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, 2023 and 2022, we had cash, cash equivalents and marketable securities of $261.8 million and $204.4 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.
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 )
125
Consolidated Balance Sheets
127
Consolidated Statements of Operations and Comprehensive Loss
128
Consolidated Statements of Stockholders’ Equity
129
Consolidated Statements of Cash Flows
130
Notes to Consolidated Financial Statements
131
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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, 2023 and 2022, 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, 2023, 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, 2023 and 2022, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2023, 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, 2023. 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 11, 2024
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Olema Pharmaceuticals, Inc.
Consolidated Balance Sheets
(Amounts in thousands, except for share amounts)
December 31,
December 31,
2023
2022
Assets
Current assets:
Cash and cash equivalents
$
68,539
$
23,702
Marketable securities
193,268
180,719
Prepaid expenses and other current assets
4,706
4,478
Total current assets
266,513
208,899
Operating lease right-of-use assets
2,291
2,495
Other assets and long-term deposits
8,141
4,251
Total assets
$
276,945
$
215,645
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable
$
2,698
$
374
Operating lease liabilities, current
988
1,015
Other current liabilities
17,935
15,160
Total current liabilities
21,621
16,549
Operating lease liabilities, net of current portion
1,429
1,550
Total liabilities
23,050
18,099
Commitments and contingencies (Note 12)
Stockholders’ equity:
Preferred stock, $ 0.0001 par value; 10,000,000 shares authorized as of December 31, 2023 and December 31, 2022; no shares issued and outstanding as of December 31, 2023 and December 31, 2022.
—
—
Common stock, $ 0.0001 par value; 490,000,000 shares authorized as of December 31, 2023 and December 31, 2022; 55,097,118 and 40,601,648 shares issued as of December 31, 2023 and December 31, 2022, respectively; 54,992,784 and 40,287,097 shares outstanding as of December 31, 2023 and December 31, 2022, respectively.
4
3
Additional paid-in capital
559,176
408,333
Accumulated other comprehensive gain (loss)
347
( 1,813
)
Accumulated deficit
( 305,632
)
( 208,977
)
Total stockholders’ equity
253,895
197,546
Total liabilities and stockholders’ equity
$
276,945
$
215,645
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,
2023
2022
Operating expenses:
Research and development
$
86,140
$
82,274
General and administrative
18,821
24,714
Total operating expenses
104,961
106,988
Loss from operations
( 104,961
)
( 106,988
)
Other income (expense):
Interest income
8,325
2,228
Other expense
( 19
)
( 27
)
Total other income
8,306
2,201
Net loss
$
( 96,655
)
$
( 104,787
)
Net loss per share, basic and diluted
$
( 2.14
)
$
( 2.62
)
Weighted average shares used to compute net loss per share, basic and diluted
45,247,098
39,995,460
Years Ended December 31,
2023
2022
Net loss
$
( 96,655
)
$
( 104,787
)
Other comprehensive loss:
Net unrealized gain (loss) on marketable securities
2,160
( 1,664
)
Total comprehensive loss
$
( 94,495
)
$
( 106,451
)
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, 2021
39,797,263
3
388,904
( 149
)
( 104,190
)
284,568
Stock-based compensation expense
—
—
18,453
—
—
18,453
Employee stock purchase plan expense
—
—
376
—
—
376
Issuance of shares under employee stock purchase plan
177,112
—
330
—
—
330
Exercise of stock options
87,490
—
146
—
—
146
Vesting of early exercised stock options
27,958
—
124
—
—
124
Vesting of restricted stock awards
197,274
—
—
—
—
—
Net unrealized loss on marketable securities
—
—
—
( 1,664
)
—
( 1,664
)
Net loss
—
—
—
—
( 104,787
)
( 104,787
)
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 restricted stock awards
191,296
—
—
—
—
—
Vesting of performance-based restricted stock unit awards
217,000
—
—
—
—
—
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
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,
2023
2022
Cash flows from operating activities:
Net loss
$
( 96,655
)
$
( 104,787
)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization expense
377
357
Loss on sale of equipment
111
—
Non-cash lease expense
1,297
1,301
Non-cash interest income on marketable securities
( 5,524
)
( 787
)
Stock-based compensation expense, including employee stock purchase plan expense
17,256
18,829
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
694
( 1,959
)
Other assets and long-term deposits
( 5,324
)
( 1,114
)
Accounts payable
2,324
351
Other current liabilities
2,948
7,018
Operating lease liabilities
( 1,231
)
( 1,274
)
Net cash used in operating activities
( 83,727
)
( 82,065
)
Cash flows from investing activities:
Purchase of equipment
—
( 363
)
Maturities of marketable securities
250,760
305,502
Purchases of marketable securities
( 255,625
)
( 213,660
)
Disposal of fixed assets
14
—
Net cash (used in) provided by investing activities
( 4,851
)
91,479
Cash flows from financing activities:
Proceeds from equity private placement, net of issuance costs of $ 264
129,736
—
Proceeds from exercise of stock options
2,629
146
Proceeds from issuance of common stock under the ESPP plan
1,050
330
Net cash provided by financing activities
133,415
476
Net increase in cash and cash equivalents
44,837
9,890
Cash and cash equivalents at beginning of period
23,702
13,812
Cash and cash equivalents at end of period
$
68,539
$
23,702
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 early-stage companies in the biopharmaceutical industry, including, but not limited to, successful discovery and development of its product candidates, development by competitors of new technological innovations, dependence on key personnel, the ability to attract and retain qualified employees, protection of proprietary technology, compliance with governmental regulations, the impact of geopolitical and macroeconomic events 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 nonclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel, and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.
Private Placement
On September 5, 2023, the Company entered into a securities purchase agreement with institutional and accredited investors for the private placement of 13,211,381 shares of the Company’s common stock (the “Private Placement”) at a price of $ 9.84 per share, resulting in gross proceeds of approximately $ 130.0 million. After deducting offering expenses related to the Private Placement of approximately $ 0.3 million, the net proceeds to the Company from the Private Placement were approximately $ 129.7 million. The Private Placement closed on September 12, 2023.
Liquidity
The Company had $ 261.8 million of cash, cash equivalents and marketable securities at December 31, 2023 , in addition to an available balance of $ 25.0 million under the Loan and Security Agreement (the “Loan Agreement”), by and between the Company, as borrower, and Silicon Valley Bank, a division of First-Citizens Bank & Trust Company (the “Bank”). 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.
On January 5, 2024, the Company entered into a sales agreement (the "Sales Agreement"), with Cowen and Company, LLC ("TD Cowen"), as sales agent, pursuant to which the Company may offer and sell, from time to time, shares of its common stock, having an aggregate offering price of up to $ 150.0 million (the "ATM Shares").
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The sales, if any, of the ATM Shares will be made by any method permitted that is deemed to be an “at-the-market” ("ATM") equity offering as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended, 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 ATM Shares sold by TD Cowen.
Impact of Geopolitical and Macroeconomic Events
Global economic and business activities continue to face widespread geopolitical and macroeconomic uncertainties, including labor shortages, inflation rates and the responses by central banking authorities to control such inflation, monetary supply shifts and related financial market risks and instability, recession risks, as well as potential disruptions from the Russia-Ukraine conflict and armed conflict between Israel and groups based in surrounding regions, all of which have resulted in volatility in the U.S. and global financial markets and which have led to, and may continue to lead to, additional disruptions to trade, commerce, pricing stability, credit availability and supply chain continuity globally. The extent of the impact of these factors on the Company’s operational and financial performance, including its ability to execute its business strategies and initiatives in the expected time frame, will depend on future developments, which are uncertain and cannot be predicted. Any continued or renewed disruption resulting from these factors could negatively impact the Company’s business. The Company continues to monitor the impact of these 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 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, 2023 and 2022 . 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
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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 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
The Company adopted Accounting Standard Update (“ASU”) 2016-12, Leases , Topic 842, (“Topic 842”) as of January 1, 2021. Under 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
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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.
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 the 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 nonclinical studies and clinical trials, and other related clinical trial fees, such as for investigator fees, patient screening, laboratory work, clinical trial database management, clinical trial material management and statistical compilation and analysis. Non-refundable prepayments for goods or services that will be used or rendered for future research and development activities are recorded as prepaid expenses and other current assets. 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
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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.
Property and Equipment
Property and equipment are stated at cost, net of accumulated depreciation. Depreciation is computed using the straight-line method over the estimated useful lives. The useful lives of equipment are as follows:
Estimated Useful Lives
Lab equipment
5 – 7 years
Computer equipment
5 years
When assets are sold or retired, the cost and related accumulated depreciation are removed from the balance sheets, with any resulting gain or loss recorded in operating expenses in the statements of operations and comprehensive loss. Costs of repairs and maintenance are expensed as incurred. Property and Equipment, net of accumulated depreciation are included in "Other assets and long-term deposits" in the accompanying consolidated balance sheets.
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, 2023 and 2022, 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, 2023 and 2022, respectively. The Company may be subject to U.S. Federal, state, and local tax examinations by tax authorities for years before 2023, 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, 2023 and 2022 , the Company had no accrued interest or penalties related to uncertain tax positions.
Comprehensive Loss
Comprehensive loss includes net loss and other comprehensive loss for each period presented. Other comprehensive loss represents net unrealized loss on marketable securities.
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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 nonemployees 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 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.
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. 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.
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Recent Accounting Pronouncements
In December 2023, the Financial Accounting Standards Board (“FASB”) issued a new income tax-related accounting guidance in Accounting Standard Update ("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, 2023 . 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.
• 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, 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
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December 31, 2022
(in thousands)
Level 1
Level 2
Level 3
Total
Financial Assets
Cash
$
7,273
$
—
$
—
$
7,273
Money market funds
16,549
—
—
16,549
Commercial paper
—
83,188
—
83,188
U.S. government treasury bills
77,025
—
—
77,025
Government-sponsored enterprise securities
—
20,507
—
20,507
Total
$
100,847
$
103,695
$
—
$
204,542
December 31, 2022
Gross
Gross
Amortized
Unrealized
Unrealized
Estimated
(in thousands)
Cost
Gains
Losses
Fair Value
Financial Assets
Cash and cash equivalents
$
23,822
$
—
$
—
$
23,822
Short-term marketable securities (<12 months to maturity)
182,533
17
( 1,830
)
180,720
Long-term marketable securities (>12 months to maturity)
—
—
—
—
Total
$
206,355
$
17
$
( 1,830
)
$
204,542
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.
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, 2023. During the year ended December 31, 2023, the Company did not recognize any other-than-temporary impairment loss. As of December 31, 2023 , there was no allowance for losses on available-for-sale debt securities attributable to credit risk.
As of December 31, 2023 , 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.
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4. Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following (in thousands):
December 31,
December 31,
2023
2022
Reimbursable research and development costs from a collaboration partner
$
1,491
$
1,387
Prepaid insurance
1,239
1,738
Prepaid clinical development costs
858
506
Interest receivable
673
319
Prepaid subscriptions and licenses
255
399
Other
190
129
Total
$
4,706
$
4,478
5. Other Assets and Long-Term Deposits
Other assets and long-term deposits consisted of the following (in thousands):
December 31,
December 31,
2023
2022
Clinical development project deposits
$
6,688
$
2,274
Property and equipment, net
968
1,480
Security deposits
485
497
Total
$
8,141
$
4,251
6. Other Current Liabilities
Other current liabilities consisted of the following (in thousands):
December 31,
December 31,
2023
2022
Accrued research and development related costs
$
11,322
$
9,105
Accrued employee bonuses
5,465
4,518
Accrued professional fees
903
1,091
Accrued payroll related costs
172
296
Accrued taxes
73
68
Early exercise of unvested stock options
—
82
Total
$
17,935
$
15,160
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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,
2023
2022
Options outstanding under the 2014 Stock Plan (1)
1,875,140
2,332,441
Options outstanding under the 2020 Equity Incentive Plan
5,669,961
5,332,617
Options outstanding under the 2022 Inducement Plan
1,125,641
719,800
Shares available for future grant under the 2020 Equity Incentive Plan and the 2022 Inducement Plan
2,497,813
1,392,584
Available for the 2020 Employee Stock Purchase Plan
684,497
1,018,000
Unvested performance-based restricted stock unit awards outstanding under the 2020 Equity Incentive Plan
403,000
710,000
Unvested restricted stock awards outstanding under the 2014 Stock Plan
80,703
295,911
12,336,755
11,801,353
(1) Balance as of December 31, 2022 includes 18,640 unvested early exercised stock options (see Note 8, “Stock-Based Compensation”).
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 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.
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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 nonemployees 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,
2023
2022
Risk-free interest rate
3.64
%
1.99
%
Expected term (in years)
6.02
6.03
Expected volatility
86.35
%
79.71
%
Expected dividend yield
—
—
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, 2022
8,384,858
$
8.59
8.30
$
262
Granted
2,569,485
5.92
—
—
Exercised(1)
( 774,099
)
3.88
—
—
Forfeited
( 1,509,502
)
6.86
—
—
Outstanding as of December 31, 2023
8,670,742
$
8.52
7.60
$
61,749
Options vested and exercisable as of December 31, 2023
4,694,809
$
9.88
6.83
$
30,976
Options expected to vest as of December 31, 2023
3,975,933
$
6.92
8.51
$
30,773
(1) Exercised amount includes vesting of early-exercised options and shares returned for taxes withheld for exercise and net transactions.
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The weighted-average grant-date fair value per share of options granted during the years ended December 31, 2023 and 2022 was $ 4.37 and $ 3.83 , respectively. For the years ended December 31, 2023 and 2022 , there were 2,329,483 and 1,670,701 shares vested, respectively. The weighted-average grant date fair value per share of options vested during the years ended December 31, 2023 and 2022 was $ 6.97 and $ 6.76 , respectively. The total fair value of options vested during the years ended December 31, 2023 and 2022 was $ 16.2 million and $ 11.3 million, respectively. The aggregate intrinsic value of options exercised during the years ended December 31, 2023 and 2022 was $ 3.5 million and $ 0.3 million, respectively.
As of December 31, 2023 , the total unrecognized compensation expense related to unvested options was $ 20.8 million, which the Company expects to recognize over an estimated weighted average period of 2.42 years.
Early Exercise of Stock Options
The terms of the 2014 Plan permit certain option holders to exercise options before their options are vested, subject to certain limitations. The early exercised options are subject to the same vesting provisions in the original stock option awards. Shares issued as a result of early exercise that have not vested are subject to repurchase by the Company upon termination of the purchaser’s employment, at the price paid by the purchaser. Such shares are not deemed to be outstanding for accounting purposes until they vest and are therefore excluded from shares outstanding and from basic and diluted net loss per share until the repurchase right lapses and the shares are no longer subject to the repurchase feature. A liability is recognized related to the cash proceeds of the unvested options and is reclassified into common stock and additional paid-in capital as the shares vest and the repurchase right lapses. All early exercised options are vested as of December 31, 2023.
Restricted Stock Awards
The following table summarizes the restricted stock activity under the 2014 Plan during the year ended December 31, 2023:
Number of Shares
Grant Date Fair Value
Unvested restricted stock as of December 31, 2022
295,911
$
2.40
Granted
—
Vested
( 191,296
)
2.40
Forfeited
( 23,912
)
2.40
Unvested restricted stock as of December 31, 2023
80,703
$
2.40
The total grant date fair value of the RSAs vested during the year ended December 31, 2023 , was $ 0.5 million. As of December 31, 2023 , the total unrecognized compensation expense related to unvested RSAs was $ 0.2 million, which the Company expects to recognize over an estimated weighted average period of 0.5 years.
Performance-Based Restricted Stock Unit Awards
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.
Expense recognition for PSUs commences when it is determined that attainment of the performance goal is met. As of December 31, 2023 , one of the performance goals was met related to the 35
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% of each PSU vesting, and therefore, the Company recorded $ 0.7 million stock-based compensation expense related to the PSUs for the year ended December 31, 2023.
The following table summarizes the performance-based restricted stock activity under the 2020 plan during the year ended December 31, 2023:
Number of Shares
Grant Date Fair Value
Unvested performance-based restricted stock as of December 31, 2022
710,000
$
3.38
Granted
—
Vested
( 217,000
)
3.38
Forfeited
( 90,000
)
3.38
Unvested performance-based restricted stock as of December 31, 2023
403,000
$
3.38
2020 Employee Stock Purchase Plan (“2020 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 $ 0.5 million and $ 0.4 million for the years ended December 31, 2023 and 2022, respectively.
Stock-Based Compensation Expense
Stock-based compensation expense related to awards granted under the 2014 Plan, the 2020 Plan, the ESPP and the 2022 Inducement Plan was classified in the consolidated statements of operations and comprehensive loss as follows (in thousands):
Years Ended December 31,
2023
2022
Research and development
$
11,769
$
12,462
General and administrative
5,487
6,367
Total
$
17,256
$
18,829
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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,
2023
2022
Federal statutory income tax
$
20,060
$
21,927
State income taxes, net of federal tax benefit
6,133
6,684
Foreign research and development tax credit
1,411
624
Permanent differences in non-tax-deductible executive compensation
( 2,842
)
( 1,952
)
Permanent differences in foreign jurisdiction
( 1,013
)
( 450
)
Permanent differences others
323
( 608
)
Other deferred items
750
( 308
)
Rate changes
( 63
)
( 28
)
Valuation allowance
( 24,761
)
( 25,890
)
Net expense for income taxes
$
( 2
)
$
( 1
)
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, 2023 and 2022 comprised the following (in thousands):
As of December 31,
2023
2022
Deferred tax assets:
Net operating loss carryforwards
$
44,705
$
27,449
Capitalized research and development
20,562
14,992
Equity compensation
5,105
4,786
Other
1,488
541
Total deferred tax assets
$
71,860
$
47,768
Deferred tax liabilities:
Fixed assets
$
( 281
)
$
( 341
)
Total deferred tax liabilities
( 281
)
( 341
)
Valuation allowance
( 71,579
)
( 47,427
)
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 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 $ 71.6 million and $ 47.4 million at December 31, 2023 and 2022, respectively. The change in the valuation allowance for the year end December 31, 2023 was an increase of $ 24.2 million.
At December 31, 2023 and 2022, the Company had Federal net operating losses (NOLs) of approximately $ 150.8 million and $ 115.0 million, and state NOLs of $ 187.0 million and $ 47.5 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 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, 2023. Of the total Federal net operating loss of $ 150.8 million,
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$ 3.3 million will begin to expire in 2032 and $ 147.5 million will not expire. The state NOL carryover of $ 187.0 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, 2023 and 2022 due primarily to the generation of net operating losses, as follows (in thousands):
Years Ended December 31,
2023
2022
Valuation allowance at beginning of year
$
47,427
$
21,068
Increase recorded to provision for income taxes
24,152
26,359
Valuation allowance at end of year
$
71,579
$
47,427
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 2023 may remain open to examination as carry-forward attributes generated prior may be adjusted upon examination.
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,
2023
2022
Numerator:
Net loss
$
( 96,655
)
$
( 104,787
)
Denominator:
Weighted average shares used to compute net loss per share, basic and diluted
45,247,098
39,995,460
Net loss per share, basic and diluted
$
( 2.14
)
$
( 2.62
)
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,
2023
2022
Unvested restricted common stock
80,703
295,911
Unvested performance-based restricted stock units
403,000
710,000
Options to purchase common stock
8,670,742
8,384,858
Employee stock purchase plan contingently issuable
13,988
79,153
9,168,433
9,469,922
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11. Lease
The Company leases certain of its facilities under non-cancellable operating leases expiring at various dates through 2026.
On June 1, 2013, the Company entered into a management services agreement with MandalMed, Inc. (the “MandalMed Services Agreement”) to have access to and use a portion of approximately 5,762 square feet of space for the use of laboratory benches, lab equipment, office space, and administrative and facilities services. The Company subsequently entered into six amendments to extend the agreement term to November 2023. As part of the sixth amendment, the Company gained access to use additional space of approximately 2,130 square feet for a three year period commencing on December 1, 2020 and ending on November 30, 2023. This lease was terminated during the fourth quarter of 2023. According to the terms of the MandalMed Services Agreement, the Company had previously paid a security deposit of less than $ 0.1 million and was required to pay monthly rent and common area charges. As of December 31, 2023, this security deposit had been returned to the Company.
On August 27, 2020, the Company entered into a lease agreement with 512 2nd Street LLC to lease approximately 3,500 square feet of office space in San Francisco, California (the “Office Space Lease Agreement”). The Office Space Lease Agreement was for a period of two years commencing on September 1, 2020 and ending August 31, 2022. In April 2022, the Company extended the Office Space Lease Agreement up to August 31, 2023 and had one year renewal option to extend the term up to August 31, 2024 . The Company decided not to exercise the one-year renewal option at the end of the lease term (i.e., August 31, 2023). According to the terms of the Office Space Lease Agreement, the Company had previously paid a $ 0.1 million security deposit and was required to pay monthly rent and common area charges. As of December 31, 2023, this security deposit had been returned to the Company.
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 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.
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The following table summarizes total lease expense during the years ended December 31, 2023 and 2022 (in thousands):
Years Ended December 31,
2023
2022
Straight-line operating lease expense
$
1,297
$
1,301
Short-term lease expense
164
49
Variable lease expense
140
248
Total operating lease expense
$
1,601
$
1,598
The following table summarizes supplemental cash flow information during the year ended December 31, 2023 and 2022 (in thousands):
Years Ended December 31,
2023
2022
Cash paid for amounts included measurement of lease liabilities:
Operating cash flows from operating leases
$
1,231
$
1,274
Supplemental noncash information on lease liability arising from obtaining a right-use-asset
896
297
The following table summarizes the Company’s future minimum lease payments and reconciliation of lease liabilities as of December 31, 2023 (in thousands):
Years Ended December 31,
2024
$
1,162
2025
1,245
2026
263
Total future minimum lease payments
2,670
Less: Interest
( 253
)
Total lease liabilities at present value
2,417
Lease liabilities, current
988
Lease liabilities, non-current
$
1,429
The following table summarizes lease term and discount rate as of December 31, 2023 and 2022:
Years Ended December 31,
2023
2022
Weighted-average remaining lease term (years)
2.25
2.73
Weighted-average discount rate
9.00
%
8.70
%
12. Commitments and Contingencies
Loan Agreement
On September 5, 2023, the Company entered into the Loan Agreement by and between the Company and the Bank. The Loan Agreement provides for a four-year senior secured credit facility in an aggregate principal amount of up to $ 50.0 million (the “Credit Facility”), of which $ 25.0 million became available upon the closing of the Private Placement, and the remaining $ 25.0 million may be made available upon approval of the Bank in its discretion. The Credit Facility will mature on August 1, 2027 (the “Maturity Date”). As of December 31, 2023, 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, 2024, 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
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, 2023 and 2022, costs reimbursable from Novartis were $ 2.0 million and $ 1.4 million, respectively. As of December 31, 2023 , the Company had incurred the full agreed-upon reimbursement amount. 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.
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, 2023, and 2022.
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 preclinical 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 and recorded as research and development expense in the accompanying consolidated statements of operations and comprehensive loss. 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. As of December 31, 2023 , it was determined that it is not probable to achieve any of the milestone targets, and therefore, the Company recorded zero expense related to the milestone for the year ended December 31, 2023.
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, 2023, 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, 2023 and 2022 , 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.