What changed in this filing

/stocks — the workspaceLOADING

Item 1. Financial Statements

2023-08-08 compared with 2023-05-09 · 136 added, 104 removed, 374 unchanged (39% of the section changed)

10 unchanged sentences

Operating lease right-of-use assets

Other assets and long-term deposits

Liabilities and stockholders ’ equity

2 unchanged sentences

Operating lease liabilities, current

Other current liabilities

Accrued and other current liabilities

Total current liabilities

4 unchanged sentences

Preferred stock, $ 0.0001 par value;

10,000,000 shares authorized as of March 31, 2023 and December 31, 2022;

no shares issued and outstanding as of March 31, 2023 and December 31, 2022.

10,000,000 shares authorized as of June 30, 2023 and December 31, 2022;

no shares issued and outstanding as of June 30, 2023 and December 31, 2022.

Common stock, $ 0.0001 par value;

490,000,000 shares authorized as of March 31, 2023 and December 31, 2022;

40,696,563 and 40,601,648 shares issued as of March 31, 2023 and December 31, 2022, respectively;

40,438,320 and 40,287,097 shares outstanding as of March 31, 2023 and December 31, 2022, respectively.

490,000,000 shares authorized as of June 30, 2023 and December 31, 2022;

41,324,416 and 40,601,648 shares issued as of June 30, 2023 and December 31, 2022, respectively;

41,122,482 and 40,287,097 shares outstanding as of June 30, 2023 and December 31, 2022, respectively.

Additional paid-in capital

7 unchanged sentences

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

Three Months Ended March 31,

Three Months Ended June 30,

Six Months Ended June 30,

Operating expenses:

3 unchanged sentences

Loss from operations

Other income:

Other income (expense):

Interest income

Other income:

Other (expense) income

Total other income

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 March 31,

Other comprehensive gain (loss):

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 gain (loss) on marketable securities

6 unchanged sentences

Stockholders'

Balances at March 31, 2023

Vesting of early exercised stock options

Vesting of restricted stock awards

Exercise of stock options

Issuance of shares under the employee stock purchase plan

Stock-based compensation expense

Employee stock purchase plan expense

Net unrealized gain on marketable securities

Balances at June 30, 2023

Comprehensive

Stockholders'

Balances at December 31, 2022

2 unchanged sentences

Exercise of stock options

Issuance of shares under the employee stock purchase plan

Stock-based compensation expense

1 unchanged sentence

Net unrealized gain on marketable securities

Balances at June 30, 2023

Comprehensive

Stockholders'

Balances at March 31, 2022

Vesting of early exercised stock options

Vesting of restricted stock awards

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, 2022

Comprehensive

4 unchanged sentences

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 March 31, 2022

Balances at June 30, 2022

See accompanying notes to the condensed consolidated financial statements.

2 unchanged sentences

(Amounts in thousands)

Three Months Ended March 31,

Six Months Ended June 30,

Cash flows from operating activities:

1 unchanged sentence

Depreciation and amortization expense

Loss on sale of equipment

Non-cash lease expense

Premium amortization and discount accretion on marketable securities, net

Non-cash interest income on marketable securities

Stock-based compensation expense, including employee stock purchase plan expense

1 unchanged sentence

Prepaid expenses and other current assets

Other assets and long-term deposits

Accounts payable

Other current liabilities

Accrued and other current liabilities

Operating lease liabilities

7 unchanged sentences

Proceeds from exercise of stock options

Proceeds from issuance of common stock under employee stock purchase plan

Net cash provided by financing activities

2 unchanged sentences

Cash and cash equivalents at end of period

Supplemental disclosure of non-cash investing and financing activities:

Reclassification of prepaid expenses and other current liabilities into other assets

See accompanying notes to the condensed consolidated financial statements.

5 unchanged sentences

The Company is initially focused on developing therapies for the treatment of breast cancer.

The Company’s wholly-owned, lead product candidate, OP-1250, is a novel oral therapy with combined activity as both a complete estrogen receptor (“ER”) antagonist (“CERAN”) and a selective ER degrader (“SERD”).

The Company’s wholly-owned, lead product candidate, palazestrant (OP-1250), is a novel oral therapy with combined activity as both a complete estrogen receptor (“ER”) antagonist (“CERAN”) and a selective ER degrader (“SERD”).

It is currently being evaluated as a single agent in an ongoing Phase 2 clinical study, and in Phase 1b/2 clinical studies in combination with palbociclib, ribociclib, and alpelisib, in patients with recurrent, locally advanced or metastatic estrogen receptor-positive (“ER+”), human epidermal growth factor receptor 2 negative (“HER2-”) breast cancer.

We expect to initiate in the fourth quarter of 2023 Olema’s first pivotal Phase 3 clinical trial, called OPERA-01, testing palazestrant as a monotherapy in second- and third-line metastatic breast cancer.

The Company is located in San Francisco, California and was incorporated in Delaware on August 7, 2006, under the legal name of CombiThera, Inc.

1 unchanged sentence

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).

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 geopolitical and macroeconomic events, such as the COVID-19 pandemic, ongoing conflict between Ukraine and Russia and related sanctions, recent and potential future bank failures and financial instability, 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.

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

These efforts require significant amounts of additional capital, adequate personnel, and infrastructure and extensive compliance-reporting capabilities.

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 $ 186.0 million of cash, cash equivalents and marketable securities at March 31, 2023, which management believes is sufficient to fund its operating expenses and capital expenditure requirements into 2025.

The Company had $ 167.4 million of cash, cash equivalents and marketable securities at June 30, 2023, which management believes is sufficient to fund its operating expenses and capital expenditure requirements into the second quarter of 2025.

Impact of Geopolitical and Macroeconomic Events

2 unchanged sentences

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.

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

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 geopolitical and macroeconomic factors on its results of operations, financial condition and cash flows.

Summary of Significant Accounting Policies

6 unchanged sentences

Unaudited Interim Financial Information

The interim condensed consolidated balance sheet as of March 31, 2023, and the statements of operations and comprehensive loss, stockholders’ equity and cash flows for the three months ended March 31, 2023 and 2022 are unaudited.

The interim condensed consolidated balance sheet as of June 30, 2023, and the statements of operations and comprehensive loss, and stockholders’ equity for the three and six months ended June 30, 2023 and 2022, and the statements of cash flows for the six months ended June 30, 2023 and 2022 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-month periods are also unaudited.

The results of operations for the three months ended March 31, 2023 are not necessarily indicative of the results to be expected for the year ending December 31, 2023 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 six-month periods are also unaudited.

The results of operations presented in these unaudited condensed consolidated financial statements are not necessarily indicative of the results to be expected for the year ending December 31, 2023, or for any other future annual or interim period.

The condensed consolidated balance sheet as of December 31, 2022 included herein was derived from the audited financial statements as of that date.

8 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 as of March 31, 2023 and December 31, 2022.

Cash deposits are all in reputable financial institutions in the United States as of June 30, 2023, and December 31, 2022.

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

55 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 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 and contract 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.

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.

17 unchanged sentences

Recent Accounting Pronouncements

There were no new accounting pronouncements that were relevant to the Company as of and for the three months ended March 31, 2023.

There were no new accounting pronouncements that were relevant to the Company as of and for the six months ended June 30, 2023.

Fair Value Measurement

6 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.

March 31, 2023

June 30, 2023

(in thousands)

4 unchanged sentences

Government-sponsored enterprise securities

March 31, 2023

June 30, 2023

(in thousands)

4 unchanged sentences

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

As of March 31, 2023, the Company does not have any marketable securities with maturities beyond one year.

As of June 30, 2023, the Company does not have any marketable securities with maturities beyond one year.

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

1 unchanged sentence

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 were 23 marketable securities that have been in a consecutive loss position for more than 12 months as of March 31, 2023.

They had $ 0.8 million unrealized loss with a fair value of $ 63.7 million as of March 31, 2023.

The Company does not believe that the total unrealized losses of $ 1.0 million as of March 31, 2023 are credit-related but are rather a reflection of current market yields and/or current marketplace bid/ask spreads.

During the three months ended March 31, 2023 and 2022, respectively, the Company did not recognize any other-than-temporary impairment loss.

As of March 31, 2023, there was no allowance for losses on available-for-sale debt securities attributable to credit risk.

As of March 31, 2023, all of the Company’s cash and cash equivalents consisted of cash on deposit with U.S.

banks denominated in U.S.

There were 14 marketable securities that have been in a consecutive loss position for more than 12 months as of June 30, 2023.

These marketable securities had $ 0.5 million unrealized losses with a fair value of $ 39.0 million as of June 30, 2023.

The Company does not believe that the total unrealized losses of $ 0.5 million as of June 30, 2023 are credit-related but are rather a reflection of current market yields and/or current marketplace bid/ask spreads.

During the three and six months ended June 30, 2023, the Company did not recognize any other-than-temporary impairment loss.

As of June 30, 2023, there was no allowance for losses on available-for-sale debt securities attributable to credit risk.

As of June 30, 2023, all of the Company’s cash and cash equivalents consisted of cash on deposit with U.S.

banks denominated in U.

dollars and Australian dollars.

8 unchanged sentences

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

Prepaid insurance

Reimbursable research and development costs from a collaboration partner

Prepaid clinical development costs

Prepaid insurance

Research and development tax incentive credit receivable

Prepaid subscriptions and licenses

Prepaid clinical development costs

Interest receivable

Other Current Liabilities

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

Accrued and Other Current Liabilities

Accrued and other current liabilities consisted of the following (in thousands):

Accrued research and development related costs

Accrued payroll related costs

Accrued professional fees

Accrued employee bonuses

Accrued professional fees

Accrued payroll related costs

Accrued taxes

1 unchanged sentence

Stock-Based Compensation

In 2014, the Company’s Board of Directors and stockholders approved and adopted the Company’s 2014 Stock Plan (the “2014 Plan”).

In 2014, the Company’s Board of Directors (the “Board”) and stockholders approved and adopted the Company’s 2014 Stock Plan (the “2014 Plan”).

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

1 unchanged sentence

However, any outstanding awards granted under the 2014 Plan will remain outstanding, subject to the terms of the 2014 Plan award agreements, until such outstanding options are exercised or until any awards terminate or expire by their terms.

In 2020, the Company’s Board of Directors and stockholders approved and adopted the 2020 Equity Incentive Plan (the “2020 Plan”).

In 2020, the Board and the Company’s 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;

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 2014 Plan that, on or after the 2020 Plan becomes effective, terminate or expire prior to exercise or settlement;

are not issued because the award is settled in cash;

2 unchanged sentences

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.

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

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

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

13 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,

Risk-free interest rate

7 unchanged sentences

Outstanding as of December 31, 2022

Outstanding as of March 31, 2023(2)

Options vested and exercisable as of March 31, 2023

Options expected to vest as of March 31, 2023

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

(2) Balance as of March 31, 2023 includes 11,650 unvested early exercised stock options.

Outstanding as of June 30, 2023(2)

Options vested and exercisable as of June 30, 2023

Options expected to vest as of June 30, 2023

(1) Exercised amount includes vesting of early-exercised options and shares returned for taxes withheld for exercise and net transactions.

(2) Balance as of June 30, 2023 includes 4,660 unvested early-exercised stock options.

Early Exercise of Stock Options

4 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 March 31, 2023.

Accordingly, the Company has recorded the unvested portion of the exercise proceeds of less than $ 0.1 million in other current liabilities as of June 30, 2023.

Restricted Stock Awards

The following table summarizes the restricted stock activity under the 2014 Plan during the three months ended March 31, 2023:

The following table summarizes the restricted stock activity under the 2014 Plan during the six months ended June 30, 2023:

Number of Shares

1 unchanged sentence

Unvested restricted stock as of December 31, 2022

Unvested restricted stock as of March 31, 2023

Unvested restricted stock as of June 30, 2023

Performance-Based Restricted Stock Unit Awards

2 unchanged sentences

Expense recognition for PSUs commences when it is determined that attainment of the performance goal is probable or met.

As of March 31, 2023, it was determined that the performance goals were not yet met, and therefore, the Company recorded zero stock-based compensation expense related to the PSUs for the three months ended March 31, 2023.

As of June 30, 2023, it was determined that the performance goals were not yet met, and therefore, the Company recorded zero stock-based compensation expense related to the PSUs for the three and six months ended June 30, 2023.

2020 Employee Stock Purchase Plan

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

In 2020, the Board and the Company’s stockholders approved and adopted the ESPP.

The ESPP permits eligible employees who elect to participate in an offering under the ESPP to have up to 15 % of their eligible earnings withheld, subject to certain limitations, to purchase shares of common stock pursuant to the ESPP.

1 unchanged sentence

or (ii) 85 % of the fair market value of a share of the Company’s common stock on the date of purchase.

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

Each offering period is not to exceed 27 months and will include one or more purchase periods (each a “Purchase Period”) as approved by the Board in the offering.

The current offering period will consist of two (2) six-month Purchase Periods during which payroll deductions of the participants are accumulated under the ESPP.

2 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 $ 0.1 million for the three months ended March 31, 2023 and 2022, respectively.

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, 2023, respectively.

Stock-Based Compensation Expense

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

Three Months Ended March 31,

Three Months Ended June 30,

Six Months Ended June 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 March 31,

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

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

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:

Three Months Ended March 31,

Unvested restricted common stock

Unvested restricted stock awards outstanding

Unvested performance-based restricted stock unit awards outstanding

1 unchanged sentence

Employee stock purchase plan contingently issuable

Included in the potentially dilutive options to purchase common stock are 11,650 unvested stock options that were early exercised by an employee and a non-employee in September 2020 (see Note 7, “Stock-Based Compensation”).

Included in the potentially dilutive options to purchase common stock for the three and six months ended June 30, 2023 and June 30, 2022 are 4,660 unvested stock options that were early exercised 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 months ended March 31, 2023 and 2022.

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, 2023 and 2022.

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

On June 1, 2013, the Company entered into a management services agreement with MandalMed, Inc.

(“MandalMed”) (the “MandalMed Services Agreement”) to have access to and use a portion of approximately

5,762 square feet of space for the use of laboratory benches, lab equipment, office space, and administrative and facilities services.

(the “MandalMed Services Agreement”) to have access to and use a portion of approximately 5,762 square feet of space for the use of laboratory benches, lab equipment, office space, and administrative and facilities services.

The Company subsequently entered into six amendments to extend the agreement term to November 2023.

As part of the sixth amendment, the Company gained access to use additional space of approximately 2,130 square feet (the “Additional Space”) for a three year period commencing on December 1, 2020 and ending on November 30, 2023.

As part of the sixth amendment, the Company gained access to use additional space of approximately 2,130 square feet for a three year period commencing on December 1, 2020 and ending on November 30, 2023.

According to the terms of the MandalMed Services Agreement, the Company paid a security deposit of less than $ 0.1 million and is required to pay monthly rent and common area charges.

2 unchanged sentences

In April 2022, the Company extended the Office Space Lease Agreement up to August 31, 2023 and has one year renewal option to extend the term up to August 31, 2024 .

The Company decided not to exercise the one-year renewal option at the end of the lease term.

According to the terms of the Office Space Lease Agreement, the Company paid a $ 0.1 million security deposit and is required to pay monthly rent and common area charges.

3 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 months ended March 31, 2023 and 2022, respectively (in thousands):

Three Months Ended March 31

The following table summarizes total lease expense during the three and six months ended June 30, 2023 (in thousands):

Three Months Ended June 30,

Six Months Ended June 30,

Straight-line operating lease expense

2 unchanged sentences

Total operating lease expense

The following table summarizes supplemental cash flow information during the three months ended March 31, 2023 and 2022, respectively (in thousands):

Three Months Ended March 31

The following table summarizes supplemental cash flow information during the three and six months ended June 30, 2023 (in thousands):

Three Months Ended June 30,

Six Months Ended June 30,

Cash paid for amounts included measurement of lease liabilities:

Operating cash flows from operating leases

The following table summarizes the Company’s future minimum lease payments and reconciliation of lease liabilities as of March 31, 2023 (in thousands):

Years Ended December 31,

2023 (from April 2023)

The following table summarizes the Company’s future minimum lease payments and reconciliation of lease liabilities as of June 30, 2023 (in thousands):

Years Ending December 31,

2023 (from July 2023)

Total future minimum lease payments

2 unchanged sentences

Lease liabilities, non-current

The following table summarizes lease term and discount rate as of March 31, 2023:

Three Months Ended March 31

The following table summarizes lease term and discount rate as of June 30, 2023:

Weighted-average remaining lease term (years)

4 unchanged sentences

(“Novartis”) and on January 13, 2022, the Company entered into the amended and restated clinical collaboration and supply agreement with Novartis (as amended and restated, the “Novartis Agreement”).

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 (“PI3K a ”) Inhibitor Piqray® (alpelisib) (collectively the “Novartis Study Drugs”) as part of the Company’s planned Phase 1b clinical study of OP-1250 in patients with metastatic estrogen receptor-positive breast cancer.

The collaboration is focused on the evaluation of the safety, tolerability and efficacy of palazestrant in combination with Novartis’ proprietary CDK4/6 inhibitor Kisqali® (ribociclib) and/or Novartis’ proprietary phosphatidylinositol 3-kinase (“PI3K a ”) Inhibitor Piqray® (alpelisib) (collectively the “Novartis Study Drugs”) as part of the Company’s planned Phase 1b clinical study of palazestrant 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.

1 unchanged sentence

All inventions and data developed in the performance of the clinical trials for the combined therapies (other than those specific to each component study drug), will be jointly owned by the parties.

The Company is responsible for manufacturing, packaging and labeling OP-1250, and for packaging and labeling all drugs used in the clinical trials for the combined therapies (other than the Novartis Study Drugs).

The Company is responsible for manufacturing, packaging and labeling palazestrant, and for packaging and labeling all drugs used in the clinical trials for the combined therapies (other than the Novartis Study Drugs).

Novartis is responsible for manufacturing and delivering to the Company the Novartis Study Drugs in such quantities as reasonably needed for the clinical trials for the combined therapies.

1 unchanged sentence

The Novartis Agreement will terminate upon completion of all activities outlined in the development plan and the relevant protocols.

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

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 months ended March 31, 2023 and 2022, costs reimbursable from Novartis were $ 0.5 million and $ 0 million, respectively.

As of March 31, 2023, the receivable due from Novartis was $ 1.0 million, which is recorded under prepaid expenses and other current assets in the accompanying condensed consolidated financial statements.

For the three and six months ended June 30, 2023, costs reimbursable from Novartis were $ 0.8 million and $ 1.4 million, respectively.

As of June 30, 2023, the receivable due from Novartis was $ 1.8 million, which is recorded under prepaid expenses and other current assets in the accompanying condensed consolidated balance sheets.

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.

(“Pfizer”) (the “Pfizer Agreement”), to evaluate the safety and tolerability of palazestrant 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.

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.

As part of the collaboration, the parties granted to each other a non-exclusive, royalty-free license under certain of the parties’ respective patent rights in the combination of IBRANCE® and OP-1250 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.

As part of the collaboration, the parties granted to each other a non-exclusive, royalty-free license under certain of the parties’ respective patent rights in the combination of IBRANCE® and palazestrant 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.

All inventions and data developed in the performance of the clinical trials for the combined therapies (other than those specific to each component study drug), will be jointly owned by the parties.

Pfizer is responsible for manufacturing and delivering to us IBRANCE® (palbociclib) in such quantities as reasonably needed for the clinical trials for the combined therapies.

Pfizer is responsible for manufacturing and delivering to us IBRANCE® in such quantities as reasonably needed for the clinical trials for the combined therapies.

The Pfizer Agreement will terminate upon completion of all activities outlined in the study plan and the relevant protocols.

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.

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 accompanying condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2023, and 2022.

License Agreement

1 unchanged sentence

Under the terms of the Aurigene Agreement, Aurigene will provide to the Company an exclusive license to its portfolio of novel small molecule inhibitors of the target.

Financial terms of the Aurigene Agreement include a

$ 8.0 million upfront payment for rights to a pre-existing Aurigene program and potential future milestone payments of up to $ 60.0 million in clinical development and regulatory milestones, and up to $ 370.0 million in commercial milestones.

Financial terms of the Aurigene Agreement include a $ 8.0 million upfront payment for rights to a pre-existing Aurigene program and potential future milestone payments of up to $ 60.0 million in clinical development and regulatory milestones, and up to $ 370.0 million in commercial milestones.

Aurigene is also eligible to receive mid-single digits to the low double digits royalties on product sales, if any.

3 unchanged sentences

The term of the Aurigene Agreement will continue until the expiration of the last-to-expire of all payment obligations with respect to all licensed products thereunder, unless terminated earlier in accordance with the terms of the Aurigene Agreement.

The Aurigene Agreement may be terminated (a) by the Company for convenience, in its sole discretion, upon prior written notice to Aurigene, (b) by either the Company or Aurigene in connection with the other party’s uncured material breach or (c) by either the Company or Aurigene in connection with the insolvency of the other party.

The Aurigene Agreement may be terminated (a) by the Company for

convenience, in its sole discretion, upon prior written notice to Aurigene, (b) by either the Company or Aurigene in connection with the other party’s uncured material breach or (c) by either the Company or Aurigene in connection with the insolvency of the other party.

The $ 8.0 million upfront payment was incurred in June 2022 and recorded as research and development expense in the accompanying condensed consolidated statements of operations and comprehensive loss.

1 unchanged sentence

Payments due to Aurigene upon or subsequent to regulatory approval will be accrued as a provision to cost of sales in the period when achievement of respective milestone target is probable.

As of March 31, 2023, it was determined that it is not probable to achieve any of the milestone target, and therefore, the Company recorded zero expense related to the milestone for the three months ended March 31, 2023.

As of June 30, 2023, it was determined that it is not probable to achieve any of the milestone target, and therefore, the Company recorded zero expense related to the milestone for the three and six months ended June 30, 2023.

Management Services Agreements

2 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 March 31, 2023, the Company did not have material contractual commitments with respect to these arrangements.

As of June 30, 2023, the Company did not have material contractual commitments with respect to these arrangements.

Contingencies

4 unchanged sentences

In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties.

In addition, the Company has entered into indemnification agreements with members of its Board of Directors and executive officers that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers.

In addition, the Company has entered into indemnification agreements with members of its Board and executive officers that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers.

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 March 31, 2023 and December 31, 2022, the Company had not incurred any material costs as a result of such indemnifications.

As of June 30, 2023, and December 31, 2022, 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