What changed in this filing

/stocks — the workspaceLOADING

Item 1. Financial Statements

2022-11-08 compared with 2022-08-09 · 111 added, 90 removed, 423 unchanged (32% of the section changed)

2 unchanged sentences

Condensed Consolidated Balance Sheets

(Amounts in thousands, except per share amounts)

(Amounts in thousands, except for share amounts)

September 30,

Current assets:

16 unchanged sentences

Preferred stock, $ 0.0001 par value;

10,000,000 shares authorized as of June 30, 2022 and December 31, 2021;

no shares issued and outstanding as of June 30, 2022 and December 31, 2021.

10,000,000 shares authorized as of September 30, 2022 and December 31, 2021;

no shares issued and outstanding as of September 30, 2022 and December 31, 2021.

Common stock, $ 0.0001 par value;

490,000,000 shares authorized as of June 30, 2022 and December 31, 2021;

40,401,626 and 40,337,046 shares issued as of June 30, 2022 and December 31, 2021, respectively;

39,974,459 and 39,797,263 shares outstanding as of June 30, 2022 and December 31, 2021, respectively.

490,000,000 shares authorized as of September 30, 2022 and December 31, 2021;

40,455,427 and 40,337,046 shares issued as of September 30, 2022 and December 31, 2021, respectively;

40,084,568 and 39,797,263 shares outstanding as of September 30, 2022 and December 31, 2021, respectively.

Additional paid-in capital

6 unchanged sentences

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Amounts in thousands, except per share amounts)

Three Months Ended June 30,

Six Months Ended June 30,

(Amounts in thousands, except for share and per share amounts)

Three Months Ended September 30,

Nine Months Ended September 30,

Operating expenses:

9 unchanged sentences

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

Three Months Ended September 30,

Nine Months Ended September 30,

Other comprehensive (loss) gain:

Net unrealized (loss) gain on marketable securities

Total comprehensive loss

2 unchanged sentences

Condensed Consolidated Statements of Stockholders’ Equity (Unaudited)

(In thousands)

(Amounts in thousands, except for share amounts)

Comprehensive

Stockholders'

Balances at March 31, 2022

Balances at June 30, 2022

Vesting of early exercised stock options

1 unchanged sentence

Exercise of stock options

Issuance of shares under the employee stock purchase plan

Stock-based compensation expense

1 unchanged sentence

Net unrealized loss on marketable securities

Balances at June 30, 2022

Balances at September 30, 2022

Comprehensive

8 unchanged sentences

Net unrealized loss on marketable securities

Balances at June 30, 2022

Balances at September 30, 2022

Comprehensive

Stockholders'

Balances at March 31, 2021

Income (Loss)

Balances at June 30, 2021

Vesting of early exercised stock options

1 unchanged sentence

Exercise of stock options

Issuance of shares under the employee stock purchase plan

Stock-based compensation expense

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

Comprehensive

7 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

See accompanying notes to the condensed consolidated financial statements.

1 unchanged sentence

Condensed Consolidated Statements of Cash Flows

(In thousands)

Six Months Ended June 30,

(Amounts in thousands)

Nine Months Ended September 30,

Cash flows from operating activities:

24 unchanged sentences

Reclassification of prepaid expenses and other current liabilities into other assets

Purchases of property and equipment included in accounts payable or other current liabilities

Vesting of early exercised stock options

Purchases of property and equipment included in accounts payable

See accompanying notes to the condensed consolidated financial statements.

10 unchanged sentences

The Company’s principal operations are based in San Francisco, California, and has operations in Cambridge, Massachusetts.

Olema Oncology Australia Pty Ltd was incorporated on January 6, 2021 and is a wholly-owned subsidiary of the Company (collectively with Olema Pharmaceuticals, Inc.

referred to as “Olema” or the “Company” herein).

It operates in one business segment and therefore has only one reportable segment.

The Company is subject to risks and uncertainties common to early-stage companies in the biopharmaceutical industry, including, but not limited to, successful discovery and development of its product candidates, development by competitors of new technological innovations, dependence on key personnel, the ability to attract and retain qualified employees, protection of proprietary technology, compliance with governmental regulations, the impact of COVID-19, the ability to secure additional capital to fund operations and commercial success of its product candidates.

The Company is subject to risks and uncertainties common to early-stage companies in the biopharmaceutical industry, including, but not limited to, successful discovery and development of its product candidates, development by competitors of new technological innovations, dependence on key personnel, the ability to attract and retain qualified employees, protection of proprietary technology, compliance with governmental regulations, the impact of COVID-19 and other geopolitical and macroeconomic events, the ability to secure additional capital to fund operations and commercial success of its product candidates.

OP-1250 and any future product candidates the Company may develop will require extensive nonclinical and clinical testing and regulatory approval prior to commercialization.

1 unchanged sentence

Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.

The Company had $ 240.7 million of cash, cash equivalents and marketable securities at June 30, 2022, which management believes is sufficient to fund its operating expenses and capital expenditure requirements into the second half of 2024.

Impact of COVID-19

The Company had $ 222.6 million of cash, cash equivalents and marketable securities at September 30, 2022, which management believes is sufficient to fund its operating expenses and capital expenditure requirements into the second half of 2024.

Impact of COVID-19 and Other Geopolitical and Macroeconomic Events

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, contract 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.

2 unchanged sentences

In March 2022, the Company fully re-opened its offices to all employees and continues to comply with protocols implemented by respective health authorities.

The Company continues to monitor developments related to COVID-19 and may close its offices again in the future as the COVID-19 pandemic continues to evolve.

The Company continues to monitor developments related to COVID-19 and may

close its offices again in the future.

The extent to which the COVID-19 pandemic may affect the Company’s business, operations and development timelines and plans in the future, including the resulting impact on its expenditures and capital needs, remains uncertain.

In addition to the ongoing COVID-19 pandemic, global economic and business activities continue to face widespread macroeconomic uncertainties, including labor shortages, inflation and monetary supply shifts, recession risks and potential disruptions from the Russia-Ukraine conflict, which has resulted in volatility in the U.S.

and global financial markets and which has led to, and may continue to lead to, additional disruptions to trade, commerce, pricing stability, credit availability and supply chain continuity globally.

The extent of the impact of these factors on the Company’s operational and financial performance, including its ability to execute its business strategies and initiatives in the expected time frame, will depend on future developments, which are uncertain and cannot be predicted.

Any continued or renewed disruption resulting from these factors could negatively impact the Company’s business.

The Company continues to monitor the impact of these macroeconomic factors on its results of operations, financial condition and cash flows.

Summary of Significant Accounting Policies

Basis of Presentation and Consolidation

The accompanying interim unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“US GAAP”) and applicable rules and regulations of the Securities and Exchange Commission (the “SEC”) regarding interim financial reporting, and the instructions to Form 10-Q and Article 10 of Regulation S-X.

The accompanying interim unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“US GAAP”) and applicable rules and regulations of the Securities and Exchange Commission (the “SEC”) regarding interim financial reporting, and the instructions to Form 10-Q and Article 10 of Regulation S-X.

Accordingly, they do not include all of the information and footnotes required by US GAAP for complete financial statements.

These condensed consolidated financial statements include the accounts of Olema Pharmaceuticals, Inc.

and its wholly-owned subsidiary, Olema Oncology Australia Pty Ltd incorporated on January 6, 2021.

and its wholly-owned subsidiary, Olema Oncology Australia Pty Ltd.

All intercompany balances and transactions have been eliminated upon consolidation.

Unaudited Interim Financial Information

The interim condensed consolidated balance sheet as of June 30, 2022, the statements of operations and comprehensive loss, and stockholders’ equity for the three and six months ended June 30, 2022 and 2021, and the statements of cash flows for the six months ended June 30, 2022 and 2021 are unaudited.

The interim condensed consolidated balance sheet as of September 30, 2022, the statements of operations and comprehensive loss, and stockholders’ equity for the three and nine months ended September 30, 2022 and 2021, and the statements of cash flows for the nine months ended September 30, 2022 and 2021 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, 2022 are not necessarily indicative of the results to be expected for the year ending December 31, 2022 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, 2022 are not necessarily indicative of the results to be expected for the year ending December 31, 2022 or for any other future annual or interim period.

The condensed consolidated balance sheet as of December 31, 2021 included herein was derived from the audited financial statements as of that date.

1 unchanged sentence

Use of Estimates

The accompanying condensed consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”).

The accompanying condensed consolidated financial statements are prepared in accordance with US GAAP.

The preparation of the condensed consolidated financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the condensed consolidated financial statements and reported amounts of expenses during the reporting period.

Significant areas that require management’s estimates include accruals of research and development expenses, including accrual of research contract costs, stock-based compensation assumptions, including the fair value of common stock.

On an ongoing basis, the Company evaluates its estimates and judgments, which are based on historical and anticipated results and trends and on various other assumptions that management believes to be reasonable under the circumstances.

On an ongoing basis, the Company evaluates its estimates and

judgments, which are based on historical and anticipated results and trends and on various other assumptions that management believes to be reasonable under the circumstances.

Actual results could differ from those estimates.

1 unchanged sentence

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, 2022 and December 31, 2021.

Cash deposits are all in reputable financial institutions in the United States and as of September 30, 2022 and December 31, 2021.

Cash and cash equivalents consisted of cash on deposit with U.S.

26 unchanged sentences

The Company’s future results of operations involve a number of other risks and uncertainties.

Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, uncertainty of results of clinical trials and reaching milestones, uncertainty of regulatory approval of the Company’s current and potential future product candidates, uncertainty of market acceptance of the Company’s product candidates, competition from substitute products and larger companies, securing and protecting proprietary technology, strategic relationships and dependence on key individuals or sole-source suppliers.

Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations

include, but are not limited to, uncertainty of results of clinical trials and reaching milestones, uncertainty of regulatory approval of the Company’s current and potential future product candidates, uncertainty of market acceptance of the Company’s product candidates, competition from substitute products and larger companies, securing and protecting proprietary technology, strategic relationships and dependence on key individuals or sole-source suppliers.

The Company’s product candidates require approvals from the U.S.

28 unchanged sentences

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 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 and other current

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

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

37 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, 2022

September 30, 2022

(in thousands)

4 unchanged sentences

Government-sponsored enterprise securities

June 30, 2022

September 30, 2022

(in thousands)

5 unchanged sentences

The Company considers its investment portfolio of marketable securities to be available-for-sale.

The Company does not believe that the unrealized losses are credit related but are rather a reflection of current market yields and/or current marketplace bid/ask spreads.

The Company has not recognized an allowance for credit losses as of June 30, 2022.

In addition, no marketable securities had been in a consecutive loss position for more than 12 months as of June 30, 2022.

As of June 30, 2022, all of the Company’s cash and cash equivalents consisted of cash on deposit with U.S.

The Company periodically reviews its available-for-sale marketable securities for other-than-temporary impairment.

The Company considers factors such as the duration, severity and the reason for the decline in value, the potential recovery period and its intent to sell.

For debt securities, the Company also considers whether (i) it is more likely than not that the Company will be required to sell the debt securities before recovery of their amortized cost basis, and (ii) the amortized cost basis cannot be recovered as a result of credit losses.

There was one marketable security that has been in a consecutive loss position for more than 12 months as of September 30, 2022.

It had $ 0.1 million unrealized loss with a fair value of $ 6.9 million as of September 30, 2022.

The Company does not believe that the total unrealized losses of $ 2.7 million as of September 30, 2022 are credit related but are rather a reflection of current market yields and/or current marketplace bid/ask spreads.

During the three and nine months ended September 30, 2022, the Company did not recognize any other-than-temporary impairment loss.

As of September 30, 2022, there was no allowance for losses on available-for-sale debt securities attributable to credit risk.

As of September 30, 2022, all of the Company’s cash and cash equivalents consisted of cash on deposit with U.S.

banks denominated in U.

2 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):

Prepaid insurance

September 30,

Reimbursable research and development costs from a collaboration partner

Interest receivable on marketable securities

Prepaid subscriptions and licenses

Prepaid insurance

Prepaid research contracts

Prepaid clinical trial costs

Reimbursable research and development costs from a collaboration partner

Other Current Liabilities

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

September 30,

Accrued R&D related costs

7 unchanged sentences

The 2014 Plan permitted the grant of options and restricted stock awards (including restricted stock purchase rights and restricted stock bonus awards).

The maximum aggregate number of shares that may be subject to awards and sold under the 2014 Plan as of December 31, 2019 was 717,360 shares, which was subsequently increased to 4,842,180 in September 2020.

The 2014 Plan was terminated on the date the 2020 Equity Incentive Plan (the “2020 Plan”), which is described below, became effective, and no additional awards will be made pursuant to the 2014 Plan.

1 unchanged sentence

In 2020, the Company’s Board of Directors and stockholders approved and adopted the 2020 Plan.

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

The maximum number of shares of common stock that may be issued under the 2020 Plan will not exceed 6,494,510 shares of the Company’s common stock, which is the sum of (i) 2,152,080 new shares, plus (ii) an additional number of shares not to exceed 4,342,430 shares, consisting of any shares of the Company’s common stock subject to outstanding stock options or other stock awards granted under the Company’s 2014 Plan that, on or after the 2020 Plan becomes effective, terminate or expire prior to exercise or settlement;

2 unchanged sentences

or are reacquired or withheld (or not issued) to satisfy a tax withholding obligation or the purchase or exercise price.

In addition, the number of shares of the Company’s common stock reserved for issuance under the 2020 Plan automatically increases on January 1 of each year for a period of ten years , beginning on January 1, 2021 and continuing through January 1, 2030, in an amount equal to the lesser of (1) 5 % of the total number of shares of the Company’s common stock outstanding on December 31 of the immediately preceding year, or (2) a lesser number of shares determined by the Company’s board of directors no later than December 31 of the immediately preceding year.

The maximum number of shares of the common stock that may be issued on the exercise of incentive stock options under the 2020 Plan is 19,483,530 shares.

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

immediately preceding year, or (2) a lesser number of shares determined by the Company’s board of directors no later than December 31 of the immediately preceding year.

In 2022, the Company’s Board of Directors approved and adopted the 2022 Inducement Plan (the “2022 Inducement Plan”).

Under the 2022 Inducement Plan, initially 2,000,000 shares of common stock were reserved for issuance.

The 2022 Inducement 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 shall be established at 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.

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.

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.

Stock options and stock appreciation rights granted under the Plan generally expire ten years after the date of grant.

9 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 and the 2022 Inducement Plan were as follows, presented as a weighted average:

Six Months Ended June 30,

Nine Months Ended September 30,

Risk-free interest rate

7 unchanged sentences

Outstanding as of December 31, 2021

Outstanding as of June 30, 2022(2)

Options vested and exercisable as of June 30, 2022

Options expected to vest as of June 30, 2022

Outstanding as of September 30, 2022(2)

Options vested and exercisable as of September 30, 2022

Options expected to vest as of September 30, 2022

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

(2) Balance as of June 30, 2022 includes 32,619 unvested early exercised stock options.

(2) Balance as of September 30, 2022 includes 25,629 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, 2022, 102,906 of such shares had vested with the remaining shares vesting over their respective terms.

As of September 30, 2022, 109,896 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.

3 unchanged sentences

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 $ 0.1 million in other current liabilities as of June 30, 2022.

Accordingly, the Company has recorded the unvested portion of the exercise proceeds of $ 0.1 million in other current liabilities as of September 30, 2022.

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, 2022:

The following table summarizes the restricted stock activity under the Plan during the nine months ended September 30, 2022:

Number of Shares

1 unchanged sentence

Unvested restricted stock as of December 31, 2021

Unvested restricted stock as of June 30, 2022

Unvested restricted stock as of September 30, 2022

2020 Employee Stock Purchase Plan

8 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 and $ 0.2 million for the three and six months ended June 30, 2022, respectively.

Stock-based compensation expense related to the ESPP was $ 0.1 million and $ 0.3 million for the three and nine months ended September 30, 2022, respectively.

Stock-Based Compensation Expense

Stock-based compensation expense related to awards granted under the 2014 Plan, the 2020 Plan, the 2020 ESPP Plan and the 2022 Inducement Plan was classified in the condensed consolidated statements of operations and comprehensive loss as follows (in thousands):

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Nine Months Ended September 30,

Research and development

3 unchanged sentences

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,

Three Months Ended September 30,

Nine Months Ended September 30,

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

1 unchanged sentence

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:

September 30,

Unvested restricted common stock

3 unchanged sentences

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.

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 25,629 unvested stock options that were early exercised by an employee and a non-employee in September 2020 (see Note 7, “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, 2022 and 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, 2022 and 2021.

The Company leases certain of its facilities under non-cancellable operating leases expiring at various dates through 2026.

12 unchanged sentences

According to the terms of the Laboratory Lease Agreement, the Company paid a $ 0.4 million security deposit and is required to pay monthly rent and common area charges.

The following table summarizes total lease expense during the three and six months ended June 30, 2022 (in thousands):

Three Months Ended June 30,

Six Months Ended June 30,

The following table summarizes total lease expense during the three and nine months ended September 30, 2022 (in thousands):

Three Months Ended September 30,

Nine Months Ended September 30,

Straight-line operating lease expense

2 unchanged sentences

Total operating lease expense

The following table summarizes supplemental cash flow information during the three and six months ended June 30, 2022 (in thousands):

Three Months Ended June 30,

Six Months Ended June 30,

The following table summarizes supplemental cash flow information during the three and nine months ended September 30, 2022 (in thousands):

Three Months Ended September 30,

Nine Months Ended September 30,

Cash paid for amounts included measurement of lease liabilities:

1 unchanged sentence

Supplemental noncash information on lease liability arising from obtaining a right-of-use asset

The following table summarizes the Company’s future minimum lease payments and reconciliation of lease liabilities as of June 30, 2022 (in thousands):

The following table summarizes the Company’s future minimum lease payments and reconciliation of lease liabilities as of September 30, 2022 (in thousands):

Years Ending December 31,

2022 (from July 2022)

2022 (from October 2022)

Total future minimum lease payments

2 unchanged sentences

Lease liabilities, non-current

The following table summarizes lease term and discount rate as of June 30, 2022:

The following table summarizes lease term and discount rate as of September 30, 2022:

September 30,

Weighted-average remaining lease term (years)

5 unchanged sentences

The collaboration is focused on the evaluation of the safety, tolerability and efficacy of OP-1250 in combination with Novartis’ proprietary CDK4/6 inhibitor Kisqali® (ribociclib) and/or Novartis’ proprietary phosphatidylinositol 3-kinase inhibitor Piqray® (alpelisib) (collectively the “Novartis Study Drugs”) as part of the Company’s planned Phase 1b clinical trial of OP-1250 in patients with metastatic estrogen receptor-positive breast cancer.

The Company will be responsible for the conduct of the clinical trials for the combined therapies in accordance with a mutually agreed development plan.

will be responsible for the conduct of the clinical trials for the combined therapies in accordance with a mutually agreed development plan.

As part of the collaboration, the parties granted to each other a non-exclusive, royalty- free license under certain of the parties’ respective background patent rights and other technology to use the parties’ respective study drugs in research and development, solely to the extent reasonably needed for the other party’s activities in the collaboration.

5 unchanged sentences

Either party may terminate the Novartis Agreement for the uncured material breach or insolvency of the other party, if it reasonably deems it necessary in order to protect the safety, health or welfare of subjects enrolled in the clinical trials for the combined therapies due to the existence of a material safety issue, or in certain circumstances for an unresolved clinical hold with respect to either the Novartis Study Drugs or OP-1250.

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.

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.

Costs associated with research activities performed under the agreement are included in research and development expenses in the accompanying condensed consolidated financial statements, with any reimbursable costs from Novartis reflected as a reduction of such expenses.

For the three and six months ended June 30, 2022, costs reimbursable from Novartis were $ 0.5 million and $ 0.5 million, respectively.

As of June 30, 2020, the receivable due from Novartis was $ 0.5 million, which is recorded under prepaid expenses and other current assets in the accompanying condensed consolidated financial statements.

For the three and nine months ended September 30, 2022, costs reimbursable from Novartis were $ 0.5 million and $ 1.1 million, respectively.

As of September 30, 2020, the receivable due from Novartis was $ 1.1 million, which is recorded under prepaid expenses and other current assets in the accompanying condensed consolidated financial statements.

Clinical Trial Agreement

6 unchanged sentences

Either party may terminate the Pfizer Agreement for the uncured material breach or insolvency of the other party, if it reasonably deems it necessary in order to protect the safety, health or welfare of subjects enrolled in the clinical trials for the combined therapies due to the existence of a material safety issue, or in certain circumstances for an unresolved clinical hold with respect to either the IBRANCE® (palbociclib) or OP-1250.

In addition, either party may terminate the Pfizer Agreement if certain disputes between the parties are not resolved after following the applicable dispute resolution procedures or if either party determines to discontinue clinical development for medical, scientific, legal or other reasons.

In addition, either party may terminate the Pfizer Agreement if certain disputes between the parties

are not resolved after following the applicable dispute resolution procedures or if either party determines to discontinue clinical development for medical, scientific, legal or other reasons.

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 and comprehensive loss for the three and six months ended June 30, 2022 and 2021.

License Agreement

14 unchanged sentences

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, 2022, the Company did not have material contractual commitments with respect to these arrangements.

As of September 30, 2022, the Company did not have material contractual commitments with respect to these arrangements.

Contingencies

From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of business.

The Company accrues a liability for such matters when it is probable that future expenditures will be made, and such expenditures can be reasonably estimated.

The Company accrues a liability for such matters when it is probable that future expenditures will be

made, and such expenditures can be reasonably estimated.

For all periods presented, the Company was not a party to any pending material litigation or other material legal proceedings.

3 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, 2022 and December 31, 2021, the Company had not incurred any material costs as a result of such indemnifications.

As of September 30, 2022 and December 31, 2021, 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