0001558370-24-015613 | 10-Q | XBRL Viewer

Risks and Fair Value

9 Months Ended

Sep. 30, 2024

9. Risks and Fair Value

Concentration of Credit Risk and of Significant Suppliers and Customers

Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents and accounts receivable. The Company has its cash and cash equivalents balances at two accredited financial institutions, in amounts that exceed federally insured limits. The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships.

The Company is dependent on a small number of third-party manufacturers to supply products for research and development activities in its preclinical and clinical programs and for sales of its products. The Company’s development programs as well as revenue from future product sales could be adversely affected by a significant interruption in the supply of any of the components of these products.

Three specialty distributor customers accounted for the following percentages of the Company’s total revenue:


	Three Months Ended						Nine Months Ended
	September 30,						September 30,
	2024			2023			2024			2023
Customer 1		41	%		47	%		45	%		51	%
Customer 2		26			24			23			23
Customer 3		9			12			11			11

Three specialty distributor customers accounted for the following percentages of the Company’s accounts receivable, net:


	As of
	September 30,			December 31,
	2024			2023
Customer 1		46	%		50	%
Customer 2		28			28
Customer 3		9			11

Change in Fair Value of Derivative Liabilities

Other income (expenses) from the change in the fair values of derivative liabilities as presented on the Company’s consolidated statements of operations and comprehensive loss includes the following:


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2024		2023		2024		2023
Change in the fair value of the Conversion Option Derivative Liability	$	—	$	7,144	$	2,598	$	1,712
Change in the fair value of Royalty Fee Derivative Liability		7,613		(34)		(2,076)		(34)
Barings Royalty Fee		(537)		(388)		(1,625)		(388)
Total	$	7,076	$	6,722	$	(1,103)	$	1,290

Fair Value of Financial Assets and Liabilities

The following tables present information about the Company’s financial assets and liabilities that are measured at fair value on a recurring basis as of September 30, 2024 and December 31, 2023 and indicate the level of the fair value hierarchy utilized to determine such fair value:


	Fair Value Measurements as of
	September 30, 2024 Using:
	Level 1		Level 2		Level 3		Total
Assets:
Cash equivalents:
Money market funds	$	414,734	$	—	$	—	$	414,734

Liability:
Derivative liabilities	$	—	$	—	$	14,465	$	14,465


	Fair Value Measurements as of
	December 31, 2023 Using:
	Level 1		Level 2		Level 3		Total
Assets:
Cash equivalents:
Money market funds	$	187,951	$	—	$	—	$	187,951

Liability:
Derivative liabilities	$	—	$	—	$	29,987	$	29,987

Barings Credit Agreement and Royalty Fee Derivative Liability

At September 30, 2024, the Barings Credit Facility, net of the Royalty Fee Derivative Liability, was carried at amortized cost totaling $68,525, comprised of the $67,815 non-current liability (Note 7) and $710 accrued interest (Note 6). The estimated fair value of the Barings Credit Facility, without the Royalty Fee Derivative Liability, was $74,009 at September 30, 2024. At December 31, 2023, the Barings Credit Facility, net of the Royalty Fee Derivative Liability, was carried at amortized cost totaling $66,590 comprised of the $65,787 non-current liability (Note 7) and $803 accrued interest (Note 6). The estimated fair value of the Barings Credit Facility, without the Royalty Fee Derivative Liability, was $72,295 at December 31, 2023.

The fair value of the Royalty Fee Derivative Liability is estimated using a Monte Carlo simulation. The use of this approach requires the use of Level 3 unobservable inputs. The main inputs when determining the fair value of the Royalty Fee Derivative Liability are the amount and timing of the expected future revenue of the Company, the estimated volatility of these revenues, and the discount rate corresponding to the risk of revenue. The estimated fair value presented is not necessarily indicative of an amount that could be realized in a current market exchange. The use of alternative inputs and estimation methodologies could have a material effect on these estimates of fair value.

The main inputs to valuing the Royalty Fee Derivative Liability are as follows:


	As of
	September 30,			December 31,
	2024			2023
Revenue volatility		64.0	%		67.0	%
Revenue discount rate		15.8	%		15.8	%

Convertible Notes and Conversion Option Derivative Liability

At December 31, 2023, the Convertible Notes, net of the Conversion Option Derivative Liability, were carried at amortized cost totaling $20,024, comprised of the $9,138 non-current liability (Note 7) and $10,886 accrued interest (Note 6).

The fair value of the Convertible Notes with and without the conversion option as of December 31, 2023 was estimated using a binomial lattice approach. The use of this approach required the use of Level 3 unobservable inputs. The main input when determining the fair value of the Convertible Notes was the bond yield that pertained to the host instrument without the conversion option. The significant assumption used in determining the bond yield was the market yield movements of a comparable instrument issued as of the valuation date, which was assessed and updated each period. The main input when determining the fair value for disclosure purposes was the bond yield which was updated each period to reflect the yield of a comparable instrument issued as of the valuation date. The fair value of the Conversion Option Derivative Liability immediately before the Conversion was determined based on the intrinsic value of the separated conversion option.

Insider Trading Arrangements

3 Months Ended

Sep. 30, 2024

Jun. 30, 2024

Trading Arrangements, by Individual

Material Terms of Trading Arrangement


Name (Title)	Action Taken (Date of Action)	Type of Trading Arrangement	Nature of Trading Arrangement	Duration of Trading Arrangement	Aggregate Number of Securities
Nadia K. Waheed (Chief Medical Officer)	Adoption (June 1, 2024)	Durable Rule 10b5-1 trading arrangement for sell-to-cover transactions relating to all equity awards that have or may be granted	Sale	Until final settlement of any covered RSUs	Indeterminable (1)

(1) The number of shares subject to covered RSUs that will be sold to satisfy applicable tax withholding obligations upon vesting is unknown as the number will vary based on the extent to which vesting conditions are satisfied, the market price of the Company’s common stock at the time of settlement and the potential future grant of additional RSUs subject to this arrangement. This trading arrangement, which applies to RSUs whether vesting is based on the passage of time and/or the achievement of performance goals, provides for the automatic sale of shares that would otherwise be issuable on each settlement date of a covered RSU in an amount sufficient to satisfy the applicable withholding obligation, with the proceeds of the sale delivered to the Company in satisfaction of the applicable withholding obligation.

Rule 10b5-1 Arrangement Adopted

false

Non-Rule 10b5-1 Arrangement Adopted

false

Rule 10b5-1 Arrangement Terminated

false

Non-Rule 10b5-1 Arrangement Terminated

false

Nadia K. Waheed

Trading Arrangements, by Individual

Name

Nadia K. Waheed

Title

Chief Medical Officer

Rule 10b5-1 Arrangement Adopted

true

Adoption Date

Jun. 01, 2024

Net Loss Per Share - Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Reconciliation of net loss attributable to common stockholders for basic and diluted net loss per share
Net loss attributable to common stockholders, basic		$ (516)		$ (51,516)
Interest expense on Convertible Notes		1,004		3,232
Change in fair value of derivative liability and gains on extinguishment of debt		(22,051)		(16,619)
Net loss attributable to common stockholders, diluted		$ (21,563)		$ (64,903)
Weighted average common shares outstanding, basic (in shares)	166,992,735	79,373,272	154,990,112	78,276,341
Shares issuable in connection with conversion of Convertible Notes, as if converted (in shares)		5,769,232		5,769,232
Weighted average common shares outstanding, diluted (in shares)	166,992,735	85,142,504	154,990,112	84,045,573
Net loss per share attributable to common stockholders, diluted (in dollars per share)	$ (0.22)	$ (0.25)	$ (0.94)	$ (0.77)

- Definition

The amount of net income (loss) for the period available to each share of common stock or common unit outstanding during the reporting period and to each share or unit that would have been outstanding assuming the issuance of common shares or units for all dilutive potential common shares or units outstanding during the reporting period.

+ References

+ Details

- Definition

Amount, after deduction of tax, noncontrolling interests, dividends on preferred stock and participating securities; of income (loss) available to common shareholders.

+ References

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+ Details

- Definition

Amount, after deduction of tax, noncontrolling interests, dividends on preferred stock and participating securities, and addition from assumption of issuance of common shares for dilutive potential common shares; of income (loss) available to common shareholders.

+ References + Details

Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands	Common Stock	Additional Paid-in Capital	Accumulated Deficit	Total
Balance at Dec. 31, 2022	$ 8	$ 652,213	$ (616,842)	$ 35,379
Balance, shares at Dec. 31, 2022	77,201,819
Stockholders' Equity (Deficit)
Issuance of common stock upon exercise of stock options		78		78
Issuance of common stock upon exercise of stock options, shares	26,443
Issuance of common stock upon vesting of restricted stock units (in shares)	288,376
Stock-based compensation expense		4,572		4,572
Net Income (Loss)			(30,318)	(30,318)
Balance at Mar. 31, 2023	$ 8	656,863	(647,160)	9,711
Balance, shares at Mar. 31, 2023	77,516,638
Balance at Dec. 31, 2022	$ 8	652,213	(616,842)	35,379
Balance, shares at Dec. 31, 2022	77,201,819
Stockholders' Equity (Deficit)
Net Income (Loss)				(51,516)
Balance at Sep. 30, 2023	$ 8	676,203	(668,358)	7,853
Balance, shares at Sep. 30, 2023	79,412,114
Balance at Mar. 31, 2023	$ 8	656,863	(647,160)	9,711
Balance, shares at Mar. 31, 2023	77,516,638
Stockholders' Equity (Deficit)
Issuance of common stock upon exercise of stock options		403		403
Issuance of common stock upon exercise of stock options, shares	97,435
Issuance of common stock in connection with employee stock purchase plan		418		418
Issuance of common stock in connection with employee stock purchase plan, shares	176,406
Issuance of common stock upon vesting of restricted stock units (in shares)	73,117
Issuance of common stock, net of issuance costs		8,824		8,824
Issuance of common stock, net of issuance costs, shares	1,370,208
Stock-based compensation expense		4,413		4,413
Net Income (Loss)			(20,682)	(20,682)
Balance at Jun. 30, 2023	$ 8	670,921	(667,842)	3,087
Balance, shares at Jun. 30, 2023	79,233,804
Stockholders' Equity (Deficit)
Issuance of common stock upon exercise of stock options		62		62
Issuance of common stock upon exercise of stock options, shares	16,216
Issuance of common stock upon vesting of restricted stock units (in shares)	17,376
Issuance of common stock, net of issuance costs		708		708
Issuance of common stock, net of issuance costs, shares	144,718
Stock-based compensation expense		4,512		4,512
Net Income (Loss)			(516)	(516)
Balance at Sep. 30, 2023	$ 8	676,203	(668,358)	7,853
Balance, shares at Sep. 30, 2023	79,412,114
Balance at Dec. 31, 2023	$ 12	788,697	(697,578)	91,131
Balance, shares at Dec. 31, 2023	114,963,193
Stockholders' Equity (Deficit)
Issuance of common stock upon exercise of stock options		4,870		4,870
Issuance of common stock upon exercise of stock options, shares	1,025,384
Issuance of common stock upon vesting of restricted stock units (in shares)	532,717
Issuance of common stock, net of issuance costs	$ 3	316,350		316,353
Issuance of common stock, net of issuance costs, shares	32,413,560
Issuance of common stock in connection with conversion of Convertible Notes		52,499		52,499
Issuance of common stock upon conversion of Convertible Notes, Shares	5,769,232
Stock-based compensation expense		7,978		7,978
Net Income (Loss)			(64,848)	(64,848)
Balance at Mar. 31, 2024	$ 15	1,170,394	(762,426)	407,983
Balance, shares at Mar. 31, 2024	154,704,086
Balance at Dec. 31, 2023	$ 12	788,697	(697,578)	91,131
Balance, shares at Dec. 31, 2023	114,963,193
Stockholders' Equity (Deficit)
Net Income (Loss)				(145,118)
Balance at Sep. 30, 2024	$ 16	1,194,701	(842,696)	352,021
Balance, shares at Sep. 30, 2024	156,654,938
Balance at Mar. 31, 2024	$ 15	1,170,394	(762,426)	407,983
Balance, shares at Mar. 31, 2024	154,704,086
Stockholders' Equity (Deficit)
Issuance of common stock upon exercise of stock options	$ 1	1,703		1,704
Issuance of common stock upon exercise of stock options, shares	245,554
Issuance of common stock in connection with employee stock purchase plan		492		492
Issuance of common stock in connection with employee stock purchase plan, shares	120,806
Issuance of common stock upon vesting of restricted stock units (in shares)	553,917
Stock-based compensation expense		11,293		11,293
Net Income (Loss)			(43,777)	(43,777)
Balance at Jun. 30, 2024	$ 16	1,183,882	(806,203)	377,695
Balance, shares at Jun. 30, 2024	155,624,363
Stockholders' Equity (Deficit)
Issuance of common stock upon exercise of stock options		4,178		4,178
Issuance of common stock upon exercise of stock options, shares	961,030
Issuance of common stock upon vesting of restricted stock units (in shares)	69,545
Stock-based compensation expense		6,641		6,641
Net Income (Loss)			(36,493)	(36,493)
Balance at Sep. 30, 2024	$ 16	$ 1,194,701	$ (842,696)	$ 352,021
Balance, shares at Sep. 30, 2024	156,654,938

Related Party Transactions

9 Months Ended

Sep. 30, 2024

Related Party Transactions

Related Party Transactions

15. Related Party Transactions

The Company has engaged Boston Image Reading Center LLC (“BIRC”) to provide certain clinical development-related services to the Company. Nadia Waheed, M.D. M.P.H., who has served as the Company’s Chief Medical Officer since June 1, 2024, is a Director of BIRC. For the three and nine months ended September 30, 2024, the Company incurred fees for clinical development-related services rendered by BIRC while being deemed a related party since June 1, 2024 of $8 and $51, respectively. As of September 30, 2024, there was $0 and $47 recorded in accounts payable and accrued expenses for BIRC, respectively.

Jeffrey Heier, M.D., a former member of the Company’s Board of Directors and the Company’s current Chief Scientific Officer, and Peter Kaiser, M.D., the Company’s Chief Development Officer since April 16, 2024, are each affiliated with i2Vision, Inc. and its affiliated entities (collectively “i2Vision”). The Company has engaged i2Vision to provide services with respect to the clinical advancement of AXPAXLI. For the three and nine months ended September 30, 2024, the Company incurred fees and expenses related to services rendered by i2Vision of $623, including $313 for pass-through costs, and $1,961, including $349 for pass-through costs, respectively. The Company incurred fees and expenses related to services rendered by i2Vision of $(8), including $0 for pass-through costs, and $257, including $102 for pass-through costs, for the three and nine months ended September 30, 2023, respectively. As of September 30, 2024 and December 31, 2023, there was $153 and $0 recorded in accounts payable for i2Vision, respectively. As of September 30, 2024 and December 31, 2023, there was $410 and $0 recorded in accrued expenses for i2Vision, respectively. As of September 30, 2024 and December 31, 2023, there was $416 and $0 recorded in prepaid expenses and other current assets for i2Vision, respectively.

The Company has engaged Wilmer Cutler Pickering Hale and Dorr LLP (“WilmerHale”) to provide certain legal services to the Company. Christopher White, who served as the Company’s Chief Business Officer until March 6, 2024, is the brother of a partner at WilmerHale who has not participated in providing legal services to the Company. Upon Mr. White’s departure, WilmerHale ceased to be a related party to the Company. For the three and nine months ended September 30, 2024, the Company incurred fees for legal services rendered by WilmerHale while being deemed a related party through March 31, 2024 of $0 and $1,080, respectively. The Company incurred fees for legal services rendered by WilmerHale of $323 and $956 for the three and nine months ended September 30, 2023, respectively. As of December 31, 2023, there was $298 recorded in accounts payable for WilmerHale. As of December 31, 2023, there was $0 recorded in accrued expenses for WilmerHale.

The Company had engaged Heier Consulting, LLC (“Heier Consulting”), an entity affiliated with Dr. Heier, to provide advice or expertise on one or more of the Company’s development-stage drug or medical device products relating to retinal diseases or conditions under a consultant agreement (the “Consultant Agreement”). On February 21, 2024, the Company entered into an employment agreement with Dr. Heier (the “Heier Employment Agreement”) under

which Dr. Heier agreed to serve as Chief Scientific Officer of the Company. In connection with entering into the Heier Employment Agreement, the Heier Consulting Agreement was terminated. In addition, in connection with his commencement of employment, Dr. Heier resigned from the Company’s board of directors, effective February 21, 2024. Compensation for the consulting services was in the form of cash and stock-based awards. The total grant date fair value of stock-based awards granted to Dr. Heier was $96, which was recognized to expense on a straight-line basis over the respective vesting periods. The Company did not incur any cash-based fees for services rendered by Heier Consulting for the three months ended September 30, 2024. The Company incurred cash-based fees for services rendered by Heier Consulting for the three months ended September 30, 2023 of $13. The Company incurred cash-based fees for services rendered by Heier Consulting before termination of the Consultant Agreement of approximately $5 and $18 for the nine months ended September 30, 2024 and 2023, respectively. As of September 30, 2024 and December 31, 2023, there were $0 and $6 recorded in accounts payable for Heier Consulting, respectively. As of September 30, 2024 and December 31, 2023, there were $0 and $0 recorded in accrued expenses for Heier Consulting, respectively.

- Definition

The entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.

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+ Details

Net Loss Per Share - Schedule of Antidilutive Securities, Excluded from Computation of Diluted Net Loss per Share (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Net Loss Per Share
Dilutive impact from potentially issuable common shares	$ 0	$ 0	$ 0	$ 0
Total common stock equivalents	22,800,519	17,959,906	22,800,519	17,959,906
Options to purchase common stock
Net Loss Per Share
Total common stock equivalents	19,784,690	16,306,543	19,784,690	16,306,543
Restricted stock units
Net Loss Per Share
Total common stock equivalents	3,015,829	1,653,363	3,015,829	1,653,363

Net Loss Per Share (Tables)

9 Months Ended

Sep. 30, 2024

Net Loss Per Share

Schedule of basic and diluted net (loss) income per share attributable to common stockholders

Basic net loss per share was calculated as follows for the three and nine months ended September 30, 2024 and 2023:


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2024		2023		2024		2023
Numerator:
Net loss attributable to common stockholders	$	(36,493)	$	(516)	$	(145,118)	$	(51,516)
Denominator:
Weighted average common shares outstanding, basic		166,992,735		79,373,272		154,990,112		78,276,341
Net loss per share - basic	$	(0.22)	$	(0.01)	$	(0.94)	$	(0.66)

Diluted net loss per share was calculated as follows for the three months ended September 30, 2023 and the nine months ended September 30, 2023:


	Three Months Ended		Nine Months Ended
	September 30,		September 30,
		2023		2023
Net loss attributable to common stockholders, basic	$	(516)	$	(51,516)
Interest expense on Convertible Notes		1,004		3,232
Change in fair value of derivative liability and gains on extinguishment of debt		(22,051)		(16,619)
Net loss attributable to common stockholders, diluted	$	(21,563)	$	(64,903)

Weighted average common shares outstanding, basic		79,373,272		78,276,341
Shares issuable in connection with conversion of Convertible Notes, as if converted		5,769,232		5,769,232
Weighted average common shares outstanding, diluted		85,142,504		84,045,573

Net loss per share attributable to common stockholders, diluted	$	(0.25)	$	(0.77)

Schedule of antidilutive securities, excluded from computation of diluted net loss per share


	Three Months Ended September 30,		Nine Months Ended September 30,
	2024	2023	2024	2023
Options to purchase common stock	19,784,690	16,306,543	19,784,690	16,306,543
Restricted stock units	3,015,829	1,653,363	3,015,829	1,653,363
	22,800,519	17,959,906	22,800,519	17,959,906

Income Taxes

9 Months Ended

Sep. 30, 2024

Income Taxes

Income Taxes

12. Income Taxes

The Company did not provide for any income taxes in its unaudited condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2024 and 2023, respectively. The Company has provided a valuation allowance for the full amount of its net deferred tax assets because, at September 30, 2024 and December 31, 2023, it was more likely than not that any future benefit from deductible temporary differences and net operating loss and tax credit carryforwards would not be realized.

- Definition

The entire disclosure for income tax.

+ References

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+ Details

Financial Liabilities - Barings Credit Agreement - Terms (Details) - Barings Credit Facility - USD ($) $ in Thousands	Aug. 02, 2023	Sep. 30, 2024
Financial Liabilities
Borrowing capacity under the agreement	$ 82,474
Principal amount of debt issued	82,474
Proceeds from issuance of debt, net	$ 77,290
Debt Instrument, Variable Interest Rate, Type [Extensible Enumeration]	us-gaap:SecuredOvernightFinancingRateSofrMember
Interest rate floor (as a percent)	1.50%
Basis spread (as a percent)	6.75%
Royalty fees payable as percentage of net sales.	3.50%
Minimum liquidity amount	$ 20,000	$ 20,000

Derivative Liability

9 Months Ended

Sep. 30, 2024

Derivative Liability

Derivative Liability

8. Derivative Liability

Barings Credit Agreement

The Barings Credit Agreement (Note 7) contains the embedded Barings Royalty Fee Obligation that meets the criteria to be bifurcated and accounted for separately from the Barings Credit Facility (the “Royalty Fee Derivative Liability”). The Royalty Fee Derivative Liability was recorded at fair value upon the entering into the Barings Credit Facility and is subsequently remeasured to fair value at each reporting period. The Royalty Fee Derivative Liability was initially valued and is remeasured using a “with-and-without” method. The “with-and-without” methodology involves valuing the whole instrument on an as-is basis with the embedded Barings Royalty Fee Obligation and then valuing the instrument without the embedded Barings Royalty Fee Obligation. Royalty payments are estimated using a Monte Carlo simulation. Refer to Note 9 for details regarding the determination of fair value.

A roll-forward of the Royalty Fee Derivative Liability is as follows:


	As of
Balance at December 31, 2023	$	12,389
Change in fair value		2,076
Balance at September 30, 2024	$	14,465

Convertible Notes

The Convertible Notes (Note 7), which were extinguished in March 2024, contained the Conversion Option Derivative Liability, an embedded conversion option that meets the criteria to be bifurcated and accounted for separately from the Convertible Notes. The Conversion Option Derivative Liability was recorded at fair value upon the issuance of the Convertible Notes and was subsequently remeasured to fair value at each reporting period. The Conversion Option Derivative Liability was initially valued and was subsequently remeasured using a “with-and-without” method. The “with-and-without” methodology involves valuing the whole instrument on an as-is basis with the embedded conversion option and then valuing the instrument without the embedded conversion option. The difference between the entire instrument with the embedded conversion option compared to the instrument without the embedded conversion option is the fair value of the derivative, recorded as the Conversion Option Derivative Liability. Refer to Note 9 for details regarding the determination of fair value.

A roll-forward of the Conversion Option Derivative Liability is as follows:


	As of
Balance at December 31, 2023	$	17,598
Change in fair value		(2,598)
Balance at March 28, 2024		15,000
Extinguishment in connection with Conversion		(15,000)
Balance at September 30, 2024	$	—

Net Loss Per Share - Basic (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended						9 Months Ended
	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2024	Sep. 30, 2023
Basic net loss per share attributable to common stockholders
Net loss attributable to common stockholders	$ (36,493)	$ (43,777)	$ (64,848)	$ (516)	$ (20,682)	$ (30,318)	$ (145,118)	$ (51,516)
Weighted average common shares outstanding, basic (in shares)	166,992,735			79,373,272			154,990,112	78,276,341
Net loss per share - basic (in dollar per share)	$ (0.22)			$ (0.01)			$ (0.94)	$ (0.66)

- Definition

The amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.

+ References

+ Details

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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+ Details

Financial Liabilities (Tables)

9 Months Ended

Sep. 30, 2024

Barings Credit Facility

Debt Instrument [Line Items]

Summary of debt


	September 30,		December 31,
	2024		2023
Barings Credit Facility	$	82,474		82,474
Less: unamortized discount		(14,659)		(16,687)
Total	$	67,815		65,787

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

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+ Details

Cash Equivalents and Restricted Cash (Tables)

9 Months Ended

Sep. 30, 2024

Cash Equivalents and Restricted Cash

Reconciliation of cash, cash equivalents, and restricted cash reported within the balance sheet to the total amounts shown in the statement of cash flows


	September 30,		September 30,
	2024		2023
Cash and cash equivalents	$	427,220	$	110,550
Restricted cash (non-current)		1,614		1,764
Total cash, cash equivalents and restricted cash as shown on the statements of cash flows	$	428,834	$	112,314

Licensing Agreements and Deferred Revenue

9 Months Ended

Sep. 30, 2024

Licensing Agreements and Deferred Revenue

Licensing Agreements and Deferred Revenue

3. Licensing Agreements and Deferred Revenue

Incept License Agreement (in-licensing)

On September 13, 2018, the Company entered into a second amended and restated license agreement with Incept, LLC (“Incept”) to use and develop certain intellectual property (the “Incept License Agreement”). Under the Incept License Agreement, as amended and restated, the Company was granted a worldwide, perpetual, exclusive license to use specific Incept technology to develop and commercialize products that are delivered to or around the human eye for diagnostic, therapeutic or prophylactic purposes relating to ophthalmic diseases or conditions. The Company is obligated to pay low single-digit royalties on net sales of commercial products developed using the licensed technology, commencing with the date of the first commercial sale of such products and until the expiration of the last to expire of the patents covered by the license.

The terms and conditions of the Incept License Agreement are described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 11, 2024.

Royalties paid under this agreement related to product sales (the “Incept Royalties”) were $491 and $1,373 for the three and nine months ended September 30, 2024, respectively, and $451 and $1,264 for the three and nine months ended September 30, 2023, respectively. The Incept Royalties have been charged to cost of product revenue.

AffaMed License Agreement (out-licensing)

On October 29, 2020, the Company entered into a license agreement (“AffaMed License Agreement”) with AffaMed Therapeutic Limited (“AffaMed”) for the development and commercialization of the Company’s DEXTENZA product regarding ocular inflammation and pain following cataract surgery and allergic conjunctivitis and for the Company’s PAXTRAVA product candidate (collectively the “AffaMed Licensed Products”) regarding open-angle glaucoma or ocular hypertension, in each case in mainland China, Taiwan, Hong Kong, Macau, South Korea, and the countries of the Association of Southeast Asian Nations. The Company retains development and commercialization rights for the AffaMed Licensed Products in the rest of the world.

The terms and conditions of the AffaMed License Agreement are described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 11, 2024.

The Company recognized collaboration revenue related to its performance obligation regarding the conduct of a Phase 2 clinical trial of PAXTRAVA (the “Phase 2 Clinical Trial of PAXTRAVA performance obligation”) of $78 and $200 for the three and nine months ended September 30, 2024, respectively, and $131 and $449 for the three and nine months ended September 30, 2023, respectively.

As of September 30, 2024, the aggregate amount of the transaction price allocated to the partially unsatisfied Phase 2 Clinical Trial of PAXTRAVA performance obligation was $190. This amount is expected to be recognized as this performance obligation is satisfied through June 2025.

Deferred revenue activity for the nine months ended September 30, 2024 was as follows:



	Deferred Revenue
Deferred revenue at December 31, 2023	$	14,390
Amounts recognized into revenue		(200)
Deferred revenue at September 30, 2024	$	14,190

Financial Liabilities - MidCap Credit Agreement (Details) - USD ($) $ in Thousands	1 Months Ended		3 Months Ended	9 Months Ended
	Aug. 31, 2023	Mar. 31, 2023	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Financial Liabilities
Proceeds From Issuance of Protective Advance					$ 2,000
Gain (loss) on extinguishment of debt			$ 14,190	$ (27,950)	14,190
Repayment from issuance of short-term bridge loan					2,000
MidCap Credit Facility
Financial Liabilities
Proceeds From Issuance of Protective Advance		$ 2,000
Repayment of Protective Advance		$ 2,000
Repayment of debt	$ 26,157
Gain (loss) on extinguishment of debt			$ (717)		$ (717)

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

+ Details

Nature of the Business and (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023	Sep. 30, 2023	Aug. 02, 2023
Nature of Business
Accumulated deficit	$ 842,696	$ 697,578
Cash and cash equivalents	427,220	$ 195,807	$ 110,550
Barings Credit Facility
Nature of Business
Debt Instrument, covenants, minimum liquidity requirement	$ 20,000			$ 20,000

- Definition

Amount of accumulated undistributed earnings (deficit).

+ References + Details

Financial Liabilities - Barings Credit Agreement - Summary (Details) - Barings Credit Facility - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Credit Agreement
Barings Credit Facility	$ 82,474	$ 82,474
Less: unamortized discount	(14,659)	(16,687)
Total	67,815	$ 65,787
Due for repayment in 2029	$ 82,474

Inventory (Tables)

9 Months Ended

Sep. 30, 2024

Inventory

Components of inventory


	September 30,		December 31,
	2024		2023
Raw materials	$	196	$	302
Work-in-process		1,400		1,012
Finished goods		809		991
	$	2,405	$	2,305

Expenses

9 Months Ended

Sep. 30, 2024

Expenses

Expenses

6. Expenses

Restructuring

On May 29, 2024, the Company’s board of directors approved a strategic reduction in force to eliminate 37 full-time employees of the Company, primarily in research and development and technical operations and representing approximately 13% of the Company’s workforce, as part of an initiative to prioritize Company resources on the clinical development of AXPAXLI for the treatment of wet AMD.

The Company substantially completed the reduction in force and recorded the related restructuring costs, primarily for paid leave for terminated employees, severance, and related costs, in the three months ended June 30, 2024. The accrued restructuring costs remaining at June 30, 2024 were paid in the three months ended September 30, 2024.

A roll-forward of the costs accrued with regard to this restructuring is as follows:


	As of
Accrued restructuring costs at March 31, 2024		—
Restructuring costs incurred during the period		1,601
Restructuring costs paid during the period		(395)
Accrued restructuring costs at June 30, 2024		1,206
Restructuring costs paid during the period		(1,206)
Accrued restructuring costs at September 30, 2024		—

Restructuring costs incurred during the nine months ended September 30, 2024 are included in general and administrative expenses on the consolidated statements of operations and comprehensive loss.

Accrued Expenses

Accrued expenses and other current liabilities consisted of the following:


	September 30,		December 31,
	2024		2023
Accrued payroll and related expenses		11,106		8,156
Accrued research and development expenses	$	8,047	$	1,488
Accrued rebates and programs		5,658		5,117
Accrued professional fees		3,139		691
Accrued interest payable on Barings Credit Facility (Note 7)		710		803
Accrued other		1,791		1,525
Accrued interest payable on Convertible Notes (Note 7)		—		10,886
	$	30,451	$	28,666

Derivative Liability (Tables)

9 Months Ended

Sep. 30, 2024

Convertible Notes

Financial Liabilities

Summary of roll-forward of the derivative liability


	As of
Balance at December 31, 2023	$	17,598
Change in fair value		(2,598)
Balance at March 28, 2024		15,000
Extinguishment in connection with Conversion		(15,000)
Balance at September 30, 2024	$	—

Barings Credit Facility

Financial Liabilities

Summary of roll-forward of the derivative liability


	As of
Balance at December 31, 2023	$	12,389
Change in fair value		2,076
Balance at September 30, 2024	$	14,465

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

+ Details

- Definition

Tabular disclosure of pertinent information about a derivative or group of derivatives on a disaggregated basis, such as for individual instruments, or small groups of similar instruments. May include a combination of the type of instrument, risks being hedged, notional amount, hedge designation, related hedged item, inception date, maturity date, or other relevant item.

+ References + Details

Risks and Fair Value - Fair Value Measurement (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Liability:
Notes Payable, Noncurrent	$ 67,815	$ 65,787
Non-current liability		9,138
Barings Credit Facility
Liability:
Notes payable, amortized cost, including accrued interest	68,525	66,590
Notes Payable, Noncurrent	67,815	65,787
Accrued interest payable	710	803
Estimated fair value	74,009	72,295
Debt instrument carrying amount	82,474	82,474
Convertible Notes
Liability:
Accrued interest payable		10,886
Debt instrument carrying amount		20,024
Non-current liability		9,138
Recurring Basis
Liability:
Derivative liabilities	$ 14,465	$ 29,987
Derivative Liability, Statement of Financial Position [Extensible Enumeration]	Derivative Liability, Noncurrent	Derivative Liability, Noncurrent
Money Market Funds \| Recurring Basis
Assets:
Cash equivalents	$ 414,734	$ 187,951
Level 1 \| Money Market Funds \| Recurring Basis
Assets:
Cash equivalents	414,734	187,951
Level 3 \| Recurring Basis
Liability:
Derivative liabilities	$ 14,465	$ 29,987

Subsequent Events

9 Months Ended

Sep. 30, 2024

Subsequent Events

Subsequent Events

16. Subsequent Events

On October 4, 2024, the Company’s board of directors amended the 2019 Inducement Plan, as amended, to increase the aggregate number of shares issuable thereunder from 4,804,000 to 6,054,000 shares of common stock.

Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares	Sep. 30, 2024	Dec. 31, 2023
Condensed Consolidated Balance Sheets
Preferred stock, par value	$ 0.0001	$ 0.0001
Preferred stock, shares authorized	5,000,000	5,000,000
Preferred stock, shares issued	0	0
Preferred stock, shares outstanding	0	0
Common stock, par value	$ 0.0001	$ 0.0001
Common stock, shares authorized	400,000,000	200,000,000
Common stock, shares issued	156,654,938	114,963,193
Common stock, shares outstanding	156,654,938	114,963,193

Stock-Based Awards - Additional Information (Details)		3 Months Ended	9 Months Ended
Stock-Based Awards - Additional Information (Details)	Jun. 12, 2024 shares	Sep. 30, 2024 item $ / shares shares	Sep. 30, 2024 item $ / shares shares	Apr. 16, 2024 shares	Apr. 15, 2024 shares	Feb. 20, 2024 shares	Feb. 19, 2024 shares	Jan. 01, 2024 shares	Dec. 31, 2023 shares
Stock-Based Awards
Number of stock based compensation plans \| item		3	3
Stock options expired or forfeited (in shares)		795,230	1,835,491
2021 Incentive Plan
Stock-Based Awards
Additional number of shares authorized for issuance	7,000,000
Number of shares of common stock available for issuance		8,806,487	8,806,487
2019 Inducement Plan
Stock-Based Awards
Number of shares of common stock authorized for issuance				4,804,000	3,804,000	3,804,000	1,054,000
Number of shares of common stock available for issuance		258,481	258,481
2014 Employee Stock Purchase Plan
Stock-Based Awards
Number of shares of common stock authorized for issuance								606,186	398,784
Number of shares of common stock available for issuance		485,380	485,380
Common Stock
Stock-Based Awards
Shares issuable under options, granted (in shares)		847,287	7,675,358
Exercise price (in dollars per share) \| $ / shares		$ 8.05	$ 7.22
Common Stock \| 2021 Incentive Plan
Stock-Based Awards
Shares issuable under options, granted (in shares)		532,087	4,860,714
Common Stock \| 2019 Inducement Plan
Stock-Based Awards
Shares issuable under options, granted (in shares)		315,200	2,814,644
Restricted Stock Units (RSUs)
Stock-Based Awards
Granted (in shares)		359,410	2,971,167
Number of RSU is equivalent to common share		1	1
RSU expired or forfeited (in shares)		159,658	426,500
Restricted Stock Units (RSUs) \| 2021 Incentive Plan
Stock-Based Awards
Granted (in shares)		254,346	1,610,117
Restricted Stock Units (RSUs) \| 2019 Inducement Plan
Stock-Based Awards
Granted (in shares)		105,064	1,361,050

Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Revenue:
Total revenue, net	$ 15,425	$ 15,081	$ 46,641	$ 43,642
Costs and operating expenses:
Cost, Product and Service [Extensible List]	Product revenue, net	Product revenue, net	Product revenue, net	Product revenue, net
Cost of product revenue	$ 1,561	$ 1,377	$ 4,396	$ 3,895
Research and development	37,054	15,019	86,646	44,860
Selling and marketing	10,573	9,315	30,750	31,304
General and administrative	12,235	8,584	46,054	25,915
Total costs and operating expenses	61,423	34,295	167,846	105,974
Loss from operations	(45,998)	(19,214)	(121,205)	(62,332)
Other income (expense):
Interest income	5,653	1,212	15,611	2,524
Interest expense	(3,224)	(3,426)	(10,471)	(7,187)
Change in fair value of derivative liabilities	7,076	6,722	(1,103)	1,290
Gains and losses on extinguishment of debt, net		14,190	(27,950)	14,190
Other expense				(1)
Total other income (expense), net	9,505	18,698	(23,913)	10,816
Net loss	$ (36,493)	$ (516)	$ (145,118)	$ (51,516)
Net loss per share, basic (in dollars per share)	$ (0.22)	$ (0.01)	$ (0.94)	$ (0.66)
Weighted average common shares outstanding, basic (in shares)	166,992,735	79,373,272	154,990,112	78,276,341
Net loss per share, diluted (in dollars per share)	$ (0.22)	$ (0.25)	$ (0.94)	$ (0.77)
Weighted average common shares outstanding, diluted (in shares)	166,992,735	85,142,504	154,990,112	84,045,573
Product revenue, net
Revenue:
Total revenue, net	$ 15,347	$ 14,950	$ 46,441	$ 43,193
Collaboration revenue
Revenue:
Total revenue, net	$ 78	$ 131	$ 200	$ 449

Risks and Fair Value - Change in Fair Value of Derivative Labilities (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Change in Fair Value of Derivative Liabilities
Barings Royalty Fees	$ (537)	$ (388)	$ (1,625)	$ (388)
Total	$ 7,076	6,722	(1,103)	1,290
Conversion Option Derivative Liability
Change in Fair Value of Derivative Liabilities
Change in fair value of derivative liability		$ 7,144	$ 2,598	$ 1,712
Derivative, Gain (Loss), Statement of Income or Comprehensive Income [Extensible Enumeration]	Total	Total	Total	Total
Royalty Fee Derivative Liability
Change in Fair Value of Derivative Liabilities
Change in fair value of derivative liability	$ 7,613	$ (34)	$ (2,076)	$ (34)
Derivative, Gain (Loss), Statement of Income or Comprehensive Income [Extensible Enumeration]	Total	Total	Total	Total

Risks and Fair Value (Tables)

9 Months Ended

Sep. 30, 2024

Risks and Fair Value

Summary of Concentration of Credit Risk and of Significant Suppliers and Customers


	Three Months Ended						Nine Months Ended
	September 30,						September 30,
	2024			2023			2024			2023
Customer 1		41	%		47	%		45	%		51	%
Customer 2		26			24			23			23
Customer 3		9			12			11			11


	As of
	September 30,			December 31,
	2024			2023
Customer 1		46	%		50	%
Customer 2		28			28
Customer 3		9			11

Schedule of change in fair value of derivative liabilities


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2024		2023		2024		2023
Change in the fair value of the Conversion Option Derivative Liability	$	—	$	7,144	$	2,598	$	1,712
Change in the fair value of Royalty Fee Derivative Liability		7,613		(34)		(2,076)		(34)
Barings Royalty Fee		(537)		(388)		(1,625)		(388)
Total	$	7,076	$	6,722	$	(1,103)	$	1,290

Schedule of assets and liabilities measured at fair Value on recurring basis


	Fair Value Measurements as of
	September 30, 2024 Using:
	Level 1		Level 2		Level 3		Total
Assets:
Cash equivalents:
Money market funds	$	414,734	$	—	$	—	$	414,734

Liability:
Derivative liabilities	$	—	$	—	$	14,465	$	14,465


	Fair Value Measurements as of
	December 31, 2023 Using:
	Level 1		Level 2		Level 3		Total
Assets:
Cash equivalents:
Money market funds	$	187,951	$	—	$	—	$	187,951

Liability:
Derivative liabilities	$	—	$	—	$	29,987	$	29,987

Royalty Fee Derivative Liability

Risks and Fair Value

Schedule of main inputs to valuing the Derivative Liability


	As of
	September 30,			December 31,
	2024			2023
Revenue volatility		64.0	%		67.0	%
Revenue discount rate		15.8	%		15.8	%

Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023	Sep. 30, 2023	Dec. 31, 2022
Cash Equivalents and Restricted Cash
Cash and cash equivalents	$ 427,220	$ 195,807	$ 110,550
Restricted cash (non-current)	1,614		1,764
Total cash, cash equivalents and restricted cash as shown on the statements of cash flows	$ 428,834	$ 197,571	$ 112,314	$ 104,064

Equity (Details) - USD ($)					1 Months Ended	3 Months Ended				9 Months Ended
Equity (Details) - USD ($)	Mar. 28, 2024	Feb. 26, 2024	Feb. 21, 2024	Aug. 09, 2021	Jun. 30, 2024	Sep. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Jun. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
Class of Stock [Line Items]
Increase in common stock shares authorized					200,000,000
Common stock, shares authorized					400,000,000	400,000,000				400,000,000		200,000,000
Common stock, par value						$ 0.0001				$ 0.0001		$ 0.0001
Gross proceeds from private placement										$ 316,353,000
Valued at the closing price							$ 52,499,000
Proceeds from issuance of common stock upon public offering, net of issuance costs											$ 9,532,000
Convertible Notes
Class of Stock [Line Items]
Conversion shares common stock	5,769,232
Common Stock
Class of Stock [Line Items]
Number of shares issued							32,413,560	144,718	1,370,208
Conversion shares common stock							5,769,232
Additional Paid-in Capital
Class of Stock [Line Items]
Valued at the closing price							$ 52,499,000
Additional Paid-in Capital \| Convertible Notes
Class of Stock [Line Items]
Valued at the closing price	$ 52,499,000
Securities Purchase Agreement
Class of Stock [Line Items]
Number of shares issued			32,413,560
Common stock, par value			$ 0.0001
Common stock, price per share			$ 7.52
Securities Purchase Agreement \| Pre-Funded Warrants
Class of Stock [Line Items]
Number of shares callable by warrants			10,805,957
Offering price of warrants			$ 7.519
Weighted average exercise price to purchase common stock			$ 0.001
Private Placement
Class of Stock [Line Items]
Proceeds from issuance of common stock upon public offering, net of issuance costs		$ 316,353
2021 Sales Agreement
Class of Stock [Line Items]
Number of shares issued								144,718			1,514,926
Gross proceeds from issuance of common stock								$ 734,000			$ 9,897,000
Proceeds from issuance of common stock upon public offering, net of issuance costs								$ 708,000			$ 9,532,000
2021 Sales Agreement \| Common Stock
Class of Stock [Line Items]
Number of shares issued						0				0
Maximum aggregate proceeds from offering				$ 100,000,000

Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	Sep. 30, 2024	Nov. 11, 2024
Document And Entity Information [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2024
Document Transition Report	false
Entity File Number	001-36554
Entity Registrant Name	Ocular Therapeutix, Inc.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	20-5560161
Entity Address, Address Line One	15 Crosby Drive
Entity Address, City or Town	Bedford
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	01730
City Area Code	781
Local Phone Number	357-4000
Title of 12(b) Security	Common Stock, $0.0001 par value per share
Trading Symbol	OCUL
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		157,217,427
Entity Central Index Key	0001393434
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q3
Amendment Flag	false

Commitments and Contingencies

9 Months Ended

Sep. 30, 2024

Commitments and Contingencies

Commitments and Contingencies

14. Commitments and Contingencies

Indemnification Agreements

In the ordinary course of business, the Company enters into agreements that may include indemnification provisions. Pursuant to such agreements, the Company may indemnify, hold harmless and defend indemnified parties for losses suffered or incurred by the indemnified party. Some of the provisions will limit losses to those arising from third-party actions. In some cases, the indemnification will continue after the termination of the agreement. The maximum potential amount of future payments the Company could be required to make under these provisions is not determinable. To date, the Company has not incurred any material costs as a result of such indemnifications.

Equity

9 Months Ended

Sep. 30, 2024

Equity

Equity

10. Equity

In June 2024, the Company adopted an amended and restated certificate of incorporation increasing the number of its authorized shares of its common stock by 200,000,000 shares to 400,000,000 shares.

On February 21, 2024, the Company entered into a securities purchase agreement (the “Securities Purchase Agreement”) with certain institutional accredited investors (the “Investors”), pursuant to which the Company issued and sold to the Investors in a private placement an aggregate of 32,413,560 shares of the Company’s common stock, par value $0.0001 per share (the “Shares”), at a price of $7.52 per share, and, to certain Investors in lieu of Shares, pre-funded warrants to purchase 10,805,957 shares of the Company’s common stock (the “Pre-Funded Warrants”), at a price of $7.519 per Pre-Funded Warrant (the “2024 Private Placement”). Each Pre-Funded Warrant issued in the 2024 Private Placement has an exercise price of $0.001 per share, is currently exercisable and will remain exercisable until the Pre-Funded Warrant is exercised in full. The 2024 Private Placement closed on February 26, 2024. The Company received total net proceeds from the 2024 Private Placement of approximately $316,353 after deducting placement agent fees and offering expenses. The Company accounts for the Pre-Funded Warrants as a component of permanent equity. In connection with entering into the Securities Purchase Agreement, also on February 21, 2024, the Company entered into a registration rights agreement with the Investors, pursuant to which the Company agreed to register for resale the Shares and the shares of the Company’s common stock issuable upon exercise of the Pre-Funded Warrants (together with the Shares, the “Registrable Securities”). The Company filed a registration statement regarding the Registrable Securities on Form S-3 with the SEC on March 25, 2024.

On March 28, 2024, the Company issued 5,769,232 shares of its common stock to the holder of the Convertible Notes in connection with the Conversion. The newly issued shares of common stock were valued at fair value, being the closing price of the Company’s common stock on that day, and resulted in an increase in additional paid-in capital of $52,499.

On August 9, 2021, the Company and Jefferies LLC (“Jefferies”) entered into an Open Market Sale Agreement (the “2021 Sales Agreement”) under which the Company may offer and sell shares of its common stock having an aggregate offering price of up to $100,000 from time to time through Jefferies, acting as agent. The Company did not offer or sell shares of its common stock under the 2021 Sales Agreement during the three and nine months ended September 30, 2024. During the three and nine months ended September 30, 2023, the Company sold 144,718 and 1,514,926 shares of common stock, respectively, under the 2021 Sales Agreement, resulting in gross proceeds to the Company of $734 and $9,897, and net proceeds, after accounting for issuance costs, of $708 and $9,532, respectively.

- Definition

The entire disclosure for equity.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (b)
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-URI https://asc.fasb.org/1943274/2147481112/505-10-50-13

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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-Paragraph 13
-Subparagraph (h)
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-URI https://asc.fasb.org/1943274/2147481112/505-10-50-13

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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-URI https://asc.fasb.org/1943274/2147481112/505-10-50-14

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org/1943274/2147477968/946-235-50-2

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
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-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477968/946-235-50-2

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 505
-Name Accounting Standards Codification
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-Paragraph 6
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478448/946-505-50-6

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Subparagraph (a)
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-URI https://asc.fasb.org/1943274/2147480237/815-40-50-6

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.3-04)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480008/505-10-S99-1

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
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-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(e)(1))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480678/235-10-S99-1

Reference 10: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 505
-Name Accounting Standards Codification
-Publisher FASB
-URI https://asc.fasb.org/505/tableOfContent

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org/1943274/2147481112/505-10-50-13

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (g)
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-URI https://asc.fasb.org/1943274/2147481112/505-10-50-13

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (i)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-13

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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-Name Accounting Standards Codification
-Section 50
-Paragraph 14
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-14

Reference 15: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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-Name Accounting Standards Codification
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Reference 16: http://www.xbrl.org/2003/role/disclosureRef
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Reference 17: http://www.xbrl.org/2003/role/disclosureRef
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Reference 18: http://www.xbrl.org/2003/role/disclosureRef
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Reference 19: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org/1943274/2147481112/505-10-50-18

+ Details

Pay vs Performance Disclosure - USD ($) $ in Thousands	3 Months Ended						9 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2024	Sep. 30, 2023
Pay vs Performance Disclosure
Net Income (Loss)	$ (36,493)	$ (43,777)	$ (64,848)	$ (516)	$ (20,682)	$ (30,318)	$ (145,118)	$ (51,516)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References

+ Details

Related Party Transactions - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
Related Party Transactions
Accounts payable	$ 4,001		$ 4,001		$ 4,389
Accrued expenses	30,451		30,451		28,666
Prepaid expenses and other current assets	13,151		13,151		7,794
BIRC \| Chief Medical Officer
Related Party Transactions
Expenses incurred	8		51
Accounts payable	0		0
Accrued expenses	47		47
i2 Vision Inc \| Related Party
Related Party Transactions
Expenses incurred	623	$ (8)	1,961	$ 257
Pass-through costs	313	0	349	102
Accounts payable	153		153		0
Accrued expenses	410		410		0
Prepaid expenses and other current assets	416		416		0
WilmerHale \| Chief Business Officer
Related Party Transactions
Expenses incurred	0	323	$ 1,080	956
Accounts payable					298
Accrued expenses					0
Heier Consulting LLC \| Related Party
Related Party Transactions
Total grant date fair value of stock-based awards granted			$ 96
Expenses incurred		$ 13	$ 5	$ 18
Accounts payable	0		0		6
Accrued expenses	$ 0		$ 0		$ 0

Nature of the Business

9 Months Ended

Sep. 30, 2024

Nature of the Business

Nature of the Business

1. Nature of the Business

Ocular Therapeutix, Inc. (the “Company”) was incorporated on September 12, 2006 under the laws of the State of Delaware. The Company is a biopharmaceutical company committed to improving vision in the real world through the development and commercialization of innovative therapies for retinal diseases and other eye conditions. AXPAXLI (axitinib intravitreal implant), the Company’s product candidate for retinal disease, is based on its ELUTYX proprietary bioresorbable hydrogel-based formulation technology. AXPAXLI is currently in Phase 3 clinical trials for wet age-related macular degeneration (“wet AMD”).

The Company also leverages the ELUTYX technology in its commercial product DEXTENZA (dexamethasone insert) 0.4mg, a corticosteroid approved by the U.S. Food and Drug Administration for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis, and in its product candidate PAXTRAVA (travoprost intracameral implant or OTX-TIC), which is currently in a Phase 2 clinical trial for the treatment of open-angle glaucoma or ocular hypertension.

The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, new technological innovations, protection of proprietary technology, dependence on key personnel, dependence on specific programs, compliance with government regulations, regulatory approval and compliance, reimbursement, uncertainty of market acceptance of products and the need to obtain additional financing. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval, prior to commercialization. Approved products will require significant sales, marketing and distribution support. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained, that any products developed will obtain necessary government regulatory approval and adequate reimbursement or that any approved products will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from product sales. The Company operates in an environment of rapidly changing technology and substantial competition from pharmaceutical and biotechnology companies. In addition, the Company is dependent upon the services of its employees and consultants. The Company may not be able to generate significant revenue from sales of any product for several years, if at all. Accordingly, the Company will need to obtain additional capital to finance its operations.

The Company has incurred losses and negative cash flows from operations since its inception, and the Company expects to continue to generate operating losses and negative cash flows from operations in the foreseeable future. As of September 30, 2024, the Company had an accumulated deficit of $842,696. Based on its current operating plan which includes estimates of anticipated cash inflows from product sales and cash outflows from operating expenses and capital expenditures, the Company believes that its existing cash and cash equivalents of $427,220 as of September 30, 2024 will enable it to fund its planned operating expenses, debt service obligations and capital expenditures at least through the next 12 months from the issuance date of these unaudited condensed consolidated financial statements while the Company observes a minimum liquidity covenant of $20,000 in its credit facility (Note 7).

The future viability of the Company is dependent on the Company’s ability to generate cash flows from the sales of the Company’s product candidates, such as AXPAXLI, if and as approved, and the sales of DEXTENZA, and to raise additional capital to finance its operations. The Company will need to finance its operations through public or private securities offerings, debt financings, collaborations, strategic alliances, licensing agreements, royalty agreements, or marketing and distribution agreements. Although the Company has been successful in raising capital in the past, there is no assurance that it will be successful in obtaining such additional financing on terms acceptable to the Company, if at all. If the Company is unable to obtain funding on a timely basis, in sufficient amounts, or at all, the Company could be forced to delay, reduce or eliminate some or all of its research and development programs for product candidates, product portfolio expansion or commercialization efforts, any of which could adversely affect its business prospects, or the Company may be unable to continue operations.

Risks and Fair Value - The main inputs to valuing the Royalty Fee Derivative Liability (Details) - Royalty Fee Derivative Liability - Level 3	Sep. 30, 2024	Dec. 31, 2023
Revenue volatility
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Derivative Liability, Measurement Input	0.640	0.670
Revenue discount rate
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Derivative Liability, Measurement Input	0.158	0.158

Subsequent Events (Details) - 2019 Inducement Plan - shares	Oct. 04, 2024	Apr. 16, 2024	Apr. 15, 2024	Feb. 20, 2024	Feb. 19, 2024
Subsequent Events
Number of shares of common stock authorized for issuance		4,804,000	3,804,000	3,804,000	1,054,000
Subsequent Event
Subsequent Events
Number of shares of common stock authorized for issuance	6,054,000

Derivative Liability - Liability roll forward (Details) - USD ($) $ in Thousands	3 Months Ended	6 Months Ended	9 Months Ended
	Mar. 28, 2024	Sep. 30, 2024	Sep. 30, 2024	Mar. 31, 2024
Royalty Fee Derivative Liability
Derivative Liability Roll forward
Beginning Balance	$ 12,389		$ 12,389
Change in fair value			2,076
Ending Balance		$ 14,465	$ 14,465
Derivative Liability, Statement of Financial Position [Extensible Enumeration]		Derivative Liability, Noncurrent	Derivative Liability, Noncurrent
Conversion Option Derivative Liability
Derivative Liability Roll forward
Beginning Balance	17,598	$ 15,000	$ 17,598
Change in fair value	(2,598)
Extinguishment upon Conversion		$ (15,000)
Ending Balance	$ 15,000
Derivative Liability, Statement of Financial Position [Extensible Enumeration]		Derivative Liability, Noncurrent	Derivative Liability, Noncurrent	Derivative Liability, Noncurrent

Licensing Agreements and Deferred Revenue (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Collaboration Agreement
Revenue recognized	$ 15,425	$ 15,081	$ 46,641	$ 43,642
Total deferred revenue:
Deferred revenue, beginning balance			14,390
Amounts recognized into revenue			(200)
Deferred revenue, ending balance	14,190		14,190
Incept
Collaboration Agreement
Royalties paid	491	451	1,373	1,264
License Agreement \| AffaMed \| OTX-TIC Product
Collaboration Agreement
Revenue recognized	78	$ 131	200	$ 449
Transaction price allocated to performance obligations partially unsatisfied	$ 190		$ 190

Stock-Based Awards (Tables)

9 Months Ended

Sep. 30, 2024

Stock-Based Awards

Schedule of stock-based compensation expense related to stock options


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2024		2023		2024		2023
Research and development	$	2,796	$	1,115	$	6,595	$	3,390
Selling and marketing		787		934		2,313		2,948
General and administrative		3,058		2,463		17,004		7,159
	$	6,641	$	4,512	$	25,912	$	13,497

Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Current assets:
Cash and cash equivalents	$ 427,220	$ 195,807
Accounts receivable, net	30,235	26,179
Inventory	2,405	2,305
Restricted cash		150
Prepaid expenses and other current assets	13,151	7,794
Total current assets	473,011	232,235
Property and equipment, net	10,050	11,739
Restricted cash	1,614	1,614
Operating lease assets	5,694	6,472
Total assets	490,369	252,060
Current liabilities:
Accounts payable	4,001	4,389
Accrued expenses and other current liabilities	30,451	28,666
Deferred revenue	190	255
Operating lease liabilities	1,717	1,586
Total current liabilities	36,359	34,896
Other liabilities:
Operating lease liabilities, net of current portion	5,592	6,878
Derivative liabilities	14,465	29,987
Deferred revenue, net of current portion	14,000	14,135
Notes payable, net	67,815	65,787
Other non-current liabilities	117	108
Convertible Notes, net		9,138
Total liabilities	138,348	160,929
Commitments and contingencies (Note 14)
Stockholders' equity:
Preferred stock, $0.0001 par value; 5,000,000 shares authorized and no shares issued or outstanding at September 30, 2024 and December 31, 2023, respectively
Common stock, $0.0001 par value; 400,000,000 and 200,000,000 shares authorized and 156,654,938 and 114,963,193 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively	16	12
Additional paid-in capital	1,194,701	788,697
Accumulated deficit	(842,696)	(697,578)
Total stockholders' equity	352,021	91,131
Total liabilities and stockholders' equity	$ 490,369	$ 252,060

Financial Liabilities - Convertible Notes, Terms (Details) - USD ($) $ in Thousands		3 Months Ended	9 Months Ended
	Mar. 28, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Mar. 01, 2019
Financial Liabilities
Gain (loss) on extinguishment of debt		$ 14,190	$ (27,950)	$ 14,190
Convertible Notes
Financial Liabilities
Principal amount of debt issued					$ 37,500
Interest rate (as a percent)					6.00%
Conversion shares common stock	5,769,232
Total fair value amount	$ 52,499
Accrued interest	11,361
Conversion of debt, derecognition of principal	(37,500)
Conversion of debt, unamortized discount	(27,950)
Conversion of debt, conversion option derivative liability	$ (15,000)
Gain (loss) on extinguishment of debt		$ 14,907	$ (27,950)	$ 14,907

Inventory (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Inventory
Raw materials	$ 196	$ 302
Work-in-process	1,400	1,012
Finished goods	809	991
Total inventory	$ 2,405	$ 2,305

Risks and Fair Value - Concentration of Credit Risk (Details)	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2024 item customer	Sep. 30, 2023 customer	Sep. 30, 2024 item customer	Sep. 30, 2023 customer	Dec. 31, 2023 customer
Concentration risk
Number Of financial institutions \| item	2		2
Total revenue \| Customer
Concentration risk
Number of major customers	3	3	3	3
Total revenue \| Customer \| Customer one
Concentration risk
Concentration risk	41.00%	47.00%	45.00%	51.00%
Total revenue \| Customer \| Customer two
Concentration risk
Concentration risk	26.00%	24.00%	23.00%	23.00%
Total revenue \| Customer \| Customer three
Concentration risk
Concentration risk	9.00%	12.00%	11.00%	11.00%
Accounts receivable \| Customer
Concentration risk
Number of major customers			3		3
Accounts receivable \| Customer \| Customer one
Concentration risk
Concentration risk			46.00%		50.00%
Accounts receivable \| Customer \| Customer two
Concentration risk
Concentration risk			28.00%		28.00%
Accounts receivable \| Customer \| Customer three
Concentration risk
Concentration risk			9.00%		11.00%

Financial Liabilities

9 Months Ended

Sep. 30, 2024

Financial Liabilities

Financial Liabilities

7. Financial Liabilities

Barings Credit Agreement

On August 2, 2023 (the “Closing Date”), the Company entered into a credit and security agreement (the “Barings Credit Agreement”) with Barings Finance LLC (“Barings”), as administrative agent, and the lenders party thereto, providing for a secured term loan facility for the Company (the “Barings Credit Facility”) in the aggregate principal amount of $82,474 (the “Total Credit Facility Amount”). The Company borrowed the full amount of $82,474 at closing and received proceeds of $77,290, after the application of an original issue discount and fees. Indebtedness under the Barings Credit Facility matures on the earlier to occur of (i) the six-year anniversary of the Closing Date and (ii) the date that is 91 days prior to the maturity date for the Company’s Convertible Notes (as defined below). Indebtedness under the Barings Credit Facility incurs interest based on the Secured Overnight Financing Rate (“SOFR”), subject to a minimum 1.50% floor, plus 6.75%. The Company is obligated to make interest payments on its indebtedness under the Barings Credit Facility on a monthly basis, commencing on the Closing Date; to pay annual administration fees; and to pay, on the maturity date, any principal and accrued interest that remains outstanding as of such date. In addition, the Company is obligated to pay a fee in an amount equal to the Total Credit Facility Amount, which amount shall be reduced by the total amount of interest and principal prepayment fees paid under the Barings Credit Agreement (such fee, the “Barings Royalty Fee”). The Company is required to pay the Barings Royalty Fee in installments to Barings, for the benefit of the lenders, on a quarterly basis in an amount equal to three and one-half percent (3.5%) of the net sales of DEXTENZA occurring during such quarter, subject to the terms, conditions and limitations specified in the Barings Credit Agreement, until the Barings Royalty Fee is paid in full. The Barings Royalty Fee is due and payable upon a change of control of the Company. The Company may, at its option, prepay any or all of the Barings Royalty Fee at any time without penalty. In connection with the Barings Credit Agreement, the Company granted the lenders thereto a first-priority security interest in all assets of the Company, including its intellectual property, subject to certain agreed-upon exceptions. The Barings Credit Agreement includes a negative covenant requiring the Company to maintain a minimum liquidity amount of $20,000. The Barings Credit Agreement also includes customary affirmative and negative covenants.

The Company determined that the embedded obligation to pay the Barings Royalty Fee (the “Barings Royalty Fee Obligation”) is required to be separated from the Barings Credit Facility and accounted for as a freestanding derivative instrument subject to derivative accounting. The allocation of proceeds to the Barings Royalty Fee Obligation resulted in a discount on the Barings Credit Facility. The Company is amortizing the discount to interest expense over the term of the Barings Credit Facility using the effective interest method. Accrued or paid Barings Royalty Fees are included in the change in fair value of derivative liabilities on the consolidated statements of operations and comprehensive loss (Note 9).

A summary of the Barings Credit Facility at September 30, 2024 and December 31, 2023 is as follows:


	September 30,		December 31,
	2024		2023
Barings Credit Facility	$	82,474		82,474
Less: unamortized discount		(14,659)		(16,687)
Total	$	67,815		65,787

As of September 30, 2024, the full principal for the Barings Credit Facility of $82,474 was due for repayment in 2029.

Convertible Notes

On March 1, 2019, the Company issued $37,500 of convertible notes, which accrued interest at an annual rate of 6% of their outstanding principal amount which was payable, along with the principal amount, at maturity unless earlier converted, repurchased or redeemed (as amended the “Convertible Notes”). The terms and conditions of the Convertible Notes are described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 11, 2024.

The Company has determined that the embedded conversion option was required to be separated from the Convertible Notes and has accounted for the embedded conversion option as a freestanding derivative instrument subject to derivative accounting (the “Conversion Option Derivative Liability”).

On March 28, 2024, the Company issued 5,769,232 shares of its common stock with a total fair value of $52,499 (Note 10) to the holder of the Convertible Notes in connection with the conversion of the principal amount of the Convertible Notes (the “Conversion”) and paid the holder $11,361 for accrued interest. The extinguishment of obligations under the Convertible Notes and the resulting derecognition of the principal of the Convertible Notes ($37,500), the unamortized discount ($27,950), and the Conversion Option Derivative Liability ($15,000), resulted in a net loss of $27,950, which was charged to losses on extinguishment of debt on the unaudited condensed consolidated statements of operations and comprehensive loss for the nine months ended September 30, 2024.

Concurrently with entering into the Barings Credit Agreement, on August 2, 2023, the Company and the holders of the Convertible Notes extended the maturity of the Convertible Notes, which would otherwise have matured on March 1, 2026, to a date 91 days following the maturity of the indebtedness under the Barings Credit Facility, unless earlier converted, repurchased or redeemed (the “Amendment”). The Company accounted for the Amendment as an extinguishment of debt in accordance with the guidance in Accounting Standards Codification Topic 470-50 Debt (“ASC 470-50”). Details of the accounting for the Amendment are described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 11, 2024. Application of ASC 470-50 resulted in a gain on extinguishment of debt of $14,907, which was charged to gains and losses on extinguishment of debt, net, on the consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2023.

MidCap Credit Agreement

The Company entered into a credit and security agreement in 2014 (as amended, the “MidCap Credit Agreement”) establishing a credit facility (the “MidCap Credit Facility”). The terms and conditions of the MidCap Credit Agreement and the MidCap Credit Facility are described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 11, 2024. In connection with entering into the Barings Credit Facility, in August 2023 the Company paid MidCap Financial Trust, as administrative agent, and its other lenders an aggregate of

$26,157 in satisfaction of the Company’s obligations under the MidCap Credit Facility. In connection with its satisfaction of its obligations, the Company extinguished the MidCap Credit Facility, and all liens and security interests securing the indebtedness under the MidCap Credit Agreement were released. The extinguishment of the MidCap Credit Facility resulted in a loss of $717, which was charged to gains and losses on extinguishment of debt, net, on the consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2023.

In March 2023, the Company requested, and received, a protective advance of $2,000 under the MidCap Credit Agreement as a short-term bridge loan in response to the closure of Silicon Valley Bank by the California Department of Financial Protection and Innovation. This protective advance was deemed a credit extension. The Company repaid the full principal amount of $2,000 in March 2023.

- Definition

The entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481544/470-10-50-6

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481544/470-10-50-6

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 405
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477092/405-40-50-1

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 405
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)(3)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477092/405-40-50-1

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 405
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)(2)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477092/405-40-50-1

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 405
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)(1)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477092/405-40-50-1

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 405
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477092/405-40-50-1

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Subparagraph (h)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1B

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(c))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480678/235-10-S99-1

Reference 10: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 470
-Name Accounting Standards Codification
-Publisher FASB
-URI https://asc.fasb.org/470/tableOfContent

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 835
-SubTopic 30
-Name Accounting Standards Codification
-Section 45
-Paragraph 2
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482925/835-30-45-2

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1B

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Subparagraph (g)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1B

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Subparagraph (i)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1B

Reference 15: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1C
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1C

Reference 16: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1C
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1C

Reference 17: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1C
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1C

Reference 18: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1E
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1E

Reference 19: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1I
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1I

Reference 20: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1I
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1I

Reference 21: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1I
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1I

+ Details

Stock-Based Awards - Stock-Based Compensation (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Stock-Based Awards
Stock-based compensation expense	$ 6,641	$ 4,512	$ 25,912	$ 13,497
Stock based compensation expense, accelerated cost			7,493
Unrecognized stock-based compensation cost	45,049		$ 45,049
Weighted average period of unrecognized stock-based compensation cost expected to be recognized			2 years 9 months
Research and development expense
Stock-Based Awards
Stock-based compensation expense	2,796	1,115	$ 6,595	3,390
Selling and marketing expense
Stock-Based Awards
Stock-based compensation expense	787	934	2,313	2,948
General and administrative expense
Stock-Based Awards
Stock-based compensation expense	$ 3,058	$ 2,463	$ 17,004	$ 7,159

Licensing Agreements and Deferred Revenue (Tables)

9 Months Ended

Sep. 30, 2024

Licensing Agreements and Deferred Revenue

Schedule of deferred revenue



	Deferred Revenue
Deferred revenue at December 31, 2023	$	14,390
Amounts recognized into revenue		(200)
Deferred revenue at September 30, 2024	$	14,190

Expenses - Restructuring (Details) $ in Thousands		3 Months Ended
Expenses - Restructuring (Details) $ in Thousands	May 29, 2024 employee	Sep. 30, 2024 USD ($)	Jun. 30, 2024 USD ($)
Expenses
Restructuring and Related Cost, Number of Positions Eliminated \| employee	37
Restructuring and Related Cost, Number of Positions Eliminated, Period Percent	13.00%
Restructuring Roll-Forward
Accrued restructuring costs at beginning of period		$ 1,206
Restructuring costs incurred during the period			$ 1,601
Restructuring Charges, Statement of Income or Comprehensive Income [Extensible Enumeration]			General and Administrative Expense.
Restructuring costs paid during the period		$ (1,206)	$ (395)
Accrued restructuring costs at end or period			$ 1,206

Expenses - Accrued Expenses (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Expenses
Accrued payroll and related expenses	$ 11,106	$ 8,156
Accrued research and development expenses	8,047	1,488
Accrued rebates and programs	5,658	5,117
Accrued professional fees	3,139	691
Accrued interest payable on Barings Credit Facility (Note 7)	710	803
Accrued other	1,791	1,525
Accrued interest payable on Convertible Notes (Note 7)		10,886
Total	$ 30,451	$ 28,666

Summary of Significant Accounting Policies

9 Months Ended

Sep. 30, 2024

Summary of Significant Accounting Policies

Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). The significant accounting policies used in preparation of these unaudited condensed consolidated financial statements are consistent with those described in Note 2 - Summary of Significant Accounting Policies in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 11, 2024. The following information updates, and should be read in conjunction with, the significant accounting policies described in Note 2 - Summary of Significant Accounting Policies in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 11, 2024.

Warrants

The Company accounts for issued warrants, including pre-funded warrants, as either liability or equity. Warrants are considered liabilities if they are mandatorily redeemable and they require settlement in cash or other assets, or a variable number of shares. Contracts that may require settlement for cash are liabilities, regardless of the probability of the occurrence of the triggering event. If warrants do not otherwise require liability classification, the Company assesses whether the warrants are indexed to its common stock. Liability-classified warrants are measured at fair value on the issuance date and at the end of each reporting period. Any change in the fair value of the warrants after the issuance date is recorded in the consolidated statements of operations as a gain or loss. Equity-classified warrants are accounted for at fair value on the issuance date with no changes in fair value recognized after the issuance date.

Use of Estimates

The preparation of these unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of these unaudited condensed consolidated financial statements, and the reported amounts of revenues and expenses during the reporting periods. Significant estimates and assumptions reflected in these unaudited condensed consolidated financial statements include, but are not limited to, the measurement and recognition of reserves for variable consideration related to product sales, revenue recognition related to a collaboration agreement that contains multiple promises, the fair value of derivatives, stock-based compensation, and realizability of net deferred tax assets. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from the Company’s estimates.

Unaudited Interim Financial Information

The balance sheet at December 31, 2023 was derived from the Company’s audited consolidated financial statements but does not include all disclosures required by GAAP. The accompanying unaudited condensed consolidated financial statements as of September 30, 2024 and for the three and nine months ended September 30, 2024 and 2023 have been prepared by the Company, pursuant to the rules and regulations of the SEC for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. However, the Company believes that the disclosures are adequate to make the information presented not misleading. These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements and the notes thereto for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 11, 2024. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s financial position as of September 30, 2024, the results of operations for the three and nine months ended September 30, 2024 and 2023, and cash flows for the nine months ended September 30, 2024 and 2023 have been made. The results of operations for the three and nine months ended September 30, 2024 and 2023 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2024.

Recently Issued Accounting Pronouncements

In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2023-07 Segment Reporting - Improvements to Reportable Segment Disclosures. The amendments require disclosure of incremental segment information on an annual and interim basis. The amendments also require companies with a single reportable segment to provide all disclosures required by this amendment and all existing segment disclosures in Accounting Standards Codification Topic 280 Segment Reporting. The amendments are effective for fiscal years beginning after December 15, 2023, and interim periods beginning after December 15, 2024. The Company does not expect the adoption of the amendments to have a significant impact on its consolidated financial statements.

In December 2023, the FASB issued ASU No. 2023-09 Income Taxes - Improvements to Income Tax Disclosures. The amendments require (i) enhanced disclosures in connection with an entity's effective tax rate reconciliation and (ii) income taxes paid disaggregated by jurisdiction. The amendments are effective for annual periods beginning after December 15, 2024. The Company does not expect the adoption of the amendments to have a significant impact on its consolidated financial statements.

In November 2024, the FASB issued ASU No. 2024-03 Disaggregation of Income Statement Expenses. The new standard requires disclosures about specific types of expenses included in the expense captions presented on the face of the income statement as well as disclosures about selling expenses and is effective for annual reporting periods beginning after December 15, 2026 and interim reporting periods beginning after December 15, 2027. The Company does not expect the adoption of the amendments to have a significant impact on its consolidated financial statements.

Summary of Significant Accounting Policies (Policies)	9 Months Ended
Summary of Significant Accounting Policies (Policies)	Sep. 30, 2024
Summary of Significant Accounting Policies
Basis of Presentation	Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). The significant accounting policies used in preparation of these unaudited condensed consolidated financial statements are consistent with those described in Note 2 - Summary of Significant Accounting Policies in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 11, 2024. The following information updates, and should be read in conjunction with, the significant accounting policies described in Note 2 - Summary of Significant Accounting Policies in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 11, 2024.
Warrants	Warrants The Company accounts for issued warrants, including pre-funded warrants, as either liability or equity. Warrants are considered liabilities if they are mandatorily redeemable and they require settlement in cash or other assets, or a variable number of shares. Contracts that may require settlement for cash are liabilities, regardless of the probability of the occurrence of the triggering event. If warrants do not otherwise require liability classification, the Company assesses whether the warrants are indexed to its common stock. Liability-classified warrants are measured at fair value on the issuance date and at the end of each reporting period. Any change in the fair value of the warrants after the issuance date is recorded in the consolidated statements of operations as a gain or loss. Equity-classified warrants are accounted for at fair value on the issuance date with no changes in fair value recognized after the issuance date.
Use of Estimates	Use of Estimates The preparation of these unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of these unaudited condensed consolidated financial statements, and the reported amounts of revenues and expenses during the reporting periods. Significant estimates and assumptions reflected in these unaudited condensed consolidated financial statements include, but are not limited to, the measurement and recognition of reserves for variable consideration related to product sales, revenue recognition related to a collaboration agreement that contains multiple promises, the fair value of derivatives, stock-based compensation, and realizability of net deferred tax assets. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from the Company’s estimates.
Unaudited Interim Financial Information	Unaudited Interim Financial Information The balance sheet at December 31, 2023 was derived from the Company’s audited consolidated financial statements but does not include all disclosures required by GAAP. The accompanying unaudited condensed consolidated financial statements as of September 30, 2024 and for the three and nine months ended September 30, 2024 and 2023 have been prepared by the Company, pursuant to the rules and regulations of the SEC for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. However, the Company believes that the disclosures are adequate to make the information presented not misleading. These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements and the notes thereto for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 11, 2024. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s financial position as of September 30, 2024, the results of operations for the three and nine months ended September 30, 2024 and 2023, and cash flows for the nine months ended September 30, 2024 and 2023 have been made. The results of operations for the three and nine months ended September 30, 2024 and 2023 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2024.
Recently Issued Accounting Pronouncements	Recently Issued Accounting Pronouncements In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2023-07 Segment Reporting - Improvements to Reportable Segment Disclosures. The amendments require disclosure of incremental segment information on an annual and interim basis. The amendments also require companies with a single reportable segment to provide all disclosures required by this amendment and all existing segment disclosures in Accounting Standards Codification Topic 280 Segment Reporting. The amendments are effective for fiscal years beginning after December 15, 2023, and interim periods beginning after December 15, 2024. The Company does not expect the adoption of the amendments to have a significant impact on its consolidated financial statements. In December 2023, the FASB issued ASU No. 2023-09 Income Taxes - Improvements to Income Tax Disclosures. The amendments require (i) enhanced disclosures in connection with an entity's effective tax rate reconciliation and (ii) income taxes paid disaggregated by jurisdiction. The amendments are effective for annual periods beginning after December 15, 2024. The Company does not expect the adoption of the amendments to have a significant impact on its consolidated financial statements. In November 2024, the FASB issued ASU No. 2024-03 Disaggregation of Income Statement Expenses. The new standard requires disclosures about specific types of expenses included in the expense captions presented on the face of the income statement as well as disclosures about selling expenses and is effective for annual reporting periods beginning after December 15, 2026 and interim reporting periods beginning after December 15, 2027. The Company does not expect the adoption of the amendments to have a significant impact on its consolidated financial statements.

Net Loss Per Share

9 Months Ended

Sep. 30, 2024

Net Loss Per Share

Net Loss Per Share

13. Net Loss Per Share

Basic net loss per share was calculated as follows for the three and nine months ended September 30, 2024 and 2023:


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2024		2023		2024		2023
Numerator:
Net loss attributable to common stockholders	$	(36,493)	$	(516)	$	(145,118)	$	(51,516)
Denominator:
Weighted average common shares outstanding, basic		166,992,735		79,373,272		154,990,112		78,276,341
Net loss per share - basic	$	(0.22)	$	(0.01)	$	(0.94)	$	(0.66)

Diluted net loss per share was calculated as follows for the three months ended September 30, 2023 and the nine months ended September 30, 2023:


	Three Months Ended		Nine Months Ended
	September 30,		September 30,
		2023		2023
Net loss attributable to common stockholders, basic	$	(516)	$	(51,516)
Interest expense on Convertible Notes		1,004		3,232
Change in fair value of derivative liability and gains on extinguishment of debt		(22,051)		(16,619)
Net loss attributable to common stockholders, diluted	$	(21,563)	$	(64,903)

Weighted average common shares outstanding, basic		79,373,272		78,276,341
Shares issuable in connection with conversion of Convertible Notes, as if converted		5,769,232		5,769,232
Weighted average common shares outstanding, diluted		85,142,504		84,045,573

Net loss per share attributable to common stockholders, diluted	$	(0.25)	$	(0.77)

For the three and nine months ended September 30, 2024, respectively, there was no dilutive impact from potentially issuable common shares. Therefore, diluted net loss per share was the same as basic net loss per share. As of September 30, 2024, the Pre-Funded Warrants (Note 10) are included in the calculation of basic and diluted net loss per share.

The Company excluded the following potentially issuable common shares, outstanding as of September 30, 2024 and 2023, respectively, from the computation of diluted net loss per share for the three and nine months ended September 30, 2024 and 2023, respectively, because they had an anti-dilutive impact.


	Three Months Ended September 30,		Nine Months Ended September 30,
	2024	2023	2024	2023
Options to purchase common stock	19,784,690	16,306,543	19,784,690	16,306,543
Restricted stock units	3,015,829	1,653,363	3,015,829	1,653,363
	22,800,519	17,959,906	22,800,519	17,959,906

Expenses (Tables)

9 Months Ended

Sep. 30, 2024

Expenses

Schedule of restructuring costs


	As of
Accrued restructuring costs at March 31, 2024		—
Restructuring costs incurred during the period		1,601
Restructuring costs paid during the period		(395)
Accrued restructuring costs at June 30, 2024		1,206
Restructuring costs paid during the period		(1,206)
Accrued restructuring costs at September 30, 2024		—

Schedule of accrued expenses


	September 30,		December 31,
	2024		2023
Accrued payroll and related expenses		11,106		8,156
Accrued research and development expenses	$	8,047	$	1,488
Accrued rebates and programs		5,658		5,117
Accrued professional fees		3,139		691
Accrued interest payable on Barings Credit Facility (Note 7)		710		803
Accrued other		1,791		1,525
Accrued interest payable on Convertible Notes (Note 7)		—		10,886
	$	30,451	$	28,666

Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Cash flows from operating activities:
Net loss	$ (145,118)	$ (51,516)
Adjustments to reconcile net loss to net cash used in operating activities
Stock-based compensation expense	25,912	13,497
Non-cash interest expense	3,158	4,553
Change in fair value of derivative liabilities	1,103	(1,290)
Depreciation and amortization expense	2,835	2,025
(Gains) and losses on extinguishment of debt, net	27,950	(14,190)
Gain on disposal of property and equipment		(1)
Changes in operating assets and liabilities:
Accounts receivable	(4,056)	(2,264)
Prepaid expenses and other current assets	(5,357)	(834)
Inventory	(100)	(283)
Accounts payable	(430)	(73)
Operating lease assets	778	1,174
Accrued expenses	(568)	2,019
Deferred revenue	(200)	551
Operating lease liabilities	(1,155)	(1,148)
Net cash used in operating activities	(95,248)	(47,780)
Cash flows from investing activities:
Purchases of property and equipment	(1,086)	(5,628)
Net cash used in investing activities	(1,086)	(5,628)
Cash flows from financing activities:
Proceeds from issuance of short-term bridge loan		2,000
Proceeds from issuance of Barings notes payable		82,474
Proceeds from exercise of stock options	10,752	543
Proceeds from issuance of common stock pursuant to employee stock purchase plan	492	418
Payments of debt refinancing costs		(5,184)
Proceeds from issuance of common stock upon public offering, net of issuance costs		9,532
Repayment of MidCap notes payable		(26,125)
Repayment from issuance of short-term bridge loan		(2,000)
Proceeds from issuance of common stock and pre-funded warrants upon private placement, net of issuance costs	316,353
Net cash provided by financing activities	327,597	61,658
Net increase in cash, cash equivalents and restricted cash	231,263	8,250
Cash, cash equivalents and restricted cash at beginning of period	197,571	104,064
Cash, cash equivalents and restricted cash at end of period	428,834	112,314
Supplemental disclosure of cash flow information:
Cash paid for interest	18,198	2,865
Supplemental disclosure of non-cash investing and financing activities:
Additions to property and equipment included in accounts payable and accrued expenses	$ 76	$ 267

Cash Equivalents and Restricted Cash

9 Months Ended

Sep. 30, 2024

Cash Equivalents and Restricted Cash

Cash Equivalents and Restricted Cash

4. Cash Equivalents and Restricted Cash

The Company’s unaudited condensed consolidated statements of cash flows include restricted cash with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on such statements. A reconciliation of the cash, cash equivalents, and restricted cash reported within the balance sheets that sum to the total of the same amounts shown in the unaudited condensed consolidated statement of cash flows is as follows:


	September 30,		September 30,
	2024		2023
Cash and cash equivalents	$	427,220	$	110,550
Restricted cash (non-current)		1,614		1,764
Total cash, cash equivalents and restricted cash as shown on the statements of cash flows	$	428,834	$	112,314

The Company held restricted cash as security deposits for its real estate leases.

Stock-Based Awards

9 Months Ended

Sep. 30, 2024

Stock-Based Awards

Stock-Based Awards

11. Stock-Based Awards

For the three and nine months ended September 30, 2024, the Company had three stock-based compensation plans under which it was able to grant stock-based awards, the 2021 Stock Incentive Plan, as amended (the “2021 Plan”), the

2019 Inducement Stock Incentive Plan, as amended (the “2019 Inducement Plan”), and the 2014 Employee Stock Purchase Plan (the “ESPP”) (collectively, the “Stock Plans”). The 2021 Plan and the 2019 Inducement Plan provide for the grant of non-statutory stock options, restricted stock awards, restricted stock units (“RSUs”), stock appreciation rights and other stock-based awards. The 2021 Plan also provides for the grant of incentive stock options.

The terms and conditions of the Stock Plans are described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 11, 2024. Subsequent updates to Stock Plans during the three and nine months ended September 30, 2024 are as follows:

2021 Plan - On June 12, 2024, the Company’s shareholders approved an amendment of the 2021 Plan to increase the aggregate number of shares issuable thereunder by 7,000,000.

2019 Inducement Plan - On February 20, 2024, the Company’s board of directors amended the 2019 Inducement Plan to increase the aggregate number of shares issuable thereunder from 1,054,000 to 3,804,000 shares of common stock. On April 16, 2024, the board of directors of the Company further amended the 2019 Inducement Plan to increase the aggregate number of shares issuable thereunder from 3,804,000 to 4,804,000 shares of common stock.

ESPP - On January 1, 2024, the number of shares available for issuance under the ESPP increased from 398,784 to 606,186.

As of September 30, 2024, 8,806,487, 258,481, and 485,380 shares of common stock remained available for issuance under the 2021 Plan, the 2019 Inducement Plan, and the ESPP, respectively.

Stock options and RSUs

During the three and nine months ended September 30, 2024, the Company granted options to purchase 847,287 and 7,675,358 shares of common stock, respectively, at a weighted exercise price of $8.05 and $7.22 per share, respectively. Of these, options to purchase 532,087 and 4,860,714 shares of common stock, respectively, were granted under the 2021 Plan, and options to purchase 315,200 and 2,814,644 shares of common stock, respectively, were granted under the 2019 Inducement Plan.

During the three and nine months ended September 30, 2024, the Company granted 359,410 and 2,971,167 RSUs, respectively. Of these, 254,346 and 1,610,117 RSUs, respectively, were granted under the 2021 Plan, and 105,064 and 1,361,050 RSUs, respectively, were granted under the 2019 Inducement Plan. Each RSU is settleable for one share of common stock upon vesting.

During the three and nine months ended September 30, 2024, 795,230 and 1,835,491 stock options, respectively, and 159,658 and 426,500 RSUs, respectively, expired or were forfeited.

Stock-based Compensation

The Company recorded stock-based compensation expense related to stock options and RSUs in the following expense categories of its unaudited condensed consolidated statements of operations and comprehensive loss:


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2024		2023		2024		2023
Research and development	$	2,796	$	1,115	$	6,595	$	3,390
Selling and marketing		787		934		2,313		2,948
General and administrative		3,058		2,463		17,004		7,159
	$	6,641	$	4,512	$	25,912	$	13,497

During the nine months ended September 30, 2024 vesting of certain stock options and RSUs granted to two former executives of the Company was accelerated upon their departures from the Company, resulting in incremental stock-based compensation expense of $7,493.

As of September 30, 2024, the Company had an aggregate of $45,049 of unrecognized stock-based compensation cost, which is expected to be recognized over a weighted average period of 2.75 years.

Inventory

9 Months Ended

Sep. 30, 2024

Inventory

Inventory

5. Inventory

Inventory consisted of the following:


	September 30,		December 31,
	2024		2023
Raw materials	$	196	$	302
Work-in-process		1,400		1,012
Finished goods		809		991
	$	2,405	$	2,305