What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2025-11-10 compared with 2025-08-11 · 77 added, 79 removed, 230 unchanged (40% of the section changed)

23 unchanged sentences

Our pivotal Phase 3 clinical trial of palazestrant as a monotherapy in second/third-line ER+/HER2- MBC, OPERA-01, is ongoing.

In the second quarter of 2025, 90mg of once-daily palazestrant was selected as the dose for Part 2 of OPERA-01.

We anticipate top-line results for this trial in the second half of 2026, expect to

submit the New Drug Application in 2027, and anticipate U.S.

90mg of once-daily palazestrant has been selected as the dose for Part 2 of OPERA-01.

We anticipate top-line results for this trial in the second half of 2026, expect to submit the New Drug

Application in 2027, and anticipate U.S.

Food and Drug Administration (FDA) approval and commercial launch in late 2027.

In combination, we are currently investigating palazestrant in multiple Phase 1/2 studies with CDK4/6 inhibitors (palbociclib or ribociclib), a phosphatidylinositol-3-kinase alpha (PI3Ka) inhibitor (alpelisib), with an mTOR inhibitor (everolimus).

We presented updated results from the ongoing Phase 1b/2 study of palazestrant in combination with ribociclib in patients with ER+/HER2- advanced or metastatic breast cancer at the San Antonio Breast Cancer Symposium (SABCS) in December 2024.

In combination, we are investigating palazestrant in multiple Phase 1/2 studies with CDK4/6 inhibitors (palbociclib or ribociclib), a phosphatidylinositol-3-kinase alpha (PI3Ka) inhibitor (alpelisib), with an mTOR inhibitor (everolimus).

We have also entered into a clinical trial collaboration and supply agreement with Pfizer Inc.

(Pfizer) to evaluate the safety and combinability of palazestrant and atirmociclib, Pfizer's investigative selective CDK4 inhibitor, in patients with ER+/HER2- MBC.

We expect to initiate this Phase 1b/2 study in the fourth quarter of 2025.

We presented updated results from the ongoing Phase 1b/2 study of palazestrant in combination with ribociclib in patients with ER+/HER2- advanced or MBC at the San Antonio Breast Cancer Symposium (SABCS) in December 2024.

In March 2025, we disclosed updated median progression-free survival (mPFS) from this study at the TD Cowen 45th Annual Health Care Conference.

2 unchanged sentences

the mPFS in this population was 13.1 months.

We expect to present mature data from this trial at the European Society for Medical Oncology (ESMO) Congress in October 2025.

We believe these data will further support our thesis that palazestrant possesses key characteristics to make it a potential backbone endocrine therapy of preference for ER+/HER2- breast cancer, while also potentially providing a basis for the pivotal Phase 3 clinical trial of palazestrant in combination with ribociclib in front-line ER+/HER2- MBC, called OPERA-02.

The execution of OPERA-02 will be supported by our clinical trial collaboration and supply agreement with Novartis Pharma AG (collectively, with affiliated entities, Novartis), entered into in November 2024 (Novartis Pharma Agreement).

In October 2025, we presented updated data from this study at the European Society for Medical Oncology (ESMO) Congress.

As of the data cutoff date of July 8, 2025, in the 120 mg palazestrant dose cohort, with a median follow-up of more than 19 months, mPFS are mature.

mPFS was 15.5 months for all patients and 12.2 months for those who received prior treatment with CDK4/6i, including 9.2 months for patients with estrogen receptor 1 (ESR1) wild-type tumors and 13.8 months for patients with tumors with ESR1 mutations.

In the 90 mg palazestrant dose cohort, with a median follow-up of 10.8 months, mPFS was not reached.

Further, we have initiated patient enrollment in the pivotal Phase 3 clinical trial of 90 mg of once-daily palazestrant in combination with 600 mg of ribociclib daily in front-line ER+/HER2- MBC, called OPERA-02.

The execution of OPERA-02 is supported by our clinical trial collaboration and supply agreement with Novartis Pharma AG (collectively, with affiliated entities, Novartis), entered into in November 2024 (Novartis Pharma Agreement).

Under the terms of the Novartis Pharma Agreement, Novartis will provide Olema with ribociclib drug supply for OPERA-02.

In the second quarter of 2025, 90mg of once-daily palazestrant was selected as the dose for OPERA-02.

We expect to initiate OPERA-02 in the third quarter of 2025, anticipate top-line data in 2028, and anticipate potential approval and commercial launch in the frontline MBC setting in the U.S.

We anticipate top-line data in 2028 and anticipate potential FDA approval and commercial launch in the frontline MBC setting in the U.S.

Our second product candidate in clinical development, called OP-3136, is a novel, orally-available small molecule that potently and selectively inhibits KAT6, an epigenetic target that is dysregulated in breast and other cancers.

1 unchanged sentence

In April 2025, we presented new preclinical data at the AACR Annual Meeting demonstrating the anti-tumor activity of OP-3136 in prostate, ovarian, and non-small cell lung cancer models.

We expect initial clinical results from the OP-3136 Phase 1 study in 2026, potential additional data readout in 2027, and potential initiation of a Phase 3 clinical trial in 2028.

Based on our internal estimates, we believe that the current global market potential for OP-3136 in the second/third-line ER+/HER2- metastatic breast cancer market is approximately $5 billion.

We expect initial clinical results from the OP-3136 Phase 1 study in mid-2026, potential additional data readout in 2027, and potential initiation of a Phase 3 clinical trial in 2028.

Based on our internal estimates, we believe that the current global market potential for OP-3136 in the second/third-line ER+/HER2- MBC market is approximately $5 billion.

Since our inception, we have devoted substantially all of our resources to organizing and staffing our company, research and development activities, business planning, raising capital, establishing and maintaining our intellectual property portfolio, conducting non-clinical studies and clinical trials and providing general and administrative support for these operations.

5 unchanged sentences

We have incurred significant operating losses since the commencement of our operations.

Our net losses were $43.8 million and $30.4 million for the three months ended June 30, 2025 and 2024, respectively, and $74.2 million and $61.4 million for the six months ended June 30, 2025 and 2024, respectively.

Our net losses were $42.2 million and $34.6 million for the three months ended September 30, 2025 and 2024, respectively, and $116.4 million and $95.9 million for the nine months ended September 30, 2025 and 2024, respectively.

We expect to incur significant and increasing losses for the foreseeable future as we continue to advance our product candidates, make potential milestone payments to our licensors, and as we continue to operate as a public company.

net losses may fluctuate significantly from period to period, depending on the timing of expenditures on our research and development activities.

As of June 30, 2025, we had an accumulated deficit of $509.3 million.

Our net losses may fluctuate significantly from period to period, depending on the timing of expenditures on our research and development activities.

As of September 30, 2025, we had an accumulated deficit of $551.5 million.

Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures and general and administrative expenditures.

18 unchanged sentences

We may be unable to raise additional funds or to enter into such agreements or arrangements on favorable terms, or at all.

Our ability to raise additional funds may be adversely impacted by potential worsening global economic

conditions and volatility in, the credit and financial markets in the United States and worldwide resulting from geopolitical and macroeconomic conditions.

Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions and volatility in, the credit and financial markets in the United States and worldwide resulting from geopolitical and macroeconomic conditions.

Our failure to obtain sufficient funds on acceptable terms when needed could have a material adverse effect on our business, results of operations or financial condition, including requiring us to have to delay, reduce or eliminate our product development or future commercialization efforts.

20 unchanged sentences

• expenses related to regulatory activities, including filing fees paid to regulatory agencies;

• facility costs including rent, depreciation and maintenance expenses.

• allocated facility-related costs, which include rent, depreciation and maintenance expenses, and other operating costs.

Internal expenses include employee and personnel-related costs and expenses, including salaries, benefits and stock-based compensation expense for employees and personnel engaged in research and development functions.

We expense research and development expenses in the periods in which they are incurred.

Costs for certain activities, such as manufacturing and non-clinical studies and clinical trials, are generally recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and collaborators.

Costs for certain activities, such as manufacturing, non-clinical studies, and clinical trials, are generally recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and collaborators.

We typically use our employee, consultant and infrastructure resources across our development programs.

9 unchanged sentences

In addition, we cannot forecast whether palazestrant, OP-3136 or any other future product candidates we may develop may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.

We are also unable to predict when, if ever, we will generate revenue from our product candidates to offset these expenses.

We are also unable to predict when, if ever, we will generate revenue from our

product candidates to offset these expenses.

Our expenditures on current and future non-clinical and clinical development programs are subject to numerous uncertainties in timing and cost to completion.

19 unchanged sentences

General and administrative

General and administrative expenses consist primarily of personnel expenses, including salaries, benefits and stock-based compensation expense, for personnel in executive, finance, accounting, business development, legal, human resources, information technology (IT), and administrative functions.

General and administrative expenses consist primarily of personnel expenses, including salaries, benefits and stock-based compensation expense, for personnel in executive, finance, accounting, business development, communications, legal, human resources, information technology (IT), and administrative functions.

General and administrative expenses also include costs not otherwise included in research and development expenses, including corporate facility costs, depreciation and other expenses, which include direct or allocated expenses for rent and maintenance of facilities and insurance, and professional fees for legal, patent and consulting services.

3 unchanged sentences

Total other income consists of interest income and other income (expense).

Interest income primarily consists of interests earned from our cash equivalents and marketable securities.

Other income (expense) primarily consists of unrealized foreign currency remeasurement gain (loss) and miscellaneous income (expense) not related to operating activities.

Interest income primarily consists of interest earned from our cash equivalents and marketable securities.

Other income (expense) primarily consists of unrealized foreign currency remeasurement gain (loss), interest expense, and other miscellaneous income (expense) not related to operating activities.

Results of operations

Comparison of the three months ended June 30, 2025 and 2024

The following table summarizes our results of operations for the three months ended June 30, 2025 and 2024:

Three Months Ended June 30,

Comparison of the three months ended September 30, 2025 and 2024

The following table summarizes our results of operations for the three months ended September 30, 2025 and 2024:

Three Months Ended September 30,

(in thousands)

7 unchanged sentences

Total other income

¹ The amount for the three months ended June 30, 2025 include a one-time milestone payment to Aurigene of $10 million.

Research and development expenses

The following table summarizes our research and development expenses by functional area for the three months ended June 30, 2025 and 2024:

Three Months Ended June 30,

The following table summarizes our research and development expenses by functional area for the three months ended September 30, 2025 and 2024:

Three Months Ended September 30,

(in thousands)

CROs, CMOs and other clinical development related third-party vendor expenses

Milestone payment to Aurigene

Compensation and related benefits

2 unchanged sentences

Total research and development expenses

Research and development expenses for the three months ended June 30, 2025 were $43.9 million, compared to $29.1 million for the three months ended June 30, 2024.

The increase of $14.8 million was primarily related to (i) a one-time $10.0 million milestone payment to Aurigene, (ii) increased spending on clinical development-related activities as we continue to advance palazestrant through late-stage clinical trials, (iii) increased spending related to the advancement of OP-3136, and (iv) increased personnel-related costs due to higher headcount, partially offset by a decrease in non-cash stock-based compensation expense of $0.5million.

Research and development expenses for the three months ended September 30, 2025 were $40.0 million, compared to $33.2 million for the three months ended September 30, 2024.

The increase of $6.7 million was primarily related to (i) increased spending on clinical development-related activities as we continue to advance palazestrant through late-stage clinical trials, (ii) increased spending related to the advancement of OP-3136, and (iii) increased personnel-related costs due to higher headcount, partially offset by a decrease in non-cash stock-based compensation expense of $1.7 million mainly due to lower fair value of options granted in 2025.

General and administrative expenses

General and administrative expenses for the three months ended June 30, 2025 were $4.0 million compared to $4.4 million for the three months ended June 30, 2024.

The decrease of $0.4 million was primarily due to a decrease in non-cash stock-based compensation expense.

Other income for the three months ended June 30, 2025 was $4.1 million, compared to $3.1 million for the three months ended June 30, 2024.

General and administrative expenses for the three months ended September 30, 2025 were $5.9 million compared to $4.4 million for the three months ended September 30, 2024.

The increase of $1.5 million was primarily attributable to higher corporate-related costs and an increase in non-cash stock-based compensation expense of $0.3 million due to higher headcount, partially offset by lower fair value of options granted in 2025.

Other income for the three months ended September 30, 2025 was $3.7 million, compared to $3.1 million for the three months ended September 30, 2024.

The increase of $0.6 million was primarily due to an increase in interest income from our investments in interest-bearing money market funds and marketable securities.

Comparison of the six months ended June 30, 2025 and 2024

The following table summarizes our results of operations for the six months ended June 30, 2025 and 2024:

Six Months Ended June 30,

Comparison of the nine months ended September 30, 2025 and 2024

The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024:

Nine Months Ended September 30,

(in thousands)

6 unchanged sentences

Interest income

Other income (expense)

Total other income

¹ The amounts for the six months ended June 30, 2025 and 2024 include one-time milestone payments to Aurigene of $10 million and $5M, respectively.

¹The amounts for the nine months ended September 30, 2025 and 2024 include one-time milestone payments to Aurigene of $10,000 and $5,000, respectively.

Research and development expenses

The following table summarizes our research and development expenses by functional area for the six months ended June 30, 2025 and 2024:

Six Months Ended June 30,

The following table summarizes our research and development expenses by functional area for the nine months ended September 30, 2025 and 2024:

Nine Months Ended September 30,

(in thousands)

5 unchanged sentences

Total research and development expenses

Research and development expenses for the six months ended June 30, 2025 were $74.5 million, compared to $59.0 million for the six months ended June 30, 2024.

The increase of $15.5 million was primarily related to (i) increased spending on clinical development-related activities as we continue to advance palazestrant through late-stage clinical trials, (ii) increased spending related to the advancement of OP-3136, (iii) increased personnel-related costs due to higher headcount, and (iv) $5.0 million higher milestone payment to Aurigene, partially offset by a decrease in non-cash stock-based compensation expense of $0.6 million.

Research and development expenses for the nine months ended September 30, 2025 were $114.5 million, compared to $92.2 million for the nine months ended September 30, 2024.

The increase of $22.3 million was primarily related to (i) increased spending on clinical development-related activities as we continue to advance palazestrant through late-stage clinical trials, (ii) increased spending related to the advancement of OP-3136, (iii) $5.0 million higher milestone payment to Aurigene, and (iv) increased personnel-related costs due to higher headcount, partially offset by a decrease in non-cash stock-based compensation expense of $2.3 million mainly due to lower fair value of options granted in 2025.

General and administrative expenses

General and administrative expenses for the six months ended June 30, 2025 were $8.2 million compared to $8.9 million for the six months ended June 30, 2024.

The decrease of $0.7 million was primarily related to a decrease in non-cash stock-based compensation expense of $0.9 million, partially offset by increased spending on corporate-related costs.

Other income for the six months ended June 30, 2025 was $8.6 million, compared to $6.5 million for the six months ended June 30, 2024.

General and administrative expenses for the nine months ended September 30, 2025 were $14.1 million compared to $13.3 million for the nine months ended September 30, 2024.

The increase of $0.8 million was primarily related to higher corporate-related costs, partially offset by a decrease in non-cash stock-based compensation expense of $0.6 million due to lower fair value options granted in 2025.

Other income for the nine months ended September 30, 2025 was $12.2 million, compared to $9.6 million for the nine months ended September 30, 2024.

The increase of $2.6 million was primarily due to an increase in interest income from our investments in interest-bearing money market funds and marketable securities.

2 unchanged sentences

Since our inception, we have not generated any revenue from product sales and have incurred significant operating losses and negative cash flows from our operations.

Through June 30, 2025, we had received aggregate gross proceeds of $790.1 million from sales of our common stock, convertible preferred stock and issuance of convertible promissory notes, stock option exercises, sale of stock through the Company’s 2020 Employee Stock Purchase Plan (ESPP).

As of June 30, 2025, we had $361.9 million in cash, cash equivalents and marketable securities and accumulated deficit of $509.3 million.

We had an outstanding liability under our Credit Facility, as defined below, of $3.0 million as of June 30, 2025.

Through September 30, 2025, we had received aggregate gross proceeds of $793.2 million from sales of our common stock, convertible preferred stock and issuance of convertible promissory notes, stock option exercises, sale of stock through the Company’s 2020 Employee Stock Purchase Plan (ESPP) and borrowings under our Credit Facility, as defined below.

As of September 30, 2025, we had $329.0 million in cash, cash equivalents and marketable securities and accumulated deficit of $551.5 million.

On September 5, 2023, we entered into a loan and security agreement (the Original Loan Agreement) with Silicon Valley Bank, a division of First Citizens Bank & Trust Company (the Bank), which provided us with an aggregate principal amount of up to $50.0 million (the Original Credit Facility), of which $25.0 million became available in September 2023 (Term Loan A) upon the closing of a private placement and issuance of our common stock to selected institutional and accredited investors pursuant to a securities purchase agreement, and the remaining $25.0 million could have been made available upon approval of the Bank in its discretion.

2 unchanged sentences

On June 27, 2025, we entered into a Second Amendment to Loan and Security Agreement (the Second Amendment, and the Original Loan Agreement, as amended by the First Amendment, the Credit Facility) with the Bank, which, among other things, (i) decreased the interest rate to a floating rate equal to the greater of 6.0% or the prime rate, and (ii) extended the draw period of Term Loan A to January 15, 2026.

As of June 30, 2025, we had drawn down $3.0 million from the Credit Facility.

As of September 30, 2025, we had an outstanding liability of $3.0 million under our Credit Facility, representing the full amount drawn to date.

On November 29, 2024, we entered into a securities purchase agreement for a private placement of (i) 19,928,875 shares of our common stock at a price of $9.08 per share and (ii) pre-funded warrants to purchase up to an aggregate of 7,604,163 shares of our common stock at a price of $9.0799 per pre-funded warrant, which represents the per share purchase price of the common stock sold in the private placement less the $0.0001 per share exercise price for each pre-funded warrant to selected institutional and accredited investors (the 2024 Private Placement).

The aggregate gross proceeds for the 2024 Private Placement was approximately $250.0 million.

The aggregate gross proceeds for the 2024 Private Placement were approximately $250.0 million.

After deducting offering expenses related to the 2024 Private Placement of approximately $13.0 million, the net proceeds to us from the 2024 Private Placement were approximately $237.0 million.

1 unchanged sentence

Thereafter, on January 10, 2025, we entered into exchange agreements with certain investors pursuant to which we issued pre-funded warrants to purchase up to 6,070,000 shares of our common stock at an exercise price of $0.0001 per share, in exchange for 6,070,000 shares of our common stock previously outstanding and held by such investors.

Certain holders of pre-funded warrants (together with

such holder’s affiliates and other attribution parties) may not exercise pre-funded warrants held by them to the extent that immediately prior to or after giving effect to such exercise such holder would own more than 9.99% of our outstanding common stock immediately after exercise, which percentage may be changed at the holder’s election to a lower or higher percentage not in excess of 19.99% upon 61 days’ notice to us, subject to the terms of the pre-funded warrants.

Certain holders of pre-funded warrants (together with such holder’s affiliates and other attribution parties) may not exercise pre-funded warrants held by them to the extent that immediately prior to or after giving effect to such exercise such holder would own more than 9.99% of our outstanding common stock immediately after exercise, which percentage may be changed at the holder’s election to a lower or higher percentage not in excess of 19.99% upon 61 days’ notice to us, subject to the terms of the pre-funded warrants.

Refer to Note 12 of our notes to the condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q for further information regarding the exchange transactions.

3 unchanged sentences

During the year ended December 31, 2024, we issued 1,772,278 shares of our common stock under the 2024 Sales Agreement at a weighted-average price of $13.19 for net proceeds of $22.8 million after deducting related issuance costs.

On January 6, 2025, we entered into a sales agreement (the 2025 Sales Agreement) with TD Securities (USA) LLC, (TD Cowen) as sales agent, pursuant to which the Company may offer and sell, from time to time, shares of the Company's common stock, having an aggregate offering price of up to $150.0 million (the 2025 ATM Shares).

The 2025 Sales Agreement replaced our 2024 Sales Agreement, and no further sales may be made pursuant to the 2024 Sales Agreement.

1 unchanged sentence

We have agreed to pay TD Cowen a commission of up to 3.0% of the aggregate gross proceeds from any 2025 ATM Shares sold by TD Cowen.

There were no sales under the 2025 Sales Agreement during the six months ended June 30, 2025 and as of June 30, 2025, $150.0 million remained available for issuance under the 2025 Sales Agreement.

There were no sales under the 2025 Sales Agreement during the nine months ended September 30, 2025 and as of September 30, 2025, $150.0 million remained available for issuance under the 2025 Sales Agreement.

We expect to incur significant expenses and operating losses for the foreseeable future as we advance the clinical development of palazestrant, OP-3136 and non-clinical studies.

8 unchanged sentences

In addition, if we obtain marketing approval for our product candidates, we expect to incur significant commercialization expenses related to program sales, marketing, manufacturing and distribution to the extent that such sales, marketing and distribution are not the responsibility of potential collaborators.

Furthermore, we have incurred and expect to continue to incur additional costs associated with

operating as a public company.

Furthermore, we have incurred and expect to continue to incur additional costs associated with operating as a public company.

The amount and timing of our future funding requirements will depend on many factors, including the pace and results of our development efforts.

We expect our cash, cash equivalents, and marketable securities as of June 30, 2025, as well as the available balance under the Credit Facility, will enable us to fund our current operating plan for at least the next 12 months from the filing date of these condensed consolidated financial statements.

We expect our cash, cash equivalents, and marketable securities as of September 30, 2025, as well as the available balance under the Credit Facility, will enable us to fund our current operating plan for at least the next 12 months from the filing date of these condensed consolidated financial statements.

Refer to Notes 9, 10 and 11 of our notes to the condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q for further information regarding our material cash requirements;

other than as set forth therein, there have been no material changes outside the ordinary course of business during the three and six months ended June 30, 2025 to our commitments and contingencies disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K.

other than as set forth therein, there have been no material changes outside the ordinary course of business during the three and nine months ended September 30, 2025 to our commitments and contingencies disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K.

If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts.

17 unchanged sentences

To the extent that we raise additional capital through the sale of equity or convertible debt securities, existing stockholders’ ownership interests will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of existing stockholders.

Debt financing,

if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.

If we raise funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us.

Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.

If we raise funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us.

If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

The following table shows a summary of our cash flows for each of the periods presented:

Six Months Ended June 30,

Nine Months Ended September 30,

(in thousands)

Net cash used in operating activities

Net cash used in investing activities

Net cash provided by (used in) financing activities

Net cash provided by investing activities

Net cash (used in) provided by financing activities

Net decrease in cash and cash equivalents

Operating activities

Net cash used in operating activities during the six months ended June 30, 2025 consisted primarily of our net loss of $74.2 million, non-cash interest income on our marketable securities of $3.8 million and net decrease in operating assets and liabilities of $5.2 million, offset by non-cash charges of $9.3 million.

Net cash used in operating activities during the nine months ended September 30, 2025 consisted primarily of our net loss of $116.4 million, non-cash interest income on our marketable securities of $5.1 million and net decrease in operating assets and liabilities of $0.4 million, offset by non-cash charges of $13.6 million.

The net loss consisted primarily of $114.5 million in research and development expenses and $14.1 million in general and administrative expenses.

The non-cash charges consisted primarily of stock-based compensation expense of $13.3 million, depreciation and amortization expenses of $0.3 million, and non-cash lease expense of less than $0.1 million, net of cash payments of $0.9 million.

The net decrease in operating assets and liabilities was primarily due to (i) a decrease of $3.6 million in accounts payable, which is primarily related to timing of invoicing by vendors and related payments, (ii) an increase of other assets and long-term deposits of $1.7 million due to project deposits paid to CROs as we advance OP-3136 and prepare initiation activities for OPERA-02, and (iii) an increase in prepaid expenses and other current assets of $1.3 million.

The changes are partially offset by an increase of $1.5 million in accrued and other current liabilities.

Net cash used in operating activities during the six months ended June 30, 2024 consisted primarily of our net loss of $61.4 million and non-cash interest income on our marketable securities of $4.5 million, offset by a net increase in operating assets and liabilities of $4.0 million and non-cash charges of $10.8 million.

The net decrease in operating assets and liabilities was primarily due to (i) an increase of other assets and long-term deposits of $5.6 million due to project deposits paid to CROs as we advance OP-3136 and conduct initiation activities for OPERA-02, (ii) a decrease of $1.2 million in accounts payable, which is primarily related to timing of invoicing by vendors and related payments, and (iii) an increase in prepaid expenses and other current assets of $1.0 million.

These changes were partially offset by an increase of $7.4 million in other current liabilities, which is primarily related to increased spending on clinical development-related activities as we advanced palazestrant through late-stage clinical trials and OP-3136 program, as well as initiation activities for OPERA-02.

Net cash used in operating activities during the nine months ended September 30, 2024 consisted primarily of our net loss of $95.5 million and non-cash interest income on our marketable securities of $6.5 million, offset by non-cash charges of $16.5 million and net increase in operating assets and liabilities of $7.8 million.

The net loss consisted primarily of $92.2 million in research and development expenses and $13.3 million in general and administrative expenses.

The non-cash charges consisted primarily of stock-based compensation expense of $16.3 million, depreciation and amortization expenses of $0.3 million, and non-cash lease expense of less than $0.1 million, net of cash payments of $0.9 million.

The net increase in operating assets and liabilities was primarily due to (i) an increase of $3.2 million in accrued and other current liabilities, (ii) an increase of $1.7 million in accounts payable, and (iii) a decrease of $1.6 million in prepaid expenses and other current assets, which is primarily due to the reimbursable research and development costs received from a collaboration partner.

The changes were partially offset by an increase of $2.4 million in other assets and long-term deposits.

The net increase in operating assets and liabilities was primarily due to (i) an increase of $9.0 million in accrued and other current liabilities and (ii) a decrease of $1.5 million in prepaid expenses and other current assets, which is primarily due to the reimbursable research and development costs received from a collaboration partner.

The net increases in operating liabilities were primarily offset by an increase of $2.6 million in other assets and long-term deposits.

Investing Activities

Net cash used in investing activities during the six months ended June 30, 2025 was predominantly due to purchases of marketable securities which were partially offset by maturities of marketable securities.

Net cash used in investing activities during the six months ended June 30, 2024 was predominantly due to purchases of marketable securities which were partially offset by maturities of marketable securities.

Net cash provided by investing activities during the nine months ended September 30, 2025 was predominantly due to maturities of marketable securities which were partially offset by purchases of marketable securities.

Net cash provided by investing activities during the nine months ended September 30, 2024 was predominantly due to maturities of marketable securities which were partially offset by purchases of marketable securities.

Financing activities

Net cash used in financing activities during the six months ended June 30, 2025 was predominately due to the $6.5 million payment of issuance costs related to the 2024 Private Placement, partially offset by $3.0 million draw down under our Credit Facility, $0.7 million from the sale of our common stock under the ESPP, and $0.5 million from the exercise of stock options.

Net cash provided by financing activities during the six months ended June 30, 2024 consists of $22.8 million in net proceeds from the sale of 2024 ATM Shares, $1.0 million from the exercise of stock options, and $0.7 million from the sale of our common stock under the ESPP.

Net cash used in financing activities during the nine months ended September 30, 2025 was predominately due to the $6.5 million payment of issuance costs related to the 2024 Private Placement, partially offset by $3.0 million draw down under our Credit Facility, $0.7 million from the sale of our common stock under the ESPP, and $0.5 million from the exercise of stock options.

Net cash provided by financing activities during the nine months ended September 30, 2024 consists of $22.8 million in net proceeds from the sale of 2024 ATM Shares, $1.1 million from the exercise of stock options, and $0.7 million from the sale of our common stock under the ESPP.

Critical accounting policies and significant judgments and estimates

5 unchanged sentences

Our actual results may differ from these estimates under different assumptions or conditions.

During the three months ended June 30, 2025, there were no material changes to our critical accounting policies and estimates as reported in our Annual Report on Form 10-K.

During the three months ended September 30, 2025, there were no material changes to our critical accounting policies and estimates as reported in our Annual Report on Form 10-K.

Quantitative and Qualitative Disclosures About Market Risk.

During the three months ended June 30, 2025, there were no material changes to our market risk disclosures reported in our Annual Report on Form 10-K.

During the three months ended September 30, 2025, there were no material changes to our market risk disclosures reported in our Annual Report on Form 10-K.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis