Item 7A. Quantitative and Qualitative Disclosures About Market Risk
Item 7A. Quantitative and Qualitative Disclosures About Market Risk.
Interest rate risk
We are exposed to market risks in the ordinary course of our business. These risks primarily include interest rate sensitivities. As of December 31, 2024 and 2023, we had cash, cash equivalents and marketable securities of $434.1 million and $261.8 million, respectively. We generally hold our cash in interest-bearing bank accounts and money market funds. Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates. An immediate 100 basis point change in interest rates would not have a material effect on the fair market value of our cash, cash equivalents and marketable securities.
Financial institution risk
Substantially all of our cash is held with a single financial institution. Due to its size, this financial institution represents a minimal credit risk. Cash amounts held at financial institutions are insured by the Federal Deposit Insurance Corporation up to $250,000.
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Foreign currency exchange risk
Our expenses are generally denominated in U.S. dollars. To date, we have not had any significant foreign currency transactions, and we do not have a formal hedging program with respect to foreign currency. A 10.0% increase or decrease in current exchange rates would not have a material effect on our financial results.
Effects of inflation
Inflation generally affects us by increasing our cost of labor and research and development costs. We do not believe that inflation has had a material effect on our results of operations during the periods presented.
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Item 8. Consolidated Financial Statements and Supplementary Data.
Olema Pharmaceuticals, Inc.
Index to consolidated financial statements
Page
Report of Independent Registered Public Accounting Firm (PCAOB ID No. 42 )
130
Consolidated Balance Sheets
132
Consolidated Statements of Operations and Comprehensive Loss
133
Consolidated Statements of Stockholders’ Equity
134
Consolidated Statements of Cash Flows
135
Notes to Consolidated Financial Statements
136
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Report of Independent Registered Public Accounting Firm
To the Stockholders and the Board of Directors of Olema Pharmaceuticals, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Olema Pharmaceuticals, Inc. (the Company) as of December 31, 2024 and 2023, the related consolidated statements of operations and comprehensive loss, stockholders' equity, and cash flows for each of the two years in the period ended December 31, 2024, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2024, in conformity with U.S. generally accepted accounting principles.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audit, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective or complex judgments. The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the account or disclosure to which it relates.
Clinical Trial Accrual
Description of the Matter
As discussed in Note 2 in the consolidated financial statements, the Company enters into contracts with contract research organizations (CROs) to conduct clinical services on their behalf. Judgments and estimates are required to determine the amounts accrued for estimated ongoing research and development costs. The Company analyzes the progress of the studies or clinical trials, including the phase or
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completion of activities, invoices received and contracted costs. Auditing the Company’s accrual for clinical trial costs is complex since the information necessary to estimate the accruals is accumulated from the CROs and the Company's assessment of that information is subject to variability and uncertainty. In addition, in certain circumstances, the determination of the nature and amounts of services that have been received during the reporting period requires judgment because the timing and pattern of vendor invoicing does not correspond to the level of services provided, and there may be delays in invoicing from clinical study sites and other vendors.
How We Addressed the Matter in Our Audit
To test the clinical trial accrual, our audit procedures included, among others, reading a sample of the Company’s contracts with the CROs to understand key financial and contractual terms and testing the accuracy and completeness of the underlying data used in the accrual computations. We also evaluated management’s estimates of the vendor’s progress for a sample of clinical trials by inquiring of the Company’s operations personnel overseeing the clinical trials and obtaining information directly from third party vendors regarding their estimate of costs that have been incurred through December 31, 2024. We analyzed the data underlying the accrual balance to evaluate the impact of reasonable changes in the data on the recorded amount of the clinical trial accrual. To evaluate the completeness of the accruals, we also examined subsequent invoices from the service providers and cash disbursements to the service providers, to the extent such invoices were received, or payments were made prior to the date that the consolidated financial statements were issued.
/s/ Ernst & Young LLP
We have served as the Company‘s auditor since 2020.
Iselin, New Jersey
March 18, 2025
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Olema Pharmaceuticals, Inc.
Consolidated Balance Sheets
(Amounts in thousands, except for share amounts)
December 31,
December 31,
2024
2023
Assets
Current assets:
Cash and cash equivalents
$
139,480
$
68,539
Marketable securities
294,606
193,268
Prepaid expenses and other current assets
4,387
4,706
Total current assets
438,473
266,513
Operating lease right-of-use assets
1,314
2,291
Other assets and long-term deposits
11,192
8,141
Total assets
$
450,979
$
276,945
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable
$
4,460
$
2,698
Operating lease liabilities, current
1,172
988
Other current liabilities
36,126
17,935
Total current liabilities
41,758
21,621
Operating lease liabilities, net of current portion
257
1,429
Total liabilities
42,015
23,050
Commitments and contingencies (Note 12)
Stockholders’ equity:
Preferred stock, $ 0.0001 par value; 10,000,000 shares authorized as of December 31, 2024 and December 31, 2023; no shares issued and outstanding as of December 31, 2024 and December 31, 2023.
—
—
Common stock, $ 0.0001 par value; 490,000,000 shares authorized as of December 31, 2024 and December 31, 2023; 74,312,608 and 55,097,118 shares issued as of December 31, 2024 and December 31, 2023, respectively; 74,312,608 and 54,992,784 shares outstanding as of December 31, 2024 and December 31, 2023, respectively.
6
4
Additional paid-in capital
843,921
559,176
Accumulated other comprehensive income
143
347
Accumulated deficit
( 435,106
)
( 305,632
)
Total stockholders’ equity
408,964
253,895
Total liabilities and stockholders’ equity
$
450,979
$
276,945
See accompanying notes to the consolidated financial statements.
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Olema Pharmaceuticals, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(Amounts in thousands, except for share and per share amounts)
Years Ended December 31,
2024
2023
Operating expenses:
Research and development
$
124,517
$
86,140
General and administrative
17,741
18,821
Total operating expenses
142,258
104,961
Loss from operations
( 142,258
)
( 104,961
)
Other income (expense):
Interest income
12,682
8,325
Other income (expense):
102
( 19
)
Total other income
12,784
8,306
Net loss
$
( 129,474
)
$
( 96,655
)
Net loss per share, basic and diluted
$
( 2.20
)
$
( 2.14
)
Weighted average shares used to compute net loss per share, basic and diluted
58,743,522
45,247,098
Years Ended December 31,
2024
2023
Net loss
$
( 129,474
)
$
( 96,655
)
Other comprehensive loss:
Net unrealized (loss) gain on marketable securities
( 204
)
2,160
Total comprehensive loss
$
( 129,678
)
$
( 94,495
)
See accompanying notes to the consolidated financial statements.
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Olema Pharmaceuticals, Inc.
Consolidated Statements of Stockholders’ Equity
(Amounts in thousands, except for share amounts)
Accumulated
Additional
Other
Total
Common Stock
Paid-in
Comprehensive
Accumulated
Stockholders'
Shares
Amount
Capital
(Loss) Gain
Deficit
Equity
Balances at December 31, 2022
40,287,097
$
3
$
408,333
$
( 1,813
)
( 208,977
)
$
197,546
Issuance of shares under equity private placement, net of issuance costs of $ 264
13,211,381
1
129,735
—
—
129,736
Stock-based compensation expense
—
—
16,804
—
—
16,804
Exercise of stock options
733,867
—
2,722
—
—
2,722
Issuance of shares under employee stock purchase plan
333,503
—
1,050
—
—
1,050
Employee stock purchase plan expense
—
—
452
—
—
452
Vesting of early exercised stock options
18,640
—
80
—
—
80
Vesting of performance-based restricted stock unit awards
217,000
—
—
—
—
—
Vesting of restricted stock awards
191,296
—
—
—
—
—
Net unrealized gain on marketable securities
—
—
—
2,160
—
2,160
Net loss
—
—
—
—
( 96,655
)
( 96,655
)
Balances at December 31, 2023
54,992,784
—
$
4
—
$
559,176
—
$
347
—
—
( 305,632
)
—
$
253,895
Issuance of shares and pre-funded warrants under equity private placement, net of issuance costs of $ 12,998
19,928,875
2
236,999
—
—
237,001
Issuance of shares under at-the-market offering, net of issuance costs of $ 166
1,772,278
—
22,787
—
—
22,787
Exchange of common stock shares for pre-funded warrants
( 3,420,000
)
—
—
—
—
—
Stock-based compensation expense
—
—
22,009
—
—
22,009
Exercise of stock options
430,159
—
1,518
—
—
1,518
Issuance of shares under employee stock purchase plan
112,853
—
859
—
—
859
Employee stock purchase plan expense
—
—
573
—
—
573
Vesting of performance-based restricted stock unit awards
403,000
—
—
—
—
—
Vesting of restricted stock awards
92,659
—
—
—
—
—
Net unrealized loss on marketable securities
—
—
—
( 204
)
—
( 204
)
Net loss
—
—
—
—
( 129,474
)
( 129,474
)
Balances at December 31, 2024
74,312,608
$
6
$
843,921
$
143
( 435,106
)
$
408,964
See accompanying notes to the consolidated financial statements.
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Olema Pharmaceuticals, Inc.
Consolidated Statements of Cash Flows
(Amounts in thousands)
Years Ended December 31,
2024
2023
Cash flows from operating activities:
Net loss
$
( 129,474
)
$
( 96,655
)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization expense
393
377
Loss on disposal of equipment
9
111
Non-cash lease expense
1,150
1,297
Non-cash interest income on marketable securities
( 8,175
)
( 5,524
)
Stock-based compensation expense, including employee stock purchase plan expense
22,582
17,256
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
( 429
)
694
Other assets and long-term deposits
( 2,957
)
( 5,324
)
Accounts payable
2,510
2,324
Other current liabilities
11,202
2,948
Operating lease liabilities
( 1,162
)
( 1,231
)
Net cash used in operating activities
( 104,351
)
( 83,727
)
Cash flows from investing activities:
Maturities of marketable securities
301,592
250,760
Purchases of marketable securities
( 394,959
)
( 255,625
)
Purchase of equipment
( 159
)
—
Disposal of fixed assets
—
14
Net cash used in investing activities
( 93,526
)
( 4,851
)
Cash flows from financing activities:
Proceeds from equity private placement, net of issuance costs of $ 6,498
243,501
129,736
Proceeds from at-the-market offering, net of issuance costs of $ 166
22,787
—
Proceeds from exercise of stock options
1,671
2,629
Proceeds from issuance of common stock under the ESPP plan
859
1,050
Net cash provided by financing activities
268,818
133,415
Net increase in cash and cash equivalents
70,941
44,837
Cash and cash equivalents at beginning of period
68,539
23,702
Cash and cash equivalents at end of period
$
139,480
$
68,539
Supplemental disclosure of non-cash investing and financing activities:
Issuance costs for equity private placement not paid in cash by the end of period
$
6,500
$
—
Exchange common stock shares for pre-funded warrants
$
31,054
$
—
Research and development project deposit applied against final study invoices
$
748
$
—
System implementation cost included in other current liabilities
$
( 337
)
$
—
See accompanying notes to the consolidated financial statements.
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Olema Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
1. Nature of the Business and Basis of Presentation
Olema Pharmaceuticals, Inc. (“Olema” or the “Company”) is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of next-generation targeted therapies for women’s cancers. The Company is advancing a pipeline of novel therapies by leveraging its deep understanding of endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance. The Company's wholly-owned, lead product candidate, palazestrant (OP-1250), is a novel, orally-available small molecule with dual activity as both a complete estrogen receptor ("ER") antagonist ("CERAN") and selective ER degrader ("SERD"). In addition to its lead product candidate, Olema is developing a potent KAT6 inhibitor (OP-3136).
The Company is located in San Francisco, California and was incorporated in Delaware on August 7, 2006, under the legal name of CombiThera, Inc. and on March 25, 2009, was renamed Olema Pharmaceuticals, Inc. The Company’s principal operations are based in San Francisco, California, and it 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 late-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 discussed in further detail below, the ability to secure additional capital to fund operations and commercial success of its product candidates. Palazestrant, OP-3136 and any future product candidates the Company may develop will require extensive non-clinical 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.
Liquidity
The Company had $ 434.1 million of cash, cash equivalents and marketable securities at December 31, 2024 , in addition to an available balance of $ 25.0 million under the Loan and Security Agreement dated as of September 5, 2023 (the “Original Loan Agreement”), 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 12. Commitments and Contingencies for details. Management believes that the Company’s cash, cash equivalents, marketable securities, and the amounts available under the Loan Agreement will be sufficient to fund the Company’s current operating plan for at least the next 12 months from the filing date of these consolidated financial statements.
Private Placement
On November 29, 2024, the Company entered into a securities purchase agreement for a private placement of (i) 19,928,875 shares of the Company’s common stock at a price of $ 9.08 per share and (ii) pre-funded warrants to purchase up to an aggregate of 7,604,163 shares of the Company's common stock at a price of $ 9.0799 per pre-funded warrant, which represents the per share purchase price of the Company's common stock sold in the private placement less the $ 0.0001 per share exercise price for each pre-funded warrant to selected institutional and accredited investors (the “2024 Private Placement”). The aggregate gross proceeds for the 2024 Private Placement were approximately $ 250.0 million. After deducting offering expenses related to the
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2024 Private Placement of approximately $ 6.5 million (the remaining $ 6.5 million was included in Other current liabilities in the consolidated balance sheets) , the net proceeds to the Company from the 2024 Private Placement were approximately $ 243.5 million.
On September 5, 2023, the Company entered into a stock purchase agreement for a private placement of 13,211,381 shares of our common stock, at a price of $ 9.84 per share, to selected institutional and accredited investors (the "2023 Private Placement"), resulting in gross proceeds of approximately $ 130.0 million. After deducting offering expenses related to the 2023 Private Placement of approximately $ 0.3 million, the net proceeds to the Company from the 2023 Private Placement were approximately $ 129.7 million.
At-The-Market Offering
On January 5, 2024, the Company entered into a sales agreement (the “2024 Sales Agreement”) with Cowen and Company, LLC ("Cowen and Company”) as sales agent, pursuant to which the Company may offer and sell, from time to time, shares of the Company's common stock, having an aggregate offering price of up to $ 150.0 million (the “2024 ATM Shares”). The sales of the 2024 ATM Shares will be made by any method permitted that is deemed to be an "at-the-market" equity offering as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended ("Securities Act"), including sales made directly on or through the Nasdaq Global Select Market. The Company agreed to pay Cowen and Company a commission of up to 3.0 % of the aggregate gross proceeds from any 2024 ATM Shares sold by Cowen and Company. During the year ended December 31, 2024, the Company issued 1,772,278 shares of the Company's common stock under the 2024 Sales Agreement at a weighted-average price of $ 13.19 for net proceeds of $ 22.8 million after deducting related issuance costs. As of December 31, 2024, approximately $ 126.6 million remained available for issuance under the 2024 Sales Agreement.
On January 6, 2025, the Company entered into a sales agreement (the "2025 Sales Agreement") with TD Securities (USA) LLC, ("TD Cowen") as sales agent, pursuant to which the Company may offer and sell, from time to time, shares of the Company's common stock, having an aggregate offering price of up to $ 150.0 million (the “2025 ATM Shares”). The 2025 Sales Agreement replaces the prior 2024 Sales Agreement. The sales of the 2025 ATM Shares will be made by any method permitted that is deemed to be an "at-the-market" equity offering as defined in Rule 415(a)(4) promulgated under the Securities Act, including sales made directly on or through the Nasdaq Global Select Market. The Company has agreed to pay TD Cowen a commission of up to 3.0 % of the aggregate gross proceeds from any 2025 ATM Shares sold by TD Cowen.
Impact of Geopolitical and Macroeconomic Events
Global economic and business activities continue to face widespread uncertainty related to the geopolitical and macroeconomic environment, generally, including economic uncertainty, market volatility, labor shortages, tariffs and trade tensions, the ongoing conflicts between Ukraine and Russia and in the Middle East, as well as any related political or economic responses and counter-responses or otherwise by various global actors, inflation rates and the responses by central banking authorities to control such inflation, monetary supply shifts and related financial instability. 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 geopolitical and macroeconomic factors on its results of operations, financial condition and cash flows.
2. Summary of Significant Accounting Policies
Basis of Presentation and Consolidation
The accompanying consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) and applicable rules and regulations of the Securities and Exchange Commission (the “SEC”) regarding financial reporting, and the instructions to Form 10-K and Article 10 of Regulation S-X. These consolidated financial statements include the accounts of Olema
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Pharmaceuticals, Inc. and its wholly owned subsidiary, Olema Oncology Australia Pty Ltd. All intercompany balances and transactions have been eliminated upon consolidation.
Use of Estimates
The accompanying consolidated financial statements are prepared in accordance with GAAP. The preparation of the 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 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. Actual results could differ from those estimates.
Cash and Cash Equivalents
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 December 31, 2024 and 2023 . Cash and cash equivalents consisted of cash on deposit with U.S. banks, including the Company’s bank account for its Australia subsidiary, denominated in U.S. dollars and Australian dollars and investments in interest bearing money market funds.
Marketable Securities
All marketable securities have been classified as “available-for-sale” and are carried at estimated fair value as determined based upon quoted market prices or pricing models for similar securities. Management determines the appropriate classification of its investments at the time of purchase and reevaluates such designation as of each balance sheet date. Unrealized gains and losses are excluded from net loss and are reported as a component of comprehensive loss. Realized gains and losses and declines in fair value judged to be other than temporary, if any, on available-for-sale securities are included in interest income. The cost of securities sold is based on the specific-identification method. Interest earned on marketable securities is included in interest income.
The Company periodically assesses its available-for-sale marketable securities for other-than-temporary impairment. For debt securities in an unrealized loss position, the Company first considers its intent to sell, or whether it is more likely than not that the Company will be required to sell the debt securities before recovery of their amortized cost basis. If either of these criteria are met, the amortized cost basis of such debt securities is written down to fair value through other expense.
For debt securities in an unrealized loss position that do not meet the aforementioned criteria, the Company assesses whether the decline in the fair value of such debt securities has resulted from credit losses or other factors. The Company considers the extent to which fair value is less than amortized cost, any changes to the rating of the security by a rating agency, and any adverse conditions specifically related to the securities, among other factors. If this assessment indicates that a credit loss may exist, the Company then compares the present value of cash flows expected to be collected from such securities to their amortized cost basis. If the present value of cash flows expected to be collected is less than the amortized cost basis, a credit loss exists and an allowance for credit losses is recorded through other expense, limited by the amount that the fair value is less than the amortized cost basis. Any additional impairment not recorded through an allowance for credit losses is recognized in other comprehensive loss. The Company has not recorded any impairments for its marketable securities.
Concentration of Credit Risk and Other Risks and Uncertainties
Financial instruments that potentially subject the Company to concentration of credit risk consist of cash, cash equivalents, and marketable securities. The Company invests in a variety of financial instruments and, by its
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policy, limits these financial instruments to high credit quality securities issued by the U.S. government, U.S. government-sponsored agencies and highly rated banks and corporations, subject to certain concentration limits. The Company’s cash, cash equivalents, and marketable securities are held by financial institutions in the United States that management believes are of high credit quality. Amounts on deposit with individual banking institutions may at times exceed the limits insured by the Federal Deposit Insurance Corporation (“FDIC”); however, the Company has not experienced any losses on such deposits.
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.
The Company’s product candidates require approvals from the U.S. Food and Drug Administration (“FDA”) and comparable foreign regulatory agencies prior to commercial sales in their respective jurisdictions. There can be no assurance that any product candidates will receive the necessary approvals. If the Company were denied approval, approval was delayed or the Company was unable to maintain approval for any product candidate, it could have a materially adverse impact on the Company.
Leases
Under Accounting Standards Update ("ASU") 2026-12, Leases, Topic 842, ("Topic 842"), lessees are required to recognize for all leases (with the exception of short-term leases) at the commencement date: (1) a lease liability, which is a lessee’s obligation to make lease payments arising from a lease, measured on a discounted basis; and (2) a right-of-use (“ROU”) asset, which is an asset that represents the lessee’s right to use, or control the use of, a specified asset for the lease term. Leases will be classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the consolidated statements of operations and comprehensive loss.
At the inception of an arrangement, the Company determines if an arrangement is, or contains, a lease based on the facts and circumstances present in that arrangement. Lease classification, recognition, and measurement are then determined at the lease commencement date. For arrangements that contain a lease, the Company (i) identifies lease and non-lease components, (ii) determines the consideration in the contract, (iii) determines whether the lease is an operating or finance lease; and (iv) recognizes lease ROU assets and liabilities. Lease liabilities and their corresponding ROU assets are recorded based on the present value of future lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable and as such, the Company uses the incremental borrowing rate based on the information available at the lease commencement date, which represents an internally developed rate that would be incurred to borrow, on a collateralized basis, over a similar term, an amount equal to the lease payments in a similar economic environment.
Most leases include options to renew and, or terminate the lease, which can impact the lease term. The exercise of these options is at the Company’s discretion. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise such options. For any lease modification, the Company reassesses the lease classification, remeasures the related lease liability using an updated discount rate that reflects the modified lease term, and adjusts the related ROU asset under the lease modification guidance under Topic 842.
The Company has operating leases for its research and development and office facilities. Fixed lease payments on operating leases are recognized over the expected term of the lease on a straight-line basis. Variable lease expenses that are not considered fixed are recognized as incurred. Fixed and variable lease expense on operating leases is recognized within operating expenses within our consolidated statements of operations and comprehensive loss.
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The Company elected to not apply the recognition requirements of Topic 842 to short-term leases with terms of 12 months or less. Additional information and disclosures required by Topic 842 are contained in Note 11 “Lease” in this Annual Report.
Research and Development Costs
Research and development costs are expensed as incurred. 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 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. Such amounts are recognized as an expense as the goods are delivered or the related services are performed.
Costs incurred in obtaining technology licenses that do not meet the definition of a business are charged immediately to research and development expense if the technology licensed has not reached technological feasibility and has no alternative future uses.
Reimbursements of certain costs associated with research activities performed under the agreement with Novartis Institutes for BioMedical Research, Inc. (“Novartis”) are recorded as a reduction of research and development expenses and as a receivable due from Novartis, which is recorded under prepaid expenses and other current assets in the accompanying consolidated financial statements, as described in Note 12, Commitments and Contingencies – Clinical Collaboration and Supply Agreement.
Research Contract Costs and Accruals
The Company has from time to time entered into various research and development and other agreements with commercial firms, researchers, universities and others for provisions of goods and services. These agreements are generally cancelable, and the related costs are recorded as research and development expenses as incurred.
The Company records accruals for estimated ongoing research and development costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the projects, studies or clinical trials, including the phase or completion of events, invoices received and contracted costs. Judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ materially from the Company’s estimates. The Company’s historical accrual estimates have not been materially different from the actual costs.
Internal-Use Software
The Company capitalizes certain costs incurred for the development and implementation of computer software for internal-use. These costs generally relate to the implementation of the third-party developed software for the Company's regulatory and quality purposes. The Company capitalizes these costs when it is determined that it is probable that the project will be completed and the software will be used to perform the function intended, and the preliminary project stage is completed. Capitalized internal-use software development and implementation costs are included in Other assets and long-term deposits within the consolidated balance sheets. Capitalized implementation costs are amortized on a straight-line basis over the estimated useful lives of five years . Costs related to the preliminary project stage, post-implementation, training and maintenance are expensed as incurred.
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Income Taxes
Income taxes are computed using the asset and liability approach that requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the Company’s consolidated financial statements. In estimating future tax consequences, the Company considers all expected future events other than enactment of changes in tax laws or rates. A valuation allowance is recorded, if necessary, to reduce net deferred tax assets to their realizable values if management does not believe it is more likely than not that the net deferred tax assets will be realized. As of December 31, 2024 and 2023, the Company has recorded full valuation allowance against its net deferred tax assets.
The Company had no unrecognized tax benefits for the years ended December 31, 2024 and 2023, respectively. The Company may be subject to U.S. Federal, state, and local tax examinations by tax authorities for years before 2024, which may include adjustments to carry-forward attributes (see Note 9, “Income Taxes”).
The Company’s policy is to recognize interest and penalties related to uncertain tax positions in the provision for income taxes. As of December 31, 2024 and 2023 , the Company had no accrued interest or penalties related to uncertain tax positions.
Comprehensive Loss
Comprehensive loss includes net loss and other comprehensive (loss) gain for each period presented. Other comprehensive (loss) gain represents net unrealized (loss) gain on marketable securities.
Stock-Based Compensation
Stock-based compensation cost, including grants of stock options and restricted stock awards issued under the Company’s equity incentive plans and ESPP, is measured at the grant date based on the estimated fair value of the award and is recognized as an expense on a straight-line basis over the requisite service period, which is generally the vesting period. Stock-based compensation cost for performance-based restricted stock unit awards issued under the Company’s equity incentive plan is measured at the grant date based on the estimated fair value of the award, which is based on the closing stock price on the grant date, and is recognized as an expense when the Company determines that it is probable that the performance goals will be achieved, which the Company assess on a quarterly basis. The Company recognizes stock compensation in accordance with ASC 718, Compensation — Stock Compensation (“ASC 718”). The Company’s determination of the fair value of stock options with time-based vesting on the date of grant utilizes the Black-Scholes option-pricing model. The Company estimates volatility using stock prices of peer companies and its historical data, risk-free rates using the implied yield currently available on U.S. Treasury zero-coupon issues with a remaining term equal to the expected term, and dividend yield using the Company’s expectations and historical data. The Company uses the simplified method to calculate the expected term of employee stock option grants. Under the simplified method, the expected term is estimated to be the mid-point between the vesting date and the contractual term of the option. For awards with graded vesting, in which specified tranches of the options vest on different dates, the Company uses a single weighted average expected life to value the entire award, which is equal to the average of the weighted average vesting period of the award and the contractual term of the award. Equity instruments issued to non-employees are recorded at their fair value on the grant date and without subsequent remeasurement. The amount of stock-based compensation expense recognized during a period is based on the value of the portion of the awards that are ultimately expected to vest, including awards with graded vesting. As part of the requirements of ASC 718, the Company has elected to account for forfeitures of stock option grants as they occur.
Foreign Currency Transactions
The functional currency of Olema Oncology Australia Pty Ltd, the Company’s wholly-owned subsidiary, is the U.S. dollar. 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. Income and expense elements are remeasured to U.S. dollars using the average exchange rates in effect
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during the period. Remeasurement gains and losses are recorded as other income (expense) on the consolidated statements of operations.
The Company is subject to foreign currency risk with respect to its clinical and manufacturing contracts denominated in currencies other than the U.S. dollar, predominantly the Australian dollar and the Euro. Payments on contracts denominated in foreign currencies are made at the spot rate on the day of payment. Changes in the exchange rate between billing dates and payment dates are recorded within other income (expense) on the consolidated statements of operations.
Pre-funded Warrants
The Company issued pre-funded warrants in connection with the Purchase Agreement. The Company accounts for the pre-funded warrants as a freestanding equity-linked financial instrument that met the criteria for equity classification pursuant to Accounting Standards Codification 480, Distinguishing Liabilities from Equity ("ASC 480"), and ASC 815, Derivatives and Hedging ("ASC 815"). Accordingly, the Company recorded the pre-funded warrants as a component of stockholders' equity within additional paid-in capital. The Company valued the pre-funded warrants at issuance, concluding that their sales price approximated their fair value. See Note 7 for further disclosure.
Net Loss Per Common Share
Basic net loss per common share is computed by dividing the net loss per common share by the weighted average number of common shares outstanding for the period without consideration of common stock equivalents. Diluted net loss per common share is computed by adjusting net loss to reallocate undistributed earnings based on the potential impact of dilutive securities, and by dividing the diluted net loss by the weighted average number of common shares outstanding for the period, including potential dilutive common shares. For purpose of this calculation, outstanding stock options, including unvested early exercised options, unvested restricted stock awards, unvested performance-based restricted stock unit awards and contingently issuable common stock related to the 2020 Employee Stock Purchase Plan (the “ESPP”) are considered potential dilutive common shares. Basic shares outstanding includes the weighted average effect of the Company's outstanding pre-funded warrants, the exercise of which requires little or no consideration for the delivery of shares of common stock. Since the Company was in a loss position for all periods presented, basic net loss per share is the same as diluted net loss per share for all periods as the inclusion of all potential common shares outstanding would have been anti-dilutive.
Segment Reporting
The Company's chief operating decision maker (“CODM”), the Chief Executive Officer , manages its business activities as a single operating and reportable segment at the consolidated level. Accordingly, the Company's CODM uses consolidated net loss to measure segment loss, allocate resources and assess performance. Further, the CODM reviews and utilizes functional expenses (research and development, and general and administrative) at the consolidated level to manage the Company’s operations. Other segment items included in consolidated net loss is interest income, which is reflected in the consolidated statements of operations and comprehensive loss.
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Recent Accounting Pronouncements Adopted
In August 2020, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40) , which simplifies the accounting for convertible instruments and equity-linked financial instruments in addition to amending the earnings per share ("EPS") guidance in ASC 260 to improve the consistency of the diluted EPS calculation. The standard addresses issues identified as a result of the complexity associated with applying U.S. GAAP for certain financial instruments with characteristics of liabilities and equity. The standard eliminates the current models that require separation of beneficial conversion and cash conversion features from convertible instruments and simplifies the derivative scope exception guidance pertaining to equity classification of contracts in an entity’s own equity. The standard is effective for public companies, excluding entities eligible to be smaller reporting companies, for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. For all other entities, the standard is effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. The Company adopted ASU 2020-06 as of January 1, 2024 . The adoption did not make an impact on its consolidated financial statements.
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU 2023-07”) , which requires all public entities, including public entities with a single reportable segment, to provide in interim and annual periods one or more measures of segment profit or loss used by the chief operating decision maker to allocate resources and assess performance. Additionally, the standard requires disclosures of significant segment expenses and other segment items as well as incremental qualitative disclosures. The Company adopted ASU 2023-07 effective January 1, 2024 , on a retrospective basis. The adoption of 2023-07 did not change the way that the Company identifies its reportable segments and, as a result, did not have a material impact on the Company’s segment-related disclosures. Refer to the Segment Reporting section in Note 2 "Summary of Significant Accounting Policies".
Recent Accounting Pronouncements Not Yet Adopted
In December 2023, the FASB issued a new income tax-related accounting guidance in ASU 2023-09, Improvements to Income Tax Disclosures. The standard requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid. For public business entities, the new requirements will be effective for annual periods beginning after December 15, 2024. The guidance will be applied on a prospective basis with the option to apply the standard retrospectively. Early adoption is permitted. The Company did not early adopt this guidance as of December 31, 2024. The Company does not expect the adoption of ASU 2023-09 to have a material impact on its consolidated financial statements.
3. Fair Value Measurement
The Company assesses the fair value of financial instruments based on the provisions of ASC 820, Fair Value Measurements. ASC 820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value hierarchy which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The standard describes three levels of inputs that may be used to measure fair value:
• Level 1 — Inputs are unadjusted quoted prices in active markets for identical assets or liabilities accessible to the reporting entity at the measurement date.
• Level 2 — Inputs other than quoted prices included in Level 1 that are observable for the asset or liability, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
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• 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.
December 31, 2024
(in thousands)
Level 1
Level 2
Level 3
Total
Financial Assets
Cash
$
6,489
$
—
$
—
$
6,489
Money market funds
118,955
—
—
118,955
Commercial paper
—
109,432
—
109,432
Corporate bonds
43,409
—
43,409
U.S. government treasury bills
144,741
—
—
144,741
Government-sponsored enterprise securities
—
11,714
—
11,714
Total
$
270,185
$
164,555
$
—
$
434,740
December 31, 2024
Gross
Gross
Amortized
Unrealized
Unrealized
Estimated
(in thousands)
Cost
Gains
Losses
Fair Value
Financial Assets
Cash and cash equivalents
$
142,706
$
4
$
—
$
142,710
Short-term marketable securities (<12 months to maturity)
219,062
185
( 57
)
219,190
Long-term marketable securities (>12 months to maturity)
72,829
53
( 42
)
72,840
Total
$
434,597
$
242
$
( 99
)
$
434,740
December 31, 2023
(in thousands)
Level 1
Level 2
Level 3
Total
Financial Assets
Cash
$
3,570
$
—
$
—
$
3,570
Money market funds
59,280
—
—
59,280
Commercial paper
—
105,017
—
105,017
Corporate bonds
—
12,627
—
12,627
U.S. government treasury bills
60,012
—
—
60,012
Government-sponsored enterprise securities
—
21,606
—
21,606
Total
$
122,862
$
139,250
$
—
$
262,112
December 31, 2023
Gross
Gross
Amortized
Unrealized
Unrealized
Estimated
(in thousands)
Cost
Gains
Losses
Fair Value
Financial Assets
Cash and cash equivalents
$
68,844
$
—
$
—
$
68,844
Short-term marketable securities (<12 months to maturity)
169,966
176
( 8
)
170,134
Long-term marketable securities (>12 months to maturity)
22,955
179
—
23,134
Total
$
261,765
$
355
$
( 8
)
$
262,112
The Company considers its marketable securities with maturities beyond one year as current assets, based on their highly liquid nature and because such marketable securities represent the investment of cash that is available for current operations. The Company considers its investment portfolio of marketable securities to be available-for-sale.
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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 were no marketable securities that have been in a consecutive loss position for more than 12 months as of December 31, 2024. During the year ended December 31, 2024, the Company did not recognize any other-than-temporary impairment loss. As of December 31, 2024 , there was no allowance for losses on available-for-sale debt securities attributable to credit risk.
As of December 31, 2024 , all of the Company’s cash and cash equivalents consisted of cash on deposit with U.S. banks denominated in U. S. dollars and Australian dollars.
4. Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following (in thousands):
December 31,
December 31,
2024
2023
Interest receivable
$
2,120
$
673
Prepaid insurance
1,033
1,239
Prepaid subscriptions and licenses
728
255
Prepaid clinical development costs
140
858
Other
366
190
Reimbursable research and development costs from a collaboration partner
—
1,491
Total
$
4,387
$
4,706
5. Other Assets and Long-Term Deposits
Other assets and long-term deposits consisted of the following (in thousands):
December 31,
December 31,
2024
2023
Clinical development project deposits
$
9,263
$
6,688
Property and equipment, net
746
968
System implementation costs
683
—
Security deposits
485
485
Other
15
—
Total
$
11,192
$
8,141
6. Other Current Liabilities
Other current liabilities consisted of the following (in thousands):
December 31,
December 31,
2024
2023
Accrued research and development related costs
$
22,768
$
11,322
Accrued professional fees
7,545
903
Accrued employee bonuses
5,661
5,465
Accrued payroll related costs
111
172
Accrued taxes
41
73
Total
$
36,126
$
17,935
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7. Common Stock
As of each of the balance sheet dates below, the Company had reserved shares of common stock for issuance in connection with the following:
December 31,
December 31,
2024
2023
Options outstanding under the 2014 Stock Plan
1,875,140
1,875,140
Options outstanding under the 2020 Equity Incentive Plan
7,786,735
5,669,961
Options outstanding under the 2022 Inducement Plan
1,691,182
1,125,641
Shares available for future grant under the 2020 Equity Incentive Plan and the 2022 Inducement Plan
2,056,300
2,497,813
Shares available for the 2020 Employee Stock Purchase Plan
1,122,615
684,497
Unvested performance-based restricted stock unit awards outstanding under the 2020 Equity Incentive Plan
—
403,000
Unvested restricted stock awards outstanding under the 2014 Stock Plan
—
80,703
Shares available for issuance related to pre-funded warrants
11,024,163
—
25,556,135
12,336,755
Pre-Funded Warrants
In December 2024, the Company issued pre-funded warrants to purchase up to 7,604,163 shares of the Company's common stock in the 2024 Private Placement at $ 9.07998 per share of the common stock, less the $ 0.0001 per share exercise price of each warrant. Also, in December 2024, the Company issued pre-funded warrants to purchase up to 3,420,000 shares of the Company's common stock in exchange of 3,420,000 shares of the Company's common stock previously held by investors. The warrants were recorded as a component of stockholders’ equity within additional paid-in capital and have no expiration date.
8. Stock-Based Compensation
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). 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.
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 initially issuable under the 2020 Plan was a number not to 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 date on which the 2020 Plan became effective, terminated or expired prior to exercise or settlement; were not issued because the award was settled in cash; were forfeited because of the failure to vest; or were 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
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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 Board no later than December 31 of the immediately preceding year.
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. 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. Stock options and stock appreciation rights granted under the plans generally expire ten years after the date of grant.
Stock Option Valuation
The fair value of stock option grants is estimated using the Black-Scholes option-pricing model. The Company lacks company-specific historical and implied volatility information. Therefore, it estimated its expected stock volatility based on the historical volatility of a publicly traded set of peer companies in addition to its own historical volatility. For options with service-based vesting conditions, the expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The expected term of stock options granted to non-employees is equal to the contractual term of the option award. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is 0 % since the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future.
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:
December 31,
December 31,
2024
2023
Risk-free interest rate
3.91
%
3.64
%
Expected term (in years)
6.03
6.02
Expected volatility
85.00
%
86.35
%
Expected dividend yield
—
—
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Stock Option Activity
The following table summarizes the stock option activity under the 2014 Plan, the 2020 Plan and the 2022 Inducement Plan:
Weighted
Weighted
Average
Average
Remaining
Aggregate
Number of
Exercise
Contractual
Intrinsic
Shares
Price
Term
Value
(in years)
(in thousands)
Outstanding as of December 31, 2023
8,670,742
$
8.52
7.60
$
61,749
Granted
3,478,850
14.21
—
—
Exercised (1)
( 460,744
)
4.09
—
—
Forfeited
( 335,791
)
14.17
—
—
Outstanding as of December 31, 2024
11,353,057
$
10.28
6.37
$
7,519
Options vested and exercisable as of December 31, 2024
6,376,793
$
9.41
5.05
$
5,958
Options expected to vest as of December 31, 2024
4,976,264
$
11.40
8.05
$
1,561
(1) Exercised amount includes shares returned for taxes withheld for exercise and net transactions.
The weighted-average grant-date fair value per share of options granted during the years ended December 31, 2024 and 2023 was $ 10.40 and $ 4.37 , respectively. For the years ended December 31, 2024 and 2023 , there were 2,213,715 and 2,329,483 shares vested, respectively. The weighted-average grant date fair value per share of options vested during the years ended December 31, 2024 and 2023 was $ 6.58 and $ 6.97 , respectively. The total fair value of options vested during the years ended December 31, 2024 and 2023 was $ 14.6 million and $ 16.2 million, respectively. The aggregate intrinsic value of options exercised during the years ended December 31, 2024 and 2023 was $ 3.3 million and $ 3.5 million, respectively.
As of December 31, 2024 , the total unrecognized compensation expense related to unvested options was $ 34.5 million, which the Company expects to recognize over an estimated weighted average period of 2.61 years.
Restricted Stock Awards
The following table summarizes the restricted stock awards (the RSAs) activity under the 2014 Plan during the year ended December 31, 2024:
Number of Shares
Grant Date Fair Value
Unvested restricted stock as of December 31, 2023
92,659
$
2.40
Granted
—
Vested
( 92,659
)
2.40
Forfeited
—
Unvested restricted stock as of December 31, 2024
—
$
—
The total grant date fair value of the RSAs vested during the year ended December 31, 2024, was $ 0.2 million. As of December 31, 2024, the was no unrecognized compensation expense related to the RSAs. The Company recorded s tock-based compensation expense of $ 0.2 million related to the vested shares of restricted stock awards for the year ended December 31, 2024.
Performance-Based Restricted Stock Unit Awards
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In November 2022, the Company granted to certain employees 710,000 shares of performance-based restricted stock unit awards (the PSUs) under the 2020 Plan as consideration for services subject to performance conditions with a fair value based on the closing price of the underlying common stock on the date of grant. 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. As of December 31, 2024, the performance goal related to the 65 % tranche of the PSUs was met and related stock-based compensation expense of $ 1.4 million was recorded. As of December 31, 2023, the performance goal related to the 35 % tranche of the PSUs was met and related stock-based compensation expense of $ 0.7 million was recorded.
The following table summarizes the performance-based restricted stock activity under the 2020 plan during the year ended December 31, 2024:
Number of Shares
Grant Date Fair Value
Unvested performance-based restricted stock as of December 31, 2023
403,000
$
3.38
Granted
—
Vested
( 403,000
)
3.38
Forfeited
—
—
Unvested performance-based restricted stock as of December 31, 2024
—
$
—
2020 Employee Stock Purchase Plan (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. The price of the common stock purchased under the ESPP is equal to the lesser of (i) 85 % of the fair market value of a share of the Company’s common stock on the first day of an offering; 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 Board in the offering. A total of 430,416 shares of common stock were initially reserved for issuance pursuant to the ESPP. Subsequently, the number of shares of the Company’s common stock reserved for issuance under the ESPP automatically increases on January 1 of each year for a period of up to ten years , commencing on January 1, 2021 and continuing through January 1, 2030, in amount equal to the lesser of (i) 1 % of the total number of shares of the Company’s common stock outstanding on December 31 of the preceding calendar year, (ii) 860,832 shares of common stock, or (iii) a lesser number of shares determined by the Board no later than December 31 of the preceding calendar year.
The ESPP is a compensatory plan as defined by the authoritative guidance for stock-based compensation. 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 $ 0.6 million and $ 0.5 million for the years ended December 31, 2024 and 2023, respectively.
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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 consolidated statements of operations and comprehensive loss as follows (in thousands):
Years Ended December 31,
2024
2023
Research and development
$
16,543
$
11,769
General and administrative
6,039
5,487
Total
$
22,582
$
17,256
9. Income Taxes
The reconciliation of the Federal statutory income tax (provision) benefit to the Company’s effective income tax provision is as follows (in thousands):
Years Ended December 31,
2024
2023
Federal statutory income tax
$
27,309
$
20,060
State income taxes, net of federal tax benefit
8,550
6,133
Foreign research and development tax credit
2,210
1,411
Permanent differences in non-tax-deductible executive compensation
( 3,348
)
( 2,842
)
Permanent differences in foreign jurisdiction
( 1,650
)
( 1,013
)
Permanent differences others
( 469
)
323
Other deferred items
351
750
Rate changes
( 90
)
( 63
)
Valuation allowance
( 32,865
)
( 24,761
)
Net expense for income taxes
$
( 2
)
$
( 2
)
Deferred income taxes reflect the net tax effects of loss and credit carryforwards and temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. The Company’s deferred income tax assets and liabilities at December 31, 2024 and 2023 comprised the following (in thousands):
As of December 31,
2024
2023
Deferred tax assets:
Net operating loss carryforwards
$
60,600
$
44,705
Capitalized research and development
35,639
20,562
Equity compensation
6,963
5,105
Lease Liability
405
682
Other
1,482
1,452
Total deferred tax assets
$
105,089
$
72,506
Deferred tax liabilities:
Fixed assets
$
( 215
)
$
( 281
)
Right-of-use assets
( 372
)
$
( 646
)
Total deferred tax liabilities
( 587
)
( 927
)
Valuation allowance
( 104,502
)
( 71,579
)
Net deferred tax assets
$
—
$
—
In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax
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assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income and tax planning strategies in making this assessment. Based on the level of historical operating results and the uncertainty of the economic conditions, the Company has recorded a valuation allowance of $ 104.5 million and $ 71.6 million at December 31, 2024 and 2023, respectively. The change in the valuation allowance for the year end December 31, 2024 was an increase of $ 32.9 million.
At December 31, 2024 and 2023, the Company had Federal net operating losses (NOLs) of approximately $ 190.2 million and $ 150.8 million, and state NOLs of $ 296.7 million and $ 187.0 million, respectively. As a result of the Tax Act, as modified by the CARES Act, for U.S. income tax purposes, NOLs generated in tax years beginning before January 1, 2018 can still be carried forward for up to 20 years , but net operating losses generated for tax years beginning after December 31, 2017 are carryforward indefinitely and can be used to offset taxable income, but the deductibility of such Federal NOLs may be limited to 80 % of current year taxable income for tax years beginning on or after December 31, 2024. Of the total Federal NOLs of $ 190.2 million, $ 3.3 million will begin to expire in 2032 and $ 186.9 million will not expire. The state NOL carryover of $ 296.7 million will begin to expire in 2032.
Pursuant to Internal Revenue Code (IRC) Sections 382 and 383, annual use of the Company’s net operating loss and research and development credit carryforwards may be limited in the event a cumulative change in ownership of more than 50% occurs within a three-year period. The Company has not completed an ownership change analysis pursuant to IRC Section 382. If ownership changes within the meaning of IRC Section 382 are identified as having occurred, the amount of remaining tax attribute carryforwards available to offset future taxable income and income tax expense in future years may be significantly restricted or eliminated. Further, the Company’s deferred tax assets associated with such tax attributes could be significantly reduced upon realization of an ownership change within the meaning of IRC Section 382 that has occurred or may occur in the future. Any adjustment to the Company’s tax attributes as a result of an ownership change will result in a corresponding decrease to the valuation allowance recorded against the Company’s deferred tax assets.
The Company’s valuation allowance increased during the years ended December 31, 2024 and 2023 due primarily to the generation of net operating losses, as follows (in thousands):
Years Ended December 31,
2024
2023
Valuation allowance at beginning of year
$
71,579
$
47,427
Increase recorded to provision for income taxes
32,923
24,152
Valuation allowance at end of year
$
104,502
$
71,579
The Company has not incurred any material interest or penalties as of the current reporting date with respect to income tax matters. The Company is subject to U.S. Federal and state income taxes. The Federal and state income tax returns for tax years prior to 2024 may remain open to examination as carry-forward attributes generated prior may be adjusted upon examination.
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10. Net Loss Per Common Share
Net Loss Per Common Share
Basic and diluted net loss per common share was calculated as follows (in thousands, except share and per share amounts):
Years Ended December 31,
2024
2023
Numerator:
Net loss
$
( 129,474
)
$
( 96,655
)
Denominator:
Weighted average shares used to compute net loss per share, basic and diluted*
58,743,522
45,247,098
Net loss per share, basic and diluted
$
( 2.20
)
$
( 2.14
)
* reflects the weighted average effect of the pre-funded warrants issued on December 4, 2024 for basic and diluted net loss per share.
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:
Years Ended December 31,
2024
2023
Options to purchase common stock
11,353,057
8,670,742
Unvested performance-based restricted stock units
—
403,000
Unvested restricted common stock
—
80,703
Employee stock purchase plan contingently issuable
—
13,988
11,353,057
9,168,433
11. Lease
The Company leases certain of its facilities under non-cancellable operating leases expiring at various dates through 2026.
On December 15, 2020, the Company entered into a lease agreement with Tennieh LLC to lease approximately 9,800 square feet of office and lab space in San Francisco, California (the Laboratory Lease Agreement). The Laboratory Lease Agreement is for a period of five years commencing approximately February 1, 2021 and ending January 31, 2026. 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.
On August 17, 2023, the Company entered into a sublease agreement with Dropbox, Inc. to sublease approximately 6,713 square feet of office space in San Francisco, California (the Dropbox Sublease Agreement). 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. 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 consolidated financial statements.
On August 23, 2023, the Company entered into a lease agreement with The Cambridge Redevelopment Authority to lease approximately 4,020 square feet of office space in Cambridge, Massachusetts (the Cambridge Lease Agreement). The Cambridge Lease Agreement is for a period of three years commencing on September 15, 2023 and ending September 14, 2026. According to the terms of the Cambridge Lease Agreement, the Company paid a less than $ 0.1 million security deposit and is required to pay monthly rent and
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common area charges. 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 consolidated financial statements.
The following table summarizes total lease expense during the years ended December 31, 2024 and 2023 (in thousands):
Years Ended December 31,
2024
2023
Straight-line operating lease expense
$
1,150
$
1,297
Short-term lease expense
—
164
Variable lease expense
382
140
Total operating lease expense
$
1,532
$
1,601
The following table summarizes supplemental cash flow information during the year ended December 31, 2024 and 2023 (in thousands):
Years Ended December 31,
2024
2023
Cash paid for amounts included measurement of lease liabilities:
Operating cash flows from operating leases
$
1,162
$
1,231
Supplemental noncash information on lease liability arising from obtaining a right-use-asset
—
896
The following table summarizes the Company’s future minimum lease payments and reconciliation of lease liabilities as of December 31, 2024 (in thousands):
Years Ended December 31,
2025
$
1,245
2026
263
Total future minimum lease payments
1,508
Less: Interest
( 79
)
Total lease liabilities at present value
1,429
Lease liabilities, current
1,172
Lease liabilities, non-current
$
257
The following table summarizes lease term and discount rate as of December 31, 2024 and 2023:
Years Ended December 31,
2024
2023
Weighted-average remaining lease term (years)
1.27
2.25
Weighted-average discount rate
9.00
%
9.00
%
12. Commitments and Contingencies
Clinical Trial Collaboration and Supply Agreement with Novartis
On November 29, 2024, the Company entered into a Clinical Trial Collaboration and Supply Agreement (the Novartis Pharma Agreement) with Novartis Pharma AG (Novartis). Pursuant to the Agreement, Novartis will provide the Company with ribociclib drug supply for the Company’s planned Phase 3 OPERA-02 trial of palazestrant in combination with ribociclib in ER+/HER2- frontline advanced or metastatic breast cancer (the "OPERA-02 trial").
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Under the Agreement, the Company will supply (including manufacturing, packaging and labeling) palazestrant and letrozole for the OPERA-02 trial. Novartis will manufacture and supply (including primary packaging) the Company with a specified amount of ribociclib, which amount is expected to be sufficient for the OPERA-02 trial. 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. Any inventions developed in the performance of the clinical studies for the combined therapies (other than those specific to each component study drug) are jointly owned by the parties. Except as otherwise specified below, the Novartis Pharma Agreement does not grant any right of first negotiation to participate in future clinical trials, and each party retains all rights and ability to evaluate their respective compounds in any studies or clinical trials, either as a monotherapy or in combination with any other product or compound, in any therapeutic area. The parties retain their independent rights to commercialize their respective therapies both alone and with third parties.
The Company granted Novartis a right of first negotiation with respect to (a) the grant to any person or entity any right, license or sublicense to exploit palazestrant, in any field or territory, other than to third party service providers, or (b) the sale or other transfer to any person or entity of palazestrant and any related assets (each referred to herein as an Olema Compound Transaction). If the Company desires to or does, at any time, (a) solicit or entertain any third party proposal or indication of interest with respect to an Olema Compound Transaction, or (b) negotiate (including in response to any proposal or indication of interest received by the Company), enter into or perform under, in each case, any written definitive agreement with a third party with respect to or that contemplates an Olema Compound Transaction, then the Company must provide written notice to Novartis regarding such Olema Compound Transaction, along with certain other specified information. Novartis will have 30 days after receipt of such notice to elect to enter into exclusive good faith negotiations with respect to such Olema Compound Transaction for a period of up to 120 days .
If the Company’s board of directors (or a duly authorized board committee) determines that the Company should pursue or explore a change of control of the Company or sale of all or substantially all of its assets (an Olema Change of Control), other than in response to an unsolicited bona fide acquisition proposal (a Proposed Sale), the Company must promptly notify Novartis of such determination. In the event Novartis elects to engage in negotiations with the Company in respect of such Proposed Sale, then from the date such notice is given until 45 days after the later of (a) the date on which the foregoing notice is given to Novartis, (b) the date on which Novartis is given notice that a data room has been populated as required by the Novartis Pharma Agreement, and (c) entry by the Company and Novartis into a customary nondisclosure agreement, Novartis will have the exclusive right (but no obligation) to conduct due diligence on the Company and its business and negotiate with the Company and its representatives the definitive terms and conditions of the Proposed Sale.
If the Company or its affiliates receive an unsolicited bona fide acquisition proposal from a third party, the Company must promptly notify its board of directors (or a duly authorized board committee) of the receipt thereof and request that they consider the merits of such acquisition proposal. If, after such consideration, the Company’s board of directors (or authorized committee) authorizes the Company to engage in negotiations with regard to such acquisition proposal, then the Company must notify Novartis in writing within 24 hours of receipt of such authorization. To the extent possible in light of any confidentiality obligations, such notice must include a summary of the key structural, non-financial terms of such acquisition proposal.
In the event of an Olema Compound Transaction or Olema Change of Control involving a third party other than Novartis (the first to occur, a Repayment Trigger Event), the Company must promptly pay, or procure the payment of, the Repayment Amount (as defined below) to Novartis. Notwithstanding the foregoing, if the Novartis Pharma Agreement is terminated as a result of certain patient safety issues, lack of product efficacy, regulatory issues or clinical hold issues prior to the consummation of the Olema Compound Transaction or Olema Change of Control, then the Company shall not be obligated to pay the Repayment Amount unless (a) the Olema Change of Control or Olema Compound Transaction occurs after such termination and (b) prior to the fifth anniversary of such Olema Change of Control or Olema Compound Transaction (as applicable), the Company or its affiliates (or the applicable acquirer, successor, licensee or optionholder of the Company or its affiliates) enrolls a subject in any clinical study involving the combination of palazestrant and ribociclib (the
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Olema Combination) or submits any filing with any regulatory authority relating to the Olema Combination. The “Repayment Amount” is the proportion of approximately $ 275 million that is represented by the number of units of ribociclib actually supplied to the Company under the Supply Agreement as of immediately prior to the Repayment Trigger Event as compared to the total number of units that could be supplied under the Novartis Pharma Agreement.
The foregoing rights of first negotiation, first offer and notice and repayment obligations remain in effect until the first to occur of: (a) the date that is 120 days after filing of the New Drug Application for the Olema Combination, (b) one year after any expiration or termination of the Novartis Pharma Agreement, and (c) such time as the Novartis Pharma Agreement is terminated by the Company due to Novartis’ material breach. However, in the event the Novartis Pharma Agreement is terminated due to certain patient safety issues, lack of product efficacy, regulatory issues or clinical hold issues prior to the consummation of an Olema Change of Control or Olema Compound Transaction, then the Repayment Obligation shall survive until the fifth anniversary of such Olema Change of Control or Olema Compound Transaction (as applicable) or, if payment of the Repayment Amount is required, until the next business day after the Repayment Amount has been received by Novartis.
The Novartis Pharma Agreement will terminate on the fifth anniversary of the date on which the first dose of palazestrant is administered to the first study subject. Either party may terminate the Novartis Pharma Agreement for the uncured material breach or insolvency of the other party, for failure to comply with certain anti-corruption obligations, in the event of a change of control 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 studies for the combined therapies due to the existence of a material safety issue, if the parties jointly decide that the Olema Combination is not achieving sufficiently superior levels of efficacy, if any regulatory authority action prevents a party (or the Letrozole supplier) from supplying its product, in the event of an unresolved force majeure event, or in certain circumstances for an unresolved clinical hold with respect to ribociclib, palazestrant or letrozole (or the combination of ribociclib and palazestrant or ribociclib and letrozole). In addition, Novartis may terminate the Novartis Pharma Agreement if the Company has failed to commence the OPERA-02 trial on or prior to March 31, 2026 or if the Company consummates an Olema Compound Transaction, and the Company may terminate the Novartis Pharma Agreement if the Company terminates the OPERA-02 trial other than due to a material safety issue, efficacy issue, regulatory action or upon a clinical hold.
Loan Agreement
On September 5, 2023, the Company entered into the Original Loan Agreement by and between the Company and the Bank. The Original Loan Agreement provided for a four-year senior secured credit facility in an aggregate principal amount of up to $ 50.0 million (the Original Credit Facility), of which $ 25.0 million became available upon the closing of the 2023 Private Placement, and the remaining $ 25.0 million could have been made available upon approval of the Bank in its discretion. The Original Credit Facility was to mature on August 1, 2027 (the Original Maturity Date).
On June 28, 2024, the Company entered into a First Amendment to Loan and Security Agreement (the Amendment), by and between the Company and the Bank, which amends the terms of the Original Loan Agreement (the Original Loan Agreement, as amended, the "Loan Agreement"), in order to, among other things, (i) increase the aggregate principal amount of the Original Credit Facility from up to $ 50 million to up to $ 100 million, of which $ 25 million is currently available, an additional $ 25 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 million which may be made available upon approval of the Bank (the Original Credit Facility, as amended, the Credit Facility), and (ii) extend the Original Maturity Date to July 1, 2028 . As of December 31, 2024, the Company had not drawn down from the Credit Facility.
The obligations under the Loan Agreement are secured by substantially all of the assets of the Company, subject to limited exceptions.
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During the term of the Credit Facility, interest will accrue on any outstanding balance due under the Credit Facility at a floating rate per annum equal to the higher of (i) 8.0 % and (ii) the prime rate. During an event of default, any outstanding amount under the Credit Facility will bear interest at a rate of 3.0 % in excess of the otherwise applicable rate of interest. The Company will pay certain fees with respect to the Credit Facility, including a prepayment fee on any amount advanced under the Credit Facility to the extent paid prior to the Maturity Date, a final payment fee on the amount advanced under the Credit Facility, and an unused commitment fee of 1.5 % on the portion of Credit Facility that remains undrawn as of June 30, 2025, as well as certain other fees and expenses of the Bank.
The Loan Agreement contains customary events of default, including, but not limited to, nonpayment of principal, interest, fees or other amounts; material inaccuracy of a representation or warranty; failure to perform or observe covenants; cross-defaults with certain other indebtedness; bankruptcy and insolvency events; material monetary judgment defaults; material adverse change occurs; delisting; and a material impairment in the Bank’s security interest. Upon the occurrence of an event of default (subject, in certain cases, to notice and grace periods), obligations under the Loan Agreement may be accelerated.
The Loan Agreement also contains a number of customary representations, warranties and covenants that, among other things, limit the ability of the Company to (subject to certain qualifications and exceptions): create liens and encumbrances; incur additional indebtedness; merge, dissolve, liquidate or consolidate; make acquisitions, investments, advances or loans; dispose of or transfer assets; pay dividends or make other payments in respect of its capital stock; amend certain material documents; redeem or repurchase certain debt; make payments on subordinated debt; and engage in certain transactions with affiliates.
Clinical Collaboration and Supply Agreement with Novartis
On July 22, 2020, the Company entered into a non-exclusive clinical collaboration and supply agreement with Novartis Institutes for BioMedical Research, Inc. ("Novartis"). On January 13, 2022, the Company entered into an amended and restated clinical collaboration and supply agreement with Novartis, and on October 9, 2023, the Company and Novartis entered into the amendment no. 1 (the "Novartis Amendment") to the amended and restated clinical collaboration and supply agreement (as amended, the Novartis Agreement). 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 Phase 1b/2 clinical study of palazestrant in patients with metastatic estrogen receptor-positive breast cancer. The Novartis Amendment, among other things, expanded the Company's clinical collaboration with Novartis, increasing the size of the ongoing Phase 1/2 clinical study testing palazestrant in combination with ribociclib to approximately 60 patients. The Company 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. 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 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. In accordance with an agreed budget, subject to certain thresholds, Novartis will reimburse the Company for a majority of the direct outside costs that the Company incurs related to conducting the activities under the agreed development plan in conducting the clinical trials for the combined therapies.
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
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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 palazestrant. 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 consolidated financial statements, with any reimbursable costs from Novartis reflected as a reduction of such expenses. For the years ended December 31, 2024 and 2023, costs reimbursable from Novartis were zero and $ 2.0 million, respectively. As of December 31, 2023, the receivable due from Novartis was $ 1.5 million, which is recorded under prepaid expenses and other current assets in the accompanying consolidated balance sheets. This balance was fully collected in cash during the year ended December 31, 2024.
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 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 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.
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 IBRANCE®). 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® or palazestrant. 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 consolidated statements of operations and comprehensive loss for the years ended December 31, 2024, and 2023.
License Agreement
In June 2022, the Company entered into an exclusive global license agreement with Aurigene Discovery Technologies Limited ("Aurigene") to research, develop and commercialize novel small molecule inhibitors of an undisclosed oncology target (the "Aurigene Agreement”).
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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. Aurigene is also eligible to receive mid-single digits to the low double digits royalties as percentages of product sales, if any. During the research term, the Company will contribute funding to Aurigene to facilitate Aurigene’s ongoing discovery efforts. The Company and Aurigene will jointly direct further pre-clinical work and, if successful, the Company will lead clinical development as well as regulatory and commercial activities. The Company and Aurigene jointly own collaboration compounds and rights to any inventions made during the research term.
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 $ 8.0 million upfront payment was incurred in June 2022. Costs incurred and milestones payments due to Aurigene prior to regulatory approval are recognized as research and development expenses in the period incurred. 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. 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 2024. There was no other milestone met for the year ended December 31, 2024.
Management Services Agreements
The Company conducts research and development programs internally and through third parties that include, among others, arrangements with vendors, consultants, CMOs, and CROs. The Company has contractual arrangements in the normal course of business with these parties, however, the contracts with these parties are cancelable generally on reasonable notice within one year and the Company’s obligations under these contracts are primarily based on services performed through termination dates plus certain cancelation charges, if any, as defined in each of the respective agreements. 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 December 31, 2024, 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. For all periods presented, the Company was not a party to any pending material litigation or other material legal proceedings.
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Indemnification Agreements
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 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 December 31, 2024 and 2023 , the Company had not incurred any material costs as a result of such indemnifications.
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Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
None.