What changed in this filing

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Item 2. Management’s Discussion and Analysis

2023-11-07 compared with 2023-08-08 · 73 added, 63 removed, 206 unchanged (40% of the section changed)

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Our lead product candidate, palazestrant (OP-1250), is a novel oral therapy with combined activity as both a complete ER antagonist, or CERAN, and a selective ER degrader, or SERD, which we believe will drive deeper, more durable responses than existing therapies.

Palazestrant, both as a monotherapy and in combination with inhibitors of cyclin-dependent kinase 4 and 6, or CDK4/6, demonstrated robust anti-tumor activity in a range of preclinical xenograft models of breast cancer, including in ESR1 and PIK3CA mutations and central nervous system, or CNS, metastasis.

Palazestrant, both as a monotherapy and in combination with inhibitors of cyclin-dependent kinase 4 and 6, or CDK4/6, demonstrated robust anti-tumor activity in a range of preclinical xenograft models of breast cancer, including in ESR1 and PIK3C a mutations and central nervous system, or CNS, metastasis.

In August 2020, we initiated an ongoing Phase 1/2 monotherapy dose escalation and expansion study evaluating palazestrant for the treatment of recurrent, locally advanced or metastatic ER-positive, or ER+, human epidermal growth factor receptor 2-negative, or HER2-, breast cancer.

We reported initial data from the Phase 1a dose escalation portion of this study in November 2021, which provided proof-of-concept for palazestrant as a monotherapy treatment for ER+/HER2- breast cancer.

We reported additional monotherapy data from the Phase 1b dose expansion portion of this study in October 2022 and initiated the Phase 2 portion of the study.

We plan to present Phase 2 clinical data for palazestrant as a monotherapy at the European Society for Medical Oncology Congress 2023 in October 2023.

We expect to initiate our proposed Phase 3 monotherapy clinical trial for the treatment of advanced or metastatic breast cancer (OPERA-01) in the fourth quarter of 2023.

In 2022, we also initiated Phase 1b/2 dose escalation and expansion studies evaluating palazestrant in combination with CDK4/6 inhibitors palbociclib and ribociclib and phosphatidylinositol 3 kinase alpha, or PI3K a,

inhibitor, alpelisib.

We reported additional monotherapy data from the Phase 1b dose expansion portion of this study in October 2022.

In October 2023 at the European Society for Medical Oncology, or ESMO, Congress 2023, we presented Phase 2 clinical data for palazestrant as a monotherapy which highlighted that:

● Across 86 heavily pretreated patients, where 42% of patients were fourth-line or later at study entry, 120 mg once-daily, monotherapy palazestrant was well tolerated and achieved a median progression-

free survival, or PFS, of 4.6 months and clinical benefit rate, or CBR, of 40%, and a median PFS of 5.6 months and CBR of 52% in patients with ESR1 mutations at baseline.

● In a subset analysis of 49 second- or third-line patients with or without prior chemotherapy, the median PFS was 7.2 months and CBR was 48% across all patients, and the median PFS was 7.3 months and CBR was 59% in ESR1-mutant patients.

We expect to enroll the first patient in our proposed Phase 3 monotherapy clinical trial for the treatment of advanced or metastatic breast cancer (OPERA-01) in the fourth quarter of 2023.

In December 2022, we reported initial data from the Phase 1a dose escalation portion of the study in combination with palbociclib which demonstrated combinability including no drug-drug interaction, or DDI, between the two agents.

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Exposure of palbociclib and palazestrant in combination with each other was consistent with observed monotherapy exposure levels.

We anticipate presenting updated results from the Phase 2 expansion portion of the palazestrant-palbociclib combination clinical study and from the Phase 1b dose escalation portion of the palazestrant-ribociclib combination clinical study in the fourth quarter of 2023.

In October 2023, we announced the expansion of our clinical collaboration with Novartis Institutes for BioMedical Research, Inc., or Novartis, increasing the size of the ongoing Phase 1/2 clinical study testing palazestrant in combination with ribociclib to approximately 60 patients.

In July 2022, we were granted Fast Track designation from the U.S.

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Our goal is to transform the standard of care for women living with cancers by developing more effective therapies that apply our deep understanding and collective expertise in endocrine-driven cancers, nuclear receptor activities and mechanisms of acquired resistance.

On March 9, 2023, we announced a corporate restructuring and portfolio prioritization to focus our resources on the late-stage clinical development of palazestrant for the treatment of ER+/HER2- metastatic breast cancer.

In October 2023, we announced a new pipeline asset, reporting new preclinical data regarding the discovery of novel compounds targeting KAT6, an epigenetic target that is dysregulated in breast and other cancers, demonstrating potent anti-tumor activity.

We are developing this asset in collaboration with Aurigene Discovery Technologies Limited, or Aurigene.

We expect to file an Investigational New Drug, or IND, application with the FDA in 2024 .

In March 2023, we announced a corporate restructuring and portfolio prioritization to focus our resources on the late-stage clinical development of palazestrant for the treatment of ER+/HER2- metastatic breast cancer.

In September 2023, we entered into a stock purchase agreement for a private placement of 13,211,381 shares of our common stock, at a price of $9.84 per share, to selected institutional and accredited investors resulting in gross proceeds of approximately $130.0 million, or the Private Placement.

We also entered into the Loan and Security Agreement, or the Loan Agreement, with Silicon Valley Bank, a division of First-Citizens Bank & Trust Company, or the Bank, providing us with up to $50.0 million of borrowing capacity, or the Credit Facility, of which $25.0 million became available upon the closing of the Private Placement on September 12, 2023, and the remaining $25.0 million may be made available upon approval of the Bank in its discretion.

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 nonclinical studies and clinical trials and providing general and administrative support for these operations.

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We believe that this strategy allows us to maintain a more efficient infrastructure by eliminating the need for us to invest in our own manufacturing facilities, equipment and personnel while also enabling us to focus our expertise and resources on the development of our product candidates.

As of June 30, 2023, we had cash, cash equivalents, and marketable securities of $167.4 million.

Based on our current operating plan, we believe that our cash, cash equivalents, and marketable securities as of June 30, 2023 will be sufficient to fund our planned operating expenses and capital expenditure requirements into the second quarter of 2025.

As of September 30, 2023, we had cash, cash equivalents, and marketable securities of $276.9 million.

We believe that our cash, cash equivalents, and marketable securities as of September 30, 2023, as well as the available balance under the Credit Facility, will be sufficient to fund our current operating plan into 2027.

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

Our net losses were $20.1 million and $32.9 million for the three months ended June 30, 2023 and 2022, respectively, and $48.4 million and $55.9 million for the six months ended June 30, 2023 and 2022, respectively.

Our net losses were $21.5 million and $22.7 million for the three months ended September 30, 2023 and 2022, respectively, and $69.9 million and $78.6 million for the nine months ended September 30, 2023 and 2022, respectively.

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

Our 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, 2023, we had an accumulated deficit of $257.4 million.

As of September 30, 2023, we had an accumulated deficit of $278.9 million.

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

Cash used to fund operating expenses is impacted

by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and other current liabilities.

Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and other current liabilities.

We expect to continue to incur net operating losses for at least the next several years, and we expect our research and development expenses, general and administrative expenses, and capital expenditures will continue to increase.

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Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials, potential milestone payments to our licensors, and our expenditures on other research and development activities.

We will require substantial additional funding to develop our product candidate and support our continuing operations.

We will require substantial additional funding to develop our product candidate and support our continuing operations beyond our current operating plans.

Until such time that we can generate significant revenue from product sales or other sources, if ever, we expect to finance our operations through the sale of equity, debt financings or other capital sources, which could include income from collaborations, strategic partnerships or marketing, distribution, licensing or other strategic arrangements with third parties, or from grants.

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 the recent disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from geopolitical

and macroeconomic events, such as the COVID-19 pandemic, the ongoing conflict between Ukraine and Russia and related sanctions, and recent bank failures.

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.

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We cannot provide assurance that we will ever be profitable or generate positive cash flow from operating activities.

Global economic and business activities continue to face widespread geopolitical and macroeconomic uncertainties, including labor shortages, inflation and monetary supply shifts, bank failures and related financial market risks and instability, recession risks, as well as potential disruptions from the Russia-Ukraine conflict, all of which have resulted in volatility in the U.S.

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, risk of a U.S.

government shutdown, 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 disruptions to trade, commerce, pricing stability, credit availability and supply chain continuity globally.

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We track outsourced development costs by product candidate or nonclinical program, but we do not allocate personnel costs, other internal costs or external consultant costs to specific product candidates or nonclinical programs.

Research and development expenses to advance the development of our lead product candidate and nonclinical program were $18.0 million and $27.1 million for the three months ended June 30, 2023 and 2022, respectively, and $40.8 million and $43.1 million for the six months ended June 30, 2023 and 2022, respectively.

Research and development expenses to advance the development of our lead product candidate and nonclinical program were $19.5 million and $17.6 million for the three months ended September 30, 2023 and 2022, respectively, and $60.3 million and $60.7 million for the nine months ended September 30, 2023 and 2022, respectively.

While our research and development expenses may fluctuate from period to period, we generally expect our research and development expenses to increase substantially in absolute dollars for the foreseeable future as we advance palazestrant or any other future product candidates we may develop into and through nonclinical studies and clinical trials and pursue regulatory approval of our product candidates.

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While our general and administrative expenses may fluctuate from period to period, we generally expect that our general and administrative expenses will increase in the foreseeable future as we increase our headcount to support the continued research and development of our programs and the growth of our business.

standards applicable to companies listed on a national securities exchange, additional insurance expenses, investor relations activities and other administrative and professional services.

We also anticipate incurring additional expenses associated with operating as a public company, including increased expenses related to the building and improving of our IT infrastructure, including cyber security monitoring, legal, other regulatory and compliance, director and officer insurance, investor and public relations and tax-related services associated with maintaining compliance with the rules and regulations of the SEC and standards applicable to companies listed on a national securities exchange, additional insurance expenses, investor relations activities and other administrative and professional services.

Total other income

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

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

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

Results of operations

Comparison of the three months ended June 30, 2023 and 2022

The following table summarizes our results of operations for the three months ended June 30, 2023 and 2022:

Three Months Ended June 30,

Comparison of the three months ended September 30, 2023 and 2022

The following table summarizes our results of operations for the three months ended September 30, 2023 and 2022:

Three Months Ended September 30,

(in thousands)

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Interest income

Other (expense) income

Other expense

Total other income

Research and development expenses

Research and development expenses for the three months ended June 30, 2023 were $18.0 million, compared to $27.1 million for the three months ended June 30, 2022.

The decrease of $9.1 million was primarily due to decreased spending on (i) preclinical research programs, which included the $8.0 million upfront payment in connection with the exclusive global license agreement entered into in June 2022 between the Company and Aurigene Discovery Technologies Limited, or the Aurigene Agreement, incurred and paid in June 2022, (ii) clinical pharmacology-related costs, and (iii) personnel-related expenses, which primarily related to lower headcount as a result of the restructuring and portfolio prioritization during the first quarter of 2023, and a decrease of approximately $0.2 million in non-cash stock-based compensation expense.

Total decreases were primarily offset by increased spending on clinical operations-related activities as we continue to advance palazestrant into late-stage clinical trials.

Research and development expenses for the three months ended September 30, 2023 were $19.5 million, compared to $17.6 million for the three months ended September 30, 2022.

The increase of $1.8 million was primarily due to increased spending on clinical operations and development-related activities as we continue to advance palazestrant into late-stage clinical trials.

The increase was partially offset by decreased spending on (i) clinical pharmacology-related costs, and (ii) personnel-related expenses, which primarily related to lower headcount as a result of the restructuring and portfolio prioritization during the first quarter of 2023 .

General and administrative expenses

General and administrative expenses for the three months ended June 30, 2023 were $3.6 million compared to $6.2 million for the three months ended June 30, 2022.

General and administrative expenses for the three months ended September 30, 2023 were $3.9 million compared to $5.6 million for the three months ended September 30, 2022.

The decrease of $1.7 million was primarily due to decreased spending on (i) corporate- and legal-related costs, and (ii) personnel-related expenses, primarily due to lower headcount as a result of the restructuring and portfolio prioritization, and a decrease of approximately $0.2 million in non-cash stock-based compensation expense .

Other income for the three months ended June 30, 2023 was $1.5 million, which primarily consisted of interest income from our marketable securities of $1.6 million, partially offset by unrealized foreign currency remeasurement loss on our foreign-currency-denominated monetary accounts.

Comparison of the six months ended June 30, 2023 and 2022

The following table summarizes our results of operations for the six months ended June 30, 2023 and 2022:

Six Months Ended June 30,

Other income for the three months ended September 30, 2023 was $1.8 million, which primarily consisted of interest income from our marketable securities of $1.9 million, partially offset by losses from the sale of the fixed assets.

Comparison of the nine months ended September 30, 2023 and 2022

The following table summarizes our results of operations for the nine months ended September 30, 2023 and 2022:

Nine Months Ended September 30,

(in thousands)

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Interest income

Other (expense) income

Other expense

Total other income

Research and development expenses

Research and development expenses for the six months ended June 30, 2023 were $40.8 million, compared to $43.1 million for the six months ended June 30, 2022.

The decrease of $2.2 million was primarily due to decreased spending on (i) preclinical research programs, including the $8.0 million upfront payment in correction with the Aurigene Agreement incurred and paid in June 2022, and (ii) personnel-related expenses, which primarily related to lower headcount as a result of the restructuring and portfolio prioritization, and a decrease of approximately $0.2 million in non-cash stock-based compensation expense.

Research and development expenses for the nine months ended September 30, 2023 were $60.3 million, compared to $60.7 million for the nine months ended September 30, 2022.

The decrease of $0.4 million was primarily due to decreased spending on preclinical research programs, including the $8.0 million upfront payment in connection with the exclusive global license agreement entered into in June 2022 between the Company and Aurigene, or the Aurigene Agreement, incurred and paid in June 2022, and (ii) personnel-related expenses, which primarily related to lower headcount as a result of the restructuring and portfolio prioritization, and a decrease of approximately $0.2 million in non-cash stock-based compensation expense.

Total decreases were primarily offset by increased spending on clinical operations-related activities as we continue to advance palazestrant into late-stage clinical trials .

General and administrative expenses

General and administrative expenses for the six months ended June 30, 2023 were $10.4 million compared to $13.5 million for the six months ended June 30, 2022.

General and administrative expenses for the nine months ended September 30, 2023 were $14.3 million compared to $19.1 million for the nine months ended September 30, 2022.

The decrease of $4.8 million was primarily due to decreased spending on (i) corporate and legal-related costs, and (ii) personnel-related expenses, which primarily related to lower headcount as a result of the restructuring and portfolio prioritization, and a decrease of approximately $0.8 million in non-cash stock-based compensation expense .

Other income for the six months ended June 30, 2023 was $2.8 million, which primarily consisted of interest income from our marketable securities of $2.9 million, partially offset by unrealized foreign currency remeasurement loss on our foreign-currency denominated monetary accounts.

Other income for the nine months ended September 30, 2023 was $4.7 million, which primarily consisted of interest income from our marketable securities of $4.8 million, partially offset by losses from the sale of the disposed assets.

Liquidity and capital resources

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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, 2023, we had received aggregate gross proceeds of $395.5 million from sales of our common stock, convertible preferred stock and issuance of convertible promissory notes, stock option exercises, and the sale of stock through the Company’s 2020 Employee Stock Purchase Plan, or ESPP.

As of June 30, 2023, we had $167.4 million in cash, cash equivalents and marketable securities and accumulated deficit of $257.4 million.

We had no debt outstanding as of June 30, 2023.

Through September 30, 2023, we had received aggregate gross proceeds of $526.1 million from sales of our common stock, convertible

preferred stock and issuance of convertible promissory notes, stock option exercises, and sale of stock through the Company’s 2020 Employee Stock Purchase Plan, or ESPP.

As of September 30, 2023, we had $276.9 million in cash, cash equivalents and marketable securities and accumulated deficit of $278.9 million.

We had no debt outstanding as of September 30, 2023.

In September 2023, we completed the Private Placement resulting in gross proceeds of approximately $130.0 million.

After deducting offering expenses related to the Private Placement of approximately $0.2 million, the net proceeds to from the Private Placement were approximately $129.8 million .

Also on September 5, 2023, we entered into the Loan Agreement which provides for the Credit Facility in an aggregate principal amount of up to $50.0 million, of which $25.0 million became available upon the closing of the Private Placement, and the remaining $25.0 million may be made available upon approval of the Bank in its discretion.

The Credit Facility will mature on August 1, 2027.

As of September 30, 2023, we had not drawn down from the Credit Facility, and had no other debt outstanding.

We expect to incur significant expenses and operating losses for the foreseeable future as we advance the clinical development of palazestrant and nonclinical studies.

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Our primary uses of cash are to fund our research and development activities, including with respect to palazestrant and other nonclinical programs, business planning, establishing and maintaining our intellectual property portfolio, hiring personnel, raising capital and providing general and administrative support for these operations.

We currently have no financing commitments, such as lines of credit or guarantees, that are expected to affect our liquidity over the next five years.

Other than as noted above, we currently have no financing commitments, such as lines of credit or guarantees, that are expected to affect our liquidity over the next five years.

Future funding and material cash requirements

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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, 2023 will enable us to fund our operating expenses and capital expenditure requirements into the second quarter of 2025.

Total operating expenses of $21.6 million for the three months ended June 30, 2023 reflects a $8.0 million reduction of costs versus the three months ended March 31, 2023 as a result of the restructuring and portfolio prioritization announced in March 2023.

We anticipate our cash, cash equivalents, and marketable securities balance to range between $120.0 to $125.0 million for the year ending December 31, 2023.

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.

We expect our cash, cash equivalents, and marketable securities as of September 30, 2023, as well as the available balance under the Credit Facility, will enable us to fund our current operating plan into 2027.

We anticipate our cash, cash equivalents, and marketable securities balance to range between $250.0 to $255.0 million on December 31, 2023.

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.

Our future capital requirements will depend on many factors, including:

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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)

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Operating activities

Net cash used in operating activities in the six months ended June 30, 2023 consisted primarily of our net loss of $48.4 million and a net decrease in operating assets and liabilities of $1.1 million, partially offset by non-cash charges of $7.0 million.

Net cash used in operating activities in the nine months ended September 30, 2023 consisted primarily of our net loss of $69.9 million and a net increase in operating assets and liabilities of $5.4 million, partially offset by non-cash charges of $10.1 million.

The net loss consisted primarily of $60.3 million in research and development expenses and $14.3 million in general and administrative expenses.

The non-cash charges consisted primarily of stock-based compensation expense of $12.9 million and depreciation and amortization expenses of $0.3 million , primarily offset by non-cash interest income on our marketable securities of $3.3 million .

The net decrease in operating assets and liabilities was primarily due to (i) a decrease of $2.7 million in accrued and other current liabilities and (ii) an increase of $0.1 million in other assets and long-term deposits.

The net increase in operating assets and liabilities was primarily due to (i) an increase of $5.3 million in other assets and long-term deposits, and (ii) a decrease of $2.2 million in accrued and other current liabilities and.

The changes were partially offset by (i) an increase of $1.8 million in accounts payable, which is primarily a result of timing of invoice payment, and (ii) a decrease of $0.3 million in prepaid expenses and other current assets.

Net cash used in operating activities in the six months ended June 30, 2022 consisted primarily of our net loss of $55.9 million, partially offset by non-cash charges of $9.9 million and a net increase in operating assets and liabilities of $1.7 million.

Net cash used in operating activities in the nine months ended September 30, 2022 consisted primarily of our net loss of $78.6 million, partially offset by non-cash charges of $14.0 million and a net decrease in operating assets and liabilities of $2.2 million.

The net loss consisted primarily of $60.7 million in research and development expenses and $19.1 million in general and administrative expenses.

The non-cash charges consisted primarily of stock-based compensation expense of $9.7 million and depreciation and amortization expenses of $0.1 million, and non-cash lease expense of less than $0.1 million, net of cash payments of $0.6 million.

The net increase in operating assets and liabilities was primarily due to (i) an increase of $1.9 million in accrued and other current liabilities, (ii) an increase of $0.1 million in accounts payable, which is primarily a result of timing of invoice payment, and (iii) a decrease of $0.2 million in prepaid expenses and other current assets.

The changes were partially offset by a net increase of $0.5 million in other assets and long-term deposits.

The non-cash charges consisted primarily of stock-based compensation expense of $14.0 million and depreciation and amortization expenses of less than $0.1 million, including premium amortization on our marketable securities, and non-cash lease expense of less than $0.1 million, net of cash payments of $1.0 million.

The net decrease in operating assets and liabilities was primarily due to (i) an increase of $3.3 million in other current liabilities and (ii) a decrease of $0.1 million in prepaid expenses and other current assets.

The changes are partially offset by (i) a net increase of $1.1 million in other assets and (ii) an increase of less than $0.1 million in accounts payable, which is primarily a result of timing of invoice payment.

Investing Activities

Net cash provided by investing activities in the six months ended June 30, 2023 was predominately due to maturities of marketable securities which was partially offset by purchase of marketable securities.

Net cash provided by investing activities in the six-month ended June 30, 2022 was predominately due to maturities of marketable securities which was partially offset by purchase of marketable securities.

Net cash provided by investing activities in the nine months ended September 30, 2023 was predominately due to maturities of marketable securities which was partially offset by purchase of marketable securities.

Net cash provided by investing activities in the nine months ended September 30, 2022 was predominately due to maturities of marketable securities which was partially offset by purchase of marketable securities.

Financing activities

Net cash provided by financing activities during the six months ended June 30, 2023 consists of $1.6 million and $0.7 million in net proceeds from the exercise of stock options and the sale of our common stock under the 2020 ESPP, respectively.

Net cash provided by financing activities during the six months ended June 30, 2022 represents $0.1 million in net proceeds from the sale of our common stock under the 2020 ESPP and exercise of stock options .

Net cash provided by financing activities during the nine months ended September 30, 2023 consists of $129.8 million in net proceeds from the Private Placement, $2.4 million from the exercise of stock options, and $0.7 million from the sale of our common stock under the 2020 ESPP.

Net cash provided by financing activities during the nine months ended September 30, 2022 consists of $0.1 million and $0.1 million in net proceeds from the sale of our common stock under the 2020 ESPP and the exercise of stock options, respectively.

Contractual obligations and commitments

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

There have been no material changes outside the ordinary course of business during the six months ended June 30, 2023 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 nine months ended September 30, 2023 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.

Critical accounting policies and significant judgements and estimates

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

During the six months ended June 30, 2023, there were no material changes to our critical accounting policies and estimates as reported in our Annual Report on Form 10-K.

During the nine months ended September 30, 2023, 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 six months ended June 30, 2023, there were no material changes to our market risk disclosures reported in our Annual Report on Form 10-K.

During the nine months ended September 30, 2023, 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