What changed in this filing

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Item 1. Financial Statements

2024-11-07 compared with 2024-08-08 · 60 added, 73 removed, 325 unchanged (29% of the section changed)

3 unchanged sentences

(In thousands, except share and per share data)

September 30,

Current assets

18 unchanged sentences

Preferred stock, $ .0001 par value per share;

200,000,000 shares authorized and no shares issued or outstanding as of June 30, 2024 and December 31, 2023

200,000,000 shares authorized and no shares issued or outstanding as of September 30, 2024 and December 31, 2023

Common stock, $ .0001 par value per share;

1,000,000,000 shares authorized as of June 30, 2024 and December 31, 2023;

93,643,341 shares and 70,453,342 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively

1,000,000,000 shares authorized as of September 30, 2024 and December 31, 2023;

94,408,911 shares and 70,453,342 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively

Additional paid-in capital

Accumulated other comprehensive income (loss)

Accumulated other comprehensive income

Accumulated deficit

5 unchanged sentences

(In thousands, except share and per share data)

Three months ended June 30,

Six months ended June 30,

Three months ended September 30,

Nine months ended September 30,

Operating expenses

6 unchanged sentences

Other comprehensive income (loss):

Unrealized gain (loss) on available-for-sale securities

Unrealized gain on available-for-sale securities

Total comprehensive loss

17 unchanged sentences

Balance as of June 30, 2023

Exercise of stock options

Stock-based compensation

Other comprehensive income

Balance as of September 30, 2023

Other Comprehensive

11 unchanged sentences

Balance as of June 30, 2024

Exercise of stock options

Stock-based compensation

Other comprehensive income

Balance as of September 30, 2024

The accompanying notes are an integral part of these condensed financial statements.

2 unchanged sentences

(In thousands)

Six months ended June 30,

Nine months ended September 30,

Cash flows from operating activities

27 unchanged sentences

Right-of-use asset obtained in exchange for new operating lease liability, net of tenant improvement receivable

Reduction to right-of-use due to tenant improvement receivable

Property and equipment purchases included in accounts payable and accrued other expenses

Deferred offering costs included in accounts payable and accrued other expenses

The accompanying notes are an integral part of these condensed financial statements.

8 unchanged sentences

The Company is currently studying sevasemten in Phase 2 trials, which are being held in the U.S.

and certain countries in Europe and Australasia.

In addition, the Company has initiated a Phase 2 trial of EDG-7500, for the potential treatment of hypertrophic cardiomyopathy (HCM).

and Israel and in certain countries in Europe and Australasia.

In addition, the Company is enrolling a multipart Phase 2 trial with EDG-7500, for the potential treatment of hypertrophic cardiomyopathy (HCM).

The Company is using its proprietary drug discovery platform to develop a pipeline of precision medicine product candidates that target key muscle proteins and modulators to address a broad array of serious muscle disorders.

Risks and Uncertainties

The board of directors of the Company discusses with management macroeconomic and geopolitical developments, including inflation, instability in the banking and financial services sector, tightening of the credit markets, the upcoming U.S.

presidential election, international conflicts, public health pandemics, cybersecurity and sanctions so that the Company can be prepared to react to new developments as they arise.

presidential administration, international conflicts, public health pandemics, cybersecurity and sanctions so that the Company can be prepared to react to new developments as they arise.

The board of directors and the management of the Company are carefully monitoring these developments and the resulting economic impact on its financial condition and results of operations.

Liquidity and Capital Resources

The Company has an accumulated deficit of $ 304.8 million and cash, cash equivalents and marketable securities of $ 511.8 million as of June 30, 2024.

The Company has an accumulated deficit of $ 338.9 million and cash, cash equivalents and marketable securities of $ 492.5 million as of September 30, 2024.

The Company’s ability to fund ongoing operations is highly dependent upon raising additional capital through the issuance of equity securities and issuing debt or other financing vehicles.

6 unchanged sentences

The aggregate gross proceeds from the January 2024 Offering were $ 240.0 million, and the net proceeds were $ 231.9 million after deducting underwriting discounts and commissions of $ 7.5 million and offering expenses of $ 0.6 million.

On May 10, 2024, we entered into a sales agreement with Leerink Partners LLC (Leerink Sales Agreement) under which we may offer and sell shares of common stock, having aggregate sales proceeds of up to $ 175,000,000 from time to time, through an “at the market offering” program (Leerink ATM) under which Leerink Partners LLC will act as sales agent.

We have not yet offered or sold any shares of common stock related to the Leerink ATM.

On May 10, 2024, the Company entered into a sales agreement with Leerink Partners LLC (Leerink Sales Agreement) under which the Company may offer and sell shares of common stock, having aggregate sales proceeds of up to $ 175,000,000 from time to time, through an “at the market offering” program (Leerink ATM) under which Leerink Partners LLC will act as sales agent.

The Company has not yet offered or sold any shares of common stock related to the Leerink ATM.

The Company’s ability to secure capital is dependent upon success in developing its technology and product candidates.

4 unchanged sentences

The financial statements do not reflect any adjustments relating to the recoverability and reclassification of assets and liabilities that might be necessary if the Company is unable to continue as a going concern.

The Company believes that the $ 511.8 million of cash, cash equivalents and marketable securities on hand as of June 30, 2024 will be sufficient to fund its operations in the normal course of business and meet its liquidity needs through at least the next 12 months from the issuance of these financial statements.

The Company believes that the $ 492.5 million of cash, cash equivalents and marketable securities on hand as of September 30, 2024 will be sufficient to fund its operations in the normal course of business and meet its liquidity needs through at least the next 12 months from the issuance of these financial statements.

NOTE 2 SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

10 unchanged sentences

The Company considers all liquid investments with a maturity of three months or less when purchased to be cash equivalents.

Cash equivalents as of June 30, 2024 and December 31, 2023 primarily consist of money market funds and cash.

Cash equivalents as of September 30, 2024 and December 31, 2023 primarily consist of money market funds and cash.

Concentrations of Credit Risk

7 unchanged sentences

The Company capitalizes certain legal, professional, accounting and other third-party fees that are directly associated with in-process equity issuances as deferred offering costs until such equity issuances are consummated.

After consummation of the equity issuance, these costs are recorded as a reduction in the capitalized amount associated with the equity issuance.

Should the equity issuance be abandoned, the deferred offering costs are expensed immediately as a

charge to operating expenses in the statement of operations.

Deferred offering costs were $ 0.3 million as of June 30, 2024 and December 31, 2023.

After consummation of the equity issuance, these costs are recorded as a reduction in the capitalized amount associated with

the equity issuance.

Should the equity issuance be abandoned, the deferred offering costs are expensed immediately as a charge to operating expenses in the statement of operations.

Deferred offering costs were $ 0.3 million as of September 30, 2024 and December 31, 2023.

Such costs are classified in other non-current assets in the accompanying balance sheets.

20 unchanged sentences

If impairment is recognized, the carrying value of the impaired asset is reduced to its fair value.

There were no impairment charges or long-lived assets disposed of during three and six months ended June 30, 2024 and 2023.

There were no impairment charges or long-lived assets disposed of during three and nine months ended September 30, 2024 and 2023.

Deferred income taxes are provided on temporary differences between financial statement and income tax reporting.

4 unchanged sentences

Deferred tax liabilities are recognized for temporary differences that will be taxable in future years.

The Company evaluated its tax positions and determined it has no uncertain tax positions as of June 30, 2024.

The Company evaluated its tax positions and determined it has no uncertain tax positions as of September 30, 2024.

Fair Value of Financial Instruments

19 unchanged sentences

The following tables summarize the Company’s financial assets measured at fair value on a recurring basis by level within the fair value hierarchy (in thousands):

As of June 30, 2024

As of September 30, 2024

Cash equivalents:

5 unchanged sentences

government treasury and agency securities

Supranational and sovereign government securities

Total financial assets

As of December 31, 2023

7 unchanged sentences

Supranational and sovereign government securities

Total financial assets

The Company’s money market funds are classified as Level 1 because they are valued using quoted market prices.

5 unchanged sentences

There were no transfers of financial assets between Level 1, Level 2, or Level 3, during the periods presented.

As of June 30, 2024, the remaining contractual maturities of $ 417.6 million of marketable securities were less than one year and $ 51.7 million of marketable securities were between 1 and 2 years .

As of September 30, 2024, the remaining contractual maturities of $ 409.0 million of marketable securities were less than one year and $ 37.7 million of marketable securities were between 1 and 2 years .

The Company periodically reviews its portfolio of debt securities to determine if any investment is impaired due to credit loss or other potential valuation concerns.

For debt securities where the fair value of the investment is less than the amortized cost basis, the Company has assessed at the individual security level for various quantitative factors including, but not limited to, the nature of the investments, changes in credit ratings, interest rate fluctuations, industry analyst reports, and the severity of impairment.

Unrealized losses on marketable securities at June 30, 2024 were primarily due to changes in interest rates, including market credit spreads, and not due to increased credit risks associated with specific securities.

Unrealized losses on marketable securities at September 30, 2024 were primarily due to changes in interest rates, including market credit spreads, and not due to increased credit risks associated with specific securities.

Comprehensive Income (Loss)

Comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and/or circumstances from non-owner sources.

The Company’s only element of other comprehensive income (loss) was net unrealized gain (loss) on marketable securities.

The Company’s only element of other comprehensive income was net unrealized gain on marketable securities.

Stock-Based Compensation

3 unchanged sentences

The fair value of stock options is determined using the Black-Scholes option-pricing model.

The determination of fair value for stock-based awards on the date of grant using an option-pricing model requires management to make certain assumptions including expected volatility, expected term, risk-free interest rate and expected dividends in addition to the Company’s common stock valuation (see Note 4).

Research and Development Expenses and Accrued Research and Development Expenses

25 unchanged sentences

The Company is authorized to issue two classes of stock designated as common stock and preferred stock.

As of June 30, 2024, the total number of shares authorized was 1,200,000,000 .

As of September 30, 2024, the total number of shares authorized was 1,200,000,000 .

The total number of shares of common stock authorized was 1,000,000,000 .

14 unchanged sentences

or (3) such other amount as the Company’s board of directors may determine.

As of June 30, 2024, there were 4,163,037 shares available for future issuance under the 2021 Plan.

As of September 30, 2024, there were 1,506,606 shares available for future issuance under the 2021 Plan.

During the nine months ended September 30, 2024, the Company issued 2,751,497 stock options with a fair value of $ 34.5 million that vest over a weighted average period of 3.9 years and 557,027 restricted stock units (RSUs) with a fair value of $ 9.5 million that vest over a weighted average period of 4 years .

Inducement Equity Incentive Plan

Effective August 10, 2024, the Company’s board of directors adopted the Company’s 2024 Inducement Equity Incentive Plan (the Inducement Plan) and, subject to the adjustment provisions of the Inducement Plan, reserved 2,000,000 shares of the Company’s common stock for issuance pursuant to equity awards granted under the Inducement Plan.

The Inducement Plan was adopted without stockholder approval pursuant to the applicable The Nasdaq Stock Market LLC’s (Nasdaq) Listing Rules.

The Inducement Plan provides for the grant of equity-based awards, including nonstatutory stock options, stock appreciation rights, restricted stock, restricted stock units, and performance awards, and its terms are substantially similar to the 2021 Plan, including with respect to treatment of equity awards in the event of a “merger” or “change in control” as defined under the Inducement Plan, but with such other terms and conditions intended to comply with the Nasdaq inducement award exception or to comply with the Nasdaq acquisition and merger exception.

In accordance with the Nasdaq Listing Rules, awards under the Inducement Plan may only be made to individuals not previously employees or non-employee directors of the Company (or following such individuals’ bona fide period of non-employment with the Company), as an inducement material to the individuals’ entry into employment with the Company, or, to the extent permitted by the Nasdaq Listing Rules, in connection with a merger or acquisition.

As of September 30, 2024, there were 2,000,000 shares available for future issuance under the Inducement Plan.

Founder Stock Options

1 unchanged sentence

This grant is separate from the Company’s equity incentive plans discussed above.

As of June 30, 2024, 1,531,780 options were both outstanding and exercisable .

There were no options exercised during the three and six months ended June 30, 2024.

As of September 30, 2024, 1,456,780 options were both outstanding and exercisable.

75,000 options were exercised during the three and nine months ended September 30, 2024.

Total stock-based compensation expense related to all equity plans, including Founder Stock Options was allocated as follows (in thousands):

Three months ended June 30,

Six months ended June 30,

Three months ended September 30,

Nine months ended September 30,

Research and development

2 unchanged sentences

NOTE 5 COMMITMENTS AND CONTINGENCIES

Lease Agreements

In January 2022, the Company entered into a lease agreement for approximately 18,614 square feet of office and laboratory space in Boulder, Colorado (the Boulder Lease) with aggregate base rent payments of approximately $ 3.3 million over the initial 8.2 -year term of the lease.

Further, the Company provided a standby letter of credit (LOC) of $ 0.8 million during the term of the lease as collateral for the Company’s obligations under the lease.

Provided there has been no event of default by the Company during the initial 36-month term, the Company will replace the initial LOC with a replacement LOC in the amount of $ 0.5 million.

The Boulder Lease includes two tenant improvement allowances, which includes one for $ 1.0 million in construction costs to be fully reimbursed by the lessor (the First Allowance) and one for $ 2.0 million in construction costs to be repaid to the lessor as additional rent payments over the initial term of the lease (the Second Allowance).

Both the First Allowance and Second Allowance have been received in full.

The receipt of $ 2.0

million under the Second Allowance resulted in an increase to operating lease liabilities and an increase to aggregate base rent payments totaling $ 2.5 million.

In February 2023, the Boulder Lease was modified to occupy an additional 9,624 square feet of office space (the Expansion Space) with aggregate payments of approximately $ 1.5 million over the initial 7.3 year term of the lease.

The Expansion Space includes an improvement allowance in the amount of $ 0.5 million to be fully reimbursed by the lessor.

As of June 30, 2024, $ 0 was received by the lessor under the allowance associated with the Expansion Space.

Under the Boulder Lease and the Expansion Space (collectively, the Lease), the Company has the option to extend the Lease for two additional terms of five years each.

The Company is obligated to pay the lessor an amount not to exceed 5 % of the net rents from the property for operating costs.

Such amounts are not included in the measurement of the lease liabilities and are recognized as variable lease expense when they are incurred.

Variable lease expense was $ 0.1 million and $ 0.2 million for the three and six months ended June 30, 2024, respectively and $ 0.1 million and $ 0.2 million for the three and six months ended June 30, 2023, respectively.

The Lease is classified as an operating lease.

The Company recorded lease liabilities and ROU lease assets for the Lease based on the present value of lease payments over the expected lease term, discounted using the Company’s incremental borrowing rate.

The option to extend the Lease was not recognized as part of the Company’s lease liabilities and ROU lease assets, as such extensions are not reasonably certain to occur.

As of June 30, 2024, the weighted-average remaining lease term and the weighted-average discount rate for the Lease was 5.8 years and 6.4 %, respectively.

Rent expense under the Lease was $ 0.1 million and $ 0.3 million for the three and six months ended June 30, 2024, respectively and $ 0.1 million and $ 0.3 million for the three and six months ended June 30, 2023, respectively.

Future minimum lease payments under the Lease as of June 30, 2024 are as follows (in thousands):

Year Ending December 31,

2024, remaining

Total undiscounted future minimum lease payments

tenant improvement receivable

Total lease liability

Liabilities for loss contingencies arising from claims, assessments, litigation, fines, penalties and other sources are recorded when it is probable that a liability has been incurred and the amount can be reasonably estimated.

From time to time, the Company may become involved in legal proceedings arising in the ordinary course of business.

The Company was not subject to any material legal proceedings during the three and six months ended June 30, 2024 and no material legal proceedings are currently pending or threatened.

The Company was not subject to any material legal proceedings during the three and nine months ended September 30, 2024 and no material legal proceedings are currently pending or threatened.

Indemnification Agreements

3 unchanged sentences

To date, the Company has not incurred any material costs as a result of such indemnifications.

The Company is not aware of any claims under indemnification arrangements, and it has not accrued any liabilities related to such obligations in its financial statements as of June 30, 2024.

The Company is not aware of any claims under indemnification arrangements, and it has not accrued any liabilities related to such obligations in its financial statements as of September 30, 2024.

NOTE 6 NET LOSS PER SHARE

6 unchanged sentences

The following table sets forth the computation of the basic and diluted net loss per share (in thousands, except share and per share data):

Three months ended June 30,

Six Months Ended June 30,

Three months ended September 30,

Nine Months Ended September 30,

Weighted-average shares outstanding used in computing net loss per share, basic and diluted

1 unchanged sentence

The following weighted average outstanding shares of potentially dilutive securities were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods presented because including them would have been anti-dilutive:

Three months ended June 30,

Six Months Ended June 30,

Three months ended September 30,

Nine Months Ended September 30,

Options to purchase common stock

2 unchanged sentences

Property and equipment consisted of the following amounts (in thousands):

As of June 30,

As of September 30,

As of December 31,

7 unchanged sentences

Property and equipment, net

Depreciation expense was $ 0.5 million and $ 1.0 million for the three and six months ended June 30, 2024 and $ 0.4 million and $ 0.6 million for the three and six months ended June 30, 2023, respectively.

Depreciation expense was $ 0.5 million and $ 1.5 million for the three and nine months ended September 30, 2024 and $ 0.4 million and $ 1.1 million for the three and nine months ended September 30, 2023, respectively.

NOTE 8 ACCRUED OTHER EXPENSES

Accrued other expenses consisted of the following amounts (in thousands):

As of June 30,

As of September 30,

As of December 31,

3 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Financial Statements