0000950170-22-024465 | 10-Q | XBRL Viewer | Amylyx Pharmaceuticals INC

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Convertible Notes - Additional Information (Details) - USD ($)		1 Months Ended		2 Months Ended	9 Months Ended
	Jul. 31, 2021	Jan. 31, 2021	Dec. 31, 2020	Feb. 28, 2021	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021
Debt Instrument [Line Items]
Change in fair value of convertible notes						$ 5,228,000
Preferred Shares Issued							37,107,459
Series C-2 Redeemable Convertible Preferred Shares
Debt Instrument [Line Items]
Preferred Shares Issued					0		3,170,585
2021 Notes
Debt Instrument [Line Items]
Aggregate convertible notes issued		$ 27,300,000
Notes mature date		Jun. 30, 2022
Notes secured and carried interest rate		3.00%
Debt instrument, description					The Company recorded the $1.2 million of proceeds received in December 2020 as proceeds received in advance of issuance of 2021 Notes in the consolidated balance sheet as of December 31, 2020, as the subscription agreement and commitment to issue the 2021 Notes was not effective until January 2021.
Percentage of price offered to each share of common stock		85.00%
Diluted capital dividend		$ 600,000,000.0
Change in fair value of convertible notes						$ 5,200,000
Debt instrument, inception date		Sep. 30, 2021
Convertible debt outstanding		$ 14,300,000			$ 0		$ 0
Convertible notes payable to related party					$ 0		$ 0
Convertible notes settlement date		2021-07
2021 Notes \| Series C Preferred Stock
Debt Instrument [Line Items]
Preferred stock conversion price per share	$ 10.265809
2021 Notes \| Series C-2 Redeemable Convertible Preferred Shares
Debt Instrument [Line Items]
Preferred stock conversion price per share	$ 8.725938
Change in fair value of convertible notes	$ 5,200,000
Preferred Shares Issued	3,170,585
2021 Notes \| Maximum
Debt Instrument [Line Items]
Proceeds from sale of equity		$ 10,000,000.0
2021 Notes \| Special Purpose acquisition Corp \| Maximum
Debt Instrument [Line Items]
Percentage of voting securities		50.00%
2021 Notes in December 2020
Debt Instrument [Line Items]
Proceeds received in advance			$ 1,200,000
2021 Notes in January and February 2021
Debt Instrument [Line Items]
Proceeds received in advance				$ 26,100,000

Redeemable Convertible Preferred Stock - Schedule of Redeemable Convertible Preferred Stock (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021	Sep. 30, 2021	Jul. 31, 2021	Jul. 01, 2021	Jun. 30, 2021	Mar. 31, 2021	Dec. 31, 2020
Temporary Equity [Line Items]
Preferred Shares Authorized		37,710,624
Preferred Shares Issued		37,107,459
Preferred Shares Outstanding	0	37,107,459
Carrying Value		$ 239,351
Temporary equity, liquidation preference		$ 416,466
Common Stock Issuable Upon Conversion		39,474,330
Series A Redeemable Convertible Preferred Share
Temporary Equity [Line Items]
Preferred Shares Authorized	0	6,289,609
Preferred Shares Issued	0	6,289,609
Preferred Shares Outstanding	0	6,289,609	6,289,609			6,289,609	6,289,609	6,289,609
Carrying Value		$ 7,675	$ 7,675			$ 7,675	$ 7,675	$ 7,675
Temporary equity, liquidation preference		$ 7,730
Common Stock Issuable Upon Conversion		6,407,256
Series B Redeemable Convertible Preferred Shares
Temporary Equity [Line Items]
Preferred Shares Authorized	0	15,100,000
Preferred Shares Issued	0	14,496,835
Preferred Shares Outstanding	0	14,496,835	14,496,835			14,496,835	14,496,835	14,496,835
Carrying Value		$ 64,387	$ 64,387			$ 64,387	$ 64,387	$ 64,387
Temporary equity, liquidation preference		$ 246,070
Common Stock Issuable Upon Conversion		16,746,059
Series C-1 Redeemable Convertible Preferred Shares
Temporary Equity [Line Items]
Preferred Shares Authorized	0	13,150,430			13,150,430
Preferred Shares Issued	0	13,150,430		13,150,430
Preferred Shares Outstanding	0	13,150,430	13,150,430
Carrying Value		$ 134,791	$ 134,791
Temporary equity, liquidation preference		$ 135,000
Common Stock Issuable Upon Conversion		13,150,430
Series C-2 Redeemable Convertible Preferred Shares
Temporary Equity [Line Items]
Preferred Shares Authorized	0	3,170,585			3,170,585
Preferred Shares Issued	0	3,170,585
Preferred Shares Outstanding	0	3,170,585	3,170,585
Carrying Value		$ 32,498	$ 32,498
Temporary equity, liquidation preference		$ 27,666
Common Stock Issuable Upon Conversion		3,170,585

Stock Option and Grant Plan - Summary of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended	9 Months Ended		12 Months Ended
	Jun. 30, 2022	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021
Share-Based Payment Arrangement [Abstract]
Number of Options, Outstanding		5,339,011
Number of Options, Granted		3,968,720
Number of Options, Exercised	(669,040)	(669,040)
Number of Options, Cancelled or forfeited		(63,242)
Number of Options, Outstanding		8,575,449		5,339,011
Number of Options, Options exercisable		1,792,734
Number of Options, Options unvested		6,782,715
Weighted average grant-date fair value of options granted during the period		$ 14.32
Weighted-Average Exercise Price, Outstanding		5.54
Weighted-Average Exercise Price, Granted		19.22
Weighted-Average Exercise Price, Exercised		0.37
Weighted-Average Exercise Price, Cancelled or forfeited		13.28
Weighted-Average Exercise Price, Outstanding		12.22		$ 5.54
Weighted-Average Exercise Price, Options exercisable		5.13
Weighted-Average Exercise Price, Options unvested		$ 14.10
Weighted- Average Remaining Contractual Term (in years), Outstanding		8 years 4 months 24 days		8 years 8 months 12 days
Weighted- Average Remaining Contractual Term (in years), Options exercisable		7 years
Weighted- Average Remaining Contractual Term (in years), Options unvested		8 years 9 months 18 days
Aggregate Intrinsic Value, Outstanding		$ 15,627
Aggregate intrinsic value, exercised		5,961	$ 4,500
Aggregate Intrinsic Value, Outstanding		137,204		$ 15,627
Aggregate Intrinsic Value, Options exercisable		41,265
Aggregate Intrinsic Value, Options unvested		$ 95,939

Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Payables and Accruals [Abstract]
External research and development	$ 7,505	$ 5,666
Payroll and employee related expenses	8,994	4,280
Accrued consulting and other professional fees	6,750	2,820
Other accrued expenses	356	258
Total accrued expenses	$ 23,605	$ 13,024

Stockholders' Equity (Deficit) - Schedule of Common Stock Reserved for Future Issuance (Details) - shares	Sep. 30, 2022	Dec. 31, 2021
Class Of Stock [Line Items]
Common stock authorized	300,000,000	56,500,000
Common stock issued and outstanding	58,533,226	7,020,487
Total common stock authorized and reserved for future issuance	12,319,971	46,257,833
Unreserved common stock available for future issuance	229,146,803	3,221,680
Series A Redeemable Convertible Preferred Stock
Class Of Stock [Line Items]
Total common stock authorized and reserved for future issuance		6,407,256
Series B Redeemable Convertible Preferred Stock
Class Of Stock [Line Items]
Total common stock authorized and reserved for future issuance		16,746,059
Series C-1 Redeemable Convertible Preferred Stock
Class Of Stock [Line Items]
Total common stock authorized and reserved for future issuance		13,150,430
Series C-2 Redeemable Convertible Preferred Stock
Class Of Stock [Line Items]
Total common stock authorized and reserved for future issuance		3,170,585
Common Stock Reserved for the Exercise of Stock Options
Class Of Stock [Line Items]
Total common stock authorized and reserved for future issuance	8,575,449	5,339,011
Common Stock Reserved for the Unvested Restricted Stock Units
Class Of Stock [Line Items]
Total common stock authorized and reserved for future issuance	687,913
Common Stock Reserved for Future Issuance of Share-based Awards
Class Of Stock [Line Items]
Total common stock authorized and reserved for future issuance	3,056,609	1,444,492

Redeemable Convertible Preferred Stock (Tables)

9 Months Ended

Sep. 30, 2022

Temporary Equity Disclosure [Abstract]

Schedule of Redeemable Convertible Preferred Stock

The Company’s redeemable convertible preferred stock consisted of the following:


	December 31, 2021
	(dollars in thousands)
	Preferred Shares Authorized		Preferred Shares Issued and Outstanding		Carrying Value		Liquidation Preference		Common Stock Issuable Upon Conversion
Series A preferred stock		6,289,609		6,289,609	$	7,675	$	7,730		6,407,256
Series B preferred stock		15,100,000		14,496,835	$	64,387	$	246,070		16,746,059
Series C-1 preferred stock		13,150,430		13,150,430	$	134,791	$	135,000		13,150,430
Series C-2 preferred stock		3,170,585		3,170,585	$	32,498	$	27,666		3,170,585
		37,710,624		37,107,459	$	239,351	$	416,466		39,474,330

Leases - Summary of Condensed Consolidated Balance Sheet of Operating Leases (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Jan. 10, 2022
Assets
Operating lease right-of-use assets	$ 5,951	$ 5,000
Liabilities
Operating lease right-of-use liabilities, current	1,990
Operating lease liabilities, net of current portion	4,768
Total operating lease liabilities	$ 6,758	$ 5,000

CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares	Sep. 30, 2022	Dec. 31, 2021
Temporary equity, shares authorized		37,710,624
Temporary equity, shares issued		37,107,459
Temporary equity, shares outstanding	0	37,107,459
Preferred stock par value	$ 0.0001	$ 0.0001
Preferred stock shares authorized	10,000,000	0
Preferred stock shares issued	0	0
Preferred stock shares outstanding	0	0
Common stock, stated par value per share	$ 0.0001	$ 0.0001
Common stock, shares authorized	300,000,000	56,500,000
Common stock, shares, issued	58,533,226	7,020,487
Common stock, shares, outstanding	58,533,226	7,020,487
Series A Redeemable Convertible Preferred Share
Temporary equity, par value	$ 0.0001	$ 0.0001
Temporary equity, shares authorized	0	6,289,609
Temporary equity, shares issued	0	6,289,609
Temporary equity, shares outstanding	0	6,289,609
Series B Redeemable Convertible Preferred Shares
Temporary equity, par value	$ 0.0001	$ 0.0001
Temporary equity, shares authorized	0	15,100,000
Temporary equity, shares issued	0	14,496,835
Temporary equity, shares outstanding	0	14,496,835
Series C-1 Redeemable Convertible Preferred Shares
Temporary equity, par value	$ 0.0001	$ 0.0001
Temporary equity, shares authorized	0	13,150,430
Temporary equity, shares issued	0	13,150,430
Temporary equity, shares outstanding	0	13,150,430
Series C-2 Redeemable Convertible Preferred Shares
Temporary equity, par value	$ 0.0001	$ 0.0001
Temporary equity, shares authorized	0	3,170,585
Temporary equity, shares issued	0	3,170,585
Temporary equity, shares outstanding	0	3,170,585

Commitments and Contingencies

9 Months Ended

Sep. 30, 2022

Commitments and Contingencies Disclosure [Abstract]

Commitments and Contingencies

13. Commitments and Contingencies

Lease Commitments

The Company has two operating lease agreements for its office space. See Note 5, Leases, to these notes to condensed consolidated financial statements for additional information.

Letter of Credit

Restricted cash consists of $0.2 million of cash serving as collateral for a letter of credit issued for the Company’s office space, and $0.5 million as collateral for a corporate credit card program. As of September 30, 2022 and December 31, 2021, the Company’s restricted cash balance was $0.7 million and $0.2 million on its condensed consolidated balance sheets, respectively.

Legal Proceedings

The Company is not currently a party to any material legal proceedings. At each reporting date, the Company evaluates whether or not a potential loss amount or potential range of loss is probable and reasonably estimated under the provisions of the authoritative guidance that addresses accounting for contingencies. The Company recognizes expenses for its costs related to its legal proceedings, as incurred.

Royalty Payments

Between August 2016 and February 2019, the Company entered into agreements with the Grantors. Under the terms of the agreements, the Company was granted, in aggregate, $4.3 million. These grants were provided to the Company for the purpose of furthering the research and development of AMX0035 as a therapeutic benefit for ALS disease and Alzheimer’s disease. Under the terms of the arrangements, the Company would receive a tranche of funds as it completes certain milestones. Pursuant to the terms of the grant agreements, the Company has certain payment obligations that are contingent upon future events such as the achievement of commercialization or the receipt of proceeds from a revenue generating transaction resulting from the projects for which the grants are used for.

Pursuant to the terms of the respective grant agreements among the Company, ALS Association and ALS Finding a Cure, the Company will be required to make royalty payments to each Grantor in the total amount equal to 150% of the grant received. The royalty payments will be achieved through a combination of the following payment methods: (i) an annual installment payment of 3% of net sales of any products developed under the project for which the grant was used for and (ii) 3% of cash proceeds resulting from revenue generating transaction under the project for which the grants are used for. During the three and nine months ended September 30, 2022, the Company recorded less than $0.1 million in royalty expense, which is included in cost of sales in the condensed consolidated financial statements.

Under the terms of the respective grant agreements among the Company, Alzheimer’s Drug Discovery Foundation, the Alzheimer’s Association, and Cure Alzheimer’s Fund, the Company will make royalty payments up to the maximum amount of $15.0 million to each Grantor (or $45.0 million in aggregate). The royalty payment will be made through a combination of the following payment methods: (i) 4% of annual net sales of any product commercialized from the project for which the grant was used for and directly related to the treatment of the Alzheimer’s disease and (ii) 15% of all royalties and cash proceeds resulting from revenue generating transactions associated with the projects for which the grants were used for under the grant agreements. As the conditions that would trigger royalty payments under the agreements have not occurred, no amounts have been recorded in the condensed consolidated financial statements for the three and nine months ended September 30, 2022.

Leases- Additional Information (Details) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2022	Jan. 10, 2022
Leases [Abstract]
Operating lease, description	The Company entered into a new office space lease at 121 First Street in Cambridge, Massachusetts on January 10, 2022, for 36 months, with an option to extend the lease for 3 years.
Operating lease, term of contract		36 months
Operating lease, renewal term		3 years
Operating lease right-of-use assets	$ 5,951	$ 5,000
Operating lease liability	6,758	$ 5,000
Operating lease, cash payments	$ 800
Weighted-average remaining lease term (years)	3 years 2 months 12 days
Weighted average incremental borrowing rate	7.30%

Inventory (Tables)

9 Months Ended

Sep. 30, 2022

Inventory Disclosure [Abstract]

Summary of Inventory

Inventory consisted of the following:


	September 30, 2022		December 31, 2021
	(in thousands)
Raw materials	$	408	$	—
Work in process		45		—
Finished goods		110		—
Total inventories	$	563	$	—

Commitment and Contingencies - Additional Information (Details)	3 Months Ended	9 Months Ended	31 Months Ended
	Sep. 30, 2022 USD ($)	Sep. 30, 2022 USD ($) LeaseAgreement	Feb. 28, 2019 USD ($)	Dec. 31, 2021 USD ($)
Commitments And Contingencies [Line Items]
Number of operating lease agreements \| LeaseAgreement		2
Restricted cash	$ 719,000	$ 719,000		$ 189,000
ALS Association and ALS Finding a Cure \| Maximum \| Cost of Sales
Commitments And Contingencies [Line Items]
Royalty expense	100,000	100,000
Royalty Payments Agreements with Grantors
Commitments And Contingencies [Line Items]
Proceeds from grants			$ 4,300,000
Royalty Payments Agreements with Grantors \| ALS Association and ALS Finding a Cure
Commitments And Contingencies [Line Items]
Percentage of grant received			150.00%
Percentage of net sales of products developed under projects			3.00%
Percentage of cash proceeds from revenue generating transaction			3.00%
Royalty Payments Agreements with Grantors \| Alzheimer's Drug Discovery Foundation, the Alzheimer's Association, and Cure Alzheimer's Fund
Commitments And Contingencies [Line Items]
Maximum Royalty amount payable to each grantor			$ 15,000,000.0
Aggregate royalty amount payable to grantor			$ 45,000,000.0
Percentage of annual net sales of products commercialized from project			4.00%
Percentage of all royalties and cash proceeds from revenue generating transaction			15.00%
Collateral for Letter of Credit Issued
Commitments And Contingencies [Line Items]
Restricted cash	200,000	200,000
Collateral for Corporate Credit Card Program
Commitments And Contingencies [Line Items]
Restricted cash	$ 500,000	$ 500,000

Redeemable Convertible Preferred Stock

9 Months Ended

Sep. 30, 2022

Temporary Equity Disclosure [Abstract]

Redeemable Convertible Preferred Stock

8. Redeemable Convertible Preferred Stock

On July 1, 2021, the Company amended its certificate of incorporation in which it authorized 13,150,430 shares of Series C-1 redeemable convertible preferred stock and 3,170,585 shares of Series C-2 redeemable convertible preferred stock.

In July 2021, the Company consummated a financing transaction in which it issued 13,150,430 shares of Series C-1 redeemable convertible preferred stock. In connection with the issuance of these shares, the principal including accrued interest of the 2021 Notes totaling $27.7 million automatically converted into 3,170,585 shares of Series C-2 redeemable convertible preferred stock.

The Company’s redeemable convertible preferred stock consisted of the following:


	December 31, 2021
	(dollars in thousands)
	Preferred Shares Authorized		Preferred Shares Issued and Outstanding		Carrying Value		Liquidation Preference		Common Stock Issuable Upon Conversion
Series A preferred stock		6,289,609		6,289,609	$	7,675	$	7,730		6,407,256
Series B preferred stock		15,100,000		14,496,835	$	64,387	$	246,070		16,746,059
Series C-1 preferred stock		13,150,430		13,150,430	$	134,791	$	135,000		13,150,430
Series C-2 preferred stock		3,170,585		3,170,585	$	32,498	$	27,666		3,170,585
		37,710,624		37,107,459	$	239,351	$	416,466		39,474,330

As of December 31, 2021, the holders of the Series C Preferred Stock, or together with the Series A redeemable convertible preferred stock and the Series B redeemable convertible preferred stock, collectively, the Preferred Stock, have the following rights and preferences:

Conversion— On June 18, 2020, in connection with the conversion of the 2017 Notes, the Company adjusted the conversion price for the Series A redeemable convertible preferred stock of $1.229073 per share to $1.2065. The adjustment was made in

accordance with the anti-dilution provisions in the certificate of incorporation then in effect immediately prior to the conversion of the 2017 Notes. The adjustment to the conversion price resulted in neither modification nor extinguishment of the Series A redeemable convertible preferred stock as the terms of the Series A redeemable convertible preferred stock were not amended. The adjustment to the conversion price resulted in additional 117,650 shares of common stock to be issued to holders of the Series A redeemable convertible preferred stock upon conversion of such shares into common stock. As of December 31, 2020, these additional shares of common stock were not issued and outstanding.

In July 2021, in connection with the conversion of the 2021 Notes, the Company adjusted the conversion price for the Series B redeemable convertible preferred stock of $16.974077 per share to $14.6942. The adjustment was made in accordance with the anti-dilution provisions in the certificate of incorporation then in effect immediately prior to the conversion of the 2021 Notes. The adjustment to the conversion price resulted in additional 2,249,224 shares of common stock into which Series B redeemable convertible preferred stock would be convertible. As of December 31, 2021, these additional shares were not issued and outstanding. Each share of Preferred Stock is convertible into an equivalent number of common stock, at any time, at the option of the holder. The initial conversion price for the Series C-1 redeemable convertible preferred stock and Series C-2 redeemable convertible preferred stock is the respective original issue prices.

The conversion price for the Preferred Stock was subject to adjustments for stock splits, stock dividends, or similar recapitalization, and subject to adjustments in accordance with the anti-dilution provisions.

The shares of Preferred Stock were to automatically convert into common stock of the Company immediately upon either (a) the closing of the sale of shares of common stock to the public in a firm commitment underwritten public offering pursuant to an effective registration statement under the Securities Act, resulting in at least $75.0 million of proceeds, net of the underwriting discount and commissions, to the Company, or Qualified IPO, or (b) the date and time, or the occurrence of an event, specified by vote or written consent of the holders of a majority of the then outstanding shares of Preferred Stock.

Dividends—Dividends may be paid to the holders of the Series A redeemable convertible preferred stock. The holders the Series A redeemable convertible preferred stock are entitled to receive non-cumulative dividends at a rate per annum of $0.073744 per share when and if declared by the Board of Directors. The holders of the Series B redeemable convertible preferred stock were entitled to receive a non-cumulative dividend at the rate of 6% per annum of the Series B original issue price per share when and if declared by the Board of Directors. As of December 31, 2021, no cash dividends were declared or paid. From and after the date of issuance of the Series C Preferred Stock, the Company was not to set, declare, pay or set aside unless holders of the Series C Preferred Stock then outstanding shall first receive, or simultaneously receive, dividends on each outstanding share of Series C Preferred Stock in an amount equal to (i) in the case of dividends being distributed to common stock or any class or series of capital stock that is convertible into common stock, the equivalent dividend on an as-converted basis or (ii) in the case of dividends being distributed on a series or class not convertible into common stock, an additional dividend equal to a dividend rate calculated based on the respective original issue price of the Series C Preferred Stock. The original issue prices per share for the Series C-1 redeemable convertible preferred stock and Series C-2 redeemable convertible preferred stock were $10.265809 and $8.725938, respectively.

Voting Rights— The holders of the Preferred Stock were entitled to vote on any matter presented to stockholders of the Company for consideration. Each holder of the Preferred Stock was entitled to cast the number of votes equal to the number of shares of common stock into which the shares of the Preferred Stock held by such holder were convertible on such date.

Redemption—The Preferred Stock did not contain any mandatory redemption features. In accordance with FASB ASC Topic 480, Distinguishing Liabilities from Equity (ASC 480), preferred stock issued with redemption provisions that are outside of the control of the Company or that contain certain redemption rights in a deemed liquidation event is required to be presented outside of stockholders’ deficit on the face of the consolidated balance sheets. The Company classified the Preferred Stock outside of the stockholders’ deficit as mezzanine equity because in the event of certain deemed liquidation events, which included events such as a sale or merger, that were not solely within the control of the Company, the shares of the Preferred Stock would have become redeemable at the option of the holders. As of June 30, 2021, the Company did not adjust the carrying values of the Preferred Stock to the redemption values of such shares since a deemed liquidation event did not occur and the shares were not probable of becoming redeemable in the future as of the consolidated balance sheet dates.

Liquidation—In the event of a liquidation, deemed liquidation, dissolution or winding up of the Company, holders of the Preferred Stock would have been entitled to be paid out of the assets of the Company that were available for distribution before any payment is made to the holders of common stock. The amount to paid would have been the greater of (i) respective original issue prices plus any dividends declared but unpaid or (ii) the amount that would have been payable had all shares of Preferred Stock been converted into common stock immediately before such event. If upon any such liquidation, deemed liquidation, dissolution or winding up of the Company, the assets of the Company available for distribution to its stockholders would have been insufficient to pay the holders of Preferred Stock the full amount to which they would have been entitled, the holders of Preferred Stock would have shared

ratably in any distribution of the assets available for distribution in proportion to the respective amounts which would otherwise be payable in respect of the shares held by them upon such distribution if all amounts payable on or with respect to such shares were paid in full.

After the payment of all preferential amounts required to be paid to the holders of Preferred Stock, the remaining assets of the Company available for distribution to its stockholders would have been distributed among the holders of the shares of common stock on a pro rata basis based on the number of shares held by each such holder.

In January 2022, upon the completion of the initial public offering, all of the Company's outstanding shares of preferred stock were converted into shares of its common stock. There were no redeemable convertible preferred stock outstanding as of September 30, 2022.

CONDENSED CONSOLIDATED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (Parenthetical) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2022	Sep. 30, 2021
Series C-1 Redeemable Convertible Preferred Shares
Issuance costs		$ 209
Series C-2 Redeemable Convertible Preferred Shares
Issuance costs		$ 50
Common Stock \| Initial Public Offering
Issuance costs	$ 19,639

Convertible Notes

9 Months Ended

Sep. 30, 2022

Debt Disclosure [Abstract]

Convertible Notes

7. CONVERTIBLE NOTES

Issuance of the 2021 Notes

In January 2021, the Company issued, in aggregate, $27.3 million in convertible notes, or 2021 Notes, to certain investors, including related parties, of which proceeds of $1.2 million were received in advance of issuance of the 2021 Notes in December 2020 and the remaining proceeds of $26.1 million were received in January and February 2021. The 2021 Notes were to mature on June 30, 2022 and carried both automatic and optional conversion features. The 2021 Notes were secured and carried an interest rate of 3%. The Company recorded the $1.2 million of proceeds received in December 2020 as proceeds received in advance of issuance of 2021 Notes in the consolidated balance sheet as of December 31, 2020, as the subscription agreement and commitment to issue the 2021 Notes was not effective until January 2021.

The 2021 Notes contained the following features:

Automatic Conversion Features—The 2021 Notes were to automatically convert into conversion shares, or Conversion Shares, upon (i) an initial public offering, (ii) any transaction in which the Company merges with, consolidates with or enters into other similar transaction with a Special Purpose acquisition Corp, or SPAC, resulting in some or all of its shares being registered for sale under applicable securities laws and listed for trading on a national or foreign exchange, or De-SPAC transaction, (iii) the acquisition of the Company by another person or entity by means of any transaction in which holders of the outstanding voting securities of the Company immediately before such transaction held less than 50% of the voting securities of the Company or the surviving corporation after such transaction or a sale of all or substantially all of the assets of the Company but excluding De-SPAC transaction, initial public offering, and the occurrence of equity financing in which the Company sold shares of its preferred stock for new money and which was neither an initial public offering or a Qualified Financing, or Change of Control, and (iv) the closing of a sale of an equity transaction in which the Company sold shares with an aggregate gross proceeds of at least $10.0 million, or Qualified Financing.

In the event of a Change of Control, De-SPAC transaction, or an initial public offering, the Conversion Shares would be common stock of the Company. In the event of a Qualified Financing, the Conversion Shares would be shares of preferred stock issued in such transaction.

Optional Conversion Feature—The holders of the 2021 Notes had the option to elect to convert their notes into Conversion Shares at the Conversion Price upon the occurrence of an equity financing in which the Company sold shares of its preferred stock for new money and which was neither an initial public offering or a Qualified Financing, or Non-Qualified Financing, and together with the initial public offering, De-SPAC transaction, Change of Control, and the Qualified Financing, or, collectively, the Conversion Events. In the event of a Non-Qualified Financing, the Conversion Shares would be the class of equity shares issued in such transaction. The 2021 Notes would be deemed to have converted into the Conversion Shares if no election was made by the holders of the 2021 Notes.

Conversion Price—Upon the occurrence of an initial public offering, the 2021 Notes would convert into shares of common stock at the conversion price equal to the lesser of (i) 85% of the price at which the Company offered each share of common stock in the initial public offering without deducting any amount for discounts, commissions, fees, or other costs and (ii) $600.0 million divided by the fully diluted capital.

Upon the occurrence of a De-SPAC transaction, the 2021 Notes would convert into shares of common stock at the conversion price equal to the lesser of (i) 85% of the common stock price in the De-SPAC transaction, which would be determined by dividing (x) the total consideration to be paid to common stockholders upon a De-SPAC transaction less the principal amount of the 2021 Notes including accrued and unpaid interest by (y) the common stock issued and outstanding immediately prior to the De-SPAC transaction and that would be exchanged as a result of the De-SPAC transaction including common stock that would be issued upon the exercise of stock options immediately before the Change of Control transaction but excluding the common stock issuable upon conversion of the 2021 Notes and (ii) $600.0 million divided by the fully diluted capital.

Upon the occurrence of a Change of Control, the 2021 Notes would convert into shares of common stock at the conversion price equal to the lesser of (i) 85% of the common stock price in the Change of Control, which would be determined by dividing (x) the total consideration to be paid to common stockholders upon a Change of Control less the principal amount of the 2021 Notes including accrued and unpaid interest by (y) the common stock issued and outstanding immediately prior to the Change of Control and that would be exchanged upon a Change of Control including common stock that would be issued upon the exercise of stock options before the Change of Control but excluding the common stock issuable upon conversion of the 2021 Notes and (ii) $600.0 million divided by the fully diluted capital.

Upon a Qualified Financing, the 2021 Notes would convert into shares of preferred stock issued in the Non-Qualified Financing at the conversion price equal to the lesser of (i) 85% of the lowest price at which the Company sold shares of its stock in the Qualified Financing and (ii) $600.0 million divided by the fully diluted capital.

Repayment—Each holder of the 2021 Notes had the option to elect to receive a payment in the amount equal to the principal amount plus accrued and unpaid interests upon a Change of Control. If a Change of Control occurred and no election was made by the holder, the principal amount and accrued and unpaid interest would be deemed to have automatically be converted into shares of the Company’s common stock of the Company immediately prior to the close of the Change of Control.

The Company qualified for and elected to account for the 2021 Notes under the fair value option and, in doing so, bypassed the analysis of potential embedded derivative features. The Company believes that the fair value option better reflects the underlying economics of the 2021 Notes. As a result, the 2021 Notes were recorded at fair value upon issuance, which was determined to be equal to principal amounts of these notes of $27.3 million. At each financial reporting period, and immediately prior to conversion, the Company remeasured the fair value of the 2021 Notes. The change in fair value of the 2021 Notes from inception to September 30, 2021 totaled $5.2 million, which is recorded as change in fair value of convertible notes in the consolidated statement of operations for the nine months ended September 30, 2021.

Conversion of the 2021 Notes

In July 2021, the Company consummated a financing transaction in which it issued shares of Series C-1 redeemable convertible preferred stock. The consummation of this financing transaction resulted in the automatic conversion of the 2021 Notes into shares of Series C-2 redeemable convertible preferred stock (together with the Series C-1 redeemable convertible preferred stock, or the Series C Preferred Stock, pursuant to their original terms. The Series C Preferred Stock was determined to have a fair value of $10.265809. Under the fair value option, the 2021 Notes were remeasured to fair value immediately prior to conversion at a price per share equal to the fair value of the Series C-1 redeemable convertible preferred stock. The Company recorded $5.2 million loss related

to change in fair value of the 2021 Notes in its consolidated statement of operations for the year ended December 31, 2021. The 2021 Notes converted into 3,170,585 shares of Series C-2 redeemable convertible preferred stock at the effective conversion price of $8.725938.

There were no convertible notes outstanding as of September 30, 2022 or December 31, 2021.

Convertible Notes—Related Parties

There were no convertible notes issued to related parties that were outstanding as of September 30, 2022 or December 31, 2021. In connection with the issuance of the 2021 Notes, the Company issued, in aggregate, $14.3 million of convertible notes to certain related parties. These notes were issued under the same terms and conditions as the 2021 Notes.

Valuation of the 2021 Notes

At the issuance date of the 2021 Notes, the Company determined that the fair value of the 2021 Notes approximated the principal amounts of the 2021 Notes as the transaction was deemed to be at arm’s length. Subsequent measurement of fair value of the 2021 Notes at each reporting period was estimated based on significant inputs not observable in the market, which represents a Level 3 measurement within the fair value hierarchy. The Company used a scenario-based analysis to incorporate estimates and assumptions concerning the Company’s prospects and market indications into a model to estimate the value of the 2021 Notes. The most significant estimates and assumptions used as inputs were those concerning timing, probability of possible scenarios for conversion or settlement of the 2021 Notes and discount rates. The fair value of the 2021 Notes upon settlement in July 2021 was determined based on the fair value of the Series C-1 redeemable convertible preferred stock issued. This method was selected as the Company concluded that the contemporaneous financing transaction was an arm’s length transaction. The issuance of the Series C-1 redeemable convertible preferred stock was considered to be a Qualified Financing (see Note 8) pursuant to the original terms of the 2021 Notes. Accordingly, the fair value calculation for the 2021 Notes immediately before conversion considered both the fair value of the Series C-1 redeemable convertible preferred stock and the conversion price, which was 85% of the fair value of the Series C-1 redeemable convertible preferred stock. The fair value of the 2021 Notes as of June 30, 2021 was determined to be the same as that on the settlement date in July 2021 based on management’s determination of no material changes to the assumptions underlying the determination of the fair value of the 2021 Notes.

Leases (Tables)

9 Months Ended

Sep. 30, 2022

Leases [Abstract]

Components of Lease Expense

Components of lease expense required by ASC 842 are presented below for the three and nine months ended September 30, 2022.


	Three Months Ended September 30,		Nine Months Ended September 30,
	2022		2022
	(in thousands)		(in thousands)
Lease cost
Operating lease cost	$	544	$	1,592
Total lease cost	$	544	$	1,592

Summary of Condensed Consolidated Balance Sheet of Operating Leases

The following table summarizes the presentation in the Company’s condensed consolidated balance sheet of its operating leases (in thousands):


	As of September 30, 2022
Assets
Operating lease right-of-use assets	$	5,951

Liabilities
Operating lease right-of-use liabilities, current	$	1,990
Operating lease right-of-use liabilities, net of current portion		4,768
Total operating lease liabilities	$	6,758

Summary of Future Minimum Lease Payments

Future minimum lease payments under non-cancelable leases as of September 30, 2022, were as detailed below (in thousands):


	As of September 30, 2022
2022 (remaining 3 months)	$	597
2023		2,417
2024		2,478
2025		1,586
2026		476
Total undiscounted lease payments		7,554
Less: imputed interest		(796	)
Total operating lease liabilities	$	6,758

Future minimum lease payments under non-cancelable leases as of December 31, 2021, were as detailed below (in thousands):


	As of December 31, 2021
2022	$	532
2023		541
2024		555
2025		563
2026		476
Total operating lease liabilities	$	2,667

Stock Option and Grant Plan (Tables)

9 Months Ended

Sep. 30, 2022

Share-Based Payment Arrangement [Abstract]

Summary of Stock Option Activity

A summary of option activity for the nine months ended September 30, 2022, is as follows:


	Number of Options			Weighted- Average Exercise Price		Weighted- Average Remaining Contractual Term (in years)		Aggregate Intrinsic Value (in thousands)
Outstanding at December 31, 2021		5,339,011		$	5.54		8.7	$	15,627
Granted		3,968,720		$	19.22
Exercised		(669,040	)	$	0.37			$	5,961
Cancelled or forfeited		(63,242	)	$	13.28
Outstanding at September 30, 2022		8,575,449		$	12.22		8.4	$	137,204
Options exercisable as of September 30, 2022		1,792,734		$	5.13		7.0	$	41,265
Options unvested as of September 30, 2022		6,782,715		$	14.10		8.8	$	95,939
Weighted average grant-date fair value of options granted during the period	$	14.32

Summary of Restricted Stock Unit Activity

A summary of restricted stock unit activity for the nine months ended September 30, 2022, is as follows:


	Number of shares			Weighted Average Grant Date Fair Value
Nonvested as of December 31, 2021		—		$	—
Granted		693,613		$	18.62
Vested		—		$	—
Forfeited		(5,700	)	$	21.59
Nonvested as of September 30, 2022		687,913		$	18.60

Summary of Stock-Based Compensation

Stock-based compensation expense recorded in the condensed consolidated statements of comprehensive income for the three and nine months ended September 30, 2022 and 2021, is as follows:


	Three Months Ended September 30,				Nine Months Ended September 30,
	2022		2021		2022		2021
	(in thousands)				(in thousands)
Research and development	$	1,416	$	187	$	4,001	$	578
Selling, general and administrative		4,108		615		11,622		1,467
Total stock-based compensation expense	$	5,524	$	802	$	15,623	$	2,045

Summary of Stock-Based Compensation by Type of Award

The following table summarizes stock-based compensation by type of award:


	Three Months Ended September 30,				Nine Months Ended September 30,
	2022		2021		2022		2021
	(in thousands)				(in thousands)
Stock options	$	4,748	$	802	$	13,611	$	2,045
Restricted stock units		776		—		2,012		—
Total stock-based compensation expense	$	5,524	$	802	$	15,623	$	2,045

Summary of Unrecognized Stock-Based Compensation Expense and Weighted-Average Recognition Period

The following table summarizes unrecognized stock-based compensation expense as of September 30, 2022, by type of awards, and the weighted-average period over which that expense is expected to be recognized. The total unrecognized stock-based compensation expense will be adjusted for actual forfeitures as they occur.


	As of September 30, 2022
	Unrecognized Expense		Weighted-average Recognition Period
	(in thousands)		(in years)
Stock options	$	59,563		3.13
Restricted stock units	$	10,781		3.38

Stock Option and Grant Plan - Additional Information (Details) - USD ($)			9 Months Ended
	Jan. 06, 2022	Jan. 05, 2022	Sep. 30, 2022	Sep. 30, 2021
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Aggregate intrinsic value, exercised			$ 5,961,000	$ 4,500,000
Total fair value of stock options vested			$ 5,100,000	$ 700,000
2015 Plan
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Number of shares granted	0	0
2022 Plan
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Shares available for future issuance			3,056,609
Options expiration period			10 years
Common stock available for issuance		7,650,000
Percentage of increase in common stock reserved for issuance		5.00%
2022 Plan \| Nonemployee Director \| Maximum
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Compensation to be paid		$ 750,000
2022 Plan \| Board of Director
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Compensation to be paid		$ 1,000,000
2022 Plan \| ISOs
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Shares available for future issuance		7,650,000

Stock Option and Grant Plan - Summary of Stock-Based Compensation (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Total stock-based compensation expense	$ 5,524	$ 802	$ 15,623	$ 2,045
Research and Development
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Total stock-based compensation expense	1,416	187	4,001	578
Selling, General and Administrative
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Total stock-based compensation expense	$ 4,108	$ 615	$ 11,622	$ 1,467

Stock Option and Grant Plan - Summary of Stock-Based Compensation by Type of Award (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Total stock-based compensation expense	$ 5,524	$ 802	$ 15,623	$ 2,045
Stock Options
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Total stock-based compensation expense	4,748	$ 802	13,611	$ 2,045
Restricted Stock Units
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Total stock-based compensation expense	$ 776		$ 2,012

Subsequent Events - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions		1 Months Ended
	Oct. 11, 2022	Jan. 31, 2022	Sep. 30, 2022	Dec. 31, 2021
Subsequent Event [Line Items]
Number of common stock for sale in underwritten public offering			58,533,226	7,020,487
Number of shares sale in underwritten public offering		11,369,369
Stock price		$ 19.00
Net proceeds of sale in underwritten public offering common stock		$ 196.4
Subsequent Event
Subsequent Event [Line Items]
Number of common stock for sale in underwritten public offering	7,697,812
Number of shares sale in underwritten public offering	1,004,062
Stock price	$ 32.00
Gross proceeds of sale in underwritten public offering common stock	$ 246.3
Net proceeds of sale in underwritten public offering common stock	$ 230.8

Short-Term Investments - Schedule of Short-term Investments Classified as Available-for-sale (Details) - Short-term Investments - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Schedule Of Available For Sale Securities [Line Items]
Amortized Cost Basis	$ 55,030	$ 45,932
Unrealized Loss	(171)	(5)
Fair Value	54,859	45,927
Commercial Paper
Schedule Of Available For Sale Securities [Line Items]
Amortized Cost Basis	30,957	33,979
Unrealized Loss		(1)
Fair Value	30,957	33,978
Treasury Bills
Schedule Of Available For Sale Securities [Line Items]
Amortized Cost Basis	5,999
Unrealized Loss	(1)
Fair Value	5,998
Corporate Debt Securities
Schedule Of Available For Sale Securities [Line Items]
Amortized Cost Basis	18,074	11,953
Unrealized Loss	(170)	(4)
Fair Value	$ 17,904	$ 11,949

Redeemable Convertible Preferred Stock - Additional Information (Details) - USD ($)	9 Months Ended	12 Months Ended
	Sep. 30, 2022	Dec. 31, 2021	Sep. 30, 2021	Jul. 31, 2021	Jul. 01, 2021	Jun. 30, 2021	Mar. 31, 2021	Dec. 31, 2020	Jun. 18, 2020	Jun. 17, 2020
Temporary Equity [Line Items]
Temporary equity, shares issued		37,107,459
Temporary equity, shares authorized		37,710,624
Additional common stock issued to holders of redeemable convertible preferred stock		39,474,330
Cash dividend declared or paid		$ 0
Preferred Shares Outstanding	0	37,107,459
Minimum
Temporary Equity [Line Items]
Proceeds from underwritten public offering net of underwriting discount and commissions	$ 75,000,000.0
Series A Redeemable Convertible Preferred Share
Temporary Equity [Line Items]
Temporary equity, shares issued	0	6,289,609
Temporary equity, shares authorized	0	6,289,609
Additional common stock issued to holders of redeemable convertible preferred stock		6,407,256
Non-cumulative Dividends per share entitled to receive	$ 0.073744
Preferred Shares Outstanding	0	6,289,609	6,289,609			6,289,609	6,289,609	6,289,609
Series B Redeemable Convertible Preferred Shares
Temporary Equity [Line Items]
Temporary equity, shares issued	0	14,496,835
Temporary equity, shares authorized	0	15,100,000
Additional common stock issued to holders of redeemable convertible preferred stock		16,746,059
Percentage of non-cumulative dividends entitled to receive	6.00%
Preferred Shares Outstanding	0	14,496,835	14,496,835			14,496,835	14,496,835	14,496,835
Series C-1 Redeemable Convertible Preferred Shares
Temporary Equity [Line Items]
Temporary equity, shares issued	0	13,150,430		13,150,430
Temporary equity issue price per share	$ 10.265809
Temporary equity, shares authorized	0	13,150,430			13,150,430
Additional common stock issued to holders of redeemable convertible preferred stock		13,150,430
Preferred Shares Outstanding	0	13,150,430	13,150,430
Series C-2 Redeemable Convertible Preferred Shares
Temporary Equity [Line Items]
Temporary equity, shares issued	0	3,170,585
Temporary equity issue price per share	$ 8.725938
Temporary equity, shares authorized	0	3,170,585			3,170,585
Additional common stock issued to holders of redeemable convertible preferred stock		3,170,585
Preferred Shares Outstanding	0	3,170,585	3,170,585
2021 Notes \| Series C-2 Redeemable Convertible Preferred Shares
Temporary Equity [Line Items]
Temporary equity, shares issued				3,170,585
Notes including accrued interest				$ 27,700,000
2017 Notes \| Series A Redeemable Convertible Preferred Share
Temporary Equity [Line Items]
Temporary equity conversion price per share									$ 1.2065	$ 1.229073
Additional common stock issued to holders of redeemable convertible preferred stock									117,650
2017 Notes \| Series B Redeemable Convertible Preferred Shares
Temporary Equity [Line Items]
Temporary equity conversion price per share				$ 14.6942		$ 16.974077
Additional common stock issued to holders of redeemable convertible preferred stock				2,249,224

Leases - Summary of Future Minimum Lease Payments (Detail) - USD ($) $ in Thousands	Sep. 30, 2022	Jan. 10, 2022	Dec. 31, 2021
Leases [Abstract]
2022 (remaining 3 months)	$ 597
2023	2,417
2024	2,478
2025	1,586
2026	476
Total undiscounted lease payments	7,554
Less: imputed interest	(796)
Total operating lease liabilities	$ 6,758	$ 5,000
2022			$ 532
2023			541
2024			555
2025			563
2026			476
Total operating lease liabilities			$ 2,667

Short-Term Investments (Tables)

9 Months Ended

Sep. 30, 2022

Investments, Debt and Equity Securities [Abstract]

Schedule of Short-term Investments Classified as Available-for-sale

Short-term investments, which are classified as available-for-sale, consisted of the following:


Balance at September 30, 2022:	Amortized Cost Basis		Unrealized Loss			Fair Value
	(in thousands)
Treasury bills	$	5,999	$	(1	)	$	5,998
Commercial paper		30,957		—			30,957
Corporate debt securities		18,074		(170	)		17,904
Total short-term investments	$	55,030	$	(171	)	$	54,859


Balance at December 31, 2021:	Amortized Cost Basis		Unrealized Loss			Fair Value
	(in thousands)
Commercial paper	$	33,979	$	(1	)	$	33,978
Corporate debt securities		11,953		(4	)		11,949
Total short-term investments	$	45,932	$	(5	)	$	45,927

Stockholders' Equity (Deficit) (Tables)

9 Months Ended

Sep. 30, 2022

Equity [Abstract]

Schedule of common stock reserved for future issuance

The Company had reserved shares of common stock for issuance in connection with the following:


	September 30, 2022		December 31, 2021
Common stock authorized		300,000,000		56,500,000
Common stock issued and outstanding		58,533,226		7,020,487
Common stock authorized and reserved for future issuances:
Series A redeemable convertible preferred stock		—		6,407,256
Series B redeemable convertible preferred stock		—		16,746,059
Series C-1 redeemable convertible preferred stock		—		13,150,430
Series C-2 redeemable convertible preferred stock		—		3,170,585
Common stock reserved for the exercise of stock options		8,575,449		5,339,011
Common stock reserved for the unvested restricted stock units		687,913		—
Common stock reserved for future issuance of share-based awards		3,056,609		1,444,492
Total common stock authorized and reserved for future issuance		12,319,971		46,257,833
Unreserved common stock available for future issuance		229,146,803		3,221,680

Related Party Transactions

9 Months Ended

Sep. 30, 2022

Related Party Transactions

12. Related party transactions

Convertible Notes

In connection with the issuance of the 2021 Notes, the Company issued, in aggregate, $14.3 million of convertible promissory notes to Morningside Ventures Investments Limited, and certain members of the board of directors of the Company. Morningside Ventures Investments Limited is a 5% significant stockholder and has appointed representatives to the board of directors of the Company. These notes were issued under the same terms and conditions as the 2021 Notes (see Note 7).

Supplier Agreements

In the ordinary course of business, the Company may purchase materials or supplies or services from entities that are associated with a party that meets the criteria of a related party of the Company. These transactions are reviewed quarterly and to date have not been material to the Company’s condensed consolidated financial statements.

Fair Value Measurements

9 Months Ended

Sep. 30, 2022

Fair Value Disclosures [Abstract]

Fair Value Measurements

4. FAIR VALUE MEASUREMENTS

The following table presents information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicates the level of the fair value hierarchy utilized to determine such fair values:


	September 30, 2022
	Level 1		Level 2		Level 3		Total
	(in thousands)
Assets:
Money market funds	$	85,386	$	—	$	—	$	85,386
Short-term investments:
Treasury bills		5,998		—		—		5,998
Commercial paper		—		30,957		—		30,957
Corporate debt securities		—		17,904		—		17,904
Restricted cash	719			—		—		719
Total financial assets	$	92,103	$	48,861	$	—	$	140,964


	December 31, 2021
	Level 1		Level 2		Level 3		Total
	(in thousands)
Assets:
Money market funds	$	49,271	$	—	$	—	$	49,271
Short-term investments:
Commercial paper		—		33,978		—		33,978
Corporate debt securities		—		11,949		—		11,949
Restricted cash		189		—		—		189
Total financial assets	$	49,460	$	45,927	$	—	$	95,387

The Company classifies its money market funds and treasury bills as Level 1 assets under the fair value hierarchy, as these assets have been valued using quoted market prices for identical assets in active markets without any valuation adjustment. The Company classifies its commercial paper and corporate debt securities as Level 2 assets under the fair value hierarchy, as these assets have been valued using information obtained through a third-party pricing service at each balance sheet date, using observable market inputs that may include trade information, broker or dealer quotes, bids, offers, or a combination of these data sources.

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References + Details

Nature of the Business - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands	1 Months Ended
	Jan. 31, 2022	Sep. 30, 2022	Dec. 31, 2021
Subsidiary Sale Of Stock [Line Items]
Number of shares issued and sold	11,369,369
Stock price	$ 19.00
Proceeds from initial public offering, net of issuance costs	$ 196,400
Accumulated deficit		$ 311,516	$ 155,845

Summary of Significant Accounting Policies (Policies)	9 Months Ended
Summary of Significant Accounting Policies (Policies)	Sep. 30, 2022
Accounting Policies [Abstract]
Basis of Presentation and Consolidation	Basis of Presentation and Consolidation The accompanying condensed consolidated financial statements are unaudited and have been prepared in conformity with accounting principles generally accepted in the U.S., or GAAP, and include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification, or ASC, and ASU of the Financial Accounting Standards Board, or FASB.
Use of Estimates	Use of Estimates The preparation of the condensed consolidated financial statements in conformity with GAAP requires the Company’s management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amount of expenses during the reporting period. Actual results could differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies in developing the estimates and assumptions that are used in the preparation of the financial statements. Management must apply significant judgment in this process. Management’s estimation process often may yield a range of potentially reasonable estimates and management must select an amount that falls within that range of reasonable estimates. Estimates are used in the following areas, among others: reserves for variable consideration; recoverability of inventories, including those produced in preparation for product launches; determining the fair value of the Company’s common stock prior to the Company’s IPO in January 2022; determining the fair value of convertible notes; accrued expenses; stock option valuations; valuation allowance for deferred tax assets and research and development expenses.
Revenue recognition	Revenue recognition In June 2022, AMX0035 received marketing authorization with conditions as ALBRIOZA by Health Canada for the treatment of ALS, and the Company launched ALBRIOZA in Canada in July 2022. In September 2022, AMX0035 received approval as RELYVRIO by the FDA for the treatment of ALS in adults, and the Company launched RELYVRIO in the U.S. in October 2022. The Company enters into arrangements with wholesalers, or Customers, to distribute ALBRIOZA, RELYVRIO and future approved products. In accordance with ASC Topic 606 - Revenue from Contracts with Customers, or Topic 606, revenue is recognized when the customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to be entitled to in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of Topic 606, the Company performs the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) the Company satisfies a performance obligation. The Company only applies the five-step model to arrangements that meet the definition of a contract under Topic 606, including when it is probable that the Company will collect the consideration the Company expects to be entitled to in exchange for the goods or services the Company transfers to its customer. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Product Revenue, Net The Company sells its approved products to its Customers. These Customers subsequently resell our products to specialty pharmacy providers, as well as other retail pharmacies and certain medical centers or hospitals. In addition to distribution agreements with the Customers, the Company enters into arrangements with specialty pharmacies, health care providers and payors that provide for government mandated and/or privately negotiated rebates with respect to the purchase of our products. The Company recognizes revenue on product sales when the Customer obtains control of our product, which occurs at a point in time (upon delivery). Product revenues are recorded net of applicable reserves for variable consideration, which are described below. If taxes should be collected from Customers relating to product sales and remitted to governmental authorities, they will be excluded from revenue. The Company expenses incremental costs of obtaining a contract when incurred, if the expected amortization period of the asset that the Company would have recognized is one year or less. However, no such costs were incurred during the three and nine months ended September 30, 2022. Reserves for Variable Consideration Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established. Components of variable consideration include trade discounts and allowances, product returns, third-party payor rebates, and other allowances that are offered within contracts between the Company, its Customers and payors relating to the sale of our products. These reserves, as detailed below, are based on the amounts earned, or to be claimed on the related sales, and are classified as reductions of accounts receivable (if the amount is payable to the Customer) or a current liability (if the amount is payable to a party other than a Customer). These estimates take into consideration a range of possible outcomes which are probability-weighted in accordance with the expected value method in Topic 606 for relevant factors such as current contractual and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and payment patterns. Overall, these reserves reflect in the transaction price the amount of consideration to which the Company expects to be entitled to based on the terms of the respective underlying contracts. The amount of variable consideration which is included in the transaction price may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period. Our analyses also contemplated application of the constraint in accordance with the guidance, under which the Company determined a material reversal of revenue was not probable to occur in a future period for the estimates detailed below as of September 30, 2022 and, therefore, the transaction price was not reduced further during the three and nine months ended September 30, 2022. Actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future vary from our estimates, the Company will adjust these estimates, which would affect product revenue, net and earnings in the period such variances become known. Trade Discounts and Allowances The Company generally provides Customers with prompt payment discounts that are explicitly stated in our contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized. Payment from Customers is typically due within 30 calendar days of the invoice date, without consideration to the prompt payment discounts. Product Returns Consistent with industry practice, the Company generally offers Customers a limited right of return for product that has been purchased from us based on the product’s expiration date, which is set to lapse within a specified period stated in the contract. Additionally, our limited right of return policy allows for eligible returns from Customers in circumstances where product was shipped in error or was damaged in shipping, product was returned pursuant to an official drug recall, or product was dispensed to a patient who has passed away or who is no longer able to continue therapy. The Company estimates the amount of product sales that may be returned by our Customers and record this estimate as a reduction of revenue in the period the related product revenue is recognized, as well as reductions to accounts receivable on the condensed consolidated balance sheets. The Company currently estimates returns using quantitative and qualitative information including, but not limited to, expected experience with actual returns, projected demand, levels of inventory in the distribution channel, product dating and expiration period, and whether products have been discontinued, among others. The Company has not received any returns to date and believe that returns of product in future periods will be minimal. Payor Rebates The Company contracts with certain government and private payor organizations, primarily government and commercial insurance companies, for the payment of rebates with respect to utilization of our products. The Company estimates these rebates and records such estimates in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability. Other Incentives Other incentives which the Company offers include voluntary patient assistance programs, such as our co-pay assistance program, which are intended to provide financial assistance to qualified commercially-insured patients with prescription drug co-payments required by payors. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with product that has been recognized as revenue for each reporting period. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included as a component of accrued expenses and other current liabilities on the condensed consolidated balance sheets.
Inventory	Inventory The Company values its inventories at the lower of cost or estimated net realizable value. The Company determines the cost of its inventories, which includes amounts related to materials and manufacturing overhead, on a first-in, first-out basis. The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and it writes down any excess and obsolete inventories to their estimated realizable value in the period in which the impairment is first identified. Such impairment charges, should they occur, are recorded within cost of sales. The determination of whether inventory costs will be realizable requires estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required which would be recorded as cost of sales in the condensed consolidated statements of operations. The Company capitalizes inventory costs associated with the Company’s products after regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized. Inventory acquired prior to receipt of regulatory approval of a product candidate is expensed as research and development expense as incurred. Inventory that can be used in either the production of clinical or commercial product is expensed as research and development expense when materials are released to production for use in the manufacture of drugs still in development.
Recently Adopted Accounting Pronouncements	Recently Adopted Accounting Pronouncements Effective January 1, 2022, the Company adopted the requirements under the FASB, ASC 842, Leases, or ASC 842, using the cumulative effect adjustment transition option. Comparative periods have not been restated. This standard requires entities that lease assets to recognize the assets and liabilities for the rights and obligations created by those leases on the balance sheet. The Company elected the available package of practical expedients which allows it to not reassess previous accounting conclusions around whether arrangements are or contain leases, the classification of its leases, and the treatment of initial direct costs. The Company has made an accounting policy election to keep leases with an initial term of 12 months or less off of the balance sheet. ASC 842 was issued in order to increase transparency and comparability of financial reporting related to leasing arrangements. The main difference between previous GAAP, or ASC 840, and ASC 842 is the recognition of right-of-use lease assets and lease liabilities by lessees for those leases that were classified as operating leases under ASC 840. At January 1, 2022, the Company recorded right-of-use assets of $2.2 million and operating lease liabilities of $2.2 million. Adoption of the standard did not have a material impact on the consolidated statements of operations. For additional information regarding how the Company is accounting for leases under ASC 842, refer to Note 5, Leases.
New Accounting Pronouncements Not Yet Adopted	New Accounting Pronouncements Not Yet Adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326) Measurement of Credit Losses on Financial Instruments, or ASU 2016-13. The provisions of ASU 2016-13 modify the impairment model to utilize an expected loss methodology in place of the currently used incurred loss methodology and require a consideration of a broader range of reasonable and supportable information to inform credit loss estimates. Credit losses relating to available-for-sale debt securities will be recorded through an allowance for credit losses rather than as a direct write-down to the security. ASU 2016-13 requires a cumulative effect adjustment to the consolidated balance sheet as of the beginning of the first reporting period in which the guidance is effective. In November 2019, the FASB issued ASU 2019-10, Financial Instruments—Credit Losses (Topic 326), Derivatives and Hedging (Topic 815) and Leases (Topic 842): Effective Dates, which defers the effective date of ASU 2016-13 to fiscal years beginning after December 15, 2022 for all entities except Securities and Exchange Commission filers that are not smaller reporting companies. ASU 2016-13 will be effective for the Company beginning January 1, 2023. The Company intends to adopt the ASU when it becomes effective. The Company is currently evaluating the impact of this ASU and does not expect that adoption of this standard will have a material impact on its condensed consolidated financial statements and related disclosures.

- Definition

Disclosure of inventory accounting policy for inventory classes, including, but not limited to, basis for determining inventory amounts, methods by which amounts are added and removed from inventory classes, loss recognition on impairment of inventories, and situations in which inventories are stated above cost.

+ References + Details

Fair Value Measurements (Tables)

9 Months Ended

Sep. 30, 2022

Fair Value Disclosures [Abstract]

Schedule of Financial Assets and Liabilities Measured at Fair Value on Recurring Basis


	September 30, 2022
	Level 1		Level 2		Level 3		Total
	(in thousands)
Assets:
Money market funds	$	85,386	$	—	$	—	$	85,386
Short-term investments:
Treasury bills		5,998		—		—		5,998
Commercial paper		—		30,957		—		30,957
Corporate debt securities		—		17,904		—		17,904
Restricted cash	719			—		—		719
Total financial assets	$	92,103	$	48,861	$	—	$	140,964


	December 31, 2021
	Level 1		Level 2		Level 3		Total
	(in thousands)
Assets:
Money market funds	$	49,271	$	—	$	—	$	49,271
Short-term investments:
Commercial paper		—		33,978		—		33,978
Corporate debt securities		—		11,949		—		11,949
Restricted cash		189		—		—		189
Total financial assets	$	49,460	$	45,927	$	—	$	95,387

Related Party Transactions - Additional Information (Details) - 2021 Notes - USD ($)	Sep. 30, 2022	Dec. 31, 2021	Jan. 31, 2021
Related Party Transaction [Line Items]
Convertible debt outstanding	$ 0	$ 0	$ 14,300,000
Morningside Ventures Investments Limited \| Board of Director
Related Party Transaction [Line Items]
Convertible debt outstanding			$ 14,300,000
Percentage of stockholding			5.00%

Net Loss Per Share - Schedule of Antidilutive Shares Excluded from the Calculation of Diluted Net Loss Per Share (Details) - shares	9 Months Ended	12 Months Ended
	Sep. 30, 2022	Dec. 31, 2021
Common Stock Reserved for the Exercise of Stock Options
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Antidilutive shares excluded from the calculation of net loss per share	8,575,449	5,339,011
Common Stock Reserved for the Unvested Restricted Stock Units
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Antidilutive shares excluded from the calculation of net loss per share	687,913
Redeemable Convertible Preferred Stock
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Antidilutive shares excluded from the calculation of net loss per share		39,474,330

Subsequent Events

9 Months Ended

Sep. 30, 2022

Subsequent Events [Abstract]

Subsequent Events

15. Subsequent Events

The Company has evaluated all subsequent events after September 30, 2022 and through the date of this filing, and there were no material subsequent events requiring disclosure except as described below.

On October 11, 2022, the Company completed the sale in an underwritten public offering of 7,697,812 shares of common stock, including 1,004,062 shares of common stock pursuant to the underwriters' exercise in full of their option to purchase additional shares, at a public offering price of $32.00 per share, resulting in gross proceeds of $246.3 million and net proceeds of approximately $230.8 million.

On November 1, 2022, Isaac Cheng, MD, a member of the board of directors of the Company, submitted his resignation from the board of directors, effective as of close of business on November 1, 2022. Dr. Cheng’s decision to resign was not the result of any disagreement with the Company on any matter relating to its operations, policies practices or any issues relating to the Company’s accounting principles, practices, financial statements or disclosures.

Net Loss Per Share

9 Months Ended

Sep. 30, 2022

Earnings Per Share [Abstract]

Net Loss Per Share

11. NET LOSS PER SHARE

Net Loss per Share Attributable to Common Stockholders—Because the Company reports a net loss attributable to common stockholders, basic and diluted net loss per share attributable to common stockholders are the same for both periods presented. All preferred stock, stock options and restricted stock units have been excluded from the computation of diluted weighted-average shares outstanding because such securities would have an antidilutive impact. The following common stock equivalents outstanding at each period end have been excluded from the calculation of diluted net loss per share because their inclusion would have been antidilutive:


	September 30,		December 31,
	2022		2021
Options to purchase common stock		8,575,449		5,339,011
Unvested restricted stock units		687,913		—
Redeemable convertible preferred stock		—		39,474,330

Stock Option and Grant Plan - Summary of Restricted Stock Unit Activity (Details) - Restricted Stock Unit - $ / shares	9 Months Ended	12 Months Ended
	Sep. 30, 2022	Dec. 31, 2021
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Number of shares, Granted		693,613
Number of shares, Forfeited	(5,700)
Number of shares, Nonvested	687,913
Weighted Average Grant Date Fair Value, Granted	$ 18.62
Weighted Average Grant Date Fair Value, Forfeited	21.59
Weighted Average Grant Date Fair Value, Nonvested	$ 18.60

CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Current assets:
Cash and cash equivalents	$ 107,734	$ 50,191
Short-term investments	54,859	45,927
Prepaid expenses and other current assets	8,336	5,392
Accounts receivable, net	137
Inventories	563
Deferred offering costs	570	3,441
Total current assets	172,199	104,951
Property and equipment, net	2,118	474
Restricted cash	719	189
Operating lease right-of-use assets	5,951
Other assets	456
Total assets	181,443	105,614
Current liabilities:
Accounts payable	7,052	4,372
Accrued expenses and other current liabilities	23,605	13,024
Operating lease liabilities, current portion	1,990
Total current liabilities	32,647	17,396
Operating lease liabilities, net of current portion	4,768
Deferred rent		35
Total liabilities	37,415	17,431
Commitments and contingencies (Note 13)
Redeemable convertible preferred stock		239,351
Stockholders’ equity (deficit):
Preferred stock, $0.0001 par value; 10,000,000 and 0 shares authorized as of June 30, 2022 and December 31, 2021, respectively; 0 shares issued or outstanding as of June 30, 2022 and December 31, 2021
Common stock, $0.0001 par value; 300,000,000 and 56,500,000 shares authorized as of June 30, 2022 and December 31, 2021, respectively; 58,533,226 and 7,020,487 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively	6	1
Additional paid-in capital	456,263	4,667
Accumulated deficit	(311,516)	(155,845)
Accumulated other comprehensive (loss) income	(725)	9
Total stockholders’ equity (deficit)	144,028	(151,168)
Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit)	$ 181,443	105,614
Series A Redeemable Convertible Preferred Share
Current liabilities:
Redeemable convertible preferred stock		7,675
Series B Redeemable Convertible Preferred Shares
Current liabilities:
Redeemable convertible preferred stock		64,387
Series C-1 Redeemable Convertible Preferred Shares
Current liabilities:
Redeemable convertible preferred stock		134,791
Series C-2 Redeemable Convertible Preferred Shares
Current liabilities:
Redeemable convertible preferred stock		$ 32,498

Accrued Expenses

9 Months Ended

Sep. 30, 2022

Payables and Accruals [Abstract]

Accrued Expenses

6. Accrued Expenses

Accrued expenses consisted of the following:


	September 30, 2022		December 31, 2021
	(in thousands)
External research and development	$	7,505	$	5,666
Payroll and employee related expenses		8,994		4,280
Accrued consulting and other professional fees		6,750		2,820
Other accrued expenses		356		258
Total accrued expenses	$	23,605	$	13,024

Inventory - Additional Information (Details) $ in Millions	9 Months Ended
Inventory - Additional Information (Details) $ in Millions	Sep. 30, 2022 USD ($)
Public Utilities, Inventory [Line Items]
Inventory acquired expensed as research and development expense	$ 25.7
Finished Goods \| Maximum
Public Utilities, Inventory [Line Items]
Shelf life	15 months
Finished Goods \| Minimum
Public Utilities, Inventory [Line Items]
Shelf life	12 months

Inventory

9 Months Ended

Sep. 30, 2022

Inventory Disclosure [Abstract]

Inventory

14. INVENTORY

Inventory consisted of the following:


	September 30, 2022		December 31, 2021
	(in thousands)
Raw materials	$	408	$	—
Work in process		45		—
Finished goods		110		—
Total inventories	$	563	$	—

The Company capitalizes inventory costs associated with the Company’s products after regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized. Inventory on hand determined to not have a future economic benefit and acquired prior to receipt of the marketing authorization for ALBRIOZA in Canada, totaling approximately $25.7 million, was expensed as research and development expense as incurred. The Company began to capitalize the costs determined to have a probable future economic benefit associated with the production of ALBRIOZA upon receipt of Health Canada approval in June 2022. Finished goods have a shelf life of 12-15 months from the date of manufacture.

Inventory - Summary of Inventory (Details) $ in Thousands	Sep. 30, 2022 USD ($)
Inventory Disclosure [Abstract]
Raw materials	$ 408
Work in process	45
Finished goods	110
Total inventories	$ 563

Stock Option and Grant Plan - Summary of Unrecognized Stock-Based Compensation Expense and Weighted-Average Recognition Period (Details) $ in Thousands	9 Months Ended
	Sep. 30, 2022 USD ($)
Common Stock Reserved for the Exercise of Stock Options
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Unrecognized Expense	$ 59,563
Weighted-average Recognition Period	3 years 1 month 17 days
Restricted Stock Units
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Unrecognized Expense	$ 10,781
Weighted-average Recognition Period	3 years 4 months 17 days

Accrued Expenses (Tables)

9 Months Ended

Sep. 30, 2022

Payables and Accruals [Abstract]

Schedule of Accrued Expenses

Accrued expenses consisted of the following:


	September 30, 2022		December 31, 2021
	(in thousands)
External research and development	$	7,505	$	5,666
Payroll and employee related expenses		8,994		4,280
Accrued consulting and other professional fees		6,750		2,820
Other accrued expenses		356		258
Total accrued expenses	$	23,605	$	13,024

Short-Term Investments - Additional Information (Details) - USD ($)	3 Months Ended	9 Months Ended	12 Months Ended
	Sep. 30, 2022	Sep. 30, 2022	Dec. 31, 2021
Debt Securities, Available-for-Sale [Line Items]
Available-for-sale investments contractual maturity period		1 year	1 year
Realized gains	$ 0	$ 0
Realized loss	$ 0	0
Short-term Investments
Debt Securities, Available-for-Sale [Line Items]
Impairment charges		$ 0	$ 0

Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	Sep. 30, 2022	Nov. 07, 2022
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Sep. 30, 2022
Document Fiscal Year Focus	2022
Document Fiscal Period Focus	Q3
Trading Symbol	AMLX
Entity Registrant Name	Amylyx Pharmaceuticals, Inc.
Entity Central Index Key	0001658551
Current Fiscal Year End Date	--12-31
Entity File Number	001-41199
Entity Tax Identification Number	46-4600503
Entity Address, Address Line One	43 Thorndike St.
Entity Address, City or Town	Cambridge
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02141
City Area Code	617
Local Phone Number	682-0917
Entity Current Reporting Status	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	true
Entity Ex Transition Period	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		66,256,218
Entity Interactive Data Current	Yes
Title of 12(b) Security	Common Stock, $0.0001 par value per share
Security Exchange Name	NASDAQ
Entity Incorporation, State or Country Code	DE
Document Quarterly Report	true
Document Transition Report	false

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Revenues:
Product revenue, net	$ 345		$ 345
Revenue from Contract with Customer, Product and Service [Extensible Enumeration]	us-gaap:ProductMember		us-gaap:ProductMember
Grant revenue		$ 285		$ 285
Total revenues	$ 345	285	$ 345	285
Operating expenses:
Cost of sales	172		172
Research and development	24,914	12,853	70,637	30,646
Selling, general and administrative	29,940	10,350	86,284	24,012
Total operating expenses	55,026	23,203	157,093	54,658
Loss from operations	(54,681)	(22,918)	(156,748)	(54,373)
Other income (expense), net:
Interest income	601	3	1,134	6
Change in fair value of convertible notes				(5,228)
Other income (expense), net	199	(227)	138	8
Total other income (expense), net	800	(224)	1,272	(5,214)
Loss before income taxes	(53,881)	(23,142)	(155,476)	(59,587)
(Benefit) provision for income taxes	(125)		195
Net loss	$ (53,756)	$ (23,142)	$ (155,671)	$ (59,587)
Net loss per share attributable to common stockholders -basic	$ (0.92)	$ (3.42)	$ (2.77)	$ (9.20)
Net loss per share attributable to common stockholders -diluted	$ (0.92)	$ (3.42)	$ (2.77)	$ (9.20)
Weighted-average shares used in computing net loss per share attributable to common stockholders-basic	58,533,226	6,757,152	56,163,194	6,477,140
Weighted-average shares used in computing net loss per share attributable to common stockholders-diluted	58,533,226	6,757,152	56,163,194	6,477,140

Fair Value Measurements - Schedule of Financial Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) - Fair Value Measurements, Recurring - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Total financial assets	$ 140,964	$ 95,387
Money market funds
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Total financial assets	85,386	49,271
Restricted cash
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Total financial assets	719	189
Level 1
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Total financial assets	92,103	49,460
Level 1 \| Money market funds
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Total financial assets	85,386	49,271
Level 1 \| Restricted cash
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Total financial assets	719	189
Level 2
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Total financial assets	48,861	45,927
Short-term Investments \| Treasury Bills
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Total financial assets	5,998
Short-term Investments \| Commercial Paper
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Total financial assets	30,957	33,978
Short-term Investments \| Corporate Debt Securities
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Total financial assets	17,904	11,949
Short-term Investments \| Level 1 \| Treasury Bills
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Total financial assets	5,998
Short-term Investments \| Level 2 \| Commercial Paper
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Total financial assets	30,957	33,978
Short-term Investments \| Level 2 \| Corporate Debt Securities
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Total financial assets	$ 17,904	$ 11,949

Summary of Significant Accounting Policies

9 Months Ended

Sep. 30, 2022

Accounting Policies [Abstract]

Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

Significant Accounting Policies

The Company’s significant accounting policies are disclosed in the audited consolidated financial statements for the year ended December 31, 2021 and the notes thereto, which are included in the Company’s most recent Annual Report on Form 10-K. Since the date of those consolidated financial statements, there have been no material changes to its significant accounting policies, with the exception of significant accounting policies related to the adoption of FASB ASC Topic 842, Leases, effective January 1, 2022, as well as significant accounting policies over revenue and inventory, as described below.

Basis of Presentation and Consolidation

The accompanying condensed consolidated financial statements are unaudited and have been prepared in conformity with accounting principles generally accepted in the U.S., or GAAP, and include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification, or ASC, and ASU of the Financial Accounting Standards Board, or FASB.

Use of Estimates

The preparation of the condensed consolidated financial statements in conformity with GAAP requires the Company’s management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amount of expenses during the reporting period. Actual results could differ from those estimates.

Management considers many factors in selecting appropriate financial accounting policies in developing the estimates and assumptions that are used in the preparation of the financial statements. Management must apply significant judgment in this process. Management’s estimation process often may yield a range of potentially reasonable estimates and management must select an amount that falls within that range of reasonable estimates. Estimates are used in the following areas, among others: reserves for variable consideration; recoverability of inventories, including those produced in preparation for product launches; determining the fair value of the Company’s common stock prior to the Company’s IPO in January 2022; determining the fair value of convertible notes; accrued expenses; stock option valuations; valuation allowance for deferred tax assets and research and development expenses.

Revenue recognition

In June 2022, AMX0035 received marketing authorization with conditions as ALBRIOZA by Health Canada for the treatment of ALS, and the Company launched ALBRIOZA in Canada in July 2022. In September 2022, AMX0035 received approval as RELYVRIO by the FDA for the treatment of ALS in adults, and the Company launched RELYVRIO in the U.S. in October 2022.

The Company enters into arrangements with wholesalers, or Customers, to distribute ALBRIOZA, RELYVRIO and future approved products. In accordance with ASC Topic 606 - Revenue from Contracts with Customers, or Topic 606, revenue is recognized when the customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to be entitled to in exchange for those goods or services.

To determine revenue recognition for arrangements that the Company determines are within the scope of Topic 606, the Company performs the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) the Company satisfies a performance obligation. The Company only applies the five-step model to arrangements that meet the definition of a contract under Topic 606, including when it is probable that the Company will collect the consideration the Company expects to be entitled to in exchange for the goods or services the Company transfers to its customer. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

Product Revenue, Net

The Company sells its approved products to its Customers. These Customers subsequently resell our products to specialty pharmacy providers, as well as other retail pharmacies and certain medical centers or hospitals. In addition to distribution agreements with the Customers, the Company enters into arrangements with specialty pharmacies, health care providers and payors that provide for government mandated and/or privately negotiated rebates with respect to the purchase of our products.

The Company recognizes revenue on product sales when the Customer obtains control of our product, which occurs at a point in time (upon delivery). Product revenues are recorded net of applicable reserves for variable consideration, which are described below.

If taxes should be collected from Customers relating to product sales and remitted to governmental authorities, they will be excluded from revenue. The Company expenses incremental costs of obtaining a contract when incurred, if the expected amortization period of the asset that the Company would have recognized is one year or less. However, no such costs were incurred during the three and nine months ended September 30, 2022.

Reserves for Variable Consideration

Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established. Components of variable consideration include trade discounts and allowances, product returns, third-party payor rebates, and other allowances that are offered within contracts between the Company, its Customers and payors relating to the sale of our products. These reserves, as detailed below, are based on the amounts earned, or to be claimed on the related sales, and are classified as reductions of accounts receivable (if the amount is payable to the Customer) or a current liability (if the amount is payable to a party other than a Customer). These estimates take into consideration a range of possible outcomes which are probability-weighted in accordance with the expected value method in Topic 606 for relevant factors such as current contractual and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and

payment patterns. Overall, these reserves reflect in the transaction price the amount of consideration to which the Company expects to be entitled to based on the terms of the respective underlying contracts.

The amount of variable consideration which is included in the transaction price may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period. Our analyses also contemplated application of the constraint in accordance with the guidance, under which the Company determined a material reversal of revenue was not probable to occur in a future period for the estimates detailed below as of September 30, 2022 and, therefore, the transaction price was not reduced further during the three and nine months ended September 30, 2022. Actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future vary from our estimates, the Company will adjust these estimates, which would affect product revenue, net and earnings in the period such variances become known.

Trade Discounts and Allowances

The Company generally provides Customers with prompt payment discounts that are explicitly stated in our contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized. Payment from Customers is typically due within 30 calendar days of the invoice date, without consideration to the prompt payment discounts.

Product Returns

Consistent with industry practice, the Company generally offers Customers a limited right of return for product that has been purchased from us based on the product’s expiration date, which is set to lapse within a specified period stated in the contract. Additionally, our limited right of return policy allows for eligible returns from Customers in circumstances where product was shipped in error or was damaged in shipping, product was returned pursuant to an official drug recall, or product was dispensed to a patient who has passed away or who is no longer able to continue therapy.

The Company estimates the amount of product sales that may be returned by our Customers and record this estimate as a reduction of revenue in the period the related product revenue is recognized, as well as reductions to accounts receivable on the condensed consolidated balance sheets. The Company currently estimates returns using quantitative and qualitative information including, but not limited to, expected experience with actual returns, projected demand, levels of inventory in the distribution channel, product dating and expiration period, and whether products have been discontinued, among others. The Company has not received any returns to date and believe that returns of product in future periods will be minimal.

Payor Rebates

The Company contracts with certain government and private payor organizations, primarily government and commercial insurance companies, for the payment of rebates with respect to utilization of our products. The Company estimates these rebates and records such estimates in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability.

Other Incentives

Other incentives which the Company offers include voluntary patient assistance programs, such as our co-pay assistance program, which are intended to provide financial assistance to qualified commercially-insured patients with prescription drug co-payments required by payors. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with product that has been recognized as revenue for each reporting period. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included as a component of accrued expenses and other current liabilities on the condensed consolidated balance sheets.

Inventory

The Company values its inventories at the lower of cost or estimated net realizable value. The Company determines the cost of its inventories, which includes amounts related to materials and manufacturing overhead, on a first-in, first-out basis. The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and it writes down any excess and obsolete inventories to their estimated realizable value in the period in which the impairment is first identified. Such impairment charges, should they occur, are recorded within cost of sales. The determination of whether inventory costs will be realizable requires estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required which would be recorded as cost of sales in the condensed consolidated statements of operations.

The Company capitalizes inventory costs associated with the Company’s products after regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized. Inventory acquired prior to receipt of regulatory approval of a product candidate is expensed as research and development expense as incurred. Inventory that can be used in either the production of clinical or commercial product is expensed as research and development expense when materials are released to production for use in the manufacture of drugs still in development.

Recently Adopted Accounting Pronouncements

Effective January 1, 2022, the Company adopted the requirements under the FASB, ASC 842, Leases, or ASC 842, using the cumulative effect adjustment transition option. Comparative periods have not been restated. This standard requires entities that lease assets to recognize the assets and liabilities for the rights and obligations created by those leases on the balance sheet. The Company elected the available package of practical expedients which allows it to not reassess previous accounting conclusions around whether arrangements are or contain leases, the classification of its leases, and the treatment of initial direct costs. The Company has made an accounting policy election to keep leases with an initial term of 12 months or less off of the balance sheet. ASC 842 was issued in order to increase transparency and comparability of financial reporting related to leasing arrangements. The main difference between previous GAAP, or ASC 840, and ASC 842 is the recognition of right-of-use lease assets and lease liabilities by lessees for those leases that were classified as operating leases under ASC 840. At January 1, 2022, the Company recorded right-of-use assets of $2.2 million and operating lease liabilities of $2.2 million. Adoption of the standard did not have a material impact on the consolidated statements of operations. For additional information regarding how the Company is accounting for leases under ASC 842, refer to Note 5, Leases.

New Accounting Pronouncements Not Yet Adopted

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326) Measurement of Credit Losses on Financial Instruments, or ASU 2016-13. The provisions of ASU 2016-13 modify the impairment model to utilize an expected loss methodology in place of the currently used incurred loss methodology and require a consideration of a broader range of reasonable and supportable information to inform credit loss estimates. Credit losses relating to available-for-sale debt securities will be recorded through an allowance for credit losses rather than as a direct write-down to the security. ASU 2016-13 requires a cumulative effect adjustment to the consolidated balance sheet as of the beginning of the first reporting period in which the guidance is effective. In November 2019, the FASB issued ASU 2019-10, Financial Instruments—Credit Losses (Topic 326), Derivatives and Hedging (Topic 815) and Leases (Topic 842): Effective Dates, which defers the effective date of ASU 2016-13 to fiscal years beginning after December 15, 2022 for all entities except Securities and Exchange Commission filers that are not smaller reporting companies. ASU 2016-13 will be effective for the Company beginning January 1, 2023. The Company intends to adopt the ASU when it becomes effective. The Company is currently evaluating the impact of this ASU and does not expect that adoption of this standard will have a material impact on its condensed consolidated financial statements and related disclosures.

Nature of the Business

9 Months Ended

Sep. 30, 2022

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Nature of the Business

1. Nature of the Business

Amylyx Pharmaceuticals, Inc., together with its wholly owned subsidiaries, known as Amylyx or the Company, is a commercial-stage biopharmaceutical company with a mission to one day end the suffering caused by neurodegenerative diseases. The Company is focused on the development and potential global commercialization of its product candidate, AMX0035 (sodium phenylbutyrate and taurursodiol, also known as ursodoxicoltaurine) for the treatment of amyotrophic lateral sclerosis, or ALS. In June 2022, AMX0035 received marketing authorization with conditions as ALBRIOZA by Health Canada for the treatment of ALS, and the Company launched ALBRIOZA in Canada on July 29, 2022. In September 2022, AMX0035 was approved as RELYVRIO by the U.S Food and Drug Administration, or FDA, for the treatment of ALS, and the Company launched RELYVRIO in the United States of America, or U.S., on October 24, 2022. The Company’s Marketing Authorisation Application, or MAA, for AMX0035 for the treatment of ALS remains under review by the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA. The Company is developing AMX0035 for other neurodegenerative diseases by leveraging its unique knowledge and relationships in the neurodegenerative space.

In January 2022, the Company completed an initial public offering, or the IPO, in which the Company issued and sold 11,369,369 shares of its common stock at a price of $19.00 per share. After deducting underwriting discounts and commissions and estimated offering expenses, the Company received net proceeds of approximately $196.4 million. Upon the completion of IPO, all of the Company’s outstanding shares of preferred stock were converted into shares of its common stock. Refer to Note 15 for additional information regarding the Company's follow-on public offering of its common stock, completed in October 2022.

Risks and Uncertainties

The Company is subject to risks and uncertainties common to companies in the biotechnology industry, including, but not limited to, the outcome of preclinical studies and clinical trials, market acceptance and the successful commercialization of ALBRIOZA which received marketing authorization with conditions in Canada in June 2022, and RELYVRIO, which was approved by the FDA in the U.S. in September 2022, potential difficulties with or delays in timing with respect to the regulatory approval processes of the EMA and other comparable foreign authorities, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, ability to secure additional capital to fund operations, and risks associated with the ongoing COVID-19 global pandemic. The COVID-19 pandemic may have an adverse impact on the Company’s operations, supply chains and distribution systems or those of its contractors, and increase expenses, including as a result of impacts associated with preventive and precautionary measures that are being taken, such as restrictions on travel and border crossings. The Company and its contractors may experience disruptions in supply of items that are essential for its research and development and commercial activities, including, for example, raw materials and bulk drug substances that the Company imports from Europe and Canada used in the manufacturing of AMX0035, and any future product candidates. In addition, the continued spread of COVID-19 has disrupted global healthcare and healthcare regulatory systems which could divert healthcare resources away from, or materially delay, approval by health authorities worldwide with respect to AMX0035 and any future product candidates. Furthermore, the Company’s ongoing and anticipated clinical trials may be negatively affected by the ongoing COVID-19 outbreak. Site initiation, patient enrollment and patient follow-up visits may be delayed, for example, due to prioritization of hospital resources toward the COVID-19 outbreak, travel restrictions, the inability to access sites for initiation and monitoring, and difficulties recruiting or retaining patients in the Company’s ongoing and planned clinical trials.

Economic uncertainty in various global markets, including the U.S. and Europe, caused by political instability and conflict, such as Russia's invasion of Ukraine, and economic challenges caused by the COVID-19 pandemic, have led to market disruptions, including significant volatility in commodity prices, credit and capital market instability and supply chain interruptions, which have caused record inflation globally. The Company's business, financial condition and results of operations could be materially and adversely affected by further negative impact on the global economy and capital markets resulting from these global economic conditions, particularly if such conditions are prolonged or worsen.

Although, to date, our business has not been materially impacted by these global economic and geopolitical conditions, it is impossible to predict the extent to which our operations will be impacted in the short and long term, or the ways in which such instability could impact our business and results of operations. The extent and duration of these market disruptions, whether as a result of the military conflict between Russia and Ukraine, geopolitical tensions, record inflation or otherwise, are impossible to predict, but could be substantial. Any such disruptions may also magnify the impact of other risks described in this report.

There can be no assurance that the Company will be able to successfully complete the development of, or receive additional regulatory approval for, any products developed, and if approved, that any products will be commercially viable. Any products resulting from the Company’s current research and development efforts will require significant additional research and development, including extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts will require significant amounts of additional capital, adequate personnel, infrastructure, and extensive compliance reporting capabilities. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.

Going Concern

In accordance with Accounting Standards Update, or ASU, 2014-15, Disclosure of Uncertainties About an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40), the Company has evaluated whether there are conditions and events that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the unaudited consolidated financial statements are issued.

Since its inception, the Company has devoted substantially all of its efforts to research and development and pre-commercialization activities, including recruiting management and technical staff, raising capital, producing materials for preclinical studies and clinical trials, and building infrastructure to support such activities. Expenses have primarily been for research and development and related general and administrative costs. The Company has generated revenues through five grants from ALS Association, ALS Finding a Cure Foundation, Cure Alzheimer’s Fund, Alzheimer’s Drug Discovery Foundation and Alzheimer’s Association, or Grantors. In addition to money received from its grants, the Company has also financed its operations through the public offering of its common stock, private sales of preferred stock, and convertible notes.

The accompanying condensed consolidated financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company has incurred recurring losses and negative cash flows from operations since inception. As of September 30, 2022, the Company had an accumulated deficit of $311.5 million. The Company expects its operating losses and negative operating cash flows to continue into the foreseeable future as it continues initial sales of ALBRIOZA in Canada and launches RELYVRIO in the U.S., and continues to build capabilities and develop AMX0035, and any future product candidates. In the event that management does not achieve revenue anticipated in its operating plan, management has the ability and commitment to reduce operating expenses as necessary. The Company expects that its cash, cash equivalents and short-term investments as of September 30, 2022, together with the net proceeds from the Company's follow-on public offering, and product revenue from RELYVRIO and ALBRIOZA sales, will enable the Company to fund its ongoing operating expenses and capital expenditure requirements for at least the twelve-month period following the issuance of these condensed consolidated financial statements.

Stockholders' Equity (Deficit) - Additional Information (Details)	9 Months Ended
	Sep. 30, 2022 USD ($) Vote	Sep. 30, 2021 USD ($)
Equity [Abstract]
Voting rights \| Vote	1
Dividends paid	$ 0	$ 0
Dividends declared	$ 0	$ 0

Stock Option and Grant Plan

9 Months Ended

Sep. 30, 2022

Share-Based Payment Arrangement [Abstract]

Stock Option and Grant Plan

10. Stock Option and Grant Plan

Stock Incentive Plan

In January 2022, the Company’s board of directors adopted, and its stockholders approved the 2022 Stock Option and Incentive Plan, or 2022 Plan, which became effective on January 5, 2022, at which point no further grants would be made under the 2015 Stock Option and Restricted Stock Plan, or 2015 Plan. Under the 2022 Plan, the Company may grant incentive stock options, or ISOs, non-statutory stock options, stock appreciation rights, restricted stock units, restricted stock awards and other stock-based awards. As of September 30, 2022, there were 3,056,609 shares available for future issuance under the 2022 Plan. The options issued under the 2022 Plan expire after 10 years.

Initially, subject to adjustment as provided in the 2022 Plan, the aggregate number of shares of the Company’s common stock available for issuance under the 2022 Plan is 7,650,000. The number of shares of the Company’s common stock reserved for issuance under the 2022 Plan will automatically increase on January 1 of each year commencing January 1, 2023, by 5% of the total number of shares of the Company’s common stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares as

may be determined by the Company’s board of directors. The maximum current number of shares that may be issued pursuant to the exercise of ISOs under the 2022 Plan is 7,650,000.

The maximum number of shares of the Company’s common stock subject to awards granted under the 2022 Plan or otherwise during a single calendar year to any individual nonemployee director, taken together with any cash fees paid by the Company to such nonemployee director during the calendar year for serving on the Company’s board of directors, will not exceed $750,000 in total value, or, with respect to the calendar year in which a nonemployee director is first appointed or elected to the Company’s board of directors, $1,000,000.

All options and awards granted under the 2015 Plan consisted of the Company’s common stock. As of January 6, 2022, no additional stock awards have been or will be granted under the 2015 Plan. Although the 2015 Plan was terminated as to future awards in January 2022, it continues to govern the terms of options that remain outstanding under the 2015 Plan.

General Option Information

A summary of option activity for the nine months ended September 30, 2022, is as follows:


	Number of Options			Weighted- Average Exercise Price		Weighted- Average Remaining Contractual Term (in years)		Aggregate Intrinsic Value (in thousands)
Outstanding at December 31, 2021		5,339,011		$	5.54		8.7	$	15,627
Granted		3,968,720		$	19.22
Exercised		(669,040	)	$	0.37			$	5,961
Cancelled or forfeited		(63,242	)	$	13.28
Outstanding at September 30, 2022		8,575,449		$	12.22		8.4	$	137,204
Options exercisable as of September 30, 2022		1,792,734		$	5.13		7.0	$	41,265
Options unvested as of September 30, 2022		6,782,715		$	14.10		8.8	$	95,939
Weighted average grant-date fair value of options granted during the period	$	14.32

The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the options and the fair value of the Company’s common stock for those options that had exercise prices lower than the fair value of the Company’s common stock. The aggregate intrinsic value of options exercised during the nine months ended September 30, 2022 and 2021 was $6.0 million and $4.5 million, respectively.

The total fair value of stock options vested during the nine months ended September 30, 2022 and 2021 was $5.1 million and $0.7 million, respectively.

Restricted Stock Unit Activity

A summary of restricted stock unit activity for the nine months ended September 30, 2022, is as follows:


	Number of shares			Weighted Average Grant Date Fair Value
Nonvested as of December 31, 2021		—		$	—
Granted		693,613		$	18.62
Vested		—		$	—
Forfeited		(5,700	)	$	21.59
Nonvested as of September 30, 2022		687,913		$	18.60

Summary of Stock-Based Compensation Expense

Stock-based compensation expense recorded in the condensed consolidated statements of comprehensive income for the three and nine months ended September 30, 2022 and 2021, is as follows:


	Three Months Ended September 30,				Nine Months Ended September 30,
	2022		2021		2022		2021
	(in thousands)				(in thousands)
Research and development	$	1,416	$	187	$	4,001	$	578
Selling, general and administrative		4,108		615		11,622		1,467
Total stock-based compensation expense	$	5,524	$	802	$	15,623	$	2,045

The following table summarizes stock-based compensation by type of award:


	Three Months Ended September 30,				Nine Months Ended September 30,
	2022		2021		2022		2021
	(in thousands)				(in thousands)
Stock options	$	4,748	$	802	$	13,611	$	2,045
Restricted stock units		776		—		2,012		—
Total stock-based compensation expense	$	5,524	$	802	$	15,623	$	2,045


	As of September 30, 2022
	Unrecognized Expense		Weighted-average Recognition Period
	(in thousands)		(in years)
Stock options	$	59,563		3.13
Restricted stock units	$	10,781		3.38

Leases - Components of Lease Expense (Details) - USD ($) $ in Thousands	3 Months Ended	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2022
Leases [Abstract]
Operating lease cost	$ 544	$ 1,592
Total lease cost	$ 544	$ 1,592

Leases

9 Months Ended

Sep. 30, 2022

Leases [Abstract]

Leases

5. Leases

The Company adopted ASC 842 on January 1, 2022. ASC 842 allows the Company to elect a package of practical expedients, which include: (i) an entity need not reassess whether any expired or existing contracts are or contain leases; (ii) an entity need not reassess the lease classification for any expired or existing leases; and (iii) an entity need not reassess any initial direct costs for any existing leases. Another practical expedient allows the Company to use hindsight in determining the lease term when considering lessee options to extend or terminate the lease and to purchase the underlying asset. The Company has elected to utilize this package of practical expedients and has not elected the hindsight methodology in its implementation of ASC 842.

The Company leases its office facilities under non-cancelable operating leases that expire at various dates through October 2026. The Company entered into a new office space lease at 121 First Street in Cambridge, Massachusetts on January 10, 2022, for 36 months, with an option to extend the lease for 3 years. The Company initially recognized a right-of-use asset of $5.0 million and a lease liability of $5.0 million upon commencement.

Components of lease expense required by ASC 842 are presented below for the three and nine months ended September 30, 2022.


	Three Months Ended September 30,		Nine Months Ended September 30,
	2022		2022
	(in thousands)		(in thousands)
Lease cost
Operating lease cost	$	544	$	1,592
Total lease cost	$	544	$	1,592

Lease liabilities are measured by calculating the present value of remaining lease payments under the lease arrangement. Since the rates implicit in our leases are not readily determinable, the Company uses estimated incremental borrowing rates in determining the discount rate used to calculate the present value of remaining lease payments. The incremental borrowing rate is the rate of interest that the Company would have to pay to borrow, on a collateralized basis, an amount equal to the lease payments over a similar term equal to the lease term in a similar economic environment. The incremental borrowing rate is based on the information available at commencement date. As the Company has no recent external borrowings, the incremental borrowing is a hypothetical rate based on our understanding of what our credit rating would be and adjusted to reflect a collateralized borrowing.

The Company’s leases contain renewal options that can extend the lease for additional years. Because the Company is not reasonably certain to exercise these renewal options, they are not considered in determining the lease terms, and associated potential additional payments are excluded from lease payments. The Company has elected to account for each lease component and its associated non-lease components as a single lease component and has allocated all of the contract consideration across lease components only. The Company has existing net leases in which the non-lease components (e.g., common area maintenance) are paid separately from rent based on actual costs incurred and therefore are not included in the operating lease right-of-use assets and lease liabilities and are reflected as an expense in the period incurred.

The following table summarizes the presentation in the Company’s condensed consolidated balance sheet of its operating leases (in thousands):


	As of September 30, 2022
Assets
Operating lease right-of-use assets	$	5,951

Liabilities
Operating lease right-of-use liabilities, current	$	1,990
Operating lease right-of-use liabilities, net of current portion		4,768
Total operating lease liabilities	$	6,758

During the nine months ended September 30, 2022, the Company made cash payments of $0.8 million for operating leases. Future minimum lease payments under non-cancelable leases as of September 30, 2022, were as detailed below (in thousands):


	As of September 30, 2022
2022 (remaining 3 months)	$	597
2023		2,417
2024		2,478
2025		1,586
2026		476
Total undiscounted lease payments		7,554
Less: imputed interest		(796	)
Total operating lease liabilities	$	6,758

As of September 30, 2022, the weighted average remaining lease term was 3.2 years and the weighted average incremental borrowing rate used to determine the operating lease right-of-use assets was 7.3%.

ASC 840 Disclosures

Future minimum lease payments under non-cancelable leases as of December 31, 2021, were as detailed below (in thousands):


	As of December 31, 2021
2022	$	532
2023		541
2024		555
2025		563
2026		476
Total operating lease liabilities	$	2,667

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Cash flows used in operating activities:
Net loss	$ (155,671)	$ (59,587)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense	15,623	2,045
Depreciation expense	305	30
Amortization (accretion) of investment premiums (discounts)	(196)	23
Change in fair value of convertible notes		5,228
Changes in operating assets and liabilities:
Accounts receivable, net	(137)
Inventories	(563)
Interest receivable	(61)
Prepaid expenses and other current assets	(2,879)	(1,764)
Operating lease right-of-use assets	1,208
Other assets	(456)	125
Accounts payable	2,654	(716)
Accrued expenses and deferred rent	10,435	8,061
Operating lease liabilities	(436)
Net cash used in operating activities	(130,174)	(46,555)
Cash flows used in investing activities:
Purchases of property and equipment	(1,906)	(167)
Purchases of investments	(154,313)	(49,053)
Proceeds from maturities of short-term investments	145,411
Net cash used in investing activities	(10,808)	(49,220)
Cash flows provided by financing activities:
Proceeds from initial public offering	200,897
Initial public offering costs paid	(1,518)
Proceeds from issuance of convertible notes—related parties		14,272
Proceeds from issuance of convertible notes		11,887
Proceeds from issuance of Series C-1 redeemable convertible preferred stock, net of issuance costs		134,791
Issuance costs related to conversion of convertible notes		(50)
Payment of deferred offering costs		(1,527)
Proceeds from exercise of stock options	248	198
Net cash provided by financing activities	199,627	159,571
Effect of exchange rate changes on cash, cash equivalents and restricted cash	(572)	4
Net increase in cash, cash equivalents and restricted cash	58,073	63,800
Cash, cash equivalents and restricted cash, beginning of period	50,380	13,066
Cash, cash equivalents and restricted cash, end of period	108,453	76,866
Supplemental disclosure of cash flow information:
Unrealized loss on short-term investments	165	(5)
Purchases of property and equipment included in accounts payable	43	41
Right-of-use assets and liabilities upon ASC842 adoption	2,201
Right-of-use assets obtained in exchange for lease liabilities	4,958
Movement of deferred offering costs to equity	4,518
Initial public offering costs included in accounts payable and accrued expenses	526
Public offering costs included in accounts payable and accrued expenses	570
Deferred offering costs included in accounts payable and accrued expenses		189
Conversion of convertible notes and accrued interest into redeemable convertible preferred stock		$ 32,548
Conversion of preferred stock to common stock upon initial public offering	239,351
Income taxes paid	$ 27

CONDENSED CONSOLIDATED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) $ in Thousands	Total	Series A Redeemable Convertible Preferred Share	Series B Redeemable Convertible Preferred Shares	Series C-1 Redeemable Convertible Preferred Shares	Series C-2 Redeemable Convertible Preferred Shares	Common Stock	Additional Paid-In Capital	Accumulated Other Comprehensive Loss	Accumulated Deficit
Beginning Balance, Shares at Dec. 31, 2020		6,289,609	14,496,835
Beginning Balance at Dec. 31, 2020		$ 7,675	$ 64,387
Beginning Balance, Shares at Dec. 31, 2020						6,137,206
Beginning Balance at Dec. 31, 2020	$ (66,725)					$ 1	$ 1,188		$ (67,914)
Issuance of common stock upon exercise of stock options, Shares						290,032
Issuance of common stock upon exercise of stock options	31						31
Stock-based compensation expense	586						586
Net loss	(14,523)								(14,523)
Ending Balance, Shares at Mar. 31, 2021		6,289,609	14,496,835
Ending Balance at Mar. 31, 2021		$ 7,675	$ 64,387
Ending Balance, Shares at Mar. 31, 2021						6,427,238
Ending Balance at Mar. 31, 2021	(80,631)					$ 1	1,805		(82,437)
Beginning Balance, Shares at Dec. 31, 2020		6,289,609	14,496,835
Beginning Balance at Dec. 31, 2020		$ 7,675	$ 64,387
Beginning Balance, Shares at Dec. 31, 2020						6,137,206
Beginning Balance at Dec. 31, 2020	(66,725)					$ 1	1,188		(67,914)
Net loss	(59,587)
Ending Balance, Shares at Sep. 30, 2021		6,289,609	14,496,835	13,150,430	3,170,585
Ending Balance at Sep. 30, 2021		$ 7,675	$ 64,387	$ 134,791	$ 32,498
Ending Balance, Shares at Sep. 30, 2021						6,799,157
Ending Balance at Sep. 30, 2021	(124,070)					$ 1	3,431	$ (1)	(127,501)
Beginning Balance, Shares at Mar. 31, 2021		6,289,609	14,496,835
Beginning Balance at Mar. 31, 2021		$ 7,675	$ 64,387
Beginning Balance, Shares at Mar. 31, 2021						6,427,238
Beginning Balance at Mar. 31, 2021	(80,631)					$ 1	1,805		(82,437)
Issuance of common stock upon exercise of stock options, Shares						9,684
Issuance of common stock upon exercise of stock options	3						3
Stock-based compensation expense	657						657
Net loss	(21,922)								(21,922)
Ending Balance, Shares at Jun. 30, 2021		6,289,609	14,496,835
Ending Balance at Jun. 30, 2021		$ 7,675	$ 64,387
Ending Balance, Shares at Jun. 30, 2021						6,436,922
Ending Balance at Jun. 30, 2021	(101,893)					$ 1	2,465		(104,359)
Issuance of common stock upon exercise of stock options, Shares				13,150,430		362,235
Issuance of common stock upon exercise of stock options	164			$ 134,791			164
Conversion of preferred stock into common stock upon initial public offering, Shares					3,170,585
Conversion of preferred stock into common stock upon initial public offering					$ 32,498
Stock-based compensation expense	802						802
Other comprehensive loss	(1)							(1)
Net loss	(23,142)								(23,142)
Ending Balance, Shares at Sep. 30, 2021		6,289,609	14,496,835	13,150,430	3,170,585
Ending Balance at Sep. 30, 2021		$ 7,675	$ 64,387	$ 134,791	$ 32,498
Ending Balance, Shares at Sep. 30, 2021						6,799,157
Ending Balance at Sep. 30, 2021	$ (124,070)					$ 1	3,431	(1)	(127,501)
Beginning Balance, Shares at Dec. 31, 2021	37,107,459	6,289,609	14,496,835	13,150,430	3,170,585
Beginning Balance at Dec. 31, 2021	$ 239,351	$ 7,675	$ 64,387	$ 134,791	$ 32,498
Beginning Balance, Shares at Dec. 31, 2021	7,020,487					7,020,487
Beginning Balance at Dec. 31, 2021	$ (151,168)					$ 1	4,667	9	(155,845)
Conversion of preferred stock into common stock upon initial public offering, Shares						39,474,330
Conversion of preferred stock into common stock upon initial public offering	239,351					$ 4	239,347
Conversion of preferred stock into common stock upon initial public offering, Shares		(6,289,609)	(14,496,835)	(13,150,430)	(3,170,585)
Conversion of preferred stock into common stock upon initial public offering		$ (7,675)	$ (64,387)	$ (134,791)	$ (32,498)
Issuance of common stock upon initial public offering, net of issuance costs, Shares						11,369,369
Issuance of common stock upon initial public offering, net of issuance costs	196,379					$ 1	196,378
Stock-based compensation expense	4,392						4,392
Other comprehensive loss	(160)							(160)
Net loss	(47,848)								(47,848)
Ending Balance, Shares at Mar. 31, 2022						57,864,186
Ending Balance at Mar. 31, 2022	$ 240,946					$ 6	444,784	(151)	(203,693)
Beginning Balance, Shares at Dec. 31, 2021	37,107,459	6,289,609	14,496,835	13,150,430	3,170,585
Beginning Balance at Dec. 31, 2021	$ 239,351	$ 7,675	$ 64,387	$ 134,791	$ 32,498
Beginning Balance, Shares at Dec. 31, 2021	7,020,487					7,020,487
Beginning Balance at Dec. 31, 2021	$ (151,168)					$ 1	4,667	9	(155,845)
Issuance of common stock upon exercise of stock options, Shares	669,040
Net loss	$ (155,671)
Ending Balance, Shares at Sep. 30, 2022	0	0	0	0	0
Ending Balance, Shares at Sep. 30, 2022	58,533,226					58,533,226
Ending Balance at Sep. 30, 2022	$ 144,028					$ 6	456,263	(725)	(311,516)
Beginning Balance, Shares at Mar. 31, 2022						57,864,186
Beginning Balance at Mar. 31, 2022	$ 240,946					$ 6	444,784	(151)	(203,693)
Issuance of common stock upon exercise of stock options, Shares	669,040
Issuance of common stock upon exercise of stock options	$ 248						248
Stock-based compensation expense	5,707						5,707
Other comprehensive loss	(45)							(45)
Net loss	(54,067)								(54,067)
Ending Balance, Shares at Jun. 30, 2022						58,533,226
Ending Balance at Jun. 30, 2022	192,789					$ 6	450,739	(196)	(257,760)
Stock-based compensation expense	5,524						5,524
Other comprehensive loss	(529)							(529)
Net loss	$ (53,756)								(53,756)
Ending Balance, Shares at Sep. 30, 2022	0	0	0	0	0
Ending Balance, Shares at Sep. 30, 2022	58,533,226					58,533,226
Ending Balance at Sep. 30, 2022	$ 144,028					$ 6	$ 456,263	$ (725)	$ (311,516)

Short-Term Investments

9 Months Ended

Sep. 30, 2022

Investments, Debt and Equity Securities [Abstract]

Short-Term Investments

3. SHORT-TERM INVESTMENTS

Short-term investments, which are classified as available-for-sale, consisted of the following:


Balance at September 30, 2022:	Amortized Cost Basis		Unrealized Loss			Fair Value
	(in thousands)
Treasury bills	$	5,999	$	(1	)	$	5,998
Commercial paper		30,957		—			30,957
Corporate debt securities		18,074		(170	)		17,904
Total short-term investments	$	55,030	$	(171	)	$	54,859


Balance at December 31, 2021:	Amortized Cost Basis		Unrealized Loss			Fair Value
	(in thousands)
Commercial paper	$	33,979	$	(1	)	$	33,978
Corporate debt securities		11,953		(4	)		11,949
Total short-term investments	$	45,932	$	(5	)	$	45,927

As of September 30, 2022 and December 31, 2021, all investments had contractual maturities within one year. The amortized cost of available-for-sale securities is adjusted for amortization of premiums and accretion of discounts until maturity. Such amortization and accretion are included in interest income. There were no realized gains and losses recognized during the three and nine months ended September 30, 2022. The Company evaluates short-term investments for other-than-temporary impairment at the balance sheet date. Declines in fair value, if any, determined to be other-than-temporary are also included in other income, net.

When assessing short-term investments for other-than-temporary declines in value, the Company considers such factors as, among other things, how significant the decline in value is as a percentage of the original cost, how long the market value of the investment has been less than its original cost, and the Company’s ability and intent to retain the investment for a period of time sufficient to allow for any anticipated recovery in fair value and market conditions in general. The Company has the ability

to hold its investments until maturity and generally does not intend to sell any investments prior to recovery of their amortized cost basis for any investment in an unrealized loss position. As of September 30, 2022 and December 31, 2021, there were no impairment charges on short-term investments.

Stockholders' Equity (Deficit)

9 Months Ended

Sep. 30, 2022

Equity [Abstract]

Stockholders' Equity (Deficit)

9. Stockholders’ EQUITY (DEFICIT)

Common Stock

Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders provided, however, that, except as otherwise required by law, holders of common stock shall not be entitled to vote on any amendment to the Corporation’s Certificate of Incorporation that relates solely to the terms of one or more outstanding series of Preferred Stock if the holders of such affected series are entitled, either separately or together with the holders of one or more other such series, to vote thereon pursuant to the Certificate of Incorporation or pursuant to the Delaware General Corporation Law. Common stockholders are entitled to receive dividends, as may be declared by the Company’s Board of Directors, if any, subject to the preferential dividend rights of the Preferred Stock. No dividends have been declared or paid during the nine months ended September 30, 2022 and 2021.

The Company had reserved shares of common stock for issuance in connection with the following:


	September 30, 2022		December 31, 2021
Common stock authorized		300,000,000		56,500,000
Common stock issued and outstanding		58,533,226		7,020,487
Common stock authorized and reserved for future issuances:
Series A redeemable convertible preferred stock		—		6,407,256
Series B redeemable convertible preferred stock		—		16,746,059
Series C-1 redeemable convertible preferred stock		—		13,150,430
Series C-2 redeemable convertible preferred stock		—		3,170,585
Common stock reserved for the exercise of stock options		8,575,449		5,339,011
Common stock reserved for the unvested restricted stock units		687,913		—
Common stock reserved for future issuance of share-based awards		3,056,609		1,444,492
Total common stock authorized and reserved for future issuance		12,319,971		46,257,833
Unreserved common stock available for future issuance		229,146,803		3,221,680

- Definition

The entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income.

+ References

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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+ Details

Net Loss Per Share (Tables)

9 Months Ended

Sep. 30, 2022

Earnings Per Share [Abstract]

Schedule of Antidilutive Shares Excluded from the Calculation of Diluted Net Loss Per Share

The following common stock equivalents outstanding at each period end have been excluded from the calculation of diluted net loss per share because their inclusion would have been antidilutive:


	September 30,		December 31,
	2022		2021
Options to purchase common stock		8,575,449		5,339,011
Unvested restricted stock units		687,913		—
Redeemable convertible preferred stock		—		39,474,330

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Statement of Comprehensive Income [Abstract]
Net loss	$ (53,756)	$ (23,142)	$ (155,671)	$ (59,587)
Other comprehensive loss:
Foreign currency translation adjustment	(559)	4	(569)	4
Net unrealized gain (loss) on investments held	30	(5)	(165)	(5)
Other comprehensive loss	(529)	(1)	(734)	(1)
Comprehensive loss	$ (54,285)	$ (23,143)	$ (156,405)	$ (59,588)

- 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

Summary of Significant Accounting Policies - Additional Information (Details) - USD ($)	3 Months Ended	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2022	Jan. 10, 2022	Jan. 01, 2022
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Incremental costs expenses	$ 0	$ 0
Operating lease right-of-use assets	5,951,000	5,951,000	$ 5,000,000.0
Operating lease, liabilities	$ 6,758,000	$ 6,758,000	$ 5,000,000.0
Maximum
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Amortization Recognized Period		1 year
ASC 842
New Accounting Pronouncements or Change in Accounting Principle [Line Items]
Operating lease right-of-use assets				$ 2,200,000
Operating lease, liabilities				$ 2,200,000