What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-11-06 compared with 2024-08-06 · 91 added, 66 removed, 250 unchanged (39% of the section changed)

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• Clinical Data .

We believe that, overall, while the interim clinical data from the ReDiscover Trial disclosed to date are preliminary, the data support selective target engagement across doses and mutation types with an encouraging interim safety and tolerability profile.

In September 2024, we announced interim clinical data for RLY-2608 with a data cut-off date of August 12, 2024.

This interim clinical data showed that among patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer who received the 600 mg BID dose in combination with fulvestrant, or our recommended Phase 2 dose, and who did not have a PTEN or AKT co-mutation, the median progression free survival was 9.2 months and the objective response rate was 33% across all mutations and 53% in patients with kinase mutations.

Additionally, the interim clinical data showed that RLY-2608 in combination with fulvestrant was generally well tolerated in the patients treated across all doses as of the August 12, 2024 data cut-off date.

The overall tolerability profile consisted of mostly low-grade treatment-related adverse events that were manageable and reversible, and safety outcomes were generally as expected across dose levels based on exposure and consistent with mutant-selective PI3Kα inhibition.

We believe that, overall, while the interim clinical data from the ReDiscover Trial disclosed to date are preliminary, the data suggest interim efficacy signals in the patient population defined above, and support selective target engagement across doses and mutation types with an encouraging interim safety and tolerability profile.

• Lirafugratinib (RLY-4008).

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The first part of the trial, or the dose escalation, is complete, and the second part of the trial, or the dose expansion, is ongoing at a 70 mg once daily, or QD, recommended Phase 2 dose in patients with cholangiocarcinoma, or CCA, and other FGFR2-altered solid tumors.

Enrollment for the ReFocus Trial has been closed to allow the data to mature and inform our future clinical development decisions.

Enrollment for the ReFocus Trial has been closed to allow the data to mature and inform

our future clinical development decisions.

In September 2024, we announced that we plan to seek a global commercialization partner for lirafugratinib in order to maintain focus on the remainder of our portfolio.

This announcement followed a meeting with the U.S.

Food and Drug Administration, or the FDA, regarding the lirafugratinib regulatory path, at which meeting the FDA suggested that we first file a new drug application, or NDA, in CCA, followed by a tumor agnostic supplemental NDA for FGFR2 fusions with data from more patients and more follow up.

• Clinical Data .

In October 2024, we presented updated interim FGFR2 fusion tumor agnostic clinical data at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics.

We believe that while the interim clinical data from the ReFocus Trial disclosed to date are preliminary, the data show interim efficacy signals in the CCA pan-FGFR, or FGFRi, treatment-naïve, FGFR2-fusion CCA cohort and non-CCA solid tumor expansion cohorts and further support our hypothesis that selective inhibition of FGFR2 can improve the treatment for patients with FGFR2-driven tumors.

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In addition to the clinical stage product candidates described above, we announced three discovery stage programs in June 2024, including two novel programs from our genetic disease portfolio to address clinically and commercially validated targets in vascular malformations and Fabry disease, respectively, and an NRAS-selective inhibitor.

We also have more than five additional active discovery stage programs across both precision oncology and genetic diseases.

We also have five additional active discovery stage programs across both precision oncology and genetic diseases.

We are focused on using the novel insights derived from our approach to transform the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of our therapies.

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To date, we have principally financed our operations through private placements of preferred stock and common stock, convertible debt, and proceeds from public offerings of our common stock.

We have also received an aggregate of $121.8 million in connection with the Genentech Agreement through June 30, 2024.

In August 2021, we entered into a sales agreement, or the Sales Agreement, with Cowen and Company, LLC, or Cowen, pursuant to which we may offer and sell shares of our common stock having aggregate gross proceeds of up to $300.0 million from time to time in "at-the-market" offerings through Cowen, as our sales agent, or At-the-Market Offerings.

As of June 30, 2024, we have sold 4,915,669 shares of common stock under the Sales Agreement, from which we have received $48.2 million in proceeds, which were net of $1.2 million in commissions paid to Cowen.

In September 2024, we completed a public offering, or the September 2024 Offering, of 32,857,143 shares of common stock, including the exercise in full of the underwriters’ option to purchase an additional 4,285,714 shares, at an offering price of $7.00 per share.

We received proceeds of $218.2 million, which was net of $11.8 million in underwriting discounts and other offering expenses.

In August 2021, we entered into a sales agreement, or the 2021 Sales Agreement, with Cowen and Company, LLC, or Cowen, pursuant to which we could offer and sell shares of our common stock having aggregate gross proceeds of up to $300.0 million from time to time in "at-the-market" offerings through Cowen, as our sales agent.

As of September 30, 2024, we sold 4,915,669 shares of common stock under the 2021 Sales Agreement, from which we received $48.2 million in proceeds, which were net of $1.2 million in commissions paid to Cowen.

In August 2024, the 2021 Sales Agreement was terminated by mutual agreement between us and Cowen.

Separately, we entered into a new sales agreement, or the 2024 Sales Agreement, with TD Securities (USA) LLC, or TD Securities, pursuant to which we may offer and sell shares of our common stock having aggregate gross proceeds of up to $250.0 million from time to time in “at-the-market” offerings through TD Securities, as our sales agent.

As of September 30, 2024, we have not sold any shares under the 2024 Sales Agreement.

In January 2024, we entered into a securities purchase agreement with Nextech Crossover I SCP for the private placement of 2,500,000 shares of common stock at $12.00 per share, or the Private Placement.

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In December 2020, we entered into a global collaboration and license agreement with Genentech, Inc., a member of the Roche Group, or Genentech, for the development and commercialization of RLY-1971 (now referred to as migoprotafib, or GDC-1971), or the Genentech Agreement.

Under the terms of the Genentech Agreement, we received $75.0 million in an upfront payment in 2021, as well as $45.0 million in milestone payments from Genentech as of June 30, 2024.

Under the terms of the Genentech Agreement, we received $75.0 million in an upfront payment in 2021, as well as $45.0 million in milestone payments from Genentech as of September 30, 2024.

On July 11, 2024, we received notice that Genentech exercised its right to terminate the Genentech Agreement.

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Until the Termination Date, the obligations of the parties under the Genentech Agreement will continue as currently provided.

As a result of the termination of the Genentech Agreement, we will not be entitled to receive any further milestones or other payments due after the Termination Date.

As a result of the termination of the Genentech Agreement, we will not be entitled to receive any further milestones or other payments due after the

Termination Date.

The parties will also cease to have any development or commercialization obligations after the Termination Date and the licenses that we granted to Genentech pursuant to the Genentech Agreement will cease to be in effect as of the Termination Date.

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Our financial condition and results of operations may also be impacted by other factors we may not be able to control, such as public health crises, global supply chain disruptions, uncertain global economic conditions, global trade disputes or political instability as further discussed in the section "Risk Factors" in this Quarterly Report on Form 10-Q.

We do not believe that such factors had a material adverse impact on our results of operations during the three and six months ended June 30, 2024 and 2023.

We do not believe that such factors had a material adverse impact on our results of operations during the three and nine months ended September 30, 2024 and 2023.

Since our inception, we have incurred significant operating losses on an aggregate basis.

Our ability to generate product revenue sufficient to achieve profitability will depend on the successful development and eventual commercialization of one or more of our current or future product candidates.

Our net losses were $173.6 million and $192.7 million for the six months ended June 30, 2024 and 2023, respectively.

As of June 30, 2024, we had an accumulated deficit of $1.6 billion.

Our net losses were $261.7 million and $258.5 million for the nine months ended September 30, 2024 and 2023, respectively.

As of September 30, 2024, we had an accumulated deficit of $1.7 billion.

These losses have resulted primarily from costs incurred in connection with research and development activities, licensing and patent investment, and general and administrative costs associated with our operations.

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If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and may be forced to reduce or terminate our operations.

We believe our cash, cash equivalents, and investments of $688.4 million as of June 30, 2024 will enable us to fund our operating expenses and capital expenditure requirements into the second half of 2026.

We believe our cash, cash equivalents, and investments of $839.6 million as of September 30, 2024 will enable us to fund our operating expenses and capital expenditure requirements into the second half of 2027.

We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.

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Results of Operations

Comparison of the three months ended June 30, 2024 and 2023

The following table summarizes our results of operations for the three months ended June 30, 2024 and 2023:

Three Months Ended June 30,

Comparison of the three months ended September 30, 2024 and 2023

The following table summarizes our results of operations for the three months ended September 30, 2024 and 2023:

Three Months Ended September 30,

(in thousands)

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Other income, net

We recognized no revenue for the three months ended June 30, 2024 compared to $0.1 million for the three months ended June 30, 2023.

The change of $0.1 million was due to completion of research and development services provided under the Genentech Agreement in 2023.

We recognized no revenue for the three months ended September 30, 2024 compared to $25.2 million for the three months ended September 30, 2023.

The decrease of $25.2 million was primarily due to recognition of $25.0 million in variable consideration under the Genentech Agreement previously constrained during the three months ended September 30, 2023.

By comparison, no amounts were recognized during the three months ended September 30, 2024, as research and development services provided under the Genentech Agreement were completed in 2023.

Research and Development Expenses

The following summarizes our research and development expenses for the three months ended June 30, 2024 and 2023:

Three Months Ended June 30,

The following summarizes our research and development expenses for the three months ended September 30, 2024 and 2023:

Three Months Ended September 30,

(in thousands)

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Total research and development expenses

Research and development expenses were $92.0 million for the three months ended June 30, 2024 compared to $88.2 million for the three months ended June 30, 2023.

The change of $3.8 million was primarily due to additional external costs in connection with the ReDiscover Trial for RLY-2608.

Research and development expenses were $76.6 million for the three months ended September 30, 2024 compared to $81.5 million for the three months ended September 30, 2023.

The decrease of $4.9 million was primarily due to the impact of prioritization of certain programs in our pipeline, as previously disclosed in 2023 and earlier in 2024.

Change in Fair Value of Contingent Consideration Liability

Change in fair value of our contingent consideration liability under the Merger Agreement with ZebiAI was a decrease of $11.4 million for the three months ended June 30, 2024 compared to a decrease of $2.2 million for the three months ended June 30, 2023.

Change in fair value of our contingent consideration liability under the Merger Agreement with ZebiAI was $0 for the three months ended September 30, 2024 compared to a decrease of $1.2 million for the three months ended September 30, 2023.

During the three months ended June 30, 2024, the Contingent Milestone Payments and Contingent Earnout Payments were both reduced to $0.

During the three months ended September 30, 2024, there were no further changes to such amounts.

General and Administrative Expenses

General and administrative expenses were $20.1 million for the three months ended June 30, 2024 and 2023.

In comparing the periods, increases in stock compensation expense were offset by decreases in other employee costs, insurance fees, and other expenses.

General and administrative expenses were $19.8 million for the three months ended September 30, 2024 compared to $18.5 million for the three months ended September 30, 2023.

The increase of $1.3 million was primarily due to an increase in stock compensation expense, partially offset by decreases in other employee compensation costs and certain other general and administrative expenses.

Other Income, Net

Other income, net, was $8.5 million for the three months ended June 30, 2024 compared to $7.5 million for the three months ended June 30, 2023.

The change of $1.0 million was primarily a result of fluctuations in interest rates.

Comparison of the six months ended June 30, 2024 and 2023

The following table summarizes our results of operations for the six months ended June 30, 2024 and 2023:

Six Months Ended June 30,

Other income, net, was $8.3 million for the three months ended September 30, 2024 compared to $7.8 million for the three months ended September 30, 2023.

The increase of $0.4 million was primarily a result of fluctuations in interest rates.

Comparison of the nine months ended September 30, 2024 and 2023

The following table summarizes our results of operations for the nine months ended September 30, 2024 and 2023:

Nine Months Ended September 30,

(in thousands)

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Other income, net

We recognized revenue of $10.0 million for the six months ended June 30, 2024 compared to $0.3 million for the six months ended June 30, 2023.

The change of $9.7 million was primarily due to a payment of $10.0 million in connection with a milestone achieved under the Genentech Agreement during the six months ended June 30, 2024.

We recognized revenue of $10.0 million for the nine months ended September 30, 2024 compared to $25.5 million for the nine months ended September 30, 2023.

The decrease of $15.5 million was primarily due to recognition of $25.0 million in variable consideration under the Genentech Agreement previously constrained during the nine months ended September 30, 2023.

By comparison, only $10.0 million was recognized during the nine months ended September 30, 2024, specifically in connection with a milestone achieved under the Genentech Agreement.

Research and Development Expenses

The following summarizes our research and development expenses for the six months ended June 30, 2024 and 2023:

Six Months Ended June 30,

The following summarizes our research and development expenses for the nine months ended September 30, 2024 and 2023:

Nine Months Ended September 30,

(in thousands)

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Total research and development expenses

Research and development expenses were $174.4 million for the six months ended June 30, 2024 compared to $171.0 million for the six months ended June 30, 2023.

The change of $3.4 million was primarily due to additional external costs in connection with the ReDiscover Trial for RLY-2608 and increases in stock compensation expense, offset by the impact of prioritization of certain programs in our pipeline, as previously disclosed in 2023 and earlier in 2024.

Research and development expenses were $251.0 million for the nine months ended September 30, 2024 compared to $252.5 million for the nine months ended September 30, 2023.

The decrease of $1.5 million was primarily due to the impact of prioritization of certain programs in our pipeline, as previously disclosed in 2023 and earlier in 2024, partially offset by an increase in stock compensation expense.

Change in Fair Value of Contingent Consideration Liability

Change in fair value of our contingent consideration liability under the Merger Agreement with ZebiAI was a decrease of $13.2 million for the six months ended June 30, 2024 compared to a decrease of $3.2 million for the six months ended June 30, 2023.

During the six months ended June 30, 2024, the Contingent Milestone Payments and Contingent Earnout Payments were both reduced to $0.

Change in fair value of our contingent consideration liability under the Merger Agreement with ZebiAI was a decrease of $13.2 million for the nine months ended September 30, 2024 compared to a decrease of $4.4 million for the nine months ended September 30, 2023.

During the nine months ended September 30, 2024, the Contingent Milestone Payments and Contingent Earnout Payments were both reduced to $0.

General and Administrative Expenses

General and administrative expenses were $39.9 million for the six months ended June 30, 2024 compared to $39.7 million for the six months ended June 30, 2023.

The change of $0.2 million was primarily due to an increase in stock compensation expense, offset by decreases in other employee compensation costs, insurance fees, and other expenses.

General and administrative expenses were $59.7 million for the nine months ended September 30, 2024 compared to $58.2 million for the nine months ended September 30, 2023.

The increase of $1.5 million was primarily due to an increase in stock compensation expense, partially offset by decreases in other employee compensation costs and certain other general and administrative expenses.

Other Income, Net

Other income, net, was $17.5 million for the six months ended June 30, 2024 compared to $14.5 million for the six months ended June 30, 2023.

The change of $3.0 million was primarily a result of fluctuations in interest rates.

Other income, net, was $25.8 million for the nine months ended September 30, 2024 compared to $22.3 million for the nine months ended September 30, 2023.

The increase of $3.5 million was primarily a result of fluctuations in interest rates.

Liquidity and Capital Resources

As of June 30, 2024, we had cash, cash equivalents, and investments of $688.4 million.

As of September 30, 2024, we had cash, cash equivalents, and investments of $839.6 million.

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

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To date, we have principally financed our operations through private placements of preferred stock and common stock, convertible debt, and proceeds from public offerings of our common stock.

In September 2024, we completed the September 2024 Offering of 32,857,143 shares of common stock, including the exercise in full of the underwriters’ option to purchase an additional 4,285,714 shares, at an offering price of $7.00 per share.

We received proceeds of $218.2 million, which was net of $11.8 million in underwriting discounts and other offering expenses.

In August 2024, we filed a universal shelf registration statement on Form S-3ASR with the SEC, or the 2024 Shelf, to register for sale an amount of our common stock, preferred stock, debt securities, warrants and/or units in one or more offerings, which became effective upon filing with the SEC (File No.

In August 2021, we also entered into the Sales Agreement with Cowen pursuant to which we may offer and sell shares of our common stock having aggregate gross proceeds of up to $300.0 million from time to time in At-the-Market Offerings through Cowen, as our sales agent.

The 2024 Shelf replaced our prior universal shelf registration statement filed with the SEC in August 2021 (File No.

333-258768), which would have expired in August 2024.

In August 2021, we entered into the 2021 Sales Agreement with Cowen, pursuant to which we had the ability to offer and sell shares of our common stock having aggregate gross proceeds of up to $300.0 million from time to time in "at-the-market" offerings through Cowen, as our sales agent.

In August 2024, the 2021 Sales Agreement was terminated by mutual agreement between us and Cowen.

Separately, we entered into the 2024 Sales Agreement with TD Securities, pursuant to which we may offer and sell shares of our common stock having aggregate gross proceeds of up to $250.0 million from time to time in “at-the-market” offerings through TD Securities, as our sales agent.

As of September 30, 2024, we have not sold any shares under the 2024 Sales Agreement.

In January 2024, we entered into a securities purchase agreement with Nextech Crossover I SCP for the Private Placement.

We received $29.8 million in proceeds from the Private Placement, which were net of $0.2 million in offering expenses.

As of June 30, 2024, we have received $120.0 million in upfront and milestone payments from Genentech pursuant to the Genentech Agreement.

As of September 30, 2024, we have received $120.0 million in upfront and milestone payments from Genentech pursuant to the Genentech Agreement.

The following table summarizes our sources and uses of cash for each of the periods presented:

Six Months Ended June 30,

Nine Months Ended September 30,

(in thousands)

Cash used in operating activities

Cash provided by investing activities

Cash (used in) provided by investing activities

Cash provided by financing activities

Net decrease in cash, cash equivalents, and restricted cash

Net increase (decrease) in cash, cash equivalents, and restricted cash

Operating Activities

During the six months ended June 30, 2024, we used $116.2 million of cash on operating activities, primarily resulting from our net loss of $173.6 million, offset by non-cash charges of $36.6 million and cash provided by changes in our operating assets and liabilities of $20.8 million.

During the six months ended June 30, 2023, we used $135.7 million of cash on operating activities, primarily resulting from our net loss of $192.7 million, offset by non-cash charges of $40.1 million and cash provided by changes in our operating assets and liabilities of $16.9 million.

During the nine months ended September 30, 2024, we used $191.2 million of cash on operating activities, primarily resulting from our net loss of $261.7 million, offset by non-cash charges of $57.3 million and cash provided by changes in our operating assets and liabilities of $13.2 million.

During the nine months ended September 30, 2023, we used $211.1 million of cash on operating activities, primarily resulting from our net loss of $258.5 million and cash used to fund changes in our operating assets and liabilities of $11.9 million, offset by non-cash charges of $59.2 million.

Investing Activities

During the six months ended June 30, 2024, net cash provided by investing activities was $56.1 million, primarily consisting of $57.9 million in proceeds from net maturities of investments, offset by $1.8 million for the acquisition of property and equipment.

During the six months ended June 30, 2023, net cash provided by investing activities was $126.6 million, primarily consisting of $130.0 million in proceeds from net maturities of investments, offset by $3.4 million for the acquisition of property and equipment.

During the nine months ended September 30, 2024, net cash used in investing activities was $70.1 million, primarily consisting of $68.1 million in net purchases of investments and $2.0 million for the acquisition of property and equipment.

During the nine months ended September 30, 2023, net cash provided by investing activities was $198.0 million, primarily consisting of $202.0 million in proceeds from net maturities of investments, offset by $4.0 million for the acquisition of property and equipment.

Financing Activities

During the six months ended June 30, 2024, net cash provided by financing activities was $50.5 million, primarily consisting of $47.7 million in net proceeds from the Private Placement and At-the-Market Offerings, as well as $2.7 million in proceeds from the exercise of stock options and purchases under our 2020 Employee Stock Purchase Plan, or ESPP.

During the six months ended June 30, 2023, net cash provided by financing activities was $3.4 million, primarily consisting of $3.4 million in proceeds from the exercise of stock options and purchases under our ESPP.

During the nine months ended September 30, 2024, net cash provided by financing activities was $269.4 million, primarily consisting of $265.9 million in net proceeds from the Private Placement, at-the-market offerings, and the September 2024 Offering, as well as $3.5 million in proceeds from the exercise of stock options and purchases under our 2020 Employee Stock Purchase Plan, or ESPP.

During the nine months ended September 30, 2023, net cash provided by financing activities was $12.8 million, primarily consisting of $9.4 million in net proceeds from at-the-market offerings, as well as $3.5 million in proceeds from the exercise of stock options and purchases under our ESPP.

Funding Requirements

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In addition, we continue to incur additional costs associated with operating as a public company.

As of June 30, 2024, we had cash, cash equivalents, and investments of $688.4 million.

As of September 30, 2024, we had cash, cash equivalents, and investments of $839.6 million.

We believe that our existing cash, cash equivalents, and investments will enable us to fund our operating expenses and capital expenditure requirements into the second half of 2027.

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• the costs of preparing, filing, and prosecuting patent applications, maintaining, and enforcing our intellectual property rights and defending intellectual property-related claims;

• our headcount growth and associated costs as we expand our business operations and our research and development activities;

• our headcount growth and associated costs if and as we expand our business operations and our research and development activities;

• the costs of operating as a public company.

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Contractual Obligations and Commitments

There were no material changes to our contractual obligations and commitments during the three months ended June 30, 2024.

On July 11, 2024, we received notice that Genentech exercised its right to terminate the Genentech Agreement, as further discussed in the section "Management's Discussion and Analysis of Financial Condition and Results of Operations" in this Quarterly Report on Form 10-Q.

There were no other material changes to our contractual obligations and commitments during the three months ended September 30, 2024.

For more information on our contractual obligations and commitments, please refer to "Management’s Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the year ended December 31, 2023, as well as Note 9, Commitments and Contingencies, of the notes to our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.

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For a discussion of our critical accounting estimates, see "Management’s Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on February 22, 2024, the notes to our audited financial statements appearing in our Annual Report on Form 10-K, and the notes to the financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.

There have been no material changes to these critical accounting policies and estimates through June 30, 2024 from those discussed in our Annual Report on Form 10-K for the year ended December 31, 2023.

There have been no material changes to these critical accounting policies and estimates through September 30, 2024 from those discussed in our Annual Report on Form 10-K for the year ended December 31, 2023.

Recently Issued and Adopted Accounting Pronouncements

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We are exposed to market risk related to changes in interest rates of our investment portfolio of cash equivalents and short-term investments.

As of June 30, 2024, our cash equivalents consisted of money market funds.

As of June 30, 2024, our investments consisted of investments in U.S.

As of September 30, 2024, our cash equivalents consisted of money market funds.

As of September 30, 2024, our investments consisted of investments in U.S.

treasury bills and United States agency securities that have contractual maturities of less than two years.

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The potential change in fair value for interest rate sensitive instruments has been assessed on a hypothetical 100 basis point adverse movement across all maturities.

As of June 30, 2024, we estimate that such hypothetical 100 basis point adverse movement would not result in a material impact on our condensed consolidated results of operations.

As of June 30, 2024, we had no debt outstanding and, therefore, are not exposed to interest rate risk with respect to debt.

As of September 30, 2024, we estimate that such hypothetical 100 basis point adverse movement would not result in a material impact on our condensed consolidated results of operations.

As of September 30, 2024, we had no debt outstanding and, therefore, are not exposed to interest rate risk with respect to debt.

Foreign currency exchange risk

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To date, foreign currency transaction gains and losses have not been material to our financial statements and we have not had a formal hedging program with respect to foreign currency.

We estimate that a 10% increase or decrease in current exchange rates would not have a material effect on our financial results for the three and six months ended June 30, 2024 and 2023.

We estimate that a 10% increase or decrease in current exchange rates would not have a material effect on our financial results for the three and nine months ended September 30, 2024 and 2023.

While we have not engaged in the hedging of our foreign currency transactions to date, we are evaluating the costs and benefits of initiating such a program and may in the future hedge selected significant transactions denominated in currencies other than the U.S.

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Our disclosure controls and procedures have been designed to provide reasonable assurance of achieving their objectives.

Based on that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that, as of June 30, 2024, our disclosure controls and procedures were effective.

Based on that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that, as of September 30, 2024, our disclosure controls and procedures were effective.

Changes in Internal Control Over Financial Reporting

There has been no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the fiscal quarter ended June 30, 2024 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

There has been no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the fiscal quarter ended September 30, 2024 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

PART II—OTHE R INFORMATION

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