What changed in this filing

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Item 1. Financial Statements

2021-11-10 compared with 2021-08-10 · 115 added, 89 removed, 428 unchanged (32% of the section changed)

3 unchanged sentences

(Amounts in thousands, except per share amounts)

September 30,

Current assets:

13 unchanged sentences

Preferred stock, $ 0.0001 par value;

10,000,000 shares authorized as of June 30, 2021 and December 31, 2020;

no shares issued and outstanding as of June 30, 2021 and December 31, 2020.

10,000,000 shares authorized as of September 30, 2021 and December 31, 2020;

no shares issued and outstanding as of September 30, 2021 and December 31, 2020.

Common stock, $ 0.0001 par value;

490,000,000 shares authorized as of June 30, 2021 and December 31, 2020;

40,256,637 and 40,169,738 shares issued as of June 30, 2021 and December 31, 2020, respectively;

39,552,588 and 39,308,238 shares outstanding as of June 30, 2021 and December 31, 2020, respectively.

490,000,000 shares authorized as of September 30, 2021 and December 31, 2020;

40,277,390 and 40,169,738 shares issued as of September 30, 2021 and December 31, 2020, respectively;

39,681,298 and 39,308,238 shares outstanding as of September 30, 2021 and December 31, 2020, respectively.

Additional paid-in capital

Accumulated other comprehensive loss

Accumulated other comprehensive income

Accumulated deficit

5 unchanged sentences

(Amounts in thousands, except per share amounts)

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Nine Months Ended September 30,

Operating expenses:

8 unchanged sentences

Total other income (expense), net

Net loss per share, basic and diluted

Weighted average shares used to compute net loss per share, basic and diluted

Three Months Ended June 30,

Six Months Ended June 30,

Other comprehensive loss:

Net unrealized loss on marketable securities

Repurchase and retirement of Series A and Series A-1 convertible preferred stock

Net loss attributable to common stockholders

Net loss per share attributable to common stockholders, basic and diluted

Weighted average shares used to compute net loss per share attributable to common stockholders, basic and diluted

Three Months Ended September 30,

Nine Months Ended September 30,

Other comprehensive income:

Net unrealized gain on marketable securities

Total comprehensive loss

6 unchanged sentences

Stockholders'

Balances at March 31, 2021

Income (Loss)

Balances at June 30, 2021

Vesting of early exercised stock options

4 unchanged sentences

Employee stock purchase plan expense

Net unrealized loss on marketable securities

Balances at June 30, 2021

Net unrealized gain on marketable securities

Balances at September 30, 2021

Preferred Stock

8 unchanged sentences

Employee stock purchase plan expense

Net unrealized loss on marketable securities

Balances at June 30, 2021

Net unrealized gain on marketable securities

Balances at September 30, 2021

Preferred Stock

Comprehensive

Stockholders'

Balances at March 31, 2020

Issuance of Series B convertible stock, net of issuance costs of $ 130

Stock-based compensation expense

Balances at June 30, 2020

Issuance costs of Series B convertible stock

Repurchase and retirement of Series A and Series A-1 convertible preferred stock

Issuance of Series C convertible preferred stock, net of issuance costs of $ 1,637

Exercise of stock options

Vesting of restricted stock awards

Stock-based compensation expense

Balances at September 30, 2020

Preferred Stock

Comprehensive

Stockholders'

5 unchanged sentences

Issuance of Series B convertible preferred stock in connection with the conversion of convertible notes

Repurchase and retirement of Series A and Series A-1 convertible preferred stock

Issuance of Series C convertible preferred stock, net of issuance costs of $ 1,637

Exercise of stock options

Vesting of restricted stock awards

Stock-based compensation expense

Balances at June 30, 2020

Balances at September 30, 2020

See accompanying notes to the condensed consolidated financial statements.

2 unchanged sentences

(In thousands)

Six Months Ended June 30,

Nine Months Ended September 30,

Cash flows from operating activities:

5 unchanged sentences

Changes in operating assets and liabilities:

Prepaid expenses, other current assets

Prepaid expenses and other current assets and other assets

Accounts payable

11 unchanged sentences

Proceeds from issuance of Series B convertible preferred stock, net of issuance costs

Proceeds from issuance of Series C convertible preferred stock, net of issuance costs

Repurchase of shares of Series A and Series A-1 convertible preferred stock

Proceeds from the settlement of non-recourse notes

Payments of costs related to initial public offering

Net cash provided by financing activities

3 unchanged sentences

Supplemental disclosure of non-cash investing and financing activities:

Purchases of property and equipment included in accounts payable and accrued liabilities

Purchases of property and equipment included in accounts payable

Conversion of convertible notes into Series B convertible preferred stock

Offering costs included in other current liabilities - Series B

Deferred offering costs included in other current liabilities

Series C convertible preferred stock issuance costs included in other current liabilities

Vesting of early exercised stock options

21 unchanged sentences

In connection with the IPO, the Company amended and restated its amended and restated certificate of incorporation to change the authorized capital stock to 490,000,000 shares designated as common stock and 10,000,000 shares designated as preferred stock, all with a par value of $ 0.0001 per share.

The Company had $ 318.1 million of cash, cash equivalents and marketable securities at June 30 2021, which management believes is sufficient to fund its operating expenses and capital expenditure requirements for at least the next 12 months from the filing date of these condensed consolidated financial statements.

The Company had $ 306.0 million of cash, cash equivalents and marketable securities at September 30 2021, which management believes is sufficient to fund its operating expenses and capital expenditure requirements for at least the next 12 months from the filing date of these condensed consolidated financial statements.

Impact of COVID-19

The extent of the impact of the COVID-19 pandemic on the Company’s business, operations and development timelines and plans remains uncertain, and will depend on certain developments, including the duration of the outbreak and its impact on the Company’s development activities, planned clinical trial enrollment, future trial sites, CROs, third-party manufacturers, and other third parties with whom the Company does business, as well as its impact on regulatory authorities and the Company’s key scientific and management personnel.

The extent of the impact of the COVID-19 pandemic on the Company’s business, operations and development timelines and plans remains uncertain, and will depend on certain developments, including the duration of the outbreak and its impact on the Company’s development activities, planned clinical trial enrollment, future trial sites, clinical research organizations (“CROs”), third-party manufacturers, and other third parties with whom the Company does business, as well as its impact on regulatory authorities and the Company’s key scientific and management personnel.

During 2020, although the Company modified its operations and practices due to the COVID-19 pandemic and to comply with federal, state and local requirements, its business, operations and development timelines were not material adversely affected.

8 unchanged sentences

Unaudited Interim Financial Information

The interim condensed consolidated balance sheet as of June 30, 2021, the statements of operations and comprehensive loss, and stockholders’ equity (deficit) for the three and six months ended June 30, 2021 and 2020, and the statements of cash flows for the six months ended June 30, 2021 and 2020 are unaudited.

The interim condensed consolidated balance sheet as of September 30, 2021, the statements of operations and comprehensive loss, and stockholders’ equity (deficit) for the three and nine months ended September 30, 2021 and 2020, and the statements of cash flows for the nine months ended September 30, 2021 and 2020 are unaudited.

The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the annual financial statements and reflect, in the opinion of management, all adjustments of a normal and recurring nature that are necessary for the fair presentation of the Company’s condensed consolidated financial statements included in this report.

The financial data and the other information disclosed in these notes to the condensed consolidated financial statements related to the three- and six-month periods are also unaudited.

The results of operations for the six months ended June 30, 2021 are not necessarily indicative of the results to be expected for the year ending December 31, 2021 or for any other future annual or interim period.

The financial data and the other information disclosed in these notes to the condensed consolidated financial statements related to the three- and nine-month periods are also unaudited.

The results of operations for the nine months ended September 30, 2021 are not necessarily indicative of the results to be expected for the year ending December 31, 2021 or for any other future annual or interim period.

The condensed consolidated balance sheet as of December 31, 2020 included herein was derived from the audited financial statements as of that date.

9 unchanged sentences

Cash and cash equivalents are defined as short-term, highly liquid investments with original maturities of 90 days or less at the date of purchase.

Cash deposits are all in reputable financial institutions in the United States and as of June 30, 2021 and December 31, 2020, cash and cash equivalents consisted of cash on deposit with U.S.

Cash deposits are all in reputable financial institutions in the United States and as of September 30, 2021 and December 31, 2020, cash and cash equivalents consisted of cash on deposit with U.S.

banks denominated in U.S.

24 unchanged sentences

Research and development expenses consist of costs incurred to discover, research and develop product candidates.

These costs are recorded within research and development expenses in the condensed consolidated statements of operations and include personnel expenses, stock-based compensation expenses, allocated general and administrative expenses, and external costs including fees paid to consultants and clinical research organizations (“CROs”) and contract manufacturing organizations (“CMOs”), in connection with nonclinical studies and clinical trials, and other

related clinical trial fees, such as for investigator fees, patient screening, laboratory work, clinical trial database management, clinical trial material management and statistical compilation and analysis.

These costs are recorded within research and development expenses in the condensed consolidated statements of operations and include personnel expenses, stock-based compensation expenses, allocated general and administrative expenses, and external costs including fees paid to consultants, CROs and contract manufacturing organizations (“CMOs”), in

connection with nonclinical studies and clinical trials, and other related clinical trial fees, such as for investigator fees, patient screening, laboratory work, clinical trial database management, clinical trial material management and statistical compilation and analysis.

Non-refundable prepayments for goods or services that will be used or rendered for future research and development activities are recorded as prepaid expenses.

Such amounts are recognized as an expense as the goods are delivered or the related services are performed.

Costs incurred in obtaining technology licenses are charged immediately to research and development expense if the technology licensed has not reached technological feasibility and has no alternative future uses.

Research Contract Costs and Accruals

9 unchanged sentences

Diluted net loss per common share is computed by adjusting net loss to reallocate undistributed earnings based on the potential impact of dilutive securities, and by dividing the diluted net loss by the weighted average number of common shares outstanding for the period, including potential dilutive common shares.

For purpose of this calculation, outstanding stock options, unvested restricted stock awards, contingently issuable common stock related to the 2020 Employee Stock Purchase Plan (the “ESPP”), and convertible preferred stock are considered potential dilutive common shares.

For purpose of this calculation, outstanding stock options, including unvested early exercised options, unvested restricted stock awards, contingently issuable common stock related to the 2020 Employee Stock Purchase Plan (the “ESPP”), and convertible preferred stock are considered potential dilutive common shares.

Since the Company was in a loss position for all periods presented, basic net loss per share is the same as diluted net loss per share for all periods as the inclusion of all potential common shares outstanding would have been anti-dilutive.

2 unchanged sentences

In periods in which the Company reported a net loss, diluted net loss per common share is the same as basic net loss per common share, since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive.

The Company reported a net loss for the three- and six-month periods ended June 30, 2021 and 2020.

The Company reported a net loss for the three- and nine-month periods ended September 30, 2021 and 2020.

Recent Accounting Pronouncements

3 unchanged sentences

The Company has elected to use this exemption to delay adopting new or revised accounting standards until such time as those standards apply to private companies.

As a result, the Company’s financial statements may not be comparable to the financial statements of issuers

who are required to comply with the effective date for new or revised accounting standards that are applicable to public companies.

The Company expects to lose its status as an emerging growth company on December 31, 2021, when it expects to qualify as a large accelerated filer based on its market capitalization as of June 30, 2021, according to Rule 12b-2 of the Securities Exchange Act of 1934, as amended.

As a result, the Company’s financial statements may not be comparable to the financial statements of issuers who are required to comply with the effective date for new or revised accounting standards that are applicable to public companies.

The Company expects to lose its status as an emerging growth company on December

31, 2021, when it expects to qualify as a large accelerated filer based on its market capitalization as of June 30, 2021, according to Rule 12b-2 of the Securities Exchange Act of 1934, as amended.

As a result, the Company intends to adopt all accounting pronouncements currently deferred under the extended transition period available for emerging growth companies according to public company standards at December 31, 2021.

31 unchanged sentences

For non-public entities, ASU 2016-02 is effective for annual reporting periods beginning after December 15, 2021, including interim periods within those fiscal years, and early adoption is permitted.

The Company expects to adopt this new guidance under ASU 2016-02 as of January 1, 2021 at December 31, 2021 on the Company’s 2021 Form 10-K filing and is in the process of completing its review of its existing lease agreements under Topic 842.

The Company expects to adopt this new guidance under ASU 2016-02 as of January 1, 2021 at December 31, 2021 on the Company’s 2021 Form 10-K filing using the modified retrospective approach.

The Company will elect the practical expedients upon transition to not reassess prior conclusions related to contracts containing leases, lease classification and initial direct costs.

The Company will also elect the practical expedient for lessees to combine lease and non-lease components for all asset classes and to keep leases with an initial term of 12 months or less off the balance sheet and recognize the associated lease payments in the statements of operations on a straight-line basis over the lease term.

Company is in the process of completing its review of its existing lease agreements under Topic 842 and assessment of the impact of adoption of the ASU.

The Company anticipates recording a right-of-use asset and lease liability to account for its facility leases and will record a cumulative-effect adjustment in the period of adoption.

20 unchanged sentences

● Level 3 — Unobservable inputs that are supported by little or no market activity that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.

June 30, 2021

September 30, 2021

(in thousands)

5 unchanged sentences

Government-sponsored enterprise securities

June 30, 2021

September 30, 2021

(in thousands)

9 unchanged sentences

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

September 30,

Lab equipment

5 unchanged sentences

Prepaid expenses and other current assets consisted of the following (in thousands):

September 30,

Prepaid clinical trial costs

2 unchanged sentences

Prepaid research contracts

Prepaid professional services

Other Current Liabilities

Other current liabilities consisted of the following (in thousands):

September 30,

(in thousands)

1 unchanged sentence

Accrued employee bonuses

Accrued payroll related costs

Accrued professional fees

Accrued payroll related costs

Early exercise of unvested stock options

11 unchanged sentences

On the settlement date, the principal and accrued interest then outstanding under the 2020 Notes of $ 3.0 million were converted into 638,270 shares of Series B convertible preferred stock (“March 2020 conversion”).

On the settlement date, the unamortized debt discount on the 2020 Notes was $ 0.4 million and the intrinsic value of the BCF was $ 2.6 million representing an increase of $ 1.5 million from the issuance date of the 2020 Notes.

The March 2020 conversion was accounted for as a debt extinguishment.

1 unchanged sentence

Convertible Preferred Stock

As of June 30, 2020, there were 16,067,762 shares of convertible preferred stock outstanding.

As of September 30, 2020, there were 23,765,075 shares of convertible preferred stock outstanding.

Upon the closing of the Company’s IPO, each then outstanding share of convertible preferred stock was converted into one share of common stock.

As of June 30, 2021 and December 31, 2020, there was no convertible preferred stock outstanding.

As of September 30, 2021 and December 31, 2020, there was no convertible preferred stock outstanding.

Refer to Note 6 “Convertible Preferred Stock” included in the Annual Report on Form 10-K for the year ended December 31, 2020 filed on March 17, 2021 with the SEC.

14 unchanged sentences

The 2020 Plan permits the grant of options restricted stock awards, stock appreciation rights, restricted stock unit awards, performance awards, and other awards.

The exercise price for each option and stock appreciation right is established in the discretion of the Board, provided that the exercise price of a stock option will not be less than 100 % of the fair market value of the Company’s common stock on the date of grant.

Company’s common stock on the date of grant.

Specific vesting for stock options and stock appreciation rights is service related and determined in each award agreement, where stock options and stock appreciation rights are fully vested at the grant date or follow a graded vesting schedule.

3 unchanged sentences

The Company lacks company-specific historical and implied volatility information.

Therefore, it estimated its expected stock volatility based on the historical volatility of a publicly traded set of peer companies.

For options with service- based vesting conditions, the expected term of the Company’s stock options has been determined utilizing the

“simplified” method for awards that qualify as “plain-vanilla” options.

Therefore, it estimated its expected stock volatility based on the historical volatility of a publicly traded set of peer companies in addition to its own historical volatility.

For options with service- based vesting conditions, the expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options.

The expected term of stock options granted to nonemployees is equal to the contractual term of the option award.

3 unchanged sentences

The assumptions that the Company used to determine the estimated grant-date fair value of stock options granted to employees and directors under the 2020 Plan were as follows, presented as a weighted average:

September 30,

Risk-free interest rate

8 unchanged sentences

Outstanding as of December 31, 2020

Outstanding as of June 30, 2021(2)

Options vested and exercisable as of June 30, 2021

Options expected to vest as of June 30, 2021

Outstanding as of September 30, 2021(2)

Options vested and exercisable as of September 30, 2021

Options expected to vest as of September 30, 2021

(1) Exercised amount includes vesting of early exercised options.

(2) Balance as of June 30, 2021 includes 112,227 unvested early exercised stock options.

(2) Balance as of September 30, 2021 includes 53,588 unvested early exercised stock options.

Early Exercise of Stock Options

In September 2020, one employee and one non-employee paid $ 0.6 million to early exercise 135,525 options with exercise prices ranging from $ 4.406 per share to $ 4.824 per share.

As of June 30, 2021, 23,298 of such shares had vested with the remaining shares vesting over their respective terms.

As of September 30, 2021, 81,937 of such shares had vested with the remaining shares vesting over their respective terms.

The terms of the 2014 Plan permit certain option holders to exercise options before their options are vested, subject to certain limitations.

2 unchanged sentences

Such shares are not deemed to be outstanding for accounting purposes until they vest and are therefore excluded from shares outstanding and from basic and diluted net loss per share until the repurchase right lapses and the shares are no longer subject to the repurchase feature.

A liability is recognized related to the cash proceeds of the unvested options and is reclassified into common stock and additional paid-in capital as the shares vest and the

repurchase right lapses.

Accordingly, the Company has recorded the unvested portion of the exercise proceeds of $ 0.5 million in other current liabilities as of June 30, 2021.

A liability is recognized related to the cash proceeds of the unvested options and is reclassified into common stock and additional paid-in capital as the shares vest and the repurchase right lapses.

Accordingly, the Company has recorded the unvested portion of the exercise proceeds of $ 0.2 million in other current liabilities as of September 30, 2021.

Restricted Stock Awards

In June 2020, the Company granted to certain employees 789,095 shares of restricted common stock (the “RSAs”) under the 2014 Plan as consideration for services with a deemed value of $ 2.40 per share, or $ 1.9 million.

The following table summarizes the restricted stock activity under the Plan during the six months ended June 30, 2021:

The following table summarizes the restricted stock activity under the Plan during the nine months ended September 30, 2021:

Number of Shares

1 unchanged sentence

Unvested restricted stock as of December 31, 2020

Unvested restricted stock as of June 30, 2021

Unvested restricted stock as of September 30, 2021

Stock-Based Compensation Expense

Stock-based compensation expense related to awards granted under the 2014 Plan, including the RSAs, the 2020 Plan and the 2020 ESPP was classified in the statements of operations and comprehensive loss as follows (in thousands):

Three Months Ended June 30,

Six Months Ended June 30,

Stock-based compensation expense related to awards granted under the 2014 Plan, including the RSAs, the 2020 Plan and the 2020 ESPP was classified in the condensed consolidated statements of operations and comprehensive loss as follows (in thousands):

Three Months Ended September 30,

Nine Months Ended September 30,

Research and development

7 unchanged sentences

Each offering period is not to exceed 27 months and includes one or more purchase periods (each a “Purchase Period”) as approved by the Company’s board of directors in the offering.

The current offering period consists of two (2) six-month purchase periods (each a “Purchase Period”) during which payroll deductions of the participants are accumulated under the ESPP.

The current offering period consists of two (2) six-month

purchase periods (each a “Purchase Period”) during which payroll deductions of the participants are accumulated under the ESPP.

The last business day of each Purchase Period is referred to as the “Purchase Date.” The first Purchase Period commenced on November 18, 2020 with a purchase date of May 15, 2021.

3 unchanged sentences

The Company uses the Black-Scholes option-pricing model to estimate the fair value of stock offered under the ESPP.

Stock-based compensation expense related to the ESPP was $ 0.1 million for the three and six months ended June 30, 2021.

Stock-based compensation expense related to the ESPP was less than $ 0.1 million and $ 0.1 million for the three and nine months ended September 30, 2021, respectively.

Net Loss Per Share

1 unchanged sentence

Basic and diluted net loss per share was calculated as follows (in thousands, except share and per share amounts):

Three Months Ended June 30,

Six Months Ended June 30,

Weighted average shares used to compute net loss per share, basic and diluted

Net loss per share, basic and diluted

Three Months Ended September 30,

Nine Months Ended September 30,

Repurchase and retirement of Series A and Series A-1 convertible preferred stock

Net loss attributable to common stockholders

Weighted average shares used to compute net loss per share attributable to common stockholders, basic and diluted

Net loss per share attributable to common stockholders, basic and diluted

The potentially dilutive shares that were excluded from the calculation of diluted net loss per share because their effect would have been anti-dilutive for the periods presented are as follows:

2 unchanged sentences

Employee stock purchase plan contingently issuable

Shares available for future grant under the 2014 Stock Plan

Convertible preferred stock (as converted to common shares)

1 unchanged sentence

The Company determined the purchase of the stock to be non-substantive, and as such, the shares subject to the promissory notes will not be deemed outstanding until such time as the promissory notes have been repaid.

Accordingly, the Company has excluded these shares from the calculation of basic and diluted net loss per share for the three and six months ended June 30, 2020.

As of December 31, 2020, all outstanding principal and accrued interest relating to the Non-Recourse Notes were settled in full by the two noteholders, and as a result, the Company issued 211,621 shares of common stock to the noteholders and included these shares in the basic and diluted net loss per share for three and six months ended June 30, 2021.

Also included in the potentially dilutive options to purchase common stock are 112,227 unvested stock options that were early exercised by an employee and a non-employee in September 2020 (see Note 9, “Stock-Based Compensation”).

Accordingly, the Company has excluded these shares from the calculation of basic and diluted net loss per share for the three and nine months ended September 30, 2020.

Also included in the potentially dilutive options to purchase common stock are 53,588

unvested stock options that were early exercised by an employee and a non-employee in September 2020 (see Note 9, “Stock-Based Compensation”).

The Company determined the early exercises to be non-substantive as the shares were subject to repurchase rights.

Accordingly, the Company has excluded these shares from the calculation of basic and diluted net loss per share for the three and six months ended June 30, 2021.

Accordingly, the Company has excluded these shares from the calculation of basic and diluted net loss per share for the three and nine months ended September 30, 2021.

Commitments and Contingencies

5 unchanged sentences

Rent for the Additional Space is $ 9,000 for the first year and $ 18,000 for the second and third years.

The Company recorded rent expense of $ 0.1 million during the three and six months ended June 30, 2021.

The rent expense under the MandalMed Services Agreement during the three and six months ended June 30, 2020 was immaterial.

The Company recorded rent expense of $ 0.1 and $ 0.2 million during the three and nine months ended September 30, 2021, respectively.

The rent expense under the MandalMed Services Agreement during the three and nine months ended September 30, 2020 was immaterial.

On August 27, 2020, the Company entered into a lease agreement with 512 2nd Street LLC to lease approximately 3,500 square feet of office space in San Francisco, California (the “Office Space Lease Agreement”).

2 unchanged sentences

Monthly rent is $ 23,330 and $ 24,030 for the first and second years of the lease term, respectively.

The Company recorded rent expense under the Office Space Lease Agreement of $ 0.1 million during the three and six months ended June 30, 2021.

The Company recorded rent expense under the Office Space Lease Agreement of $ 0.1 million during the three and $ 0.2 million during the nine months ended September 30, 2021, respectively.

On December 15, 2020, the Company entered into a lease agreement with Tennieh LLC to lease approximately 9,800 square feet of office space in San Francisco, California (the “Laboratory Lease Agreement”).

2 unchanged sentences

Monthly rent is $ 61,056 for the first year of the lease terms and increases to $ 68,676 by the fifth year of the lease term.

The Company recorded $ 0.2 million and $ 0.3 million rent expense for under the Laboratory Lease Agreement during the three and six months ended June 30, 2021.

The Company recorded $ 0.2 million and $ 0.5 million rent expense for under the Laboratory Lease Agreement during the three and nine months ended September 30, 2021, respectively.

The Company conducts research and development programs internally and through third parties that include, among others, arrangements with vendors, consultants, CMOs, and CROs.

1 unchanged sentence

In addition, these agreements may, from time to time, be subjected to amendments as a result of any change orders executed by the parties.

As of June 30, 2021, the Company did not have material contractual commitments with respect to these arrangements.

The following table summarizes the Company’s future contractual obligations and commitments related to the facility lease agreements discussed above as of June 30, 2021 (in thousands):

As of September 30, 2021, the Company did not have material contractual commitments with respect to these arrangements.

The following table summarizes the Company’s future contractual obligations and commitments related to the facility lease agreements discussed above as of September 30, 2021 (in thousands):

Year Ending December 31,

2021 (from July, 2021)

2021 (from October, 2021)

Clinical Collaboration and Supply Agreement

11 unchanged sentences

In addition, Novartis may terminate the Novartis Agreement if certain disputes between the parties are not resolved after following the applicable dispute resolution procedures, and the Company may terminate the Novartis Agreement in the event the Company terminates all clinical trials of the combined therapies other than due to a material safety issue or upon a clinical hold.

For the six months ended June 30, 2021, costs incurred reimbursable by Novartis were not material to the condensed consolidated financial statements.

For the nine months ended September 30, 2021, costs incurred reimbursable by Novartis were not material to the condensed consolidated financial statements.

Clinical Trial Agreement

In November 2020, the Company entered into a non-exclusive clinical trial agreement with Pfizer Inc.

(“Pfizer”) (the “Pfizer Agreement”), to evaluate the safety and tolerability of OP-1250 in combination with Pfizer’s proprietary CDK4/6 inhibitor IBRANCE® (palbociclib) in patients with recurrent, locally advanced or metastatic ER+, HER2- breast cancer in a clinical trial.

ER+, HER2- breast cancer in a clinical trial.

Under the terms of the non-exclusive agreement, the Company will be responsible for conducting the clinical trial for the combined therapies and Pfizer is responsible for supplying IBRANCE® to the Company at no cost to the Company.

5 unchanged sentences

The Pfizer Agreement does not grant any right of first negotiation to participate in future clinical trials, and each of the parties retains all rights and ability to evaluate their respective compounds.

Costs incurred in connection to the Pfizer Agreement are included in the Research and Development expense in the condensed consolidated statements of operations for the three and nine months ended September 30, 2021.

Contingencies

6 unchanged sentences

The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited.

As of June 30, 2021 and December 31, 2020, the Company had not incurred any material costs as a result of such indemnifications.

As of September 30, 2021, and December 31, 2020, the Company had not incurred any material costs as a result of such indemnifications.

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