0001558370-24-015155 | 10-Q | XBRL Viewer | Scholar Rock Holding Corp

Commitments and Contingencies

9 Months Ended

Sep. 30, 2024

9. Commitments and Contingencies

Operating Lease

In November 2019, the Company entered into a lease of office and laboratory space at 301 Binney Street in Cambridge, Massachusetts to be used as its new corporate headquarters (the “Lease”). The expiration date of the Lease was originally in August 2025 and included an option to extend the term by two years. The base rent under the original Lease was $6.9 million per year, subject to an annual increase of 3.5%, and the Company was subject to a free-rent period through mid-August 2020. Variable lease payments include the Company’s allocated share of costs incurred and expenditures made by the landlord in the operation and management of the building. The Lease included incentives of $14.1 million in the form of an allowance for tenant improvements related to the design and build out of the space. In connection with the Lease, the Company has secured a letter of credit for $2.3 million which renews automatically each year. The Lease commencement date, for accounting purposes, was reached in September 2020.

In May 2024, the Company entered into the First Amendment (the “Lease Amendment”) to the Lease to extend the term for approximately two years, commencing on August 19, 2025 (the “First Extension Term”) with the base rent to start at approximately $6.2 million per year, followed by a 3% annual increase. Pursuant to the Lease Amendment, the Company also has an option to extend the term of the Lease by five years, upon the expiration of the First Extension Term.

Other information related to the Lease is as follows (in thousands, except lease term and discount rate):


	For Three Months Ended		For Nine Months Ended
	September 30,		September 30,
	2024		2024
Lease Cost:
Operating lease cost	$	1,714	$	5,290
Variable lease cost		363		1,086
Total lease cost	$	2,077	$	6,376


	For Nine Months Ended
	September 30,
	2024
Other information:
Operating cash flows used for operating leases	$	6,000
Weighted average remaining lease term		2.9
Weighted average incremental borrowing rate		13.1	%

Legal Proceedings

The Company, from time to time, may be party to litigation arising in the ordinary course of its business. The Company was not subject to any material legal proceedings during the nine months ended September 30, 2024 and 2023.

Marketable Securities (Tables)

9 Months Ended

Sep. 30, 2024

Marketable Securities

Summary of investments

The following table summarizes the Company’s investments as of September 30, 2024 (in thousands):


			Gross
	Amortized		Unrealized				Estimated
	Cost		Gains		Losses		Fair Value
Marketable securities available-for-sale:
U.S. treasury obligations and government agency securities	$	62,546	$	128	$	—	$	62,674
Total available-for-sale securities	$	62,546	$	128	$	—	$	62,674

The following table summarizes the Company’s investments as of December 31, 2023 (in thousands):


			Gross
	Amortized		Unrealized				Estimated
	Cost		Gains		Losses		Fair Value
Marketable securities available-for-sale:
U.S. treasury obligations and government agency securities	$	177,991	$	93	$	(1)	$	178,083
Total available-for-sale securities	$	177,991	$	93	$	(1)	$	178,083

CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Cash flows from operating activities:
Net loss	$ (179,840)	$ (119,663)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	1,542	2,172
Amortization of debt discount and debt issuance costs	206	215
Equity-based compensation	27,126	20,191
Amortization/accretion of investment securities	(3,945)	(4,417)
Non-cash operating lease expense	4,034	5,546
Change in operating assets and liabilities:
Prepaid expenses and other current assets	(5,734)	2,817
Other assets	608	387
Accounts payable	606	(2,026)
Accrued expenses	8,821	(6,924)
Operating lease liabilities	(4,744)	(6,117)
Other liabilities	(116)	(58)
Net cash used in operating activities	(151,436)	(107,877)
Cash flows from investing activities:
Purchases of property and equipment	(76)	(71)
Proceeds from sale of property and equipment		13
Purchases of marketable securities	(82,710)	(186,673)
Maturities of marketable securities	202,100	253,000
Net cash provided by investing activities	119,314	66,269
Cash flows from financing activities:
Proceeds from sale of common shares, net of issuance costs		5,223
Proceeds from pre-funded and common warrant exercises	6,106
Debt modification payment	(125)
Proceeds from stock option exercises	677	819
Other		3
Net cash provided by financing activities	6,658	6,045
Net decrease in cash, cash equivalents and restricted cash	(25,464)	(35,563)
Cash, cash equivalents and restricted cash, beginning of period	104,262	105,773
Cash, cash equivalents and restricted cash, end of period	78,798	70,210
Supplemental disclosure of non-cash items:
Property and equipment purchases in accounts payable & accrued expenses	22
Operating lease liability, adjustment from rent modification	9,451
Supplemental cash flow information:
Cash paid for interest	$ 5,003	$ 4,743

Summary of Significant Accounting Policies (Policies)

9 Months Ended

Sep. 30, 2024

Summary of Significant Accounting Policies

Cash, Cash Equivalents and Restricted Cash

The following table reconciles cash, cash equivalents and restricted cash per the balance sheet to the statement of cash flows (in thousands):


	As of September 30,
	2024		2023
Cash and cash equivalents	$	76,391	$	67,598
Restricted cash		2,407		2,612
	$	78,798	$	70,210

Unaudited Interim Financial Information

The consolidated financial statements of the Company included herein have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). The unaudited consolidated financial statements include the accounts of Scholar Rock Holding Corporation and its wholly owned subsidiaries. All intercompany transactions and balances have been eliminated in consolidation. In the opinion of management, the information furnished reflects all adjustments, all of which are of a normal and recurring nature, necessary for a fair presentation of

the results for the reported interim periods. The Company considers events or transactions that occur after the balance sheet date but before the financial statements are issued to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. The results of operations for interim periods are not necessarily indicative of results to be expected for the full year or any other interim period.

Use of Estimates

The preparation of financial statements in accordance with accounting principles generally accepted in the U.S. (“GAAP”) requires management to make estimates and judgments that may affect the reported amounts of assets and liabilities and related disclosures of contingent assets and liabilities at the date of the financial statements and the related reporting of revenues and expenses during the reporting period. Management bases its estimates on historical experience and on various assumptions that are believed to be reasonable under the circumstances. Actual results could differ from those estimates.

Recently Adopted and Recently Issued Accounting Pronouncements

Recently Adopted Accounting Pronouncements

In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). The standard requires that a financial asset or a group of financial assets measured at amortized cost basis to be presented at the net amount expected to be collected. Under previous GAAP, a company only considered past events and current conditions in measuring an incurred loss. Under ASU 2016-13, the information that a company must consider is broadened in developing an expected credit loss estimate for assets measured either collectively or individually. The use of forecasted information incorporates more timely information in the estimate of expected credit loss. The guidance is applied using a modified retrospective, or prospective approach, depending on a specific amendment. In November 2019, the FASB deferred the effective date for smaller reporting companies to fiscal years beginning after December 15, 2022. Therefore, the new standard was effective for the Company on January 1, 2023. The Company established processes and internal controls to comply with the new credit loss standard and related disclosure requirements. The Company’s investment policy has primary objectives of preservation of capital and maintenance of liquidity. As a result, the Company typically invests in money market funds, U.S. treasury obligations and government agency securities. The Company believes that such funds are subject to minimal credit risk. The Company has not experienced any credit losses and does not believe it is exposed to any significant credit risk on these investments. The adoption of this standard did not have a material impact on the Company’s consolidated financial position and results of operations.

Recently Issued Accounting Pronouncements

In November 2023, the FASB issued Accounting Standards Update 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU 2017-07”). The standard requires disclosure of incremental segment information on an annual and interim basis and allows for multiple measures of a segment’s profit or loss provided that one of those measures is consistent with GAAP. The amendments in this update do not change how a public company identifies its operating segments, aggregates those operating segments, or applies the quantitative thresholds to determine its reportable segments, but rather requires public entities to provide in interim periods all disclosures about a reporting segment’s profit or loss and assets that are currently required annually. ASU 2023-07 becomes effective for the annual period starting on January 1, 2024, and for interim periods starting on January 1, 2025. The option for early adoption is permitted, however, the Company has decided not to early adopt, does not anticipate a material impact to its net financial position, and is still evaluating the impact on its disclosures in future years as a result of the adoption of ASU 2023-07.

In December 2023, the FASB issued Accounting Standards Update 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), which enhances the transparency of income tax disclosures to provide information to investors to better assess how a company’s operations and related tax risks, tax planning and operational opportunities affect its tax rate and prospects for future cash flows. This requires public entities to disclose additional categories in the rate reconciliation regarding federal and state income taxes, and provide more details surrounding reconciling items if a quantitative threshold is met. The effective date for public companies is for annual periods starting on January 1, 2025. Early adoption is permitted for annual financial statements that have not yet been issued or made

available for issuance, however, the Company has decided not to early adopt, does not anticipate a material impact to its net financial position, and is still evaluating the impact on its disclosures will be in future years as a result of the adoption of ASU 2023-09.

Prepaid Expenses and Other Assets (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Prepaid expenses and other current assets
Prepaid external research and development expense	$ 8,876	$ 4,059
Prepaid other	2,706	2,281
Receivables	1,120	1,076
Prepaid insurance	739	635
Prepaid professional and consulting expense	421	205
Total prepaid expenses and other current assets	13,862	8,256
Other long-term assets
Prepaid external research and development expense	3,397	4,074
Prepaid other	394	312
Prepaid insurance	18	31
Total other long-term assets	$ 3,809	$ 4,417

Subsequent Events

9 Months Ended

Sep. 30, 2024

Subsequent Events

Subsequent Events

12. Subsequent Events

On October 8, 2024, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with J.P. Morgan Securities LLC, Jefferies LLC and Piper Sandler & Co., as representatives of the several underwriters named therein (the “Underwriters”), relating to the issuance and sale of an aggregate of 10,265,488 shares of the Company’s common stock at $28.25 per share and pre-funded warrants to purchase 353,983 shares of its common stock. The offering price per pre-funded warrant was $28.2499, which equals the per share public offering price for the common shares less the $0.0001 exercise price for each such pre-funded warrant. The pre-funded warrants are exercisable at any time and only expire when exercised in full. The offering closed on October 10, 2024. Pursuant to the Underwriting Agreement, the Company also granted the Underwriters a 30-day option to purchase up to 1,592,920 additional shares (the “Option Shares”) of common stock, which was exercised in full on October 16, 2024. Total proceeds of the transaction, including the Option Shares were approximately $324.4 million, net of underwriting discounts and estimated offering expenses.

Equity-Based Compensation - Assumptions (Details) - Employee Stock Option	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Assumptions used in determining the fair value of options
Risk-free interest rate	4.09%	3.87%
Expected dividend yield	0.00%	0.00%
Expected term (years to liquidity)	6 years	6 years 1 month 13 days
Expected volatility	91.15%	90.54%

Equity-Based Compensation

9 Months Ended

Sep. 30, 2024

Equity-Based Compensation

Equity-Based Compensation

8. Equity-Based Compensation

The Company recorded equity-based compensation expense related to all equity-based awards, which was allocated as follows in the consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2024 and 2023 (in thousands):


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2024		2023		2024		2023
Research and development expense	$	4,398	$	2,858	$	11,980	$	8,341
General and administrative expense		5,252		4,345		15,146		11,850
	$	9,650	$	7,203	$	27,126	$	20,191

The following table summarizes the Company’s unrecognized equity-based compensation expense as of September 30, 2024:



	As of September 30, 2024
		Unrecognized Expense (in thousands)	Weighted Average Remaining Period of Recognition (years)
Restricted Stock Units	$	35,001	2.8
Stock Options		40,456	2.6
	$	75,457

Restricted Stock Units

The following table summarizes the Company’s restricted stock unit activity for the current year:


		Weighted
		Average Grant
	Number of Units	Date Fair Value
Restricted stock units as of December 31, 2023	2,089,552	$	11.92
Granted	2,126,820	$	13.52
Vested	(649,559)	$	12.38
Forfeited	(179,956)	$	12.42
Restricted stock units as of September 30, 2024	3,386,857	$	12.82

The total fair value of restricted stock units vested during the nine months ended September 30, 2024 was $8.6 million.

Stock Options

The following table summarizes the Company’s stock option activity for the current year:


				Weighted
		Weighted		Average
	Number of	Average		Remaining	Aggregate
	Shares	Exercise Price		Contractual Term	Intrinsic Value
				(in years)	(in thousands)
Outstanding as of December 31, 2023	7,300,953	$	15.00	7.90	$	52,299
Granted	2,835,756	$	13.52
Exercised	(94,988)	$	5.79
Cancelled	(371,557)	$	19.94
Outstanding as of September 30, 2024	9,670,164	$	14.47	7.80	$	2,967
Options exercisable as of September 30, 2024	4,831,989	$	16.50	6.72	$	2,310

Using the Black-Scholes option pricing model, the weighted average fair value of options granted during the nine months ended September 30, 2024 was $10.38.

The following weighted average assumptions were used in determining the fair value of options granted in the nine months ended September 30, 2024 and 2023:


	Nine Months Ended
	September 30,
	2024		2023
Risk-free interest rate	4.09	%	3.87	%
Expected dividend yield	0.0	%	0.0	%
Expected term (years to liquidity)	6.00		6.12
Expected volatility	91.15	%	90.54	%

Nature of the Business (Details) - USD ($) $ in Thousands	1 Months Ended	3 Months Ended						9 Months Ended
Nature of the Business (Details) - USD ($) $ in Thousands	Oct. 31, 2024	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
Net Income (Loss)		$ (64,479)	$ (58,508)	$ (56,853)	$ (42,359)	$ (37,925)	$ (39,379)	$ (179,840)	$ (119,663)
Accumulated deficit		$ (856,261)						$ (856,261)		$ (676,421)
Sale of common shares, net of issuance costs						$ 4,396	$ 827
Subsequent event
Sale of common shares, net of issuance costs	$ 324,400

- Definition

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

+ References

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-URI https://asc.fasb.org/1943274/2147482790/220-10-45-1A

Reference 36: http://www.xbrl.org/2003/role/disclosureRef
-Topic 220
-SubTopic 10
-Name Accounting Standards Codification
-Section 45
-Paragraph 1B
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482790/220-10-45-1B

Reference 37: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 942
-SubTopic 220
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.9-04(22))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478524/942-220-S99-1

+ Details

- Definition

Amount of accumulated undistributed earnings (deficit).

+ References + Details

- Definition

Equity impact of the value of new stock issued during the period. Includes shares issued in an initial public offering or a secondary public offering.

+ References + Details

Equity-Based Compensation (Tables)

9 Months Ended

Sep. 30, 2024

Equity-Based Compensation

Summary of allocation of equity-based compensation


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2024		2023		2024		2023
Research and development expense	$	4,398	$	2,858	$	11,980	$	8,341
General and administrative expense		5,252		4,345		15,146		11,850
	$	9,650	$	7,203	$	27,126	$	20,191

Summary of unrecognized equity-based compensation expense



	As of September 30, 2024
		Unrecognized Expense (in thousands)	Weighted Average Remaining Period of Recognition (years)
Restricted Stock Units	$	35,001	2.8
Stock Options		40,456	2.6
	$	75,457

Summary of stock activity


		Weighted
		Average Grant
	Number of Units	Date Fair Value
Restricted stock units as of December 31, 2023	2,089,552	$	11.92
Granted	2,126,820	$	13.52
Vested	(649,559)	$	12.38
Forfeited	(179,956)	$	12.42
Restricted stock units as of September 30, 2024	3,386,857	$	12.82

Summary of stock option activity


				Weighted
		Weighted		Average
	Number of	Average		Remaining	Aggregate
	Shares	Exercise Price		Contractual Term	Intrinsic Value
				(in years)	(in thousands)
Outstanding as of December 31, 2023	7,300,953	$	15.00	7.90	$	52,299
Granted	2,835,756	$	13.52
Exercised	(94,988)	$	5.79
Cancelled	(371,557)	$	19.94
Outstanding as of September 30, 2024	9,670,164	$	14.47	7.80	$	2,967
Options exercisable as of September 30, 2024	4,831,989	$	16.50	6.72	$	2,310

Schedule of weighted average assumptions in fair value


	Nine Months Ended
	September 30,
	2024		2023
Risk-free interest rate	4.09	%	3.87	%
Expected dividend yield	0.0	%	0.0	%
Expected term (years to liquidity)	6.00		6.12
Expected volatility	91.15	%	90.54	%

Fair Value of Financial Assets and Liabilities

9 Months Ended

Sep. 30, 2024

Fair Value of Financial Assets and Liabilities

Fair Value of Financial Assets and Liabilities

3. Fair Value of Financial Assets and Liabilities

The following tables summarize the assets and liabilities measured at fair value on a recurring basis at September 30, 2024 and December 31, 2023 (in thousands):


	Fair Value Measurements at September 30, 2024
	Total		Level 1		Level 2		Level 3
Assets:
Money market funds, included in cash and cash equivalents	$	70,960	$	70,960	$	—	$	—
U.S. treasury obligations, included in cash and cash equivalents		—		—		—		—
Marketable securities:
U.S. treasury obligations and government agency securities		62,674		62,674		—		—
Total assets	$	133,634	$	133,634	$	—	$	—


	Fair Value Measurements at December 31, 2023
	Total		Level 1		Level 2		Level 3
Assets:
Money market funds, included in cash and cash equivalents	$	61,764	$	61,764	$	—	$	—
U.S. treasury obligations, included in cash and cash equivalents		30,765		30,765		—		—
Marketable securities:
U.S. treasury obligations and government agency securities		178,083		178,083		—		—
Total assets	$	270,612	$	270,612	$	—	$	—

Cash, cash equivalents and marketable securities are Level 1 assets and include investments in money market funds and U.S. treasury obligations and government agency securities that are valued using quoted market prices. Accordingly, money market funds and government funds are categorized as Level 1 as of September 30, 2024 and December 31, 2023. There were no transfers of assets between fair value measurement levels during the nine months ended September 30, 2024 or 2023.

The carrying amounts reflected in the balance sheets for prepaid expenses and other current assets, accounts payable, and accrued expenses approximate their fair values at September 30, 2024 and December 31, 2023, due to their short-term nature.

The Company believes the terms of its debt reflect current market conditions for an instrument with similar terms and maturity, therefore the carrying value of the Company's debt approximates its fair value based on Level 3 of the fair value hierarchy.

- 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

Reference 1: http://www.xbrl.org/2003/role/exampleRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 55
-Paragraph 107
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482078/820-10-55-107

Reference 2: http://www.xbrl.org/2003/role/exampleRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 55
-Paragraph 100
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482078/820-10-55-100

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (c)(3)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482106/820-10-50-2

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 6A
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482106/820-10-50-6A

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2E
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482106/820-10-50-2E

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 6A
-Subparagraph (h)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482106/820-10-50-6A

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 6A
-Subparagraph (f)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482106/820-10-50-6A

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 6A
-Subparagraph (e)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482106/820-10-50-6A

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 6A
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482106/820-10-50-6A

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (h)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482106/820-10-50-2

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (g)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482106/820-10-50-2

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 940
-SubTopic 820
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478119/940-820-50-1

+ Details

Net Loss per Share - Antidilutive (Details) - shares	9 Months Ended
Net Loss per Share - Antidilutive (Details) - shares	Sep. 30, 2024	Sep. 30, 2023
Anti-dilutive securities
Anti-dilutive securities excluded from the calculation of net loss per share	22,214,517	19,963,200
Pre-funded warrants
Anti-dilutive securities
Exercise of pre-funded and common warrants (in shares)	2,526,833
Outstanding warrants (in shares)	17,008,164
Pre-funded warrants \| Aggregate
Anti-dilutive securities
Exercise of pre-funded and common warrants (in shares)	10,681,528
Restricted stock units
Anti-dilutive securities
Anti-dilutive securities excluded from the calculation of net loss per share	3,386,857	2,081,607
Employee Stock Option
Anti-dilutive securities
Anti-dilutive securities excluded from the calculation of net loss per share	9,670,164	7,422,412
Warrants, non pre-funded
Anti-dilutive securities
Anti-dilutive securities excluded from the calculation of net loss per share	9,157,496	10,459,181

Accrued Expenses (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Accrued Expenses
Accrued external research and development expense	$ 15,040	$ 6,825
Accrued payroll and related expenses	9,969	10,591
Accrued professional and consulting expense	3,420	2,267
Accrued other	831	766
Accrued expenses	$ 29,260	$ 20,449

Commitments and Contingencies (Details) - USD ($) $ in Thousands	1 Months Ended		3 Months Ended	9 Months Ended
	May 31, 2024	Nov. 30, 2019	Sep. 30, 2024	Sep. 30, 2024
Lease Cost:
Operating lease cost			$ 1,714	$ 5,290
Variable lease cost			363	1,086
Total lease cost			$ 2,077	6,376
Operating cash flows used for operating leases				$ 6,000
Weighted average remaining lease term			2 years 10 months 24 days	2 years 10 months 24 days
Weighted average incremental borrowing rate			13.10%	13.10%
301 Binney St, Cambridge MA
Leased assets
Option to extend the term	true	true
Renewal term	2 years	2 years
Base rent	$ 6,200	$ 6,900
Annual upward adjustment (as a percent)	3.00%	3.50%
Incentive to lease		$ 14,100
Letter of credit		$ 2,300
301 Binney St, Cambridge MA \| First extension
Leased assets
Renewal term	5 years

Commitments and Contingencies (Tables)

9 Months Ended

Sep. 30, 2024

Commitments and Contingencies.

Summary of lease costs

Other information related to the Lease is as follows (in thousands, except lease term and discount rate):


	For Three Months Ended		For Nine Months Ended
	September 30,		September 30,
	2024		2024
Lease Cost:
Operating lease cost	$	1,714	$	5,290
Variable lease cost		363		1,086
Total lease cost	$	2,077	$	6,376


	For Nine Months Ended
	September 30,
	2024
Other information:
Operating cash flows used for operating leases	$	6,000
Weighted average remaining lease term		2.9
Weighted average incremental borrowing rate		13.1	%

Accrued Expenses

9 Months Ended

Sep. 30, 2024

Accrued Expenses

Accrued Expenses

6. Accrued Expenses

As of September 30, 2024 and December 31, 2023, accrued expenses consist of the following (in thousands):


	As of
	September 30,		December 31,
	2024		2023
Accrued external research and development expense	$	15,040	$	6,825
Accrued payroll and related expenses		9,969		10,591
Accrued professional and consulting expense		3,420		2,267
Accrued other		831		766
	$	29,260	$	20,449

Summary of Significant Accounting Policies - Cash (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023	Sep. 30, 2023	Dec. 31, 2022
Cash and cash equivalents and restricted cash
Cash and cash equivalents	$ 76,391	$ 101,855	$ 67,598
Restricted cash	2,407	2,407	2,612
Total	$ 78,798	$ 104,262	$ 70,210	$ 105,773

Summary of Significant Accounting Policies (Tables)

9 Months Ended

Sep. 30, 2024

Summary of Significant Accounting Policies

Reconciliation of cash, cash equivalents and restricted cash

The following table reconciles cash, cash equivalents and restricted cash per the balance sheet to the statement of cash flows (in thousands):


	As of September 30,
	2024		2023
Cash and cash equivalents	$	76,391	$	67,598
Restricted cash		2,407		2,612
	$	78,798	$	70,210

CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares	Sep. 30, 2024	Dec. 31, 2023
CONSOLIDATED BALANCE SHEETS
Preferred stock, par value	$ 0.001	$ 0.001
Preferred stock, shares authorized	10,000,000	10,000,000
Preferred stock, shares issued	0	0
Preferred stock, shares outstanding	0	0
Common stock, par value	$ 0.001	$ 0.001
Common stock, shares authorized	300,000,000	300,000,000
Common stock, shares issued	80,081,535	75,979,495
Common stock, shares outstanding	80,081,535	75,979,495

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Operating expenses:
Research and development	$ 48,719	$ 30,337	$ 134,185	$ 86,939
General and administrative	16,061	13,335	48,512	36,324
Total operating expenses	64,780	43,672	182,697	123,263
Loss from operations	(64,780)	(43,672)	(182,697)	(123,263)
Other income (expense), net	301	1,313	2,857	3,600
Net loss	$ (64,479)	$ (42,359)	$ (179,840)	$ (119,663)
Net loss per share, basic (in dollars per share)	$ (0.66)	$ (0.53)	$ (1.86)	$ (1.49)
Net loss per share, diluted (in dollars per share)	$ (0.66)	$ (0.53)	$ (1.86)	$ (1.49)
Weighted average common shares outstanding, basic (in shares)	97,050,637	80,606,438	96,587,149	80,115,143
Weighted average common shares outstanding, diluted (in shares)	97,050,637	80,606,438	96,587,149	80,115,143
Comprehensive loss:
Net loss	$ (64,479)	$ (42,359)	$ (179,840)	$ (119,663)
Other comprehensive income:
Unrealized (loss) gain on marketable securities	182	40	36	861
Total other comprehensive income	182	40	36	861
Comprehensive loss	$ (64,297)	$ (42,319)	$ (179,804)	$ (118,802)

Fair Value of Financial Assets and Liabilities - (Details) - Recurring - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Marketable securities:
U.S. Treasury obligations and government agency securities	$ 62,674	$ 178,083
Total assets	133,634	270,612
Money market funds
Assets:
Cash and cash equivalents	70,960	61,764
U.S. Treasury obligations
Assets:
Cash and cash equivalents		30,765
Level 1
Marketable securities:
U.S. Treasury obligations and government agency securities	62,674	178,083
Total assets	133,634	270,612
Level 1 \| Money market funds
Assets:
Cash and cash equivalents	$ 70,960	61,764
Level 1 \| U.S. Treasury obligations
Assets:
Cash and cash equivalents		$ 30,765

Equity-Based Compensation - Expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Equity-based compensation
Equity-based compensation expense	$ 9,650	$ 7,203	$ 27,126	$ 20,191
Research and development expense
Equity-based compensation
Equity-based compensation expense	4,398	2,858	11,980	8,341
General and administrative expense
Equity-based compensation
Equity-based compensation expense	$ 5,252	$ 4,345	$ 15,146	$ 11,850

Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	Sep. 30, 2024	Nov. 07, 2024
Document and Entity Information
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2024
Document Transition Report	false
Securities Act File Number	001-38501
Entity Registrant Name	SCHOLAR ROCK HOLDING CORP
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	82-3750435
Entity Address, Address Line One	301 Binney Street, 3rd Floor
Entity Address, City or Town	Cambridge
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02142
City Area Code	857
Local Phone Number	259 3860
Title of 12(b) Security	Common Stock
Trading Symbol	SRRK
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		93,614,951
Entity Central Index Key	0001727196
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q3
Amendment Flag	false

Insider Trading Arrangements	9 Months Ended
Insider Trading Arrangements	Sep. 30, 2024
Trading Arrangements, by Individual
Rule 10b5-1 Arrangement Adopted	false
Non-Rule 10b5-1 Arrangement Adopted	false
Rule 10b5-1 Arrangement Terminated	false
Non-Rule 10b5-1 Arrangement Terminated	false

Debt

9 Months Ended

Sep. 30, 2024

Debt

Debt

10. Debt

On October 16, 2020 (the “Closing Date”) the Company entered into a Loan and Security Agreement with Oxford Finance LLC (“Oxford”) and Silicon Valley Bank (“SVB”) for $50.0 million (the “Loan and Security Agreement”). Tranche 1 of $25.0 million was funded on the Closing Date. The Company had an additional $25.0 million in loan proceeds available under Tranche 2 which was funded in December 2021, in conjunction with the Company entering into the First Amendment to Loan and Security Agreement with Oxford and SVB. The Loan and Security Agreement was to mature on May 1, 2025 and required interest-only payments through November 2022, with principal payments to commence in December 2022. Pursuant to the Loan and Security Agreement, the Company was required to maintain cash in an SVB account equal to the lesser of 100% of the Company’s consolidated cash or 105% of the dollar amount of the outstanding debt.

On November 10, 2022, the Company entered into the Second Amendment to the Loan and Security Agreement ( “Amendment 2”) to increase the Company’s borrowing capacity under the Loan and Security Agreement to an amount up to $100.0 million, comprised of the original $50.0 million loan which remains outstanding and two additional $25.0 million tranches. The first $25.0 million tranche available under Amendment 2, was available at the Company’s discretion through December 2023 upon achievement of certain development and business performance milestones. The Company did not exercise this tranche. The second $25.0 million tranche available under Amendment 2, may be available upon the Company’s request, at Oxford and SVB’s discretion. Amendment 2 also extended the interest-only payment period for an additional 24 months through November 2024, with principal payments to commence in December 2024. The maturity of the loan was extended to November 2027.

Effective upon Amendment 2, the interest rate on the unpaid principal is the greater of the Wall Street Journal prime rate plus 4.60% or 9.35% per annum. Prepayment is permitted and may include a pre-payment fee ranging from 0% - 3% (of the principal amount being prepaid), depending on when the prepayment is made. The Company is also required to make a final payment equal to 2% of the original principal amount.

In conjunction with Amendment 2, the Company was required to pay $0.9 million for the accrued portion of the final payment on the previous outstanding balance.

On March 10, 2023, SVB was closed by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation (“FDIC”) as receiver. Afterward, the FDIC transferred all deposits of the former Silicon Valley Bank to Silicon Valley Bridge Bank, N.A., as operated by the FDIC. On March 27, 2023, Silicon Valley Bridge Bank was closed by the Office of the Comptroller of the Currency, and the FDIC was appointed as receiver. First Citizens Bank then entered into an agreement with the FDIC to purchase out of FDIC receivership substantially all loans and certain other assets and assume all customer deposits and certain other liabilities of Silicon Valley Bridge Bank. On March 27, 2023, Silicon Valley Bridge Bank and its U.S. branches began operating as Silicon Valley Bank, a division of First Citizens Bank.

On April 18, 2023, the Company entered into the Third Amendment to the Loan and Security Agreement to amend certain provisions relating to the Company’s operating accounts.

On May 17, 2024, the Company entered into the Fourth Amendment to the Loan and Security Agreement (“Loan Amendment No. 4”). The Company currently has $50.0 million outstanding under the Loan and Security Agreement, which was drawn down in two equal tranches. The third $25.0 million tranche is available at the Company’s discretion through December 2024, upon achievement of certain clinical and business milestones, which were amended under Loan Amendment No. 4. The fourth $25.0 million tranche may be available through June 1, 2025 (or through December 1, 2025 upon achievement of certain business milestones) upon the Company’s request, at Oxford and SVB’s discretion. Amendment No. 4 also extends the interest-only payment period for an additional six months through May 2025, with principal payments to commence in June 2025. Additionally, upon achievement of certain business performance milestones, which were achieved in October 2024, the interest-only payment period was extended through November 2025, with principal payments to commence in December 2025.

- Definition

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

+ References

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

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

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

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

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

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

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

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

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

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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
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Reference 14: http://www.xbrl.org/2003/role/disclosureRef
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-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481139/470-20-50-1I

+ Details

Fair Value of Financial Assets and Liabilities (Tables)

9 Months Ended

Sep. 30, 2024

Fair Value of Financial Assets and Liabilities

Schedule of summary of the assets and liabilities measured at fair value on a recurring basis

The following tables summarize the assets and liabilities measured at fair value on a recurring basis at September 30, 2024 and December 31, 2023 (in thousands):


	Fair Value Measurements at September 30, 2024
	Total		Level 1		Level 2		Level 3
Assets:
Money market funds, included in cash and cash equivalents	$	70,960	$	70,960	$	—	$	—
U.S. treasury obligations, included in cash and cash equivalents		—		—		—		—
Marketable securities:
U.S. treasury obligations and government agency securities		62,674		62,674		—		—
Total assets	$	133,634	$	133,634	$	—	$	—


	Fair Value Measurements at December 31, 2023
	Total		Level 1		Level 2		Level 3
Assets:
Money market funds, included in cash and cash equivalents	$	61,764	$	61,764	$	—	$	—
U.S. treasury obligations, included in cash and cash equivalents		30,765		30,765		—		—
Marketable securities:
U.S. treasury obligations and government agency securities		178,083		178,083		—		—
Total assets	$	270,612	$	270,612	$	—	$	—

Nature of the Business

9 Months Ended

Sep. 30, 2024

Nature of the Business

Nature of the Business

1. Nature of the Business

Scholar Rock Holding Corporation (the “Company”) is a late-stage biopharmaceutical company focused on the discovery, development, and delivery of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role. As a global leader in transforming growth factor beta (“TGFβ”) superfamily biology, the Company’s novel understanding of the molecular mechanisms of growth factor activation enabled the development of a proprietary platform for the discovery and development of monoclonal antibodies that locally and selectively target the precursor, or latent, forms of growth factors. By targeting the signaling proteins at the cellular level and acting in the disease microenvironment, the Company believes that it may avoid the historical dose-limiting safety challenges associated with inhibiting growth factors for therapeutic effect.

The Company’s first product candidate, apitegromab, is a highly selective, fully human, monoclonal antibody, with a unique mechanism of action that results in inhibition of the activation of the growth factor, myostatin, in skeletal muscle. Apitegromab is being developed as a potential first muscle-targeted therapy for the treatment of spinal muscular atrophy (“SMA”). The Company is conducting SAPPHIRE, a pivotal Phase 3 clinical trial to evaluate the efficacy and safety of apitegromab in patients with nonambulatory Type 2 and Type 3 SMA. The Company completed enrollment of SAPPHIRE in 2023. In October 2024, the Company announced positive top-line results that showed the study achieved its primary endpoint. Additionally, in 2024, the Company announced data from the Phase 2 TOPAZ trial extension period which showed patient outcomes at 48 months of treatment with apitegromab. The FDA granted Fast Track designation, Rare Pediatric Disease designation and Orphan Drug designation to apitegromab for the treatment of SMA in May 2021, August 2020 and March 2018, respectively. The European Medicines Agency (“EMA”) granted Priority Medicine (“PRIME”) designation in March 2021 and the EC granted Orphan Medicinal Product designation in December 2018 to apitegromab for the treatment of SMA.

In October 2023, the Company announced an expansion into cardiometabolic disorders by advancing its anti-myostatin program with SRK-439, a novel, fully human anti-myostatin monoclonal antibody, for evaluation in cardiometabolic disorders, including obesity, towards a potential investigational new drug (“IND”) submission in 2025. To inform the development of SRK-439, in May 2024 the Company initiated the Phase 2 EMBRAZE proof-of-concept trial, designed to assess the safety and efficacy of apitegromab to preserve muscle mass in individuals living with obesity and on background therapy of a GLP-1 receptor agonist (“GLP-1 RA”). In September 2024, the Company announced that it had completed enrollment in the Phase 2 EMRAZE proof-of-concept trial. Top-line results from this trial are expected in the second quarter of 2025.

The Company’s second product candidate, SRK-181, a highly selective inhibitor of the activation of latent TGFβ is being developed for the treatment of cancers that are resistant to checkpoint inhibitor therapies, such as anti-PD-1 or anti-PD-L1 antibody therapies (referred to together as anti-PD-(L)1 antibody therapies). SRK-181 is being evaluated in the Company’s Phase 1 DRAGON proof-of-concept clinical trial in patients with locally advanced or metastatic solid tumors that exhibit resistance to anti-PD-(L)1 antibody therapies. The Phase 1 DRAGON trial completed enrollment in December 2023 and continues to treat patients who remain on study. This two-part clinical trial consists of a dose escalation portion (Part A) and a dose expansion evaluating SRK-181 in combination with an approved anti-PD- (L)1 antibody therapy (Part B). Part B includes the following active cohorts: urothelial carcinoma, cutaneous melanoma, non-small cell lung cancer, clear cell renal cell carcinoma, and head and neck squamous cell carcinoma. Safety, efficacy and biomarker data were presented in November 2023 at the Society for Immunotherapy of Cancer 38th Annual Meeting and in June 2024 at the American Society of Clinical Oncology (“ASCO”) annual meeting.

Additionally, the Company continues to create a pipeline of product candidates to deliver novel therapies to underserved patients suffering from a wide range of serious diseases, including neuromuscular disorders, cardiometabolic disorders, cancer, fibrosis, and iron-restricted anemia. The Company was originally formed in May 2012. Its principal offices are in Cambridge, Massachusetts.

Since its inception, the Company’s operations have focused on research and development of monoclonal antibodies that selectively inhibit activation of growth factors for therapeutic effect, as well as establishing the Company’s intellectual property portfolio and performing research and development activities. The Company has primarily financed its operations through various equity financings, including in October 2024 (Note 12), as well as research and development collaboration agreements and the Company’s debt facility (Note 10).

Revenue generation activities have been limited to two collaborations, both containing research services and the issuance of a license. The first agreement, executed in 2013, was with Janssen Biotech, Inc., a subsidiary of Johnson & Johnson and was terminated in July 2022. The second agreement (the “Gilead Collaboration Agreement”), with Gilead Sciences, Inc. (“Gilead”), was in effect between December 2018 and January 2022. No revenues have been recorded from the sale of any commercial product.

The Company is subject to a number of risks similar to other life science companies, including, but not limited to, successful discovery and development of its drug candidates, raising additional capital, development by its competitors of new technological innovations, protection of proprietary technology and regulatory approval and market acceptance of the Company’s product candidates. The Company has incurred recurring losses since its inception, including net losses of $179.8 million and $119.7 million for the nine months ended September 30, 2024 and 2023, respectively. In addition, the Company had an accumulated deficit of $856.3 million as of September 30, 2024. The Company anticipates that it will continue to incur significant operating losses for the next several years as it continues to develop its product candidates.

The Company believes that its existing cash, cash equivalents, and marketable securities at September 30, 2024 together with the approximately $324.4 million in net proceeds from the follow-on offering completed in October 2024 will be sufficient to allow the Company to fund its current operations through at least a period of one year after the date these financial statements are issued.

Subsequent Events (Details) - USD ($) $ / shares in Units, $ in Thousands			1 Months Ended	3 Months Ended
	Oct. 10, 2024	Oct. 08, 2024	Oct. 31, 2024	Jun. 30, 2023	Mar. 31, 2023
Subsequent Events
Sale of common shares, net of issuance costs				$ 4,396	$ 827
Common Stock
Subsequent Events
Sale of common shares, net of issuance costs (in shares)				550,594	68,696
Sale of common shares, net of issuance costs				$ 1
Subsequent event
Subsequent Events
Sale of common shares, net of issuance costs			$ 324,400
Subsequent event \| Underwriting agreement
Subsequent Events
Sale of common shares, net of issuance costs (in shares)		10,265,488
Sale of stock price (in dollars per share)		$ 28.25
Warrant to purchase preferred stock converted into warrant to purchase common stock		353,983
Subsequent event \| Underwriting agreement \| Common Stock
Subsequent Events
Sale of stock price (in dollars per share)		$ 28.2499
Subsequent event \| Underwriting agreement \| Pre-funded warrants
Subsequent Events
Sale of stock price (in dollars per share)		$ 0.0001
Subsequent event \| Over-Allotment Option
Subsequent Events
Sale of common shares, net of issuance costs (in shares)	1,592,920

Common Stock - (Details) - USD ($) $ / shares in Units, $ in Millions			9 Months Ended
	Oct. 10, 2024	Oct. 08, 2024	Sep. 30, 2024	Jun. 30, 2024	May 31, 2024	Dec. 31, 2023	Nov. 30, 2022	Jun. 30, 2022	Nov. 30, 2020
Equity
Common stock, shares authorized			300,000,000	300,000,000	150,000,000	300,000,000
Pre-funded warrants
Equity
Warrant to purchase (in shares)								25,510,205	2,179,487
Exercise of pre-funded and common warrants (in shares)			2,526,833
Outstanding warrants (in shares)			17,008,164
Pre-funded warrants \| Aggregate
Equity
Exercise of pre-funded and common warrants (in shares)			10,681,528
Warrants, non pre-funded
Equity
Warrant to purchase (in shares)								10,459,181
Exercise of pre-funded and common warrants (in shares)			830,660
Outstanding warrants (in shares)			9,157,496
Warrant exercise price (in dollars per share)								$ 7.35
ATM Offering
Equity
Maximum aggregate offering price							$ 100.0
Sale of common shares, net of issuance costs (in shares)			0
ATM Offering \| Aggregate
Equity
Sale of shares			$ 5.2
Sale of common shares, net of issuance costs (in shares)			619,290
Over-Allotment Option \| Subsequent event
Equity
Sale of common shares, net of issuance costs (in shares)	1,592,920
Underwriting agreement \| Subsequent event
Equity
Sale of common shares, net of issuance costs (in shares)		10,265,488
Warrant to purchase (in shares)		353,983
Sale of stock price (in dollars per share)		$ 28.25

Marketable Securities - Summary of Investments (Details) $ in Thousands	Sep. 30, 2024 USD ($) security	Dec. 31, 2023 USD ($) security
Marketable securities available-for-sale
Amortized Cost	$ 62,546	$ 177,991
Gross Unrealized Gains	128	93
Gross Unrealized Losses		(1)
Estimated Fair Value	62,674	178,083
Fair value of marketable securities with unrealized loss, less than a year	$ 0	$ 11,900
Number of investments with unrealized loss, less than a year \| security	0	3
U.S. Treasury obligations
Marketable securities available-for-sale
Amortized Cost	$ 62,546	$ 177,991
Gross Unrealized Gains	128	93
Gross Unrealized Losses		(1)
Estimated Fair Value	$ 62,674	$ 178,083

- Definition

Amount of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale).

+ References

Reference 1: http://www.xbrl.org/2003/role/exampleRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 55
-Paragraph 103
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482078/820-10-55-103

Reference 2: http://www.xbrl.org/2003/role/exampleRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 55
-Paragraph 100
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482078/820-10-55-100

Reference 3: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 820
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-Section 50
-Paragraph 2
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-URI https://asc.fasb.org/1943274/2147482106/820-10-50-2

Reference 4: http://www.xbrl.org/2009/role/commonPracticeRef
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-URI https://asc.fasb.org/1943274/2147482106/820-10-50-2

Reference 5: http://www.xbrl.org/2009/role/commonPracticeRef
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-URI https://asc.fasb.org/1943274/2147482106/820-10-50-2

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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Reference 8: http://www.xbrl.org/2009/role/commonPracticeRef
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-Paragraph 1
-Subparagraph (b)
-Publisher FASB
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 942
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-Section S99
-Paragraph 1
-Subparagraph (SX 210.9-03(6))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478546/942-210-S99-1

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 326
-SubTopic 30
-Name Accounting Standards Codification
-Section 45
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479130/326-30-45-1

+ Details

CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Current assets:
Cash and cash equivalents	$ 76,391	$ 101,855
Marketable securities	62,674	178,083
Prepaid expenses and other current assets	13,862	8,256
Total current assets	152,927	288,194
Property and equipment, net	3,156	4,600
Operating lease right-of-use asset	16,834	11,417
Restricted cash	2,407	2,407
Other long-term assets	3,809	4,417
Total assets	179,133	311,035
Current liabilities:
Accounts payable	4,071	3,465
Accrued expenses	29,260	20,449
Operating lease liability	6,041	7,408
Short-term debt		1,334
Other current liabilities		85
Total current liabilities	39,372	32,741
Long-term portion of operating lease liability	10,466	4,392
Long-term debt	50,099	48,684
Total liabilities	99,937	85,817
Commitments and contingencies (Note 9)
Stockholders' equity:
Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares issued and outstanding at September 30, 2024 and December 31, 2023
Common stock, $0.001 par value; 300,000,000 shares authorized; 80,081,535 and 75,979,495 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively	80	76
Additional paid-in capital	935,249	901,471
Accumulated other comprehensive income	128	92
Accumulated deficit	(856,261)	(676,421)
Total stockholders' equity	79,196	225,218
Total liabilities and stockholders' equity	$ 179,133	$ 311,035

Debt (Details) - Loan and Security Agreement - USD ($) $ in Millions				1 Months Ended
	May 17, 2024	Nov. 10, 2022	Oct. 16, 2020	Dec. 31, 2021
Debt
Line of credit maximum		$ 100.0	$ 50.0
Proceeds from credit facility			$ 25.0	$ 25.0
Interest only period		24 months
Debt Instrument, Variable Interest Rate, Type [Extensible Enumeration]		us-gaap:PrimeRateMember
Final payment fee (as a percent)		2.00%
Repayments of debt		$ 0.9
Percentage of dollar value of company's consolidated cash			100.00%
Amount of cash required in a lender's account as a percentage of outstanding obligation (as a percent)			105.00%
Long-term portion of loan	$ 50.0
Interest additional period	6 months
Minimum
Debt
Variable rate (as a percent)		4.60%
Prepayment penalty (as a percent)		0.00%
Maximum
Debt
Variable rate (as a percent)		9.35%
Prepayment penalty (as a percent)		3.00%
Tranche One
Debt
Line of credit maximum		$ 25.0
Tranche Two
Debt
Line of credit maximum		$ 25.0
Tranche Three
Debt
Line of credit maximum	$ 25.0
Tranche Four
Debt
Line of credit maximum	$ 25.0

Equity-Based Compensation - Unrecognized Expense (Details) $ in Thousands	9 Months Ended
	Sep. 30, 2024 USD ($)
Equity-based compensation
Unrecognized Expense	$ 75,457
Restricted stock units
Equity-based compensation
Unrecognized Expense	$ 35,001
Weighted Average Remaining Period of Recognition	2 years 9 months 18 days
Employee Stock Option
Equity-based compensation
Unrecognized Expense	$ 40,456
Weighted Average Remaining Period of Recognition	2 years 7 months 6 days

Common Stock

9 Months Ended

Sep. 30, 2024

Common Stock.

Common Stock

7. Common Stock

In June 2024, the stockholders approved an amendment to our amended and restated certificate of incorporation to increase the number of authorized shares of common stock from 150,000,000 to 300,000,000.

The Company has had a sales agreement in place during various time periods with Jefferies LLC with respect to an at-the-market (“ATM”) offering program. Under this program, the Company is able to offer and sell, from time to time at its sole discretion, shares of its common stock through Jefferies as its sales agent. In an ATM offering, exchange-listed companies incrementally sell newly issued shares into the secondary trading market through a designated broker-dealer at prevailing market prices. The current ATM agreement, established in November 2022, allows for the sale of shares of common stock having an aggregate offering price of up to $100 million. As of September 30, 2024, the Company has sold 619,290 shares, generating net proceeds of $5.2 million, under the ATM program. No sales were made under the ATM program during the nine months ended September 30, 2024.

The Company has issued pre-funded warrants, as well as warrants as part of its financing activities. Both the pre-funded warrants and warrants meet the conditions for equity classification and are recorded as a component of stockholders’ equity within additional paid-in capital. In June 2022 and November 2020, the Company issued 25,510,205 and 2,179,487 pre-funded warrants, respectively. During the nine months ended September 30, 2024, 2,526,833 of the Company’s pre-funded warrants were exercised. As of September 30, 2024, the Company has 17,008,164 pre-funded warrants outstanding. In June 2022, the Company also issued 10,459,181 warrants with an exercise price of $7.35. During the nine months ended September 30, 2024, 830,660 of the Company’s warrants were exercised. As of September 30, 2024, the Company has 9,157,496 warrants outstanding. In October 2024, the Company issued pre-funded warrants to purchase up to 353,983 shares of common stock (see Note 12).

Accrued Expenses (Tables)

9 Months Ended

Sep. 30, 2024

Accrued Expenses

Summary of accrued expenses

As of September 30, 2024 and December 31, 2023, accrued expenses consist of the following (in thousands):


	As of
	September 30,		December 31,
	2024		2023
Accrued external research and development expense	$	15,040	$	6,825
Accrued payroll and related expenses		9,969		10,591
Accrued professional and consulting expense		3,420		2,267
Accrued other		831		766
	$	29,260	$	20,449

Equity-Based Compensation - Restricted stock (Details) - Restricted stock units $ / shares in Units, $ in Millions	9 Months Ended
	Sep. 30, 2024 USD ($) $ / shares shares
Number of Shares/Units
Outstanding, beginning (in shares) \| shares	2,089,552
Granted (in shares) \| shares	2,126,820
Vested (in shares) \| shares	(649,559)
Forfeited (in shares) \| shares	(179,956)
Outstanding, end (in shares) \| shares	3,386,857
Weighted Average Grant Date Fair Value
Outstanding, beginning (in dollars per share) \| $ / shares	$ 11.92
Granted (in dollars per share) \| $ / shares	13.52
Vested (in dollars per share) \| $ / shares	12.38
Forfeited (in dollars per share) \| $ / shares	12.42
Outstanding, end (in dollars per share) \| $ / shares	$ 12.82
Fair value of non-option awards vested \| $	$ 8.6

Equity-Based Compensation - Stock Options (Details) - Employee Stock Option $ / shares in Units, $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2024 USD ($) $ / shares shares	Dec. 31, 2023 USD ($) $ / shares shares
Number of Units
Outstanding, beginning (in shares) \| shares	7,300,953
Granted (in shares) \| shares	2,835,756
Exercised (in shares) \| shares	(94,988)
Cancelled (in shares) \| shares	(371,557)
Outstanding, end (in shares) \| shares	9,670,164	7,300,953
Options exercisable, end (in shares) \| shares	4,831,989
Weighted Average Exercise Price
Outstanding, beginning (in dollars per share)	$ 15.00
Granted (in dollars per share)	13.52
Exercised (in dollars per share)	5.79
Cancelled (in dollars per share)	19.94
Outstanding, end (in dollars per share)	14.47	$ 15.00
Options exercisable, end (in dollars per share)	$ 16.50
Stock options
Weighted average remaining contractual term	7 years 9 months 18 days	7 years 10 months 24 days
Weighted average remaining contractual term, exercisable	6 years 8 months 19 days
Aggregate intrinsic value, beginning \| $	$ 52,299
Aggregate intrinsic value, end \| $	2,967	$ 52,299
Aggregate intrinsic value, exercisable \| $	$ 2,310
Weighted average grant date fair value (in dollars per share)	$ 10.38

Summary of Significant Accounting Policies

9 Months Ended

Sep. 30, 2024

Summary of Significant Accounting Policies

Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

Summary of Significant Accounting Policies

The significant accounting policies used in preparation of the unaudited consolidated financial statements are described in the Company’s audited consolidated financial statements as of and for the year ended December 31, 2023, and the notes thereto, which are included in the Company’s Annual Report on Form 10-K. There have been no material changes to the significant accounting policies previously disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.

Cash, Cash Equivalents and Restricted Cash

The following table reconciles cash, cash equivalents and restricted cash per the balance sheet to the statement of cash flows (in thousands):


	As of September 30,
	2024		2023
Cash and cash equivalents	$	76,391	$	67,598
Restricted cash		2,407		2,612
	$	78,798	$	70,210

Unaudited Interim Financial Information

Use of Estimates

Recently Adopted Accounting Pronouncements

Recently Issued Accounting Pronouncements

Prepaid Expenses and Other Assets (Tables)

9 Months Ended

Sep. 30, 2024

Prepaid Expense and Other Assets

Schedule of prepaid expenses and other current assets

As of September 30, 2024 and December 31, 2023, prepaid expenses and other assets consist of the following (in thousands):


	As of
	September 30,		December 31,
	2024		2023
Prepaid external research and development expenses	$	8,876	$	4,059
Prepaid other		2,706		2,281
Receivables		1,120		1,076
Prepaid insurance		739		635
Prepaid professional and consulting expense		421		205
	$	13,862	$	8,256

Schedule of other long-term assets


	As of
	September 30,		December 31,
	2024		2023
Prepaid external research and development expenses	$	3,397	$	4,074
Prepaid other		394		312
Prepaid insurance		18		31
	$	3,809	$	4,417

Pay vs Performance Disclosure - USD ($) $ in Thousands	3 Months Ended						9 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2024	Sep. 30, 2023
Pay vs Performance Disclosure
Net Income (Loss)	$ (64,479)	$ (58,508)	$ (56,853)	$ (42,359)	$ (37,925)	$ (39,379)	$ (179,840)	$ (119,663)

- Definition

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

+ References

+ Details

Net Loss per Share (Tables)

9 Months Ended

Sep. 30, 2024

Net Loss per Share

Summary of anti-dilutive securities


	Nine Months Ended September 30,
	2024	2023
Restricted stock units	3,386,857	2,081,607
Stock options	9,670,164	7,422,412
Warrants	9,157,496	10,459,181
	22,214,517	19,963,200

CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands	Common Stock	Additional Paid-in Capital	Accumulated Other Comprehensive Income (Loss)	Accumulated Deficit	Total
Balance at beginning at Dec. 31, 2022	$ 52	$ 771,699	$ (884)	$ (510,632)	$ 260,235
Balance at beginning (in shares) at Dec. 31, 2022	51,672,579
Increase (decrease) in Stockholders' Equity
Unrealized (loss) gain on marketable securities			555		555
Sale of common shares, net of issuance costs		827			827
Sale of common shares, net of issuance costs (in shares)	68,696
Exercise of stock options		243			243
Exercise of stock options (in shares)	28,706
Issuance of common shares upon RSU vesting (in shares)	219,378
Equity-based compensation expense		6,170			6,170
Other		2			2
Net Income (Loss)				(39,379)	(39,379)
Balance at end at Mar. 31, 2023	$ 52	778,941	(329)	(550,011)	228,653
Balance at end (in shares) at Mar. 31, 2023	51,989,359
Balance at beginning at Dec. 31, 2022	$ 52	771,699	(884)	(510,632)	260,235
Balance at beginning (in shares) at Dec. 31, 2022	51,672,579
Increase (decrease) in Stockholders' Equity
Unrealized (loss) gain on marketable securities					861
Net Income (Loss)					(119,663)
Balance at end at Sep. 30, 2023	$ 56	797,927	(23)	(630,295)	167,665
Balance at end (in shares) at Sep. 30, 2023	56,260,574
Balance at beginning at Mar. 31, 2023	$ 52	778,941	(329)	(550,011)	228,653
Balance at beginning (in shares) at Mar. 31, 2023	51,989,359
Increase (decrease) in Stockholders' Equity
Unrealized (loss) gain on marketable securities			266		266
Sale of common shares, net of issuance costs	$ 1	4,395			4,396
Sale of common shares, net of issuance costs (in shares)	550,594
Exercise of stock options		292			292
Exercise of stock options (in shares)	53,333
Issuance of common shares upon RSU vesting (in shares)	273,035
Exercise of pre-funded and common warrants	$ 2	(2)
Exercise of pre-funded and common warrants (in shares)	2,293,466
Equity-based compensation expense		6,818			6,818
Other		1			1
Net Income (Loss)				(37,925)	(37,925)
Balance at end at Jun. 30, 2023	$ 55	790,445	(63)	(587,936)	202,501
Balance at end (in shares) at Jun. 30, 2023	55,159,787
Increase (decrease) in Stockholders' Equity
Unrealized (loss) gain on marketable securities			40		40
Exercise of stock options		280			280
Exercise of stock options (in shares)	49,604
Issuance of common shares upon RSU vesting (in shares)	24,290
Exercise of pre-funded and common warrants	$ 1	(1)
Exercise of pre-funded and common warrants (in shares)	1,026,893
Equity-based compensation expense		7,203			7,203
Net Income (Loss)				(42,359)	(42,359)
Balance at end at Sep. 30, 2023	$ 56	797,927	(23)	(630,295)	167,665
Balance at end (in shares) at Sep. 30, 2023	56,260,574
Balance at beginning at Dec. 31, 2023	$ 76	901,471	92	(676,421)	225,218
Balance at beginning (in shares) at Dec. 31, 2023	75,979,495
Increase (decrease) in Stockholders' Equity
Unrealized (loss) gain on marketable securities			(142)		(142)
Exercise of stock options		280			280
Exercise of stock options (in shares)	47,293
Issuance of common shares upon RSU vesting (in shares)	360,373
Exercise of pre-funded and common warrants	$ 4	6,102			6,106
Exercise of pre-funded and common warrants (in shares)	3,357,493
Equity-based compensation expense		8,164			8,164
Net Income (Loss)				(56,853)	(56,853)
Balance at end at Mar. 31, 2024	$ 80	916,017	(50)	(733,274)	182,773
Balance at end (in shares) at Mar. 31, 2024	79,744,654
Balance at beginning at Dec. 31, 2023	$ 76	901,471	92	(676,421)	225,218
Balance at beginning (in shares) at Dec. 31, 2023	75,979,495
Increase (decrease) in Stockholders' Equity
Unrealized (loss) gain on marketable securities					36
Net Income (Loss)					(179,840)
Balance at end at Sep. 30, 2024	$ 80	935,249	128	(856,261)	79,196
Balance at end (in shares) at Sep. 30, 2024	80,081,535
Balance at beginning at Mar. 31, 2024	$ 80	916,017	(50)	(733,274)	182,773
Balance at beginning (in shares) at Mar. 31, 2024	79,744,654
Increase (decrease) in Stockholders' Equity
Unrealized (loss) gain on marketable securities			(4)		(4)
Exercise of stock options		47			47
Exercise of stock options (in shares)	6,617
Issuance of common shares upon RSU vesting (in shares)	240,797
Equity-based compensation expense		9,312			9,312
Net Income (Loss)				(58,508)	(58,508)
Balance at end at Jun. 30, 2024	$ 80	925,376	(54)	(791,782)	133,620
Balance at end (in shares) at Jun. 30, 2024	79,992,068
Increase (decrease) in Stockholders' Equity
Unrealized (loss) gain on marketable securities			182		182
Exercise of stock options		223			223
Exercise of stock options (in shares)	41,078
Issuance of common shares upon RSU vesting (in shares)	48,389
Equity-based compensation expense		9,650			9,650
Net Income (Loss)				(64,479)	(64,479)
Balance at end at Sep. 30, 2024	$ 80	$ 935,249	$ 128	$ (856,261)	$ 79,196
Balance at end (in shares) at Sep. 30, 2024	80,081,535

Marketable Securities

9 Months Ended

Sep. 30, 2024

Marketable Securities

Marketable Securities

4. Marketable Securities

The following table summarizes the Company’s investments as of September 30, 2024 (in thousands):


			Gross
	Amortized		Unrealized				Estimated
	Cost		Gains		Losses		Fair Value
Marketable securities available-for-sale:
U.S. treasury obligations and government agency securities	$	62,546	$	128	$	—	$	62,674
Total available-for-sale securities	$	62,546	$	128	$	—	$	62,674

The following table summarizes the Company’s investments as of December 31, 2023 (in thousands):


			Gross
	Amortized		Unrealized				Estimated
	Cost		Gains		Losses		Fair Value
Marketable securities available-for-sale:
U.S. treasury obligations and government agency securities	$	177,991	$	93	$	(1)	$	178,083
Total available-for-sale securities	$	177,991	$	93	$	(1)	$	178,083

The aggregate fair value of marketable securities with unrealized losses was $0 and $11.9 million at September 30, 2024 and December 31, 2023, respectively. At September 30, 2024 and December 31, 2023, no investments and three investments, respectively, were in an unrealized loss position. All such investments have been in an unrealized loss position for less than a year and these losses are considered temporary. The Company has the ability and intent to hold these investments until a recovery of their amortized cost, which may not occur until maturity.

The Company believes that U.S. treasury obligations and government agency securities are subject to minimal credit risk. As a result, the Company did not record any charges for credit-related impairments for its available-for-sale securities for the nine months ended September 30, 2024.

Net Loss per Share

9 Months Ended

Sep. 30, 2024

Net Loss per Share

Net Loss per Share

11. Net Loss per Share

The Company calculates basic net loss per share by dividing net loss by the weighted average number of common shares outstanding, excluding restricted common stock. The weighted average number of common shares used in the basic and diluted net loss per share calculation includes the pre-funded warrants issued in connection with the Company’s November 2020 and June 2022 follow-on offerings as the pre-funded warrants are exercisable at any time for nominal cash consideration. As of September 30, 2024, 10,681,528 pre-funded warrants have been exercised and 17,008,164 pre-funded warrants remain outstanding. The Company has generated a net loss in all periods presented, so the basic and diluted net loss per share are the same, as the inclusion of the potentially dilutive securities would be anti-dilutive.

The following table sets forth the outstanding common stock equivalents, presented based on amounts outstanding at each period end, that have been excluded from the calculation of diluted net loss per share for the periods indicated because their inclusion would have been anti-dilutive:


	Nine Months Ended September 30,
	2024	2023
Restricted stock units	3,386,857	2,081,607
Stock options	9,670,164	7,422,412
Warrants	9,157,496	10,459,181
	22,214,517	19,963,200

Prepaid Expenses and Other Assets

9 Months Ended

Sep. 30, 2024

Prepaid Expense and Other Assets

Prepaid Expenses and Other Assets

5. Prepaid Expenses and other Assets

As of September 30, 2024 and December 31, 2023, prepaid expenses and other assets consist of the following (in thousands):


	As of
	September 30,		December 31,
	2024		2023
Prepaid external research and development expenses	$	8,876	$	4,059
Prepaid other		2,706		2,281
Receivables		1,120		1,076
Prepaid insurance		739		635
Prepaid professional and consulting expense		421		205
	$	13,862	$	8,256

As of September 30, 2024 and December 31, 2023, other long-term assets consist of the following (in thousands):


	As of
	September 30,		December 31,
	2024		2023
Prepaid external research and development expenses	$	3,397	$	4,074
Prepaid other		394		312
Prepaid insurance		18		31
	$	3,809	$	4,417