Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2021 | Oct. 31, 2021 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2021 | |
Current Fiscal Year End Date | --12-31 | |
Document Transition Report | false | |
Entity File Number | 001-34899 | |
Entity Registrant Name | Pulse Biosciences, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 46-5696597 | |
Entity Address, Address Line One | 3957 Point Eden Way | |
Entity Address, City or Town | Hayward | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94545 | |
City Area Code | 510 | |
Local Phone Number | 906-4600 | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Trading Symbol | PLSE | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 29,631,283 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q3 | |
Entity Central Index Key | 0001625101 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 41,991 | $ 12,463 |
Investments | 8,012 | |
Accounts receivable | 72 | |
Inventory | 4,281 | |
Prepaid expenses and other current assets | 2,866 | 1,864 |
Total current assets | 49,210 | 22,339 |
Property and equipment, net | 2,446 | 2,478 |
Intangible assets, net | 3,382 | 3,882 |
Goodwill | 2,791 | 2,791 |
Right-of-use assets | 8,954 | 9,438 |
Other assets | 365 | 365 |
Total assets | 67,148 | 41,293 |
Current liabilities: | ||
Accounts payable | 2,706 | 1,717 |
Accrued expenses | 4,971 | 5,326 |
Deferred revenue | 7 | |
Lease liability, current | 749 | 542 |
Note payable, current | 1,086 | |
Total current liabilities | 9,519 | 7,585 |
Lease liability, less current | 10,242 | 10,814 |
Total liabilities | 19,761 | 18,399 |
Commitments and contingencies (Note 8) | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value; authorized – 50,000 shares; no shares issued and outstanding | ||
Common stock, $0.001 par value: authorized – 500,000 shares; issued and outstanding – 29,631 shares and 25,550 shares at September 30, 2021 and December 31, 2020, respectively | 29 | 25 |
Additional paid-in-capital | 268,142 | 195,410 |
Accumulated other comprehensive loss | (1) | |
Accumulated deficit | (220,784) | (172,540) |
Total stockholders' equity | 47,387 | 22,894 |
Total liabilities and stockholders' equity | $ 67,148 | $ 41,293 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2021 | Dec. 31, 2020 |
Condensed Consolidated Balance Sheets [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 50,000,000 | 50,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 500,000,000 | 500,000,000 |
Common stock, shares issued | 29,631,000 | 25,550,000 |
Common stock, shares outstanding | 29,631,000 | 25,550,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements Of Operations And Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Revenues: | ||||
Total revenues | $ 574 | $ 574 | ||
Cost and expenses: | ||||
Cost of revenues | 727 | 727 | ||
Research and development | 6,460 | $ 6,968 | 22,982 | $ 19,019 |
Sales and marketing | 3,404 | 1,746 | 10,697 | 4,926 |
General and administrative | 4,256 | 4,191 | 13,772 | 12,264 |
Total costs and expenses | 14,847 | 12,905 | 48,178 | 36,209 |
Loss from operations | (14,273) | (12,905) | (47,604) | (36,209) |
Other income (expense): | ||||
Interest income (expense), net | (9) | 9 | (640) | 108 |
Total other income (expense) | (9) | 9 | (640) | 108 |
Net loss | (14,282) | (12,896) | (48,244) | (36,101) |
Other comprehensive gain (loss): | ||||
Unrealized gain (loss) on available-for-sale securities | 1 | 1 | (3) | |
Comprehensive loss | $ (14,282) | $ (12,895) | $ (48,243) | $ (36,104) |
Net loss per share: | ||||
Basic and diluted net loss per share | $ (0.48) | $ (0.51) | $ (1.76) | $ (1.60) |
Weighted average shares used to compute net loss per common share - basic and diluted | 29,612 | 25,223 | 27,400 | 22,540 |
Product [Member] | ||||
Revenues: | ||||
Total revenues | $ 574 | $ 574 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements Of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (48,244) | $ (36,101) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 349 | 310 |
Amortization of intangible assets | 500 | 499 |
Stock-based compensation | 10,990 | 7,686 |
Net premium amortization and discount on available-for-sale securities | 13 | (6) |
Loss on disposal of fixed assets | 119 | |
Gain on U.S. Treasury securities | (8) | |
Changes in operating assets and liabilities: | ||
Accounts receivable | (72) | |
Inventory | (4,281) | |
Prepaid expenses and other current assets | (2,087) | 431 |
Other receivables | 32 | |
Right-of-use assets | 484 | 352 |
Other long-term assets | 129 | |
Accounts payable | 975 | (595) |
Accrued expenses | (355) | 1,352 |
Deferred revenue | 7 | |
Lease liabilities | (365) | (104) |
Accrued interest on note payable | 651 | |
Other assets | (174) | |
Net cash used in operating activities | (41,403) | (26,110) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (303) | (162) |
Purchases of investments | (25,516) | |
Maturities of investments | 8,000 | 4,510 |
Sale of investments | 17,000 | |
Net cash provided by (used in) investing activities | 7,697 | (4,168) |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock under employee stock purchase plan | 810 | 490 |
Proceeds from exercises of warrants | 4,217 | 112 |
Proceeds from exercises of stock options | 678 | 349 |
Proceeds from issuance of common stock | 56,697 | 29,498 |
Proceeds from insurance loan agreement | 1,939 | |
Payments made on insurance loan agreement | (875) | |
Tax payments related to shares withheld for vested restricted stock units | (232) | |
Net cash provided by financing activities | 63,234 | 30,449 |
Net increase in cash and cash equivalents | 29,528 | 171 |
Cash and cash equivalents at beginning of period | 12,463 | 6,899 |
Cash and cash equivalents at end of period | 41,991 | 7,070 |
Supplemental disclosure of noncash investing and financing activities: | ||
Equipment purchases included in accounts payable and accrued expenses | 14 | 263 |
Change in unrealized gains on available-for-sale securities | 1 | (3) |
Accrued interest settled via issuance of common stock from private placement equity offering from private placement equity offering | $ 629 | |
Issuance costs for rights offering in accounts payable | $ 64 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Income (Loss) [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2019 | $ 21 | $ 153,401 | $ 4 | $ (122,689) | $ 30,737 |
Balance, shares at Dec. 31, 2019 | 20,825,000 | ||||
Issuance of shares upon exercise of stock options | 349 | 349 | |||
Issuance of shares upon exercise of stock options, shares | 86,000 | ||||
Issuance of shares under employee stock purchase plan | 490 | 490 | |||
Issuance of shares under employee stock purchase plan, shares | 83,000 | ||||
Issuance of shares upon exercise of warrants | 112 | 112 | |||
Issuance of shares upon exercise of warrants, shares | 16,000 | ||||
Issuance of common stock and warrants in connection with rights offering, net of issuance cost of $565 | $ 4 | 29,430 | 29,434 | ||
Issuance of common stock and warrants in connection with rights offering, net of issuance cost of $565, shares | 4,280,000 | ||||
Stock-based compensation expense | 7,686 | 7,686 | |||
Unrealized gain on available-for-sale securities | (3) | (3) | |||
Net loss | (36,101) | (36,101) | |||
Balance at Sep. 30, 2020 | $ 25 | 191,468 | 1 | (158,790) | 32,704 |
Balance, shares at Sep. 30, 2020 | 25,290,000 | ||||
Balance at Jun. 30, 2020 | $ 25 | 188,197 | (145,894) | 42,328 | |
Balance, shares at Jun. 30, 2020 | 25,149,000 | ||||
Issuance of shares upon exercise of stock options | 340 | 340 | |||
Issuance of shares upon exercise of stock options, shares | 85,000 | ||||
Issuance of shares under employee stock purchase plan | 235 | 235 | |||
Issuance of shares under employee stock purchase plan, shares | 40,000 | ||||
Issuance of shares upon exercise of warrants | 112 | 112 | |||
Issuance of shares upon exercise of warrants, shares | 16,000 | ||||
Stock-based compensation expense | 2,648 | 2,648 | |||
Rights offering, additional issuance costs | (64) | (64) | |||
Unrealized gain on available-for-sale securities | 1 | 1 | |||
Net loss | (12,896) | (12,896) | |||
Balance at Sep. 30, 2020 | $ 25 | 191,468 | 1 | (158,790) | 32,704 |
Balance, shares at Sep. 30, 2020 | 25,290,000 | ||||
Balance at Dec. 31, 2020 | $ 25 | 195,410 | (1) | (172,540) | $ 22,894 |
Balance, shares at Dec. 31, 2020 | 25,550,000 | 25,550,000 | |||
Issuance of common stock as part of debt extinguishment and private investment, net of issuance cost | $ 3 | 49,891 | $ 49,894 | ||
Issuance of common stock as part of debt extinguishment and private investment, net of issuance cost, shares | 3,049,000 | ||||
Issuance of shares upon exercise of stock options | 508 | $ 508 | |||
Issuance of shares upon exercise of stock options, shares | 45,000 | 44,981 | |||
Issuance of shares under employee stock purchase plan | 810 | $ 810 | |||
Issuance of shares under employee stock purchase plan, shares | 91,000 | ||||
Issuance of shares upon exercise of warrants | $ 1 | 3,333 | 3,334 | ||
Issuance of shares upon exercise of warrants, shares | 585,000 | ||||
Issuance of common stock as part of ATM offering | 7,432 | 7,432 | |||
Issuance of common stock as part of ATM offering, shares | 289,000 | ||||
Issuance of common stock upon vesting of restriced stock units, net of shares withheld for employee taxes | (232) | (232) | |||
Issuance of common stock upon vesting of restriced stock units, net of shares withheld for employee taxes, shares | 22,000 | ||||
Stock-based compensation expense | 10,990 | 10,990 | |||
Unrealized gain on available-for-sale securities | $ 1 | 1 | |||
Net loss | (48,244) | (48,244) | |||
Balance at Sep. 30, 2021 | $ 29 | 268,142 | (220,784) | $ 47,387 | |
Balance, shares at Sep. 30, 2021 | 29,631,000 | 29,631,000 | |||
Balance at Jun. 30, 2021 | $ 29 | 266,223 | (206,502) | $ 59,750 | |
Balance, shares at Jun. 30, 2021 | 29,606,000 | ||||
Debt extinguishment and private investment, additional issuance costs | (47) | (47) | |||
Issuance of shares under employee stock purchase plan | 389 | 389 | |||
Issuance of shares under employee stock purchase plan, shares | 25,000 | ||||
Stock-based compensation expense | 1,577 | 1,577 | |||
Net loss | (14,282) | (14,282) | |||
Balance at Sep. 30, 2021 | $ 29 | $ 268,142 | $ (220,784) | $ 47,387 | |
Balance, shares at Sep. 30, 2021 | 29,631,000 | 29,631,000 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Stockholders' Equity (Parenthetical) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Condensed Consolidated Statement of Stockholders' Equity [Abstract] | ||
Issuance costs | $ 100 | $ 565 |
Description Of The Business
Description Of The Business | 9 Months Ended |
Sep. 30, 2021 | |
Description Of The Business [Abstract] | |
Description Of The Business | 1. Description of the Business Pulse Biosciences, Inc. is a novel bioelectric medicine company committed to health innovation using an entirely new and proprietary energy modality. The Company’s CellFX ® System is the first commercial product to harness the distinctive advantages of the Company’s proprietary Nano-Pulse Stimulation™ (“NPS”) technology. The CellFX System delivers nanosecond duration pulses of electrical energy, each less than a millionth of a second long, to non-thermally clear targeted cells while sparing adjacent non-cellular tissue, to treat a variety of medical conditions for which an optimal solution remains unfulfilled. In February 2021, the Company received 510(k) clearance from the U.S. Food and Drug Administration (the “FDA”) for the CellFX System with initial clearance for a general indication for dermatologic procedures requiring ablation and resurfacing of the skin. In January 2021, the Company received Conformité Européene (“CE”) marking approval for the CellFX System, which allows for marketing of the system in the European Union (“EU”) and, in June 2021, the Company received Health Canada approval for the CellFX System, which allows for marketing of the system in Canada. The CE mark and Health Canada approvals allow for use of the CellFX System in dermatological procedures requiring ablation and resurfacing of the skin for the reduction, removal, and/or clearance of cellular-based benign lesions, including Sebaceous Hyperplasia (“SH”), Seborrheic Keratosis (“SK”), and cutaneous non-genital warts. The Company commenced a controlled launch of the CellFX System in February 2021 with key opinion leaders in dermatology (Note 9) and, in August 2021, the Company began to convert some of these key opinion leaders from the controlled launch program onto sales agreements, thereby triggering revenue recognition. The Company was incorporated in Nevada on May 19, 2014. On June 18, 2018, the Company reincorporated from the State of Nevada to the State of Delaware. The Company is located in Hayward, California. The Company’s activities are subject to significant risks and uncertainties, including the need for additional capital. The Company does not currently have any cash flows from operations. It has recently commenced revenue-generating operations and will need to raise additional capital to finance its operations. However, there can be no assurances that the Company will be able to obtain additional financing on acceptable terms and in the amounts necessary to fully fund its operating requirements. |
Summary Of Significant Accounti
Summary Of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2021 | |
Summary Of Significant Accounting Policies [Abstract] | |
Summary Of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Going Concern As of September 30, 2021, the Company had an accumulated deficit of $ 220.8 million, cash outflows from operations of $ 41.4 million for the nine months then ended, cash and cash equivalents of $ 42.0 million and a net loss of $ 14.3 million. The Company has recently begun to generate revenue from product sales, but anticipates net losses for the next several years or until it can generate substantial product revenue and achieve profitability. Based on the Company’s current operating plan, the Company has determined that, with its current financial resources, the Company would be able to operate into the third quarter of 2022. As the Company’s operating plan does not allow the Company to operate for a period of twelve months from the date the condensed consolidated financial statements are issued without additional financing, based on the Accounting Standards Codification (“ASC”) 205-40, Presentation of Financial Statements – Going Concern , the Company is required to disclose that substantial doubt regarding the Company’s ability to continue as a going concern exists. This evaluation initially cannot take into consideration the potential mitigating effects of plans that have not been fully implemented as of the date the financial statements are issued. To continue to fund the operations of the Company beyond this time period, management has developed plans, which primarily consist of raising additional capital through some combination of public or private equity offerings, debt financings, the Company’s at-the-market equity offering program, and/or potential new collaborations. There is no assurance, however, that any additional financing or any revenue-generating collaboration will be available when needed or that management of the Company will be able to obtain financing or enter into a collaboration on terms acceptable to the Company. The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The 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. Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared on a basis consistent with the Company’s December 31, 2020 audited Consolidated Financial Statements and include all adjustments, consisting of only normal recurring adjustments, necessary to fairly state the information set forth herein. The condensed consolidated financial statements have been prepared in accordance with the applicable rules and regulations of the Securities and Exchange Commission (the “SEC”) and, as permitted by such rules and regulations, omit certain information and footnote disclosures necessary to present the financial statements in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). The condensed consolidated balance sheet as of December 31, 2020 was derived from the audited consolidated financial statements as of that date but does not include all of the information and footnotes required by U.S. GAAP for complete financial statements. These condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020. The results of operations for the three-month and nine-month periods ended September 30, 2021, are not necessarily indicative of the results to be expected for the entire year or any future periods. Certain prior period balances have been reclassified to conform to the current period presentation in the consolidated financial statements and the accompanying notes. Sales and marketing expenses are reclassified out of general and administrative expenses, both of which are presented as separate line items. Amortization of intangible assets are reclassified to general and administrative expenses. Principles of Consolidation The accompanying condensed consolidated financial statements include the financial statements of Pulse Biosciences, Inc. and its wholly-owned subsidiaries. Intercompany balances and transactions, if any, have been eliminated in consolidation. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires the Company to make estimates and assumptions that affect the amounts reported in the Financial Statements and accompanying notes to the condensed consolidated financial statements. Estimates include, but are not limited to, the valuation of cash equivalents and investments, the valuation and recognition of share-based compensation, inventory valuation, warranty obligations, and the useful lives assigned to long-lived assets. The Company evaluates its estimates and assumptions based on historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could differ materially from these estimates. Significant Accounting Policies The Company’s significant accounting policies are described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020. The Company continually evaluates the accounting policies and estimates used in preparing the consolidated financial statements. During the nine-month period ended September 30, 2021, the Company received 510(k) clearance, CE marking approval, and Health Canada clearance for their proprietary CellFX System and began to capitalize inventory in preparation for commercialization. Additionally, during the three-month period ended September 30, 2021, the Company entered into sales contracts with customers and began to recognize revenue. See Note 10 for additional details. Valuation of Inventory Inventory is stated at lower of cost or net realizable value. The Company establishes the inventory basis by determining the cost based on standard costs approximating the purchase costs on a first-in, first-out basis. Net realizable value is the estimated selling price in the ordinary course of the Company’s business, less reasonably predictable costs of completion, disposal, and transportation. The cost basis of the Company’s inventory will be reduced for any products that are considered excessive or obsolete based upon assumptions about future demand and market conditions. At September 30, 2021, there is no reduction to the balance of inventory for excessive and obsolete inventory. Revenue from Contracts with Customers The Company recognizes revenue at a point in time when it satisfies performance obligations by transferring control of promised goods to its customers. The amount of revenue recognized is equal to the consideration which the Company is entitled to in exchange for the promised goods, excluding any amounts assessed by government authorities for taxes which might be collected from a customer. Sales contracts often involve the sale and delivery of multiple products, each of which typically represent a separate performance obligation in the contract. While the Company sells these products on a stand-alone basis at their respective stand-alone selling prices (“SSP”), initial customer contracts will likely involve the bundling of products which will be delivered concurrently to the customer and have the same pattern of transfer. In such instances, the full consideration of the contract will be recognized upon delivery of the products. The Company generally requires receipt of full payment prior to shipment, however, from time to time, payment terms may be extended to customers upon which the Company will perform a necessary credit evaluation to ensure future collectability of the outstanding balance. The Company does not believe any portion of the outstanding accounts receivable balance to be uncollectible, and has therefore not recorded an allowance against the accounts receivable balance. Refer to Note 10 for further details. Product Warranty The Company provides a standard warranty on eligible products which provides the customer assurances that the products comply with the agreed-upon specifications. The standard warranty does not provide any services in addition to those assurances. The Company accrues a warranty reserve for products sold based upon the best estimate of the nature, frequency, and costs of future claims. These estimates are inherently uncertain given the short history of sales, and changes to the historical or projected warranty experience may cause material changes to the warranty reserve in the future. The warranty reserve is included within Accrued expenses on the consolidated balance sheets. Warranty expense is recorded as a component of Cost of Revenues in the consolidated statements of operations. Warranty accrual activity consisted of the following for the three- and nine-month periods ended September 30, 2021 and 2020 (in thousands): Three-Month Periods Ended Nine-Month Periods Ended September 30, September 30, 2021 2020 2021 2020 Beginning balance $ — $ — $ — $ — Add: Accruals for warranties issued during the period 27 — 27 — Less: Settlements made during the period — — — — Ending balance $ 27 $ — $ 27 $ — Net Loss per Share The Company calculates basic net loss per share by dividing net loss by the weighted-average number of shares of common stock outstanding during the period. Diluted net loss per share is computed by giving effect to all potential dilutive common stock equivalents outstanding during the period. For purposes of this calculation, options to purchase common stock and common stock warrants are considered common stock equivalents. Potential common shares that have an anti-dilutive effect (i.e., those that increase income per share or decrease loss per share) are excluded from the calculation of diluted net loss per share. Basic and diluted net loss per common share is the same for all periods presented because all warrants, stock options and restricted stock units outstanding are anti-dilutive. The following outstanding stock options, warrants and restricted stock units were excluded from the computation of diluted net loss per share for the periods presented because including them would have had an anti-dilutive effect: Nine-Month Periods Ended September 30, 2021 2020 Common stock warrants 600 793,464 Common stock options 5,946,009 5,207,326 Restricted stock units 76,903 34,402 Total 6,023,512 6,035,192 Recent Accounting Pronouncement In December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes , which eliminates certain exceptions related to the general principles in ASC 740 and makes amendments to other areas with the intention of simplifying various aspects related to accounting for income taxes. The new standard is effective for fiscal years beginning after December 15, 2020, including interim periods therein; with early adoption permitted. The Company adopted the Topic 740 effective January 1, 2021. The adoption did not have a material impact on the Company’s financial statements. |
Fair Value Of Financial Instrum
Fair Value Of Financial Instruments | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Of Financial Instruments [Abstract] | |
Fair Value Of Financial Instruments | 3. Fair Value of Financial Instruments The authoritative guidance with respect to fair value established a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three levels, and requires that assets and liabilities carried at fair value be classified and disclosed in one of three categories, as presented below. Level 1 - Observable inputs such as quoted prices in active markets for an identical asset or liability that the Company has the ability to access as of the measurement date. Financial assets and liabilities utilizing Level 1 inputs include money market funds. Level 2 - Inputs, other than quoted prices included within Level 1, which are directly observable for the asset or liability or indirectly observable through corroboration with observable market data. Financial assets and liabilities utilizing Level 2 inputs include commercial paper, corporate bonds, U.S. Treasury Securities, and asset-backed securities. Level 3 - Unobservable inputs for which there is little or no market data for the asset or liability which requires the reporting entity to develop its own assumptions. The Company did not classify any of its investments within Level 3 of the fair value hierarchy. The following table sets forth the fair value of the Company’s financial assets measured on a recurring basis as of September 30, 2021 and December 31, 2020, respectively (in thousands): September 30, 2021 December 31, 2020 Assets Classification Level 1 Level 2 Level 3 Total Level 1 Level 2 Level 3 Total Money market funds Cash and cash equivalents $ 28,675 $ — $ — $ 28,675 $ 7,176 $ — $ — $ 7,176 U.S. Treasury Securities Cash and cash equivalents — 10,000 — 10,000 — 2,004 — 2,004 U.S. Treasury Securities Investments — — — — — 8,012 — 8,012 Total assets measured at fair value $ 28,675 $ 10,000 $ — $ 38,675 $ 7,176 $ 10,016 $ — $ 17,192 The Company did no t have any financial liabilities measured on a recurring basis as of September 30, 2021 or December 31, 2020. During the nine-month period ended September 30, 2021, there were no transfers between Level 1, Level 2 or Level 3 assets or liabilities reported at fair value on a recurring basis and the valuation techniques used did not change compared to the Company’s established practice. |
Balance Sheet Components
Balance Sheet Components | 9 Months Ended |
Sep. 30, 2021 | |
Balance Sheet Components [Abstract] | |
Balance Sheet Components | 4. Balance Sheet Components Inventory Inventory consisted of the following (in thousands): September 30, December 31, 2021 2020 Raw materials $ 1,362 $ — Work in process 1,218 — Finished goods 1,701 — Total inventory $ 4,281 $ — Property and Equipment, Net Property and equipment, net consisted of the following (in thousands): September 30, December 31, 2021 2020 Leasehold improvements $ 2,827 $ 2,805 Laboratory equipment 986 878 Furniture, fixtures, and equipment 578 517 Software 202 128 Construction in progress 118 66 4,711 4,394 Less: Accumulated depreciation ( 2,265 ) ( 1,916 ) Property and equipment, net $ 2,446 $ 2,478 Depreciation expense was $ 0.1 million for each of the three-month periods ended September 30, 2021 and 2020 and was $ 0.3 million for each of the nine-month periods ended September 30, 2021 and 2020. Intangible Assets, Net Intangible assets primarily consist of acquired licenses to utilize certain patents, know-how and technology relating to the Company’s NPS technology for biomedical applications acquired from Old Dominion University Research Foundation (“ODURF”), Eastern Virginia Medical School, and the University of Southern California. In addition, the Company entered into a Sponsored Research Agreement with Old Dominion University’s Frank Reidy Research Center for Bioelectrics, which includes certain intellectual property rights arising from the research. The Company is amortizing the intangible assets over an estimated useful life of 12 years. Intangible assets, net consisted of the following (in thousands): September 30, December 31, 2021 2020 Acquired patents and licenses $ 7,985 $ 7,985 Less: Accumulated amortization ( 4,603 ) ( 4,103 ) Intangible assets, net $ 3,382 $ 3,882 A schedule of the amortization of intangible assets for the remainder of 2021 and the succeeding five fiscal years is as follows (in thousands): Year Ending December 31: 2021 (remaining 3 months) $ 166 2022 665 2023 665 2024 665 2025 665 2026 556 Total $ 3,382 Accrued Expenses Accrued expenses consisted of the following (in thousands): September 30, December 31, 2021 2020 Compensation $ 3,549 $ 3,324 Director and officer liability insurance (Note 12) — 1,563 Controlled launch (Note 9) 632 — Clinical trial costs and fees 367 188 Professional fees 77 87 Warranty 27 — Other 319 164 Total accrued expenses $ 4,971 $ 5,326 |
Goodwill
Goodwill | 9 Months Ended |
Sep. 30, 2021 | |
Goodwill [Abstract] | |
Goodwill | 5. Goodwill In 2014, the Company acquired three companies, ThelioPulse, Inc., BioElectroMed Corp. and NanoBlate Corp. (the “Acquisitions”), for aggregate consideration of $ 5.5 million. In accordance with ASC Topic 805, Business Combinations , the Company recorded goodwill of $ 2.8 million in connection with the Acquisitions as the consideration paid exceeded the fair value of the net tangible assets and the intangible assets acquired. The Company reviews goodwill for impairment at least annually or whenever changes in circumstances indicate that the carrying amount of goodwill may not be recoverable. Based on the Company’s annual impairment test as of December 31, 2020 the Company determined that no impairment of goodwill existed and was not aware of any indicators of impairment at such date. In addition, there were no indicators of impairment at September 30, 2021. |
Stockholders' Equity And Stock-
Stockholders' Equity And Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2021 | |
Stockholders' Equity And Stock-Based Compensation [Abstract] | |
Stockholders' Equity And Stock-Based Compensation | 6. Stockholders’ Equity and Stock-Based Compensation Private Placement Securities Purchase Agreement On June 30, 2021, the Company entered into a Securities Purchase Agreement with Robert W. Duggan, the Company’s largest stockholder and Board Chairman, pursuant to which the Company issued and sold to Mr. Duggan 3,048,780 shares of the Company’s common stock, par value $ 0.001 per share, in a private placement (the “Private Placement”), at a price per share of $ 16.40 , which was the market closing price on the date of the transaction. These shares were paid for through (i) the conversion of $ 41 million aggregate principal amount, together with all accrued and unpaid interest outstanding, owed to Mr. Duggan under the Loan Agreement by and between the Company and Mr. Duggan (Note 8), and (ii) additional cash in the amount of approximately $ 8.4 million. Upon the closing of this Private Placement and satisfaction of the outstanding debt, the Loan Agreement terminated, without any early termination fees or penalties being owed by the Company, and no additional amounts were owed to Mr. Duggan under the Loan Agreement. The cash proceeds of approximately $ 8.4 million were received by the Company in July 2021. At-the-Market Equity Offering On February 4, 2021, the Company entered into a sales agreement (the “Sales Agreement”) with Stifel, Nicolaus & Company, Inc. (“Stifel”) as sales agent, pursuant to which the Company may offer and sell, from time to time, through Stifel, up to $ 60.0 million in shares of common stock, by any method permitted by law deemed to be an “at-the-market” offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended. The Company has no obligation to make any sales of its common stock pursuant to such Sales Agreement. During the three-month period ended September 30, 2021, the Company did not issue or sell any shares of common stock under the Sales Agreement. During the nine-month period ended September 30, 2021, the Company issued and sold 288,490 shares of common stock under the Sales Agreement. The shares were sold at a weighted average price of $ 27.73 per share for aggregate net proceeds of approximately $ 7.4 million, after deducting sales commissions and offering costs payable by the Company. Rights Offering In June 2020, the Company completed a rights offering to purchase up to $ 30 million of units, each unit consisting of one share of the Company’s common stock, par value $ 0.001 per share, and 0.15 warrants to purchase shares of common stock (the “Units”) at a price of $ 7.01 per Unit (the “Rights Offering”). The common stock and warrants comprising the Units separated upon the closing of the Rights Offering and were issued separately. A total of 4,279,600 shares of common stock and 641,571 warrants (the “Rights Offering Warrants”) were issued and sold in the Rights Offering for net proceeds of approximately $ 29.4 million. Each Rights Offering Warrant was exercisable for one share of the Company’s common stock at an exercise price equal to $ 7.01 , the subscription price for the Units. The Rights Offering Warrants were exercisable immediately and expired on the fifth anniversary of the completion of the Rights Offering, or June 16, 2025, subject to certain redemption rights by the Company. The Rights Offering Warrants were subject to redemption by the Company, on or after December 16, 2020, six months after the issue date, for $ 0.01 per warrant, with not less than 30 days written notice, if the volume weighted average price of our common stock equaled or exceeded 200 % of the exercise price for the Rights Offering Warrants for 10 consecutive trading days. Common Stock Warrants In connection with a private placement in November 2014 of the Company’s common stock, par value $ 0.001 per share, the Company issued warrants as compensation to the placement agent to purchase a total of 299,625 shares of its common stock at an exercise price of $ 2.67 per share (the “Private Placement Warrants”). The Private Placement Warrants are exercisable for period of seven years from issuance. In March 2021, warrants to purchase 45,638 shares of common stock were net exercised, resulting in the issuance of 40,563 shares of common stock. As of September 30, 2021, there were Private Placement Warrants to purchase up to 600 shares of common stock still outstanding. In connection with the closing of the Company’s initial public offering in May 2016, the Company issued warrants as compensation to its underwriters, to purchase a total of 574,985 shares of its common stock at an exercise price of $ 5.00 per share (the “IPO Warrants”). The IPO Warrants were exercisable for a period of five years from issuance. In March 2021, warrants to purchase 85,385 shares of common stock were net exercised, resulting in the issuance of 68,958 shares of common stock. As of September 30, 2021, there were no IPO Warrants outstanding. In connection with the Rights Offering, the Company issued warrants to purchase a total of 641,571 shares of its common stock at an exercise price of $ 7.01 . On December 31, 2020, the Company met the requirements for redemption of these warrants and delivered a notice of redemption to redeem all of the outstanding warrants that remained unexercised at February 5, 2021, for the redemption price of $ 0.01 per warrant. Pursuant to the redemption, the Company redeemed 5,139 warrants. Prior to the February 5, 2021 redemption date, 636,432 warrants were exercised, generating approximately $ 4.5 million of total gross proceeds to the Company. As of September 30, 2021, there were no Rights Offering Warrants outstanding. Equity Plans 2017 Equity Incentive Plan and 2017 Inducement Equity Incentive Plan The Board of Directors of the Company (the “Board”) previously adopted, and the Company’s stockholders approved, the Company’s 2017 Equity Incentive Plan (the “2017 Plan”). The 2017 Plan has a 10 -year term, and provides for the grant of stock options, stock appreciation rights, restricted stock, restricted stock units, performance units, and performance shares to employees, directors and consultants of the Company and any parent or subsidiary of the Company, as the Compensation Committee of the Board may determine. Subject to an annual evergreen increase and adjustment in the case of certain capitalization events, the Company initially reserved 1,500,000 shares of the Company’s common stock for issuance pursuant to awards under the 2017 Plan. In addition, shares remaining available under the Company’s 2015 Equity Incentive Plan, as amended (the “2015 Plan”), and shares reserved but not issued pursuant to outstanding equity awards that expire or terminate without being exercised or that are forfeited or repurchased by the Company will be added to the shares of common stock available for issuance under the 2017 Plan. The 2017 Plan is administered by the Board’s Compensation Committee. Effective January 1, 2021, the Company’s Board authorized an increase in the number of shares of common stock available under the 2017 Plan by 1,022,002 shares pursuant to the evergreen provision of the 2017 Plan. Pursuant to the 2017 Plan, the 2021 share increase is determined based on the least of (i) 1,200,000 shares, (ii) 4 % of the Company’s common stock outstanding at December 31 of the immediately preceding year, or (iii) such number of shares as determined by the Board. As of September 30, 2021, 506,917 shares of common stock remained available for issuance under the 2017 Plan. During November 2017, the Board adopted the 2017 Inducement Equity Incentive Plan (the “Inducement Plan”) and reserved 1,000,000 shares of the Company’s common stock for issuance pursuant to equity awards granted under the Inducement Plan. The Inducement Plan was adopted without stockholder approval. The Inducement Plan has a 10 -year term, and provides for the grant of equity-based awards, including nonstatutory stock options, restricted stock units, restricted stock, stock appreciation rights, performance shares and performance units, and its terms are substantially similar to the 2017 Plan, including with respect to treatment of equity awards in the event of a “merger” or “change in control” as defined under the Inducement Plan. Options issued under the Inducement Plan may have a term up to ten years and have variable vesting provisions. New hire grants generally vest 25 % per year starting upon the first anniversary of the grant. Equity-based awards issued under the Inducement Plan are only issuable to individuals not previously engaged as employees or as non-employee directors of the Company prior to the Inducement Plan’s adoption date. In May 2021, the Board approved an amendment to the Inducement Plan to reserve an additional 1,000,000 shares of the Company’s common stock for issuance pursuant to the Inducement Plan. As of September 30, 2021, 1,040,346 shares of common stock remained available for issuance under the Inducement Plan. Certain stock options awarded to the Company’s executives and other key employees contain performance conditions related to certain financial measures and achievements of strategic/operational milestones (the “Performance Options”). As of September 30, 2021, not all of the performance conditions are probable to be achieved. Compensation expense has only been recognized for those conditions that are assumed to be probable. During February 2021, the Compensation Committee approved of a modification to certain vesting conditions of outstanding Performance Options. The Company had no t recognized any compensation expense in relation to these Performance Options as the performance condition was previously deemed to be improbable. However, upon modification those specific performance conditions are now deemed probable and fully vested. As such, during the nine-month period ended September 30, 2021, the full expense in relation to the amended performance conditions was recognized resulting in $ 4.2 million of additional stock-compensation expense. A summary of stock option activity under the 2015 Plan, 2017 Plan and Inducement Plan for the nine-months ended September 30, 2021 is presented below: Stock Options Outstanding Weighted Number average of shares exercise price Balances — December 31, 2020 5,039,194 $ 14.26 Options granted 1,128,338 Options exercised ( 44,981 ) Options canceled ( 111,279 ) Options expired ( 65,263 ) Balances — September 30, 2021 5,946,009 $ 15.73 Exercisable — September 30, 2021 3,150,036 $ 16.00 2017 Employee Stock Purchase Plan The Board previously adopted and the stockholders approved the Company’s 2017 Employee Stock Purchase Plan (the “2017 ESPP”). The 2017 ESPP is a broad-based plan that provides employees of the Company and its designated affiliates with the opportunity to become stockholders through periodic payroll deductions that are applied towards the purchase of Company common shares at a discount from the then-current market price. Subject to adjustment in the case of certain capitalization events, a total of 250,000 common shares of the Company were available for purchase at adoption of the 2017 ESPP. Pursuant to the 2017 ESPP, the annual share increase pursuant to the evergreen provision is determined based on the least of (i) 450,000 shares, (ii) 1.5 % of the Company’s common stock outstanding at December 31 of the immediately preceding year, or (iii) such number of shares as determined by the Board. Effective January 1, 2021, pursuant to the evergreen provision of the 2017 ESPP, the number of shares of common stock available under the 2017 ESPP was increased by 383,250 shares. During the nine-month period ended September 30, 2021, the Company issued 91,378 shares of common stock under the 2017 ESPP. As of September 30, 2021, 649,096 shares of common stock remained available for issuance under the 2017 ESPP. Stock-based Compensation Total stock-based compensation expense consisted of the following (in thousands): Three-Month Periods Ended Nine-Month Periods Ended September 30, September 30, 2021 2020 2021 2020 Cost of revenue $ 37 $ — $ 37 $ — Research and development 418 1,183 4,586 2,957 Sales and marketing 65 312 2,326 903 General and administrative 1,057 1,154 4,041 3,826 Total stock-based compensation expense $ 1,577 $ 2,649 $ 10,990 $ 7,686 The Company estimated the fair value of employee stock options on the grant date using the Black-Scholes option pricing model. The estimated fair value of employee stock options is amortized on a straight-line basis over the requisite service period of the awards. The Company reviews, and when deemed appropriate, updates the assumptions used on a periodic basis. Due to the limited trading history of the Company’s common stock, the Company utilizes a portfolio of comparable companies to estimate volatility. The fair value of employee stock options was estimated using the following weighted-average assumptions: Three-Month Periods Ended September 30, Nine-Month Periods Ended September 30, 2021 2020 2021 2020 Expected term in years 6.1 5.8 - 6.1 5.3 - 6.1 5.3 - 6.1 Expected volatility 78 % 70 % 78 % 70 % Risk-free interest rate 0.9 % 0.3 - 0.4 % 0.9 - 1.1 % 0.4 - 0.5 % Dividend yield — — — — The Company estimated the fair value of ESPP on the grant date using the Black-Scholes option pricing model. The estimated fair value of ESPP is amortized on a straight-line basis over the requisite service period of the awards. The Company reviews, and when deemed appropriate, updates the assumptions used on a periodic basis. The Company utilizes its estimated volatility in the Black-Scholes option pricing model to determine the fair value of ESPP. The fair value of ESPP was estimated using the following weighted-average assumptions: Three-Month Periods Ended September 30, Nine-Month Periods Ended September 30, 2021 2020 2021 2020 Expected term in years 0.5 - 1.0 0.5 - 1.0 0.5 - 1.0 0.5 - 1.0 Expected volatility 78 % 70 % 78 % 70 % Risk-free interest rate 0.06 - 0.07 % 0.1 % 0.06 - 0.1 % 0.1 - 1.0 % Dividend yield — — — — |
Research Grants And Agreements
Research Grants And Agreements | 9 Months Ended |
Sep. 30, 2021 | |
Research Grants And Agreements [Abstract] | |
Research Grants And Agreements | 7. Research Grants and Agreements Sponsored Research Agreement The Company may sponsor research activities (“SRAs”) performed by ODURF. ODURF is compensated by the Company for its conduct of each study in accordance with the budget and payment terms set forth in the applicable task order. In March 2021, the Company agreed to sponsor a task order in the amount of $ 0.3 million for research performed during the subsequent 12 -month period to be funded through monthly payments to ODURF. In May 2021, the Company agreed to sponsor an additional task order in the amount of $ 0.3 million for research performed during the subsequent 12 -month period to be funded through monthly payments to ODURF. Payments will be made upon ODURF certifying, to the Company’s reasonable satisfaction, that ODURF has met its obligations pursuant to the specified task order and statement of work. The principal investigator may transfer funds with the budget as needed without the Company’s approval so long as the obligations of ODURF under the task order and statement of work remain unchanged and unimpaired. During the three-month periods ended September 30, 2021 and 2020, the Company incurred costs relating to the SRAs equal to $ 0.1 million and $ 0.2 million, respectively; and during the nine-month periods ended September 30, 2021 and 2020, incurred costs equal to $ 0.2 million and $ 0.6 million, respectively. |
Commitments And Contingencies
Commitments And Contingencies | 9 Months Ended |
Sep. 30, 2021 | |
Commitments And Contingencies [Abstract] | |
Commitments And Contingencies | 8. Commitments and Contingencies Loan Agreement On March 11, 2021, the Company and Robert W. Duggan, the Board Chairman, entered into a Loan Agreement in connection with Mr. Duggan lending the principal sum of $ 41.0 million to the Company. The Loan Agreement bore interest at a rate per annum equal to 5.0 %, payable quarterly commencing on July 1, 2021. During the nine-month periods ended September 30, 2021, the Company recorded $ 0.6 million of interest expense in relation to this Loan Agreement. In June 2021, the Loan Agreement was terminated and $ 41.0 million principal, together with approximately $ 0.6 million of accrued and unpaid interest, was fully settled via issuance of the Company’s common stock at a price per share of $ 16.40 . Refer to Note 6 for additional details of the private placement sale. Insurance Loan Agreement On May 13, 2021, the Company secured its annual director and officer liability insurance policy. The total premiums for the policy are approximately $ 2.6 million, of which the Company made a down payment of $ 0.7 million and financed the balance of $ 1.9 million via an Insurance Loan Agreement. The Insurance Loan Agreement has an annual interest rate of 3.69 % and requires monthly payments through February 2022, upon which the Insurance Loan Agreement will be paid in full. The outstanding principal portion of the Insurance Loan Agreement, together with any accrued and unpaid interest, is recorded as a note payable in the balance sheet. Operating Leases In January 2017, the Company entered into a five-year lease (the “Existing Lease”) for approximately 15,700 square feet for its corporate headquarters located in Hayward, California. The lease commenced in July 2017. In May 2019, the Company entered into Lease Amendment 1 (the “Lease Amendment”) in relation to the Existing Lease and added the lease of new premises of approximately 13,300 square feet and 21,300 square feet, (“Expansion Premises 1” and “Expansion Premises 2”, respectively). Additionally, the term of the Existing Lease was extended to October 2029 to be coterminous with Expansion Premises 1 and Expansion Premises 2. The Company evaluated the lease amendment under the provisions of ASC 842. It concluded that the Lease Amendment would be accounted for as a single contract with the Existing Lease because the additional lease payments due to the Lease Amendment was not commensurate with the right-of-use asset granted to the Company. Though the Lease Amendment was accounted for as a single contract, the Existing Premises, Expansion Premises 1 (occupied in November 2019) and Expansion Premises 2 (occupied in May 2020) are accounted for as separate lease components. Accordingly, the Company measured and allocated consideration to each lease component as of the modification date. Information related to the Compan y’s right-of-use assets and related lease liabilities are as follows (in thousands, except for remaining lease term and discount rate): Year Ending December 31: 2021 (remaining 3 months) $ 447 2022 1,806 2023 1,845 2024 1,910 2025 1,976 2026 2,046 Thereafter 6,191 Total lease payments 16,221 Less imputed interest ( 5,230 ) Total lease liabilities $ 10,991 Other supplemental information: Current operating lease liabilities $ 749 Non-current operating lease liabilities 10,242 Total lease liabilities $ 10,991 Cash paid for operating lease liabilities $ 1,196 Weighted average remaining lease term 8.08 Weighted average discount rate 10 % Rent expense, including common area maintenance charges, was $ 0.5 million for each of the three-month periods ended September 30 , 2021 and 2020; and was approximately $ 1.5 million and $ 1.2 million during the nine-month periods ended September 30, 2021 and 2020, respectively. Legal Proceedings The Company maintains indemnification agreements with its directors and officers that may require the Company to indemnify them against liabilities that arise by reason of their status or service as directors or officers, except as prohibited by applicable law. From time to time, the Company may be involved in a variety of claims, lawsuits, investigations, and proceedings relating to securities laws, corporate governance, product liability and promotion, patent infringement, contract disputes, employment disputes, and other matters relating to various claims that arise in the normal course of the Company’s business, such as demands to inspect Company records and correspondence from the SEC and other government officials. The Company currently believes that these ordinary course matters are not material to the condensed consolidated financial statements of the business; however, the results of litigation and claims are inherently unpredictable. |
Controlled Launch
Controlled Launch | 9 Months Ended |
Sep. 30, 2021 | |
Controlled Launch [Abstract] | |
Controlled Launch | 9. Controlled Launch In February 2021, the Company received 510(k) clearance from the U.S. FDA for its proprietary CellFX System with initial clearance for a general dermatologic indication. In January 2021, the Company received CE marking approval for the CellFX System, which allows for marketing of the system in the EU for treatment of general dermatologic conditions, including SH, SK, and cutaneous non-genital warts. Additionally, in June 2021 the Company received Health Canada approval for the CellFX System, which allows for marketing of the system in Canada for use in dermatological procedures requiring ablation and resurfacing of the skin for the reduction, removal, and/or clearance of cellular-based benign lesions. The Company commenced a controlled launch of the CellFX System in February 2021 with key opinion leaders in dermatology via its CellFX Expectations Excelled Program (the “Program”). As part of the Program, the Company will select up to a total of approximately 80 key opinion leaders in dermatology across the United States, EU and Canada to be the first physician consultants to launch the CellFX System and the associated CellFX commercial procedures into their respective markets and geographies. The Company has already executed consulting agreements to retain most of these key opinion leaders to participate in the Program. According to the Program plan, the Company provides and sets up a CellFX System at each consultant’s site and provides the consultant with the necessary related products and components, free of charge, to complete the requirements of the Program. Each CellFX System and any unused component products remain the property of the Company throughout the Program. Each consultant identifies and recruits up to 40 or 50 patients, depending on the contract, for participation in the Program, performing a CellFX procedure on each of the appropriately selected patients. Under the Program, the consultants and their patients complete evaluation surveys about their experiences with the CellFX System and provide other information helpful to the Company. Upon completion of the procedures and the survey feedback, the consultants earn either credits which can be used towards the future purchase of the CellFX System or, in some jurisdictions, fair payment for their time and effort completing the paperwork required under the Program. Credits earned and, if applicable, any other payments earned are limited to a maximum amount dependent on number of surveys received by the Company. Upon completion of the maximum number of patient procedures, each consultant may choose to either enter into a purchase agreement with the Company, under which the consultant may use the credits earned (or other payments earned, as applicable) towards the purchase of the already-delivered CellFX System, or the consultant must return the CellFX System to the Company. As patient procedures and surveys are completed under the Program, the Company accrues the value of the credits earned, which are recorded in accrued expenses, with a corresponding charge to sales and marketing expense. During the three-month and nine-month periods ended September 30, 2021, the Company recorded $ 0.6 million and $ 1.2 million, respectively, of sales and marketing expense in relation to the Program. During the three-month period ended September 30, 2021, certain consultants completed the Program and entered into purchase agreements with the Company, whereby they used their credits or other earned payments towards the purchase of a CellFX System. Approximately $ 0.5 million of accrued liability was recognized as revenue as a result of the purchase. See Note 10 for additional detail of revenue transactions. |
Revenue
Revenue | 9 Months Ended |
Sep. 30, 2021 | |
Revenue [Abstract] | |
Revenue | 10. Revenue The Company recognizes revenue at a point in time when it satisfies performance obligations by transferring control of promised goods to its customers. The amount of revenue recognized is equal to the consideration which the Company is entitled to in exchange for the promised goods, excluding any amounts assessed by government authorities for taxes which might be collected from a customer. Sales contracts often involve the sale and delivery of multiple performance obligations in the contract. Performance Obligations Systems consist of the CellFX console and its embedded software, handpieces, and disposable tips. The console is a physical piece of hardware used by the customer to perform patient procedures. Individually the console and software are not distinct, therefore the Company combines the console and embedded software to form one distinct system performance obligation. Payment for systems is generally due prior to shipment, and the system performance obligation is satisfied upon delivery of the system to the customer. Handpieces are attached to the console and used in conjunction with tips to perform patient procedures. Generally, upon initial sale of a system to a customer, the Company will include two handpieces. The handpiece has a shorter expected useful life than the console, and a customer can purchase additional handpieces when needed, as they are available for sale on a stand-alone basis. Payment for handpieces is generally due prior to shipment, and handpieces represent a distinct performance obligation which is satisfied either upon shipment, or upon delivery of the handpiece to the customer, depending on the specific contract. Tips are single-patient multiple-use products that come in different sizes, each of which are to be used for specific procedures. Tips are attached to the handpiece for use in patient procedures and, upon detachment from the handpiece, a tip cannot be reused, and it must be disposed of. Tips are available for sale on a stand-alone basis and payment is generally due prior to shipment. Tips represent a distinct performance obligation which is satisfied either upon shipment, or upon delivery of the tips to the customer, depending on the specific contract. Cycle units (“CUs”) are credits that authorize the customer to perform a procedure, or cycle. Each procedure requires a specific number of CUs, dependent upon type of tip used and procedure level selected. As the procedure is performed, the applicable number of CUs are decremented. When the customer’s balance of CUs on a specific system is depleted, the system will no longer function until the customer purchases additional CUs. Customers can purchase additional CUs via the Company’s CellFX Marketplace which is an online marketplace accessible directly from the CellFX System. Payment for CUs is due upon order placement and the CUs are immediately available for download to the console via CellFX CloudConnect. CUs represent a distinct performance obligation which is satisfied upon delivery of the CUs to CellFX CloudConnect. Transaction Price When there are multiple performance obligations present, the total transaction price shall be allocated to each of the performance obligations based upon the relative SSPs of those performance obligations. The Company establishes SSPs based on multiple factors including, prices charged by the Company for similar offerings, product-specific business objectives, and the estimated cost to provide the performance obligation. However, upon the sale of a new CellFX System, all performance obligations are delivered concurrently and therefore there is no impact to revenue recognition timing, and the Company has determined allocations are not necessary. Should the customer purchase additional CUs, handpieces, or tips at a later time, those purchases will be made under separate purchase agreements, generally containing only one performance obligation each, therefore no price allocation is necessary in that scenario either. The Company evaluates the possible impact of variable consideration in determining the transaction price, in particular the possibility of future returns or credits. Sales agreements allow for a right of return only if the product does not conform to the agreed upon quality standards or if the product was shipped due to Company error. The Company anticipates such returns will be minimal and has made no adjustments to the transaction price for any estimated returns. The Company has made an accounting policy election to exclude from the measurement of the transaction price all taxes which are imposed on and concurrent with a specific revenue-producing transaction and collected by the entity from a customer. Controlled Launch Agreements In August 2021 the Company began to recognize revenue in relation to the conversion of consultants from the Program to sales agreements (Note 9). These customers were already in possession of the system, handpiece, and tips. As such, upon execution of these purchase agreements, the Company recognized revenue for the full transaction price listed on the agreements because control of all performance obligations were transferred at that time. These customers have separately purchased CUs in order to operate the systems and the revenue for these CUs was recognized upon delivery of the CUs to CellFX CloudConnect. |
Segment And Geographic Informat
Segment And Geographic Information | 9 Months Ended |
Sep. 30, 2021 | |
Segment Reporting [Abstract] | |
Segment Reporting | 11. Segment Reporting The Company operates and manages the business as one reportable and operating segment. The Company’s Chief Executive Officer and Chief Financial Officer act as the chief operating decision makers (“CODM”) of the Company. The CODM reviews the results of the Company on a consolidated basis, however in making certain operating decisions and assessing performance, the CODM will additionally review the disaggregated revenue results by product and geography. All of the Company’s long-lived assets are based in the United States. Revenue by product consisted of the following (in thousands): Three-Month Periods Ended Nine-Month Periods Ended September 30, September 30, 2021 2020 2021 2020 Systems $ 490 $ — $ 490 $ — Cycle units 84 — 84 — Total consolidated revenue $ 574 $ — $ 574 $ — Revenue by geography consisted of the following (in thousands): Three-Month Periods Ended Nine-Month Periods Ended September 30, September 30, 2021 2020 2021 2020 North America $ 405 $ — $ 405 $ — Rest of World 169 — 169 — Total consolidated revenue $ 574 $ — $ 574 $ — |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2021 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 12. Related Party Transactions Kenneth A. Clark, a director of the Company since November 2017, is a member of the law firm of Wilson Sonsini Goodrich and Rosati (“WSGR”), which also serves as the outside corporate counsel to the Company. During the three- and nine-month periods ended September 30, 2021, the Company incurred expenses reported in general and administrative in the consolidated statement of operations for legal services rendered by WSGR totaling approximately $ 0.2 million and $ 0.6 million, respectively. In June 2020, the Company incurred approximately $ 0.4 million of legal expenses in connection with the rights offering which was offset against the gross proceeds. During the three-month period ended September 30, 2021, there were no additional offsetting amounts incurred. During the nine-month period ended September 30, 2021, the Company incurred $ 0.2 million of legal expenses in connection with the at-the-market equity offering which was offset against the gross proceeds (Note 6). In October 2021, Mr. Clark resigned from the Company’s Board as disclosed on Form 8-K filed on October 6, 2021. In May 2020, the Company determined not to renew its director and officer liability insurance policies due to disproportionately high premiums quoted by insurance companies. Instead, Robert W. Duggan, majority stockholder and Board Chairman , and the Company entered into a letter agreement, dated May 12, 2020 (the “Letter Agreement”), pursuant to which Mr. Duggan agreed with the Company to personally provide indemnity coverage on substantially the same terms as the Company’s prior coverage program for a one-year period, and deposited security for such obligations. On May 13, 2021, in accordance with terms of the Letter Agreement, the Company paid Mr. Duggan the amount of $ 2.5 million. The Company did not enter into a new Letter Agreement with Mr. Duggan for the subsequent policy period, and in May 2021 secured its director and officer liability insurance through third-party insurance carriers. In June 2020, the Company completed the Rights Offering (Note 6). Mr. Duggan participated in the Rights Offering and purchased an aggregate of 2,561,873 Units. On March 11, 2021, the Company and Mr. Duggan entered into a Loan Agreement in connection with Mr. Duggan lending the principal sum of $ 41.0 million to the Company (Note 8). On June 30, 2021, the Company and Mr. Duggan entered into a Securities Purchase Agreement (Note 6), pursuant to which the Company issued and sold to Mr. Duggan 3,048,780 shares of the Company’s common stock, par value $ 0.001 per share, in a Private Placement, at a price per share of $ 16.40 , for an aggregate investment in the amount of $ 50.0 million. The shares were paid for through (i) the conversion of the $ 41 million aggregate principal amount under the Loan Agreement, together with all accrued and unpaid interest outstanding, owed to Mr. Duggan under the Loan Agreement by and between the Company and Mr. Duggan (Note 8), and (ii) additional cash in the amount of approximately $ 8.4 million. Upon the closing of this Private Placement and satisfaction of the outstanding debt, the Loan Agreement terminated, without any early termination fees or penalties being owed by the Company, and no additional amounts were owed to Mr. Duggan under the Loan Agreement. |
Summary Of Significant Accoun_2
Summary Of Significant Accounting Policies (Policy) | 9 Months Ended |
Sep. 30, 2021 | |
Summary Of Significant Accounting Policies [Abstract] | |
Going Concern | Going Concern As of September 30, 2021, the Company had an accumulated deficit of $ 220.8 million, cash outflows from operations of $ 41.4 million for the nine months then ended, cash and cash equivalents of $ 42.0 million and a net loss of $ 14.3 million. The Company has recently begun to generate revenue from product sales, but anticipates net losses for the next several years or until it can generate substantial product revenue and achieve profitability. Based on the Company’s current operating plan, the Company has determined that, with its current financial resources, the Company would be able to operate into the third quarter of 2022. As the Company’s operating plan does not allow the Company to operate for a period of twelve months from the date the condensed consolidated financial statements are issued without additional financing, based on the Accounting Standards Codification (“ASC”) 205-40, Presentation of Financial Statements – Going Concern , the Company is required to disclose that substantial doubt regarding the Company’s ability to continue as a going concern exists. This evaluation initially cannot take into consideration the potential mitigating effects of plans that have not been fully implemented as of the date the financial statements are issued. To continue to fund the operations of the Company beyond this time period, management has developed plans, which primarily consist of raising additional capital through some combination of public or private equity offerings, debt financings, the Company’s at-the-market equity offering program, and/or potential new collaborations. There is no assurance, however, that any additional financing or any revenue-generating collaboration will be available when needed or that management of the Company will be able to obtain financing or enter into a collaboration on terms acceptable to the Company. The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The 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. |
Basis Of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared on a basis consistent with the Company’s December 31, 2020 audited Consolidated Financial Statements and include all adjustments, consisting of only normal recurring adjustments, necessary to fairly state the information set forth herein. The condensed consolidated financial statements have been prepared in accordance with the applicable rules and regulations of the Securities and Exchange Commission (the “SEC”) and, as permitted by such rules and regulations, omit certain information and footnote disclosures necessary to present the financial statements in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). The condensed consolidated balance sheet as of December 31, 2020 was derived from the audited consolidated financial statements as of that date but does not include all of the information and footnotes required by U.S. GAAP for complete financial statements. These condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020. The results of operations for the three-month and nine-month periods ended September 30, 2021, are not necessarily indicative of the results to be expected for the entire year or any future periods. Certain prior period balances have been reclassified to conform to the current period presentation in the consolidated financial statements and the accompanying notes. Sales and marketing expenses are reclassified out of general and administrative expenses, both of which are presented as separate line items. Amortization of intangible assets are reclassified to general and administrative expenses. |
Principles Of Consolidation | Principles of Consolidation The accompanying condensed consolidated financial statements include the financial statements of Pulse Biosciences, Inc. and its wholly-owned subsidiaries. Intercompany balances and transactions, if any, have been eliminated in consolidation. |
Use Of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires the Company to make estimates and assumptions that affect the amounts reported in the Financial Statements and accompanying notes to the condensed consolidated financial statements. Estimates include, but are not limited to, the valuation of cash equivalents and investments, the valuation and recognition of share-based compensation, inventory valuation, warranty obligations, and the useful lives assigned to long-lived assets. The Company evaluates its estimates and assumptions based on historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could differ materially from these estimates. |
Significant Accounting Policies | Significant Accounting Policies The Company’s significant accounting policies are described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020. The Company continually evaluates the accounting policies and estimates used in preparing the consolidated financial statements. During the nine-month period ended September 30, 2021, the Company received 510(k) clearance, CE marking approval, and Health Canada clearance for their proprietary CellFX System and began to capitalize inventory in preparation for commercialization. Additionally, during the three-month period ended September 30, 2021, the Company entered into sales contracts with customers and began to recognize revenue. See Note 10 for additional details. |
Valuation Of Inventory | Valuation of Inventory Inventory is stated at lower of cost or net realizable value. The Company establishes the inventory basis by determining the cost based on standard costs approximating the purchase costs on a first-in, first-out basis. Net realizable value is the estimated selling price in the ordinary course of the Company’s business, less reasonably predictable costs of completion, disposal, and transportation. The cost basis of the Company’s inventory will be reduced for any products that are considered excessive or obsolete based upon assumptions about future demand and market conditions. At September 30, 2021, there is no reduction to the balance of inventory for excessive and obsolete inventory. |
Revenue from Contracts with Customers | Revenue from Contracts with Customers The Company recognizes revenue at a point in time when it satisfies performance obligations by transferring control of promised goods to its customers. The amount of revenue recognized is equal to the consideration which the Company is entitled to in exchange for the promised goods, excluding any amounts assessed by government authorities for taxes which might be collected from a customer. Sales contracts often involve the sale and delivery of multiple products, each of which typically represent a separate performance obligation in the contract. While the Company sells these products on a stand-alone basis at their respective stand-alone selling prices (“SSP”), initial customer contracts will likely involve the bundling of products which will be delivered concurrently to the customer and have the same pattern of transfer. In such instances, the full consideration of the contract will be recognized upon delivery of the products. The Company generally requires receipt of full payment prior to shipment, however, from time to time, payment terms may be extended to customers upon which the Company will perform a necessary credit evaluation to ensure future collectability of the outstanding balance. The Company does not believe any portion of the outstanding accounts receivable balance to be uncollectible, and has therefore not recorded an allowance against the accounts receivable balance. Refer to Note 10 for further details. |
Product Warranty | Product Warranty The Company provides a standard warranty on eligible products which provides the customer assurances that the products comply with the agreed-upon specifications. The standard warranty does not provide any services in addition to those assurances. The Company accrues a warranty reserve for products sold based upon the best estimate of the nature, frequency, and costs of future claims. These estimates are inherently uncertain given the short history of sales, and changes to the historical or projected warranty experience may cause material changes to the warranty reserve in the future. The warranty reserve is included within Accrued expenses on the consolidated balance sheets. Warranty expense is recorded as a component of Cost of Revenues in the consolidated statements of operations. Warranty accrual activity consisted of the following for the three- and nine-month periods ended September 30, 2021 and 2020 (in thousands): Three-Month Periods Ended Nine-Month Periods Ended September 30, September 30, 2021 2020 2021 2020 Beginning balance $ — $ — $ — $ — Add: Accruals for warranties issued during the period 27 — 27 — Less: Settlements made during the period — — — — Ending balance $ 27 $ — $ 27 $ — |
Net Loss Per Share | Net Loss per Share The Company calculates basic net loss per share by dividing net loss by the weighted-average number of shares of common stock outstanding during the period. Diluted net loss per share is computed by giving effect to all potential dilutive common stock equivalents outstanding during the period. For purposes of this calculation, options to purchase common stock and common stock warrants are considered common stock equivalents. Potential common shares that have an anti-dilutive effect (i.e., those that increase income per share or decrease loss per share) are excluded from the calculation of diluted net loss per share. Basic and diluted net loss per common share is the same for all periods presented because all warrants, stock options and restricted stock units outstanding are anti-dilutive. The following outstanding stock options, warrants and restricted stock units were excluded from the computation of diluted net loss per share for the periods presented because including them would have had an anti-dilutive effect: Nine-Month Periods Ended September 30, 2021 2020 Common stock warrants 600 793,464 Common stock options 5,946,009 5,207,326 Restricted stock units 76,903 34,402 Total 6,023,512 6,035,192 |
Recent Accounting Pronouncement | Recent Accounting Pronouncement In December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes , which eliminates certain exceptions related to the general principles in ASC 740 and makes amendments to other areas with the intention of simplifying various aspects related to accounting for income taxes. The new standard is effective for fiscal years beginning after December 15, 2020, including interim periods therein; with early adoption permitted. The Company adopted the Topic 740 effective January 1, 2021. The adoption did not have a material impact on the Company’s financial statements. |
Summary Of Significant Accoun_3
Summary Of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Summary Of Significant Accounting Policies [Abstract] | |
Schedule Of Warranty Accrual Activity | Three-Month Periods Ended Nine-Month Periods Ended September 30, September 30, 2021 2020 2021 2020 Beginning balance $ — $ — $ — $ — Add: Accruals for warranties issued during the period 27 — 27 — Less: Settlements made during the period — — — — Ending balance $ 27 $ — $ 27 $ — |
Anti-Dilutive Shares Excluded From Computation Of Diluted Net Loss Per Share | Nine-Month Periods Ended September 30, 2021 2020 Common stock warrants 600 793,464 Common stock options 5,946,009 5,207,326 Restricted stock units 76,903 34,402 Total 6,023,512 6,035,192 |
Fair Value Of Financial Instr_2
Fair Value Of Financial Instruments (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Of Financial Instruments [Abstract] | |
Fair Value Of Financial Assets Measured On A Recurring Basis | September 30, 2021 December 31, 2020 Assets Classification Level 1 Level 2 Level 3 Total Level 1 Level 2 Level 3 Total Money market funds Cash and cash equivalents $ 28,675 $ — $ — $ 28,675 $ 7,176 $ — $ — $ 7,176 U.S. Treasury Securities Cash and cash equivalents — 10,000 — 10,000 — 2,004 — 2,004 U.S. Treasury Securities Investments — — — — — 8,012 — 8,012 Total assets measured at fair value $ 28,675 $ 10,000 $ — $ 38,675 $ 7,176 $ 10,016 $ — $ 17,192 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Balance Sheet Components [Abstract] | |
Schedule Of Inventory | September 30, December 31, 2021 2020 Raw materials $ 1,362 $ — Work in process 1,218 — Finished goods 1,701 — Total inventory $ 4,281 $ — |
Schedule Of Property And Equipment, Net | September 30, December 31, 2021 2020 Leasehold improvements $ 2,827 $ 2,805 Laboratory equipment 986 878 Furniture, fixtures, and equipment 578 517 Software 202 128 Construction in progress 118 66 4,711 4,394 Less: Accumulated depreciation ( 2,265 ) ( 1,916 ) Property and equipment, net $ 2,446 $ 2,478 |
Schedule Of Intangible Assets, Net | September 30, December 31, 2021 2020 Acquired patents and licenses $ 7,985 $ 7,985 Less: Accumulated amortization ( 4,603 ) ( 4,103 ) Intangible assets, net $ 3,382 $ 3,882 |
Schedule Of Amortization Of Intangible Assets | Year Ending December 31: 2021 (remaining 3 months) $ 166 2022 665 2023 665 2024 665 2025 665 2026 556 Total $ 3,382 |
Schedule Of Accrued Expenses | September 30, December 31, 2021 2020 Compensation $ 3,549 $ 3,324 Director and officer liability insurance (Note 12) — 1,563 Controlled launch (Note 9) 632 — Clinical trial costs and fees 367 188 Professional fees 77 87 Warranty 27 — Other 319 164 Total accrued expenses $ 4,971 $ 5,326 |
Stockholders' Equity And Stoc_2
Stockholders' Equity And Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Stockholders' Equity [Line Items] | |
Summary Of Stock Option Activity | Stock Options Outstanding Weighted Number average of shares exercise price Balances — December 31, 2020 5,039,194 $ 14.26 Options granted 1,128,338 Options exercised ( 44,981 ) Options canceled ( 111,279 ) Options expired ( 65,263 ) Balances — September 30, 2021 5,946,009 $ 15.73 Exercisable — September 30, 2021 3,150,036 $ 16.00 |
Summary Of Stock-Based Compensation Expense | Three-Month Periods Ended Nine-Month Periods Ended September 30, September 30, 2021 2020 2021 2020 Cost of revenue $ 37 $ — $ 37 $ — Research and development 418 1,183 4,586 2,957 Sales and marketing 65 312 2,326 903 General and administrative 1,057 1,154 4,041 3,826 Total stock-based compensation expense $ 1,577 $ 2,649 $ 10,990 $ 7,686 |
Employee Stock Option [Member] | |
Stockholders' Equity [Line Items] | |
Schedule Of Fair Value Of Employee Stock Options | Three-Month Periods Ended September 30, Nine-Month Periods Ended September 30, 2021 2020 2021 2020 Expected term in years 6.1 5.8 - 6.1 5.3 - 6.1 5.3 - 6.1 Expected volatility 78 % 70 % 78 % 70 % Risk-free interest rate 0.9 % 0.3 - 0.4 % 0.9 - 1.1 % 0.4 - 0.5 % Dividend yield — — — — |
2017 Employee Stock Purchase Plan [Member] | |
Stockholders' Equity [Line Items] | |
Schedule Of Fair Value Of Employee Stock Options | Three-Month Periods Ended September 30, Nine-Month Periods Ended September 30, 2021 2020 2021 2020 Expected term in years 0.5 - 1.0 0.5 - 1.0 0.5 - 1.0 0.5 - 1.0 Expected volatility 78 % 70 % 78 % 70 % Risk-free interest rate 0.06 - 0.07 % 0.1 % 0.06 - 0.1 % 0.1 - 1.0 % Dividend yield — — — — |
Commitments And Contingencies (
Commitments And Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Commitments And Contingencies [Abstract] | |
Schedule Of Maturity Lease Payments | Year Ending December 31: 2021 (remaining 3 months) $ 447 2022 1,806 2023 1,845 2024 1,910 2025 1,976 2026 2,046 Thereafter 6,191 Total lease payments 16,221 Less imputed interest ( 5,230 ) Total lease liabilities $ 10,991 |
Schedule Of Information Related To Right-Of-Use Assets And Lease Liabilities | Other supplemental information: Current operating lease liabilities $ 749 Non-current operating lease liabilities 10,242 Total lease liabilities $ 10,991 Cash paid for operating lease liabilities $ 1,196 Weighted average remaining lease term 8.08 Weighted average discount rate 10 % |
Segment Reporting (Tables)
Segment Reporting (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Segment Reporting [Abstract] | |
Schedule Of Revenue By Product And Geographic Location | Revenue by product consisted of the following (in thousands): Three-Month Periods Ended Nine-Month Periods Ended September 30, September 30, 2021 2020 2021 2020 Systems $ 490 $ — $ 490 $ — Cycle units 84 — 84 — Total consolidated revenue $ 574 $ — $ 574 $ — Revenue by geography consisted of the following (in thousands): Three-Month Periods Ended Nine-Month Periods Ended September 30, September 30, 2021 2020 2021 2020 North America $ 405 $ — $ 405 $ — Rest of World 169 — 169 — Total consolidated revenue $ 574 $ — $ 574 $ — |
Summary Of Significant Accoun_4
Summary Of Significant Accounting Policies (Narrative) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Summary Of Significant Accounting Policies [Abstract] | |||||
Accumulated deficit | $ (220,784,000) | $ (220,784,000) | $ (172,540,000) | ||
Cash used in operating activities | (41,403,000) | $ (26,110,000) | |||
Cash, cash equivalents, and investments | 42,000,000 | 42,000,000 | |||
Net loss | (14,282,000) | $ (12,896,000) | (48,244,000) | $ (36,101,000) | |
Inventory valuation reserve | $ 0 | $ 0 |
Summary Of Significant Accoun_5
Summary Of Significant Accounting Policies (Schedule Of Warranty Accrual Activity) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2021 | Sep. 30, 2021 | |
Summary Of Significant Accounting Policies [Abstract] | ||
Add: Accruals for warranties issued during the period | $ 27 | $ 27 |
Ending balance | $ 27 | $ 27 |
Summary Of Significant Accoun_6
Summary Of Significant Accounting Policies (Anti-Dilutive Shares Excluded From Computation Of Diluted Net Loss Per Share) (Details) - shares | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 6,023,512 | 6,035,192 |
Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 600 | 793,464 |
Employee Stock Option [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 5,946,009 | 5,207,326 |
Restricted Stock Units [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 76,903 | 34,402 |
Fair Value Of Financial Instr_3
Fair Value Of Financial Instruments (Narrative) (Details) - USD ($) | Sep. 30, 2021 | Dec. 31, 2020 |
Fair Value Of Financial Instruments [Abstract] | ||
Liabilities measured at fair value | $ 0 | $ 0 |
Transfers between level 1, 2, or 3 | $ 0 |
Fair Value Of Financial Instr_4
Fair Value Of Financial Instruments (Fair Value Of Financial Assets Measured On A Recurring Basis) (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
ASSETS | ||
Total assets measured at fair value | $ 38,675 | $ 17,192 |
Cash And Cash Equivalents [Member] | Money Market Funds [Member] | ||
ASSETS | ||
Total cash and cash equivalents | 28,675 | 7,176 |
Cash And Cash Equivalents [Member] | U.S. Treasury Securities [Member] | ||
ASSETS | ||
Total cash and cash equivalents | 10,000 | 2,004 |
Investments [Member] | U.S. Treasury Securities [Member] | ||
ASSETS | ||
Total investments | 8,012 | |
Level 1 [Member] | ||
ASSETS | ||
Total assets measured at fair value | 28,675 | 7,176 |
Level 1 [Member] | Cash And Cash Equivalents [Member] | Money Market Funds [Member] | ||
ASSETS | ||
Total cash and cash equivalents | 28,675 | 7,176 |
Level 2 [Member] | ||
ASSETS | ||
Total assets measured at fair value | 10,000 | 10,016 |
Level 2 [Member] | Cash And Cash Equivalents [Member] | U.S. Treasury Securities [Member] | ||
ASSETS | ||
Total cash and cash equivalents | $ 10,000 | 2,004 |
Level 2 [Member] | Investments [Member] | U.S. Treasury Securities [Member] | ||
ASSETS | ||
Total investments | $ 8,012 |
Balance Sheet Components (Narra
Balance Sheet Components (Narrative) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Balance Sheet Components [Abstract] | ||||
Depreciation expense | $ 100 | $ 100 | $ 349 | $ 310 |
Intangible asset useful life | 12 years |
Balance Sheet Components (Sched
Balance Sheet Components (Schedule Of Inventory) (Details) $ in Thousands | Sep. 30, 2021USD ($) |
Balance Sheet Components [Abstract] | |
Raw materials | $ 1,362 |
Work in process | 1,218 |
Finished goods | 1,701 |
Total inventory | $ 4,281 |
Balance Sheet Components (Sch_2
Balance Sheet Components (Schedule Of Property And Equipment, Net) (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 4,711 | $ 4,394 |
Less: Accumulated depreciation | (2,265) | (1,916) |
Property and equipment, net | 2,446 | 2,478 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 2,827 | 2,805 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 986 | 878 |
Furniture, Fixtures, And Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 578 | 517 |
Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 202 | 128 |
Construction In Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 118 | $ 66 |
Balance Sheet Components (Sch_3
Balance Sheet Components (Schedule Of Intangible Assets, Net) (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Balance Sheet Components [Abstract] | ||
Acquired patents and licenses | $ 7,985 | $ 7,985 |
Less: Accumulated amortization | (4,603) | (4,103) |
Intangible assets, net | $ 3,382 | $ 3,882 |
Balance Sheet Components (Sch_4
Balance Sheet Components (Schedule Of Amortization Of Intangible Assets) (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Balance Sheet Components [Abstract] | ||
2021 (remaining 3 months) | $ 166 | |
2022 | 665 | |
2023 | 665 | |
2024 | 665 | |
2025 | 665 | |
2026 | 556 | |
Intangible assets, net | $ 3,382 | $ 3,882 |
Balance Sheet Components (Sch_5
Balance Sheet Components (Schedule Of Accrued Expenses) (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Balance Sheet Components [Abstract] | ||
Compensation | $ 3,549 | $ 3,324 |
Director and officer liability insurance (Note 12) | 1,563 | |
Controlled launch (Note 9) | 632 | |
Clinical trial costs and fees | 367 | 188 |
Professional fees | 77 | 87 |
Warranty | 27 | |
Other | 319 | 164 |
Accrued expenses | $ 4,971 | $ 5,326 |
Goodwill (Narrative) (Details)
Goodwill (Narrative) (Details) | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2014USD ($)entity | |
Business Acquisition, Equity Interests Issued or Issuable [Line Items] | |||
Number of purchased companies | entity | 3 | ||
Goodwill | $ 2,791,000 | $ 2,791,000 | $ 2,800,000 |
Goodwill impairment | $ 0 | $ 0 | |
TPI, BEM And NB [Member] | |||
Business Acquisition, Equity Interests Issued or Issuable [Line Items] | |||
Aggregate consideration | $ 5,500,000 |
Stockholders' Equity And Stoc_3
Stockholders' Equity And Stock-Based Compensation (Narrative) (Details) | Feb. 05, 2021$ / sharesshares | Feb. 04, 2021USD ($)$ / sharesshares | Jan. 01, 2021shares | Mar. 31, 2021shares | Feb. 28, 2021USD ($) | Feb. 04, 2021USD ($)$ / sharesshares | Jun. 30, 2020USD ($)$ / sharesshares | Sep. 30, 2021USD ($)$ / sharesshares | Sep. 30, 2020USD ($)shares | Sep. 30, 2021USD ($)$ / sharesshares | Sep. 30, 2020USD ($)shares | Jun. 30, 2021$ / shares | May 31, 2021shares | Dec. 31, 2020$ / sharesshares | Nov. 30, 2017shares | Dec. 31, 2016$ / sharesshares | Dec. 31, 2014$ / sharesshares |
Stockholders' Equity [Line Items] | |||||||||||||||||
Common stock, par value | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | ||||||||||||||
Proceeds from issuance of common stock | $ | $ 56,697,000 | $ 29,498,000 | |||||||||||||||
Common stock, shares issued | 29,631,000 | 29,631,000 | 25,550,000 | ||||||||||||||
Options granted | 1,128,338 | ||||||||||||||||
Warrants exercised | 44,981 | ||||||||||||||||
Exercise price | $ / shares | $ 16 | $ 16 | |||||||||||||||
Total stock-based compensation expense | $ | $ 1,577,000 | $ 2,649,000 | $ 10,990,000 | 7,686,000 | |||||||||||||
Cash received from option exercises | $ | $ 678,000 | 349,000 | |||||||||||||||
2017 Employee Stock Purchase Plan [Member] | |||||||||||||||||
Stockholders' Equity [Line Items] | |||||||||||||||||
Common stock, shares issued | 91,378 | 91,378 | |||||||||||||||
Shares authorized | 250,000 | 250,000 | |||||||||||||||
Additional common stock reserved for issuance | 383,250 | ||||||||||||||||
Increase in shares available for issuance threshold of common stock outstanding, number of shares | 450,000 | ||||||||||||||||
Increase in shares available for issuance threshold of common stock outstanding, percent outstanding | 1.50% | ||||||||||||||||
Shares available for grant | 649,096 | 649,096 | |||||||||||||||
2017 Inducement Equity Incentive Plan [Member] | |||||||||||||||||
Stockholders' Equity [Line Items] | |||||||||||||||||
Term period | 10 years | ||||||||||||||||
Shares authorized | 1,000,000 | 1,000,000 | |||||||||||||||
Shares available for grant | 1,040,346 | 1,040,346 | |||||||||||||||
2017 Plan [Member] | |||||||||||||||||
Stockholders' Equity [Line Items] | |||||||||||||||||
Term period | 10 years | ||||||||||||||||
Shares authorized | 1,500,000 | 1,500,000 | |||||||||||||||
Additional common stock reserved for issuance | 1,022,002 | ||||||||||||||||
Increase in shares available for issuance threshold of common stock outstanding, number of shares | 1,200,000 | ||||||||||||||||
Increase in shares available for issuance threshold of common stock outstanding, percent outstanding | 4.00% | ||||||||||||||||
Shares available for grant | 506,917 | 506,917 | |||||||||||||||
Rights Offering [Member] | |||||||||||||||||
Stockholders' Equity [Line Items] | |||||||||||||||||
Price per share | $ / shares | $ 7.01 | ||||||||||||||||
Value of warrants/rights | $ | $ 30,000,000 | ||||||||||||||||
Net proceeds | $ | $ 4,500,000 | $ 29,400,000 | |||||||||||||||
Warrants/rights outstanding | 641,571 | 0 | 0 | ||||||||||||||
Warrants exercised | 5,139 | 636,432 | |||||||||||||||
Exercise price of warrants/rights | $ / shares | $ 7.01 | ||||||||||||||||
Redemption per warrant | $ / shares | $ 0.01 | $ 0.01 | |||||||||||||||
Period the warrants are exercisable after issuance | 30 days | ||||||||||||||||
Percentage requirement for warrant redemption | 200.00% | ||||||||||||||||
Period of time required for redemption of warrants | 10 days | ||||||||||||||||
Number of common shares called by issuance of warrants | 4,279,600 | ||||||||||||||||
Rights Offering [Member] | Rights Offering [Member] | |||||||||||||||||
Stockholders' Equity [Line Items] | |||||||||||||||||
Common stock, par value | $ / shares | $ 0.001 | ||||||||||||||||
Number of warrants to purchase shares of common stock | 0.15 | ||||||||||||||||
First Vesting Portion [Member] | 2017 Inducement Equity Incentive Plan [Member] | |||||||||||||||||
Stockholders' Equity [Line Items] | |||||||||||||||||
Vesting percentage | 25.00% | ||||||||||||||||
General And Administrative [Member] | |||||||||||||||||
Stockholders' Equity [Line Items] | |||||||||||||||||
Total stock-based compensation expense | $ | $ 1,057,000 | 1,154,000 | $ 4,041,000 | 3,826,000 | |||||||||||||
Research And Development [Member] | |||||||||||||||||
Stockholders' Equity [Line Items] | |||||||||||||||||
Total stock-based compensation expense | $ | $ 418,000 | $ 1,183,000 | 4,586,000 | $ 2,957,000 | |||||||||||||
Employee Stock Option [Member] | |||||||||||||||||
Stockholders' Equity [Line Items] | |||||||||||||||||
Total stock-based compensation expense | $ | $ 0 | 4,200,000 | |||||||||||||||
Private Placement [Member] | |||||||||||||||||
Stockholders' Equity [Line Items] | |||||||||||||||||
Common stock, par value | $ / shares | $ 0.001 | ||||||||||||||||
Proceeds from issuance of common stock | $ | $ 8,400,000 | ||||||||||||||||
Chairman, Robert W. Duggan [Member] | Private Placement [Member] | |||||||||||||||||
Stockholders' Equity [Line Items] | |||||||||||||||||
Shares sold | 3,048,780 | ||||||||||||||||
Common stock, par value | $ / shares | $ 0.001 | $ 0.001 | |||||||||||||||
Price per share | $ / shares | $ 16.40 | $ 16.40 | |||||||||||||||
Proceeds from issuance of common stock | $ | $ 8,400,000 | ||||||||||||||||
Aggregate issuance costs | $ | $ 41,000,000 | ||||||||||||||||
Common stock, shares issued | 3,048,780 | 3,048,780 | |||||||||||||||
Net proceeds | $ | $ 50,000,000 | ||||||||||||||||
Common Stock [Member] | |||||||||||||||||
Stockholders' Equity [Line Items] | |||||||||||||||||
Warrants exercised | 85,000 | 45,000 | 86,000 | ||||||||||||||
Common Stock [Member] | Rights Offering [Member] | |||||||||||||||||
Stockholders' Equity [Line Items] | |||||||||||||||||
Warrants/rights outstanding | 641,571 | 641,571 | |||||||||||||||
Robert W. Duggan [Member] | Rights Offering [Member] | |||||||||||||||||
Stockholders' Equity [Line Items] | |||||||||||||||||
Number of common shares called by issuance of warrants | 2,561,873 | ||||||||||||||||
Robert W. Duggan [Member] | Private Placement [Member] | |||||||||||||||||
Stockholders' Equity [Line Items] | |||||||||||||||||
Price per share | $ / shares | $ 16.40 | ||||||||||||||||
MDB Capital Group, LLC [Member] | Initial Public Offering [Member] | |||||||||||||||||
Stockholders' Equity [Line Items] | |||||||||||||||||
Price per share | $ / shares | $ 5 | ||||||||||||||||
Common stock received from rights/warrants exercised | 68,958 | ||||||||||||||||
Warrants/rights outstanding | 0 | 0 | |||||||||||||||
Warrants exercised | 85,385 | ||||||||||||||||
Exercisable period of warrants or rights | 5 years | ||||||||||||||||
Number of common shares called by issuance of warrants | 574,985 | ||||||||||||||||
MDB Capital Group, LLC [Member] | Private Placement [Member] | |||||||||||||||||
Stockholders' Equity [Line Items] | |||||||||||||||||
Price per share | $ / shares | $ 2.67 | ||||||||||||||||
Common stock received from rights/warrants exercised | 40,563 | ||||||||||||||||
Warrants/rights outstanding | 600 | 600 | |||||||||||||||
Warrants exercised | 45,638 | ||||||||||||||||
Exercisable period of warrants or rights | 7 years | ||||||||||||||||
Number of common shares called by issuance of warrants | 299,625 | ||||||||||||||||
Stifel, Nicolaus & Company Inc. [Member] | At the Market Offering [Member] | |||||||||||||||||
Stockholders' Equity [Line Items] | |||||||||||||||||
Value of warrants/rights | $ | $ 60,000,000 | $ 60,000,000 | |||||||||||||||
Net proceeds | $ | $ 7,400,000 | ||||||||||||||||
Warrants/rights outstanding | 288,490 | 288,490 | |||||||||||||||
Exercise price of warrants/rights | $ / shares | $ 27.73 | $ 27.73 |
Stockholders' Equity And Stoc_4
Stockholders' Equity And Stock-Based Compensation (Summary Of Stock Warrant Activity) (Details) | 9 Months Ended |
Sep. 30, 2021$ / sharesshares | |
Stockholders' Equity And Stock-Based Compensation [Abstract] | |
Beginning Balance, Number of shares | 5,039,194 |
Options granted, Number of shares | 1,128,338 |
Options exercised, Number of shares | (44,981) |
Options canceled, Number of shares | (111,279) |
Options expired, Number of shares | (65,263) |
Ending Balance, Number of shares | 5,946,009 |
Beginning Balance, Weighted average exercise price per share | $ / shares | $ 14.26 |
Ending Balance, Weighted average exercise price per share | $ / shares | $ 15.73 |
Stockholders' Equity And Stoc_5
Stockholders' Equity And Stock-Based Compensation (Summary Of Stock Option Activity) (Details) | 9 Months Ended |
Sep. 30, 2021$ / sharesshares | |
Stockholders' Equity And Stock-Based Compensation [Abstract] | |
Beginning Balance, Number of shares | 5,039,194 |
Options granted, Number of shares | 1,128,338 |
Options exercised, Number of shares | (44,981) |
Options canceled, Number of shares | (111,279) |
Options expired, Number of shares | (65,263) |
Ending Balance, Number of shares | 5,946,009 |
Exercisable, Number of shares | 3,150,036 |
Beginning Balance, Weighted average exercise price per share | $ / shares | $ 14.26 |
Ending Balance, Weighted average exercise price per share | $ / shares | 15.73 |
Exercisable, Weighted average exercise price per share | $ / shares | $ 16 |
Stockholders' Equity And Stoc_6
Stockholders' Equity And Stock-Based Compensation (Schedule Of Stock-Based Compensation Expense) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation expense | $ 1,577 | $ 2,649 | $ 10,990 | $ 7,686 |
Cost of revenue [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation expense | 37 | 37 | ||
Research And Development [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation expense | 418 | 1,183 | 4,586 | 2,957 |
Sales And Marketing [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation expense | 65 | 312 | 2,326 | 903 |
General And Administrative [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation expense | $ 1,057 | $ 1,154 | $ 4,041 | $ 3,826 |
Stockholders' Equity And Stoc_7
Stockholders' Equity And Stock-Based Compensation (Summary Of Stock-Based Compensation Expense) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Total stock-based compensation expense | $ 1,577 | $ 2,649 | $ 10,990 | $ 7,686 |
Cost of revenue [Member] | ||||
Total stock-based compensation expense | 37 | 37 | ||
Research And Development [Member] | ||||
Total stock-based compensation expense | 418 | 1,183 | 4,586 | 2,957 |
Sales And Marketing [Member] | ||||
Total stock-based compensation expense | 65 | 312 | 2,326 | 903 |
General And Administrative [Member] | ||||
Total stock-based compensation expense | $ 1,057 | $ 1,154 | $ 4,041 | $ 3,826 |
Stockholders' Equity And Stoc_8
Stockholders' Equity And Stock-Based Compensation (Schedule Of Fair Value Of Employee Stock Options) (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Employee Stock Option [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected term in years | 6 years 1 month 6 days | |||
Expected volatility | 78.00% | 70.00% | 78.00% | 70.00% |
Risk-free interest rate | 0.90% | |||
Employee Stock Option [Member] | Minimum [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected term in years | 5 years 9 months 18 days | 5 years 3 months 18 days | 5 years 3 months 18 days | |
Risk-free interest rate | 0.30% | 0.90% | 0.40% | |
Employee Stock Option [Member] | Maximum [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected term in years | 6 years 1 month 6 days | 6 years 1 month 6 days | 6 years 1 month 6 days | |
Risk-free interest rate | 0.40% | 1.10% | 0.50% | |
2017 Employee Stock Purchase Plan [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected volatility | 78.00% | 70.00% | 78.00% | 70.00% |
2017 Employee Stock Purchase Plan [Member] | Minimum [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected term in years | 6 months | 6 months | 6 months | 6 months |
Risk-free interest rate | 0.06% | 0.10% | 0.06% | 0.10% |
2017 Employee Stock Purchase Plan [Member] | Maximum [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected term in years | 1 year | 1 year | 1 year | 1 year |
Risk-free interest rate | 0.07% | 0.10% | 1.00% |
Research Grants And Agreements
Research Grants And Agreements (Narrative) (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
May 31, 2021 | Mar. 31, 2021 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Research and development expense | $ 6,460 | $ 6,968 | $ 22,982 | $ 19,019 | ||
Sponsored Research Agreement ("SRA") [Member] | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Research and development expense | $ 100 | $ 200 | $ 200 | $ 600 | ||
ODURF [Member] | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Research and development expense | $ 300 | |||||
Period of time for Sponsored Research Agreement ("SRA") | 12 months | |||||
ODURF [Member] | Sponsored Research Agreement ("SRA") [Member] | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Research and development expense | $ 300 |
Commitments And Contingencies_2
Commitments And Contingencies (Narrative) (Details) | May 13, 2021USD ($) | Jun. 30, 2021USD ($)$ / shares | Sep. 30, 2021USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2021USD ($) | Sep. 30, 2020USD ($) | Mar. 11, 2021USD ($) | May 31, 2019ft² | Jan. 31, 2017ft² | Dec. 31, 2014$ / shares |
Commitments and Contingencies [Line Items] | ||||||||||
Director and officer insurance premium payable | $ 2,600,000 | |||||||||
Insurance down payment | 700,000 | |||||||||
Financed insurance policy balance | $ 1,900,000 | |||||||||
Financed insurance policy interest rate | 3.69% | |||||||||
Rent expense, including common area maintenance charges | $ 500,000 | $ 500,000 | $ 1,500,000 | $ 1,200,000 | ||||||
MDB Capital Group, LLC [Member] | Private Placement [Member] | ||||||||||
Commitments and Contingencies [Line Items] | ||||||||||
Price per share | $ / shares | $ 2.67 | |||||||||
Robert W. Duggan [Member] | Private Placement [Member] | ||||||||||
Commitments and Contingencies [Line Items] | ||||||||||
Principal sum | $ 41,000,000 | |||||||||
Accrued interest | $ 600,000 | |||||||||
Price per share | $ / shares | $ 16.40 | |||||||||
Hayward, CA [Member] | ||||||||||
Commitments and Contingencies [Line Items] | ||||||||||
Lease term | 5 years | |||||||||
Area Of Lease | ft² | 15,700 | |||||||||
Lease Amendment [Member] | ||||||||||
Commitments and Contingencies [Line Items] | ||||||||||
Area Of Lease | ft² | 13,300 | |||||||||
Expansion Premises [Member] | ||||||||||
Commitments and Contingencies [Line Items] | ||||||||||
Area Of Lease | ft² | 21,300 | |||||||||
Loan Agreement [Member] | Robert W. Duggan [Member] | ||||||||||
Commitments and Contingencies [Line Items] | ||||||||||
Principal sum | $ 41,000,000 | |||||||||
Debt instrument, quarterly interest rate | 5.00% | |||||||||
Accrued interest | $ 600,000 |
Commitments And Contingencies_3
Commitments And Contingencies (Schedule Of Maturity Lease Payments) (Details) $ in Thousands | Sep. 30, 2021USD ($) |
Commitments And Contingencies [Abstract] | |
2021 (remaining 3 months) | $ 447 |
2022 | 1,806 |
2023 | 1,845 |
2024 | 1,910 |
2025 | 1,976 |
2026 | 2,046 |
Thereafter | 6,191 |
Total lease payments | 16,221 |
Less imputed interest | (5,230) |
Total lease liabilities | $ 10,991 |
Commitments And Contingencies_4
Commitments And Contingencies (Schedule Of Information Related To Right-Of-Use Assets And Lease Liabilities) (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Dec. 31, 2020 | |
Commitments And Contingencies [Abstract] | ||
Current operating lease liabilities | $ 749 | $ 542 |
Non-current operating lease liabilities | 10,242 | $ 10,814 |
Total lease liabilities | 10,991 | |
Cash paid for operating lease liabilities | $ 1,196 | |
Weighted average remaining lease term | 8 years 29 days | |
Weighted average discount rate | 10.00% |
Controlled Launch (Narrative) (
Controlled Launch (Narrative) (Details) $ in Millions | 3 Months Ended | 9 Months Ended |
Sep. 30, 2021USD ($) | Sep. 30, 2021USD ($)item | |
Controlled Launch [Abstract] | ||
Number of KOLs | item | 80 | |
Number of patients participating in procedure | 40 or 50 | |
Program expenses | $ 0.6 | $ 1.2 |
Revenue recognized | $ 0.5 |
Segment Reporting (Details)
Segment Reporting (Details) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2021USD ($) | Sep. 30, 2021USD ($)segment | |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Number of reportable segments | segment | 1 | |
Number of operating segments | segment | 1 | |
Revenue | $ 574 | $ 574 |
Systems Products [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenue | 490 | 490 |
Cycle Units Products [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenue | 84 | 84 |
North America [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenue | 405 | 405 |
Rest Of World [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenue | $ 169 | $ 169 |
Related Party Transactions (Nar
Related Party Transactions (Narrative) (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||||
Feb. 04, 2021USD ($) | Jun. 30, 2020USD ($)$ / sharesshares | Sep. 30, 2021USD ($)$ / sharesshares | Sep. 30, 2021USD ($)$ / sharesshares | Sep. 30, 2020USD ($) | Jun. 30, 2021$ / shares | Mar. 11, 2021USD ($) | Dec. 31, 2020$ / sharesshares | Dec. 31, 2016$ / sharesshares | Dec. 31, 2014$ / sharesshares | |
Related Party Transaction [Line Items] | ||||||||||
Common stock, shares issued | shares | 29,631,000 | 29,631,000 | 25,550,000 | |||||||
Common stock, par value | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | |||||||
Proceeds from issuance of common stock | $ 56,697 | $ 29,498 | ||||||||
Coverage period | 1 year | |||||||||
Private Placement [Member] | ||||||||||
Related Party Transaction [Line Items] | ||||||||||
Common stock, par value | $ / shares | $ 0.001 | |||||||||
Proceeds from issuance of common stock | $ 8,400 | |||||||||
Chairman, Robert W. Duggan [Member] | Private Placement [Member] | ||||||||||
Related Party Transaction [Line Items] | ||||||||||
Common stock, shares issued | shares | 3,048,780 | 3,048,780 | ||||||||
Common stock, par value | $ / shares | $ 0.001 | $ 0.001 | ||||||||
Price per share | $ / shares | $ 16.40 | $ 16.40 | ||||||||
Aggregate issuance costs | $ 41,000 | |||||||||
Net proceeds | 50,000 | |||||||||
Proceeds from issuance of common stock | $ 8,400 | |||||||||
MDB Capital Group, LLC [Member] | Initial Public Offering [Member] | ||||||||||
Related Party Transaction [Line Items] | ||||||||||
Price per share | $ / shares | $ 5 | |||||||||
Warrants/rights outstanding | shares | 0 | 0 | ||||||||
Number of common shares called by issuance of warrants | shares | 574,985 | |||||||||
MDB Capital Group, LLC [Member] | Private Placement [Member] | ||||||||||
Related Party Transaction [Line Items] | ||||||||||
Price per share | $ / shares | $ 2.67 | |||||||||
Warrants/rights outstanding | shares | 600 | 600 | ||||||||
Number of common shares called by issuance of warrants | shares | 299,625 | |||||||||
Robert W. Duggan [Member] | ||||||||||
Related Party Transaction [Line Items] | ||||||||||
Due to related parties | $ 2,500 | $ 2,500 | $ 41,000 | |||||||
Robert W. Duggan [Member] | Private Placement [Member] | ||||||||||
Related Party Transaction [Line Items] | ||||||||||
Price per share | $ / shares | $ 16.40 | |||||||||
Robert W. Duggan [Member] | Rights Offering [Member] | ||||||||||
Related Party Transaction [Line Items] | ||||||||||
Number of common shares called by issuance of warrants | shares | 2,561,873 | |||||||||
Wilson Sonsini Goodrich And Rosati (WSGR) [Member] | ||||||||||
Related Party Transaction [Line Items] | ||||||||||
Related party expenses | 200 | |||||||||
Legal Expenses [Member] | Wilson Sonsini Goodrich And Rosati (WSGR) [Member] | ||||||||||
Related Party Transaction [Line Items] | ||||||||||
Related party expenses | $ 200 | $ 600 | ||||||||
Rights Offering [Member] | ||||||||||
Related Party Transaction [Line Items] | ||||||||||
Price per share | $ / shares | $ 7.01 | |||||||||
Net proceeds | $ 4,500 | $ 29,400 | ||||||||
Warrants/rights outstanding | shares | 641,571 | 0 | 0 | |||||||
Exercise price of warrants/rights | $ / shares | $ 7.01 | |||||||||
Number of common shares called by issuance of warrants | shares | 4,279,600 | |||||||||
Value of warrants/rights | $ 30,000 | |||||||||
Rights Offering [Member] | Rights Offering [Member] | ||||||||||
Related Party Transaction [Line Items] | ||||||||||
Common stock, par value | $ / shares | $ 0.001 | |||||||||
Number of warrants to purchase shares of common stock | 0.15 | |||||||||
Rights Offering [Member] | Legal Expenses [Member] | ||||||||||
Related Party Transaction [Line Items] | ||||||||||
Related party expenses | $ 400 | |||||||||
Rights Offering [Member] | Common Stock [Member] | ||||||||||
Related Party Transaction [Line Items] | ||||||||||
Warrants/rights outstanding | shares | 641,571 | 641,571 |