# Owlet, Inc.: Form 10-Q for the period ended Sep 30, 2024

- Company: [Owlet, Inc.](/companies/owlt.md) (CIK 1816708)
- Form: 10-Q
- Filed: 2024-11-14
- Accepted by EDGAR: Nov 14, 2024, 21:01 ET
- Period: 2024-09-30
- Accession: 0001628280-24-047870
- Inline XBRL: no
- Main document: https://www.sec.gov/Archives/edgar/data/1816708/000162828024047870/owlt-20240930.htm
- All documents and exhibits: https://www.sec.gov/Archives/edgar/data/1816708/000162828024047870/

## Figures reported in this filing

Standardized XBRL line items for the period ended 2024-09-30.

| Line item | Period | Value | XBRL concept |
| --- | --- | ---: | --- |
| Revenue | 3 months, 2024-07-01 to 2024-09-30 | $22.1m | us-gaap:RevenueFromContractWithCustomerExcludingAssessedTax |
| Revenue | 9 months, 2024-01-01 to 2024-09-30 | $57.6m | us-gaap:RevenueFromContractWithCustomerExcludingAssessedTax |
| Cost of revenue | 3 months, 2024-07-01 to 2024-09-30 | $10.6m | us-gaap:CostOfGoodsAndServicesSold |
| Cost of revenue | 9 months, 2024-01-01 to 2024-09-30 | $29.2m | us-gaap:CostOfGoodsAndServicesSold |
| Gross profit | 3 months, 2024-07-01 to 2024-09-30 | $11.5m | us-gaap:GrossProfit |
| Gross profit | 9 months, 2024-01-01 to 2024-09-30 | $28.3m | us-gaap:GrossProfit |
| Research and development | 3 months, 2024-07-01 to 2024-09-30 | $2.6m | us-gaap:ResearchAndDevelopmentExpense |
| Research and development | 9 months, 2024-01-01 to 2024-09-30 | $7.3m | us-gaap:ResearchAndDevelopmentExpense |
| Operating income | 3 months, 2024-07-01 to 2024-09-30 | −$4.8m | us-gaap:OperatingIncomeLoss |
| Operating income | 9 months, 2024-01-01 to 2024-09-30 | −$12.8m | us-gaap:OperatingIncomeLoss |
| Income tax | 3 months, 2024-07-01 to 2024-09-30 | $0 | us-gaap:IncomeTaxExpenseBenefit |
| Income tax | 9 months, 2024-01-01 to 2024-09-30 | $22.0k | us-gaap:IncomeTaxExpenseBenefit |
| Net income | 3 months, 2024-07-01 to 2024-09-30 | −$5.6m | us-gaap:NetIncomeLoss |
| Net income | 9 months, 2024-01-01 to 2024-09-30 | −$3.5m | us-gaap:NetIncomeLoss |
| Diluted EPS | 3 months, 2024-07-01 to 2024-09-30 | −$0.61 | us-gaap:EarningsPerShareDiluted |
| Diluted EPS | 9 months, 2024-01-01 to 2024-09-30 | −$0.79 | us-gaap:EarningsPerShareDiluted |
| Basic EPS | 3 months, 2024-07-01 to 2024-09-30 | −$0.61 | us-gaap:EarningsPerShareBasic |
| Basic EPS | 9 months, 2024-01-01 to 2024-09-30 | −$0.79 | us-gaap:EarningsPerShareBasic |
| Diluted shares (weighted) | 3 months, 2024-07-01 to 2024-09-30 | 11,042,602 shares | us-gaap:WeightedAverageNumberOfDilutedSharesOutstanding |
| Diluted shares (weighted) | 9 months, 2024-01-01 to 2024-09-30 | 9,555,467 shares | us-gaap:WeightedAverageNumberOfDilutedSharesOutstanding |
| Operating cash flow | 9 months, 2024-01-01 to 2024-09-30 | −$14.5m | us-gaap:NetCashProvidedByUsedInOperatingActivities |
| Capital expenditure | 9 months, 2024-01-01 to 2024-09-30 | $2.0k | us-gaap:PaymentsToAcquirePropertyPlantAndEquipment |
| Cash and equivalents | at 2024-09-30 | $21.5m | us-gaap:CashAndCashEquivalentsAtCarryingValue |
| Current assets | at 2024-09-30 | $52.3m | us-gaap:AssetsCurrent |
| Total assets | at 2024-09-30 | $56.1m | us-gaap:Assets |
| Current liabilities | at 2024-09-30 | $35.7m | us-gaap:LiabilitiesCurrent |
| Total liabilities | at 2024-09-30 | $65.5m | us-gaap:Liabilities |
| Long-term debt | at 2024-09-30 | $4.6m | us-gaap:LongTermDebtNoncurrent |
| Current portion of debt | at 2024-09-30 | $10.3m | us-gaap:LongTermDebtCurrent |
| Shareholders' equity | at 2024-09-30 | −$21.5m | us-gaap:StockholdersEquity |

## Management's discussion and analysis

As filed, 32,608 characters.

*The following discussion and analysis should be read in conjunction with the unaudited condensed consolidated financial statements and notes thereto included elsewhere in this Report and in “Item 7 – Management’s Discussion and Analysis of Financial Condition and Results of Operations” of our Form 10-K. Certain statements we make under this Item 2 constitute “forward-looking statements” under the Reform Act. See “Cautionary Note Regarding Forward-Looking Statements” before Part I of this Report. You should consider our forward-looking statements in light of the risks discussed in our unaudited condensed consolidated financial statements, related notes and other financial information appearing elsewhere in this Report, the “Risk Factors” section of our Form 10–K and this Report, and our other filings with the SEC. Note that amounts within Item 2 are presented in millions and may not sum due to rounding.*

### Overview

Our mission is to empower parents with the right information at the right time, to give them more peace of mind and help them find more joy in the journey of parenting. Our digital parenting platform aims to give parents real-time data and insights to help parents feel calmer and more confident. We believe that every parent deserves peace of mind and the opportunity to feel their well-rested best. We also believe that every child deserves to live a long, happy, and healthy life, and we are working to develop products to help facilitate that belief.

### Components of Operating Results

### Revenues

We recognize revenue primarily from products and the associated mobile applications. Revenues are recognized when control of goods and services is transferred to customers in an amount that reflects the consideration expected to be received by us in exchange for those goods and services. Substantially all of our revenues were derived from product sales.

### Cost of Revenues

Cost of revenues consists of product costs, including contract manufacturing, shipping and handling, depreciation and amortization relating to tooling and manufacturing equipment and software, warranty replacement, fulfillment costs, warehousing, hosting, and reserves for excess and obsolete inventory.

### Operating Expenses

*General and Administrative.* General and administrative expenses consist primarily of salaries, benefits, stock-based compensation, and bonuses for finance and accounting, legal, human resources and administrative executives and employees, third-party legal, accounting, customer service, software, and other professional services, corporate travel and entertainment, depreciation and amortization of property and equipment, asset impairment charges, and facilities rent.

*Sales and Marketing.* Sales and marketing expenses consist primarily of salaries, commissions, benefits, stock-based compensation, and bonuses for sales and marketing employees and contractors, third-party marketing expenses such as social media and search engine marketing, retail marketing, email marketing, and print marketing.

*Research and Development.* Research and development expenses consist primarily of salaries, benefits, stock-based compensation, and bonuses for employees and contractors engaged in the design, development, maintenance and testing of our products and platforms, including clinical testing.

### Other Income (Expense)

*Interest Income (Expense), Net.* Interest income (expense), net consists of interest incurred on our outstanding borrowings, debt extinguishment costs, gain on interest for forgiveness of interest accrued related to an arrangement with a significant vendor, and amortization of the associated deferred financing costs. Interest income consists of interest earned on our money market account.

*Common Stock Warrant Liability Adjustment.* Mark to market adjustment to recognize the change in fair value of common stock warrant liabilities.

*Other Income (Expense), Net.* Other income (expense), net includes our net gain (loss) on foreign exchange transactions.

*Income Tax Provision.* Income tax provision consists primarily of U.S. federal and state income taxes related to the tax jurisdictions in which we conduct business.

### Results of Operations

The following table sets forth our results of operations for the periods, indicated in millions:

|  | Three Months Ended September 30, 2024 | 2023 | Nine Months Ended September 30, 2024 |  | 2023 |
| --- | ---: | ---: | ---: | ---: | ---: |
| Revenues | $22.1 | $9.2 | $57.6 |  | $33.0 |
| Cost of revenues | 10.6 | 5.9 | 29.2 |  | 20.3 |
| Gross profit | 11.5 | 3.3 | 28.3 |  | 12.7 |
| Operating expenses: |  |  |  |  |  |
| General and administrative | 9.8 | 5.4 | 22.1 |  | 20.4 |
| Sales and marketing | 4.0 | 3.3 | 11.8 |  | 9.8 |
| Research and development | 2.6 | 2.4 | 7.3 |  | 8.1 |
| Total operating expenses | 16.4 | 11.2 | 41.2 |  | 38.3 |
| Operating loss | (4.8) | (7.9) | (12.8) |  | (25.6) |
| Other income (expense): |  |  |  |  |  |
| Interest expense, net | (0.1) | (0.1) | (0.3) |  | (3.0) |
| Common stock warrant liability adjustment | (0.7) | 2.4 | 9.5 |  | 2.7 |
| Other income (expense), net | — | — | 0.1 |  | (0.1) |
| Total other income (expense), net | (0.8) | 2.2 | 9.4 |  | (0.4) |
| Loss before income tax provision | (5.6) | (5.6) | (3.5) |  | (26.0) |
| Income tax provision | 0.0 | 0.0 | 0.0 | — | 0.0 |
| Net loss and comprehensive loss | (5.6) | (5.6) | (3.5) |  | (26.0) |

### Revenues

*(dollars in millions)*

|  | Three Months Ended September 30, 2024 | 2023 | Change $% |  | Nine Months Ended September 30, 2024 | 2023 | Change $% |  |
| --- | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: |
| Revenues | $22.1 | $9.2 | $12.9 | 140.9% | $57.6 | $33.0 | $24.6 | 74.4% |

Revenues increased by $12.9 million, or 140.9%, from $9.2 million for the three months ended September 30, 2023 to $22.1 million for the three months ended September 30, 2024. The increase was primarily due to higher sales of Dream Sock products, reflecting an increase in consumer demand across all sales channels as compared to the same period in the prior year. During the three months ended September 30, 2023, we signed a new distribution agreement with a large retailer that offered more favorable terms. As a result, certain sales were delayed until the three months ended December 31, 2023, which reduced revenue for the three months ended September 30, 2023.

Revenues increased by $24.6 million, or 74.4%, from $33.0 million for the nine months ended September 30, 2023 to $57.6 million for the nine months ended September 30, 2024. The increase was primarily due to higher sales of Dream Sock products, reflecting an increase in consumer demand across all sales channels as compared to the same period in the prior year.

### Cost of Revenues and Gross Profit

*(dollars in millions)*

|  | Three Months Ended September 30, 2024 | 2023 | Change $% |  | Nine Months Ended September 30, 2024 | 2023 | Change $% |  |
| --- | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: |
| Cost of revenues | $10.6 | $5.9 | $4.7 | 80.7% | $29.2 | $20.3 | $8.9 | 44.0% |
| Gross profit | $11.5 | $3.3 | $8.2 | 246.8% | $28.3 | $12.7 | $15.6 | 122.9% |
| Gross margin | 52.2% | 36.3% |  |  | 49.2% | 38.5% |  |  |

31

Cost of revenues increased by $4.7 million, or 80.7%, from $5.9 million for the three months ended September 30, 2023 to $10.6 million for the three months ended September 30, 2024. The increase was primarily due to the increase in product sales. Gross margin increased from 36.3% for the three months ended September 30, 2023 to 52.2% for the three months ended September 30, 2024 primarily due to higher revenue and lower direct product and fulfillment costs.

Cost of revenues increased by $8.9 million, or 44.0%, from $20.3 million for the nine months ended September 30, 2023 to $29.2 million for the nine months ended September 30, 2024. The increase was primarily due to the increase in product sales. Gross margin increased from 38.5% for the nine months ended September 30, 2023 to 49.2% for the nine months ended September 30, 2024 primarily due to higher revenue and lower direct product and fulfillment costs.

### General and Administrative

*(dollars in millions)*

|  | Three Months Ended September 30, 2024 | 2023 | Change $% |  | Nine Months Ended September 30, 2024 | 2023 | Change $% |  |
| --- | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: |
| General and administrative | $9.8 | $5.4 | $4.3 | 79.6% | $22.1 | $20.4 | $1.7 | 8.3% |

General and administrative expense increased by $4.3 million, or 79.6%, from $5.4 million for the three months ended September 30, 2023 to $9.8 million for the three months ended September 30, 2024. The increase was driven primarily by impairment charges related to intangible assets and higher compensation expense, including accrued bonuses, severance-related expenses, and stock-based compensation as compared to the same period in the prior year.

General and administrative expense increased by $1.7 million, or 8.3%, from $20.4 million for the nine months ended September 30, 2023 to $22.1 million for the nine months ended September 30, 2024. The increase was driven primarily by impairment charges related to intangible assets and higher compensation expense, including accrued bonuses, severance-related expenses, and stock-based compensation, partially offset by lower consulting and outside services spend related to transaction costs as compared to the same period in the prior year.

### Sales and Marketing

*(dollars in millions)*

|  | Three Months Ended September 30, 2024 | 2023 | Change $% |  | Nine Months Ended September 30, 2024 | 2023 | Change $% |  |
| --- | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: |
| Sales and marketing | $4.0 | $3.3 | $0.7 | 20.6% | $11.8 | $9.8 | $2.0 | 20.5% |

Sales and marketing expense increased by $0.7 million, or 20.6%, from $3.3 million for the three months ended September 30, 2023 to $4.0 million for the three months ended September 30, 2024. The increase was driven primarily by higher compensation expense due to accrued bonuses as well as higher spend on brand and content expenses as compared to the same period in the prior year.

Sales and marketing expense increased by $2.0 million, or 20.5%, from $9.8 million for the nine months ended September 30, 2023 to $11.8 million for the nine months ended September 30, 2024. The increase was driven primarily by higher compensation expense due to accrued bonuses and higher spend on social media marketing and public relations as compared to the same period in the prior year.

### Research and Development

*(dollars in millions)*

|  | Three Months Ended September 30, 2024 | 2023 | Change $% |  | Nine Months Ended September 30, 2024 | 2023 | Change $% |  |
| --- | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: |
| Research and development | $2.6 | $2.4 | $0.1 | 5.5% | $7.3 | $8.1 | $(0.8) | (9.9%) |

Research and development expense increased by $0.1 million, or 5.5%, from $2.4 million for the three months ended September 30, 2023 to $2.6 million for the three months ended September 30, 2024. The increase was driven primarily by higher compensation expense, including accrued bonuses and severance-related expenses, partially offset by costs capitalized related to internal-use software as compared to the same period in the prior year.

Research and development expense decreased by $0.8 million, or 9.9%, from $8.1 million for the nine months ended September 30, 2023 to $7.3 million for the nine months ended September 30, 2024. The decrease was driven primarily by lower stock-based compensation expense, lower regulatory testing, and costs capitalized related to internal-use software, partially offset by accrued bonuses and severance-related expenses as compared to the same period in the prior year.

### Other Income (Expense)

*(dollars in millions)*

|  | Three Months Ended September 30, 2024 | 2023 | Change $% |  | Nine Months Ended September 30, 2024 | 2023 | Change $% |  |
| --- | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: |
| Interest expense, net | $(0.1) | $(0.1) | $— | 16.4% | $(0.3) | $(3.0) | $2.7 | (91.6%) |
| Common stock warrant liability adjustment | $(0.7) | $2.4 | $(3.1) | (128.1%) | $9.5 | $2.7 | $6.9 | 255.9% |
| Other income (expense), net | $— | $— | $— | NM\* | $0.1 | $(0.1) | $0.2 | NM\* |

\*Not meaningful ("NM").

Interest expense, net for the three months ended September 30, 2024 was mostly flat as compared to the same period in the prior year. Interest expense, net for the three months ended September 30, 2024 included $0.3 million of termination fees related to the SVB term loan and $0.2 million of other interest expense, partially offset by a $0.5 million gain on interest for forgiveness of interest accrued related to an arrangement with a significant vendor that was fully settled in September 2024.

Interest expense decreased by $2.7 million, from $3.0 million for the nine months ended September 30, 2023 to $0.3 million for the nine months ended September 30, 2024. During the nine months ended September 30, 2023, we entered into an agreement with a significant vendor to pay $3.0 million of interest over 36 months with respect to past due payables. The present value of the future payments was expensed and included within interest expense, net on the condensed consolidated statements of operations in that period. In January 2024, the agreement was amended and the schedule of interest payments was modified from 36 months to 28 months, but the amount of interest payable was unchanged. In September 2024, the agreement was amended again, allowing us to terminate the agreement with a final interest payment of $0.6 million, which was then fully settled in September 2024. The reduction in the total cumulative interest payments to $2.2 million resulted in us recording a reduction of interest expense at termination of $0.5 million.

For the three months ended September 30, 2024, we recognized a loss of $0.7 million as compared to a gain of $2.4 million for the same period in the prior year, resulting from an increase in the fair value of common stock warrants outstanding. The loss recognized for the three months ended September 30, 2024 included the increase in fair value of the Series B Warrants that were issued in February 2024, which were not outstanding during the same period in the prior year. The gain of $2.4 million for the three months ended September 30, 2023 resulted from a decrease in the fair value of common stock warrants outstanding.

For the nine months ended September 30, 2024, we recognized a gain of $9.5 million as compared to a gain of $2.7 million for the same period in the prior year resulting from a larger decrease in the fair value of common stock warrants outstanding. Additionally, the gain recognized for the nine months ended September 30, 2024 included the decrease in fair value of the Series B Warrants that were issued in February 2024, which were not outstanding during the same period in the prior year.

### Liquidity and Capital Resources

We have historically funded our operations primarily with proceeds from issuances of our convertible preferred stock, issuances of our common stock, borrowings under our loan facilities, issuances of convertible promissory notes, and sales of our products and services. As of September 30, 2024, we had cash and cash equivalents of $21.5 million.

### September 2024 Offering

On September 11, 2024, we entered into the underwriting agreement and issued 3,135,136 shares of our common stock at a price to the public of $3.70 per share, less underwriting discounts and commissions. The net proceeds we received at the closing of the offering on September 13, 2024 were $10.6 million. In addition, we incurred $0.7 million in issuance costs that were unpaid as of September 30, 2024. We provided the underwriter a discount of 7% off the offering price. We also reimbursed the underwriters for $0.2 million in fees and expenses, including legal expenses, out-of-pocket expenses, and clearing expenses.

Pursuant to the underwriting agreement, we also issued, as a portion of the underwriting compensation payable to the underwriter, a warrant to purchase up to 125,405 shares of our common stock (which was subsequently transferred to certain affiliates of the underwriter, the “Titan Warrants”). The Titan Warrants are initially exercisable on March 13, 2025 at an exercise price of $4.63 and have a term of five years from such initial exercise date.

### February 2024 Offering

On February 25, 2024, we entered into a private placement investment agreement with certain investors, pursuant to which we issued and sold to the investors (i) an aggregate of 9,250 shares of our Series B convertible preferred stock, par value $0.0001 per share and (ii) warrants to purchase an aggregate of 1,799,021 shares of our common stock, par value $0.0001 per share (the “Series B Warrants”), for an aggregate gross purchase price of $9.3 million.

Each of the Series B Warrants sold in the private placement offering is exercisable for one share of common stock at an exercise price of $7.71 per share, is immediately exercisable, and will expire on March 1, 2029. As the Series B Warrants could require cash settlement in certain scenarios, the warrants were classified as liabilities upon issuance and were initially recorded at an aggregate estimated fair value of $6.9 million. The total proceeds from the offering were first allocated to the liability-classified warrants, based on their fair values, with the residual $2.4 million allocated to the Series B convertible preferred stock.

We incurred $0.4 million of issuance costs related to the offering. Issuance costs allocated to the preferred stock of $0.1 million were recorded as a reduction to the Series B convertible preferred stock.

### Funding Requirements

In accordance with ASU No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40), we have evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within one year after the date that the accompanying condensed consolidated financial statements included elsewhere in this Report are issued.

Since inception, we have experienced recurring operating losses and generated negative cash flows from operations, resulting in an accumulated deficit of $259.1 million as of September 30, 2024. During the nine months ended September 30, 2024 and 2023, we had negative cash flows from operations of $14.5 million and $22.0 million, respectively. As of September 30, 2024, we had $21.5 million of cash on hand.

Recurring operating losses, negative cash flows from operations since inception, and a low cash balance relative to current obligations raise substantial doubt about our ability to continue as a going concern within one year after the date that the accompanying condensed consolidated financial statements included elsewhere in this Report are issued. The condensed consolidated financial statements included elsewhere in this Report have been prepared on a going concern basis and accordingly, do not include any adjustments relating to the recoverability and classification of asset carrying amounts, or the amount and classification of liabilities that might result should we be unable to continue as a going concern.

As we continue to address these financial conditions, we have undertaken the following actions:

- As described above, in September 2024, we issued 3,135,136 shares of common stock for aggregate net proceeds of $9.8 million. In February 2024, we consummated a sale of preferred stock and warrants to purchase our common stock for aggregate net proceeds of $8.9 million.
- As described below and in Note 4, *Debt and Other Financing Arrangements* within the Notes to Condensed Consolidated Financial Statements, in September 2024, we entered into a loan facility agreement with WTI Fund X, Inc. and WTI Fund XI, Inc. (collectively “WTI”) for a term loan facility of up to $15.0 million (the “WTI Loan Facility”). On September 11, 2024, we entered into an asset-based revolving credit facility (the "ABL Line of Credit") with a maximum revolving commitment of up to $15.0 million. In connection with these transactions, we used our then-existing cash to repay and extinguish all borrowings outstanding under the line of credit and term loan agreements with SVB and initiated a drawdown of $7.5 million under the WTI Loan Facility.

We have not generated sufficient cash flows from operations to satisfy our capital requirements. There can be no assurance that we will generate sufficient future cash flows from operations due to potential factors, including but not limited to inflation, recession, or reduced demand for our products. If revenues decrease from current levels, we may be unable to further reduce costs, or such reductions may limit our ability to pursue strategic initiatives and grow revenues in the future.

There can be no assurance that we will be able to obtain additional financing on terms acceptable to us, if at all. Failure to secure additional funding may require us to modify, delay or abandon some of our planned future development, or to otherwise enact further operating cost reductions, which could have a material adverse effect on our business, operating results, financial condition and ability to achieve our intended business objectives.

If we raise additional funds through further 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. If we are unable to obtain adequate financing or financing on terms satisfactory to us when we require it, our ability to continue to pursue our business objectives and to respond to business opportunities, challenges, or unforeseen circumstances could be significantly limited, and our business, financial condition and results of operations could be materially adversely affected.

We also could be required to seek funds through arrangements with partners or others that may require us to relinquish rights or jointly own some aspects of our technologies, products or services that we would otherwise pursue on our own.

### SVB Revolver and Term Loan

On November 23, 2022, we entered into the Third Amended and Restated Loan and Security Agreement (as amended, the “LSA”) with SVB. The LSA provided for a $10.0 million revolving line of credit (the “SVB Revolver”) and for a $8.5 million term loan, which amortized with equal monthly installments of $0.5 million that would have matured on October 1, 2024.

On September 11, 2024, we used existing cash to prepay and extinguish all borrowings outstanding under the LSA. In addition to normal principal and interest, we paid $0.8 million to extinguish this loan, $0.3 million of which was recorded as interest income (expense), net.

### WTI Loan Facility

On September 11, 2024 (the “Effective Date”), we entered into the WTI Loan Facility with WTI. We initiated our first drawdown under the WTI Loan Facility of $7.5 million (the “Initial Loan”) shortly after closing.

The WTI Loan Facility consists of two tranches. The first tranche of $10.0 million was available at closing and through September 30, 2024, with $2.5 million of the first tranche availability extendable until December 31, 2024 (the “First Tranche Commitment”). The second tranche of $5.0 million is available through August 15, 2025 (the ‘Second Tranche Commitment”, or together with the First Tranche Commitment, the “Loan Commitments”) upon achievement of (a) at least $48.6 million in revenue for the period commencing October 1, 2024 and ending June 30, 2025 (the “Second Tranche Condition Period”), (b) total cash burn during the Second Tranche Condition Period not to exceed $0.6 million for such period, (c) receipt by us of at least $6.0 million of net proceeds from an equity financing during a period commencing on the closing date and ending on the second tranche borrowing date, and (d) receipt by WTI of our then-current, board-approved operating and financing plan to WTI's satisfaction, as well as compliance with certain reporting conditions. The remaining $2.5 million of the First Tranche Commitment is available until December 31, 2024. Once repaid, we cannot reborrow from the WTI Loan Facility.

We have the option to prepay the outstanding loans issued under the WTI Loan Facility in whole at any time by repaying all outstanding principal and accrued interest, as well as all scheduled unpaid interest on the loan, including payment-in-kind interest (“PIK Interest”), as if the loan continued to accrue interest through its stated maturity. Provided if the fully diluted market capitalization of our Class A common stock (“common stock”) is greater than or equal to $250.0 million for 10 consecutive Trading Days, then so long as such prepayment is made within 60 days thereafter, the redemption price will be discounted by 30% of the total amount of all scheduled but unpaid interest (but excluding any PIK Interest, which will not be discounted).

The WTI Loan Facility contains certain reporting and operational covenants that must be met for us to borrow funds under the Loan Commitments and not cause an event of default. Upon the occurrence of an event of default, WTI could elect to force redemption of the outstanding balances under the WTI Loan Facility, requiring us to pay all outstanding principal and accrued interest, as well as all scheduled unpaid interest on the loan, including PIK interest. Upon the occurrence of an event of default, we will also be required to pay default interest on any overdue balances at a rate of 5.0%. The WTI Loan Facility and any loans and obligations issued thereunder are collateralized by substantially all of our assets and are guaranteed by us. As of September 30, 2024, we were in compliance with all financial covenants associated with the WTI Loan Facility.

As partial consideration for the availability and funding of the WTI Loan Facility, we entered into a Stock Issuance Agreement (the “WTI Stock Issuance Agreement”) with WTI Fund X, LLC (“Fund X”) and WTI Fund XI, LLC (“Fund XI”, and together with Fund X, the “WTI Funds”), dated as of the Effective Date. Pursuant to the WTI Stock Issuance Agreement, we issued to the WTI Funds an aggregate of 750,000 shares of redeemable common stock on the Effective Date, of which 187,500 are subject to forfeiture in the event that we do not draw on any portion of the remaining outstanding Loan Commitment. To the extent we do exercise our option under the Loan Commitments to issue additional debt, a number of forfeitable shares will 'vest' and no longer be subject to forfeiture based on the pro rata portion of the outstanding Loan Commitments drawn against.

The shares issued to WTI pursuant to the WTI Stock Issuance Agreement contain an embedded redemption option (the"Redemption Option") such that WTI may elect to force us to redeem the shares that are no longer subject to forfeiture for a price of $8.40 per share. The Redemption Option may be exercised, with respect to any amount that is equal to or less than the entire balance of such shares, at any time during the period commencing on the first trading day following the fifth anniversary of the Effective Date and continuing through the date which is 10 years after the Effective Date, subject to certain acceleration provisions set forth in the WTI Stock Issuance Agreement. We have also granted the WTI Funds an option (the “Exchange Option”) to exchange all or any portion of the shares issued pursuant to the WTI Stock Issuance Agreement that are vested and held by the WTI Funds at the time of exercise of the Exchange Option for shares of capital stock in any successor entity under certain circumstances, subject to certain conditions set forth in the WTI Stock Issuance Agreement, as well as certain rights to participate in certain future offerings.

### ABL Line of Credit

On September 11, 2024 (the “Effective Date”), we entered into a Credit and Security Agreement (the “Credit Agreement”), which provides for an asset-based revolving credit facility (the “ABL Line of Credit”) with a maximum principal amount of up to $15.0 million. The maximum amount shall increase to $20.0 million on September 11, 2025. The ABL Line of Credit is collateralized by substantially all of our assets. Loans and other obligations under the Credit Agreement bear interest at a rate per annum equal to the 1-month Secured Overnight Financing Rate (subject to a floor of 3.50%) plus a margin, which varies between 7.50% and 8.50% depending on the our earnings before interest, taxes, depreciation and amortization (“EBITDA”); provided that the interest rate shall not exceed the maximum rate permitted under applicable law.

The ABL Line of Credit matures on September 10, 2027 (the “Maturity Date”). If for any reason the Credit Agreement is terminated or all outstanding loans and other obligations are paid in full and the ABL Line of Credit is terminated before the Maturity Date, we will be obligated to pay a prepayment fee equal to a percentage of the then-current Revolving Commitment, which percentage decreases on certain anniversary of the closing date.

The Credit Agreement contains representations, warranties, covenants, and events of default customary for agreements of this type. As of September 30, 2024, we were in compliance with all financial covenants associated with the Credit Agreement and there was $9.9 million of outstanding borrowings. As of September 30, 2024, the borrowing base availability under the Credit Agreement was $0.7 million.

### Financed Insurance Premium

In July 2024, we renewed our corporate directors & officers and employment liability policies and entered into several new short-term commercial premium finance agreements with First Insurance Funding totaling $0.6 million to be paid within one year, accruing interest at a weighted average rate of 8.6%. As of September 30, 2024, the remaining principal balance on the combined financed insurance premiums was $0.5 million.

### Cash Flows

The following table summarizes our cash flow (in millions):

|  | Nine Months Ended September 30, 2024 | 2023 |
| --- | ---: | ---: |
| Net cash used in operating activities | $(14.5) | $(22.0) |
| Net cash used in investing activities | (0.7) | — |
| Net cash provided by financing activities | 20.6 | 25.9 |
| Net change in cash and cash equivalents | $5.3 | $3.9 |

#### Operating Activities

For the nine months ended September 30, 2024, net cash used in operating activities was $14.5 million as compared to net cash used in operating activities of $22.0 million in the prior year. The change in operating cash flows was primarily driven by a lower operating loss, which was $12.8 million for the nine months ended September 30, 2024 as compared to an operating loss of $25.6 million for the same period in the prior year.

#### Investing Activities

For the nine months ended September 30, 2024, we used $0.7 million to invest in various projects, including the development of our new subscription app. For the nine months ended September 30, 2023, we used substantially no cash for investing activities due to the prioritization of research and development projects that supported seeking regulatory clearances for our products.

#### Financing Activities

For the nine months ended September 30, 2024 and 2023, net cash provided by financing activities was $20.6 million and $25.9 million, respectively. The decrease is primarily driven by the higher amount proceeds raised by the Series A preferred stock offering in February 2023 as compared to the combined proceeds raised by the common stock offering in September 2024 and the Series B preferred stock offering in February 2024. Additionally, in September 2024, we drew down $7.5 million under the WTI Loan Facility and we made payments on the Term Loan totaling $5.0 million during the nine months ended September 30, 2024, compared to payments totaling $2.0 million during the nine months ended September 30, 2023.

### Critical Accounting Policies and Estimates

There have been no material changes from the critical accounting policies and estimates disclosed in our Form 10-K, other than policies disclosed in this Report.

## Market risk

As filed, 163 characters.

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information otherwise required under this Item.

## Controls and procedures

As filed, 8,151 characters.

### Limitations on Effectiveness of Controls and Procedures

In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs.

### Evaluation of Disclosure Controls and Procedures

Disclosure controls and procedures (as such terms are defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) are designed to provide reasonable assurance that information required to be disclosed by us in our Exchange Act reports is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.

Our management, with the participation of our principal executive officer and principal financial officer, evaluated, as of September 30, 2024, the effectiveness of our disclosure controls and procedures (as that term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Based on that evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were not effective as of September 30, 2024 due to the material weaknesses in our internal control over financial reporting described below.

### Material Weaknesses in Internal Control over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Rules 13(a)-15(f) and 15(d)-15(f) under the Exchange Act.

A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the Company's annual or interim financial statements will not be prevented or detected on a timely basis. The following material weaknesses in our internal control over financial reporting exist as of September 30, 2024.

We did not design and maintain an effective control environment commensurate with our financial reporting requirements. Specifically, we did not maintain a sufficient complement of personnel with an appropriate degree of internal controls and accounting knowledge, experience, and training commensurate with our accounting and financial reporting requirements. This material weakness contributed to the following additional material weaknesses:

- We did not design and maintain effective controls over the segregation of duties related to journal entries. Specifically, certain personnel have the ability to both create and post journal entries within the Company’s general ledger system. This material weakness did not result in any adjustments to the consolidated financial statements.
- We did not design and maintain effective controls over the accounting for the accuracy and existence of inventory, nor controls which verified the completeness and accuracy of accrued liabilities. Each of these material weaknesses resulted in immaterial adjustments that were recorded as out-of-period adjustments within the year ended December 31, 2022.
- We did not design and maintain effective controls over the accounting for convertible preferred stock and warrant arrangements. Further, we did not design and maintain effective controls to verify the completeness and accuracy of sales returns and accrued sales tax. Each of these material weaknesses resulted in material adjustments to several account balances and disclosures in the consolidated financial statements as of and for the year ended December 31, 2019. The sales returns material weakness also resulted in immaterial adjustments to revenue and accrued and other expenses as of and for the year ended December 31, 2022. The material weakness for accounting for convertible preferred stock and warrant arrangements also resulted in immaterial adjustments that were recorded as out-of-period adjustments within the three and nine-months ended September 30, 2024.
- We did not design and maintain effective controls over IT general controls for information systems that are relevant to the preparation of our consolidated financial statements. Specifically, we did not design and maintain (i) program change management controls to ensure that IT program and data changes affecting financial IT applications and underlying accounting records are identified, tested, authorized and implemented appropriately, (ii) user access controls to ensure appropriate segregation of duties and that adequately restrict user and privileged access to financial applications, programs, and data to appropriate Company personnel, (iii) computer operations controls to ensure that critical batch jobs are monitored, and data backups are authorized and monitored, and (iv) testing and approval controls for program development to ensure that new software development is aligned with business and IT requirements. This material weakness did not result in any adjustments to the consolidated financial statements.

Additionally, each of the material weaknesses described above could result in a misstatement of one or more account balances or disclosures that would result in a material misstatement to the interim or annual consolidated financial statements that would not be prevented or detected.

### Remediation Plan

We have initiated a plan to remediate these material weaknesses. The remediation measures will be ongoing, and although not all inclusive, remediation measures include hiring additional accounting and financial reporting personnel and implementing additional policies, procedures and controls, all of which will result in future costs for the Company.

We have taken actions to improve our IT general controls, segregation of duties over journal entries controls, inventory controls, accrued liabilities, and warrant arrangements. However, the material weaknesses will not be considered remediated until our remediation plan has been fully implemented, the applicable controls operate for a sufficient period of time, and we have concluded, through testing, that the newly implemented and enhanced controls are operating effectively.

During the three months ended September 30, 2024, we have taken actions to enhance the design of the controls we believe are necessary to remediate the material weaknesses related to the sales returns, accrued sales tax, and convertible preferred stock and warrant arrangements. While these enhancements to the design of the controls have been implemented as of September 30, 2024, we may determine the need to make further enhancements to the design of these controls. These material weaknesses will not be considered remediated until our remediation plan has been fully implemented, the applicable controls operate for a sufficient period of time, and we have concluded, through testing, that the newly implemented and enhanced controls are operating effectively.

Notwithstanding the above, our management believes that the consolidated financial statements included in this Report on Form 10-Q state fairly in all material respects our financial position, results of operations and cash flows for the periods presented.

### Changes in Internal Control over Financial Reporting

Other than the remediation efforts described above, there have been no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the three months ended September 30, 2024 that have materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

## Risk factors

As filed, 23,705 characters.

Our business, financial condition and operating results can be affected by a number of factors, including but not limited to those described as risk factors, any one or more of which could, directly or indirectly, cause our actual operating results and financial condition to vary materially from past, or anticipated future, operating results and financial condition. For a discussion of these potential risks and uncertainties, see Part I, Item 1A. "Risk Factors" in our Form 10-K, as supplemented by the risk factors below. Any of these factors, in whole or in part, could materially and adversely affect our business, financial condition, operating results and the price of our common stock.

### Risks Related to Our Business and Operations

***If any governmental authority or notified body were to require marketing authorization or similar certification for any product that we sell for which we have not obtained such marketing authorization or certification, we could be subject to regulatory enforcement actions and/or be required to cease selling or recall the product pending receipt of marketing authorization or similar certification from such other governmental authority or notified body, which can be a lengthy and time-consuming process, harm financial results and have long-term negative effects on our operations.***

We currently sell Smart Sock and Dream Sock in certain countries outside of the U.S., and we have not obtained medical device marketing authorizations, approvals, or certifications from any governmental authority or notified body, other than from the U.S. Food and Drug Administration ("FDA") for Dream Sock and BabySat and from the notified body BSI under European Union (“EU”) and United Kingdom (“UK”) EU Medical Devices Regulation (2017/745 or “MDR”) for Dream Sock. In response to inquiries from the FDA and regulatory authorities in other jurisdictions regarding the marketing of Smart Sock and Dream Sock (in the case of the FDA, prior to ceasing distribution of Smart Sock and prior to our recent marketing authorization for Dream Sock Health Notifications features), we had communicated our beliefs that such products are not medical devices that require medical device or similar marketing authorization or certification from such other regulatory authorities or notified bodies. However, certain regulatory authorities had expressed that they did not agree with that conclusion and in some instances required us to obtain marketing authorization, such as a clearance or approval, or other certification to continue to sell the product.

For example, Owlet has been corresponding with the Medical Devices Directorate, Canada's medical device regulatory authority within Health Canada, regarding the device classification requirements of Smart Sock and Dream Sock. As a result of these exchanges, Owlet ceased selling and advertising Smart Sock in Canada on December 10, 2021. We have, however, marketed and sold Dream Sock in Canada since January 2022. Health Canada, the regulatory authority responsible for the Canadian medical device market, initially asserted that Dream Sock was a medical device that can no longer be sold in Canada unless a relevant license has been issued. In the second half of 2022, we responded with our position that Dream Sock is not a medical device, and Health Canada has not affirmatively concluded that it agrees or disagrees with our position. If Health Canada does not agree with our position, we may be required to cease distribution of the product into the Canadian market and may be subject to enforcement action.

Obtaining and maintaining authorization or certification to sell any of our products as medical devices is a time-consuming and costly process and we may be precluded from selling such products if we are required to obtain marketing authorization, such as a clearance or approval, or other certification, and maintain such authorizations if received. The path to market varies among international jurisdictions and may require additional or different product testing than required to obtain FDA marketing authorization. Certifications or marketing authorizations from one foreign regulatory authority or notified body does not ensure certification or marketing authorization by any other foreign regulatory authority or notified body or by the FDA. If we fail to receive necessary certifications or marketing authorizations to commercialize our products in any jurisdictions on a timely basis, or at all, or if we later lose such certifications or marketing authorizations, our business, financial condition and results of operations could be adversely affected. Furthermore, regulatory requirements may change from time to time, which could adversely affect our ability to market new products and services, or continue to market existing products and services. Moreover, even if granted, a marketing authorization or certification could require conditions to sale, such as a prescription requirement. If regulatory authorities require such marketing authorization, including clearance or approval, or other certifications for the products that we sell, we could be subject to regulatory enforcement action, time-consuming and costly marketing authorization and certification application processes, or required to cease selling or to recall the product in the corresponding jurisdiction pending receipt of such marketing authorization or certification. We also could be required to modify the product’s functionality or limit our marketing claims for the product, whether or not we obtain such marketing authorization or other required certification. In any such event, our business could be substantially harmed.

***We are involved, and may become involved in the future, in disputes and other legal or regulatory proceedings that, if adversely decided or settled, could materially and adversely affect our business, financial condition and results of operations.***

We are, and may in the future become, party to litigation, regulatory proceedings or other disputes. In general, claims made by or against us in disputes and other legal or regulatory proceedings can be expensive and time-consuming to bring or defend against, requiring us to expend significant resources and divert the efforts and attention of our management and other personnel from our business operations. These potential claims may include but are not limited to personal injury and class action lawsuits, intellectual property claims and regulatory investigations relating to the advertising and promotional claims about our products and services and employee claims against us based on, among other things, discrimination, harassment or wrongful termination. Any one of these claims, even those without merit, may divert our financial and management resources that would otherwise be used to benefit the future performance of our operations. Any adverse determination against us in these proceedings, or even the allegations contained in the claims, regardless of whether they are ultimately found to be without merit, may also result in settlements, injunctions or damages that could have a material adverse effect on our business, financial condition and results of operations.

Additionally, in the past, securities class action litigation has often been brought against a company following a decline in the market price of its securities. In November 2021, two putative class action complaints were filed against us in the U.S. District Court for the Central District of California. Both complaints alleged violations of the Exchange Act against the Company and certain of our officers and directors on behalf of a putative class of investors who: (a) purchased the Company’s common stock between March 31, 2021 and October 4, 2021 (“Section 10(b) Claims”); or (b) held common stock in SBG as of June 1, 2021, and were eligible to vote at SBG's special meeting held on July 14, 2021 (“Section 14(a) Claims”). Both complaints allege, among other things, that we and certain of our officers and directors made false and/or misleading statements and failed to disclose certain information regarding the FDA’s likely classification of the Owlet Smart Sock as a medical device requiring marketing authorization. On September 8, 2023, the Court ruled that while the two cases were consolidated, there would be two distinct and separate classes to represent the Section 10(b) Claims and Section 14(a) Claims, respectively, and appointed lead plaintiffs and lead counsel. An amended complaint was filed for both classes on November 21, 2023, and then further amended and consolidated filings by the plaintiffs’ counsel on December 22, 2023. The Company intends to vigorously defend itself against these claims and filed on February 9, 2024 motions to dismiss the cases in response to these complaints, on behalf of itself and the named officers and directors. The plaintiffs filed oppositions to the motions to dismiss on March 24, 2024, and the Company filed replies in support of the motions to dismiss on May 10, 2024. On August 5, 2024, the Court denied Owlet’s and its officers’ motions to dismiss the Section 10(b) Claims and the Section 14(a) Claims. On September 24, 2024, the Court entered a scheduling order in the case, setting trial to begin on February 17, 2026. On September 26, 2024, the Court granted Owlet’s and its officers’ motion for reconsideration regarding the Section 10(b) Claims and dismissed all claims arising out of statements made prior to the merger.

Further, on August 26, 2024 and October 3, 2024, investors filed in the U.S. District Court for the Central District of California, derivatively on behalf of the Company, complaints asserting claims for violations of Section 14(a) of the Exchange Act, as well as state law claims, including breach of fiduciary duty, unjust enrichment and waste of corporate assets. One complaint (captioned *Janet Vargas, Derivatively on Behalf of Nominal Defendant Owlet, Inc.*, Case No. 2:24-cv-07258-FLA-PVC) asserts claims against twelve of the Company’s current or former directors and officers and six current or former directors and officers of Sandbridge Acquisition Corporation. The other (captioned *Nathan Capleton, Derivatively on Behalf of Nominal Defendant Owlet, Inc.*, Case No. 2:24-cv-08536-JAK-MAA) asserts claims against eleven of the Company’s current or former directors. Both complaints leverage the allegations made in one of the securities class action complaints. Neither complaint specifies the damages claimed in the action.

These lawsuits and any future lawsuits to which we may become a party are subject to inherent uncertainties and will likely be expensive and time-consuming to investigate, defend and resolve. Any litigation to which we are a party may result in an onerous or unfavorable judgment that may not be reversed upon appeal, or in payments of substantial monetary damages or fines, or we may decide to settle this or other lawsuits on similarly unfavorable terms, which could have a material adverse effect on our business, financial condition, results of operations or stock price.

### Risks Related to Regulation of Our Industry and Products

***Marketing authorization for our prescription-required BabySat pediatric monitor does not ensure commercial success of this product. Successful commercialization of this product will require us to implement processes, procedures and operations necessary to market and sell medical devices. We may not be successful in implementing these conditions, which could subject us to new risks.***

In June 2023, we received our first medical device marketing authorization with the 510(k) clearance from the FDA for BabySat, a prescription use-only pulse oximeter indicated for use in the home environment that measures and displays functional oxygen saturation of arterial hemoglobin and pulse rate and for spot-checking and/or continuous monitoring of well-perfused patients greater than one month old up to 18 months old and weighing between 6 and 30 pounds. In order to market and distribute BabySat or other similar medical devices, we will need to modify certain of our internal business operations so that they comply with medical device requirements and to enable distribution of the product in accordance with the limitations of use described in our marketing authorizations. For example, as the 510(k) clearance for BabySat limits distribution of this product to prescription use-only, we will be unable to utilize the direct-to-consumer model we use to distribute Dream Sock and Owlet Cam (as well as Smart Sock, in certain countries outside of the U.S.). Though we are currently exploring several new distribution channels, including working with durable medical equipment distributors, healthcare institutions, and other healthcare payor and provider channels, we may not be successful in identifying, or implementing with our current resources, an appropriate distribution channel for BabySat. Further, even though we have received FDA clearance for BabySat, we will still need to demonstrate the business and clinical rationale and justifications of this product in order for healthcare institutions and providers to be convinced of the need to prescribe it, and we may not be successful in these efforts.

***We are required to maintain authorizations or certifications for our prescription-required BabySat pediatric monitor in the U.S. and for our Dream Sock with Health Notifications in the U.S., EU and UK in order to continue commercializing and selling these products in the named jurisdictions. Failure to maintain such authorizations or certifications on a timely basis, or at all, could severely harm our business.***

In June 2023, we received 510(k) clearance from the FDA for BabySat, a prescription use-only pulse oximeter indicated for use in the home environment designed to measure and display functional oxygen saturation of arterial hemoglobin and pulse rate and for spot-checking and/or continuous monitoring of well-perfused patients greater than one month old up to 18 months old and weighing between 6 and 30 pounds. In November 2023, we obtained de novo classification from the FDA for Dream Sock with Health Notifications. As such, both of these products are regulated as medical devices by the FDA, and we must continue to maintain compliance with medical device requirements with respect to the manufacture, sale, marketing, and distribution of these products.

The FDA’s interpretations of its laws and regulations are subject to change. If the FDA changes its policy or concludes that the marketing of any of our products is not in accordance with current policies, regulations or statutory requirements, or if the FDA changes its applicable policies or if changes are introduced to applicable laws or regulations, we may be required to seek clearance or approval or other marketing authorization for these products. If we do not timely comply with updated policies or requirements, we may not be permitted to continue marketing these products until marketing authorization is obtained, or may be the subject of regulatory enforcement actions or recalls. In addition, if safety or effectiveness problems are later identified by the FDA with any of our medical device products, we may need to initiate a product recall.

In March 2024 we received EU MDR certification for Dream Sock in the EU, and in May 2024 we received UKCA MDR certification for Dream Sock in the UK. We are currently marketing and selling Dream Sock in these jurisdictions.

In order to continue to sell medical devices in the EU, products must comply with the general safety and performance requirements of the EU MDR. Continued compliance with these requirements is a prerequisite to be able to affix the European Conformity (“CE”) mark to medical devices, without which they cannot be sold or marketed in the EU. All medical devices placed on the market in the EU must meet the general safety and performance requirements laid down in Annex I to the MDR including the requirement that a medical device must be designed and manufactured in such a way that, during normal conditions of use, it is suitable for its intended purpose. Medical devices must be safe and effective and must not compromise the clinical condition or safety of patients, or the safety and health of users and – where applicable – other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art. To demonstrate compliance with the general safety and performance requirements, we have undergone a conformity assessment in the form of a technical file review conducted by our notified body. Upon completion of the technical file review the notified body issued a certificate of conformity, which the manufacturer uses as a basis for its own declaration of conformity. The aforementioned EU rules are generally applicable in the EEA. Non-compliance with the above requirements would also prevent us from continued sales of medical devices in these countries.

Following Brexit, EU laws no longer apply directly in Great Britain. The regulations on medical devices in the UK continue to be based largely on the three EU Directives which preceded the EU MDR, as implemented into national law. However, under the terms of the Protocol on Ireland/Northern Ireland, the EU MDR does apply to Northern Ireland. Consequently, there are currently different regulations in place in the UK as compared to both Northern Ireland and the EU, respectively. Ongoing compliance with both sets of regulatory requirements may result in increased costs for our business.

In addition, quality system certifications, both ISO 13485 and MDSAP requirements must be maintained as evidence of ongoing compliance for continued sales of medical devices in the US, EU and UK. We undergo an annual assessment by our notified body of the application of the quality system requirements regarding design and development, product risk profiles and post market surveillance. Failure to maintain the quality system certifications could result in regulatory enforcement action, and/or suspension of sales pending corrective action.

***As we expand into international markets, we will be required to obtain and maintain regulatory authorizations, including clearances or approvals, or other certifications in order to commercialize certain of our products in certain international markets. Failure to obtain such regulatory authorizations or certifications in relevant foreign jurisdictions may prevent us from marketing medical device products abroad.***

We currently market and intend to continue to market our products and services internationally. We expect certain of our pipeline products to be regulated as medical devices, and we have received communications from certain regulatory authorities inquiring as to the regulatory status of our Smart Sock, and whether such product is regulated as a medical device in such jurisdictions. In these communications, some regulatory authorities have asserted that Smart Sock is a medical device that must comply with medical device requirements in those jurisdictions. See our risk factor titled, “If any governmental authority or notified body were to require marketing authorization or similar certification for any product that we sell for which we have not obtained such marketing authorization or certification, we could be subject to regulatory enforcement actions and/or be required to cease selling or recall the product pending receipt of marketing authorization or similar certification from such other governmental authority or notified body, which can be a lengthy and time-consuming process, harm financial results and have long-term negative effects on our operations."

### Risks Related to Our Common Stock and Warrants

***Our failure to meet the NYSE’s continued listing requirements could result in a delisting of our common stock.***

If we fail to satisfy the NYSE's continued listing requirements, the NYSE may take steps to delist our common stock. For example, in April 2023, we were notified by NYSE that we were not in compliance with Section 802.01B of the NYSE Listed Company Manual as the average global market capitalization of our common stock over a consecutive 30 trading-day period and, at the same time, our last reported stockholders’ equity were each less than $50 million. In May 2023, we submitted a business plan advising the NYSE of the definitive actions we had taken as of the date of that submission and were planning on taking in order to bring us into compliance with NYSE continued listing standards within 18 months of receipt of the NYSE Notification (the “Cure Period”). The plan was accepted by the NYSE in July 2023. On October 10, 2024, we received formal notice from the NYSE that we had regained compliance with the NYSE’s continued listing standards. As a result of our achievement of compliance with the NYSE’s minimum market capitalization requirement for the requisite period of time, the NYSE has advised us that we are no longer considered out of compliance with these continued listing standards, and the below compliance “BC” indicator has been removed from our Class A common stock. Additionally, we are no longer noted as being below continued listing standards on the NYSE’s website (www.nyse.com). In accordance with the NYSE’s Listed Company Manual, we will be subject to a 12-month follow-up period within which we will be reviewed to confirm that we do not once again fall below any of the NYSE’s continued listing standards. There can be no assurance that we will be able to maintain compliance with these or any other NYSE listing requirements during or after the 12-month follow-up period.

Delisting from the NYSE could make trading our common stock more difficult for investors, potentially leading to declines in our share price and liquidity. In addition, without a NYSE market listing, stockholders may have a difficult time getting a quote for the sale or purchase of our common stock, the sale or purchase of our common stock would likely be made more difficult and the trading volume and liquidity of our common stock could decline. Delisting from the NYSE could also result in negative publicity and could also make it more difficult for us to raise additional capital. The absence of such a listing may adversely affect the acceptance of our common stock as currency or the value accorded by other parties. If our common stock is delisted by the NYSE, our common stock may be eligible to trade on an over-the-counter quotation system, such as the OTCQB market, where an investor may find it more difficult to sell our common stock or obtain accurate quotations as to the market value of our common stock. We cannot assure you that our common stock, if delisted from the NYSE, would be eligible to be listed on another national securities exchange or quoted on an over-the counter quotation system.

Additionally, the National Securities Markets Improvement Act of 1996, which is a federal statute, prevents or preempts the states from regulating the sale of certain securities, which are referred to as “covered securities.” If our common stock were no longer listed on the NYSE or any other national exchange, our common stock would not qualify as covered securities under such statute, and we would be subject to regulation in each state in which we offer our securities.

Filed Nov 14, 2024.
Source: SEC EDGAR, the filing index for accession 0001628280-24-047870. Last ingested by Listed: Oct 24, 2026, 14:57 ET. No prices; not investment advice.