What changed in this filing

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Item 1. Financial Statements

2023-08-02 compared with 2023-05-05 · 62 added, 41 removed, 241 unchanged (30% of the section changed)

29 unchanged sentences

195,000,000 shares authorized;

68,993,591 and 68,847,382 shares issued, and 68,993,591 and 68,847,382 shares outstanding at March 31, 2023 and December 31, 2022, respectively

81,616,909 and 68,847,382 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively

Additional paid-in capital

10 unchanged sentences

Three Months Ended

Six Months Ended

Collaboration and other research and development revenues

5 unchanged sentences

Other income, net:

Other expense, net

Other (expense) income, net

Interest income, net

7 unchanged sentences

Three Months Ended

Six Months Ended

Other comprehensive loss:

Unrealized gain (loss) on marketable debt securities

Unrealized (loss) gain on marketable debt securities

Comprehensive loss

13 unchanged sentences

( 1,127,167 )

Issuance of common stock from public offering, net commissions, underwriting discounts and offering costs

Exercise of stock options

Stock-based compensation expense

Vesting of restricted common stock awards

Issuance of common stock under employee stock purchase plan

Unrealized loss on marketable debt securities

Balance at June 30, 2023

( 1,167,457 )

Comprehensive

6 unchanged sentences

Balance at March 31, 2022

Exercise of stock options

Vesting of restricted common stock awards

Stock-based compensation expense

Issuance of common stock under employee stock purchase plan

Unrealized loss on marketable debt securities

Balance at June 30, 2022

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

2 unchanged sentences

(amounts in thousands)

Three Months Ended

Six Months Ended

Cash flow from operating activities

15 unchanged sentences

Purchases of property and equipment

Proceeds from the sale of equipment

Purchases of marketable securities

2 unchanged sentences

Cash flow from financing activities

Proceeds from offering of common stock, net of issuance costs

Proceeds from exercise of stock options

Proceeds from issuance of common stock under employee stock purchase plan

Net cash provided by financing activities

Net (decrease) increase in cash, cash equivalents, and restricted cash

Net increase (decrease) in cash, cash equivalents, and restricted cash

Cash, cash equivalents, and restricted cash, beginning of period

2 unchanged sentences

Fixed asset additions included in accounts payable and accrued expenses

Offering expenses included in accounts payable and accrued expenses

Cash paid in connection with operating lease liabilities

Remeasurement of operating lease liabilities and right-of-use assets due to lease modification

Right-of-use assets obtained in exchange of operating lease obligations

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

9 unchanged sentences

The Company is subject to risks common to companies in the biotechnology industry, including but not limited to, risks of failure of preclinical studies and clinical trials, the need to obtain marketing approval for any drug product candidate that it may identify and develop, the need to successfully commercialize and gain market acceptance of its product candidates, dependence on key personnel, protection of proprietary technology, compliance with government regulations, development by competitors of technological innovations and ability to transition from pilot-scale manufacturing to large-scale production of products.

In June 2023, the Company completed a public offering in which it sold 12,500,000 shares of its common stock and received net proceeds of approximately $ 117.1 million after deducting underwriting discounts and commissions and other offering costs.

In May 2021, the Company entered into a common stock sales agreement with Cowen and Company, LLC (“Cowen”), under which the Company from time to time can issue and sell shares of its common stock through Cowen in at-the-market offerings for aggregate gross sale proceeds of up to $ 300.0 million (the “ATM Facility”).

As of March 31, 2023, the Company has no t sold any shares of its common stock under the ATM Facility.

As of June 30, 2023, the Company has no t sold any shares of its common stock under the ATM Facility.

The Company has incurred annual net operating losses in every year since its inception.

The Company expects that its existing cash, cash equivalents and marketable securities at March 31, 2023 will enable it to fund its operating expenses and capital expenditure requirements into 2025.

The Company had an accumulated deficit of $ 1.1 billion at March 31, 2023, and will require substantial additional capital to fund its operations.

The Company expects that its existing cash, cash equivalents and marketable securities at June 30, 2023 will enable it to fund its operating expenses and capital expenditure requirements into the third quarter of 2025.

The Company had an accumulated deficit of $ 1.2 billion at June 30, 2023, and will require substantial additional capital to fund its operations.

The Company has never generated any product revenue.

10 unchanged sentences

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 three months ended March 31, 2023 and 2022 are referred to as the first quarter of 2023 and 2022, respectively.

The three months ended June 30, 2023 and 2022 are referred to as the second quarter of 2023 and 2022, respectively.

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.

3 unchanged sentences

Cash Equivalents and Marketable Securities

Cash equivalents and marketable securities consisted of the following at March 31, 2023 (in thousands):

March 31, 2023

Cash equivalents and marketable securities consisted of the following at June 30, 2023 (in thousands):

June 30, 2023

Cash equivalents and marketable securities:

Government agency securities

Money market funds

Government agency securities

Corporate notes/bonds

7 unchanged sentences

Commercial paper

As of March 31, 2023, the Company did no t hold any marketable securities that had been in an unrealized loss position for more than twelve months.

As of June 30, 2023, the Company did no t hold any marketable securities that had been in an unrealized loss position for more than twelve months.

Furthermore, the Company has determined that there were no material changes in the credit risk of the debt securities.

As of March 31, 2023, the Company holds 56 securities with an aggregate fair value of $ 83.3 million that had remaining maturities greater than one year.

There were no realized gains or losses on available-for-sale securities during the three months ended March 31, 2023 and 2022.

As of June 30, 2023, the Company holds 30 securities with an aggregate fair value of $ 48.1 million that had remaining maturities greater than one year.

There were no realized gains or losses on available-for-sale securities during the six months ended June 30, 2023 or 2022.

Fair Value Measurements

Assets measured at fair value on a recurring basis as of March 31, 2023 were as follows (in thousands):

Assets measured at fair value on a recurring basis as of June 30, 2023 were as follows (in thousands):

Quoted Prices

42 unchanged sentences

Commitments and Contingencies

In the second quarter of 2023, we entered into a License and Service Agreement pursuant to which we will lease manufacturing space for our continued research and development activities.

As of June 30, 2023, the lease has not commenced for accounting purposes and it is not expected to commence until the second quarter of 2024.

The lease agreement provides for total remaining lease payments of $ 87.8 million over a 10-year lease term.

The Company is a party to a number of license agreements under which the Company licenses patents, patent applications and other intellectual property from third parties.

7 unchanged sentences

As such, the Company anticipates that it has a substantial commitment in connection with these proceedings until such time as these proceedings have been resolved, but the amount of such commitment is not determinable.

The Company incurred an aggregate of $ 3.0 million and $ 2.1 million in expense during the three months ended March 31, 2023 and 2022, respectively, for such reimbursement.

The Company incurred an aggregate of $ 1.6 million and $ 4.6 million in expense during the three and six months ended June 30, 2023, respectively, for such reimbursement.

The Company incurred an aggregate of $ 1.8 million and $ 3.9 million in expense during the three and six months ended June 30, 2022, respectively, for such reimbursement.

Collaboration and Profit-Sharing Agreements

The Company has entered into multiple collaborations, out-licenses and strategic alliances with third parties that typically involve payments to or from the Company, including up-front payments, payments for research and development services, option payments, milestone payments and royalty payments to or from the Company.

The terms and conditions as well as the accounting analysis for the Company’s significant collaborations, out-licenses and strategic alliances are described in Note 9, “Collaboration and Profit-Sharing Agreements” to the consolidated financial statements included in the Annual Report.

statements included in the Annual Report.

There have been no material changes to the terms and conditions, or the accounting conclusions, previously disclosed in the Annual Report.

Collaboration Revenue

As of March 31, 2023, the Company’s contract liabilities were primarily related to the Company’s collaboration with BMS.

The following table presents changes in the Company’s accounts receivable and contract liabilities for the three months ended March 31, 2023 (in thousands):

For the three months ended March 31, 2023

As of June 30, 2023, the Company’s contract liabilities were primarily related to the Company’s collaboration with BMS.

The following table presents changes in the Company’s accounts receivable and contract liabilities for the six months ended June 30, 2023 (in thousands):

For the six months ended June 30, 2023

Balance at December 31, 2022

Balance at March 31, 2023

Balance at June 30, 2023

Accounts receivable

1 unchanged sentence

Deferred revenue

During the three months ended March 31, 2023, the Company recognized the following collaboration revenue (in thousands):

Three Months Ended

Revenue recognized in the period from:

March 31, 2023

Amounts included in deferred revenue at the beginning of the period

Performance obligations satisfied in previous periods

During the three and six months ended June 30, 2023, the Company did not recognize any collaboration revenue that had been allocated to deferred revenue from BMS.

Stock-based Compensation

1 unchanged sentence

Three Months Ended

Six Months Ended

Research and development

2 unchanged sentences

Restricted Stock Unit Awards

The following is a summary of restricted stock unit awards activity for the three months ended March 31, 2023:

The following is a summary of restricted stock unit awards activity for the six months ended June 30, 2023:

Unvested restricted stock unit awards as of December 31, 2022

Unvested restricted stock unit awards as of March 31, 2023

The restricted stock units issued in the three months ended March 31, 2023 include 253,100 units granted to certain employees that contain performance-based vesting provisions.

Unvested restricted stock unit awards as of June 30, 2023

The restricted stock units issued in the six months ended June 30, 2023 include 331,000 units granted to certain employees that contain performance-based vesting provisions.

The Company recognizes the fair value of the performance-based units through the expected achievement date if the performance-based vesting provisions are deemed probable.

As of March 31, 2023, total unrecognized compensation expense related to unvested restricted stock unit awards was $ 15.4 million, which the Company expects to recognize over a remaining weighted-average period of 2.85 years.

As of June 30, 2023, total unrecognized compensation expense related to unvested restricted stock unit awards was $ 14.7 million, which the Company expects to recognize over a remaining weighted-average period of 2.67 years.

Stock Options

The following is a summary of stock option activity for the three months ended March 31, 2023:

The following is a summary of stock option activity for the six months ended June 30, 2023:

Weighted Average

2 unchanged sentences

Contractual Life (years)

Value (in thousands)

Outstanding at December 31, 2022

Outstanding at March 31, 2023

Exercisable at March 31, 2023

As of March 31, 2023, total unrecognized compensation expense related to stock options was $ 32.6 million, which the Company expects to recognize over a remaining weighted-average period of 3.1 years.

Outstanding at June 30, 2023

Exercisable at June 30, 2023

As of June 30, 2023, total unrecognized compensation expense related to stock options was $ 31.5 million, which the Company expects to recognize over a remaining weighted-average period of 2.85 years.

Net Loss per Share

3 unchanged sentences

Contingently issuable shares are included in diluted loss per share based on the number of shares, if any, that would be issuable under the terms of the arrangement if the end of the reporting period was the end of the contingency period, if the results are dilutive.

For purposes of the diluted net loss per share calculation, stock options are considered to be common stock equivalents, but they were excluded from the Company’s calculation of diluted net loss per share allocable to common stockholders because their inclusion would have been anti-dilutive.

For purposes of the diluted net loss per share calculation, unvested restricted stock unit awards and outstanding stock options are considered to be common stock equivalents, but they were excluded from the Company’s calculation of diluted net loss per share allocable to common stockholders because their inclusion would have been anti-dilutive.

Therefore, basic and diluted net loss per share applicable to common stockholders were the same for all periods presented.

The following common stock equivalents were excluded from the calculation of diluted net loss per share allocable to common stockholders because their inclusion would have been anti-dilutive:

Three months ended

Unvested restricted stock and restricted stock unit awards

For the three and six months ended

Unvested restricted stock unit awards

Outstanding stock options

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