22 unchanged sentences
Preferred stock, $ 0.0001 par value;
−Removed: 80,000,000 shares authorized as of March 31, 2022 and December 31, 2021;
−Removed: no shares issued and outstanding as of March 31, 2022 and December 31, 2021
+Added: 80,000,000 shares authorized as of June 30, 2022 and December 31, 2021;
+Added: no shares issued and outstanding as of June 30, 2022 and December 31, 2021
Common stock, $ 0.0001 par value;
−Removed: 800,000,000 shares authorized as of March 31, 2022 and December 31, 2021;
−Removed: 121,732,846 and 121,382,547 shares issued at March 31, 2022 and December 31, 2021, respectively;
−Removed: 119,875,630 and 119,102,505 shares outstanding at March 31, 2022 and December 31, 2021, respectively
+Added: 800,000,000 shares authorized as of June 30, 2022 and December 31, 2021;
+Added: 122,063,473 and 121,382,547 shares issued at June 30, 2022 and December 31, 2021, respectively;
+Added: 120,545,318 and 119,102,505 shares outstanding at June 30, 2022 and December 31, 2021, respectively
Additional paid-in capital
6 unchanged sentences
(In thousands, except share and per share amounts)
−Removed: Three Months Ended March 31,
+Added: Three Months Ended June 30,
+Added: Six Months Ended June 30,
Operating expenses:
16 unchanged sentences
Condensed Consolidated Statements of Convertible Preferred Stock and Stock holders’
−Removed: Equity (Deficit)
(In thousands, except share data)
2 unchanged sentences
Stockholders'
+Added: Income (Loss)
Balance at December 31, 2021
5 unchanged sentences
Balance at March 31, 2022
+Added: Exercise of stock options
+Added: Issuance of common stock under the Employee Stock Purchase Plan
+Added: Vesting of early exercised stock options
+Added: Stock-based compensation expense
+Added: Unrealized loss on marketable securities, net
+Added: Balance at June 30, 2022
+Added: Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’
+Added: (In thousands, except share data)
Preferred Stock
10 unchanged sentences
Balance at March 31, 2021
+Added: Issuance of common stock in connection with license agreement
+Added: Exercise of stock options
+Added: Vesting of early exercised stock options
+Added: Stock-based compensation expense
+Added: Unrealized loss on marketable securities, net
+Added: Balance at June 30, 2021
The accompanying notes are an integral part of these condensed consolidated financial statements.
1 unchanged sentence
(In thousands)
−Removed: Three Months Ended March 31,
+Added: Six Months Ended June 30,
Cash flows from operating activities:
17 unchanged sentences
Purchases of property and equipment
−Removed: Net cash used in investing activities
+Added: Net cash (used in) provided by investing activities
Cash flows from financing activities:
1 unchanged sentence
Proceeds from the exercise of stock options, net of repurchases
+Added: Proceeds from issuance of common stock under the Employee Stock Purchase Plan
Net cash provided by financing activities
4 unchanged sentences
Issuance of common stock in connection with asset acquisition
+Added: Issuance of common stock in connection with license agreement
Amounts accrued for purchases of property and equipment
2 unchanged sentences
Supplemental disclosure of noncash operating activities:
+Added: Operating lease assets obtained in exchange for lease obligation
Tenant improvement allowance included in operating lease liabilities
+Added: Reduction in operating lease assets due to lease amendment
The accompanying notes are an integral part of these condensed consolidated financial statements.
13 unchanged sentences
Since inception, the Company has devoted substantially all of its efforts and resources to organizing and staffing the Company, business planning, raising capital, identifying, acquiring and in-licensing the Company’s product candidates, establishing its intellectual property portfolio, conducting research, preclinical studies, and clinical trials, establishing arrangements with third parties for the manufacture of its product candidates and related raw materials, and providing general and administrative support for these operations.
−Removed: As of March 31, 2022, the Company had $ 392.5 million in cash, cash equivalents, and short-term marketable securities, and $ 29.2 million in long-term marketable securities.
−Removed: As of March 31, 2022, the Company had an accumulated deficit of $ 274.6 million.
+Added: As of June 30, 2022, the Company had $ 371.5 million in cash, cash equivalents, and short-term marketable securities, and $ 19.3 million in long-term marketable securities.
+Added: As of June 30, 2022, the Company had an accumulated deficit of $ 310.2 million.
The Company has incurred significant operating losses and negative cash flows from operations.
−Removed: From its inception through March 31, 2022, the Company’s financial support has primarily been provided from the sale of its convertible preferred stock and the sale of its common stock in its initial public offering (IPO).
+Added: From its inception through June 30, 2022, the Company’s financial support has primarily been provided from the sale of its convertible preferred stock and the sale of its common stock in its initial public offering (IPO).
As the Company continues its expansion, it expects to use its cash, cash equivalents, and short-term marketable securities to fund research and development, working capital, and other general corporate purposes.
3 unchanged sentences
The Company’s failure to raise capital or enter into such other arrangements when needed would have a negative impact on the Company’s financial condition and could force the Company to delay, limit, reduce or terminate its research and development programs or other operations, or grant rights to develop and market product candidates that the Company would otherwise prefer to develop and market itself.
−Removed: The Company believes its cash, cash equivalents, and short-term marketable securities as of March 31, 2022 will be sufficient for the Company to fund operations for at least one year from the issuance date of these condensed consolidated financial statements.
+Added: The Company believes its cash, cash equivalents, and short-term marketable securities as of June 30, 2022 will be sufficient for the Company to fund operations for at least one year from the issuance date of these condensed consolidated financial statements.
Initial public offering
19 unchanged sentences
Unaudited interim financial information
−Removed: The accompanying condensed consolidated balance sheet as of March 31, 2022, the condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2022 and 2021, the condensed consolidated statements of convertible preferred stock and stockholders’
−Removed: equity (deficit) for the three months ended March 31, 2022 and 2021 and the condensed consolidated statements of cash flows for the three months ended March 31, 2022 and 2021 are unaudited.
−Removed: The unaudited condensed consolidated interim financial statements have been prepared on the same basis as the audited annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s condensed consolidated financial position as of March 31, 2022 and the condensed consolidated results of its operations and cash flows for the three months ended March 31, 2022 and 2021.
−Removed: The condensed consolidated financial data and other information disclosed in these notes related to the three months ended March 31, 2022 and 2021 are unaudited.
−Removed: The condensed consolidated results for the three months ended March 31, 2022 are not necessarily indicative of results to be expected for the year ending December 31, 2022 , any other interim periods, or any future year or period.
+Added: The accompanying condensed consolidated balance sheet as of June 30, 2022, the condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2022 and 2021, the condensed consolidated statements of convertible preferred stock and stockholders’
+Added: equity (deficit) for the three and six months ended June 30, 2022 and 2021 and the condensed consolidated statements of cash flows for the six months ended June 30, 2022 and 2021 are unaudited.
+Added: The unaudited condensed consolidated interim financial statements have been prepared on the same basis as the audited annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s condensed consolidated financial position as of June 30, 2022 and the condensed consolidated results of its operations and cash flows for the three and six months ended June 30, 2022 and 2021.
+Added: The condensed consolidated financial data and other information disclosed in these notes related to the three and six months ended June 30, 2022 and 2021 are unaudited.
+Added: The condensed consolidated results for the three and six months ended June 30, 2022 are not necessarily indicative of results to be expected for the year ending December 31, 2022 , any other interim periods, or any future year or period.
These unaudited condensed consolidated financial statements should be read in conjunction with the Company's audited consolidated financial statements included in its Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 24, 2022.
7 unchanged sentences
The Company considers all highly liquid investments with an original maturity of three months or less from the date of purchase to be cash equivalents.
−Removed: The Company had deposited cash of $ 408,000 as of March 31, 2022 and December 31, 2021 to secure a letter of credit in connection with the lease of the Company’s facilities (see Note 11).
+Added: The Company had deposited cash of $ 408,000 as of June 30, 2022 and December 31, 2021 to secure a letter of credit in connection with the lease of the Company’s facilities (see Note 11).
The Company has classified the restricted cash as a noncurrent asset on its condensed consolidated balance sheets.
10 unchanged sentences
Such amortization and accretion are included in interest income.
−Removed: The Company regularly reviews all its marketable securities for declines in fair value.
−Removed: The review includes the consideration of the cause of the impairment, including the creditworthiness of the security issuers, the number of securities in an unrealized loss position, the severity and duration of the unrealized losses, whether the Company has the intent to sell the securities and whether it is more likely than not that the Company will be required to sell the securities before the recovery of their amortized cost basis.
−Removed: If the decline in fair value is due to credit-related factors, a loss is recognized in net income, whereas if the decline in fair value is not due to credit-related factors, the loss is recorded in other comprehensive income (loss).
+Added: The Company regularly reviews all of its marketable securities for declines in fair value.
+Added: The review includes the consideration of the cause of the impairment, including the creditworthiness of the security issuers, the number of securities in an unrealized loss position, the severity of the unrealized loss(es), whether the Company has the intent to sell the securities and whether it is more likely than not that the Company will be required to sell the securities before the recovery of their amortized cost basis.
+Added: If the decline in fair value is due to credit-related factors, a loss is recognized in net income;
+Added: whereas, if the decline in fair value is not due to credit-related factors, the loss is recorded in other comprehensive income (loss).
Realized gains and losses on available-for-sale securities are included in other income or expense.
38 unchanged sentences
The following tables summarize the Company’s financial assets measured at fair value on a recurring basis and their respective input levels based on the fair value hierarchy (in thousands):
−Removed: Fair value measurements as of March 31, 2022 using
+Added: Fair value measurements as of June 30, 2022 using
Quoted prices in
4 unchanged sentences
Money market funds (1)
−Removed: Corporate debt securities (1)
US treasury securities (2)
−Removed: Corporate debt securities (2)
Commercial paper (2)
+Added: Corporate debt securities (2)
+Added: Yankee debt security (2)
+Added: Supranational debt security (2)
US treasury securities (3)
20 unchanged sentences
The carrying amounts of the Company’s financial instruments, including cash, prepaid and other current assets, accounts payable, and accrued expenses and other current liabilities, approximate fair value due to their short maturities.
−Removed: As of March 31, 2022, the Company has recorded a $ 2.0 million equity investment in Affini-T Therapeutics, Inc.
−Removed: at cost, subject to impairment in accordance with ASC 321, Investments—Equity Securities.
+Added: As of June 30, 2022 , the Company has recorded a $ 2.0 million equity investment in Affini-T Therapeutics, Inc.
+Added: (Affini-T) at cost, subject to impairment in accordance with ASC 321, Investments—Equity Securities.
None of the Company’s non-financial assets or liabilities are recorded at fair value on a non-recurring basis.
No transfers between levels have occurred during the periods presented.
−Removed: Cash equivalents consist of money market funds and corporate debt securities, short-term marketable securities consist of US treasury securities, corporate debt securities, commercial paper and supranational debt securities, and long-term marketable securities consist of US treasury securities.
+Added: Cash equivalents consist of money market funds, short-term marketable securities consist of US treasury securities, corporate debt securities, commercial paper, Yankee debt securities and supranational debt securities, and long-term marketable securities consist of US treasury securities.
The Company obtains pricing information from its investment manager and generally determines the fair value of marketable securities usi ng standard observable inputs, including reported trades, broker/dealer quotes, and bid and/or offers.
1 unchanged sentence
The following tables summarize the Company’s marketable securities accounted for as available-for-sale securities (in thousands, except years):
−Removed: March 31, 2022
+Added: June 30, 2022
US treasury securities
−Removed: Corporate debt securities
Commercial paper
+Added: Corporate debt securities
+Added: Yankee debt security
+Added: Supranational debt security
US treasury securities
5 unchanged sentences
US treasury securities
−Removed: As of March 31, 2022, there were 17 av ailable-for-sale securities with an estimated fair value of $ 61.2 million i n gross unrealized loss positions.
+Added: As of June 30, 2022, there were 25 av ailable-for-sale securities with an estimated fair value of $ 70.2 million that were i n gross unrealized loss positions.
None had been in such position for greater than 12 months.
As of December 31, 2021 , there were 19 available-for-sale securities with an estimated fair value of $ 68.0 million in gross unrealized loss positions.
−Removed: As of March 31, 2022 and December 31, 2021 , unrealized losses on available-for-sale securities are not attributed to credit risk.
−Removed: The Company believes that an allowance for credit losses is unnecessary because the unrealized losses on certain of the Company’s available-for-sale securities are due to market factors.
+Added: As of June 30, 2022 and December 31, 2021 , unrealized losses on available-for-sale securities are not attributed to credit risk.
+Added: The Company believes that an allowance for credit losses is unnecessary because the unrealized losses on certain of the Company’s available-for-sale securities are due to market factors and interest rate increases.
+Added: Additionally, the Company does not intend to sell the securities nor is it more likely than not that the Company will be required to sell the securities before recovery of their amortized cost basis.
Property and equipment, net
8 unchanged sentences
Property and equipment, net
−Removed: Depreciation and amortization expense related to property and equipment was $ 403,000 and $ 149,000 for the three months ended March 31, 2022 and 2021 , respectively.
+Added: Depreciation and amortization expense related to property and equipment was $ 534,000 and $ 937,000 for the three and six months ended June 30, 2022 , respectively, and $ 169,000 and $ 318,000 for the three and six months ended June 30, 2021 , respectively.
Accrued expenses and other current liabilities
18 unchanged sentences
The Company recorded IPR&D expense of $ 50.0 million during the year ended December 31, 2020 in connection with the asset acquisition.
−Removed: No IPR&D expense was recorded during the three months ended March 31, 2022 and 2021.
−Removed: As of March 31, 2022 and December 31, 2021 , no milestones had been accrued as the underlying contingencies were not probable or estimable.
+Added: No IPR&D expense was recorded during the three and six months ended June 30, 2022 and 2021.
+Added: As of June 30, 2022 and December 31, 2021 , no milestones had been accrued as the underlying contingencies were not probable or estimable.
Emerge Life Sciences, Pte.
3 unchanged sentences
Under the ELS Purchase Agreement, ELS was committed to performing certain studies on the applicable antibodies to assist in development activities, the costs of which were mutually agreed upon and for which the Company was responsible.
−Removed: The Company recorded IPR&D expense of $ 0 and $ 3.7 million during the three months ended March 31, 2022 and 2021, respectively, in connection with the asset acquisition.
+Added: No IPR&D expense was recorded during the three and six months ended June 30, 2022 .
+Added: The Company recorded IPR&D expense of $ 0 and $ 3.7 million during the three and six months ended June 30, 2021, respectively, in connection with the asset acquisition.
Pursuant to the ELS Purchase Agreement, at any time between 12 months and 36 months after the effective date of the ELS Purchase Agreement, if the Company reasonably determines that none of the Antibodies should be taken into human clinical trials due to safety, efficacy or chemistry, manufacturing and controls (CMC) issues, then the Company has the option to select another antibody developed and solely owned by ELS that is not the subject of a license, collaboration, or option to a third party (the Option).
If the Company elects to exercise the Option, then ELS will provide to the Company a list of all available antibodies that meet the aforementioned requirements, and the Company has the right to select one antibody from the list.
−Removed: Upon the Company’s selection of an antibody, ELS will assign it all rights, title and interest to such antibody (including patent and other intellectual property rights) subject to any pre-existing obligations or restrictions.
+Added: Upon the Company’s selection of an antibody, ELS will assign to the Company all rights, title and interest to such antibody (including patent and other intellectual property rights) subject to any pre-existing obligations or restrictions.
In the event that the Company wishes to have ELS conduct any studies on such optioned antibody, then after mutual agreement as to the scope of the studies, the Company will be responsible for the cost for such studies.
9 unchanged sentences
and (ii) equally split all net sublicensing revenues earned under sublicense agreements that the Company enters into with any third party before commencement of the first Phase I clinical trial for a licensed product.
−Removed: No IPR&D expense was recorded during the three months ended March 31, 2022 and 2021.
+Added: No IPR&D expense was recorded during the three and six months ended June 30, 2022 and 2021.
Katmai Pharmaceuticals, Inc.
6 unchanged sentences
The Company is also obligated to pay tiered royalties on net sales of each licensed product, at rates ranging from the mid- to high-single digit percentages, subject to a minimum annual royalty payment in the low six figures and certain permitted deductions.
−Removed: The Company recorded IPR&D expense of $ 2.0 million in connection with a development milestone payment made during the three months ended March 31, 2022.
−Removed: No IPR&D expense was recorded during the three months ended March 31, 2021.
+Added: The Company recorded IPR&D expense of $ 0 and $ 2.0 million in connection with a development milestone payment made during the three and six months ended June 30, 2022 , respectively.
+Added: No IPR&D expense was recorded during the three and six months ended June 30, 2021.
In April 2020, the Company entered into a license agreement with LifeArc (the LifeArc Agreement) under which the Company was granted an exclusive, worldwide license to certain materials, know-how, and intellectual property rights owned or controlled by LifeArc to develop, manufacture, use, and commercialize certain ULK inhibitors for all applications.
3 unchanged sentences
The Company is also obligated to pay royalties on net sales of all licensed products, in the low-single digit percentages, subject to certain reductions.
−Removed: No IPR&D expense was recorded during the three months ended March 31, 2022 and 2021.
+Added: No IPR&D expense was recorded during the three and six months ended June 30, 2022 and 2021.
University of California, San Francisco
8 unchanged sentences
In August 2021, following the achievement of the Corporate Milestone, the Company made a cash payment to the Regents in the amount of $ 1.7 million.
−Removed: No IPR&D expense was recorded during the three months ended March 31, 2022 and 2021 .
+Added: No IPR&D expense was recorded during the three and six months ended June 30, 2022 .
+Added: The Company recorded IPR&D expense of $ 5.5 million during the three and six months ended June 30, 2021 related to the issuance of 944,945 shares of the Company's common stock to the Regents.
Stockholders’
4 unchanged sentences
equity (deficit) on the consolidated balance sheets because the holders of such shares had liquidation rights in the event of a deemed liquidation that, in certain situations, were not solely within the control of the Company and would require the redemption of the then-outstanding convertible preferred stock.
−Removed: There were no shares of convertible preferred stock outstanding as of March 31, 2022 and December 31, 2021.
−Removed: The Company had 800,000,000 shares of its common stock authorized as of March 31, 2022 and December 31, 2021 .
−Removed: The Company had 121,732,846 and 121,382,547 shares of its common stock issued and 119,875,630 and 119,102,505 shares of common stock outstanding as of March 31, 2022 and December 31, 2021, respectively.
+Added: There were no shares of convertible preferred stock outstanding as of June 30, 2022 and December 31, 2021.
+Added: The Company had 800,000,000 shares of its common stock authorized as of June 30, 2022 and December 31, 2021.
+Added: The Company had 122,063,473 and 121,382,547 shares of its common stock issued and 120,545,318 and 119,102,505 shares of common stock outstanding as of June 30, 2022 and December 31, 2021, respectively.
Shares of common stock subject to repurchase
2 unchanged sentences
Any shares subject to repurchase by the Company are not deemed, for accounting purposes, to be outstanding until those shares vest.
−Removed: As of March 31, 2022 and December 31, 2021 , 121,530 shares and 212,674 shares of common stock, respectively, were subject to repurchase by the Company.
+Added: As of June 30, 2022 and December 31, 2021 , 30,384 shares and 212,674 shares of common stock, respectively, were subject to repurchase by the Company.
The unvested stock liability related to these awards is immaterial for all periods presented.
−Removed: For the three months ended March 31, 2022 and 2021, 91,144 and 91,147 shares vested, respectively.
+Added: For the three and six months ended June 30, 2022 , 91,146 and 182,290 shares vested, respectively.
+Added: For the three and six months ended June 30, 2021 , 91,146 and 182,293 shares vested, respectively.
Stock-based compensation
4 unchanged sentences
In addition, the number of shares of common stock available for issuance under the 2021 Plan may be increased annually on the first day of each calendar year during the term of the 2021 Plan, beginning in 2022, by an amount equal to the lesser of (i) 5 % of the shares of common stock outstanding on the final day of the immediately preceding calendar year or (ii) such smaller number of shares as determined by the Company’s board of directors or an authorized committee of the board of directors.
−Removed: As of March 31, 2022 , there were 16,923,767 stock-based awards available for future grant under the 2021 Plan.
+Added: As of June 30, 2022, there were 16,404,213 stock-based awards available for future grant under the 2021 Plan.
Subsequent to July 2021, no further awards will be granted under the 2018 Plan and all future stock-based awards will be granted under the 2021 Plan.
11 unchanged sentences
Outstanding at December 31, 2021
−Removed: Outstanding at March 31, 2022
−Removed: Options exercisable at March 31, 2022
−Removed: The weighted-average grant date fair value of options granted for the three months ended March 31, 2022 and 2021 was $ 8.36 and $ 2.37 , respectively.
−Removed: As of March 31, 2022, the unrecognized compensation cost related to unvested stock option grants was $ 62.4 million and is expected to be recognized as expense over approximately 3.00 years.
−Removed: The intrinsic value of the options exercised for the three months ended March 31, 2022 and 2021 was $ 3.4 million and $ 424,000 , respectively.
+Added: Outstanding at June 30, 2022
+Added: Options exercisable at June 30, 2022
+Added: The weighted-average grant date fair value of options granted for the three and six months ended June 30, 2022 was $ 5.00 and $ 7.71 , re spectively, and for the three and six months ended June 30, 2021 was $ 4.59 and $ 3.45 , respectively.
+Added: As of June 30, 2022, the unrecognized compensation cost related to unvested stock option grants was $ 61.1 million and is expected to be recognized as expense over approximately 2.76 years.
+Added: The intrinsic value of the options exercised for the three and six months ended June 30, 2022 was $ 1.0 million and $ 4.3 million, respectively.
+Added: The intrinsic value of the options exercised for the three and six months ended June 30, 2021 was $ 1.5 million and $ 1.9 million, respectively.
Prior to the Company's IPO, certain individuals were granted the ability to early exercise their stock options.
3 unchanged sentences
The cash received in exchange for exercised and unvested shares related to stock options granted is recorded as a liability for the early exercise of stock options on the accompanying condensed consolidated balance sheets and will be transferred into common stock and additional paid-in capital as the shares vest.
−Removed: As of March 31, 2022 and December 31, 2021 , there were 1,615,888 shares and 1,854,427 shares subject to repurchase by the Company, respectively.
−Removed: As of March 31, 2022 and December 31, 2021 , the Company recorded $ 2.4 million and $ 2.9 million of liabilities associated with shares issued with repurchase rights, respectively, which is recorded in accrued expenses and other current liabilities.
+Added: As of June 30, 2022 and December 31, 2021 , there were 1,448,961 shares and 1,854,427 shares subject to repurchase by the Company, respectively.
+Added: As of June 30, 2022 and December 31, 2021, the Company recorded $ 2.2 million and $ 2.9 million of liabilities associated with shares issued with repurchase rights, respectively, which is recorded in accrued expenses and other current liabilities.
The assumptions used in the Black-Scholes option pricing model to determine the fair value of the employee and nonemployee stock option grants were as follows:
−Removed: Three Months Ended March 31,
+Added: Three Months Ended June 30,
+Added: Six Months Ended June 30,
Risk-free interest rate
1 unchanged sentence
1.02 %- 1.09 %
+Added: 1.46 %- 3.23 %
+Added: 0.59 %- 1.09 %
Expected volatility
1 unchanged sentence
82.08 %- 82.54 %
+Added: 85.51 %- 87.11 %
+Added: 82.08 %- 83.88 %
Expected term (in years)
6 unchanged sentences
In addition, the number of shares of common stock available for issuance under the ESPP may be increased annually on the first day of each calendar year during the term of the ESPP, beginning in 2022, by an amount equal to the lesser of (i) 1% of the shares of common stock outstanding on the final day of the immediately preceding calendar year or (ii) such smaller number of shares as determined by the Company’s board of directors or an authorized committee of the board of directors.
−Removed: The Company recognized $ 501,000 of stock-based compensation expense related to the ESPP during the three months ended March 31, 2022.
−Removed: As of March 31, 2022 , the unrecognized compensation cost related to the ESPP was $ 3.0 million and is expected to be recognized as expense over approximately 1.71 years.
−Removed: As of March 31, 2022, $ 620,000 h as been withheld on behalf of employees for future purchase under the ESPP and is included in accrued expenses and other current liabilities on the condensed consolidated balance sheet.
−Removed: As of March 31, 2022 , 91,987 shares have been issued under the ESPP.
+Added: The Company recognized $ 167,000 and $ 668,000 of stock-based compensation expense related to the ESPP during the three and six months ended June 30, 2022.
+Added: As of June 30, 2022, the unrecognized compensation cost related to the ESPP was $ 4.6 million and is expected to be recognized as expense over approximately 1.96 years.
+Added: As of June 30, 2022, $ 44,000 h as been withheld on behalf of employees for future purchase under the ESPP and is included in accrued expenses and other current liabilities on the condensed consolidated balance sheet.
+Added: The Company issued and sold 150,642 shares under the ESPP during the three and six months ended June 30, 2022.
+Added: The assumptions used in the Black-Scholes option pricing model to determine the fair value of the stock to be purchased under the ESPP were as follows:
+Added: Three Months Ended June 30,
+Added: Six Months Ended June 30,
+Added: Risk-free interest rate
+Added: 2.24 %- 3.14 %
+Added: 2.24 %- 3.14 %
+Added: Expected volatility
+Added: 84.74 %- 87.89 %
+Added: 84.74 %- 87.89 %
+Added: Expected term (in years)
+Added: Expected dividend yield
+Added: (1) The ESPP was not in effect until July 2021.
Restricted stock
1 unchanged sentence
The weighted-average grant date fair value of restricted stock granted in 2018 was $ 0 .
−Removed: No shares of restricted stock were granted during the three months ended March 31, 2022 and 2021.
+Added: No shares of restricted stock were granted during the three and six months ended June 30, 2022 and 2021.
The restricted stock shares are subject to forfeiture upon the stockholders’
2 unchanged sentences
As such, the Company recognizes the measurement date fair value of the restricted stock over the vesting period as compensation expense.
−Removed: As of March 31, 2022 and December 31, 2021 , 119,798 shares and 212,941 shares of common stock, respectively, were subject to forfeiture.
−Removed: The summary of the Company’s restricted stock activity during the three months ended March 31, 2022 is as follows:
+Added: As of June 30, 2022 and December 31, 2021 , 38,810 shares and 212,941 shares of common stock, respectively, were subject to forfeiture.
+Added: The summary of the Company’s restricted stock activity during the six months ended June 30, 2022 is as follows:
Nonvested at December 31, 2021
−Removed: Nonvested at March 31, 2022
−Removed: At March 31, 2022 , the total unrecognized compensation related to unvested restricted stock awards granted was $ 0 .
+Added: Nonvested at June 30, 2022
+Added: At June 30, 2022 , the total unrecognized compensation related to unvested restricted stock awards granted was $ 0 .
Stock-based compensation expense
The allocation of stock-based compensation for all stock awards was as follows (in thousands):
−Removed: Three Months Ended March 31,
+Added: Three Months Ended June 30,
+Added: Six Months Ended June 30,
Research and development
1 unchanged sentence
Common stock reserved for future issuance
−Removed: Common stock reserved for future issuance consisted of the following as of March 31, 2022 and December 31, 2021:
+Added: Common stock reserved for future issuance consisted of the following as of June 30, 2022 and December 31, 2021:
Stock options issued and outstanding
3 unchanged sentences
The Company has facility leases for office space under non-cancellable and cancelable operating leases with various expiration dates through 2032 and equipment under a non-cancellable operating lease with a term expiring in 2026 .
−Removed: Operating lease cost was approximately $ 1.0 million, including variable lease costs of $ 117,000 , and short-term lease costs of $ 31,000 during the three months ended March 31, 2022 .
−Removed: Operating lease cost was approximately $ 361,000 , including variable lease costs of $ 105,000 , and short-term lease costs of $ 29,000 during the three months ended March 31, 2021 .
−Removed: The Company paid $ 273,000 and $ 268,000 in ca sh for operating leases that were included in the operating activities section of the condensed consolidated statements of cash flows for the three months ended March 31, 2022 and 2021, respectively.
−Removed: The weighted-average remaining lease term and the weighted-average discount rate of the Company’s operating leases was 9 .84 years and 7.0 % a t March 31, 2022 , respectively.
+Added: Operating lease cost was approximately $ 1.0 million and $ 2.0 million, including variable lease costs of $ 278,000 and $ 396,000 , and short-term lease costs of $ 31,000 and $ 62,000 , during the three and six months ended June 30, 2022 , respectively.
+Added: Operating lease cost was approximately $ 380,000 and $ 742,000 , including variable lease costs of $ 123,000 and $ 228,000 , and short-term lease costs of $ 30,000 and $ 59,000 , during the three and six months ended June 30, 2021, respectively.
+Added: The Company paid $ 417,000 and $ 535,000 in ca sh for operating leases that were included in the operating activities section of the condensed consolidated statements of cash flows for the six months ended June 30, 2022 and 2021, respectively.
+Added: The weighted-average remaining lease term and the weighted-average discount rate of the Company’s operating leases were 9.60 years and 8.35 % at June 30, 2022 , respectively.
The weighted-average remaining lease term and the weighted-average discount rate of the Company’s operating leases was 9.86 years and 6.9 % at December 31, 2021, respectively.
5 unchanged sentences
The 2018 Lease was again modified in November 2021 to amend the termination date from May 2024 to April 2022 .
−Removed: The Company remeasured the associated lease liability using the incremental borrowing rate at the date of the amendment selected on the basis of the remaining lease term and remaining lease payments and adjusted the operating lease asset accordingly, resulting in a $ 539,000 gain on remeasurement, which was recorded as other income (expense), net in the consolidated statements of operations and comprehensive loss.
+Added: The Company remeasured the associated lease liability using the incremental borrowing rate at the date of the second amendment selected on the basis of the remaining lease term and remaining lease payments and adjusted the operating lease asset accordingly, resulting in a $ 539,000 gain on remeasurement, which was recorded as other income (expense), net in the consolidated statements of operations and comprehensive loss.
The 2018 Lease was again modified in April 2022 to amend the termination date from April 2022 to May 2022 .
−Removed: The Company’s lea se payments consist primarily of fixed rental payments for the right to use the underlying leased assets over the lease term.
−Removed: The Company is responsible for operating expenses over base operating expenses as defined in the original lease agreement.
+Added: The Company’s lea se payments consisted primarily of fixed rental payments for the right to use the underlying leased assets over the lease term.
+Added: The Company was responsible for operating expenses over base operating expenses as defined in the original lease agreement.
In September 2020, the Company entered into a lease agreement for 59,407 square feet of laboratory and office space in San Diego, California, which represented a portion of a new facility that was under construction and which was subsequently amended in March 2021 to expand the rented premises by 18,421 square feet (the 2020 Lease).
The construction and design of the asset was the primary responsibility of the lessor.
−Removed: The Company was involved in certain aspects of construction and design for certain interior features and leasehold improvements that will be beneficial to the Company to better suit its business needs and intended purpose of the space.
+Added: The Company was involved in certain aspects of construction and design for certain interior features and leasehold improvements that is beneficial to the Company to better suit its business needs and intended purpose of the space.
The lease is accounted for as an operating lease and commenced in August 2021 .
In April 2022, the 2020 Lease was modified to amend the rent commencement date from February 2022 to May 2022 .
−Removed: The 2020 Lease, as amended, has an initial term of 10.75 years and includes aggregate monthly payments to the lessor of approximately $ 51.6 million beginning in April 2023 with a rent escalation clause, and a tenant improvement allowance of approximately $ 16.8 million.
+Added: The 2020 Lease, as amended, has an initial term of 10.75 years and includes aggregate monthly payments to the lessor of approximately $ 51.6 million beginning in May 2023 with a rent escalation clause, and a tenant improvement allowance of approximately $ 16.8 million.
The 2020 Lease is cancellable at the Company’s request after the 84 th month with 12 months written notice and a lump-sum cancellation payment of $ 2.5 million.
1 unchanged sentence
In December 2021, the Company entered into a lease agreement for 29,542 square feet of office and laboratory space in South San Francisco, California (the 2021 Lease).
−Removed: The lease will be accounted for as an operating lease with the associated operating lease assets and liabilities recorded upon commencement which is expected to be in July 2022 .
−Removed: The non-cancellable operating lease has an initial term of 124 months with an option to extend the lease term by 5 years at the then current market rates and includes aggregate monthly payments to the lessor of approximately $ 34.4 million beginning in November 2022 with a rent escalation clause and a tenant improvement allowance of approximately $ 8.2 million.
+Added: The lease will be accounted for as an operating lease with the associated operating lease assets and liabilities recorded upon commencement, which occurred in July 2022 .
+Added: T he non-cancellable operating lease has an initial term of 124 months with an option to extend the lease term by 5 years at the then current market rates and includes aggregate monthly payments to the lessor of approximately $ 34.4 million beginning in November 2022 with a rent escalation clause and a tenant improvement allowance of approximately $ 8.2 million.
The construction and design of the tenant improvements is the primary responsibility of the lessor.
3 unchanged sentences
In February 2022, the actual project costs exceeded the tenant improvement allowances by $ 5.1 million, which was paid directly to the landlord by the Company and was recorded as prepaid rent in the condensed consolidated balance sheet and as a cash outflow from operating activities in the condensed consolidated statement of cash flows.
−Removed: The Company paid a security deposit of $ 874,000 in December 2021 which was recorded as other assets in the condensed consolidated balance sheets.
−Removed: Future minimum lease payments under the operating leases with initial lease terms in excess of one year (excluding the 2021 Lease) as of March 31, 2022 are as follows (in thousands):
+Added: The Company paid a security deposit of $ 874,000 in December 2021 that was recorded as other assets in the condensed consolidated balance sheets.
+Added: Future minimum lease payments under the operating leases with initial lease terms in excess of one year (excluding the 2021 Lease) as of June 30, 2022 are as follows (in thousands):
Year ending December 31,
−Removed: 2022 (remaining nine months)
+Added: 2022 (remaining six months)
Total lease payments
5 unchanged sentences
There are no matters currently outstanding for which any such liabilities have been accrued.
−Removed: No provision for federal, state or foreign income taxes has been recorded for the three months ended March 31, 2 0 22 and 2 0 21 .
+Added: No provision for federal, state or foreign income taxes has been recorded for the three and six months ended June 30, 2 0 22 and 2 0 21 .
The Company has incurred net operating losses for all the periods presented and has not reflected any benefit of such net operating loss carryforwards in the accompanying condensed consolidated financial statements due to uncertainty around utilizing these tax attributes within their respective carryforward periods.
1 unchanged sentence
The Company’s policy is to recognize interest expense and penalties related to income tax matters as tax expense.
−Removed: For the three months ended March 31, 2022 and 2021 , the Company has no t recognized any interest or penalties related to income taxes.
+Added: For the three and six months ended June 30, 2022 and 2021 , the Company has no t recognized any interest or penalties related to income taxes.
Net loss per share
The following table summarizes the computation of basic and diluted net loss per share of the Company (in thousands, except share and per share data):
−Removed: Three Months Ended March 31,
+Added: Three Months Ended June 30,
+Added: Six Months Ended June 30,
Weighted-average shares of common stock used in computing net loss per share, basic and diluted
2 unchanged sentences
Therefore, the weighted-average number of common shares outstanding used to calculate both basic and diluted net loss per share is the same.
−Removed: The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect:
−Removed: Three Months Ended March 31,
+Added: The Company excluded the following potential common shares, presented as amounts outstanding at each period end, from the computation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect:
+Added: Three Months Ended June 30,
+Added: Six Months Ended June 30,
Convertible preferred stock issued
6 unchanged sentences
The current COVID-19 pandemic, which is impacting worldwide economic activity, poses the risk that the Company or its employees, contractors, suppliers, and other partners may be prevented from conducting business activities for an indefinite period of time, including due to shutdowns that may be requested or mandated by governmental authorities.
−Removed: During the three months ended March 31, 2022 and 2021, the Company has not experienced significant impact from the pandemic.
+Added: During the three and six months ended June 30, 2022 and 2021, the Company has not experienced significant impact from the pandemic.
The extent to which the COVID-19 pandemic will impact the Company’s business will depend on future developments that are highly uncertain and cannot be predicted at this time.
4 unchanged sentences
In December 2021, the Company loaned the Erasca Foundation $ 100,000 in exchange for a non-interest bearing promissory note that matures one year following the date of the note.
−Removed: As of March 31, 2022, $ 100,000 is recorded as a receivable in prepaid expenses and other current assets in the condensed consolidated balance sheet.
+Added: As of June 30, 2022 , $ 100,000 is recorded as a receivable in prepaid expenses and other current assets in the condensed consolidated balance sheet.
+Added: Affini-T Therapeutics, Inc.
+Added: The Company holds a $ 2.0 million equity investment in Affini-T.
+Added: One of the Company’s board members is also a member of the board of Affini-T.
+Added: Subsequent events
+Added: On August 11, 2022, the Company entered into an Open Market Sale Agreement (the Sale Agreement) with Jefferies LLC (the Agent), pursuant to which the Company may offer and sell shares of the Company’s common stock having an aggregate offering price of up to $ 200 million from time to time, in “at the market”
+Added: offerings through the Agent.
+Added: Sales of the shares of common stock, if any, will be made at prevailing market prices at the time of sale, or as otherwise agreed with the Agent.
+Added: The Agent will receive a commission from the Company of up to 3.0 % of the gross proceeds of any shares of common stock sold under the Sale Agreement.
+Added: The Company is not obligated to sell, and the Agent is not obligated to buy or sell, any shares of common stock under the Sale Agreement.
+Added: No assurance can be given that the Company will sell any shares of common stock under the Sale Agreement, or, if it does, as to the price or amount of shares of common stock that it sells or the dates when such sales will take place.
Management’s Discussion and Analysis of Financial Condition and Results of Operations.
2 unchanged sentences
This Quarterly Report contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act).
−Removed: All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding our future results of operations and financial position, business strategy, research and development plans, the anticipated timing, costs, design and conduct of our ongoing and planned preclinical studies and planned clinical trials for our product candidates, the timing and likelihood of regulatory filings and approvals for our product candidates, our ability to commercialize our product candidates, if approved, the impact of the COVID-19 pandemic on our business, the pricing and reimbursement of our product candidates, if approved, the potential to develop future product candidates, the potential benefits of current and future licenses, acquisitions, and strategic arrangements with third parties, and our intent to enter into any future strategic arrangements, the timing and likelihood of success, plans and objectives of management for future operations and future results of anticipated product development efforts, are forward-looking statements.
+Added: All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding our future results of operations and financial position, business strategy, research and development plans, the anticipated timing, costs, design and conduct of our ongoing and planned preclinical studies and planned clinical trials for our product candidates, the timing and likelihood of regulatory filings and approvals for our product candidates, our ability to commercialize our product candidates, if approved, the impact of the COVID-19 pandemic and global geopolitical events, such as the ongoing conflict between Russia and Ukraine, on our business, the pricing and reimbursement of our product candidates, if approved, the potential to develop future product candidates, the potential benefits of current and future licenses, acquisitions, and strategic arrangements with third parties, and our intent to enter into any future strategic arrangements, the timing and likelihood of success, plans and objectives of management for future operations and future results of anticipated product development efforts, are forward-looking statements.
In some cases, you can identify forward-looking statements by terms such as “may,”
33 unchanged sentences
We are pursuing a broad clinical development plan across multiple tumor types for ERAS-007, which we refer to as our HERKULES series of clinical trials, that includes both monotherapy and combinations with approved and investigational agents, such as RTK, SHP2, RAS, and/or RAF inhibitors.
−Removed: The first four HERKULES Phase 1b/2 clinical trials are exploring both tissue agnostic and tissue specific indications in patients with solid tumors and hematologic malignancies, including non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and acute myeloid leukemia (AML).
+Added: Our current HERKULES Phase 1b/2 clinical trials are exploring both tissue agnostic and tissue specific indications in patients with solid tumors, including non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic ductal adenocarcinoma (PDAC).
In May 2021, we dosed the first patient in HERKULES-1, a Phase 1b/2 clinical trial designed to evaluate ERAS-007 as a single agent and in combination with various RAS/MAPK pathway targeting agents in advanced solid tumors.
−Removed: We expect to report Phase 1b monotherapy data from HERKULES-1 in the second half of 2022.
−Removed: These data will include preliminary monotherapy safety and pharmacokinetics to support dose selection for combinations of ERAS-007.
In September 2021, we dosed the first patient in HERKULES-2, a Phase 1b/2 master protocol clinical trial for ERAS-007 and/or ERAS-601 in combination with various agents in patients with NSCLC.
−Removed: In September 2021, we dosed the first patient in HERKULES-3, a Phase 1b/2 master protocol clinical trial for ERAS-007 in combination with various agents in patients with gastrointestinal (GI)
−Removed: cancers, with an initial focus on advanced CRC.
−Removed: In September 2021, we announced a clinical trial collaboration and supply agreement with Pfizer Inc.
+Added: In September 2021, we dosed the first patient in HERKULES-3, a Phase 1b/2 master protocol clinical trial for ERAS-007 in combination with various agents in patients with gastrointestinal (GI) cancers.
+Added: In September 2021, we announced a clinical trial collaboration and supply agreement (CTCSA) with Pfizer Inc.
(Pfizer) in connection with the HERKULES-3 trial.
−Removed: Under the terms of the agreement, we are sponsoring and funding the clinical trial and Pfizer is providing its BRAF inhibitor, encorafenib (BRAFTOVI), at no cost.
−Removed: Additionally, in March 2022, we announced a clinical trial collaboration and supply agreement with Eli Lilly and Company (Lilly) in connection with the HERKULES-3 trial.
+Added: Under the terms of the agreement, we are sponsoring and funding the clinical trial and
+Added: Pfizer is providing its BRAF inhibitor, encorafenib (BRAFTOVI), at no cost.
+Added: Additionally, in March 2022, we announced a CTCSA with Eli Lilly and Company (Lilly) in connection with the HERKULES-3 trial.
Under the terms of the agreement, we are sponsoring and funding the clinical trial and Lilly is providing its EGFR antibody, cetuximab (ERBITUX), at no cost.
−Removed: Finally, HERKULES-4 is a Phase 1b/2 master protocol clinical trial for ERAS-007 and/or ERAS-601 in combination with various agents in patients with hematologic malignancies, with an initial focus on AML.
−Removed: The master protocols for each of the HERKULES-2, -3, and -4 Phase 1b/2 clinical trials provide the flexibility to explore additional combinations and expand into other NSCLC, GI cancer, and hematological malignancy indications, respectively.
−Removed: These three trials are expected to provide proof-of-concept data and may be expanded to enable potential accelerated approvals in their respective indications.
+Added: The master protocols for each of the HERKULES-2 and -3 Phase 1b/2 clinical trials provide the flexibility to explore additional combinations and expand into other NSCLC and GI cancer indications, respectively.
+Added: These two trials are expected to provide proof-of-concept (PoC) data and may be expanded to enable potential accelerated approvals in their respective indications.
+Added: We recently decided to close the HERKULES-4 clinical trial prior to enrolling patients in order to further focus our clinical efforts on solid tumors where we see the most promising avenues to make an impact on patients in the near term.
+Added: As data emerge, we will re-evaluate hematologic malignancies in the context of our overall clinical development plan.
+Added: We expect to report Phase 1b monotherapy data from HERKULES-1 in the second half of 2022.
+Added: These data will include preliminary monotherapy safety and pharmacokinetics to support dose selection for combinations of ERAS-007.
+Added: In addition, we anticipate multiple additional data readouts from our HERKULES clinical trials, including a Phase 1b combination data readout from HERKULES-3 in the first half of 2023 and a Phase 1b combination data readout from HERKULES-2 in 2023.
+Added: In June 2022, we announced an additional Phase 1b PoC clinical trial to investigate ERAS-007 in combination with a KRAS G12C inhibitor in KRAS G12C-driven NSCLC and CRC.
+Added: While we have agreed to provide ERAS-007 for this clinical trial, the trial will be funded by a grant that the principal investigators received from Stand Up To Cancer (SU2C).
ERAS-601 is designed to be a potent and selective oral inhibitor of SHP2, a convergent node for upstream RTK signaling and a critical “on/off switch”
3 unchanged sentences
In the fourth quarter of 2020, we dosed the first patient in FLAGSHP-1, a Phase 1 clinical trial for ERAS-601 in patients with advanced solid tumors.
−Removed: ERAS-601 combinations are being evaluated in the FLAGSHP-1, HERKULES-2, and HERKULES-4 clinical trials for patients with CRC, head and neck cancer, NSCLC, and AML.
+Added: ERAS-601 combinations are being evaluated in the FLAGSHP-1 and HERKULES-2 clinical trials for patients with CRC, head and neck cancer, and NSCLC.
+Added: In July 2022, we announced a CTCSA with Lilly in connection with the FLAGSHP-1 trial.
+Added: Under the terms of the agreement, we are sponsoring and funding the clinical trial and Lilly is providing its EGFR inhibitor, cetuximab (ERBITUX), at no cost.
We expect to report Phase 1 monotherapy data from FLAGSHP-1 in the second half of 2022.
These data will include preliminary monotherapy safety and pharmacokinetics to support dose selection for combinations of ERAS-601.
+Added: In addition, we anticipate a Phase 1b combination data readout from FLAGSHP-1 in triple wildtype (KRAS/NRAS/BRAF wildtype) CRC in the first half of 2023.
In February 2022, we dosed the first patient in our THUNDERBBOLT-1 Phase 1 clinical trial for ERAS-801, our CNS-penetrant EGFR inhibitor, in patients with recurrent glioblastoma multiforme (GBM).
−Removed: In the second half of 2022, we expect to file an IND with the US Food and Drug Administration (FDA) for ERAS-3490, the development candidate we nominated from our CNS-penetrant KRAS G12C inhibitor program.
+Added: In the second half of 2022, we expect to file an IND with the US Food and Drug Administration (FDA) for ERAS-3490, the CNS-penetrant development candidate we nominated from our ERAS-1 KRAS G12C inhibitor franchise.
We are also advancing seven other programs targeting key oncogenic drivers in the RAS/MAPK pathway, which we will need to successfully progress through discovery and IND-enabling activities prior to advancing these programs into clinical development, if at all.
9 unchanged sentences
We do not have any products approved for sale and have not generated any revenue.
−Removed: As of March 31, 2022, we have raised a total of $665.4 million to fund our operations, comprised primarily of gross proceeds from our IPO and the sale and issuance of convertible preferred stock.
−Removed: As of March 31, 2022, we had cash, cash equivalents and marketable securities of $421.8 million.
+Added: As of June 30, 2022, we have raised a total of $665.4 million to fund our operations, comprised primarily of gross proceeds from our IPO and the sale and issuance of convertible preferred stock.
+Added: As of June 30, 2022, we had cash, cash equivalents and marketable securities of $390.8 million.
We have incurred significant operating losses since inception.
−Removed: Our net losses were $36.5 million and $18.0 million for the three months ended March 31, 2022 and 2021, respectively.
−Removed: As of March 31, 2022, we had an accumulated deficit of $274.6 million.
+Added: Our net losses were $35.6 million and $28.2 million for the three months ended June 30, 2022 and 2021, respectively, and $72.1 million and $46.2 million for the six months ended June 30, 2022 and 2021, respectively.
+Added: As of June 30, 2022, we had an accumulated deficit of $310.2 million.
We expect our expenses and operating losses will increase substantially for the foreseeable future, particularly if and as we conduct our ongoing and planned clinical trials and preclinical studies;
8 unchanged sentences
Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials and preclinical studies and our expenditures on other research and development activities.
−Removed: Based upon our current operating plans, we believe that our cash, cash equivalents and marketable securities as of March 31, 2022 will be sufficient to fund our operations into the second half of 2024.
+Added: Based upon our current operating plans, we believe that our cash, cash equivalents and marketable securities as of June 30, 2022 will be sufficient to fund our operations into the second half of 2024.
We do not expect to generate any revenues from product sales until we successfully complete development and obtain regulatory approval for one or more of our product candidates, which we expect will take a number of years and may never occur.
11 unchanged sentences
The extent to which the COVID-19 pandemic impacts our results will depend on future developments that are highly uncertain and cannot be predicted, including new information that may emerge concerning the severity of the virus and the actions to contain its impact.
+Added: Additionally, inflation generally affects us by increasing our employee-related costs and other expenses.
+Added: Our financial condition and results of operations may also be impacted by other factors we may not be able to control, such as global supply chain disruptions, uncertain global economic conditions, global trade disputes or political instability.
+Added: We do not believe that such factors had a material adverse impact on our results of operations during the three months ended June 30, 2022.
Our acquisition and license agreements
16 unchanged sentences
The following table summarizes our research and development expenses incurred for the following periods (in thousands):
−Removed: Three Months Ended March 31,
+Added: Three Months Ended June 30,
+Added: Six Months Ended June 30,
Other clinical program
26 unchanged sentences
significant and changing government regulation and regulatory guidance;
−Removed: the impact of any interruptions to our operations or to those of the third parties with whom we work due to the ongoing COVID-19 pandemic;
+Added: the impact of any interruptions to our operations or to those of the third parties with whom we work due to the ongoing COVID-19 pandemic and other events (such as the ongoing conflict between Russia and Ukraine and the increased rate of inflation in the United States);
the extent to which we establish additional collaboration, license or other arrangements.
20 unchanged sentences
Results of operations
−Removed: Comparison of the three months ended March 31, 2022 and 2021
−Removed: The following table summarizes our results of operations for the three months ended March 31, 2022 and 2021 (in thousands):
−Removed: Three Months Ended March 31,
+Added: Comparison of the three months ended June 30, 2022 and 2021
+Added: The following table summarizes our results of operations for the three months ended June 30, 2022 and 2021 (in thousands):
+Added: Three Months Ended June 30,
Operating expenses:
6 unchanged sentences
Research and development expenses
−Removed: Research and development expenses were $27.4 million for the three months ended March 31, 2022 compared to $12.2 million for the three months ended March 31, 2021.
−Removed: The increase of $15.2 million was primarily driven by a $7.8 million increase in expenses incurred in connection with clinical trials, preclinical studies and discovery activities, a $3.4 million increase in personnel costs primarily due to an increase in headcount, a $2.2 million increase in stock-based compensation expense primarily due to increases in our stock price and headcount, a $0.8 million increase in outsourced services and consulting fees and a $0.6 million increase in facilities and depreciation
+Added: Research and development expenses were $27.5 million for the three months ended June 30, 2022 compared to $17.6 million for the three months ended June 30, 2021.
+Added: The increase of $9.9 million was primarily driven by a $4.9 million increase in expenses incurred in connection with clinical trials, preclinical studies and discovery activities, a $2.1 million increase in stock-based compensation expense primarily due to increases in our stock price and headcount, a $1.9 million increase in personnel costs primarily due to an increase in headcount, and a $0.9 million increase in facilities and depreciation.
In-process research and development expenses
−Removed: In-process research and development expenses were $2.0 for the three months ended March 31, 2022 compared to $3.7 million for the three months ended March 31, 2021.
−Removed: In-process research and development expenses for the three months ended March 31, 2022 related to a development milestone payment of $2.0 million in connection with our license agreement with Katmai Pharmaceuticals, Inc.
−Removed: In-process research and development expenses for the three months ended March 31, 2021 related to a $2.0 million upfront payment and issuance of 500,000 shares of our common stock at a price of $3.36 per share to Emerge Life Sciences, Pte.
−Removed: (ELS) in connection with the purchase agreement we entered into in March 2021 with ELS.
+Added: In-process research and development expenses were $0 for the three months ended June 30, 2022 compared to $5.5 million for the three months ended June 30, 2021.
+Added: In-process research and development expenses for the three months ended June 30, 2021 related to the issuance of 944,945 shares of our common stock at a price of $5.81 per share or a total fair value of $5.5 million in connection with the amendment to our license agreement with The Regents of the University of California, San Francisco (the Regents).
General and administrative expenses
−Removed: General and administrative expenses were $7.1 million for the three months ended March 31, 2022 compared to $3.7 million for the three months ended March 31, 2021.
−Removed: The increase of $3.4 million was primarily driven by an increase of $1.4 million in stock-based compensation expense due to increases in our stock price and headcount, an increase of $1.0 million in insurance costs, an increase of $0.7 million in personnel costs primarily due to an increase in headcount, and increases of $0.3 million in facilities and office related expenses and $0.1 million in accounting fees, partially offset by a decrease in legal fees of $0.3 million.
+Added: General and administrative expenses were $8.4 million for the three months ended June 30, 2022 compared to $5.1 million for the three months ended June 30, 2021.
+Added: The increase of $3.3 million was primarily driven by an increase of $1.3 million in stock-based compensation expense due to increases in our stock price and headcount, an increase of $1.0 million in insurance costs, an increase of $0.7 million in facilities and office related expenses, and an increase of $0.5 million in personnel costs primarily due to an increase in headcount, partially offset by decreases in legal and accounting fees of $0.6 million, in the aggregate.
Other income (expense), net
−Removed: Other income (expense), net was $47,000 for the three months ended March 31, 2022 compared to $1.6 million for the three months ended March 31, 2021.
−Removed: The decrease of $1.5 million was primarily related to the change in fair value of the preferred stock purchase right liability of $1.6 million recorded in the three months ended March 31, 2021 and no such change in fair value recorded in the three months ended March 31, 2022 as a result of the obligation of the Series B-2 shares being fulfilled upon the Series B-2 issuance in January 2021.
+Added: Other income (expense), net was $297,000 for the three months ended June 30, 2022 compared to $(30,000) for the three months ended June 30, 2021.
+Added: The increase of $327,000 was primarily related to an increase in interest earned on our cash, cash equivalents and marketable securities during the three months ended June 30, 2022.
+Added: Comparison of the six months ended June 30, 2022 and 2021
+Added: The following table summarizes our results of operations for the six months ended June 30, 2022 and 2021 (in thousands):
+Added: Six Months Ended June 30,
+Added: Operating expenses:
+Added: Research and development
+Added: In-process research and development
+Added: General and administrative
+Added: Total operating expenses
+Added: Loss from operations
+Added: Total other income (expense), net
+Added: Research and development expenses
+Added: Research and development expenses were $54.9 million for the six months ended June 30, 2022 compared to $29.8 million for the six months ended June 30, 2021.
+Added: The increase of $25.1 million was primarily driven by a $12.7 million increase in expenses incurred in connection with clinical trials, preclinical studies and discovery activities, a $5.3 million increase in personnel costs primarily due to an increase in headcount, a $4.3 million increase in stock-based compensation expense primarily due to increases in our stock price and headcount, a $1.5 million increase in facilities and depreciation, and a $0.6 million increase in outsourced services and consulting fees.
+Added: In-process research and development expenses
+Added: In-process research and development expenses were $2.0 million for the six months ended June 30, 2022 compared to $9.2 million for the six months ended June 30, 2021.
+Added: In-process research and development expenses for the six months ended June 30, 2022 related to a development milestone payment of $2.0 million in connection with our license agreement with Katmai Pharmaceuticals, Inc.
+Added: In-process research and development expenses for the six months ended June 30, 2021 related to the
+Added: issuance of 944,945 shares of our common stock at a price of $5.81 per share or a total fair value of $5.5 million in connection with the amendment to our license agreement with the Regents and a $2.0 million upfront payment and issuance of 500,000 shares of our common stock to Emerge Life Sciences, Pte.
+Added: (ELS) at a price of $3.36 per share or a total fair value of $1.7 million in connection with the purchase agreement we entered into in March 2021 with ELS.
+Added: General and administrative expenses
+Added: General and administrative expenses were $15.5 million for the six months ended June 30, 2022 compared to $8.8 million for the six months ended June 30, 2021.
+Added: The increase of $6.7 million was primarily driven by an increase of $2.7 million in stock-based compensation expense due to increases in our stock price and headcount, an increase of $1.9 million in insurance costs, an increase of $1.2 million in personnel costs primarily due to an increase in headcount, and an increase of $1.2 million in facilities and office related expenses, partially offset by decreases in legal and accounting fees of $0.8 million, in the aggregate.
+Added: Other income (expense), net
+Added: Other income (expense), net was $344,000 for the six months ended June 30, 2022 compared to $1.6 million for the six months ended June 30, 2021.
+Added: The decrease of $1.2 million was primarily related to the change in fair value of the preferred stock purchase right liability of $1.6 million recorded in the six months ended June 30, 2021 as a result of the obligation of the Series B-2 shares being fulfilled upon the Series B-2 issuance in January 2021, partially offset by an increase of $0.4 million in interest earned on our cash, cash equivalents and marketable securities during the six months ended June 30, 2022.
Liquidity and capital resources
4 unchanged sentences
Future capital requirements
−Removed: As of March 31, 2022, we had cash, cash equivalents and marketable securities of $421.8 million.
+Added: As of June 30, 2022, we had cash, cash equivalents and marketable securities of $390.8 million.
Based upon our current operating plans, we believe that our cash, cash equivalents and marketable securities will be sufficient to fund our operations into the second half of 2024.
14 unchanged sentences
willingness to pay out-of-pocket for any approved products in the absence of coverage and/or adequate reimbursement from third-party payors;
−Removed: any delays and cost increases that result from the COVID-19 pandemic;
+Added: any delays and cost increases that result from the COVID-19 pandemic and other events (such as the ongoing conflict between Russia and Ukraine and the increased rate of inflation in the United States);
the terms and timing of establishing and maintaining collaborations, licenses and other similar arrangements;
8 unchanged sentences
The following table shows a summary of our cash flows for the periods presented (in thousands):
−Removed: Three Months Ended March 31,
+Added: Six Months Ended June 30,
Net cash (used in) provided by:
4 unchanged sentences
Operating activities
−Removed: Cash used in operating activities was $25.8 million during the three months ended March 31, 2022, primarily resulting from a net loss of $36.5 million, partially reduced by stock-based compensation of $4.4 million, changes in operating assets and liabilities of $3.8 million, in-process research and development expenses of $2.0 million, which are reflected in investing activities, and depreciation expense of $0.4 million.
−Removed: Net cash provided by changes in operating assets and liabilities consisted primarily of an increase in operating lease assets and liabilities of $11.1 million primarily due to the receipt of $10.3 million in reimbursement from our landlord for tenant improvements and an increase in accounts payable of $1.9 million, partially offset by an increase in prepaid expenses and other current and long-term assets of $5.5 million, and a decrease of accrued expenses and other current liabilities of $3.7 million.
−Removed: Cash used in operating activities was $15.7 million during the three months ended March 31, 2021, primarily resulting from a net loss of $18.0 million, partially reduced by in-process research and development expenses of $3.7 million, which is reflected in noncash and investing activities, stock-based compensation expense of $0.8 million and depreciation expense of $0.1 million, partially offset by a $1.6 million change in fair value of the preferred stock purchase right liability and changes in operating assets and liabilities of $0.7 million.
−Removed: Net cash provided by changes in operating assets and liabilities consisted primarily of an increase in prepaid expenses and other current and long-term assets of $1.2 million, partially offset by increases in accounts payable, accrued expenses and other current liabilities of $0.5 million.
+Added: Cash used in operating activities was $52.9 million during the six months ended June 30, 2022, primarily resulting from a net loss of $72.1 million, partially reduced by stock-based compensation of $9.5 million, changes in operating assets and liabilities of $6.7 million, in-process research and development expenses of $2.0 million, which are reflected in investing activities, and depreciation expense of $0.9 million.
+Added: Net cash provided by changes in operating assets and liabilities consisted primarily of an increase in operating lease assets and liabilities of $11.9 million primarily due to the receipt of $10.3 million in reimbursement from our landlord for tenant improvements, partially offset by an increase in prepaid expenses and other current and long-term assets of $4.6 million, and a decrease of accrued expenses and other current liabilities of $0.6 million.
+Added: Cash used in operating activities was $33.9 million during the six months ended June 30, 2021, primarily resulting from a net loss of $46.2 million, partially reduced by in-process research and development expenses of $9.2 million, which is reflected in noncash and investing activities, stock-based compensation expense of $2.4 million, changes in operating assets and liabilities of $2.0 million and depreciation expense of $0.3 million, partially offset by a $1.6 million change in fair value of the preferred stock purchase right liability.
+Added: Net cash provided by changes in operating assets and liabilities consisted primarily of increases in accounts payable, accrued expenses and other current liabilities of $5.6 million, partially offset by an increase in prepaid expenses and other current and long-term assets of $3.5 million.
Investing activities
−Removed: Net cash used in investing activities was $1.8 million during the three months ended March 31, 2022 as compared to cash used in investing activities of $0.2 million during the three months ended March 31, 2021.
+Added: Net cash used in investing activities was $11.0 million during the six months ended June 30, 2022 as compared to cash generated from investing activities of $4.3 million during the six months ended June 30, 2021.
The increase in cash used in investing activities of $15.3 million was primarily the result of a decrease in maturities of marketable securities of $15.7 million, an increase in purchases of property and equipment of $11.2 million, and the $2.0 million payment made for our investment in Affini-T Therapeutics, Inc., partially offset by a $9.6 million decrease in purchases of marketable securities and a $4.0 million decrease in in-process research and development.
Financing activities
−Removed: Net cash provided by financing activities was $0.5 million during the three months ended March 31, 2022 as compared to $120.5 million during the three months ended March 31, 2021.
−Removed: During the three months ended March 31, 2022, we received $0.5 million from the exercise of stock options.
−Removed: During the three months ended March 31, 2021, we received $119.4 million from the sale of shares of our Series B-2 convertible preferred stock, net of issuance costs, and $1.1 million from the exercise of stock options.
+Added: Net cash generated from financing activities was $1.5 million during the six months ended June 30, 2022 as compared to $120.7 million during the six months ended June 30, 2021.
+Added: During the six months ended June 30, 2022, we received $0.8 million from the exercise of stock options and $0.6 million from the issuance of common stock under our Employee Stock Purchase Plan.
+Added: During the six months ended June 30, 2021, we received $119.4 million from the sale of shares of our Series B-2 convertible preferred stock, net of issuance costs, and $1.3 million from the exercise of stock options.
Contractual obligations and commitments
−Removed: As of March 31, 2022, there have been no material changes outside the ordinary course of our business to the contractual obligations we reported in “Management’s discussion and analysis of financial condition and results of operations –
+Added: As of June 30, 2022, there have been no material changes outside the ordinary course of our business to the contractual obligations we reported in “Management’s discussion and analysis of financial condition and results of operations –
Cash requirements due to contractual obligations and other commitments,”
9 unchanged sentences
Actual results may differ materially from these estimates.
−Removed: As of March 31, 2022, there have been no material changes to our critical accounting policies and estimates from those disclosed in “Management’s discussion and analysis of financial condition and results of operations –
+Added: As of June 30, 2022, there have been no material changes to our critical accounting policies and estimates from those disclosed in “Management’s discussion and analysis of financial condition and results of operations –
Critical accounting policies and estimates,”
16 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.