raises substantial doubt about our~~

2223

uncertainty that raises substantial doubt about our ability to continue as a going concern and, therefore, that we may be unable to realize our assets and discharge our liabilities in the normal course of business (see Liquidity and Capital Resources section).

Recent Developments

Biolase Asset Purchase Agreement

On September 30, 2024, we entered into the Biolase Asset Purchase Agreement with the Sellers, pursuant to which, subject to the terms and conditions set forth in the Biolase Asset Purchase Agreement, we were designated as the “stalking horse” bidder in connection with a sale of certain assets of Biolase under Section 363 of Title 11 of the United States Code for a total purchase price of (i) $14 million in cash subject to a downward working capital adjustment, (ii) the assumption of liabilities and (iii) the value of the Delaware Litigation. We delivered 10% of the Purchase Price to an escrow agent, which may be returned to us in the event of specified events, including termination of the Biolase Asset Purchase Agreement, subject to certain exceptions relating to a breach of the Biolase Asset Purchase Agreement by us.

The Sellers conducted a bankruptcy auction on November 4, 2024. Based on the result of that auction, we were not the winning bidder. Accordingly, we do not expect to proceed with the transaction described in the Biolase Asset Purchase Agreement except in the unlikely event the winning bidder fails to close. Subject to final Bankruptcy Court approval, the Biolase Asset Purchase Agreement will be terminated upon the sale of the Biolase assets to the prevailing bidder, and the Sellers will be required to pay us a break-up fee equal to 3% of the Purchase Price, plus a capped expense reimbursement of up to $575,000 and return amount of the Purchase Price that was placed in escrow at the signing of the Biolase Asset Purchase Agreement.

Divestiture of Software Segment

On March 1, 2024, we divested our software segment which we owned through TDO Software, Inc. (“TDO”), our wholly-owned subsidiary, by selling substantially all the assets and liabilities of TDO, our wholly owned subsidiary, for approximately $16.0 million, with $15.0 million received upon closing and the balance due approximately 12 months post-closing. A gain of $5.7 million on sale of the software business was recorded in income from discontinued operations.

Stock Listing and Reverse Stock Split

Due to our failure to comply with the continued listing standards set forth in the NYSE’s Listed Company Manual, our common stock was suspended from trading on the NYSE effective at the opening of business Eastern Standard Time on November 22, 2023. We commenced trading on the OTCQX on the same day. We withdrew our request for an appeal and our common stock was delisted from the NYSE, which may negatively impact our stockholders and the trading price and liquidity of our common stock. On June 4, 2024, we received notice from OTC that our common stock did not meet the Standards for Continued Qualification for the OTCQX per the OTCQX Rules for U.S. Companies section 2.1(A) because our stock’s bid price closed below $0.10 for more than 30 consecutive calendar days. We had a cure period of 180 calendar days to regain compliance, which expires December 2, 2024. If our common stock’s bid price did not stay at or above the $0.10 minimum for ten consecutive trading days during the cure period, then our common stock would have been moved from OTCQX to the OTC Pink market.

On June 10, 2024, our shareholders approved an amendment to our Amended and Restated Certificate of Incorporation to effect a reverse stock split of our issued shares of common stock, at a specific ratio, ranging from 1:10 to 1:200, at the discretion of our board of directors at any time prior to our 2025 annual meeting of stockholders, with the exact ratio to be determined by our board of directors without further approval or authorization of the Company’s stockholders. In September 2024, the Board approved a 1-for-200 reverse stock split.

On October 16, 2024, we filed an amendment to our Amended and Restated Certificate of Incorporation to implement a 1-for-200 reverse stock split of its issued and outstanding common stock, which was effected on October 18, 2024. The reverse stock split correspondingly adjusted the per share exercise price of all outstanding options and all shares underlying any of our outstanding warrants by reducing the conversion ratio for each outstanding warrant and increasing the applicable exercise price or conversion price in accordance with the terms of each outstanding warrant and based on the reverse stock split ratio. No fractional shares were issued in connection with the reverse stock split. Stockholders who are entitled to fractional shares will receive a cash payment in lieu of receiving fractional shares (after taking into account and aggregating all shares of our common stock then held by such stockholder) equal to the fractional share interest multiplied by $5.00 (the per share closing price of our common stock, on a post-split basis, as last reported on the OTCQX market on November 7, 2024). The reverse stock split was announced by FINRA on its OTC Daily List on November 7,2024 and took effect at the open of trading on November 8, 2024 on the OTCQX. Upon the effectiveness of the reverse stock split, the Company became compliant with OTCQX Rule 2.1(A).

common stock. All share and per share information data herein that relates to our common stock prior to the effective date has been retroactively restated to reflect the reverse stock split.

On November 7, 2024, we received notice from the OTC that our common stock no longer met the Standards for Continued Qualification for the OTCQX per the OTCQX Rules for U.S. Companies section 2.1(B) because our market capitalization has stayed below $5 million for the past 30 consecutive calendar days. We have a cure period of 90 calendar days to regain compliance. The 90-calendar day grace period expires February 7, 2025 and at that time if our market capitalization has not stayed at or above $5 million for ten consecutive trading days then our common stock will be removed from OTCQX and moved to the OTC Pink market.

Factors Affecting Our Performance and Key Business Metrics

We believe there are several important factors that impact our operating performance and results of operations. We also regularly review several operating and financial metrics to evaluate our business, measure our performance, identify trends affecting our business, formulate our business plan and make strategic decisions. We believe the following factors and key business metrics are important indicators of our performance:

•

Installed base of GentleWave Systems: We have focused on driving adoption of the GentleWave Procedure among endodontists in the United States and Canada. To drive further adoption of our system, we may continue to restructure our team of sales representatives, who are focused on system placement by directly engaging with dental practitioners and educating them about the compelling value proposition of the GentleWave Procedure. Our sales force leverages third-party data of root canal procedure volumes by practitioner, in order to enable us to efficiently and effectively identify target accounts. We believe that our current targeting strategy identifies a well-defined customer base that is accessible by our direct sales organization.

•

System utilization: Our revenue is significantly impacted by the utilization of our GentleWave System. Our objective is to establish the GentleWave Procedure as the standard of care for RCT. We intend to increase awareness of the GentleWave Procedure among dental practitioners and, in select markets where we establish a large installed base, directly with patients through various targeted direct-to-patient marketing initiatives, showcasing the benefits and points of difference of the GentleWave Procedure. We believe that once patients become aware of the GentleWave Procedure, they will seek the GentleWave Procedure over conventional RCT. We believe these initiatives will drive a greater volume of root canal procedures to dental practitioners who offer the GentleWave Procedure, thereby increasing utilization of our system.

•

Gross margins: Our results of operations depend, in part, on our ability to increase our gross margins by more effectively managing our costs to produce our GentleWave Console and single-use PI, and to scale our manufacturing operations efficiently. We are undertaking continuous cost saving programs, including implementation of lean manufacturing methods and working with our suppliers to reduce material costs. CleanFlow PI is now our leading PI and we have phased out the legacy PI and accessories designed for molar teeth (a “Molar PI”) and anteriors and premolars (an “APM PI”) in 2024. CleanFlow PI has a lower cost to manufacture on per unit basis compared to the legacy Molar PI and APM PI. We anticipate that the combination of these strategies will continue driving gross margin improvement.

•

Commercial organization: As of ~~June~~September 30, 2024, our sales and customer support team consisted of approximately 45 employees. We intend to continue to re-prioritize our commercial organization to increase the adoption of our products among existing and new customer accounts. Successfully recruiting and training a sufficient number of sales and customer support employees is required to achieve growth at the rate we expect. The effectiveness of our commercial organization re-prioritization can impact our revenue growth and our costs incurred in anticipation of such growth.

Effects of the Macroeconomic Environment

Our unaudited condensed consolidated financial statements as of and for the ~~six~~nine months ended ~~June~~September 30, 2024 reflect our estimate of the impact of the macroeconomic environment, including the impact of inflation and higher interest rates. The duration and scope of these conditions cannot be predicted; therefore, the extent to which these conditions will directly or indirectly impact our business, results of operations and financial condition, is uncertain. We are not aware of any specific event or circumstance that would require an update to our estimates, judgments and assumptions or a revision of the carrying value of our assets or liabilities as of the date of this filing.

Stock Listing

Due to our failure to comply with the continued listing standards set forth in the NYSE’s Listed Company Manual, our common stock was suspended from trading on the NYSE effective at the opening of business Eastern Standard Time on November 22, 2023. We commenced trading on the OTCQX on the same day. We withdrew our request for an appeal and our common stock was delisted from the NYSE, which may negatively impact our stockholders and the trading price and liquidity of our common stock. On June 4, 2024, we received notice from OTC that our common stock did not met the Standards for Continued Qualification for the OTCQX per the OTCQX Rules for U.S. Companies section 3.2.b.1 because our stock’s bid price closed below $0.10 for more than 30 consecutive calendar days. We have a cure period of 180 calendar days to regain compliance, which expires December 2, 2024. If our common

stock’s bid price does not stay at or above the $0.10 minimum for ten consecutive trading days during the cure period, then our common stock will be moved from OTCQX to the OTC Pink market. The OTCQX Rules also requires us to have a market capitalization of at least $5 million for at least one of every 30 consecutive calendar days. On June 10, 2024, the Company’s shareholders approved an amendment to the Company’s Amended and Restated Certificate of Incorporation to effect a reverse stock split of the Company’s issued shares of common stock, at a specific ratio, ranging from 1:10 to 1:200, at the discretion of the Company’s board of directors at any time prior to the Company’s 2025 annual meeting of stockholders, with the exact ratio to be determined by the Company’s board of directors without further approval or authorization of the Company’s stockholders. Our Board of Directors is evaluating the merits and timing to effect a reverse stock split.

Components of Our Results of Operations

As discussed in Note 3, “Discontinued Operations” to the accompanying unaudited Condensed Consolidated Financial Statements in Part I of this Quarterly Report on Form 10-Q, on March 1, 2024, we divested our software segment by selling substantially all assets and liabilities of TDO. The sale met the criteria to be accounted for as a discontinued operation as required by Accounting Standards Codification (“ASC”) 205-20. Accordingly, the financial results of the software business are reported as discontinued operations in the accompanying unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for all periods presented. Our Condensed Consolidated Statements of Cash Flows include the financial results of the software business for the ~~six~~nine months ended ~~June~~September 30, 2024 and 2023.

Revenue

Our revenue from continuing operations consists primarily of product and service revenue. We generate product revenue on the capital sale of our GentleWave Console and recurring sales of our single-use PIs and accessories. To a lesser extent, we also derive revenue from service and repair and extended warranty contracts with our existing customers. We expect our product and service revenue to increase in absolute dollars as we increase adoption and utilization of our GentleWave System, though revenues may fluctuate from quarter to quarter. We also expect the growth of recurring sales of our single-use PI and accessories to outpace the growth of capital sales of our GentleWave Console. Prior period financial statements have been recast so that software revenue is included in the discontinued operations.

Cost of Sales and Gross Margin

Cost of sales from continuing operations consists primarily of manufacturing overhead costs, material costs, and direct labor to produce our products, warranty, provisions for slow-moving and obsolete inventory, and other direct costs such as shipping and software support. A significant portion of our cost of sales currently consists of manufacturing overhead costs. These overhead costs include personnel compensation, including stock-based compensation expenses, facilities, production equipment depreciation, operations supervision, quality control, material procurement, intangible assets amortization and impairment of long-lived assets. We provide a one-year warranty on capital equipment upon initial sale, and we establish a reserve for warranty repairs based on historical warranty repair costs incurred. Provisions for warranty obligations, which are included in cost of sales, are provided for at the time of shipment. We expect our cost of sales to increase in absolute dollars for the foreseeable future primarily as, and to the extent, our revenue grows, partially offset by lower unit product manufacturing and warranty costs, though it may fluctuate from period to period. Prior period financial statements have been recast so that software cost of sales is included in the discontinued operations.

We calculate gross margin as gross profit divided by revenue. Our gross margin has been and will continue to be affected by a variety of factors, primarily, product mix and the resulting average selling prices, production volumes, manufacturing costs and product yields, and the implementation of cost reduction strategies. Our previous software segment gross margin is generally higher than our product gross margin. Prior period financial statements have been recast to exclude the software segment from continuing operations. We expect gross margin to fluctuate in the short term and to increase year over year. We are engaged in various efforts to improve our gross margin by reducing unit product costs to the extent our production volumes increase, as well as through product design improvements, reducing material costs through negotiations with suppliers and optimizing the manufacturing process and reducing the costs to service our installed base.

Operating Expenses

Selling and Marketing

Selling and marketing expenses consist primarily of personnel compensation, including stock-based compensation, related to selling, marketing, and professional education functions. Selling and marketing expenses also include commissions, training, travel expenses, promotional activities, conferences, trade shows, and professional services fees. We expect our selling and marketing expenses to decrease in absolute dollars compared to the prior year periods for the remainder of 2024 and in 2025 based on the benefits derived from recently adopted cost saving measures and additional measures we expect to adopt in the future, including reductions in headcount and the reprioritization of our commercial infrastructure, and lower spending on sales and marketing programs and initiatives, though it may fluctuate from period to period.

headcount and the reprioritization of our commercial infrastructure, and lower spending on sales and marketing programs and initiatives, though it may fluctuate from period to period.

General and Administrative

General and administrative expenses consist primarily of personnel compensation, including stock-based compensation, related to administration, finance, information technology, legal, and human resource functions. SG&A expenses also include travel expenses, professional services fees, audit fees, legal fees, insurance costs and general corporate expenses including allocated facilities-related expenses. We expect our G&A expenses to decrease in absolute dollars compared to the prior year periods for the remainder of 2024 and in 2025 based on the benefits derived from recently adopted cost saving measures and additional measures we expect to adopt in the future, including reductions in headcount and lower spending on general and administrative programs, though it may fluctuate from period to period.

Research and Development

Research and development (“R&D”) expenses consist primarily of costs incurred for proprietary R&D programs, and include costs of product engineering, product development, regulatory affairs, consulting services, materials, and depreciation, as well as other costs associated with products and technologies being developed. These expenses include employee and non-employee compensation, including stock-based compensation, supplies, materials, consulting, related travel expenses and facilities expenses. We expect our R&D expenses to decrease in absolute dollars compared to the prior year periods for the remainder of 2024 and in 2025 based on the benefits derived from recently adopted cost saving measures and additional measures we expect to adopt in the future as we become more efficient in our efforts to develop, enhance, and commercialize new products and technologies. However, we expect our R&D ~~expenses as a percentage of revenue to vary over time depending on the level and timing of initiating new product development efforts.~~

~~Impairment of Long-lived Assets~~26

~~Long-lived~~expenses ~~assets~~as ~~include~~a ~~definite-lived~~percentage ~~intangibles, long-lived fixed assets and lease right-~~of~~-use~~ ~~assets.~~revenue An impairment charge of long-lived assets is recognized when an assessment of potential impairment indicates that an asset’s carrying amount is not recoverable. The carrying amount of the asset is reduced to ~~its~~vary ~~estimated~~over ~~fair~~time ~~value~~depending ~~based~~ on ~~discounted~~the ~~cash~~level ~~flow analysis. An impairment analysis is subjective~~ and ~~assumptions~~timing ~~regarding~~of ~~future~~initiating ~~growth~~new ~~rates~~product ~~and~~development ~~operating expense levels can have a significant impact on the expected future cash flows and impairment analysis~~efforts.

~~Other~~Interest ~~Income~~and ~~(Expense),~~Other ~~Net~~Expense

~~Other~~Interest ~~(expense)~~and ~~income,~~other ~~net,~~expense consists primarily of interest expense under our outstanding term loan and interest income from investments in marketable securities.

Income from Discontinued Operations

Income from discontinued operations consists primarily of income (loss) from TDO’s software business and gain from sale of TDO’s assets and liabilities.

Results of Operations

Comparison of Three and ~~Six~~Nine Months Ended ~~June~~September 30, 2024 and 2023

The following table shows our results of operations for the three months ended ~~June~~September 30, 2024 and 2023, together with the dollar and percentage change in those items:


	Three Months Ended September 30,						Change
	2024			2023			$			%
	(in thousands, except percentages)
Revenue, net	$	8,036		$	8,163			(127	)		(2	)%
Cost of sales		4,726			7,279			(2,553	)		(35	)%
Gross profit (loss)		3,310			884			2,426			274	%
Gross margin		41	%		11	%
Operating expenses:
Selling and marketing		3,642			6,954			(3,312	)		(48	)%
General and administrative		4,872			7,708			(2,836	)		(37	)%
Research and development		1,588			2,787			(1,199	)		(43	)%
Total operating expenses		10,102			17,449			(7,347	)		(42	)%
Operating loss		(6,792	)		(16,565	)		9,773			(59	)%
Interest and other expense		(744	)		(884	)		140			(16	)%
Loss before income tax expense		(7,536	)		(17,449	)		9,913			(57	)%
Income tax expense		—			—			—			—
Loss from continued operations, net of tax		(7,536	)		(17,449	)		9,913			(57	)%
Income from discontinued operations, net of tax		—			469			(469	)		(100	)%
Net loss	$	(7,536	)	$	(16,980	)		9,444			(56	)%

	Three Months Ended June 30,						Change
	2024			2023			$			%
	(in thousands, except percentages)
Revenue, net	$	8,314		$	8,763			(449	)		(5	)%
Cost of sales		5,198			9,248			(4,050	)		(44	)%
Gross profit (loss)		3,116			(485	)		3,601			(742	)%
Gross margin		37	%		(6	)%
Operating expenses:
Selling and marketing		4,072			7,693			(3,621	)		(47	)%
General and administrative		4,163			6,416			(2,253	)		(35	)%
Research and development		1,568			2,764			(1,196	)		(43	)%
Total operating expenses		9,803			16,873			(7,070	)		(42	)%
Operating loss		(6,687	)		(17,358	)		10,671			(61	)%
Other expense, net:
Interest and financing costs, net		(759	)		(739	)		(20	)		3	%
Loss before income tax expense		(7,446	)		(18,097	)		10,651			(59	)%
Income tax expense		—			—			—			—
Loss from continued operations, net of tax		(7,446	)		(18,097	)		10,651			(59	)%
Income from discontinued operations, net of tax		81			407			(326	)		(80	)%
Net loss	$	(7,365	)	$	(17,690	)		10,325			(58	)%

The following table shows our results of operations for the nine months ended September 30, 2024 and 2023, together with the dollar and percentage change in those items:

The following table shows our results of operations for the six months ended June 30, 2024 and 2023, together with the dollar and percentage change in those items:


	Nine Months Ended September 30,						Change
	2024			2023			$			%
	(in thousands, except percentages)
Revenue, net	$	23,397		$	25,604			(2,207	)		(9	)%
Cost of sales		14,970			23,227			(8,257	)		(36	)%
Gross profit		8,427			2,377			6,050			255	%
Gross margin		36	%		9	%
Operating expenses:
Selling and marketing		12,858			22,628			(9,770	)		(43	)%
General and administrative		13,952			20,257			(6,305	)		(31	)%
Research and development		5,345			8,478			(3,133	)		(37	)%
Total operating expenses		32,155			51,363			(19,208	)		(37	)%
Operating loss		(23,728	)		(48,986	)		25,258			(52	)%
Interest and other expense		(3,443	)		(2,202	)		(1,241	)		56	%
Loss before income tax expense		(27,171	)		(51,188	)		24,017			(47	)%
Income tax expense		—			—			—			—
Loss from continued operations, net of tax		(27,171	)		(51,188	)		24,017			(47	)%
Income from discontinued operations, net of tax		5,508			1,147			4,361			380	%
Net loss	$	(21,663	)	$	(50,041	)		28,378			(57	)%

	Six Months Ended June 30,						Change
	2024			2023			$			%
	(in thousands, except percentages)
Revenue, net	$	15,361		$	17,441			(2,080	)		(12	)%
Cost of sales		10,244			15,948			(5,704	)		(36	)%
Gross profit		5,117			1,493			3,624			243	%
Gross margin		33	%		9	%
Operating expenses:
Selling and marketing		9,216			15,674			(6,458	)		(41	)%
General and administrative		9,080			12,549			(3,469	)		(28	)%
Research and development		3,757			5,691			(1,934	)		(34	)%
Total operating expenses		22,053			33,914			(11,861	)		(35	)%
Operating loss		(16,936	)		(32,421	)		15,485			(48	)%
Other expense, net:
Interest and financing costs, net		(2,699	)		(1,318	)		(1,381	)		105	%
Loss before income tax expense		(19,635	)		(33,739	)		14,104			(42	)%
Income tax expense		—			—			—			—
Loss from continued operations, net of tax		(19,635	)		(33,739	)		14,104			(42	)%
Income from discontinued operations, net of tax		5,508			678			4,830			712	%
Net loss	$	(14,127	)	$	(33,061	)		18,934			(57	)%

Revenue

Revenue from continuing operations decreased $0.41 million, or 52%, for the three months ended ~~June~~September 30, 2024 from the comparable period in the prior year, which was primarily driven by lower ~~sales~~average ~~volumes~~selling price in ~~PIs~~GentleWave consoles, partially offset by an increase in ~~sales of GentleWave consoles and an increase in~~ extended service contracts revenue. For the three months ended ~~June~~September 30, 2024, we generated $21.49 million and $45.71 million from the sale of GentleWave consoles and PIs, respectively, compared to $2.21 million and $5.61 million respectively, for the three months ended ~~June~~September 30, 2023.

Revenue from continuing operations decreased $2.12 million, or 129%, for the ~~six~~nine months ended ~~June~~September 30, 2024 from the comparable period in the prior year, which was driven by lower sales volumes in PIs, ~~partially~~and ~~offset~~lower byaverage anselling ~~increase~~price in ~~sales of~~ GentleWave consoles, ~~and~~partially inoffset ~~the~~by ~~average~~an ~~selling~~increase ~~price~~in ofextended ~~PIs~~service contract revenue. For the ~~six~~nine months ended ~~June~~September 30, 2024, we generated $46.21 million and $814.90 million from the sale of GentleWave consoles and PIs, respectively, compared to $46.23 million and $1116.34 million, respectively, for the ~~six~~nine months ended ~~June~~September 30, 2023.

Cost of sales and Gross margin

26Cost of sales decreased $2.6 million, or 35%, for the three months ended September 30, 2024 compared to the prior year period, which was primarily driven by lower manufacturing costs for PIs, as well as a $1.3 million charge due to impairment of long-lived assets recorded in prior year period.

~~Gross~~Cost ~~margin~~of sales decreased $8.3 million, or 36%, for the ~~three~~nine months ended ~~June~~September 30, 2024 ~~increased~~compared to ~~37.5% from (5.5%) for~~ the ~~comparable period in the~~ prior year period, which was primarily ~~due~~driven toby lower ~~excess~~manufacturing ~~and~~costs ~~obsolete~~for ~~inventory~~PIs ~~charges~~ and aGentleWave ~~decrease~~consoles inand ~~manufacturing~~lower ~~costs~~excess ~~for~~and ~~GentleWave~~obsolete ~~consoles~~inventory ~~and PIs~~charges. For the ~~three~~nine months ended ~~June~~September 30, 2024, we recorded $0.23 million of excess and obsolete inventory charges related to phasing out our legacy GentleWave Console ("“Gen3"”) and our legacy molar and anterior pre-molar procedure instruments. For the ~~three~~nine months ended ~~June~~September 30, 2023, we recorded $2.9 million of excess and obsolete inventory charges due to reduced sales volumes of our Gen3 and the phasing out of our legacy molar and anterior pre-molar procedure instruments, as well as a $1.3 million charge due to impairment of long-lived assets.

~~Gross~~Due ~~margin for the six months ended June 30, 2024 increased~~ to ~~33.3% from 8.6% for~~ the ~~comparable~~aforementioned ~~period~~decrease in ~~the~~cost ~~prior~~of ~~year~~sales, ~~primarily~~gross ~~due~~margin tofor the ~~aforementioned~~three ~~lower excess~~ and ~~obsolete~~nine ~~inventory~~months ~~charges~~ended ~~and~~September ~~a decrease in manufacturing costs for GentleWave consoles and PIs~~30, ~~partially~~2024 ~~offset~~increased by ~~higher~~30% ~~stock-based~~and ~~compensation.~~27% Wecompared ~~recognized~~to ~~$0.3 million of stock-based compensation during~~ the ~~six~~prior ~~months~~year ~~ended June 30~~period, ~~224 relating to the immediate vesting of RSUs granted to certain non-executive employees~~respectively.

Selling and marketing expenses

Selling and marketing expenses decreased $3.63 million, or 4748%, for the three months ended ~~June~~September 30, 2024 from the comparable period in the prior year, primarily driven by an approximately $2.60 million decrease in employee-related compensation and benefit expenses, including stock-based compensation as a result of the reduction in headcount. The decrease was also attributed lower marketing spending as we re-prioritize our commercial organization to increase the adoption of our products among existing and new customer accounts.

Selling and marketing expenses decreased $69.58 million, or 4143%, for the ~~six~~nine months ended ~~June~~September 30, 2024 from the comparable period in the prior year, primarily driven by an approximately $45.67 million decrease in employee-related compensation and benefit expenses, including stock-based compensation, as a result of the previously disclosed reduction in headcount. The decrease was also attributed lower marketing spending as we re-prioritize our commercial organization to increase the adoption of our products among existing and new customer accounts. The decrease is partially offset by expenses of $0.6 million recognized relating to the ~~immediate~~accelerated vesting of restricted stock units (“RSUs”) granted to certain non-executive employees in the ~~six~~nine months ended ~~June~~September 30, 2024.

General and administrative expenses

General and administrative expenses decreased $2.38 million, or 3537%, for the three months ended ~~June~~September 30, 2024 from the comparable period in the prior year, primarily driven by decrease in employee-related compensation and benefit expenses, including stock-based compensation and recruiting expenses, as a result of the reduction in headcount. The decrease was also driven by an impairment charge of $1.8 million for long-lived assets recorded in the prior year period. This decrease was partially offset by the transaction and financing expenses of $0.9 million related to the Biolase acquisition incurred in the three months ended September 30, 2024.

General and administrative expenses decreased $36.53 million, or 2831%, for the ~~six~~nine months ended ~~June~~September 30, 2024 from the comparable period in the prior year, primarily driven by decrease in employee-related compensation and expenses, including stock-based compensation, recruiting, travel and office expenses, as a result of the reduction in headcount. The decrease iswas also driven by an impairment charge of $1.8 million for long-lived assets recorded in the prior year period. This decrease was partially offset by the transaction and financing expenses of $0.9 million related to the Biolase acquisition and the expenses of $0.2 million recognized relating to the ~~immediate~~accelerated vesting of RSUs granted to certain non-executive employees in the ~~six~~nine months ended ~~June~~September 30, 2024.

Research and development expenses

R&D expenses decreased $1.2 million, or 43%, and $13.91 million, or 3437%, respectively, for the three and ~~six~~nine months ended ~~June~~September 30, 2024 from the comparable period in the prior year, ~~which was~~ primarily driven by a decrease in employee related compensation and benefit expenses due to lower headcount. The decrease for the ~~six~~nine months period is partially offset by expenses of $0.4 million recognized relating to the ~~immediate~~accelerated vesting of RSUs granted to certain non-executive employees in the ~~six~~nine months ended ~~June~~September 30, 2024.

~~Other~~Interest ~~expense,~~and ~~net~~other expense

~~Total~~Interest and other expense, ~~net~~ for the three and nine months ended ~~June~~September 30, 2024 ~~was~~decreased ~~essentially~~$0.1 ~~unchanged~~million, or 16%, from the comparable period in the prior year, mainly due to a $0.5 million decrease in interest income resulting from lower amounts of short-term investments, offset by lower interest expense resulting from principal repayments on our term loan.

~~Total~~Interest and other expense, ~~net~~ for the ~~six~~nine months ended ~~June~~September 30, 2024 decreased $1.42 million, or ~~105~~56%, from the comparable period in the prior year, mainly due to $1.24 million of expense for accelerated amortization of debt issuance costs resulting from the principal prepayment on our term loan in March 2024.

Income from Discontinued Operations

Income from discontinued operations for the ~~six~~nine months ended ~~June~~September 30, 2024 consists primarily of gain of $5.7 million from sale of TDO’s assets and liabilities and loss from TDO’s software business for the period from January 1, 2024 to March 1, 2024, which includes expenses of $0.3 million recognized relating to the ~~immediate~~accelerated vesting of RSUs granted to certain non-executive employees.

Liquidity and Capital Resources

Sources of liquidity

WeAs ~~have~~of ~~incurred~~September ~~significant~~30, ~~operating~~2024, ~~losses~~we ~~and~~had ~~negative~~cash and cash ~~flows~~equivalents ~~from~~and ~~operations~~short-term ~~since~~investments ~~our~~of ~~inception~~$17.3 million, an accumulated deficit of $451.7 million, and we$17.8 ~~anticipate~~million ~~that~~in weprincipal ~~will~~outstanding ~~continue~~under toour ~~incur~~term ~~losses~~loan ~~for~~facility. For the ~~next~~nine ~~several~~months ~~years~~ended September 30, 2024 and 2023, our net losses from continuing operations were $27.2 million and $51.2 million, respectively, and our net cash used in operating activities was $21.7 million and $36.6 million, respectively.

On September 27, 2022, we completed a private placement (the “Private Placement”), issuing an aggregate of approximately 23.0 million shares of our common stock at a purchase price of $0.95 per share and pre-funded warrants to purchase an aggregate of 43.3 million shares of our common stock at a purchase price of $0.949 per pre-funded warrant. The pre-funded warrants have an exercise price of $0.001 per share of common stock, are immediately exercisable and will remain exercisable until exercised in full. The aggregate net proceeds from the Private Placement, after deducting placement agent fees and other offering expenses, were $59.0 million.

As of June 30, 2024, we had cash and cash equivalents and short-term investments of $24.2 million, an accumulated deficit of $444.1 million, and $20.5 million in principal outstanding under our term loan facility. For the six months ended June 30, 2024 and 2023, our net losses from continuing operations were $19.6 million and $33.7 million, respectively, and our net cash used in operating activities was $17.4 million and $26.3 million, respectively.

Funding requirements

We have incurred significant operating losses and negative cash flows from operations since our inception, and we anticipate that we will continue to incur losses for the next several years.

We expect our operating expenses from continuing operations to continue to decrease compared to the prior year period for the remainder of 2024 and in 2025 based on the benefits derived from recently adopted cost saving measures and additional measures we expect to adopt in the future, including reductions in headcount and the reprioritization of our commercial infrastructure, and lower spending on selling, marketing, R&D and general and administrative programs and functions, though it may fluctuate from period to period. The timing and amount of our operating expenditures will depend on many factors, including:

•

the degree and rate of market acceptance of our current and future products and the GentleWave Procedure;

•

the scope and timing of investment in our sales force;

•

the impact of the macroeconomic environment, including as a result of inflation and rising interest rates, the war in Ukraine and the Gaza strip, or any other pandemic, epidemic or infectious disease outbreak, on our business;

the cost of our research and development activities;

•

the cost and timing of additional regulatory clearances or approvals;

•

the costs associated with any product recall that may occur;

•

the costs associated with the manufacturing of our products at increased production levels;

•

the costs of attaining, defending and enforcing our intellectual property rights;

•

whether we acquire third-party companies, products or technologies;

the terms and timing of any other collaborative, licensing and other arrangements that we may establish;

•

the scope, rate of progress and cost of our current or future clinical trials and registries;

•

the emergence of competing new products, technologies or alternative treatments or other adverse market developments;

•

our ability to raise additional funds to finance our operations;

•

debt service requirements; ~~and~~

•

the costs associated with being a public company.; and

•

~~Our~~the ~~unaudited~~impact ~~condensed~~of ~~consolidated~~the ~~financial~~macroeconomic ~~statements~~environment, ~~included~~including ~~elsewhere in this Quarterly Report have been prepared assuming we will continue to operate~~ as a ~~going~~result ~~concern, which contemplates the realization~~ of ~~assets~~inflation and ~~settlement~~rising ofinterest ~~liabilities~~rates, in the ~~normal~~war ~~course~~in ofUkraine ~~business,~~ and ~~do not include any adjustments to reflect~~ the ~~possible~~Gaza ~~future~~strip, ~~effects~~or onany ~~the~~other ~~recoverability~~pandemic, ~~and~~epidemic ~~classification of assets~~ or ~~the~~infectious ~~amounts~~disease ~~and~~outbreak, ~~classifications~~on ~~of liabilities that may result from uncertainty related to~~ our ~~ability to continue as a going concern~~business.

Our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report have been prepared assuming we will continue to operate as a going concern, which contemplates the realization of assets and settlement of liabilities in the normal

course of business, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from uncertainty related to our ability to continue as a going concern.

Our ability to continue as a going concern depends on our ability to continue to commercialize our products, achieve and maintain profitable operations, as well as the adherence to conditions of the outstanding term loan (see Note 10 to the Condensed Consolidated Financial Statements). Without additional financing, we will have insufficient liquidity to achieve further commercialization of our products and maintain compliance with our loan covenants. Due to these conditions, there is a material uncertainty that raises substantial doubt about our ability to continue as a going concern and, therefore, we may be unable to realize our assets and discharge our liabilities in the normal course of business.

We will require additional financing in order to fund future expected negative cash flows. Due to our failure to comply with the continued listing standards set forth in the NYSE’s Listed Company Manual, our common stock was suspended from trading on the NYSE effective at the opening of business Eastern Standard Time on November 22, 2023. We commenced trading on the OTCQX on the same day. In April 2024, we withdrew the request to appeal the NYSE’s delisting determination and our common stock was delisted from the NYSE, which may negatively impact our stockholders and the trading price and liquidity of our common stock. On

28On June 4, 2024, we received notice from OTC that our common stock did not meet the Standards for Continued Qualification for the OTCQX per the OTCQX Rules for U.S. Companies section 2.1 because our stock’s bid price closed below $0.10 for more than 30 consecutive calendar days. We had a cure period of 180 calendar days to regain compliance, which expires December 2, 2024. If our common stock’s bid price did not stay at or above the $0.10 minimum for ten consecutive trading days during the cure period, then our common stock would have been moved from OTCQX to the OTC Pink market.

On June 4, 2024, we received notice from OTC that our common stock did not met the Standards for Continued Qualification for the OTCQX per the OTCQX Rules for U.S. Companies section 3.2.b.1 because our stock’s bid price closed below $0.10 ~~for more than 30 consecutive calendar days. We have a cure period of 180 calendar days to regain compliance~~, ~~which expires December 2,~~ 2024~~. If our common stock’s bid price does not stay at or above the $0.10 minimum for ten consecutive trading days during the cure period~~, ~~then~~ our common stock will be moved from OTCQX to the OTC Pink market. The OTCQX Rules also requires us to have a market capitalization of at least $5 million for at least one of every 30 consecutive calendar days. On June 10, 2024, the Company’s shareholders approved an amendment to ~~the~~our ~~Company’s~~ Amended and Restated Certificate of Incorporation to effect a reverse stock split of the Company’s issued shares of common stock, at a specific ratio, ranging from 1:10 to 1:200, at the discretion of ~~the~~our ~~Company’s~~ board of directors at any time prior to the ~~Company’s~~ 2025 annual meeting of stockholders, with the exact ratio to be determined by ~~the~~our ~~Company’s~~ board of directors without further approval or authorization of ~~the~~our ~~Company’s~~ stockholders. ~~Our Board of Directors is evaluating the merits and timing to effect a reverse stock split.~~

On October 16, 2024, we filed an amendment to our Amended and Restated Certificate of Incorporation to implement a 1-for-200 reverse stock split of its issued and outstanding common stock. The reverse stock split of our outstanding common stock was effected at a ratio of 1 post-split share for every 200 pre-split shares as of 12:01a.m. Eastern Time on October 18, 2024. The reverse stock split correspondingly adjusted the per share exercise price of all outstanding options and all shares underlying any of our outstanding warrants by reducing the conversion ratio for each outstanding warrant and increasing the applicable exercise price or conversion price in accordance with the terms of each outstanding warrant and based on the reverse stock split ratio. No fractional shares were issued in connection with the reverse stock split. Stockholders who are entitled to fractional shares will receive a cash payment in lieu of receiving fractional shares (after taking into account and aggregating all shares of our common stock then held by such stockholder) equal to the fractional share interest multiplied by $5.00 (the per share closing price of our common stock, on a post-split basis, as last reported on the OTCQX market on November 7, 2024). The reverse stock split was announced by FINRA on its OTC Daily List on November 7,2024 and took effect at the open of trading on November 8, 2024 on the OTCQX. Upon the effectiveness of the reverse stock split, the Company became compliant with OTCQX Rule 2.1(A).

The number of shares of common stock authorized under our Amended and Restated Certificate of Incorporation is unchanged at 500,000,000 shares. The accompanying interim unaudited condensed financial statements reflect the 1-for-200 reverse split of our common stock. All share and per share information data herein that relates to our common stock prior to the effective date has been retroactively restated to reflect the reverse stock split.

Over-the-counter markets are more limited than the NYSE, and it is likely that there will be significantly less liquidity in the trading of our common stock. The delisting of our common stock from the NYSE, and the potential move from the OTCQX to the OTC Pink market, could have material adverse effects on our business, financial condition and results of operations due to, among other things:

•

reduced trading liquidity and market prices for our common and preferred stock ;

•

decreased number of institutional and other investors willing to hold or acquire our stock, coverage by securities analysts, market making activity and information available concerning trading prices and volume, as well as fewer broker-dealers willing to execute trades in our stock, thereby further restricting our ability to obtain equity financing;

•

resulting event of default or noncompliance under certain of our debt facilities and other agreements; and

•

reduced ability to retain, attract and motivate our directors, officers and employees by means of equity compensation.

Delisting our common stock from the NYSE, and the potential move from the OTCQX to the OTC Pink market, may adversely impact our liquidity, impair our stockholders’ ability to buy and sell our common stock, impair our ability to raise capital, and the market price of our common stock could decrease. Delisting our common stock or potential move from the OTCQX to the OTC Pink market could also adversely impact the perception of our financial condition and have additional negative ramifications, including further loss of confidence by our employees, the loss of institutional investor interest and fewer business opportunities.

We have active plans to mitigate these conditions~~. Specifically~~, weincluding ~~plan~~plans to further reduce negative cash flow through additional operating expense reductions. We are also actively exploring financing options, including a combination of debt, equity, and non-dilutive sources. Additionally, as detailed in Note 3 to the Consolidated Financial Statements, we closed on the sale of TDO in March 2024, and renegotiated our covenant requirements with our lender, among other terms, which resulted in us remitting $15 million of principal payments on our outstanding borrowings. Our plans are subject to inherent risks and uncertainties and there can be no assurance that our plans can be effectively implemented and, therefore, that the conditions can be effectively mitigated.

Indebtedness

On January 13, 2023, we entered into the Amendment No. 2 (the “Second Amendment”) to the Amended and Restated Credit Agreement and Guaranty by and among us, Pipstek, LLC, as the Subsidiary Guarantor, and Perceptive Credit Holdings III, LP, as the Collateral Agent and the Required Lender (the “Amended Perceptive Loan Agreement”)to replace the existing benchmark rate from the one-month LIBOR with a one-month Secured Overnight Financing Rate (“SOFR”). All other terms remain unchanged on the original agreement. For the three months ended ~~June~~September 30, 2024 and 2023, the interest rate for amounts borrowed under the Amended Perceptive Loan Agreement was the greater of the one-month SOFR and 2.00% plus the applicable margin of 9.25%.

On March 1, 2024, we entered to the Amendment No. 3 to the Amended Perceptive Loan Agreement (the “Third Amendment”). Pursuant to the Third Amendment, we made a one-time $15.0 million principal repayment on March 1, 2024, and made an amortization payment of $1.8 million on the outstanding principal on March 31, 2024 and we agreed to make monthly amortization payments on the outstanding principal amount each in the amount of $0.9 million on each payment date commencing on April 30, 2024. Accordingly, $1.0 million of the unamortized debt issuance costs were expensed.

For the ~~six~~nine months ended ~~June~~September 30, 2024 and 2023, the effective interest rate of the loan pursuant to the Amended Perceptive Loan Agreement, was 21.22% and 16.71%, respectively. As of ~~June~~September 30, 2024 and 2023, the fair value of the loan pursuant to the Amended Perceptive Loan Agreement approximates its carrying amount.

The Third Amendment also modified certain covenants included in the Amended Perceptive Loan Agreement and released all liens granted to the TDO’s software assets. Future principal repayments and the net carrying value of the Perceptive Loan, as of ~~June~~September 30, 2024, are as follows:


	Principal
	(in thousands)
Remaining 3 months of 2024	$	2,700
2025		10,800
2026		4,300
Total principal payment		17,800
Debt discounts		(916	)
Net carrying value	$	16,884

	Principal
	(in thousands)
Remaining 6 months of 2024	$	5,400
2025		10,800
2026		4,300
Total principal payment		20,500
Debt discounts		(1,189	)
Net carrying value	$	19,311

We are permitted to make voluntary prepayments, subject to a scaled prepayment premium that ranges from 7.0% to 1.0% of the aggregate principal amount outstanding on such prepayment date for prepayments made after August 23, 2022 and before August 23, 2025. No prepayment premium is required for payments made after August 23, 2025.

The Amended Perceptive Loan Agreement contains events of default, including, without limitation, upon: (i) failure to make a payment pursuant to the terms of the agreement; (ii) violation of certain covenants; (iii) payment or other defaults on other indebtedness; (iv) material adverse change in the business or change in control; (v) insolvency; (vi) significant judgments; (vii) incorrectness of representations and warranties; (viii) regulatory matters; and (ix) failure by us to maintain a valid and perfected lien on the collateral securing the borrowing. Based on the Amended Perceptive Loan Agreement, we have granted a security interest in substantially all of our assets.

The Amended Perceptive Loan Agreement includes financial covenants that require us to (i) maintain, at all times, a minimum aggregate balance of $3.0 million in cash in one or more controlled accounts, and (ii) pursuant to the Third Amendment, satisfy certain minimum revenue thresholds, measured for the consecutive 12-month periods ending on each calendar quarter-end until June 30, 2026 as follows:

For 12-month Period Ending	Revenue
	(in thousands)
June 30, 2024	$	35,500
September 30, 2024	$	33,000
December 31, 2024	$	31,500
March 31, 2025	$	31,000
June 30, 2025	$	33,000
September 30, 2025	$	35,935
December 31, 2025	$	40,160
March 31, 2026	$	44,950
June 30, 2026	$	51,500


For 12-month Period Ending	Revenue
	(in thousands)
September 30, 2024	$	33,000
December 31, 2024	$	31,500
March 31, 2025	$	31,000
June 30, 2025	$	33,000
September 30, 2025	$	35,935
December 31, 2025	$	40,160
March 31, 2026	$	44,950
June 30, 2026	$	51,500

Revenue generated from continuing and discontinued operations for the 12-months period ended ~~June~~September 30, 2024 was $3836.95 million, and the cash and cash equivalents and short term investment balance was $2417.23 million as of ~~June~~September 30, 2024. As such, we were in compliance with all financial covenants and conditions under the agreement as of ~~June~~September 30, 2024.

Summary statement of cash flows

The following table summarizes our statement of cash flows:

	Six Months Ended June 30,
	Nine Months Ended September 30,
	2024			2023
	(in thousands)
Net cash provided by (used in) :
Operating activities	$	(1721,~~407~~718	)	$	(2636,~~341~~557	)
Investing activities		3843,~~623~~039			2130,~~140~~979
Financing activities		(1922,~~522~~234	)		~~103~~3
Net increase (decrease) in cash and cash equivalents	$	1,694		$	(5,098	)
Net decrease in cash and cash equivalents	$	(913	)	$	(5,575	)

Operating Activities

Net cash used in operating activities was $1721.47 million for the ~~six~~nine months ended ~~June~~September 30, 2024, primarily consisting of net loss of $1421.17 million and gain on sales of discontinued operations of $5.7 million, as adjusted for non-cash items of $01.23 million, partially offset by a net change in our net operating assets and liabilities of $31.53 million. Non-cash items primarily consisted of $34.62 million in stock-based compensation and $1.47 million of amortization of debt issuance costs. Changes in our net operating assets and liabilities year-over-year, was primarily due to a $1.42 million increase inventory, $32.01 million decrease in accrued expenses and other liabilities on payments to vendors and a $10.27 million decrease in accrued compensation due to 2023 year-end bonus payout, partially offset by changes in accounts receivable, prepaid expenses and other assets and accounts payable attributable to timing of payment.

Net cash used in operating activities was $2636.36 million for the ~~six~~nine months ended ~~June~~September 30, 2023, primarily consisting of a net loss of $3350.10 million as adjusted for non-cash items of $410.73 million, as well as a net change in our net operating assets and liabilities of $23.01 million. Non-cash items primarily consisted of $25.08 million in ~~depreciation~~stock-based ~~and~~compensation, ~~amortization~~$3.4 million impairment of long-lived assets and $43.0 million in ~~stock-based~~depreciation ~~compensation~~and amortization. Changes in our net operating assets and liabilities year-over-year, ~~was~~were primarily due to a $4.4 million in cash receipts of ~~employee~~ERC ~~retention~~refund ~~credit~~and ~~refunds~~a $4.1 million decrease in inventory due to managing production level, partially offset by increase in accounts receivable, ~~inventory~~prepaid expenses, accrued compensation and accounts payable attributable to timing of payment.

Investing Activities

Net cash provided by investing activities was $3843.60 million for the ~~six~~nine months ended ~~June~~September 30, 2024, as a result of $2633.75 million in proceeds from maturities of available-for-sale securities and $14.2 million net proceeds from sale of discontinued operations, partially offset by the purchases of available-for-sale securities.

Net cash provided by investing activities was $21.1 million for the six months ended June 30, 2023, as a result of proceeds from maturities of available-for-sale securities partially offset by the purchases of available-for-sale securities and property and equipment. 32

Net cash provided by investing activities was $31.0 million for the nine months ended September 30, 2023, as a result of proceeds from maturities of available-for-sale securities partially offset by the purchases of available-for-sale securities and property and equipment.

Financing Activities

Net cash used in financing activities was $1922.52 million for the ~~six~~nine months ended ~~June~~September 30, 2024, primarily due to principal repayments on our term loan. Net cash used in financing activities for the ~~six~~nine months ended ~~June~~September 30, 2023 was immaterial.

Critical Accounting Policies and Estimates

Our management’s discussion and analysis of financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, the revenue generated, and expenses incurred, and related disclosures, during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions and any such differences may be material.

There were no material changes to our critical accounting policies or in the methodology used for estimates from those described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K filed with the SEC on March 11, 2024.

JOBS Act Accounting Election and Smaller Reporting Company Status

We are an “emerging growth company,” as defined in the JOBS Act. As such, we are eligible for exemptions from various reporting requirements applicable to other public companies that are not emerging growth companies, including, but not limited to, presenting only two years of audited financial statements in addition to any required unaudited interim financial statements with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure in this Quarterly Report on Form 10-Q, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation, and an exemption from the requirements to obtain a non-binding advisory vote on executive compensation or golden parachute arrangements. We have elected to take advantage of certain of the reduced disclosure obligations in this Quarterly Report on Form 10-Q and may elect to take advantage of other reduced reporting requirements in our future filings with the SEC. As a result, the information that we provide to our stockholders may be different than you might receive from other public reporting companies in which you hold equity interests.

In addition, the JOBS Act permits an “emerging growth company” such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies. We have elected to avail ourselves of this exemption and, therefore, for new or revised accounting standards applicable to public companies, we may delay adopting new or revised accounting standards until those standards would otherwise apply to private companies.

We will remain an emerging growth company until the earliest of (1) the last day of our first fiscal year (a) following the fifth anniversary of our IPO, which closed on November 2, 2021, (b) in which we have total annual gross revenues of at least $1.07235 billion or (c) in which we are deemed to be a large accelerated filer, as defined in Rule 12b-2 under the Exchange Act of 1934, as amended, which means the market value of our common stock that is held by non-affiliates exceeds $700 million as of the end of the second quarter of the prior fiscal year, and (2) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period.

We are also a “smaller reporting company” as defined in the Exchange Act. We may continue to be a smaller reporting company even after we no longer qualify as an emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as our voting and non-voting common stock held by non-affiliates is less than $250 million measured on the last business day of our second fiscal quarter, or our annual revenue is less than $100 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is less than $700 million measured on the last business day of our second fiscal quarter.

Recent Accounting Pronouncements

See Note 2 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for additional information.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

Not applicable.

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

Our management, under the supervision and with the participation of our Chief Executive Officer (principal executive officer) and our Chief Financial Officer (principal financial officer), conducted an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act of 1934, as amended, as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on that evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of ~~June~~September 30, 2024.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the quarter ended ~~June~~September 30, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Limitations on the Effectiveness of Controls

Control systems, no matter how well conceived and operated, are designed to provide a reasonable, but not an absolute, level of assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. Because of the inherent limitations in any control system, misstatements due to error or fraud may occur and not be detected.

3234

been detected. Because of the inherent limitations in any control system, misstatements due to error or fraud may occur and not be detected.

PART II—OTHER INFORMATION

Item 1. Legal Proceedings.

From time to time, we may become involved in various claims and legal proceedings., ~~Regardless~~including ofthose ~~outcome,~~related ~~litigation~~to ~~and~~compliance ~~other~~with ~~legal~~California wage and ~~administrative~~hour ~~proceedings~~laws ~~can~~and ~~have~~derivative anmatters. ~~adverse~~Management ~~impact~~presently onbelieves usthat ~~because~~the ultimate outcome of ~~defense~~these proceedings, individually and ~~settlement~~in ~~costs~~the aggregate, ~~diversion~~will ofnot ~~management~~materially ~~resources~~harm ~~and~~our ~~other~~financial ~~factors.~~position, Wecash ~~are~~flow, ~~currently~~or ~~not~~overall atrends ~~party~~in toresults ~~any~~of ~~legal~~operations. ~~proceedings~~Additionally, ~~the~~we ~~outcome~~maintain insurance policies that may cover certain of ~~which~~these claims. However, iflegal ~~determined~~proceedings ~~adversely~~are subject to ~~us,~~inherent ~~would~~uncertainties and unfavorable rulings or outcomes could occur that have, individually or in the aggregate, ~~have~~ a material adverse effect on our business, financial condition or operating results. In addition, regardless of out come, litigation and ~~results~~other legal proceedings can have an adverse impact on us because of ~~operations~~defense and settlement costs, diversion of management resources and other factors.

On October 1, 2024, we and PIPStek, LLC (“PIPStek”), our wholly-owned subsidiary, filed a proof of claim with the Bankruptcy Court for a total of not less than $59,000,000 in damages related to alleged infringement by Biolase of certain of our and PIPStek’s patents covering the use of laser systems and radial firing tips. Biolase’s infringement includes the claims asserted in the litigation styled PIPStek, LLC v. Biolase, Inc.; C.A. No. 1:23-cv-00011-JPM pending in the District Court of the District of Delaware (the “Delaware Litigation”). There can be no assurance that PIPStek will be successful in the Delaware Litigation, and any recovery on such claims will also depend part on the outcome of the Biolase Chapter 11 case before the Bankruptcy Court and the recovery to holders of unsecured claims generally.

Item 1A. Risk Factors.

We have described under the heading “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 risks and uncertainties that could cause our actual results of operations and financial condition to vary materially from past, or from anticipated future, results of operations and financial condition. These risks and uncertainties are not the only risks facing us. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also adversely affect our business, financial condition, results of operations or the market price of our common stock. Except as set forth below, there have been no material changes to the risk factors previously described in our 2023 Annual Report on Form 10-K.

Our securities trade on the OTCQX, which could affect our securities’ market price and liquidity.

On November 22, 2023, the NYSE suspended trading of our common stock and announced its intention to commence proceedings to delist our common stock from the NYSE and our common stock commenced trading on the OTCQX on the same day. We appealed the NYSE’s delisting determination, but subsequently withdrew our request for an appeal on April 11, 2024. As a result, on April 11, 2024, our common stock was delisted from the NYSE. On June 4, 2024, we were notified by the OTC, that our common stock closed below $0.10 for more than 30 consecutive calendar days and no longer meets the Standards for Continued Qualification for the OTCQX. If we do not regain compliance within the allotted compliance period, OTC will provide notice that our common stock will be moved from OTCQX to the OTC Pink market.

WeOn ~~intend~~June to4, ~~monitor~~2024, ~~the~~we ~~closing~~were ~~bid~~notified ~~price~~by ofthe OTC, that our common stock ~~and~~closed ~~consider~~below ~~our~~$0.10 ~~available~~for ~~options~~more tothan ~~resolve~~30 ~~the~~consecutive ~~noncompliance~~calendar ~~with~~days ~~the~~and ~~bid price requirement. There can be~~ no ~~assurance~~longer ~~that~~meets wethe ~~will~~Standards befor ~~able~~Continued toQualification ~~regain~~for ~~compliance with~~ the ~~bid price requirement or will otherwise be in compliance with other~~ OTCQX, ~~listing~~Rule ~~criteria~~2.1(A). IfOn ~~our~~October ~~common~~16, ~~stock~~2024, iswe ~~moved~~filed toan ~~OTC~~amendment ~~Pink~~to ~~market,~~our itAmended ~~could~~and beRestated ~~more~~Certificate ~~difficult~~of Incorporation to ~~buy~~implement ora ~~sell~~1-for-200 ~~our~~reverse ~~common~~ stock ~~and~~split toof ~~obtain~~its ~~accurate~~issued ~~quotations,~~ and ~~the~~outstanding ~~price of our~~ common stock, ~~could~~effective ~~suffer~~as aof ~~material~~October ~~decline~~18, 2024. The ~~move~~reverse tostock ~~OTC~~split ~~Pink~~was ~~market~~announced ~~could~~by ~~also~~FINRA ~~impair~~on ~~the~~its ~~liquidity~~OTC ofDaily ~~our~~List ~~common~~on ~~stock~~November 7,2024 and ~~could~~took ~~harm~~effect ~~our~~at ~~ability~~the toopen ~~raise~~of ~~capital~~trading ~~through alternative financing sources~~ on ~~terms~~November ~~acceptable to us~~8, or2024 aton ~~all,~~the ~~and~~OTCQX. ~~may~~Upon ~~result~~the ineffectiveness ~~potential loss~~ of ~~confidence~~the byreverse ~~investors,~~stock ~~employees~~split, ~~and~~the ~~fewer~~Company ~~business~~became ~~development~~compliant ~~opportunities~~with OTCQX Rule 2.1(A).

On November 7, 2024, we were notified by the OTC, that market capitalization has stayed below $5 million for the past 30 consecutive calendar days and no longer meets the Standards for Continued Qualification for the OTCQX, Rule 2.1(B). We have a cure period of 90 calendar days to regain compliance. The 90-calendar day grace period expires February 7, 2025 and at that time if our market capitalization has not stayed at or above $5 million for ten consecutive trading days then our common stock will be removed from OTCQX and moved to the OTC Pink market.

We intend to monitor our market capitalization and consider our available options to resolve the noncompliance with the market capitalization requirement. There can be no assurance that we will be able to regain compliance with the market capitalization requirement or will otherwise be in compliance with other OTCQX listing criteria. If our common stock is moved to OTC Pink market, it could be more difficult to buy or sell our common stock and to obtain accurate quotations, and the price of our common stock could suffer a material decline. The move to OTC Pink market could also impair the liquidity of our common stock and could harm our ability to raise capital through alternative financing sources on terms acceptable to us, or at all, and may result in potential loss of confidence by investors, employees, and fewer business development opportunities.

While we are evaluating possible alternatives in light of the NYSE delisting and OTC noncompliance notice, including applying to list our common stock under an alternative national securities exchange, we cannot assure you that we will be able to demonstrate compliance required for such listing. We will be required to demonstrate compliance with an applicable exchange’s initial listing requirements, which are generally more rigorous than an exchange’s continued listing requirements, in order to qualify for listing our securities.

Additionally, we could face significant material adverse consequences from trading on the OTC platform (as compared to our prior listing on NYSE), including:

•

a limited availability of market quotations for our common stock;

•

reduced liquidity for our common stock, including reduced availability of buyers or sellers of our common stock;

•

thin with sporadic fluctuations in price;

•

greater volatility and lower trading volumes;

•

depression the trading price of our common stock and make it more difficult to purchase, dispose of or obtain accurate quotations;

•

a limited amount of news and analyst coverage; and

•

a decreased ability to issue additional securities or obtain additional financing in the future.

The National Securities Markets Improvement Act of 1996, which is a federal statute, prevents or preempts states from regulating the sale of certain securities, which are referred to as “covered securities.” Our common stock no longer qualify as “covered securities” under such statute, due to the delisting from the NYSE. We are therefore subject to regulation in each state in which we offer our common stock, which may negatively impact our ability to consummate any future offering of our common stock.

In addition, our common stock may be defined as a “penny stock” under Rule 3a51-1 under the Exchange Act. “Penny stocks” are subject to Rule 15g-9, which imposes additional sales practice requirements on broker-dealers that sell low-priced securities to persons other than established customers and institutional accredited investors. For transactions covered by this rule, a broker-dealer must make a special suitability determination for the purchaser and have received the purchaser’s written consent to the transaction prior to sale. Consequently, the rule may affect the ability of broker-dealers to sell our common stock and affect the ability of holders to sell our common stock in the secondary market. To the extent our common stock is subject to the penny stock regulations, the market liquidity for our common stock will be adversely affected.

34The effect of our reverse stock split on the market price and trading of our common stock cannot be predicted with any certainty.

~~sale.~~Although ~~Consequently,~~we ~~the~~believe ~~rule~~that ~~may~~a ~~affect~~higher ~~the~~market ~~ability~~price of ~~broker-dealers to sell~~ our common stock ~~and~~may ~~affect~~help ~~the~~generate ~~ability~~greater ofor ~~holders~~broader toinvestor ~~sell~~interest, there can be no assurance that our ~~common~~reverse stock split will result in ~~the~~a ~~secondary~~share ~~market~~price that will attract new investors, including institutional investors. ToIn addition, there can be no assurance that the ~~extent~~market price of our common stock iswill ~~subject~~satisfy to the ~~penny~~investing ~~stock~~requirements ~~regulations~~of those investors. As a result, the ~~market~~trading liquidity ~~for~~of our common stock ~~will~~may benot ~~adversely~~necessarily ~~affected~~improve.

The decline in the per share price of our common stock and the decline in our overall market capitalization may be greater following the reverse stock split than would have occurred in the absence of a reverse stock split. Any reduction in our market capitalization may be magnified as a result of the smaller number of total shares of common stock outstanding following the reverse stock split.

Furthermore, even if the reverse stock split does result in an increased market price per share of our common stock, the market price per share following the reverse stock split may not increase in proportion to the reduction of the number of shares of our common stock outstanding before the implementation of the reverse stock split. Accordingly, even with an increased market price per share, the total market capitalization of shares of our common stock after a reverse stock split could be lower than the total market capitalization before the reverse stock split. Also, even if there is an initial increase in the market price per share of our common stock after a reverse stock split, the market price may not remain at that level.

The sale of securities by us in any equity or debt financing could result in dilution to our existing stockholders.

Any sale of common stock by us in a future private placement offering could result in dilution to the existing stockholders as a direct result of our issuance of additional shares of our capital stock. In addition, our business strategy may include expansion through internal growth by acquiring complementary businesses, acquiring, or establishing strategic relationships with targeted customers and suppliers. In order to do so, or to finance the cost of our other activities, we may issue additional equity securities that could dilute our stockholders’ stock ownership. We may also assume additional debt and incur impairment losses related to goodwill and other tangible assets, and this could negatively impact our earnings and results of operations.

We may require additional capital to support growth, and such capital might not be available on terms acceptable to us, if at all. This could hamper our growth and adversely affect our business.

We intend to continue to make investments to support our business growth and may require additional funds to respond to business challenges, including the need to enhance our products and services, improve our operating infrastructure or acquire complementary businesses and technologies. Accordingly, we may need to engage in public or private equity, equity-linked or debt financing to secure additional funds. If we raise additional funds through future issuances of equity or convertible debt securities, our existing stockholders could suffer significant dilution, and any new equity securities we issue could have rights, preferences and privileges superior to those of holders of our common stock. Any debt financing that we secure in the future could involve restrictive covenants relating to our capital raising activities and other financial and operational matters, including the ability to pay dividends. This may make it more difficult for us to obtain additional capital and to pursue business opportunities, including potential acquisitions. We may

not be able to obtain additional financing on terms favorable to us, if at all. If we are unable to obtain adequate financing on terms satisfactory to us when we require it, our ability to continue to support our business growth and respond to business challenges could be significantly impaired, and our business could be adversely affected.

Litigation and other legal proceedings may adversely affect our business.

From time-to-time we may become involved in legal proceedings relating to patent and other intellectual property matters, product liability claims, employee claims, tort or contract claims, federal regulatory investigations, securities class action and other legal proceedings or investigations, which could have an adverse impact on our reputation, business and financial condition and divert the attention of our management from the operation of our business. For example, on January 22, 2024, a former employee, whose position was eliminated in a reduction-in-force, filed a complaint against us alleging various violations of California wage and hour laws, including unpaid meal and rest period premiums. While at this time we believe that a loss is not probable, including due to our affirmative defenses, litigation is inherently unpredictable and can result in excessive or unanticipated verdicts and/or injunctive relief that affect how we operate our business. We could incur judgments or enter into settlements of claims for monetary damages or for agreements to change the way we operate our business, or both. There may be an increase in the scope of these matters or there may be additional lawsuits, claims, proceedings or investigations in the future, which could have a material adverse effect on our business, financial condition and results of operations. Adverse publicity about regulatory or legal action against us could damage our reputation and brand image, undermine clinicians’ confidence and reduce long-term demand for our GentleWave System, even if the regulatory or legal action is unfounded or not material to our operations.

In the past, securities class action litigation has often been brought against companies following a decline in the market price of its securities. This risk is especially relevant for us because medical technology companies have experienced significant stock price volatility in recent years. If we face such litigation, it could result in substantial costs and a diversion of management’s attention and resources, which could harm our business.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

None.

Item 3. Defaults Upon Senior Securities.

None.

Item 4. Mine Safety Disclosures.

None.

Item 5. Other Information.

During the quarter ended ~~June~~September 30, 2024, no director or officer, as defined in Rule 16a-1(f), adopted or terminated a "Rule 10b5-1 trading arrangement" or a "non-Rule 10b5-1 trading arrangement," each as defined in Regulation S-K Item 408.

Item 6. Exhibits.

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The following exhibits are filed as part of, or incorporated by reference into, this Quarterly Report on Form 10-Q unless otherwise stated.

		Incorporated by Reference
ExhibitNumber	Description	Form	File No.	Exhibit	Filing Date	Filed / Furnished Herewith
3.1	Amended and Restated Certificate of Incorporation	8-K	001-40988	3.1	11/2/2021
3.2	Amended and Restated Bylaws	8-K	001-40988	3.2	11/2/2021
3.3	Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Sonendo, Inc.	8-K	001-40988	3.1	10/22/2024
4.1	Form of Certificate of Common Stock	S-1/A	333-260136	4.1	10/25/2021
4.2	Fifth Amended and Restated Voting Agreement by and among Sonendo, Inc. and the investors listed therein	S-1/A	333-260136	4.2	10/25/2021
4.3	Third Amended and Restated Investors’ Rights Agreement by and among Sonendo, Inc. and the investors listed therein	S-1	333-260136	4.3	10/8/2021
4.4	Warrant to purchase Series C-1 preferred stock, issued to Oxford Finance LLC on December 31, 2013	S-1	333-260136	4.4	10/8/2021
4.5	Warrant to purchase Series C-1 preferred stock, issued to Oxford Finance LLC on June 30, 2014	S-1	333-260136	4.5	10/8/2021
4.6	Warrant to purchase Series C-1 preferred stock, issued to Oxford Finance LLC on December 31, 2014	S-1	333-260136	4.6	10/8/2021
4.7	Warrant to purchase Series D preferred stock	S-1	333-260136	4.7	10/8/2021
4.8	Warrant to purchase Series E preferred stock (2018)	S-1	333-260136	4.8	10/8/2021
4.9	Warrant to purchase Series E preferred stock (2019)	S-1	333-260136	4.9	10/8/2021
4.10	Warrant to purchase Series E preferred stock (2021)	S-1	333-260136	4.10	10/8/2021
4.11	Description of Common Stock	10-K	001-40988	4.11	3/23/2022
4.12	Credit Agreement Warrant to Purchase Stock	8-K	001-40988	4.1	4/7/2022
4.13	Schedule to Exhibit 4.11 - Form of Credit Agreement Warrant to Purchase Stock	8-K	001-40988	4.2	4/7/2022
4.14	Form of Credit Agreement Warrant to Purchase Stock (Warberg entities)	10-Q	001-40988	4.11	8/10/2022
4.15	Schedule to Exhibit 4.14 - Holders of Credit Agreement Warrants to Purchase Common Stock (Warberg entities)	10-Q	001-40988	4.12	8/10/2022
4.16	Form of Indenture for Senior Debt Securities	S-3	333-270366	4.6	3/8/2023
4.17	Form of Indenture for Subordinated Debt Securities	S-3	333-270366	4.7	3/8/2023
10.1	Employment Letter, dated as of June 3, 2024, by and between Sonendo, Inc. and John Bostjancic	8-K	001-40988	10.1	6/5/2024
10.2	~~Amendment to the~~ 2023 Employment Inducement Incentive Award Plan	8S-K8	~~001~~333-~~40988~~270366	1099.41	63/58/~~2024~~2023
10.3	Amendment ~~No. 3~~ to ~~Amended~~the ~~and~~2023 ~~Restated~~Employment ~~Credit~~Inducement ~~Agreement~~Incentive ~~and~~Award ~~Guaranty, dated as of March 1, 2024, by and between Sonendo, Inc. and Perceptive Credit~~Plan	8-K	001-40988	10.24	36/5/2024
31.1	Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.					*
10.4	Amendment No. 3 to Amended and Restated Credit Agreement and Guaranty, dated as of March 1, 2024, by and between Sonendo, Inc. and Perceptive Credit	8-K	001-40988	10.2	3/5/2024
10.5	Asset Purchase Agreement, dated as of September 30, 2024, by and among Sonendo, Inc., Biolase,	8-K	001-40988	2.1	10/2/2024

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	Inc., BL Acquisition Corp., BL Acquisition II, Inc. and Model Dental Office, LLC
16.1	Letter from Ernst & Young LLP to the U.S. Securities and Exchange Commissions, dated August 14, 2024	8-K	001-40988	16.1	8/16/2024
31.1	Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-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 Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-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 Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.					*
32.2	Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.					*
101.INS	Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document.					*
101.SCH	Inline XBRL Taxonomy Extension Schema Document					*
101.CAL	Inline XBRL Taxonomy Extension Calculation Linkbase Document					*
101.DEF	Inline XBRL Taxonomy Extension Definition Linkbase Document					*
101.LAB	Inline XBRL Taxonomy Extension Label Linkbase Document					*
101.PRE	Inline XBRL Taxonomy Extension Presentation Linkbase Document					*
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)					*

* Filed or furnished herewith.

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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.

	Sonendo, Inc.
Date: August 7, 2024	By:	/s/ Bjarne Bergheim
Date: November 12, 2024	By:	/s/ Bjarne Bergheim
		Bjarne Bergheim
		President, Chief Executive Officer and Director
		(principal executive officer)
Date: August 7, 2024	By:	/s/ John Bostjancic
Date: November 12, 2024	By:	/s/ John Bostjancic
		John Bostjancic
		Chief Financial Officer
		(principal financial and accounting officer)

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