What changed in this filing

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Item 1. Financial Statements

2024-11-12 compared with 2024-08-06 · 100 added, 86 removed, 505 unchanged (27% of the section changed)

3 unchanged sentences

(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, 2024 and December 31, 2023;

no shares issued and outstanding as of June 30, 2024 and December 31, 2023.

10,000,000 shares authorized as of September 30, 2024 and December 31, 2023;

no shares issued and outstanding as of September 30, 2024 and December 31, 2023.

Common stock, $ 0.0001 par value;

490,000,000 shares authorized as of June 30, 2024 and December 31, 2023;

57,258,367 and 55,097,118 shares issued as of June 30, 2024 and December 31, 2023, respectively;

57,246,411 and 54,992,784 shares outstanding as of June 30, 2024 and December 31, 2023, respectively.

490,000,000 shares authorized as of September 30, 2024 and December 31, 2023;

57,288,319 and 55,097,118 shares issued as of September 30, 2024 and December 31, 2023, respectively;

57,288,319 and 54,992,784 shares outstanding as of September 30, 2024 and December 31, 2023, respectively.

Additional paid-in capital

Accumulated other comprehensive (loss) income

Accumulated other comprehensive income

Accumulated deficit

5 unchanged sentences

(Amounts in thousands, except for 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,

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) income:

Net unrealized (loss) gain on marketable securities

Three Months Ended September 30,

Nine Months Ended September 30,

Other comprehensive income:

Net unrealized gain on marketable securities

Total comprehensive loss

3 unchanged sentences

(Amounts in thousands, except for share amounts)

Three Months Ended June 30, 2024

Three Months Ended September 30, 2024

Comprehensive

1 unchanged sentence

(Loss) Income

Balances at March 31, 2024

Issuance of shares under at-the-market offering, net of issuance costs of $ 25

Balances at June 30, 2024

Stock-based compensation expense

Issuance of shares under the employee stock purchase plan

Employee stock purchase plan expense

Exercise of stock options

Vesting of restricted stock awards

Net unrealized loss on marketable securities

Balances at June 30, 2024

Six Months Ended June 30, 2024

Net unrealized gain on marketable securities

Balances at September 30, 2024

Nine Months Ended September 30, 2024

Comprehensive

Stockholders'

(Loss) Income

Balances at December 31, 2023

5 unchanged sentences

Vesting of restricted stock awards

Net unrealized loss on marketable securities

Balances at June 30, 2024

Net unrealized gain on marketable securities

Balances at September 30, 2024

Olema Pharmaceuticals, Inc.

1 unchanged sentence

(Amounts in thousands, except for share amounts)

Three Months Ended June 30, 2023

Three Months Ended September 30, 2023

Comprehensive

1 unchanged sentence

(Loss) Income

Balances at March 31, 2023

Balances at June 30, 2023

Issuance of shares under equity private placement, net of issuance costs of $ 240

Stock-based compensation expense

Exercise of stock options

Issuance of shares under the employee stock purchase plan

Employee stock purchase plan expense

2 unchanged sentences

Net unrealized gain on marketable securities

Balances at June 30, 2023

Six Months Ended June 30, 2023

Balances at September 30, 2023

Nine Months Ended September 30, 2023

Comprehensive

2 unchanged sentences

Balances at December 31, 2022

Issuance of shares under equity private placement, net of issuance costs of $ 240

Stock-based compensation expense

Exercise of stock options

Issuance of shares under the employee stock purchase plan

Issuance of shares under employee stock purchase plan

Employee stock purchase plan expense

2 unchanged sentences

Net unrealized gain on marketable securities

Balances at June 30, 2023

Balances at September 30, 2023

See accompanying notes to the condensed consolidated financial statements.

2 unchanged sentences

(Amounts in thousands)

Six Months Ended June 30,

Nine Months Ended September 30,

Cash flows from operating activities:

14 unchanged sentences

Purchase of equipment

Disposal of fixed assets

Maturities of marketable securities

Purchases of marketable securities

Net cash (used in) provided by investing activities

Net cash provided by investing activities

Cash flows from financing activities:

Issuance of shares under at-the-market offering, net of issuance costs of $ 166

Proceeds from equity private placement, net of issuance costs of $ 240

Proceeds from exercise of stock options

21 unchanged sentences

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 $ 239.1 million of cash, cash equivalents and marketable securities at June 30, 2024 , in addition to an available balance of $ 25.0 million under the Loan and Security Agreement (the "Original Loan Agreement"), dated September 5, 2023 by and between the Company, as borrower, and Silicon Valley Bank, a division of First-Citizens Bank & Trust Company (the “Bank”), as amended by the First Amendment to Loan and Security Agreement, dated June 28, 2024, by and between the Company and the Bank (the "Amendment," and the Original Loan Agreement as amended by the Amendment, the "Loan Agreement").

The Company had $ 214.8 million of cash, cash equivalents and marketable securities at September 30, 2024 , in addition to an available balance of $ 25.0 million under the Loan and Security Agreement (the "Original Loan Agreement"), dated September 5, 2023 by and between the Company, as borrower, and Silicon Valley Bank, a division of First-Citizens Bank & Trust Company (the “Bank”), as amended by the First Amendment to Loan and Security Agreement, dated June 28, 2024, by and between the Company and the Bank (the "Amendment," and the Original Loan Agreement as amended by the Amendment, the "Loan Agreement").

See Footnote 10.

5 unchanged sentences

The Company has agreed to pay TD Cowen a commission of up to 3.0 % of the aggregate gross proceeds from any ATM Shares sold by TD Cowen.

During the three months ended June 30, 2024 , the Company issued 1,225,952 shares of its common stock under the Sales Agreement at a weighted-average price of $ 12.39 per share for net proceeds of $ 14.9 million after deducting related issuance costs.

During the six months ended June 30, 2024, the Company issued 1,772,278 shares of its common stock under the Sales Agreement at a weighted-average price of $ 13.19 for net proceeds of $ 22.8 million after deducting related issuance costs.

As of June 30, 2024 , approximately $ 126.6 million remained available for issuance under the Sales Agreement.

As of September 30, 2024 , approximately $ 126.6 million remained available for issuance under the Sales Agreement.

Impact of Geopolitical and Macroeconomic Events

12 unchanged sentences

Unaudited Interim Financial Information

The interim condensed consolidated balance sheet as of June 30, 2024, and the statements of operations and comprehensive loss, and stockholders’ equity for the three and six months ended June 30, 2024 and 2023, and the statements of cash flows for the six months ended June 30, 2024 and 2023 are unaudited.

The interim condensed consolidated balance sheet as of September 30, 2024, and the statements of operations and comprehensive loss, and stockholders’ equity for the three and nine months ended September 30, 2024 and 2023, and the statements of cash flows for the nine months ended September 30, 2024 and 2023 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.

6 unchanged sentences

The preparation of the condensed consolidated financial statements in conformity with 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.

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.

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 fewer at the date of purchase.

Cash deposits are all in reputable financial institutions in the United States as of June 30, 2024 , and December 31, 2023.

Cash deposits are all in reputable financial institutions in the United States as of September 30, 2024 , and December 31, 2023.

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, dependence on key individuals or sole-source suppliers, and geopolitical and macroeconomic factors.

securing and protecting proprietary technology, strategic relationships, dependence on key individuals or sole-source suppliers, and geopolitical and macroeconomic factors.

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

27 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 contract research organizations (“CROs”) and contract manufacturing organizations (“CMOs”), in connection with non-clinical 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.

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.

26 unchanged sentences

Accordingly, all monetary assets and liabilities of the subsidiary are remeasured into U.S.

dollars at the current period-end exchange rates and non-monetary assets are remeasured using historical exchange rates.

the current period-end exchange rates and non-monetary assets are remeasured using historical exchange rates.

Income and expense elements are remeasured to U.S.

11 unchanged sentences

Recent Accounting Pronouncements

There were no new accounting pronouncements that were relevant to the Company as of and for the three and six months ended June 30, 2024 .

In November 2023, the Financial Accounting Standards Board (the “FASB”) issued ASU No.

2023-07, Segment Reporting (Topic 280) (“ASU 2023-07”).

ASU 2023-07 expands public entities’ segment disclosures by requiring disclosure of significant segment expenses that are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and assets.

All disclosure requirements under ASU 2023-07 are also required for public entities with a single reportable segment.

The guidance is effective for the fiscal year beginning after December 15, 2023, and interim periods in fiscal years beginning after December 15, 2024.

The Company is currently evaluating the impact of this update but does not expect it to have a material impact on its consolidated financial statements and disclosures.

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.

June 30, 2024

September 30, 2024

(in thousands)

13 unchanged sentences

Government-sponsored enterprise securities

June 30, 2024

September 30, 2024

(in thousands)

12 unchanged sentences

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.

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 were no marketable securities that had been in a consecutive loss position for more than 12 months as of June 30, 2024.

During the three and six months ended June 30, 2024, the Company did not recognize any other-than-temporary impairment loss.

As of June 30, 2024 , there was no allowance for losses on available-for-sale debt securities attributable to credit risk.

As of June 30, 2024 , all of the Company’s cash and cash equivalents consisted of cash on deposit with U.S.

There were no marketable securities that had been in a consecutive loss position for more than 12 months as of September 30, 2024.

During the three and nine months ended September 30, 2024, the Company did not recognize any other-than-temporary impairment loss.

As of September 30, 2024 , there was no allowance for losses on available-for-sale debt securities attributable to credit risk.

As of September 30, 2024 , all of the Company’s cash and cash equivalents consisted of cash on deposit with U.S.

banks denominated in U.

2 unchanged sentences

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

September 30,

Prepaid subscriptions and licenses

Prepaid clinical development costs

Interest receivable

Prepaid subscriptions and licenses

Prepaid insurance

2 unchanged sentences

Other assets and long-term deposits consisted of the following (in thousands):

September 30,

Clinical development project deposits

3 unchanged sentences

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

September 30,

Accrued research and development related costs

6 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 2014 Plan was terminated on the date the Company’s 2020 Equity Incentive Plan (the “2020 Plan”), which is described below, became effective, and since that date, no additional awards have been or will be made pursuant to the 2014 Plan.

The 2014 Plan was terminated on the date the Company’s 2020 Equity Incentive Plan (the “2020 Plan”), which is described

below, became effective, and since that date, no additional awards have been or will be made pursuant to the 2014 Plan.

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.

22 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:

September 30,

Risk-free interest rate

7 unchanged sentences

Exercised (1)

Outstanding as of June 30, 2024

Options vested and exercisable as of June 30, 2024

Options expected to vest as of June 30, 2024

Outstanding as of September 30, 2024

Options vested and exercisable as of September 30, 2024

Options expected to vest as of September 30, 2024

(1) Exercised amount includes shares returned for taxes withheld for exercise and net transactions.

Restricted Stock Awards

The following table summarizes the restricted stock activity under the 2014 Plan during the six months ended June 30, 2024:

The following table summarizes the restricted stock activity under the 2014 Plan during the nine months ended September 30, 2024:

Number of Shares

1 unchanged sentence

Unvested restricted stock as of December 31, 2023

Unvested restricted stock as of June 30, 2024

Unvested restricted stock as of September 30, 2024

Performance-Based Restricted Stock Unit Awards

1 unchanged sentence

Pursuant to the terms of the PSUs, 65 % of each PSU vests upon certification by the Compensation Committee of the Company of achieving a pre-determined performance goal by June 30, 2024, and, 35 % of each PSU vests upon certification by the Compensation Committee of the Company of achieving a pre-determined performance goal by June 30, 2024.

The performance goal related to the 35 % tranche of the PSUs was met and related stock-based compensation expense was recorded in 2023.

In June 2024, pursuant to the terms of the PSUs, the Compensation Committee of the Company approved an extension of the achievement of the performance goal related to the 65 % tranche of the PSUs from June 30, 2024 to December 31, 2024.

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

During the three and six months ended June 30, 2024 , no performance goal was met, and therefore, no related stock-based compensation expense was recorded.

The following table summarizes the performance-based restricted stock activity under the 2020 plan during the six months ended June 30, 2024:

During the three and nine months ended September 30, 2024 , no performance goal was met, and therefore, no related stock-based compensation expense was recorded.

The following table summarizes the performance-based restricted stock activity under the 2020 plan during the nine months ended September 30, 2024:

Number of Shares

1 unchanged sentence

Outstanding as of December 31, 2023

Outstanding as of June 30, 2024

Outstanding as of September 30, 2024

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 $ 0.2 million and $ 0.4 million for the three and six months ended June 30, 2024, respectively.

Stock-based compensation expense related to the ESPP was $ 0.1 million and $ 0.4 million for the three and nine months ended September 30, 2024, 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 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 common 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:

Six Months Ended June 30,

Nine Months Ended September 30,

Unvested restricted stock awards

9 unchanged sentences

The Dropbox Sublease Agreement is for a period of two years commencing on September 5, 2023 and ending December 31, 2025.

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

According to the terms of the Dropbox Sublease Agreement, the

Company paid a $ 0.1 million security deposit and is required to pay monthly rent and common area charges.

The sublease was accounted for under Topic 842 and the Company recorded ROU asset and lease liability of $ 0.2 million and $ 0.2 million, respectively, in the accompanying condensed consolidated financial statements.

3 unchanged sentences

The lease was accounted for under Topic 842 and the Company recorded ROU asset and lease liability of $ 0.7 million and $ 0.7 million, respectively, in the accompanying condensed consolidated financial statements.

The following table summarizes total lease expense during the three and six months ended June 30, 2024 (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, 2024 (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, 2024 and 2023 (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, 2024 and 2023 (in thousands):

Three Months Ended September 30,

Nine Months Ended September 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 June 30, 2024 (in thousands):

Supplemental noncash information on lease liabilities arising from obtaining right-use-assets

The following table summarizes the Company’s future minimum lease payments and reconciliation of lease liabilities as of September 30, 2024 (in thousands):

Years Ending December 31,

2024 (from July 2024)

2024 (from October 2024)

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, 2024:

The following table summarizes lease term and discount rate as of September 30, 2024:

September 30,

Weighted-average remaining lease term (years)

5 unchanged sentences

On June 28, 2024, the Company entered into the Amendment which amends the Original Loan Agreement in order to, among other things, (i) increase the aggregate principal amount of the Original Credit Facility from up to $ 50.0 million to up to $ 100.0 million (the "Credit Facility"), of which $ 25.0 million is currently available, an additional $ 25.0 million will become available upon the Company achieving certain milestones related to execution of a first-line pivotal Phase 3 clinical trial of palazestrant in combination with ribociclib, and an additional $ 50.0 million which may be made available upon approval of the Bank in its discretion, and (ii) extend the maturity date to July 1, 2028 (the "Maturity Date").

As of June 30, 2024, the Company had not drawn down funds under the Credit Facility.

As of September 30, 2024, the Company had not drawn down funds under the Credit Facility.

The obligations under the Loan Agreement are secured by substantially all of the assets of the Company, subject to limited exceptions.

42 unchanged sentences

As of December 31, 2023, the Company had incurred the full agreed-upon reimbursement amount.

As of June 30, 2024 , there was no outstanding balance from the receivable due from Novartis.

As of September 30, 2024 , there was no outstanding balance from the receivable due from Novartis.

Clinical Trial Agreement

11 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 accompanying condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2024, and 2023.

License Agreement

12 unchanged sentences

The $ 5.0 million milestone payment related to initiation of the first IND-enabling safety study was incurred and recorded as research and development expenses in the accompanying condensed consolidated statement of operations and comprehensive loss during the three months ended March 31, 2024.

There was no milestone met during the three months ended June 30, 2024.

There was no milestone met during the three months ended September 30, 2024.

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 June 30, 2024, the Company did not have material contractual commitments with respect to these arrangements.

As of September 30, 2024, the Company did not have material contractual commitments with respect to these arrangements.

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, 2024 , the Company had not incurred any material costs as a result of such indemnifications.

As of September 30, 2024 , 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