Impel Pharmaceuticals (IMPL) 10-Q 14 Nov 23 2024 Q3 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	9 Months Ended
	Sep. 30, 2023	Nov. 08, 2023
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Sep. 30, 2023
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	Q3
Trading Symbol	IMPL
Entity Registrant Name	IMPEL PHARMACEUTICALS INC.
Entity Central Index Key	0001445499
Current Fiscal Year End Date	--12-31
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	true
Entity Ex Transition Period	false
Entity Current Reporting Status	Yes
Entity Shell Company	false
Entity File Number	001-40353
Entity Tax Identification Number	26-3058238
Entity Address, Address Line One	201 Elliott Avenue West
Entity Address, Address Line Two	Suite 260
Entity Address, City or Town	Seattle
Entity Address, State or Province	WA
Entity Address, Postal Zip Code	98119
City Area Code	206
Local Phone Number	568-1466
Entity Common Stock, Shares Outstanding		23,900,031
Entity Interactive Data Current	Yes
Title of 12(b) Security	Common Stock, par value $0.001 per share
Security Exchange Name	NASDAQ
Entity Incorporation, State or Country Code	DE
Document Quarterly Report	true
Document Transition Report	false

Condensed Consolidated Balance

Condensed Consolidated Balance Sheet (Unaudited) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Current assets:
Cash and cash equivalents	$ 239	$ 60,654
Restricted cash	4,502	0
Trade receivables, net	6,586	7,444
Inventory	6,864	8,427
Prepaid expenses and other current assets	5,236	3,284
Total current assets	23,427	79,809
Property and equipment, net	4,087	3,863
Operating lease right-of-use assets	3,730	3,132
Other assets	3,829	1,746
Total assets	35,073	88,550
Current liabilities:
Accounts payable	3,734	6,092
Accrued and other liabilities	8,446	12,503
Current portion of long-term debt	111,001	0
Current portion of deferred royalty obligation	0	2,027
Current portion of operating lease liability	1,562	1,541
Total current liabilities	124,743	22,163
Operating lease liability, net of current portion	2,235	1,573
Deferred royalty obligation, net of current portion	0	60,899
Long-term debt	0	48,072
Total liabilities	126,978	132,707
Commitments and contingencies (Note 6)
Stockholders '(deficit) equity
Preferred stock, $0.001 par value; 10,000,000 shares authorized: none issued	0	0
Common stock, $0.001 par value; 300,000,000 shares authorized; 23,749,005 and 23,739,313 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively	24	24
Additional paid-in capital	280,419	276,929
Accumulated deficit	(372,348)	(321,110)
Total stockholders' deficit	(91,905)	(44,157)
Total liabilities and stockholders' deficit	$ 35,073	$ 88,550

Condensed Consolidated Balanc_2

Condensed Consolidated Balance Sheet (Parenthetical) (Unaudited) - $ / shares	Sep. 30, 2023	Dec. 31, 2022
Statement of Financial Position [Abstract]
Preferred stock, par value	$ 0.001	$ 0.001
Preferred stock, shares authorized	10,000,000	10,000,000
Preferred stock, shares Issued	0	0
Common stock, par value	$ 0.001	$ 0.001
Common stock, shares authorized	300,000,000	300,000,000
Common stock, shares issued	23,749,005	23,739,313
Common stock, shares outstanding	23,749,005	23,739,313

Condensed Consolidated Statemen

Condensed Consolidated Statement of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Income Statement [Abstract]
Product revenue, net	$ 5,023	$ 3,082	$ 15,979	$ 7,644
Cost of goods sold	2,230	1,508	7,734	4,277
Gross profit	2,793	1,574	8,245	3,367
Operating expenses:
Research and development	252	3,155	3,456	10,756
Selling, general and administrative	15,352	19,659	56,659	57,553
Restructuring	0	0	1,481	0
Total operating expenses	15,604	22,814	61,596	68,309
Loss from operations	(12,811)	(21,240)	(53,351)	(64,942)
Other income (expense), net :
Interest income (expense), net	(3,661)	(3,192)	(9,609)	(11,069)
Other income (expense), net	2,658	(6,665)	11,722	(7,260)
Total other income (expense), net	(1,003)	(9,857)	2,113	(18,329)
Loss before income taxes	(13,814)	(31,097)	(51,238)	(83,271)
Provision (benefit) for income taxes	0	0	0	0
Net loss and comprehensive loss	$ (13,814)	$ (31,097)	$ (51,238)	$ (83,271)
Net loss per share - basic	$ (0.58)	$ (1.31)	$ (2.16)	$ (3.57)
Net loss per share - diluted	$ (0.58)	$ (1.31)	$ (2.16)	$ (3.57)
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic	23,749,005	23,709,546	23,747,640	23,345,946
Weighted-average shares used in computing net loss per share attributable to common stockholders, diluted	23,749,005	23,709,546	23,747,640	23,345,946

Condensed Consolidated Statem_2

Condensed Consolidated Statement of Changes in Redeemable Convertible Preferred Stock and Stockholders Deficit (Unaudited) - USD ($) $ in Thousands	Total	Sale of Common Stock [Member]	Additional Paid-In Capital	Accumulated Deficit
Beginning Balance at Dec. 31, 2021	$ 52,508	$ 23	$ 267,283	$ (214,798)
Beginning Balance, Shares at Dec. 31, 2021		23,123,062
Stock-based compensation expense	1,795		1,795
Issuance of common stock upon the exercise of stock options	149		149
Issuance of common stock upon the exercise of stock options, Shares		50,235
Net loss and comprehensive loss	(26,970)			(26,970)
Ending Balance at Mar. 31, 2022	27,482	$ 23	269,227	(241,768)
Ending Balance, Shares at Mar. 31, 2022		23,173,297
Beginning Balance at Dec. 31, 2021	52,508	$ 23	267,283	(214,798)
Beginning Balance, Shares at Dec. 31, 2021		23,123,062
Net loss and comprehensive loss	(83,271)
Ending Balance at Sep. 30, 2022	(22,289)	$ 24	275,756	(298,069)
Ending Balance, Shares at Sep. 30, 2022		23,739,313
Beginning Balance at Mar. 31, 2022	27,482	$ 23	269,227	(241,768)
Beginning Balance, Shares at Mar. 31, 2022		23,173,297
Stock-based compensation expense	1,579		1,579
Issuance of common stock upon the exercise of stock options	53		53
Issuance of common stock upon the exercise of stock options, Shares		23,016
Net loss and comprehensive loss	(25,204)			(25,204)
Ending Balance at Jun. 30, 2022	3,910	$ 23	270,859	(266,972)
Ending Balance, Shares at Jun. 30, 2022		23,196,313
Stock-based compensation expense	565		565
Issuance of common stock upon the exercise of stock options	1		1
Issuance of common stock upon the exercise of stock options, Shares		500
Issuance of common stock, net of issuance costs, shares		542,500
Issuance of common stock, net of issuance costs	(4,332)	$ 1	(4,331)
Net loss and comprehensive loss	(31,097)			(31,097)
Ending Balance at Sep. 30, 2022	(22,289)	$ 24	275,756	(298,069)
Ending Balance, Shares at Sep. 30, 2022		23,739,313
Beginning Balance at Dec. 31, 2022	(44,157)	$ 24	276,929	(321,110)
Beginning Balance, Shares at Dec. 31, 2022		23,739,313
Release Of Restricted Stock Units Shares		6,944
Stock-based compensation expense	1,319		1,319
Net loss and comprehensive loss	(30,067)			(30,067)
Ending Balance at Mar. 31, 2023	(72,905)	$ 24	278,248	(351,177)
Ending Balance, Shares at Mar. 31, 2023		23,746,257
Beginning Balance at Dec. 31, 2022	$ (44,157)	$ 24	276,929	(321,110)
Beginning Balance, Shares at Dec. 31, 2022		23,739,313
Common stock shares sold		151,026
Issuance of common stock upon the exercise of stock options, Shares	2,748
Net loss and comprehensive loss	$ (51,238)
Ending Balance at Sep. 30, 2023	(91,905)	$ 24	280,419	(372,348)
Ending Balance, Shares at Sep. 30, 2023		23,749,005
Beginning Balance at Mar. 31, 2023	(72,905)	$ 24	278,248	(351,177)
Beginning Balance, Shares at Mar. 31, 2023		23,746,257
Stock-based compensation expense	1,099		1,099
Issuance of common stock upon the exercise of stock options	5		5
Issuance of common stock upon the exercise of stock options, Shares		2,748
Net loss and comprehensive loss	(7,357)			(7,357)
Ending Balance at Jun. 30, 2023	(79,158)	$ 24	279,352	(358,534)
Ending Balance, Shares at Jun. 30, 2023		23,749,005
Stock-based compensation expense	1,067		1,067
Net loss and comprehensive loss	(13,814)			(13,814)
Ending Balance at Sep. 30, 2023	$ (91,905)	$ 24	$ 280,419	$ (372,348)
Ending Balance, Shares at Sep. 30, 2023		23,749,005

Condensed Consolidated Statem_3

Condensed Consolidated Statement of Cash Flows (Unaudited) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022
Cash flows from operating activities:
Net loss	$ (51,238)	$ (83,271)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation	3,485	3,939
Depreciation and amortization	850	895
Non-cash lease expense	1,191	846
Non-cash interest expense and amortization of debt discount and issuance costs	5,297	4,386
Loss on early extinguishment of debt	0	3,251
Change in fair value of derivatives	(11,560)	7,585
Change in fair value of warrant liabilities	(204)	(279)
Write-down of inventory to net realizable value	1,190	0
Long-lived asset impairment	417	0
Changes in operating assets and liabilities:
Accounts receivable	858	(4,777)
Inventory	(2,973)	(4,702)
Prepaid expenses and other current assets	(1,952)	(2,605)
Other assets	(38)	0
Accounts payable	(2,190)	(1,616)
Accrued liabilities	(3,134)	1,541
Operating Lease	(1,106)	(849)
Net cash used in operating activities	(61,107)	(75,656)
Cash flows from investing activities:
Purchases of property and equipment	(1,871)	(365)
Net cash used in investing activities	(1,871)	(365)
Cash flows from financing activities:
Proceeds from deferred royalty obligation, net of issuance costs	0	48,418
Proceeds from issuance of debt, net of issuance costs	7,060	47,440
Payments on long-term debt, including final payment	0	(32,853)
Proceeds from issuance of common stock upon exercise of stock options	5	203
Proceeds from issuance of common stock, net of issuance costs	0	4,332
Net cash provided by financing activities	7,065	67,540
Net decrease in cash, cash equivalents and restricted cash	(55,913)	(8,481)
Cash, cash equivalents and restricted cash - Beginning of period	60,654	88,212
Cash, cash equivalents and restricted cash - End of period	4,741	79,731
Supplemental disclosures of cash flow information:
Right-of-use asset obtained in exchange for new operating lease liability	2,123	3,779
Accrued inventory purchases	246	1,096
Recognition of derivative liabilities	0	1,905
Recognition of fair value of warrant liabilities issued in connection with issuance of debt	700	0
Purchase of property and equipment included in accounts payable and accrued liabilities	$ 158	$ 157

Organization and Description of

Organization and Description of Business	9 Months Ended
	Sep. 30, 2023
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Organization and Description of Business	1. Organization and Description of Business Impel Pharmaceuticals Inc. (“the Company”, “we”, and “our”), is a commercial-stage biopharmaceutical company focused on the development and commercialization of transformative therapies for patients suffering from diseases with high unmet medical needs, with an initial focus on diseases of the central nervous system, or CNS. The Company's lead product, Trudhesa™ (dihydroergotamine mesylate) Nasal Spray was approved by the U.S. Food and Drug Administration (“FDA”) in September of 2021. Using the Company’s proprietary Precision Olfactory Delivery (POD®) technology, Trudhesa™ gently delivers dihydroergotamine mesylate (DHE), a proven, well-established therapeutic, quickly to the bloodstream through the vascular-rich upper nasal space. The Company’s strategy is to pair its POD®, upper nasal delivery technology with well-understood therapeutics or other therapeutics where rapid vascular absorption is preferred to drive therapeutic benefit, improve patient outcomes, reduce drug development risk and expand the commercial opportunity within its target diseases. The Company was incorporated under the laws of the State of Delaware on July 24, 2008, and maintains its headquarters and principal operations in Seattle, Washington. In April of 2022, the Company changed its name from Impel NeuroPharma, Inc. to Impel Pharmaceuticals Inc. Recent Developments From the Company’s inception through September 30, 2023, it raised an aggregate of $ 405.3 million in proceeds from the issuance of its common stock, proceeds pursuant to the Revenue Interest Financing Agreement (deferred royalty obligation), sale and issuance of redeemable convertible preferred stock, convertible notes, debt and warrants. The Company had cash and cash equivalents of $ 0.2 million and restricted cash of $ 4.5 million as of September 30, 2023. The Company currently has an effective 2022 Shelf Registration Statement (the “2022 Registration Statement”) on file with the Securities and Exchange Commission (“SEC”). The 2022 Shelf Registration Statement permits the offering, issuance and sale by the Company of up to an aggregate offering price of $ 200.0 million of common stock, preferred stock, debt securities, warrants, subscription rights and/or units in one or more offerings and in any combination. In May 2022, the Company entered into a sales agreement with Cowen and Company, LLC, as a sales agent, pursuant to which the Company may offer and sell shares of its common stock, from time to time, up to an aggregate amount of gross sales proceeds of $ 50.0 million through an at-the-market program (the “2022 ATM Program”) under the 2022 Registration Statement. In October 2023, the Company filed a prospectus supplement related to its 2022 ATM Program reflecting the Company’s sale restrictions pursuant to General Instruction I.B.6 of Form S-3 and registering the sale of up to $ 9,0 million through the 2022 ATM Program. Since such filing through the date of this Form 10-Q, the Company has sold 151,026 shares of its common stock for gross proceeds of approximately $ 65,000 at an average price of $ 0.4293 under its open sales agreement as further described in Note 9. Further, the Company’s Credit Agreement and Guaranty dated March 17, 2022, as amended (the “Senior Credit Agreement”) with Oaktree Fund Administration, LLC as administrative agent (“Oaktree”), and the lenders party thereto (collectively, the “Secured Parties”), as further described in Note 8, required maintaining a minimum of $ 12.5 million in unrestricted cash and cash equivalents on hand to avoid an event of default under the Senior Credit Agreement. Among other loan covenant requirements, the Senior Credit Agreement also required the Company to provide an audit opinion of its annual financial statements not subject to any “going concern” or like qualification or exception or explanatory paragraph of going concern footnote, however, any such audit report shall not be considered qualified due to the inclusion of an explanatory paragraph in the audit opinion based on the impending maturity date of any indebtedness within twelve months from the date of issuance of the annual financial statements, the prospective breach of any financial covenant thereunder or liquidity issues due to ordinary course liabilities. The Company was not in compliance with maintaining the minimum liquidity covenant of $ 12.5 million in unrestricted cash and cash equivalents in August 2023. As a result, during the three months ended September 30, 2023, the Company entered into two amendments to (i) the Senior Credit Agreement (collectively referred to as the “Amended Senior Credit Agreement”) the Secured Parties and the Revenue Interest Financing Agreement, dated March 17, as amended (the “RIF”) with Oaktree and the purchasers party thereto (collectively, the “Purchasers”). Under the first amendment, Oaktree advanced the Company $ 3.0 million of Tranche A-2 term loans under the Amended Senior Credit Agreement and the Purchasers agreed to exchange $ 9.0 million of obligations owed to the Purchasers under the RIF for $ 9.0 million of Tranche A-2 term loans under the Amended Senior Credit Agreement. Pursuant to the second amendment, the Secured Parties advanced the Company $ 4.5 million of Tranche B term loans under the Amended Senior Credit Agreement. Affiliates of KKR Iris Investors LLC, a greater than 10 % holder of the Company’s common stock are lenders of a portion of the new amount under the Amended Senior Credit Agreement. Additionally, the Company exchanged all of its outstanding obligations, including accrued interest, of $ 51.4 million under the Senior Credit Agreement and of $ 9.0 million in Tranche A-2 term loans under the Amended Senior Credit Agreement as well as $41.0 million from the RIF into first lien Tranche A term loans. The Company had the right to draw up to an additional $ 12.5 million in Tranche B term loans over the course of 2023 subject to the Company’s achievement of certain strategic milestones, satisfaction of minimum net revenue and product units sold covenants and satisfaction of certain other covenants and conditions. The Secured Parties provided the Company with a limited forbearance of the minimum liquidity covenant though December 31, 2023. In October 2023, as the Company remained in default due to the violation of the minimum net revenue and product units sold covenant as well as a financial reporting covenant, the Company and the Secured Parties entered into the third amendment to the Amended Senior Credit Agreement (the “Third Amendment”). Pursuant to the Third Amendment, the Company drew down $ 5.0 million in Tranche B term loans and continues to have the right to draw up to an additional $ 7.5 million in Tranche B term loans over the course of 2023, subject to the Company’s achievement of certain strategic milestones, satisfaction of minimum net revenue and product units sold covenants and satisfaction of certain other covenants and conditions specified in the Amended Senior Credit Agreement. The amounts outstanding under the Amended Senior Credit Agreement are secured and collateralized by all of the Company’s assets. The Amended Senior Credit Agreement also provides for certain modifications to the existing covenants, including additional reporting obligations, minimum net revenue and product units sold covenants and additional milestones. In addition, the Amended Senior Credit Agreement includes customary events of default, the occurrence of which could result in termination of Oaktree’s commitments or the acceleration of the Company’s obligations under the Amended Senior Credit Agreement. There can be no assurance that the Company will satisfy the covenants under the Amended Senior Credit Agreement and have the ability to draw down the remaining $ 7.5 million of Tranche B term loans. An event of default will accelerate the repayment of the Tranche A and Tranche B term loans resulting in all outstanding amounts being immediately due and payable to the Secured Parties. The Company was in compliance with all covenants as of September 30, 2023, however, as of the date of filing, the Company is in default of the minimum net revenue and product units sold covenants. For more information, see Note 8. Our consolidated financial statements have been prepared using generally accepted accounting principles applicable to a going concern, which contemplates the realization of assets and liquidation of liabilities in the normal course of business. However, we have sustained substantial recurring losses from operations and negative operating cash flows. The above conditions raise substantial doubt about our ability to continue as a going concern within one year after the issuance date of these condensed consolidated financial statements. Our consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should we be unable to continue in existence. Uncertainty concerning our ability to continue as a going concern, among other factors, may hinder our ability to obtain future financing. Continued operations and our ability to continue as a going concern are dependent, among other factors, on our ability to successfully commercialize Trudhesa and our ability to obtain additional required funding in the near term and thereafter. We are exploring a wide range of options with a focus on maximizing shareholder value, including a potential sale of assets of the company, a sale of all of the company, a merger or other strategic transaction. Other potential strategic alternatives may include further restructuring or refinancing our debt, seeking additional debt or equity capital, reducing or delaying our business activities and strategic initiatives, mergers and acquisitions, licensing arrangements and partnerships, co-development agreements, or a combination of these. We have engaged financial advisors in connection with the review of strategic alternatives, however, there can be no assurance that we will be able to complete additional or alternative financings, business development transactions or other strategic alternatives. If we cannot continue as a viable entity, we will likely be required to reduce or cease operations and seek relief under the Chapter 11 of the United States Code (the “U.S. Bankruptcy Code”), and our stockholders would likely lose most or all of their investment in us. Our ongoing liquidity issues also present significant challenges to current operations. We currently expect the financing availability under the Amended Senior Credit Agreement to be sufficient to conduct the strategic review process, but we do not expect it to be sufficient to continue operations beyond this process without substantial additional investment. Our operations are also being impacted by the loss of sales representatives that we do not currently plan to replace, increased pressure from suppliers regarding payments from us that may delay or prevent our ability to obtain sufficient product from suppliers, and concern from prescribers regarding future product availability. Any of these issues can have a material impact on our sales and may further reduce our cash runway, accelerating the potential need to seek alternatives, including seeking relief under Chapter 11 of the U.S. Bankruptcy Code.

Summary of Significant Accounti

Summary of Significant Accounting Policies	9 Months Ended
	Sep. 30, 2023
Accounting Policies [Abstract]
Summary of Significant Accounting Policies	2. Summary of Significant Accounting Policies Basis of Presentation and Consolidation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles, or U.S. GAAP, and rules and regulations of the SEC for interim financial reporting. The condensed consolidated financial statements include the operations of Impel Pharmaceuticals Inc., and its wholly owned Australian subsidiary. All intercompany balances and transactions have been eliminated upon consolidation. The condensed consolidated balance sheet as of September 30, 2023, the condensed consolidated statements of operations and comprehensive loss, and changes in stockholders’ (deficit) equity for the three and nine months ended September 30, 2023 and 2022 and cash flows for the nine months ended September 30, 2023 and 2022 are unaudited. These unaudited condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly the Company’s consolidated financial position as of September 30, 2023 and its results of operations for the three and nine months ended September 30, 2023 and 2022 and cash flows for the nine months ended September 30, 2023 and 2022. The financial data and the other financial information contained in these notes to the condensed consolidated financial statements related to the three and nine month periods is also unaudited. The results of operations for the three and nine months ended September 30, 2023, are not necessarily indicative of the results to be expected for the year ending December 31, 2023 or for any other future annual or interim period. The condensed consolidated balance sheet as of December 31, 2022 included herein was derived from the audited financial statements as of that date. These condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements as of and for the year ended December 31, 2022 included in its Annual Report on Form 10-K filed with the SEC on March 27, 2023. Our significant accounting policies are described in Note 2 of the notes to the consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2022. Updates to our accounting policies, including impacts from the adoption of new accounting standards, are discussed below in this Note 2. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, management evaluates such estimates and assumptions for continued reasonableness. In particular, management makes estimates with respect to revenue recognition, inventory valuation, the fair values of derivative liabilities, stock-based compensation expense, deferred royalty obligation, lease accounting, income taxes, and additional charges as a result of, or that are associated with, any restructuring initiative as well as impairment and related charges. Appropriate adjustments, if any, to the estimates used are made prospectively based upon such periodic evaluation. Actual results could differ from those estimates. Restricted Cash Restricted cash consists primarily of cash that is restricted to utilization only under certain circumstances. Any cash that is legally restricted from use is classified as restricted cash and is held at financial institutions. Restricted cash of approximately $ 4.5 million is disclosed on the consolidated balance sheet as of September 30, 2023 and represents cash deposited by the Company into a separate account and designated as a controlled account in accordance with the terms of the Amended Senior Credit Agreement. Refer to Note 8 for the terms of the Amended Senior Credit Agreement. Segments The Company’s chief operating decision maker during the nine months ended September 30, 2023, and until November 4, 2023 was its Chairman and Chief Executive Officer. As described below, the Chairman and Chief Executive Officer resigned effective November 4, 2023. The Company’s Board of Directors appointed an Interim President and Chief Executive Officer effective upon the resignation of the Chairman and Chief Executive Officer. The Chairman and Chief Executive Officer reviewed and the Interim President and Chief Executive Officer reviews financial information on an aggregate basis for the purposes of evaluating financial performance and allocating the Company’s resources. Accordingly, the Company has determined that it operates in one segment. Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and accounts receivables. The Company’s cash is deposited with high credit quality financial institutions. At times such deposits may be in excess of the Federal Depository Insurance Corporation insured limits. Selling, General and Administrative Expense Selling, general and administrative expenses are primarily comprised of compensation and benefits associated with sales and marketing, finance, human resources, legal, information technology and other administrative personnel, outside marketing, advertising and legal expenses and other general and administrative costs. The Company expenses the cost of advertising, including promotional expenses, as incurred. Advertising expenses were $ 1.7 million and $ 7.3 million for the three and nine months ended September 30, 2023. The Company incurred $ 1.5 million and $ 5.0 million for the three and nine months ended September 30, 2022. Impairment of Long-Lived Assets Long-lived assets consist of property and equipment and right of use assets. The Company reviews property and equipment and right of use assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset or asset group may not be recoverable or that the useful life is shorter than the Company had originally estimated. Recoverability is measured by comparison of the carrying amount of the asset or asset group to the future undiscounted cash flows which the asset or asset group is expected to generate. If the asset or asset group is considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the asset or asset group exceeds the fair value of the asset or asset group. If the useful life is shorter than originally estimated, the Company amortizes the remaining carrying value over the new shorter useful life. Recently Adopted Accounting Pronouncements In June 2016 the FASB issued Accounting Standard Update (“ASU”) 2016-13, Measurement of Credit Losses on Financial Instruments (Topic 326). This introduces a new methodology for recognition of credit losses - the current expected credit loss (“CECL”) method. The CECL method requires the recognition of all losses expected over the life of a financial instrument upon origination or purchase of the instrument unless the company elects to recognize such instruments at fair value with changes in profit and loss. The Company adopted this guidance as of January 1, 2023. The adoption did not have a material impact to the Company or its disclosures. Emerging Growth Company Status The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (“JOBS Act”). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. The Company has elected to use this extended transition period for complying with certain new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that it is (1) no longer an emerging growth company or (2) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, these financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates.

Fair Value Measurements

Fair Value Measurements	9 Months Ended
	Sep. 30, 2023
Fair Value Disclosures [Abstract]
Fair Value Measurements	3. Fair Value Measurements The following table summarizes the fair value of the Company’s financial liabilities measured at fair value on a recurring basis by level within the fair value hierarchy (in thousands): September 30, 2023 Level 1 Level 2 Level 3 Total Liabilities: Common stock warrant liabilities $ — $ — $ 757 $ 757 Total financial liabilities $ — $ — $ 757 $ 757 December 31, 2022 Level 1 Level 2 Level 3 Total Liabilities: Common stock warrant liabilities $ — $ — $ 261 $ 261 Derivative liability — Deferred royalty obligation — — 11,000 11,000 Derivative liability — Oaktree term loan — — 560 560 Total financial liabilities $ — $ — $ 11,821 $ 11,821 Common Stock Warrant Liabilities Fair values of the Company’s common stock warrants are based on significant inputs not observed in the market, and thus represent a Level 3 measurement. The following table summarizes the change in the fair value of the common stock warrant liabilities, included in the Company’s Accrued other liabilities in Note 5, for the nine months ended September 30, 2023 (in thousands): Beginning balance as of December 31, 2022 $ 261 Issuance of warrants to Tranche B lenders 700 Changes in fair value ( 204 ) Ending balance as of September 30, 2023 $ 757 Pursuant to the July 2021 loan and security agreement with Oxford Finance LLC and Silicon Valley Bank (the “Loan Agreement”), the Company issued common stock warrants (see Note 8). The Company's warrants are not indexed to the Company’s common stock in the manner contemplated by ASC 815-40 because the warrant provides for an adjustment to the exercise price upon an acquisition. The Warrants were measured at fair value at inception and are subsequently remeasured at each reporting date with changes in fair value recognized as a component of other income (expense), net in the consolidated statement of operations and other comprehensive loss. The Company determined the fair value of the common stock warrants using the Black-Scholes-Merton option pricing model based on significant unobservable inputs. The significant unobservable inputs used in the fair value measurement of the warrant liabilities is the volatility rate which is based on the historical volatility of a set of peer companies, that are publicly traded. Pursuant to the September 2023 second amendment to the Senior Credit Agreement, the Company will issue to the Tranche B lenders and certain of their affiliates warrants to purchase up to 4,749,800 shares of the Company's common stock. Upon execution of the second amendment, the Company issued warrants for the purchase of 1,781,175 shares of common stock. The remaining warrants will be issued on a pro rata basis in connection with each subsequent draw by the Company of the Tranche B term loans. The Warrants are exercisable, in full or in part, at any time prior to the seventh anniversary of their issuance or the consummation of a change of control (as defined in the Warrants), whichever occurs earlier, at an exercise price of $ 0.01 per share, subject to customary anti-dilution adjustments. The Warrants are not indexed to the Company’s common stock in the manner contemplated by ASC 815-40 because the warrant provides for settlement via the surrender of preferred stock at its liquidation value. The Warrants were measured at fair value at inception and are subsequently remeasured at each reporting date with changes in fair value recognized as a component of other income (expense), net in the consolidated statement of operations and other comprehensive loss. The Company determined the fair value of the Warrants using the Black-Scholes-Merton option pricing model based on significant unobservable inputs. The significant unobservable inputs used in the fair value measurement of the warrant liabilities is the volatility rate which is based on the historical volatility of a set of peer companies that are publicly traded. Derivative Liabilities Fair values of the Company’s derivative liabilities are based on significant inputs not observed in the market, and thus represent a Level 3 measurement. The following table summarizes the change in the estimated fair value of the Company’s derivative liabilities for the nine months ended September 30, 2023 (in thousands): Beginning balance as of December 31, 2022 $ 11,560 Change in fair value of derivatives — Deferred royalty obligation ( 11,000 ) Change in fair value of derivatives — Oaktree term loan ( 560 ) Ending balance as of September 30, 2023 $ — The Senior Credit Agreement with Oaktree contained embedded derivatives requiring bifurcation as a derivative instrument. The derivative liability related to the Oaktree term loan was netted with the term loan in the consolidated financial statements (see Note 8 for additional details). The embedded derivative liability was subject to remeasurement at the end of each reporting period, with changes in fair value recognized as a component of other income (expense), net. The fair value of the embedded derivative liabilities associated with the term loan was estimated using a probability weighted discounted cash flow model to measure the fair value. This involves significant Level 3 inputs and assumptions including an (i) estimated probability and timing of a change in control and event of default, and (ii) our risk-adjusted discount rate. The fair value of the embedded derivative was determined to be zero prior to the execution of the amendments to the Senior Credit Agreement as the probability of occurrence of the underlying events was remote resulting in no value ascribed to the derivative. The embedded derivative liability associated with our deferred royalty obligation (see Note 8) is measured at fair value using an option pricing Monte Carlo simulation model and is netted with the deferred royalty obligation in the consolidated financial statements. The embedded derivative liability is subject to remeasurement at the end of each reporting period, with changes in fair value recognized as a component of other expense, net. The assumptions used in the option pricing Monte Carlo simulation model include:(i) the probability-weighted net sales of Trudhesa; (ii) our risk-adjusted discount rate; (iii) our cost of debt; and (iv) the probability of a change in control and event of default occurring during the term of the instrument. The fair value of the embedded derivative was determined to be zero just prior to the termination of the RIF as the probability of a financing event occurring was remote resulting in no value ascribed to the derivative. The Amended Senior Credit Agreement includes certain prepayment features in the Tranche B term loan requiring bifurcation as embedded derivatives. See Note 8 for additional details. The embedded derivative liability is subject to remeasurement at the end of each reporting period, with changes in fair value recognized as a component of other income (expense), net. The fair value of the embedded derivative liabilities associated with the Tranche B term loans is estimated using a probability weighted discounted cash flow model to measure the fair value. This involves significant Level 3 inputs and assumptions including an (i) estimated probability and timing of an event of default, casualty event or asset sale, and (ii) our risk-adjusted discount rate. The fair value at inception of the embedded derivative and as of September 30, 2023 was zero.

Corporate Restructuring

Corporate Restructuring	9 Months Ended
	Sep. 30, 2023
Restructuring and Related Activities [Abstract]
Corporate Restructuring	4. Corporate Restructuring On February 22, 2023, the Company announced a strategic update and corporate restructuring (the “Restructuring”) to reprioritize spend to capitalize on the continued positive momentum in payor and prescriber uptake of Trudhesa and halt research and development efforts on product candidates including INP105 to address acute agitation and aggression in autism spectrum disorder. As part of the Restructuring, the Company reduced headcount by 16 % through a reduction in its workforce. The reduction in workforce was completed by March 31, 2023. The Company incurred the following Restructuring charges consisting of winding down costs, exit and other related costs, impairments and write-offs of long-lived assets, and severance and employee-related costs (in thousands): Nine Months Ended Severance and employee-related costs $ 1,007 Long-lived asset impairments and write-offs 415 Supplemental one-time termination charges 59 Total $ 1,481 The Company estimated that it will incur total cash expenses of approximately $ 1.0 million related to the Restructuring of which $ 0.9 million was paid through September 30, 2023. The cash payments were primarily comprised of severance and other related costs. The Company also completed an evaluation of the impact of the Restructuring on the carrying value of its long-lived assets, such as property and equipment. This process includes evaluating the estimated remaining lives, significant changes in the use, and potential impairment charges related to its long-lived assets. Based on its evaluation, the Company determined that certain of its long-lived assets were impaired as of March 31, 2023, and it recognized an impairment charge o f $ 0.4 million rela ted to its long-lived assets for the nine months ended September 30, 2023. The Company may incur additional costs not currently contemplated due to events that may occur because of, or that are associated with, the Restructuring. The following table summarizes the activity related to the restructuring liabilities included in accrued liabilities on the condensed consolidated balance sheet associated with our restructuring initiatives for the nine months ended September 30, 2023 (in thousands): September 30, Balance as of December 31, 2022 $ — Restructuring, impairment and related charges 1,481 Cash payments ( 934 ) Noncash activities ( 437 ) Balance as of September 30, 2023 $ 110

Balance Sheet Components

Balance Sheet Components	9 Months Ended
	Sep. 30, 2023
Balance Sheet Related Disclosures [Abstract]
Balance Sheet Components	5. Balance Sheet Components Inventory Inventories consisted of the following (in thousands): September 30, December 31, Raw materials $ 5,055 $ 2,461 Work-in-process 3,877 4,191 Finished goods 1,536 3,334 Total inventories 10,468 9,986 Less: long-term inventories ( 3,604 ) ( 1,559 ) Total current inventories $ 6,864 $ 8,427 Inventory amounts written down to net realizable value in the consolidated statements of operations and comprehensive loss included a charge of $ 0.1 million and $ 1.2 million to cost of goods sold during the three and nine months ended September 30, 2023, related to excess and obsolescence reserves associated with Trudhesa. The Company classifies its inventories based on its anticipated levels of sales, any inventory in excess of its normal operating cycle is classified as long-term within Other Assets on its consolidated balance sheets. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following (in thousands): September 30, December 31, Prepaid insurance $ 2,390 $ 1,036 Other prepaids 2,219 1,587 Other current assets 621 649 Tax refund receivable 6 12 Total prepaid expenses and other current assets $ 5,236 $ 3,284 Accrued Liabilities Accrued liabilities consisted of the following (in thousands): September 30, December 31, Accrued sales discounts and allowances $ 3,361 $ 3,376 Accrued compensation 2,729 5,287 Accrued other liabilities 1,478 1,662 Accrued professional services 720 1,808 Accrued construction in progress 158 370 Total accrued liabilities $ 8,446 $ 12,503

Commitments and Contingencies

Commitments and Contingencies	9 Months Ended
	Sep. 30, 2023
Commitments and Contingencies Disclosure [Abstract]
Commitments and Contingencies	6. Commitments and Contingencies Legal Proceedings From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of its business activities. The Company accrues a liability for such matters when it is probable that future expenditures will be made and that such expenditures can be reasonably estimated. Significant judgment is required to determine both probability and the estimated amount. The Company did not accrue any costs as of September 30, 2023 and December 31, 2022, as no contingent liabilities were deemed to be probable.

Leases

Leases	9 Months Ended
	Sep. 30, 2023
Leases [Abstract]
Leases	7. Leases Real Estate Leases In April 2022 the Company entered into a non-cancelable operating lease for 8,045 square feet of office space. Rent is payable monthly, increasing by approximately 2.5 % each year. The term of the lease is 127 months and commenced in the first quarter of 2023. Upon commencement, the Company recorded a right-of-use asset and a lease liability on the Condensed Consolidated Balance Sheet. In September 2017, the Company entered into a non-cancelable operating lease for 11,256 square feet of office and laboratory space. Rent is payable monthly, increasing by approximately 3 % each year. The initial term of the lease was 3 years, and the Company renewed the lease for an additio nal four years with an expiration date of August 31, 2024 . Commercial Fleet Leases During 2022 and in first half of 2023, the Company took delivery of a portion of its commercial car fleet for its salesforce. Each commercial fleet lease has a term of 12 months including options to renew for a total of 54 months, we believe a total of 36 months is deemed reasonable to exercise. In addition, the Company can terminate the vehicle leases at any time without a significant penalty. For the discount rate used in the commercial fleet lease, the Company used the weighted-average rate implicit in the commercial fleet leases. As of September 30, 2023, the Company was not party to any finance leases. The following table reconciles the Company’s undiscounted operating lease cash flows to its operating lease liability (in thousands): September 30, 2023 Remaining 2023 $ 484 2024 1,571 2025 718 2026 292 2027 and thereafter 1,830 Total undiscounted cash flows 4,895 Less: imputed interest ( 1,098 ) Total lease liabilities 3,797 Less: current portion ( 1,562 ) Lease liabilities $ 2,235 The weighted average remaining lease term and the weighted average discount rate used to determine the operating lease liability were as follows: September 30, 2023 Weighted average remaining lease term (years) 5.2 Weighted average discount rate 8.1 % Operating lease expense was $ 0.5 and $ 0.3 million for the three months ended September 30, 2023 and 2022, respectively and $ 1.4 and $ 1.0 million for the nine months ended September 30, 2023 and 2022, respectively. Variable lease expense was $ 0.1 million for operating leases for both three months ended September 30 , 2023 and 2022, and $ 0.3 million for operating leases for both nine months ended September 30 , 2023 and 2022. Rent expense recognized for short term leases was $ 0.1 million for nine months ended September 30 , 2022.

Long-Term Obligations

Long-Term Obligations	9 Months Ended
	Sep. 30, 2023
Debt Disclosure [Abstract]
Long-Term Obligations	8. Long-Term Obligations Oaktree Loan and Security Agreement On March 17, 2022 (“Closing Date”), the Company entered into a Senior Credit Agreement with Oaktree under which it borrowed $ 50.0 million in the form of a term loan. The term loan has a maturity date of March 17, 2027 , and prior to the amendments entered into in August and September 2023, initially bore interest at the Secured Overnight Financing Rate (“SOFR”) + 8.75 % (with a SOFR floor of 1.00%). Once Trudhesa achieves at least $ 125.0 million in net sales over a trailing 12-month period, interest would step down to SOFR + 8.00 % (with a SOFR floor of 1.00%). The Company is required to make quarterly interest-only payments until the fourth anniversary of the Closing Date, after which the Company is required to make quarterly amortizing payments, with the remaining balance of the principal plus accrued and unpaid interest due at maturity. Prepayments of the loan, in whole or in part, would be subject to early prepayment fee which declines each year until the fourth anniversary date of the Closing Date, after which no prepayment fee is required. The Company was also required to pay an exit fee upon any payment or prepayment equal to 2.0 % of the aggregate principal amount of the loans funded under the Senior Credit Agreement. The Senior Credit Agreement contains customary representations, warranties and events o f default. If the Company defaults under its Senior Credit Agreement, the lenders may accelerate all of the Company's repayment obligations and take control of its pledged assets. The lenders could declare the Company in default under its debt obligation upon the occurrence of any event that the lenders interpret as having a material adverse effect as defined under the Senior Credit Agreement and the Revenue Interest Financing Agreement (the “RIF”, described further below under “Deferred Royalty Obligation”), thereby requiring the Company to repay the loans immediately or to attempt to reverse the lenders’ declaration through negotiation or litigation. Among other loan covenant requirements, the Senior Credit Agreement also requires the Company to provide an audit opinion of its annual financial statements not subject to any “going concern” or like qualification or exception or explanatory paragraph of going concern footnote. On March 22, 2023, the Company entered into a letter agreement with Oaktree in connection with its Senior Credit Agreement, to obtain a waiver from Oaktree for any default or event of default arising from the going concern explanatory paragraph included in the report of its Independent Registered Public Accounting Firm on its audited consolidated financial statements for the year ended December 31, 2022. Under the Senior Credit Agreement, the Company is subject to a minimum liquidity requirement of $ 12.5 million unrestricted cash balance at all times (the “liquidity covenant”) and was in violation of this covenant prior to the execution of the first amendment to the Senior Credit Agreement. The Company identified a number of embedded derivatives that require bifurcation from the term loan and that were separately accounted for in the consolidated financial statements as one compound derivative liability. Certain of these embedded features include change in control provisions, events of default and contingent rate increases and were determined to qualify as an embedded derivative under ASC 815-40. The embedded derivative and the term loan obligation have been netted to result in a net loan obligation and is classified as a Level 3 financial liability in the fair value hierarchy. The fair value of the embedded derivative liabilities associated with the term loan were estimated using the discounted cash flow method under the income approach. This involves significant Level 3 inputs and assumptions including an estimated probability and timing of a change in control and events of default (see Note 3 for additional details). The Company re-evaluates this assessment each reporting period and records any gains or losses in other income (expense). The initial recognition of the embedded derivative liability upon issuance of the Oaktree term loan was $ 0.4 million and was included in the term loan obligation in the consolidated balance sheets. At December 31, 2022 the fair value of the embedded derivative liability was $ 0.6 million. The fair value of the embedded derivative liability was zero prior to the execution of the amendments to the Senior Credit Agreement described below. In connection with the issuance of the term loan, the Company recorded debt discount and debt issuance costs of $ 2.9 million. The discount and issuance costs are amortized over the life of the term loan. A portion of the loan proceeds were used to repay in full the $ 32.9 million aggregate principal amount (including the prepayment fee and final payment fee) of loans outstanding owed to Oxford Finance LLC (“Oxford”) and Silicon Valley Bank (“SVB” and together with Oxford, the “Prior Lenders”) by the Company in the first quarter of 2022. 2023 Amendments On August 21, 2023, the Company entered into the first amendment to the Senior Credit Agreement and the RIF with Oaktree and the Purchasers (collectively, the “First Amendment” and, together with the Second Amendment (as defined below), the “Amended Senior Credit Agreement”). The Company drew down $ 3.0 million of Tranche A-2 term loans under the First Amendment and the Purchasers agreed to exchange $ 9.0 million of obligations owed to the Purchasers under the RIF for $ 9.0 million of Tranche A-2 term loans under the Amended Senior Credit Agreement. Additionally, the terms related to the interest rate were entirely modified and rate was increased to SOFR + 10.75 %. The two parties were negotiating the terms of a second amendment at the execution of the first amendment. On September 5, 2023, the Company entered into the second amendment to the Senior Credit Agreement and RIF with the Secured Parties (the “Second Amendment”). Pursuant to the Second Amendment, the Secured Parties provided the Company with first lien Tranche B term loans for an aggregate principal amount of $ 20.0 million. The Company drew down $ 4.5 million of Tranche B term loans under the Amended Senior Credit Agreement and exchanged $ 3.0 million of Tranche A-2 term loans on a dollar-to-dollar basis into Tranche B term loans. Additionally, the Company exchanged all of its outstanding obligations, including accrued interest, of $ 51.4 million under the Senior Credit Agreement and of $ 9.0 million in Tranche A-2 term loans under the Amended Senior Credit Agreement as well as $ 41.0 million from the RIF into first lien Tranche A term loans for a principal amount of $ 101.5 million that includes an in-kind forbearance fee of $ 5.0 million, providing a forbearance from the Company’s default of the minimum liquidity requirement until December 31, 2023. The Company had the right to draw up to an additional $ 12.5 million in Tranche B term loans over the remainder of 2023 subject to the Company’s achievement of certain strategic milestones, satisfaction of minimum net revenue and product units sold covenants and satisfaction of certain other covenants and conditions. In connection with the execution of the Second Amendment, the RIF was terminated. Affiliates of KKR Iris Investors LLC, a holder of greater than 10% of the Company’s common stock, are lenders of a portion of the Tranche B term loans under the Amended Senior Credit Agreement. Further, the Tranche B lenders received warrants to purchase common stock having an aggregate warrant coverage equal to an aggregate of approximately 19.99 % of the Company's outstanding shares and an exercise price of $ 0.01 per share. Warrants to purchase a total of 1,781,175 shares of common stock were issued upon execution of the second amendment. Warrants for the purchase of up to 2,968,625 shares of common stock shall be issued on a pro rata basis to each lender in connection with each subsequent draw by the Company of the Tranche B term loans. The fair value of the warrants upon issuance of $ 0.7 million was recorded as a debt discount. Refer to Note 3. Interest will be paid in kind (PIK) on both the Tranche A and Tranche B term loans through the end of the forbearance period, which was extended to December 31, 2023 under the second amendment, and accrues at SOFR + 10.75 %. Quarterly principal payments of $ 2.5 million will commence after March 2026 with the remaining balance paid upon maturity. The Tranche B lenders are entitled to a 2x multiple on invested capital (the “Tranche B Return Shortfall”) on repayment or prepayment of the Tranche B term loans. Under the second amendment, with the exception of the Tranche B Return Shortfall, any prepayment of the term loans would no longer be subject to any prepayment fees; however, any payment or prepayment of the Tranche A term loans would be subject to an exit fee of $ 3.0 million, an increase of $ 2.0 million from the exit fee under the original terms of the Senior Credit Agreement. The Tranche A lenders and Tranche B lenders will be entitled to be repaid a maximum aggregate amount of approximately $ 141.5 million (assuming the entire $ 20.0 million of Tranche B term loans are funded), plus PIK interest on the Tranche A term loan. In addition to the liquidity covenant previously included in the terms of the Senior Credit Agreement, the Second Amendment added a minimum net revenue and product units sold covenant specifying the minimum revenue and units to be sold in subsequent three-week periods beginning after September 15, 2023. Compliance with the liquidity covenant was deferred until after December 31, 2023. The Second Amendment also provided for other modifications to existing covenants, including additional reporting obligations and additional milestones. Furthermore, the Company was required to transfer $ 4.5 million to an account subject to a control agreement between the Company and Oaktree. The account is restricted as to use except in the event of commencement of bankruptcy proceedings by the Company. As such, these funds are classified as restricted cash on the condensed consolidated balance sheet as of September 30, 2023. The Company was in violation of its minimum net revenue covenant and did not meet certain contractual milestones at September 30, 2023 resulting in the execution of the third and fourth amendments to waive these events of default. See Note 14 for additional information. The amounts outstanding under the Amended Senior Credit Agreement are secured and collateralized by all of the Company’s assets. The Amended Senior Credit Agreement also provides for certain modifications to the existing covenants, including additional reporting obligations, minimum net revenue and product units sold covenants and additional milestones. In addition, the Amended Senior Credit Agreement includes customary events of default, the occurrence of which could result in termination of Oaktree’s commitments or the acceleration of the Company’s obligations under the Amended Senior Credit Agreement. The Company identified certain prepayment features in the Tranche B term loans that are embedded derivatives requiring bifurcation from the term loan and recognition as one compound derivative liability. Certain of these embedded features include events of default, casualty events or asset sales and were determined to qualify as an embedded derivative under ASC 815-40. The embedded derivative and the term loan obligation have been netted to result in a net loan obligation and is classified as a Level 3 financial liability in the fair value hierarchy. The fair value of the embedded derivative liabilities associated with the term loan were estimated using the discounted cash flow method under the income approach. This involves significant Level 3 inputs and assumptions including an estimated probability and timing of events of default, casualty events or asset sales (see Note 3 for additional details). The Company re-evaluates this assessment each reporting period and records any gains or losses in other income (expense). There was zero value upon initial recognition of the embedded derivative liability upon issuance of the Oaktree term loan. The Company determined that the First and Second Amendments were modifications under ASC 470, Debt with Conversion and Other Options and no gain or loss was recognized as a result of the amendments. The unamortized balance of debt discounts and debt issuance costs prior to the amendments of $ 4.9 million was carried over to the balance of the Tranche A term loans. The Company incurred lender fees of $ 0.4 million in relation to the amendments that were recorded as an additional debt discount. The discount and issuance costs are amortized over the life of the term loans. Debt issuance costs of $ 0.5 million were expensed as incurred. Interest expense for the three months ended September 30, 2023 and 2022 was $ 2.9 million and $ 1.6 million, respectively, and for the nine months ended September 30, 2023 and 2022 was $ 6.7 million and $ 3.1 million, respectively, and is inclusive of non-cash amortization of the debt discount and debt issuance costs and accretion of the exit fee and Tranche B Return Shortfall. The fair value of the Tranche A and Tranche B term loans at September 30, 2023 was equal to their carrying value due to the recent refinancing of the Amended Senior Credit Agreement. The Company has classified the term loans as current liabilities on the condensed consolidated balance sheet. The Company has obtained limited waivers from the Secured Parties and executed two new amendments to the Amended Senior Credit Agreement subsequent to September 30, 2023; however, as of the date of financial statement issuance, the Company failed to meet the minimum net revenue and product units sold covenants. Deferred Royalty Obligation On March 17, 2022, the Company entered into a RIF (also known as the “Deferred Royalty Obligation”) with “the Purchasers” pursuant to which the Company sold to the Purchasers the right to receive payments from us at a tiered percentage (the “Applicable Tiered Percentage”), of future net revenues of Trudhesa, including worldwide net product sales and upfront payments, and milestones, (collectively, “the Revenue Interests”). Under the terms of the RIF Agreement, the Company received $ 50.0 million (“Investment Amount”), less transaction expenses, in exchange for tiered royalty payments on worldwide net sales from Trudhesa, as follows: 7.75% on annual United States net sales up to $150.0 million; 4.75% on annual United States net sales between $150 million and $300 million; 0.75% on annual United States net sales greater than $300.0 million; and 10% of any upfront payments, milestone payments and royalties received by us from licensing or partnerships relating to Trudhesa outside the United States . In connection with the execution of the Second Amendment described above, the RIF was terminated. Prior to the Second Amendment, The Purchasers’ rights to receive the Revenue Interests would terminate on the date on which the Purchasers have received payments equal to 175% of the funded portion of the Investment Amount including the aggregate of all payments made to the Purchasers as of such date, unless the RIF is earlier terminated. If the Purchasers have not received payments equal to the 175% of the funded portion of the Investment Amount by the nine-year anniversary of the initial closing date, among other things, the Company shall pay the Purchasers an amount equal to the funded portion of the Investment Amount plus a specific annual rate of return less payments previously received. Under the RIF, the Company had an option (the “Call Option”) to repurchase future Revenue Interests at any time until the third anniversary of the Closing Date upon advance written notice. Additionally, the Purchasers had an option (the “Put Option”) to terminate the RIF and to require the Company to repurchase future Revenue Interests upon enumerated events such as a bankruptcy event, a material adverse effect or a change of control. If the Put Option or the Call Option are exercised, the required repurchase price is (i) as of any date before the one-year anniversary of the Closing Date, an amount equal to (a) 1.25 multiplied by (b) the Investment Amount, (ii) as of any date on or after the one-year anniversary of the Closing Date and before the two-year anniversary of the Closing Date, an amount equal to (a) 1.40 multiplied by (b) the Investment Amount, (iii) as of any date on or after the two-year anniversary of the Closing Date and before the three-year anniversary of the Closing Date, an amount equal to (a) 1.55 multiplied by (b) the Investment Amount, and (iv) as of any date on or after the three-year anniversary of the Closing Date, an amount equal to (a) 1.75 multiplied by (b) the Investment Amount, in each case net of the sum of any payments received by the Purchasers prior to such Put Option Closing Date or Call Option Closing Date, as applicable. If the Purchasers have not received 100% of the Investment Amount by February 15, 2027, the first tier royalty rate would be subject to an increase from 7.75 % to 10.75 %. As of September 30, 2023, the Company had made $ 1.2 million in payments to the Purchasers prior to the Second Amendment. The Company's obligations under the RIF were secured, subject to customary permitted liens and other agreed upon exceptions and subject to an intercreditor agreement with Oaktree, by a perfected security interest in (i) accounts receivable arising from net sales of Trudhesa and (ii) intellectual property that is claiming or covering Trudhesa, or any method of using, making or manufacturing Trudhesa, including regulatory approvals, clinical data and all other Trudhesa assets. As noted above, the Company determined that the first and second amendments to the Senior Credit Agreement with existing Oaktree lenders and the RIF were modifications under ASC 470, Debt with Conversion and Other Options and no gain or loss was recognized as a result of the amendments. The Company evaluated the terms of the deferred royalty obligation and concluded that the features of the Investment Amount are similar to those of a debt instrument. Accordingly, the Company accounted for the transaction as long-term debt recorded at amortized cost using the effective interest method. The Company further evaluated the terms of the debt and determined that the Put Options under the RIF that were exercisable by Purchasers upon certain contingent events were determined to be embedded derivatives requiring bifurcation and separately accounted for as a single compound derivative instrument (see Note 3). The Put Option has been determined to qualify as an embedded derivative under ASC 815-40. The embedded derivative and the deferred royalty obligation were netted to result in a net deferred royalty obligation as of December 31, 2022. The embedded derivative is classified as a Level 3 financial liability in the fair value hierarchy. The Company determined the fair value of the derivative using an option pricing Monte Carlo simulation model taking into account the probability of change of control or event of default occurring and potential repayment amounts and timing of such payments that would result under various scenarios, as further described in Note 3. The Company recorded the initial fair value of the derivative liability of $ 1.5 million which was included in the deferred royalty obligation in the consolidated balance sheet. The Company remeasured the derivative liability to fair value each reporting period until the termination of the RIF whereby the fair value of the derivative was determined to be zero. At December 31, 2022 the fair value of the derivative liability was $ 11.0 million. The fair value of the derivative liability was zero prior to the execution of the amendments to the Senior Credit Agreement described above. Interest expense recognized for the three months ended September 30, 2023 and 2022 was $ 0.8 million and $ 1.8 million, and for the nine months ended September 30, 2023 and 2022 was $ 3.4 million and $ 4.1 million, respectively. Oxford and Silicon Valley Bank Term Loan In July 2021, the Company entered into the Loan Agreement with the “Prior Lenders”, to lend the Company up to an aggregate of $ 50.0 million in a series of term loans (the “Term Loan”). The term loans accrued interest at the greater of (i) 7.95% or (ii) the sum of (a) the greater of (1) the thirty (30) day U.S. LIBOR or (2) 0.11%, plus (b) 7.84% and were subject to a prepayment fee of 1.0 % to 3.0 % depending upon when the prepayment occurs. On repayment of the Term Loans, the Company was required to make a final payment fee to the Prior Lenders equal to 6.5 % of the original principal amount of the Term Loans. On March 17, 2022, upon entering into the Senior Credit Agreement, the Company repaid the $ 30.0 million of outstanding principal, interest, including prepayment and final payment fees owed under the Loan Agreement to the Prior Lenders. The Company recorded a loss of $ 3.3 million on the early extinguishment of debt related to the unamortized debt discount associated with the fair value of the warrants, final payment fee, and unamortized debt issuance costs. The loss on early extinguishment was recognized as a component of interest expense, net in the consolidated statement of operations and other comprehensive loss. Interest expense for the three and nine months ended September 30, 2022 was $ 0.7 million and was inclusive of non-cash amortization in the amount of $ 0.2 million related to the amortization of the debt issuance costs and accretion of final payment. In connection with entering into the Loan Agreement and borrowings under the agreement, the Company issued warrants to purchase 71,522 and 23,166 , shares of its common stock, respectively, to the Prior Lenders at a per share exercisable price of $ 8.39 per share and $ 12.95 per share, respectively, all with ten year terms.

Common Stock

Common Stock	9 Months Ended
	Sep. 30, 2023
Equity [Abstract]
Common Stock	9. Common Stock Each share of common stock has the right to one vote. The holders of common stock are also entitled to receive dividends whenever funds are legally available and when declared by the board of directors, subject to the prior rights of holders of all classes of stock outstanding having priority rights as to dividends. No cash dividends have been declared by the board of directors from inception. The Company has reserved the following shares of common stock for issuance, on an as-converted basis, as follows: September 30, December 31, Stock incentive plans 7,754,000 6,351,263 Exercise of common stock warrants 1,875,863 94,688 Total 9,629,863 6,445,951 Open Market Sales Agreement In May 2022, the Company entered into a sales agreement with Cowen and Company, LLC, as a sales agent, pursuant to which the Company may offer and sell shares of its common stock, from time to time, up to an aggregate amount of gross sales proceeds of $ 50.0 million through an at-the-market Program (the “2022 ATM Program”), under the 2022 Shelf Registration Statement. As of September 30, 2023, $ 45.0 million in shares of common stock remain eligible for sale under the 2022 ATM Program. In October 2023, the Company filed a prospectus supplement related to its 2022 ATM Program reflecting the Company’s sale restrictions pursuant to General Instruction I.B.6 of Form S-3 and registering the sale of up to $ 9.0 million through the 2022 ATM Program. Since such filing through the date of this Form 10-Q, the Company has sold 151,026 shares of its common stock under the 2022 ATM Program for gross proceeds of approximately $ 65,000 at an average price of $ 0.4293 .

Stock Incentive Plans

Stock Incentive Plans	9 Months Ended
	Sep. 30, 2023
Share-Based Payment Arrangement [Abstract]
Stock Incentive Plans	10. Stock Incentive Plans As of September 30, 2023, the Com pany’s equity incentive plans authorized a total of 7,776,500 shares, of which 3,285,815 shares are available for future grant, and 4,490,685 shares are outstanding. The Company’s 2021 Stock Incentive Plan, (the “2021 Plan”), provides for annual increase in the number of shares that may be issued under the 2021 Plan automatically on January 1 of each of 2022 through 2031 by the lesser of (a) 5 % of the total number of outstanding shares of all classes of its common stock on each December 31 and (b) a number as may be determined by its board of directors. The Company’s Employee Stock Purchase Plan (the “ESPP”), provides for annual increase in the number of shares that may be issued under the 2021 Plan automatically on January 1 of each of 2022 through 2031 by the lesser of (a) 5 % of the total number of outstanding shares of all classes of its common stock on each December 31 and (b) a number as may be determined by its board of directors. Effective January 1, 2023, the 2021 Plan and ESPP reserves increased by 1,186,965 shares and 237,393 shares, respectively. Changes in shares available for grant under the 2021 Plan during the nine months ended September 30, 2023 were as follows: Shares Available for Grant Shares available for grant at December 31, 2022 1,837,854 2021 Plan reserve increase January 1, 2023 1,186,965 ESPP reserve increase January 1, 2023 237,393 Options and restricted units granted ( 1,209,516 ) Options and restricted units forfeited, cancelled, or expired 1,233,119 Shares available for grant at September 30, 2023 3,285,815 Stock-Based Compensation Expense Stock-based compensation expense recognized was as follows (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Cost of goods sold $ 45 $ ( 8 ) $ 121 $ 46 Research and development 43 8 267 618 Selling, general and administrative 979 565 3,097 3,275 Total stock-based compensation expense $ 1,067 $ 565 $ 3,485 $ 3,939 Stock Option Activity All stock option grants are awarded at fair value on the date of grant. The fair value of stock options is estimated using the Black-Scholes option pricing model and stock-based compensation is recognized on a straight-line basis over the requisite service period. Stock options granted generally become exercisable over a four-year period from the grant date. Stock options generally expire 10 years after the grant date. The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair value of the Company's common stock for those stock options that had exercise prices lower than the fair value of the Company's common stock at September 30, 2023. A summary of the Company’s stock option activity under its stock option plans was as follows (in thousands, except share and per share data and years): Options Outstanding Number of Weighted Remaining Aggregate Balance — December 31, 2022 4,275,909 $ 8.08 7.5 $ 1,038 Authorized — Granted 1,165,643 2.22 Exercised ( 2,748 ) 1.97 Cancelled ( 1,200,619 ) 7.12 Balance — September 30, 2023 4,238,185 $ 6.82 7.2 $ — Exercisable — September 30, 2023 2,485,420 $ 7.31 6.1 $ — As of September 30, 2023, there was $ 6.8 million of total unrecognized compensation cost related to unvested options that are expected to vest. The cost is expected to be recognized over a weighted-average period of 2.2 years. The fair value of stock option awards granted to employees was estimated at the date of grant usin g a Black-Scholes-Merton option pricing model with the following assumptions: Three Months Ended Nine Months Ended 2023 2022 2023 2022 Expected term (in years) 6.1 6.1 6.1 6.1 Expected volatility 71.3 %- 71.4 % 72.5 %- 74.5 % 70.7 %- 71.4 % 72.5 %- 74.5 % Risk-free interest rate 3.38 % - 3.94 % 2.90 % - 3.45 % 3.38 % - 3.95 % 1.70 % - 3.45 % Expected dividends — — — — Restricted Stock Units The Company’s Restricted Stock Units (“RSUs”) are considered non-vested share awards and require no payment from the employee. For each RSU, employees receive one share of common stock at the end of the vesting period. The employee can elect to receive the one share of common stock net of taxes or pay for taxes separately and receive the entire share. The fair value of a restricted stock unit award at the grant date is equal to the market price of the Company's common stock on the grant date. Compensation expense is recorded based on the market price of the Company’s common stock on the grant date and is recognized on a straight-line basis over the requisite service period. As of September 30, 2023, there was less than $ 0.1 million of total unrecognized compensation cost related to the Company's RSUs that are expected to vest. These costs are expected to be recognized over a weighted-average period of 0.9 years. During 2021, the Compensation Committee of the Board of Directors approved the Trudhesa Launch Equity Incentive Plan for awards of performance-based restricted stock units (“PSUs”) to certain senior executives of the Company. Each award reflects a target number of shares (“Target Shares”) that may be issued to the award recipient. These awards may be earned upon the completion of two-year performance periods ending December 31, 2022, and December 31, 2023. Whether units are earned at the end of the performance period will be determined based on the achievement of certain revenue targets over the performance period. The PSUs also include a performance objective relating to total shareholder return (“TSR”). TSR reflects the change in the value of the Company’s common stock over each performance period. Depending on the revenue achieved and the TSR during the two-year performance periods, the actual number of shares that a grant recipient receives at the end of the performance period may range from 0 % to 125 % of the Target Shares granted for the 2022 performance period and 0 % to 150 % of the Target Shares granted for the 2023 performance period. In the period it becomes probable that the minimum revenue threshold specified in the award will be achieved, we recognize expense for the proportionate share of the total fair value of the PSUs related to the vesting period that has already lapsed for the shares expected to vest and be released. The remaining fair value of the shares expected to vest and be released is expensed on a straight-line basis over the balance of the vesting period. In the event the Company determines it is no longer probable that we will achieve the minimum threshold specified in the award, we reverse all of the previously recognized compensation expense in the period such a determination is made. The fair value of the Target Shares and restricted stock awards are based on the fair value of the underlying shares on the date of grant. The fair value of the portion of the Target Shares that relate to a relative TSR performance objective was determined using a Monte Carlo simulation analy sis to estimate the total shareholder return ranking of the Company among a peer group over the remaining performance periods. The expected volatility of the Company’s common stock at the date of grant was estimated based on the average historical volatilities for comparable publicly traded pharmaceutical companies. The Company used an expected dividend yield of zero . The risk-free interest rate assumption was based on observed interest rates consistent with the approximate two-year performance measure ment period. The fair value of PSUs granted to employees was estimated at the date of grant using the following assumptions: December 31, 2021 Contractual term (in years) 2.1 Expected volatility 0.83 % Risk-free interest rate 0.70 % Expected dividends — There were no PSUs that vested during the nine months ended September 30, 2023 and 182,500 and 237,500 PSUs are outstanding as of September 30, 2023 and December 31, 2022, respectively.

Income Taxes

Income Taxes	9 Months Ended
	Sep. 30, 2023
Income Tax Disclosure [Abstract]
Income Taxes	11. Income Taxes To calculate the interim tax provision, at the end of each interim period the Company estimates the annual effective tax rate and applies that to its quarterly earnings from continuing operations. The effect of changes in the enacted tax laws or rates is recognized in the interim period in which the change occurs. The computation of the annual estimated effective tax rate at each interim period requires certain estimates and judgments including, but not limited to, the expected operating income for the year, projections of the proportion of income earned and taxed in foreign jurisdictions, permanent differences between book and tax amounts, and the likelihood of recovering deferred tax assets generated in the current year. The accounting estimates used to compute the provision for income taxes may change as new events occur, additional information is obtained, or the tax environment changes. The Company’s effective tax rate for the three and nine months ended September 30, 2023 and 2022 differs from the U.S. statutory rate due to ongoing cumulative losses and the related valuation allowance. During the three and nine months ended September 30, 2023, the Company reported U.S. pre-tax losses, consistent with prior years to date. The Company has not yet been able to establish a sustained level of profitability in the U.S. or other sufficient significant positive evidence to conclude that its U.S. deferred tax assets are more likely than not to be realized. Therefore, the Company continues to maintain a valuation allowance against its U.S. deferred tax assets.

Defined Contribution Plan

Defined Contribution Plan	9 Months Ended
	Sep. 30, 2023
Retirement Benefits [Abstract]
Defined Contribution Plan	12. Defined Contribution Plan The Company has a defined contribution retirement savings plan under Section 401(k) of the Internal Revenue Code. This plan allows eligible employees to defer a portion of their annual compensation on a pre-tax or after-tax basis. The Company makes discretionary matching contributions of up to 4 % of a participating employee’s salary. For the three and nine months ended September 30, 2023, the amount expensed under the plan was $ 0.2 million and $ 0.7 million respectively. For the three and nine months ended September 30, 2022, the amount expensed under the plan was $ 0.2 million and $ 0.6 million respectively.

Net Loss Per Share

Net Loss Per Share	9 Months Ended
	Sep. 30, 2023
Earnings Per Share [Abstract]
Net Loss Per Share	13. Net Loss Per Share The following outstanding shares of potentially dilutive securities were excluded from the computation of the diluted net loss per share for the periods presented because their effect would have been anti-dilutive: Nine Months Ended 2023 2022 Stock options to purchase common stock 4,238,185 4,281,702 Non-vested RSUs and PSUs 230,000 485,571 Warrants to purchase common stock 1,875,863 94,688 Total 6,344,048 4,861,961

Subsequent Events

Subsequent Events	9 Months Ended
	Sep. 30, 2023
Subsequent Events [Abstract]
Subsequent Events	14. Subsequent Events Amendments to Credit Agreement On October 2, 2023, the Company entered into the third amendment to the Amended Senior Credit Agreement (the “Third Amendment”) with the Secured Parties as it was in violation of its minimum net revenue covenant and did not meet certain contractual milestones and reporting requirements at September 30, 2023. Pursuant to the third amendment, the Secured Parties waived certain defaults of the Company and modified the terms of the funding of the Tranche B term loans. The Company drew $ 5.0 million of Tranche B term loans and continued to have the right to draw up to an additional $ 7.5 million in Tranche B term loans over the remainder of 2023, subject to the Company’s achievement of certain strategic milestones, satisfaction of minimum net revenue and product units sold covenants and satisfaction of certain other covenants and conditions as further amended in the third amendment. The third amendment further provides that the Company shall use best efforts, subject to applicable law and fiduciary duties, to consummate an equity financing prior to October 31, 2023, and that to the extent proceeds from such financing exceed $ 5.0 million, the Company will apply 50 % of such excess proceeds (the “Prepayment Proceeds”) to repay the Tranche B term loans. If the Prepayment Proceeds exceed the outstanding Tranche B term loans plus the Tranche B Return Shortfall, the remaining Tranche B commitment will be permanently reduced on a dollar-by-dollar basis by the amount of such excess. On November 3, 2023, the Company entered into the fourth amendment to the Amended Senior Credit Agreement with the Secured Parties to modify the timing of certain milestones associated with future funding of Tranche B term loans and to extend the date of consummation of an equity financing from October 31, 2023 to November 20, 2023. As of the date of filing, the Company is in default of the minimum net revenue and product units sold covenants. Sales of Common Stock Subsequent to September 30, 2023, Impel sold 151,026 shares of common stock for gross proceeds of approximately $ 65,000 at an average price of $ 0.4293 pursuant to the open market sales agreement. Executive Officer Transitions On October 29, 2023, Adrian Adams gave notice of his resignation from his position as Chairman of the Board of Directions and as President and Chief Executive Officer of the Company effective November 4, 2023. The Board of Directors of the Company appointed Leonard Paolillo as Interim President and Chief Executive Officer effective upon Mr. Adams’s resignation.

Summary of Significant Accoun_2

Summary of Significant Accounting Policies (Policies)	9 Months Ended
	Sep. 30, 2023
Accounting Policies [Abstract]
Basis of Presentation and Consolidation	Basis of Presentation and Consolidation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles, or U.S. GAAP, and rules and regulations of the SEC for interim financial reporting. The condensed consolidated financial statements include the operations of Impel Pharmaceuticals Inc., and its wholly owned Australian subsidiary. All intercompany balances and transactions have been eliminated upon consolidation. The condensed consolidated balance sheet as of September 30, 2023, the condensed consolidated statements of operations and comprehensive loss, and changes in stockholders’ (deficit) equity for the three and nine months ended September 30, 2023 and 2022 and cash flows for the nine months ended September 30, 2023 and 2022 are unaudited. These unaudited condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly the Company’s consolidated financial position as of September 30, 2023 and its results of operations for the three and nine months ended September 30, 2023 and 2022 and cash flows for the nine months ended September 30, 2023 and 2022. The financial data and the other financial information contained in these notes to the condensed consolidated financial statements related to the three and nine month periods is also unaudited. The results of operations for the three and nine months ended September 30, 2023, are not necessarily indicative of the results to be expected for the year ending December 31, 2023 or for any other future annual or interim period. The condensed consolidated balance sheet as of December 31, 2022 included herein was derived from the audited financial statements as of that date. These condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements as of and for the year ended December 31, 2022 included in its Annual Report on Form 10-K filed with the SEC on March 27, 2023. Our significant accounting policies are described in Note 2 of the notes to the consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2022. Updates to our accounting policies, including impacts from the adoption of new accounting standards, are discussed below in this Note 2.
Use of Estimates	Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, management evaluates such estimates and assumptions for continued reasonableness. In particular, management makes estimates with respect to revenue recognition, inventory valuation, the fair values of derivative liabilities, stock-based compensation expense, deferred royalty obligation, lease accounting, income taxes, and additional charges as a result of, or that are associated with, any restructuring initiative as well as impairment and related charges. Appropriate adjustments, if any, to the estimates used are made prospectively based upon such periodic evaluation. Actual results could differ from those estimates.
Restricted Cash	Restricted Cash Restricted cash consists primarily of cash that is restricted to utilization only under certain circumstances. Any cash that is legally restricted from use is classified as restricted cash and is held at financial institutions. Restricted cash of approximately $ 4.5 million is disclosed on the consolidated balance sheet as of September 30, 2023 and represents cash deposited by the Company into a separate account and designated as a controlled account in accordance with the terms of the Amended Senior Credit Agreement. Refer to Note 8 for the terms of the Amended Senior Credit Agreement.
Segments	Segments The Company’s chief operating decision maker during the nine months ended September 30, 2023, and until November 4, 2023 was its Chairman and Chief Executive Officer. As described below, the Chairman and Chief Executive Officer resigned effective November 4, 2023. The Company’s Board of Directors appointed an Interim President and Chief Executive Officer effective upon the resignation of the Chairman and Chief Executive Officer. The Chairman and Chief Executive Officer reviewed and the Interim President and Chief Executive Officer reviews financial information on an aggregate basis for the purposes of evaluating financial performance and allocating the Company’s resources. Accordingly, the Company has determined that it operates in one segment.
Concentration of Credit Risk	Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and accounts receivables. The Company’s cash is deposited with high credit quality financial institutions. At times such deposits may be in excess of the Federal Depository Insurance Corporation insured limits.
Selling, General and Administrative Expense	Selling, General and Administrative Expense Selling, general and administrative expenses are primarily comprised of compensation and benefits associated with sales and marketing, finance, human resources, legal, information technology and other administrative personnel, outside marketing, advertising and legal expenses and other general and administrative costs. The Company expenses the cost of advertising, including promotional expenses, as incurred. Advertising expenses were $ 1.7 million and $ 7.3 million for the three and nine months ended September 30, 2023. The Company incurred $ 1.5 million and $ 5.0 million for the three and nine months ended September 30, 2022.
Impairment of Long-Lived Assets	Impairment of Long-Lived Assets Long-lived assets consist of property and equipment and right of use assets. The Company reviews property and equipment and right of use assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset or asset group may not be recoverable or that the useful life is shorter than the Company had originally estimated. Recoverability is measured by comparison of the carrying amount of the asset or asset group to the future undiscounted cash flows which the asset or asset group is expected to generate. If the asset or asset group is considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the asset or asset group exceeds the fair value of the asset or asset group. If the useful life is shorter than originally estimated, the Company amortizes the remaining carrying value over the new shorter useful life.
Recent Accounting Pronouncements	Recently Adopted Accounting Pronouncements In June 2016 the FASB issued Accounting Standard Update (“ASU”) 2016-13, Measurement of Credit Losses on Financial Instruments (Topic 326). This introduces a new methodology for recognition of credit losses - the current expected credit loss (“CECL”) method. The CECL method requires the recognition of all losses expected over the life of a financial instrument upon origination or purchase of the instrument unless the company elects to recognize such instruments at fair value with changes in profit and loss. The Company adopted this guidance as of January 1, 2023. The adoption did not have a material impact to the Company or its disclosures.
Emerging Growth Company Status	Emerging Growth Company Status The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (“JOBS Act”). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. The Company has elected to use this extended transition period for complying with certain new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that it is (1) no longer an emerging growth company or (2) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, these financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates.

Fair Value Measurements (Tables

Fair Value Measurements (Tables)	9 Months Ended
	Sep. 30, 2023
Fair Value Disclosures [Abstract]
Summary of Fair Value, Liabilities Measured on Recurring Basis	The following table summarizes the fair value of the Company’s financial liabilities measured at fair value on a recurring basis by level within the fair value hierarchy (in thousands): September 30, 2023 Level 1 Level 2 Level 3 Total Liabilities: Common stock warrant liabilities $ — $ — $ 757 $ 757 Total financial liabilities $ — $ — $ 757 $ 757 December 31, 2022 Level 1 Level 2 Level 3 Total Liabilities: Common stock warrant liabilities $ — $ — $ 261 $ 261 Derivative liability — Deferred royalty obligation — — 11,000 11,000 Derivative liability — Oaktree term loan — — 560 560 Total financial liabilities $ — $ — $ 11,821 $ 11,821
Summary of Change in the Fair Value of the Common Stock Warrant Liabilities	The following table summarizes the change in the fair value of the common stock warrant liabilities, included in the Company’s Accrued other liabilities in Note 5, for the nine months ended September 30, 2023 (in thousands): Beginning balance as of December 31, 2022 $ 261 Issuance of warrants to Tranche B lenders 700 Changes in fair value ( 204 ) Ending balance as of September 30, 2023 $ 757
Schedule of Derivative Liabilities at Fair Value [Table Text Block]	The following table summarizes the change in the estimated fair value of the Company’s derivative liabilities for the nine months ended September 30, 2023 (in thousands): Beginning balance as of December 31, 2022 $ 11,560 Change in fair value of derivatives — Deferred royalty obligation ( 11,000 ) Change in fair value of derivatives — Oaktree term loan ( 560 ) Ending balance as of September 30, 2023 $ —

Corporate Restructuring (Tables

Corporate Restructuring (Tables)	9 Months Ended
	Sep. 30, 2023
Restructuring and Related Activities [Abstract]
Schedule of Restructuring Charges	The Company incurred the following Restructuring charges consisting of winding down costs, exit and other related costs, impairments and write-offs of long-lived assets, and severance and employee-related costs (in thousands): Nine Months Ended Severance and employee-related costs $ 1,007 Long-lived asset impairments and write-offs 415 Supplemental one-time termination charges 59 Total $ 1,481
Summary of the activity related to the restructuring liabilities	The following table summarizes the activity related to the restructuring liabilities included in accrued liabilities on the condensed consolidated balance sheet associated with our restructuring initiatives for the nine months ended September 30, 2023 (in thousands): September 30, Balance as of December 31, 2022 $ — Restructuring, impairment and related charges 1,481 Cash payments ( 934 ) Noncash activities ( 437 ) Balance as of September 30, 2023 $ 110

Balance Sheet Components (Table

Balance Sheet Components (Tables)	9 Months Ended
	Sep. 30, 2023
Balance Sheet Related Disclosures [Abstract]
Schedule of Inventories	Inventories consisted of the following (in thousands): September 30, December 31, Raw materials $ 5,055 $ 2,461 Work-in-process 3,877 4,191 Finished goods 1,536 3,334 Total inventories 10,468 9,986 Less: long-term inventories ( 3,604 ) ( 1,559 ) Total current inventories $ 6,864 $ 8,427
Schedule of prepaid expenses and other current assets	Prepaid expenses and other current assets consisted of the following (in thousands): September 30, December 31, Prepaid insurance $ 2,390 $ 1,036 Other prepaids 2,219 1,587 Other current assets 621 649 Tax refund receivable 6 12 Total prepaid expenses and other current assets $ 5,236 $ 3,284
Schedule of accrued liabilities	Accrued liabilities consisted of the following (in thousands): September 30, December 31, Accrued sales discounts and allowances $ 3,361 $ 3,376 Accrued compensation 2,729 5,287 Accrued other liabilities 1,478 1,662 Accrued professional services 720 1,808 Accrued construction in progress 158 370 Total accrued liabilities $ 8,446 $ 12,503

Leases (Tables)

Leases (Tables)	9 Months Ended
	Sep. 30, 2023
Leases [Abstract]
ScheduleOfMaturitiesOfOperatingAndFinanceLeasesLiabilitiesTableTextBlock	The following table reconciles the Company’s undiscounted operating lease cash flows to its operating lease liability (in thousands): September 30, 2023 Remaining 2023 $ 484 2024 1,571 2025 718 2026 292 2027 and thereafter 1,830 Total undiscounted cash flows 4,895 Less: imputed interest ( 1,098 ) Total lease liabilities 3,797 Less: current portion ( 1,562 ) Lease liabilities $ 2,235
Weighted average remaining lease term and the weighted average discount rate table text block	The weighted average remaining lease term and the weighted average discount rate used to determine the operating lease liability were as follows: September 30, 2023 Weighted average remaining lease term (years) 5.2 Weighted average discount rate 8.1 % Operating lease expense was $ 0.5 and $ 0.3 million for the three months ended September 30, 2023 and 2022, respectively and $ 1.4 and $ 1.0 million for the nine months ended September 30, 2023 and 2022, respectively. Variable lease expense was $ 0.1 million for operating leases for both three months ended September 30 , 2023 and 2022, and $ 0.3 million for operating leases for both nine months ended September 30 , 2023 and 2022. Rent expense recognized for short term leases was $ 0.1 million for nine months ended September 30 , 2022.

Common Stock (Tables)

Common Stock (Tables)	9 Months Ended
	Sep. 30, 2023
Equity [Abstract]
Schedule of Reserved Shares of Common Stock for Issuance, on an as-Converted Basis	The Company has reserved the following shares of common stock for issuance, on an as-converted basis, as follows: September 30, December 31, Stock incentive plans 7,754,000 6,351,263 Exercise of common stock warrants 1,875,863 94,688 Total 9,629,863 6,445,951

Stock Incentive Plans (Tables)

Stock Incentive Plans (Tables)	9 Months Ended
	Sep. 30, 2023
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Changes in shares available for grant under the 2021 Plan	Changes in shares available for grant under the 2021 Plan during the nine months ended September 30, 2023 were as follows: Shares Available for Grant Shares available for grant at December 31, 2022 1,837,854 2021 Plan reserve increase January 1, 2023 1,186,965 ESPP reserve increase January 1, 2023 237,393 Options and restricted units granted ( 1,209,516 ) Options and restricted units forfeited, cancelled, or expired 1,233,119 Shares available for grant at September 30, 2023 3,285,815
Schedule of Stock-Based Compensation Expense Recognized	Stock-based compensation expense recognized was as follows (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Cost of goods sold $ 45 $ ( 8 ) $ 121 $ 46 Research and development 43 8 267 618 Selling, general and administrative 979 565 3,097 3,275 Total stock-based compensation expense $ 1,067 $ 565 $ 3,485 $ 3,939
Stock Options [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Summary of the Company's Stock Option Activity under its Stock Option Plans	A summary of the Company’s stock option activity under its stock option plans was as follows (in thousands, except share and per share data and years): Options Outstanding Number of Weighted Remaining Aggregate Balance — December 31, 2022 4,275,909 $ 8.08 7.5 $ 1,038 Authorized — Granted 1,165,643 2.22 Exercised ( 2,748 ) 1.97 Cancelled ( 1,200,619 ) 7.12 Balance — September 30, 2023 4,238,185 $ 6.82 7.2 $ — Exercisable — September 30, 2023 2,485,420 $ 7.31 6.1 $ —
Schedule of Fair Value of Stock Option Awards Granted to Employees	The fair value of stock option awards granted to employees was estimated at the date of grant usin g a Black-Scholes-Merton option pricing model with the following assumptions: Three Months Ended Nine Months Ended 2023 2022 2023 2022 Expected term (in years) 6.1 6.1 6.1 6.1 Expected volatility 71.3 %- 71.4 % 72.5 %- 74.5 % 70.7 %- 71.4 % 72.5 %- 74.5 % Risk-free interest rate 3.38 % - 3.94 % 2.90 % - 3.45 % 3.38 % - 3.95 % 1.70 % - 3.45 % Expected dividends — — — —
PSUs [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Schedule of Fair Value of Stock Option Awards Granted to Employees	The fair value of PSUs granted to employees was estimated at the date of grant using the following assumptions: December 31, 2021 Contractual term (in years) 2.1 Expected volatility 0.83 % Risk-free interest rate 0.70 % Expected dividends —

Net Loss Per Share (Tables)

Net Loss Per Share (Tables)	9 Months Ended
	Sep. 30, 2023
Earnings Per Share [Abstract]
Schedule of Outstanding Shares of Potentially Dilutive Securities Excluded from Computation of Diluted Net Loss Per Share Attributable to Common Stockholders	The following outstanding shares of potentially dilutive securities were excluded from the computation of the diluted net loss per share for the periods presented because their effect would have been anti-dilutive: Nine Months Ended 2023 2022 Stock options to purchase common stock 4,238,185 4,281,702 Non-vested RSUs and PSUs 230,000 485,571 Warrants to purchase common stock 1,875,863 94,688 Total 6,344,048 4,861,961

Organization and Description _2

Organization and Description of Business - Additional Information (Details) - USD ($)	1 Months Ended		3 Months Ended		9 Months Ended
	Oct. 31, 2023	May 31, 2022	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Sep. 05, 2023	Dec. 31, 2022	Mar. 17, 2022
Organization Consolidation And Presentation Of Financial Statements [Line Items]
Proceeds from issuance or sale of equity, debt and warrants					$ 405,300,000
Restricted Cash			$ 4,502,000		4,502,000			$ 0
Minimum Liquidity Covenant					12,500,000
Gross sales proceeds from common stock issuance					0	$ 4,332,000
Accrued Interest			2,900,000	$ 1,600,000	6,700,000	3,100,000
Cash and cash equivalents			$ 239,000		239,000			$ 60,654,000
Common Stock
Organization Consolidation And Presentation Of Financial Statements [Line Items]
Gross Proceeds from Sale of Stocks					$ 65,000,000
Common Shares Sold					151,026
Average price per share			$ 0.4293		$ 0.4293
Common Stock, Preferred Stock, Debt Securities, Warrants, Subscription Rights
Organization Consolidation And Presentation Of Financial Statements [Line Items]
Offering price of securities for, Offering, Issuance and Sale			$ 200,000,000		$ 200,000,000
Tranche B term loans
Organization Consolidation And Presentation Of Financial Statements [Line Items]
Borrowing Amount			12,500,000		12,500,000
Tranche B Term Loans (Under Third Amendment) [Member]
Organization Consolidation And Presentation Of Financial Statements [Line Items]
Current borrowing capacity			5,000,000		5,000,000
Borrowing Amount			7,500,000		7,500,000
Senior Credit Agreement
Organization Consolidation And Presentation Of Financial Statements [Line Items]
Accrued Interest			51,400		51,400
Unrestricted cash balance			$ 12,500,000		12,500,000				$ 12,500,000
Exchange of long term debt instrument							$ 51,400,000
Accrued Interest				700,000		700,000
Amended Senior Credit Agreement [Member] | Common Stock
Organization Consolidation And Presentation Of Financial Statements [Line Items]
Rate of Common Stock Holders			10%
Amended Senior Credit Agreement [Member] | Tranche A-2 term loans
Organization Consolidation And Presentation Of Financial Statements [Line Items]
Accrued Interest			$ 9,000,000		9,000,000
Obligation Exchanged Owed to Purchasers			9,000,000
Advanced Amount			3,000,000
Amended Senior Credit Agreement [Member] | Tranche B term loans
Organization Consolidation And Presentation Of Financial Statements [Line Items]
Advanced Amount			4,500,000
Amended Senior Credit Agreement [Member] | Tranche B Term Loans (Under Third Amendment) [Member]
Organization Consolidation And Presentation Of Financial Statements [Line Items]
Remaining Borrowing Amount			7,500,000		7,500,000
RIF
Organization Consolidation And Presentation Of Financial Statements [Line Items]
Obligation Exchanged Owed to Purchasers			9,000,000
Accrued Interest			$ 800,000	$ 1,800,000	$ 3,400,000	$ 4,100,000
2022 ATM Program
Organization Consolidation And Presentation Of Financial Statements [Line Items]
Gross Proceeds from Sale of Stocks	$ 90,000,000
2022 ATM Program | Common Stock
Organization Consolidation And Presentation Of Financial Statements [Line Items]
Gross Proceeds from Sale of Stocks		$ 50,000,000

Summary of Significant Accoun_3

Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022
Debt Instrument [Line Items]
Restricted Cash	$ 4,502		$ 4,502		$ 0
Advertising expenses	$ 1,700	$ 1,500	$ 7,300	$ 5,000

Fair Value Measurements - Summa

Fair Value Measurements - Summary of Fair Value, Liabilities Measured on Recurring Basis (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Liabilities:
Total financial liabilities	$ 757	$ 11,821
Warrant Liabilities [Member]
Liabilities:
Total financial liabilities	757	261
Derivative liability - Deferred royalty obligation [Member]
Liabilities:
Total financial liabilities		11,000
Derivative liability - Oaktree term loan [Member]
Liabilities:
Total financial liabilities		560
Level 1 [Member]
Liabilities:
Total financial liabilities	0	0
Level 1 [Member] | Warrant Liabilities [Member]
Liabilities:
Total financial liabilities	0	0
Level 1 [Member] | Derivative liability - Deferred royalty obligation [Member]
Liabilities:
Total financial liabilities		0
Level 1 [Member] | Derivative liability - Oaktree term loan [Member]
Liabilities:
Total financial liabilities		0
Level 2 [Member]
Liabilities:
Total financial liabilities	0	0
Level 2 [Member] | Warrant Liabilities [Member]
Liabilities:
Total financial liabilities	0	0
Level 2 [Member] | Derivative liability - Deferred royalty obligation [Member]
Liabilities:
Total financial liabilities		0
Level 2 [Member] | Derivative liability - Oaktree term loan [Member]
Liabilities:
Total financial liabilities		0
Level 3 [Member]
Liabilities:
Total financial liabilities	757	11,821
Level 3 [Member] | Warrant Liabilities [Member]
Liabilities:
Total financial liabilities	$ 757	261
Level 3 [Member] | Derivative liability - Deferred royalty obligation [Member]
Liabilities:
Total financial liabilities		11,000
Level 3 [Member] | Derivative liability - Oaktree term loan [Member]
Liabilities:
Total financial liabilities		$ 560

Fair Value Measurements - Sum_2

Fair Value Measurements - Summary of Change in the Fair Value of the Common Stock Warrant Liabilities (Details) $ in Thousands	9 Months Ended
	Sep. 30, 2023 USD ($)
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Beginning balance as of December 31, 2022	$ 24
Ending balance as of September 30, 2023	24
Common Stock Warrant Liabilities [Member]
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Beginning balance as of December 31, 2022	261
Issuance of warrants to Tranche B lenders	700
Change in fair value	(204)
Ending balance as of September 30, 2023	$ 757

Fair Value Measurements - Chang

Fair Value Measurements - Change in the estimated fair value of the Company derivative liabilities (Details) $ in Thousands	9 Months Ended
	Sep. 30, 2023 USD ($)
Fair Value Disclosures [Abstract]
Beginning balance as of December 31, 2022	$ 11,560
Change in fair value of derivatives - Deferred royalty obligation	(11,000)
Change in fair value of derivatives - Oaktree term loan	(560)
Ending balance as of September 30, 2023	$ 0

Fair Value Measurements (Additi

Fair Value Measurements (Additional Information) (Details) - $ / shares		9 Months Ended
	Sep. 05, 2023	Sep. 30, 2023
Fair Value, Option, Quantitative Disclosures [Line Items]
Fair Value, Liability, Recurring Basis, Unobservable Input Reconciliation, Gain (Loss), Statement of Income or Comprehensive Income [Extensible Enumeration]		Derivative, Gain (Loss) on Derivative, Net
Warrant Issued On Pro Rata Basis	2,968,625
Common Stock [Member]
Fair Value, Option, Quantitative Disclosures [Line Items]
Stock Issued During Period, Shares, New Issues		151,026
Common Stock [Member] | Senior Credit Agreement [Member]
Fair Value, Option, Quantitative Disclosures [Line Items]
Warrant Issued		1,781,175
Warrant [Member] | Senior Credit Agreement [Member]
Fair Value, Option, Quantitative Disclosures [Line Items]
Stock Issued During Period, Shares, New Issues		4,749,800
Warrant, Exercise Price, Increase		$ 0.01

Corporate Restructuring - Addit

Corporate Restructuring - Additional Information (Details) - USD ($) $ in Thousands		9 Months Ended
	Feb. 22, 2023	Sep. 30, 2023
Restructuring Cost and Reserve [Line Items]
Payment for Restructuring		$ 934
Corporate Restructuring [Member]
Restructuring Cost and Reserve [Line Items]
Reduction in workforce percentage	16%
Total Estimated Cash Expenses for Restructuring		1,000
Payment for Restructuring		900
Impairment charges for long-lived assets		$ 400

Corporate Restructuring - Sched

Corporate Restructuring - Schedule of Restructuring Charges (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Restructuring and Related Activities [Abstract]
Severance and employee-related costs			$ 1,007
Long-lived asset impairments and write-offs			415
Supplemental one-time termination charges			59
Total	$ 0	$ 0	$ 1,481	$ 0

Corporate Restructuring - Summa

Corporate Restructuring - Summary of the activity related to the restructuring liabilities (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Restructuring and Related Activities [Abstract]
Restructuring Reserve, Beginning Balance			$ 0
Restructuring, impairment and related charges	$ 0	$ 0	1,481	$ 0
Cash payments			(934)
Noncash activities			(437)
Restructuring Reserve, Ending Balance	$ 110		$ 110

Balance Sheet Components - Sche

Balance Sheet Components - Schedule of Inventories (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Balance Sheet Related Disclosures [Abstract]
Raw materials	$ 5,055	$ 2,461
Work-in-process	3,877	4,191
Finished goods	1,536	3,334
Total inventories	10,468	9,986
Less: long-term inventories	(3,604)	(1,559)
Total current inventories	$ 6,864	$ 8,427

Balance Sheet Components - Sc_2

Balance Sheet Components - Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Balance Sheet Related Disclosures [Abstract]
Prepaid insurance	$ 2,390	$ 1,036
Other prepaids	2,219	1,587
Other current assets	621	649
Tax refund receivable	6	12
Total prepaid expenses and other current assets	$ 5,236	$ 3,284

Balance Sheet Components (Addit

Balance Sheet Components (Additional Information) (Details) - USD ($) $ in Thousands	3 Months Ended	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2023	Sep. 30, 2022
Balance Sheet Related Disclosures [Abstract]
Inventory Write-down		$ 1,190	$ 0
Inventory Write-Down	$ 100	$ 1,200

Balance Sheet Components - Sc_3

Balance Sheet Components - Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Balance Sheet Related Disclosures [Abstract]
Accrued sales discounts and allowances	$ 3,361	$ 3,376
Accrued compensation	2,729	5,287
Accrued other liabilities	1,478	1,662
Accrued professional services	720	1,808
Accrued construction in progress	158	370
Total accrued liabilities	$ 8,446	$ 12,503

Leases (Additional Information)

Leases (Additional Information) (Details) $ in Thousands		1 Months Ended	3 Months Ended		9 Months Ended
	Sep. 30, 2017 ft²	Apr. 30, 2022 ft²	Sep. 30, 2023 USD ($)	Sep. 30, 2022 USD ($)	Sep. 30, 2023 USD ($)	Sep. 30, 2022 USD ($)	Dec. 31, 2022 USD ($)
Lessee, Lease, Description [Line Items]
Operating lease right-of-use assets			$ 3,730		$ 3,730		$ 3,132
Operating lease liability			3,797		3,797
Operating lease expense			500	$ 300	1,400	$ 1,000
Variable lease expense			$ 100	$ 100	$ 300	300
Rent expenses						$ 100
Real Estate Leases
Lessee, Lease, Description [Line Items]
Non cancelable operating lease area | ft²	11,256	8,045
Percentage increase in rent payable monthly	3%	2.50%
Initial term of the lease	3 years
Renewed the lease	four years	127
Operating lease expiration date	Aug. 31, 2024
Commercial Fleet Leases
Lessee, Lease, Description [Line Items]
Initial term of the lease			12 months		12 months
Lease renewal term			54 months		54 months

Leases - Companys undiscounted

Leases - Companys undiscounted operating lease cash flows to its operating lease liability (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Leases [Abstract]
Remaining 2023	$ 484
2024	1,571
2025	718
2026	292
2027 and thereafter	1,830
Total undiscounted cash flows	4,895
Less: imputed interest	(1,098)
Total lease liabilities	3,797
Less: current portion	(1,562)	$ (1,541)
Lease liabilities	$ 2,235	$ 1,573

Leases - Weighted average disco

Leases - Weighted average discount rate used to determine the operating lease liability (Details)	Sep. 30, 2023
Leases [Abstract]
Weighted average remaining lease term (years)	5 years 2 months 12 days
Weighted average discount rate	8.10%

Long-Term Obligations - Additio

Long-Term Obligations - Additional Information (Details) - USD ($)				3 Months Ended		9 Months Ended
	Sep. 05, 2023	Aug. 21, 2023	Mar. 17, 2022	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Mar. 17, 2023	Dec. 31, 2022	Jul. 02, 2021
Debt Instrument [Line Items]
Long-term debt, description						The term loans accrued interest at the greater of (i) 7.95% or (ii) the sum of (a) the greater of (1) the thirty (30) day U.S. LIBOR or (2) 0.11%, plus (b) 7.84%
Warrant Issued On Pro Rata Basis	2,968,625
Final principal payment	$ 101,500,000
Lender Fee Incurred						$ 400,000
Revenue Transfer						4,500,000
Amortization of Debt Discount (Premium)						$ 700,000
Final Payment Percentage of Principal Amount Term Loan						6.50%
Common Stock Issued As Warrant Exercisable	1,781,175			23,749,005		23,749,005			23,739,313
Quarterly principal payments						$ 2,500,000
Outstanding principal, interest and final payment amount						0	$ 32,853,000
Loss on early extinguishment of debt						0	3,251,000
Payments of Debt Issuance Costs						500,000
forbearance fee	$ 5,000,000
Interest expense				$ 2,900,000	$ 1,600,000	6,700,000	3,100,000
Fair value of derivative liability				1,500,000		$ 1,500,000
Maximum [Member]
Debt Instrument [Line Items]
Prepayment fee for loan payment						3%
Minimum [Member]
Debt Instrument [Line Items]
Prepayment fee for loan payment						1%
Secured Overnight Financing Rate (SOFR) Overnight Index Swap Rate [Member]
Debt Instrument [Line Items]
interest rate		10.75%
Interest expense						$ 10,750
Oaktree Loan and Security Agreement [Member]
Debt Instrument [Line Items]
Short-term Non-bank Loans and Notes Payable			$ 50,000,000
Debt instrument, maturity date			Mar. 17, 2027
Oaktree Loan and Security Agreement [Member] | Tradhesa [Member]
Debt Instrument [Line Items]
Debt, Weighted Average Interest Rate			8%
Net revenue			$ 125,000,000
Oaktree Loan and Security Agreement [Member] | Secured Overnight Financing Rate (SOFR) Overnight Index Swap Rate [Member]
Debt Instrument [Line Items]
Debt, Weighted Average Interest Rate			8.75%
RIF
Debt Instrument [Line Items]
Interest expense				800,000	1,800,000	3,400,000	4,100,000
Payment Purchase				1,200		1,200
Fair value of derivative liability									$ 11,000,000
RIF | One year anniversary
Debt Instrument [Line Items]
Future revenue interests								1.25%
RIF | Two year anniversary
Debt Instrument [Line Items]
Future revenue interests								1.40%
RIF | Three year anniversary
Debt Instrument [Line Items]
Future revenue interests								1.55%
RIF | Four year anniversary
Debt Instrument [Line Items]
Future revenue interests								1.75%
RIF | Maximum [Member]
Debt Instrument [Line Items]
Change in royalty rate			10.75%
RIF | Minimum [Member]
Debt Instrument [Line Items]
Change in royalty rate			7.75%
RIF | Tradhesa [Member]
Debt Instrument [Line Items]
Future net Revenue Interests, descriptions			Under the terms of the RIF Agreement, the Company received $50.0 million (“Investment Amount”), less transaction expenses, in exchange for tiered royalty payments on worldwide net sales from Trudhesa, as follows: 7.75% on annual United States net sales up to $150.0 million; 4.75% on annual United States net sales between $150 million and $300 million; 0.75% on annual United States net sales greater than $300.0 million; and 10% of any upfront payments, milestone payments and royalties received by us from licensing or partnerships relating to Trudhesa outside the United States
Financing cost			$ 50,000,000
Senior Credit Agreement
Debt Instrument [Line Items]
Unrestricted cash balance			$ 12,500,000	12,500,000		12,500,000
Prepayment fee for loan payment			2%
Amortization of Debt Issuance Costs				200,000			200,000
Exchange of long term debt instrument	51,400,000
Loss on early extinguishment of debt			$ (3,300,000)
Interest expense					$ 700,000		$ 700,000
Term Loan [Member]
Debt Instrument [Line Items]
Debt Issuance Costs at closing				2,900,000		2,900,000
Outstanding principal, interest and final payment amount						32,900,000
Face value of term loan										$ 50,000,000
Fair value of term loan				$ 400,000		$ 400,000
Fair value of derivative liability									$ 600,000
Term Loan [Member] | Senior Credit Agreement
Debt Instrument [Line Items]
Outstanding principal, interest and final payment amount			$ 30,000,000
Term A Loan [Member] | Warrant [Member]
Debt Instrument [Line Items]
Common Stock Issued As Warrant Exercisable				71,522		71,522
Warrant Exercise Price Per Share				$ 8.39		$ 8.39
Term B Loan [Member] | Warrant [Member]
Debt Instrument [Line Items]
Common Stock Issued As Warrant Exercisable				23,166		23,166
Warrant Exercise Price Per Share				$ 12.95		$ 12.95
Tranche A [Member]
Debt Instrument [Line Items]
Unamortize balance of debt discount				$ 4,900,000		$ 4,900,000
Tranche A [Member] | RIF
Debt Instrument [Line Items]
Exchange of long term debt instrument	41,000,000
Tranche A [Member] | Senior Credit Agreement | Maximum [Member]
Debt Instrument [Line Items]
Exit fee						2,000,000
Tranche A [Member] | Senior Credit Agreement | Minimum [Member]
Debt Instrument [Line Items]
Exit fee						3,000,000
Tranche A-2 Term Loans [Member]
Debt Instrument [Line Items]
Exchange of long term debt instrument	3,000,000
Long-Term Debt		$ 3,000,000
Tranche A-2 Term Loans [Member] | RIF
Debt Instrument [Line Items]
Exchange of long term debt instrument		9,000,000
Debt Conversion, Converted Instrument, Amount		$ 9,000,000
Tranche A-2 Term Loans [Member] | Senior Credit Agreement
Debt Instrument [Line Items]
Exchange of long term debt instrument	9,000,000
Tranche B Term [Member]
Debt Instrument [Line Items]
Remaining borrowing capacity				12,500,000		12,500,000
Long-Term Debt				20,000,000		20,000,000
Tranche B Term [Member] | RIF
Debt Instrument [Line Items]
Long-Term Debt	20,000,000
Tranche B Term [Member] | Senior Credit Agreement
Debt Instrument [Line Items]
Long-Term Debt	$ 4,500,000
Tranche B Term [Member] | Amended Credit Agreement [Member]
Debt Instrument [Line Items]
Warrant Coverage of Outstanding Share	19.99%
Warrant execise price	$ 0.01
Tranche A And Tranche B Term loans [Member]
Debt Instrument [Line Items]
Long-Term Debt				$ 141,500,000		$ 141,500,000

Common Stock - Additional Infor

Common Stock - Additional Information (Details) - USD ($)	1 Months Ended	9 Months Ended
	May 31, 2022	Sep. 30, 2023	Sep. 30, 2022	Sep. 05, 2023	Dec. 31, 2022
Gross sales proceeds from common stock issuance		$ 0	$ 4,332,000
Common Stock, Shares, Issued		23,749,005		1,781,175	23,739,313
2022 ATM Program
gross sales proceeds		$ 9,000,000
Excess Stock, Shares Issued		151,026
Common Stock, Shares, Issued		45,000,000
Average Price Per Share		$ 0.4293
Proceeds from net of commissions		$ 65,000,000
Common Stock
Common stock, voting rights		Each share of common stock has the right to one vote.
Cash dividends declared		$ 0
Gross sales proceeds from common stock issuance		$ 65,000,000
Common Stock | 2022 ATM Program
Gross sales proceeds from common stock issuance	$ 50,000,000

Common Stock - Schedule of Rese

Common Stock - Schedule of Reserved Shares of Common Stock for Issuance, on an as-Converted Basis (Details) - shares	Sep. 30, 2023	Dec. 31, 2022
Stock Incentive Plans [Member]
Issuance of common stock, net of issuance costs	7,754,000	6,351,263
Common Stock Warrants [Member]
Issuance of common stock, net of issuance costs	1,875,863	94,688
Redeemable Convertible Preferred Stock Warrant [Member]
Issuance of common stock, net of issuance costs	9,629,863	6,445,951

Stock Incentive Plan - Addition

Stock Incentive Plan - Additional Information (Details) - USD ($) $ in Millions	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Number of Options, Beginning Balance	4,238,185		4,238,185			4,275,909
Remaining Contractual Term (Years), Exercisable			6 years 1 month 6 days
Number of shares available for grant	3,285,815		3,285,815			1,837,854
Unvested stock options, cost not yet recognized, amount	$ 6.8		$ 6.8
Unvested award, cost not yet recognized, period for recognition			2 years 2 months 12 days
Stock Options [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Award expiration period			10 years
Remaining Contractual Term (Years), Exercisable			4 years
Expected dividend yield	0%	0%	0%	0%
PSUs [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Unvested stock options, cost not yet recognized, amount	$ 0.1		$ 0.1
Unvested award, cost not yet recognized, period for recognition			10 months 24 days
Number of Shares, Vested			0
Outstanding shares	182,500		182,500			237,500
Expected dividend yield			0%				0%
2021 Stock Incentive Plan [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Increase in number of shares available for future grant			1,186,965
Percentage of total number of outstanding shares of common stock			5%
2021 Equity Incentive Plan Policies [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Number of Options, Beginning Balance	4,490,685		4,490,685
Issuance of common stock, net of issuance costs	7,776,500		7,776,500
Number of shares available for grant	3,285,815		3,285,815
2021 Employee Stock Purchase Plan [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Increase in number of shares available for future grant			237,393
Percentage of total number of outstanding shares of common stock			5%
Total Shareholder Return (TSR) [Member] | PSUs [Member] | Maximum [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Target Shares Granted					150%	125%
Total Shareholder Return (TSR) [Member] | PSUs [Member] | Minimum [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Target Shares Granted					0%	0%

Stock Incentive Plans - Changes

Stock Incentive Plans - Changes In Shares Available For Grant Under The 2021 Plan (Details)	9 Months Ended
	Sep. 30, 2023 shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Shares Available for Grant, Beginning Balance	1,837,854
Options and restricted units granted	(1,209,516)
Options and restricted units forfeited, cancelled, or expired	1,233,119
Shares Available for Grant, Ending Balance	3,285,815
2021 Stock Incentive Plan [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Increase in number of shares available for future grant	1,186,965
2021 Employee Stock Purchase Plan [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Increase in number of shares available for future grant	237,393

Stock Incentive Plan - Schedule

Stock Incentive Plan - Schedule of Stock-Based Compensation Expense Recognized (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Total stock-based compensation expense	$ 1,067	$ 565	$ 3,485	$ 3,939
Cost of goods sold [Member]
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Total stock-based compensation expense	45	8	121	46
Research and Development [Member]
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Total stock-based compensation expense	43	8	267	618
Selling, general and administrative [Member]
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Total stock-based compensation expense	$ 979	$ 565	$ 3,097	$ 3,275

Stock Incentive Plan - Summary

Stock Incentive Plan - Summary of the Company's Stock Option Activity under its Stock Option Plans (Details) - USD ($) $ / shares in Units, $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2023	Dec. 31, 2022
Share-Based Payment Arrangement [Abstract]
Shares Available for Grant, Authorized	0
Number of Options, Beginning Balance	4,275,909
Number of Options, Granted	1,165,643
Number of options, exercised	(2,748)
Number of Options, Cancelled	(1,200,619)
Number of Options, Ending Balance	4,238,185	4,275,909
Number of Options, Exercisable	2,485,420
Weighted-Average Exercise Price, Beginning Balance	$ 8.08
Weighted-Average Exercise Price, Granted	2.22
Weighted-Average Exercise Price, Exercised	1.97
Weighted-Average Exercise Price, Cancelled	7.12
Weighted-Average Exercise Price, Ending Balance	6.82	$ 8.08
Weighted-Average Exercise Price, Exercisable	$ 7.31
Remaining Contractual Term (Years), Balance	7 years 2 months 12 days	7 years 6 months
Remaining Contractual Term (Years), Exercisable	6 years 1 month 6 days
Aggregate Intrinsic Value, Beginning Balance	$ 1,038
Aggregate Intrinsic Value, Ending Balance	0	$ 1,038
Aggregate Intrinsic Value, Exercisable	$ 0

Stock Incentive Plan - Schedu_2

Stock Incentive Plan - Schedule of Fair Value of Stock Option Awards Granted to Employees (Details)	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2021
Stock Options [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	6 years 1 month 6 days
Expected dividends	0%	0%	0%	0%
Stock Options [Member] | Minimum [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Expected volatility	71.30%	72.50%	70.70%	72.50%
Risk-free interest rate	3.38%	2.90%	3.38%	1.70%
Stock Options [Member] | Maximum [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Expected volatility	71.40%	74.50%	71.40%	74.50%
Risk-free interest rate	3.94%	3.45%	3.95%	3.45%
PSUs [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Expected term (in years)					2 years 1 month 6 days
Expected volatility					0.83%
Risk-free interest rate					0.70%
Expected dividends			0%		0%

Defined Contribution Plan - Add

Defined Contribution Plan - Additional Information (Details) - USD ($) $ in Millions	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Retirement Benefits [Abstract]
Maximum Employee's Contribution, Percent			4%
Expense, Defined Contribution Plan	$ 0.2	$ 0.2	$ 0.7	$ 0.6

Net Loss Per Share - Schedule o

Net Loss Per Share - Schedule of Outstanding Shares of Potentially Dilutive Securities Excluded from Computation of Diluted Net Loss Per Share Attributable to Common Stockholders (Details) - shares	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share, amount	6,344,048	4,861,961
Stock Options to Purchase Common Stock [Member]
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share, amount	4,238,185	4,281,702
Non-Vested RSUs and PSUs [Member]
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share, amount	230,000	485,571
Warrants to Purchase Common Stock [Member]
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share, amount	1,875,863	94,688

Subsequent Events (Additional I

Subsequent Events (Additional Information) (Details) - USD ($) $ / shares in Units, $ in Thousands		9 Months Ended
	Oct. 02, 2023	Sep. 30, 2023	Sep. 30, 2022	Sep. 05, 2023
Subsequent Event [Line Items]
Gross sales proceeds from common stock issuance		$ 0	$ 4,332
Tranche B Term Loans
Subsequent Event [Line Items]
Long-Term Debt		$ 20,000
Senior Credit Agreement [Member] | Tranche B Term Loans
Subsequent Event [Line Items]
Long-Term Debt				$ 4,500
Sale of Common Stock [Member]
Subsequent Event [Line Items]
Common stock shares sold		151,026
Gross sales proceeds from common stock issuance		$ 65,000
Average price per share		$ 0.4293
Subsequent Event | Amendments to Credit Agreement | Tranche B Term Loans
Subsequent Event [Line Items]
Proceeds from Other Equity	$ 5,000
Borrowing Amount	7,500
Long-Term Debt	$ 5,000
Prepayment Proceeds Rate	50%