Item 1. Financial Statements
Item 1. Financial Statements.
Olema Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(Amounts in thousands, except for share amounts)
June 30,
December 31,
2024
2023
Assets
Current assets:
Cash and cash equivalents
$
16,892
$
68,539
Marketable securities
222,212
193,268
Prepaid expenses and other current assets
3,083
4,706
Total current assets
242,187
266,513
Operating lease right-of-use assets
1,814
2,291
Other assets and long-term deposits
10,556
8,141
Total assets
$
254,557
$
276,945
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable
$
4,354
$
2,698
Operating lease liabilities, current
1,103
988
Other current liabilities
21,078
17,935
Total current liabilities
26,535
21,621
Operating lease liabilities, net of current portion
859
1,429
Total liabilities
27,394
23,050
Commitments and contingencies (Note 10)
Stockholders’ equity:
Preferred stock, $ 0.0001 par value; 10,000,000 shares authorized as of June 30, 2024 and December 31, 2023; no shares issued and outstanding as of June 30, 2024 and December 31, 2023.
—
—
Common stock, $ 0.0001 par value; 490,000,000 shares authorized as of June 30, 2024 and December 31, 2023; 57,258,367 and 55,097,118 shares issued as of June 30, 2024 and December 31, 2023, respectively; 57,246,411 and 54,992,784 shares outstanding as of June 30, 2024 and December 31, 2023, respectively.
4
4
Additional paid-in capital
594,261
559,176
Accumulated other comprehensive (loss) income
( 118
)
347
Accumulated deficit
( 366,984
)
( 305,632
)
Total stockholders’ equity
227,163
253,895
Total liabilities and stockholders’ equity
$
254,557
$
276,945
See accompanying notes to the condensed consolidated financial statements.
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Olema Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(Amounts in thousands, except for share and per share amounts)
Three Months Ended June 30,
Six Months Ended June 30,
2024
2023
2024
2023
Operating expenses:
Research and development
$
29,109
$
17,989
$
58,992
$
40,815
General and administrative
4,421
3,612
8,877
10,388
Total operating expenses
33,530
21,601
67,869
51,203
Loss from operations
( 33,530
)
( 21,601
)
( 67,869
)
( 51,203
)
Other income:
Interest income
3,108
1,550
6,460
2,855
Other income (expense)
40
( 44
)
57
( 33
)
Total other income
3,148
1,506
6,517
2,822
Net loss
$
( 30,382
)
$
( 20,095
)
$
( 61,352
)
$
( 48,381
)
Net loss per share, basic and diluted
$
( 0.54
)
$
( 0.49
)
$
( 1.10
)
$
( 1.20
)
Weighted average shares used to compute net loss per share, basic and diluted
56,282,402
40,720,294
55,928,363
40,470,041
Three Months Ended June 30,
Six Months Ended June 30,
2024
2023
2024
2023
Net loss
$
( 30,382
)
$
( 20,095
)
$
( 61,352
)
$
( 48,381
)
Other comprehensive (loss) income:
Net unrealized (loss) gain on marketable securities
( 108
)
460
( 465
)
1,295
Total comprehensive loss
$
( 30,490
)
$
( 19,635
)
$
( 61,817
)
$
( 47,086
)
See accompanying notes to the condensed consolidated financial statements.
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Olema Pharmaceuticals, Inc.
Condensed Consolidated Statements of Stockholders’ Equity (Unaudited)
(Amounts in thousands, except for share amounts)
Three Months Ended June 30, 2024
Accumulated
Additional
Other
Total
Common Stock
Paid-in
Comprehensive
Accumulated
Stockholders'
Shares
Amount
Capital
(Loss) Income
Deficit
Equity
Balances at March 31, 2024
55,867,863
$
4
$
572,926
$
( 10 )
( 336,602 )
$
236,318
Issuance of shares under at-the-market offering, net of issuance costs of $ 25
1,225,952
—
14,886
—
—
14,886
Stock-based compensation expense
—
—
5,542
—
—
5,542
Issuance of shares under the employee stock purchase plan
70,701
—
650
—
—
650
Employee stock purchase plan expense
—
—
182
—
—
182
Exercise of stock options
29,587
—
75
—
—
75
Vesting of restricted stock awards
52,308
—
—
—
—
—
Net unrealized loss on marketable securities
—
—
—
( 108 )
—
( 108 )
Net loss
—
—
—
—
( 30,382 )
( 30,382 )
Balances at June 30, 2024
57,246,411
$
4
$
594,261
$
( 118 )
( 366,984 )
$
227,163
Six Months Ended June 30, 2024
Accumulated
Additional
Other
Total
Common Stock
Paid-in
Comprehensive
Accumulated
Stockholders'
Shares
Amount
Capital
(Loss) Income
Deficit
Equity
Balances at December 31, 2023
54,992,784
$
4
$
559,176
$
347
( 305,632 )
$
253,895
Issuance of shares under at-the-market offering, net of issuance costs of $ 166
1,772,278
—
22,787
—
—
22,787
Stock-based compensation expense
—
—
10,246
—
—
10,246
Exercise of stock options
317,989
—
1,015
—
—
1,015
Issuance of shares under the employee stock purchase plan
70,701
—
650
—
—
650
Employee stock purchase plan expense
—
—
387
—
—
387
Vesting of restricted stock awards
92,659
—
—
—
—
—
Net unrealized loss on marketable securities
—
—
—
( 465 )
—
( 465 )
Net loss
—
—
—
—
( 61,352 )
( 61,352 )
Balances at June 30, 2024
57,246,411
$
4
$
594,261
$
( 118 )
( 366,984 )
$
227,163
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Olema Pharmaceuticals, Inc.
Condensed Consolidated Statements of Stockholders’ Equity (Unaudited)
(Amounts in thousands, except for share amounts)
Three Months Ended June 30, 2023
Accumulated
Additional
Other
Total
Common Stock
Paid-in
Comprehensive
Accumulated
Stockholders'
Shares
Amount
Capital
(Loss) Income
Deficit
Equity
Balances at March 31, 2023
40,438,320
$
3
$
413,213
$
( 978 )
$
( 237,263 )
$
174,975
Stock-based compensation expense
—
—
4,040
—
—
4,040
Exercise of stock options
357,312
—
1,332
—
—
1,332
Issuance of shares under the employee stock purchase plan
270,541
—
711
—
—
711
Employee stock purchase plan expense
—
—
130
—
—
130
Vesting of early exercised stock options
6,990
—
30
—
—
30
Vesting of restricted stock awards
49,319
—
—
—
—
—
Net unrealized gain on marketable securities
—
—
—
460
—
460
Net loss
—
—
—
—
( 20,095 )
( 20,095 )
Balances at June 30, 2023
41,122,482
$
3
$
419,456
$
( 518 )
( 257,358 )
$
161,583
Six Months Ended June 30, 2023
Accumulated
Additional
Other
Total
Common Stock
Paid-in
Comprehensive
Accumulated
Stockholders'
Shares
Amount
Capital
(Loss) Income
Deficit
Equity
Balances at December 31, 2022
40,287,097
$
3
$
408,333
$
( 1,813 )
$
( 208,977 )
$
197,546
Stock-based compensation expense
—
—
8,555
—
—
8,555
Exercise of stock options
452,227
—
1,552
—
—
1,552
Issuance of shares under the employee stock purchase plan
270,541
—
711
—
—
711
Employee stock purchase plan expense
—
—
245
—
—
245
Vesting of early exercised stock options
13,980
—
60
—
—
60
Vesting of restricted stock awards
98,637
—
—
—
—
—
Net unrealized gain on marketable securities
—
—
—
1,295
—
1,295
Net loss
—
—
—
—
( 48,381 )
( 48,381 )
Balances at June 30, 2023
41,122,482
$
3
$
419,456
$
( 518 )
( 257,358 )
$
161,583
See accompanying notes to the condensed consolidated financial statements.
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Olema Pharmaceuticals, Inc.
Condensed Consolidated Statements of Cash Flows
(unaudited)
(Amounts in thousands)
Six Months Ended June 30,
2024
2023
Cash flows from operating activities:
Net loss
$
( 61,352
)
$
( 48,381
)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization expense
182
199
Non-cash lease expense
575
653
Non-cash interest income on marketable securities
( 4,546
)
( 1,972
)
Loss on sale of equipment
—
8
Stock-based compensation expense, including employee stock purchase plan expense
10,633
8,800
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
1,623
413
Other assets and long-term deposits
( 2,422
)
( 133
)
Accounts payable
1,656
1,251
Other current liabilities
3,153
( 2,692
)
Operating lease liabilities
( 553
)
( 653
)
Net cash used in operating activities
( 51,051
)
( 42,507
)
Cash flows from investing activities:
Purchase of equipment
( 159
)
—
Maturities of marketable securities
133,391
126,260
Purchases of marketable securities
( 158,254
)
( 74,760
)
Net cash (used in) provided by investing activities
( 25,022
)
51,500
Cash flows from financing activities:
Issuance of shares under at-the-market offering, net of issuance costs of $ 166
22,787
—
Proceeds from exercise of stock options
989
1,552
Proceeds from issuance of common stock under employee stock purchase plan
650
711
Net cash provided by financing activities
24,426
2,263
Net (decrease) increase in cash and cash equivalents
( 51,647
)
11,256
Cash and cash equivalents at beginning of period
68,539
23,702
Cash and cash equivalents at end of period
$
16,892
$
34,958
See accompanying notes to the condensed consolidated financial statements.
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Olema Pharmaceuticals, Inc.
Notes to condensed consolidated financial statements
(Unaudited)
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 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 $ 239.1 million of cash, cash equivalents and marketable securities at June 30, 2024 , in addition to an available balance of $ 25.0 million under the Loan and Security Agreement (the "Original Loan Agreement"), dated September 5, 2023 by and between the Company, as borrower, and Silicon Valley Bank, a division of First-Citizens Bank & Trust Company (the “Bank”), as amended by the First Amendment to Loan and Security Agreement, dated June 28, 2024, by and between the Company and the Bank (the "Amendment," and the Original Loan Agreement as amended by the Amendment, the "Loan Agreement"). See Footnote 10. 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 condensed consolidated financial statements.
At-The-Market Offering
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 our common stock, having an aggregate offering price of up to $ 150.0 million (the “ATM Shares”). The sales of the 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 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.
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During the three months ended June 30, 2024 , the Company issued 1,225,952 shares of its common stock under the Sales Agreement at a weighted-average price of $ 12.39 per share for net proceeds of $ 14.9 million after deducting related issuance costs. During the six months ended June 30, 2024, the Company issued 1,772,278 shares of its common stock under the Sales Agreement at a weighted-average price of $ 13.19 for net proceeds of $ 22.8 million after deducting related issuance costs. As of June 30, 2024 , approximately $ 126.6 million remained available for issuance under the Sales Agreement.
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 interim unaudited condensed 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 interim financial reporting, and the instructions to Form 10‑Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. These condensed consolidated financial statements include the accounts of Olema Pharmaceuticals, Inc. and its wholly-owned subsidiary, Olema Oncology Australia Pty Ltd. All intercompany balances and transactions have been eliminated upon consolidation.
Unaudited Interim Financial Information
The interim condensed consolidated balance sheet as of June 30, 2024, and the statements of operations and comprehensive loss, and stockholders’ equity for the three and six months ended June 30, 2024 and 2023, and the statements of cash flows for the six months ended June 30, 2024 and 2023 are unaudited. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the annual financial statements and reflect, in the opinion of management, all adjustments of a normal and recurring nature that are necessary for the fair presentation of the Company’s condensed consolidated financial statements included in this report. The financial data and the other information disclosed in these notes to the condensed consolidated financial statements related to the three- and six-month periods are also unaudited. The results of operations presented in these unaudited condensed consolidated financial statements are not necessarily indicative of the results to be expected for the year ending December 31, 2024, or for any other future annual or interim period. The condensed consolidated balance sheet as of December 31, 2023 included herein was derived from the audited financial statements as of that date. These interim condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements included in the Company’s Form 10‑K as filed with the SEC on March 11, 2024 (the “Annual Report”).
Use of Estimates
The accompanying condensed consolidated financial statements are prepared in accordance with GAAP. The preparation of the condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the condensed consolidated financial statements and reported amounts of expenses during the reporting period. Significant areas that require management’s estimates include accruals of research and development
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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 June 30, 2024 , and December 31, 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 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
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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 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 condensed 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 condensed 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 condensed consolidated statements of operations and include personnel expenses, stock-based compensation expenses, allocated general and administrative expenses, and external costs including fees paid to consultants and contract research organizations (“CROs”) and contract manufacturing organizations (“CMOs”), in connection with non-clinical studies and clinical trials, and other related clinical trial fees, such as for investigator fees, patient screening, laboratory work, clinical trial database management, clinical trial material management and statistical compilation and analysis. Non-refundable
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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 condensed consolidated financial statements, as described in Note 10, 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.
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
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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 condensed 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.
Recent Accounting Pronouncements
There were no new accounting pronouncements that were relevant to the Company as of and for the three and six months ended June 30, 2024 .
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.
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June 30, 2024
(in thousands)
Level 1
Level 2
Level 3
Total
Financial Assets
Cash
$
2,110
$
—
$
—
$
2,110
Money market funds
10,918
—
—
10,918
Commercial paper
—
88,804
—
88,804
Corporate bonds
—
16,460
—
16,460
U.S. government treasury bills
97,853
—
—
97,853
Government-sponsored enterprise securities
—
23,088
—
23,088
Total
$
110,881
$
128,352
$
—
$
239,233
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
June 30, 2024
Gross
Gross
Amortized
Unrealized
Unrealized
Estimated
(in thousands)
Cost
Gains
Losses
Fair Value
Financial Assets
Cash and cash equivalents
$
17,021
$
—
$
—
$
17,021
Short-term marketable securities (<12 months to maturity)
201,132
15
( 121
)
201,026
Long-term marketable securities (>12 months to maturity)
21,198
19
( 31
)
21,186
Total
$
239,351
$
34
$
( 152
)
$
239,233
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.
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.
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Table of Contents
There were no marketable securities that had been in a consecutive loss position for more than 12 months as of June 30, 2024. During the three and six months ended June 30, 2024, the Company did not recognize any other-than-temporary impairment loss. As of June 30, 2024 , there was no allowance for losses on available-for-sale debt securities attributable to credit risk.
As of June 30, 2024 , all of the Company’s cash and cash equivalents consisted of cash on deposit with U.S. 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):
June 30,
December 31,
2024
2023
Prepaid clinical development costs
$
929
$
858
Interest receivable
821
673
Prepaid subscriptions and licenses
621
255
Prepaid insurance
541
1,239
Other
171
190
Reimbursable research and development costs from a collaboration partner
—
1,491
Total
$
3,083
$
4,706
5. Other Assets and Long-Term Deposits
Other assets and long-term deposits consisted of the following (in thousands):
June 30,
December 31,
2024
2023
Clinical development project deposits
$
9,110
$
6,688
Property and equipment, net
945
968
Security deposits
485
485
Other
16
—
Total
$
10,556
$
8,141
6. Accrued and Other Current Liabilities
Accrued and other current liabilities consisted of the following (in thousands):
June 30,
December 31,
2024
2023
Accrued research and development related costs
$
17,329
$
11,322
Accrued employee bonuses
2,499
5,465
Accrued professional fees
793
903
Accrued payroll related costs
396
172
Accrued taxes
61
73
Total
$
21,078
$
17,935
7. 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.
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Table of Contents
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 were 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.
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:
June 30,
June 30,
2024
2023
Risk-free interest rate
3.93
%
3.48
%
Expected term (in years)
6.03
6.08
Expected volatility
85.24
%
87.22
%
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
3,071,250
14.56
—
—
Exercised (1)
( 344,128
)
3.86
—
—
Forfeited
( 180,013
)
16.67
—
—
Outstanding as of June 30, 2024
11,217,851
$
10.19
7.91
$
37,104
Options vested and exercisable as of June 30, 2024
5,565,712
$
9.39
6.86
$
24,380
Options expected to vest as of June 30, 2024
5,652,139
$
10.97
8.93
$
12,724
(1) Exercised amount includes shares returned for taxes withheld for exercise and net transactions.
Restricted Stock Awards
The following table summarizes the restricted stock activity under the 2014 Plan during the six months ended June 30, 2024:
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 June 30, 2024
—
$
—
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Table of Contents
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. In June 2024, pursuant to the terms of the PSUs, the Compensation Committee of the Company approved an extension of the achievement of the performance goal related to the 65 % tranche of the PSUs from June 30, 2024 to December 31, 2024.
Expense recognition for PSUs commences when it is determined that attainment of the performance goal is met. During the three and six months ended June 30, 2024 , no performance goal was met, and therefore, no related stock-based compensation expense was recorded.
The following table summarizes the performance-based restricted stock activity under the 2020 plan during the six months ended June 30, 2024:
Number of Shares
Grant Date Fair Value
Outstanding as of December 31, 2023
403,000
$
3.38
Granted
—
Vested
—
Forfeited
—
Outstanding as of June 30, 2024
403,000
$
3.38
2020 Employee Stock Purchase Plan
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 $ 0.2 million and $ 0.4 million for the three and six months ended June 30, 2024, respectively.
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Table of Contents
Stock-Based Compensation Expense
Stock-based compensation expense related to awards granted under the 2014 Plan, the 2020 Plan, the ESPP and the 2022 Inducement Plan was classified in the condensed consolidated statements of operations and comprehensive loss as follows (in thousands):
Three Months Ended June 30,
Six Months Ended June 30,
2024
2023
2024
2023
Research and development
$
4,233
$
2,969
$
7,645
$
6,057
General and administrative
1,491
1,201
2,988
2,743
Total
$
5,724
$
4,170
$
10,633
$
8,800
8. 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):
Three Months Ended June 30,
Six Months Ended June 30,
2024
2023
2024
2023
Numerator:
Net loss
$
( 30,382 )
$
( 20,095 )
$
( 61,352 )
$
( 48,381 )
Denominator:
Weighted average shares used to compute net loss per share, basic and diluted
56,282,402
40,720,294
55,928,363
40,470,041
Net loss per share, basic and diluted
$
( 0.54 )
$
( 0.49 )
$
( 1.10 )
$
( 1.20 )
The potentially dilutive shares that were excluded from the calculation of diluted net loss per share because their effect would have been anti-dilutive for the periods presented are as follows:
Six Months Ended June 30,
2024
2023
Unvested restricted stock awards
—
197,274
Unvested performance-based restricted stock unit awards
403,000
710,000
Options to purchase common stock
11,217,851
9,276,718
Employee stock purchase plan contingently issuable
—
22,749
11,620,851
10,206,741
9. 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.
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The sublease was accounted for under Topic 842 and the Company recorded ROU asset and lease liability of $ 0.2 million and $ 0.2 million, respectively, in the accompanying condensed consolidated financial statements.
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 condensed consolidated financial statements.
The following table summarizes total lease expense during the three and six months ended June 30, 2024 (in thousands):
Three Months Ended June 30,
Six Months Ended June 30,
2024
2023
2024
2023
Straight-line operating lease expense
$
287
$
326
$
575
$
653
Short-term lease expense
—
53
—
106
Variable lease expense
80
10
169
20
Total operating lease expense
$
367
$
389
$
744
$
779
The following table summarizes supplemental cash flow information during the three and six months ended June 30, 2024 and 2023 (in thousands):
Three Months Ended June 30,
Six Months Ended June 30,
2024
2023
2024
2023
Cash paid for amounts included measurement of lease liabilities:
Operating cash flows from operating leases
$
293
$
327
$
553
$
653
The following table summarizes the Company’s future minimum lease payments and reconciliation of lease liabilities as of June 30, 2024 (in thousands):
Years Ending December 31,
2024 (from July 2024)
$
610
2025
1,245
2026
263
Total future minimum lease payments
2,118
Less: Interest
( 156
)
Total lease liabilities at present value
1,962
Lease liabilities, current
1,103
Lease liabilities, non-current
$
859
The following table summarizes lease term and discount rate as of June 30, 2024:
June 30,
2024
2023
Weighted-average remaining lease term (years)
1.75
2.43
Weighted-average discount rate
9.00
%
8.69
%
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10. Commitments and Contingencies
Loan Agreement
On September 5, 2023, the Company entered into the Original Loan Agreement. 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”). On June 28, 2024, the Company entered into the Amendment which amends the Original Loan Agreement in order to, among other things, (i) increase the aggregate principal amount of the Original Credit Facility from up to $ 50.0 million to up to $ 100.0 million (the "Credit Facility"), of which $ 25.0 million is currently available, an additional $ 25.0 million will become available upon the Company achieving certain milestones related to execution of a first-line pivotal Phase 3 clinical trial of palazestrant in combination with ribociclib, and an additional $ 50.0 million which may be made available upon approval of the Bank in its discretion, and (ii) extend the maturity date to July 1, 2028 (the "Maturity Date"). As of June 30, 2024, the Company had not drawn down funds under the Credit Facility.
The obligations under the Loan Agreement are secured by substantially all of the assets of the Company, subject to limited exceptions.
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
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 the 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 1”) to amended and restated clinical collaboration and supply agreement, and on March 22, 2024, the Company and Novartis entered into the amendment no. 2 (the “Novartis Amendment 2”) to 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 1, among other things, expanded our 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 and Novartis
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Amendment 2 increased the size of the ongoing Phase 1/2 clinical study testing palazestrant in combination with ribociclib by an additional 15 patients exploring 90 mg of palazestrant in combination with 600 mg of ribociclib. 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 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 condensed consolidated financial statements, with any reimbursable costs from Novartis reflected as a reduction of such expenses. As of December 31, 2023, the Company had incurred the full agreed-upon reimbursement amount. As of June 30, 2024 , there was no outstanding balance from the receivable due from Novartis.
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
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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 condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 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”).
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 condensed 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. The $ 5.0 million milestone payment related to initiation of the first IND-enabling safety study was incurred and recorded as research and development expenses in the accompanying condensed consolidated statement of operations and comprehensive loss during the three months ended March 31, 2024. There was no milestone met during the three months ended June 30, 2024.
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 June 30, 2024, the Company did not have material contractual commitments with respect to these arrangements.
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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.
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 June 30, 2024 , the Company had not incurred any material costs as a result of such indemnifications.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.