What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-11-12 compared with 2024-08-13 · 64 added, 67 removed, 195 unchanged (40% of the section changed)

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Clinical Highlights

Pivotal Hypertension Program

In April 2023, we initiated our first pivotal trial, Advance-HTN, a randomized, double-blind, placebo-controlled Phase 2 clinical trial to evaluate the efficacy and safety of lorundrostat for the treatment of uHTN or rHTN, when used as an add-on therapy to a standardized background treatment of two or three antihypertensive medications in 261 adult subjects.

Subjects who meet screening criteria will have their existing hypertension medications discontinued and start on a standard regimen of an angiotensin II receptor blocker (ARB) and a diuretic, if previously on two medications, or a standard regimen of ARB, diuretic and calcium channel blocker if previously on three to five medications.

Subjects who remain hypertensive despite the standardized regimen are then randomized into three cohorts and treated for twelve weeks:

lorundrostat 50 mg QD, lorundrostat 50 mg QD, and an option to titrate to 100 mg QD at week four based on defined criteria or placebo.

In August 2024, we met with the U.S.

Food and Drug Administration (FDA) and aligned on maintaining the primary endpoint for Advance-HTN as the change in 24-hour ambulatory systolic BP at week twelve from baseline for active cohorts versus placebo.

The Advance-HTN trial is approximately 90% enrolled, and topline data from this trial are anticipated in the first quarter of 2025.

In December 2023, we initiated our second pivotal trial, Launch-HTN, a randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate the efficacy and safety of lorundrostat for the treatment of uHTN or rHTN, when used as an add-on therapy to their existing, prescribed background treatment of two to five antihypertensive medications in up to approximately 1,000 adult subjects.

Subjects are then randomized into three cohorts and treated for twelve weeks:

Advance-HTN is a randomized, double-blind, placebo-controlled Phase 2 clinical trial to evaluate the efficacy and safety of lorundrostat for the treatment of uHTN or rHTN, when used as an add-on therapy to a standardized background treatment of two or three antihypertensive medications with an enrollment target of 261 subjects.

Subjects who met screening criteria either discontinued their existing hypertension medications and started on a standard regimen of an angiotensin II receptor blocker (ARB) and a diuretic, if previously on two medications, or a standard regimen of ARB, diuretic and calcium channel blocker if previously on three to five medications.

Subjects who remained hypertensive despite the standardized regimen were then randomized into three cohorts for twelve weeks of the following treatment methods:

lorundrostat 50 mg QD (once daily), lorundrostat 50 mg QD, and an option to titrate to 100 mg QD at week four based on defined criteria or placebo.

The primary endpoint for Advance-HTN is the change in 24-hour ambulatory systolic BP at week twelve from baseline for active cohorts versus placebo.

Randomization of subjects was completed in the fourth quarter of 2024, and topline data from this trial is anticipated in March 2025.

Our second pivotal trial, Launch-HTN, is a global, randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate the efficacy and safety of lorundrostat for the treatment of uHTN or rHTN, when used as an add-on therapy to their existing, prescribed background treatment of two to five antihypertensive medications with a target enrollment of 1,000 adult subjects.

Subjects were randomized into three cohorts for twelve weeks of the following treatment methods:

lorundrostat 50 mg QD, lorundrostat 50 mg QD, and an option to titrate to 100 mg QD at week six based on defined criteria or placebo.

Following our discussion with the FDA about the analysis plan for Launch-HTN, the primary endpoint of the trial was changed to the assessment of automated office measured systolic BP from baseline for active cohorts versus placebo at six weeks, with the results pooled for all subjects on 50 mg QD.

The initial primary endpoint of the trial was change in office measured systolic BP at week twelve from baseline for active cohorts versus placebo.

Enrollment is ahead of schedule, and topline data from this trial are anticipated to be available in the second half of 2025.

In mid-2023, we initiated an open-label extension trial, Transform-HTN, to allow subjects to continue to receive lorundrostat and obtain long-term efficacy and safety data.

All subjects in the pivotal hypertension program, including the Advance-HTN and Launch-HTN trials, as well as the Explore-CKD trial, will be given the opportunity to participate in the extension trial.

Other Indications

Lorundrostat has been developed to normalize the production of aldosterone, and we believe this mechanism can be applied to other indications where dysregulated aldosterone biology plays a role, including CKD and cardiorenal indications.

The Explore-CKD trial is designed to evaluate lorundrostat in hypertensive subjects with Stage 2 to 3b CKD.

The Phase 2 clinical trial was modified in June 2024 from its original design to enroll both naïve to and patients on SGLT2 inhibitors.

This change reflects how SGLT2 inhibitors have quickly become standard of care for patients with CKD.

All study participants will stay on an SGLT2 inhibitor throughout the course of the trial.

We also lowered the eGFR criteria for the proof-of-concept study from 45ml/min/1.73m2 to 30ml/min/1.73m2 and eliminated the original Part B profiling portion of the study.

The study periods were reduced to four weeks, which we believe will provide ample time to demonstrate clinical benefit on BP reduction and kidney benefit.

The primary endpoint is placebo-adjusted change from baseline in systolic BP and an exploratory endpoint is placebo-adjusted percent change from baseline in urine albumin-to-creatinine ratio at week four.

The primary endpoint of the trial is the assessment of automated office measured systolic BP from baseline for active cohorts versus placebo at six weeks, with the results pooled for all subjects on 50 mg QD.

Randomization of subjects was completed in the fourth quarter of 2024, and topline data from this trial is anticipated to be available in mid first half of 2025.

Explore-CKD is a randomized, double-blind, placebo controlled, two-period, two-sequence (2x2) crossover trial designed to evaluate the safety and efficacy of 25 mg QD lorundrostat in addition to an SGLT2 inhibitor for the treatment of hypertension in subjects with Stage 2 to 3b CKD and albuminuria despite receiving stable treatment with an ACEi or ARB.

The primary endpoint is placebo-adjusted change from baseline in systolic BP at week four and an exploratory endpoint is placebo-adjusted percent change from

baseline in urine albumin-to-creatinine ratio at week four.

As this is an exploratory trial, interim data analyses may be conducted at one or more points in time.

We are ramping up enrollment under the amended protocol, and topline data from this trial are anticipated in the first half of 2025.

Enrollment is ongoing under the amended protocol, and topline data from this trial is anticipated in the second quarter of 2025.

Transform-HTN is an open-label extension trial allowing subjects to continue to receive lorundrostat and to obtain long-term efficacy and safety data.

Lorundrostat has been developed to normalize the production of aldosterone, and we believe this mechanism can be applied to other indications where dysregulated aldosterone biology plays a role.

Financial Overview

We commenced our operations in May 2019 and have devoted substantially all of our resources to date to organizing and staffing our company, business planning, raising capital, in-licensing our product candidate, lorundrostat, establishing our intellectual property portfolio, conducting research, preclinical studies, and clinical trials, and providing other general and administrative support for our operations.

As of June 30, 2024, we had cash, cash equivalents, and investments of $311.1 million.

As of September 30, 2024, we had cash, cash equivalents, and investments of $263.6 million.

From inception through the date of this Quarterly Report, we raised aggregate gross proceeds of approximately $498.8 million from the sale of common stock, convertible preferred stock, convertible notes, and pre-funded warrants.

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Our operations to date have been limited to business planning, raising capital, in-licensing and developing lorundrostat, conducting clinical trials, and other research and development activities.

Our net losses for the six months ended June 30, 2024 and 2023 were $72.5 million and $24.7 million, respectively.

As of June 30, 2024 and December 31, 2023, we had an accumulated deficit of $197.2 million and $124.7 million, respectively.

Our net losses for the nine months ended September 30, 2024 and 2023 were $128.9 million and $47.5 million, respectively.

As of September 30, 2024 and December 31, 2023, we had an accumulated deficit of $253.6 million and $124.7 million, respectively.

Our net losses may fluctuate significantly from quarter to quarter and year to year, depending on the timing of our clinical development activities and other research and development activities.

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However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all.

Our failure to raise capital or enter into such other arrangements when needed would have a negative impact on our financial condition and could force us 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.

commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

For more information, see “ Liquidity and Capital Resources .

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Such royalties are subject to reduction under specified conditions, including lack of patent coverage and generic competition.

We incurred $0 and $4.0 million of research and development expenses pursuant to the Mitsubishi License during the six months ended June 30, 2024 and 2023, respectively, that related to the initiation of our pivotal clinical program of lorundrostat.

As of June 30, 2024, we have paid an aggregate of $9.0 million in development milestone payments and have no remaining development milestone obligations under the Mitsubishi License.

We incurred $0 and $4.0 million of research and development expenses pursuant to the Mitsubishi License during the nine months ended September 30, 2024 and 2023, respectively, that related to the initiation of our pivotal clinical program of lorundrostat.

As of September 30, 2024, we have paid an aggregate of $9.0 million in development milestone payments and have no remaining development milestone obligations under the Mitsubishi License.

We are obligated to use commercially reasonable efforts to conduct and complete the development activities and to file for regulatory approval for at least one Lorundrostat Product in a major market country and consider in good faith developing at least one Lorundrostat Product in a non-major market country.

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Private Placement Offering

On February 7, 2024, we entered into a securities purchase agreement (the Purchase Agreement) with the purchasers named therein (the Purchasers), for the Private Placement of (i) 8,339,169 shares (the Shares) of our common stock at a price of $13.50 per Share, and (ii) with respect to certain Purchasers, Pre-Funded Warrants to purchase an aggregate of 549,755 shares of common stock (the Pre-Funded Warrants) in lieu of shares of common stock, at a purchase price of $13.499 per Pre-Funded Warrant (the shares of common stock

issuable upon exercise of the Pre-Funded Warrants, the Warrant Shares) for aggregate net proceeds of approximately $116.1 million.

We are using the net proceeds from the Private Placement to fund the research and development of lorundrostat and for working capital and general corporate purposes.

Each Pre-Funded Warrant has an exercise price of $0.001 per share of common stock, is immediately exercisable on the date of issuance, and will not expire.

Under the terms of the Pre-Funded Warrants, we may not effect the exercise of any portion of any Pre-Funded Warrant, and a holder will not have the right to exercise any portion of any Pre-Funded Warrant, which, upon giving effect to such exercise, would cause a holder (together with its affiliates) to own more than a specified beneficial ownership limitation of either 4.99%, 9.99%, or 19.99% (as selected by such holder prior to the issuance of the Pre-Funded Warrant) of the number of shares of common stock outstanding immediately after giving effect to such exercise, as such percentage ownership is determined in accordance with the terms of the Pre-Funded Warrants.

ownership is determined in accordance with the terms of the Pre-Funded Warrants.

However, any holder may increase or decrease such percentage to any other percentage not in excess of 19.99%, provided that any increase in such percentage shall not be effective until 61 days after such notice is delivered to us.

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Any sale of the ATM Shares to an Agent as principal would be pursuant to the terms of a separate terms agreement between us and such Agent.

We have not yet sold any ATM Shares as of June 30, 2024.

We have not yet sold any ATM Shares as of September 30, 2024.

Key Components of Results of Operations

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• costs related to manufacturing lorundrostat for our clinical trials.

We plan to substantially increase our research and development expenses for the foreseeable future as we continue the development of lorundrostat.

We have and plan to continue to substantially increase our research and development expenses for the foreseeable future as we continue the development of lorundrostat.

We cannot determine with certainty the timing of initiation, the duration, or the completion costs of current or future clinical trials and preclinical studies of lorundrostat or any future product candidates due to the inherently unpredictable nature of clinical and preclinical development.

Clinical and preclinical development timelines, the probability of success, and development costs can differ materially from expectations.

In addition, we cannot forecast whether lorundrostat or any future product candidates 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.

In addition, we cannot forecast whether lorundrostat or any future product candidates 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.

Our future development costs may vary significantly based on factors such as:

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We expect our general and administrative expenses will increase for the foreseeable future to support our increased research and development activities, manufacturing activities, and the increased costs associated with operating as a public company.

These increased costs will likely include increased expenses

related to the hiring of additional personnel, audit, legal, regulatory, and tax-related services associated with maintaining compliance with the exchange listing and the SEC requirements and requirements of the Sarbanes-Oxley Act of 2002, director and officer insurance costs, and investor and public relations costs.

These increased costs will likely include increased expenses related to the hiring of additional personnel, audit, legal, regulatory, and tax-related services associated with maintaining compliance with the exchange listing and the SEC requirements and requirements of the Sarbanes-Oxley Act of 2002, director and officer insurance costs, and investor and public relations costs.

Other Income, Net

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Results of Operations

Comparison of the Three Months Ended June 30, 2024 and 2023

Comparison of the Three Months Ended September 30, 2024 and 2023

Three Months Ended,

September 30,

2024 2023 Change

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Research and Development Expenses

Research and development expenses increased by $27.4 million for the three months ended June 30, 2024, compared to the three months ended June 30, 2023, which was primarily due to increases of $22.8 million in preclinical and clinical costs driven by the initiation of the lorundrostat pivotal program in the second quarter of 2023 and the Explore-CKD trial in the fourth quarter of 2023, $2.6 million in clinical supply, manufacturing, and regulatory costs, $1.7 million in higher compensation expense resulting from additions to headcount, increases in salaries and accrued bonuses, and increased stock-based compensation, and $0.3 million in other research and development expenses.

Research and development expenses increased by $31.5 million for the three months ended September 30, 2024, compared to the three months ended September 30, 2023, which was primarily due to increases of $26.1 million in preclinical and clinical costs driven by the initiation of the lorundrostat pivotal program in the second quarter of 2023, $3.4 million in clinical supply, manufacturing, and regulatory costs, $1.7 million in higher compensation expense resulting from additions to headcount, increases in salaries and accrued bonuses, and increased stock-based compensation, and $0.3 million in other research and development expenses.

General and Administrative Expenses

General and administrative expenses increased by $2.0 million for the three months ended June 30, 2024, compared to the three months ended June 30, 2023.

The increase was primarily due to $1.5 million in higher compensation expense resulting from additions to headcount, increases in salaries and accrued bonuses, and increased stock-based compensation, and $0.5 million in higher professional fees and other administrative expenses.

General and administrative expenses increased by $2.3 million for the three months ended September 30, 2024, compared to the three months ended September 30, 2023.

The increase was primarily due to $1.7 million in higher compensation expense resulting from additions to headcount, increases in salaries and accrued bonuses, and increased stock-based compensation, and $0.8 million in higher professional fees, partially offset by a decrease of $0.2 million in other administrative expenses.

Total Other Income, Net

Total other income, net increased by $0.6 million for the three months ended June 30, 2024, compared to the three months ended June 30, 2023, which was primarily attributable to increased interest earned on our investments in money market funds and U.S.

Comparison of the Six Months Ended June 30, 2024 and 2023

Six Months Ended,

Total other income, net increased by $0.3 million for the three months ended September 30, 2024, compared to the three months ended September 30, 2023, which was primarily attributable to increased interest earned on our investments in money market funds and U.S.

Comparison of the Nine Months Ended September 30, 2024 and 2023

Nine Months Ended,

September 30,

2024 2023 Change

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Research and Development Expenses

Research and development expenses increased by $45.9 million for the six months ended June 30, 2024, compared to the six months ended June 30, 2023, which was primarily due to increases of $39.7 million in preclinical and clinical costs, driven by the initiation of the lorundrostat pivotal program in the second quarter of 2023 and the Explore-CKD trial in the fourth quarter of 2023, $6.4 million in clinical supply, manufacturing, and regulatory costs, $3.4 million in higher compensation expense resulting from additions to headcount, increases in salaries and accrued bonuses, and increased stock-based compensation, and $0.4 million in other research and development expenses, partially offset by a decrease of $4.0 million in license fees.

Research and development expenses increased by $77.3 million for the nine months ended September 30, 2024, compared to the nine months ended September 30, 2023, which was primarily due to increases of $65.7 million in preclinical and clinical costs, driven by the initiation of the lorundrostat pivotal program in the second quarter of 2023, $9.8 million in clinical supply, manufacturing, and regulatory costs,

$5.1 million in higher compensation expense resulting from additions to headcount, increases in salaries and accrued bonuses, and increased stock-based compensation, and $0.7 million in other research and development expenses, partially offset by a decrease of $4.0 million in license fees.

General and Administrative Expenses

General and administrative expenses increased by $4.0 million for the six months ended June 30, 2024, compared to the six months ended June 30, 2023.

General and administrative expenses increased by $6.4 million for the nine months ended September 30, 2024, compared to the nine months ended September 30, 2023.

The increase was primarily due to $4.5 million in higher compensation expense resulting from additions to headcount, increases in salaries and accrued bonuses, and increased stock-based compensation, $1.4 million in higher professional fees, and $0.5 million in higher other administrative expenses.

Total Other Income, Net

Total other income, net increased by $2.1 million for the six months ended June 30, 2024, compared to the six months ended June 30, 2023, which was primarily attributable to increased interest earned on our investments in money market funds and U.S.

Total other income, net increased by $2.3 million for the nine months ended September 30, 2024, compared to the nine months ended September 30, 2023, which was primarily attributable to increased interest earned on our investments in money market funds and U.S.

Liquidity and Capital Resources

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As of June 30, 2024, we had cash, cash equivalents, and investments of $311.1 million.

As of September 30, 2024, we had cash, cash equivalents, and investments of $263.6 million.

In February 2023, we completed our IPO of 13,800,000 shares of our common stock sold at a price to the public of $16.00 per share, including the exercise in full by the underwriters of their option to purchase 1,800,000 additional shares of our common stock, for net proceeds of approximately $201.4 million, net of underwriting discounts, commissions, and offering costs.

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Funding Requirements

Based on our current operating plan, we believe that our cash, cash equivalents, and investments as of June 30, 2024 will be sufficient to allow us to fund our operations for at least twelve months.

Based on our current operating plan, we believe that our cash, cash equivalents, and investments as of September 30, 2024 will be sufficient to allow us to fund our operations for at least twelve months.

However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially.

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

Debt financing and equity 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.

Debt financing and equity 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.

Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions and the disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from factors that include but are not limited to, inflation, elevated interest rates, geopolitical conflict in and around Ukraine, Israel, and other areas of the world, diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases in unemployment rates, and uncertainty about economic stability.

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If we are unable to raise additional funds through equity or debt financings or other arrangements when needed or on terms acceptable to us, we may be required to delay, limit, reduce, or terminate our product development or future commercialization efforts or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves, or on less favorable terms than we would otherwise choose.

Comparison of the Six Months Ended June 30, 2024 and 2023

Comparison of the Nine Months Ended September 30, 2024 and 2023

Since our inception, we have primarily used our available cash to fund expenditures related to the in-license and development of lorundrostat.

The following table sets forth a summary of cash flows for the periods presented:

Six Months Ended

The following table sets forth a summary of cash flows for the periods presented (in thousands):

Nine Months Ended

September 30,

2024 2023 Change

(in thousands)

Net cash provided by (used in):

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Operating Activities

Net cash used in operating activities of $49.3 million during the six months ended June 30, 2024 increased, compared to $33.2 million during the six months ended June 30, 2023, which was primarily attributable to an increase in cash used to support our operating activities, including but not limited to, the development of lorundrostat and related clinical trial expenses, personnel and compensation expense, legal and professional fees to support our operations, and general working capital requirements.

Net cash used in operating activities was $99.5 million during the nine months ended September 30, 2024, compared to $52.2 million during the nine months ended September 30, 2023, which was primarily attributable to an increase in cash used to support our operating activities, including but not limited to, the development of lorundrostat and related clinical trial expenses, personnel and compensation expense, legal and professional fees to support our operations, and general working capital requirements.

The $47.3 million increase in cash used consisted of an increase in net loss, adjusted for non-cash expenses, of approximately $79.9 million, and the net effect of changes in working capital of $32.7 million.

Investing Activities

Net cash used in investing activities of $48.2 million during the six months ended June 30, 2024 decreased, compared to $156.4 million during the six months ended June 30, 2023.

The decrease was primarily attributable to the timing and amount of purchases and maturities of marketable securities in each period.

During the six months ended June 30, 2024 compared to the six months ended June 30, 2023, an increase in maturities of prior purchases of $140.0 million occurred, which was partially offset by an increase in purchases of $31.8 million.

Net cash provided by investing activities was $31.4 million during the nine months ended September 30, 2024, compared to net cash used of $152.4 million during the nine months ended September 30, 2023.

The change in cash provided by investing activities was primarily attributable to the timing and amount of purchases and maturities of marketable securities in each period.

During the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023, an increase in maturities of prior purchases of $218.5 million occurred, which was partially offset by an increase in purchases of $34.6 million.

Financing Activities

Net cash provided by financing activities of $116.1 million during the six months ended June 30, 2024 decreased, compared to $203.0 million during the six months ended June 30, 2023.

During the six months ended June 30, 2024, we received net proceeds of $116.1 million from the sale of Shares and Pre-Funded Warrants in the Private Placement, and during the six months ended June 30, 2023, we received aggregate gross proceeds of $220.8 million from the sale of our common stock in our IPO in February 2023 and paid $17.8 million of underwriting discounts, commissions, and offering costs in the same period.

Net cash provided by financing activities of $116.1 million during the nine months ended September 30, 2024 decreased, compared to $203.2 million during the nine months ended September 30, 2023.

During the nine months ended September 30, 2024, we received net proceeds of $116.1 million from the sale of Shares and Pre-Funded Warrants in the Private Placement, and during the nine months ended September 30, 2023, we received aggregate net proceeds of $203.0 million from the sale of our common stock in our IPO in February 2023.

Contractual Obligations and Commitments

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however, actual results may differ materially from these estimates under different assumptions or conditions.

There were no changes during the six months ended June 30, 2024 to our critical accounting estimates as disclosed in our Annual Report on Form 10-K for the year ended December 31, 2023.

For information on our

significant accounting policies, please refer to Note 2.

There were no changes during the nine months ended September 30, 2024 to our critical accounting estimates as disclosed in our Annual Report on Form 10-K for the year ended December 31, 2023.

For information on our significant accounting policies, please refer to Note 2.

“ Summary of Significant Accounting Policies ” within our Annual Report on Form 10-K for the year ended December 31, 2023.

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We intend to rely on other exemptions provided by the JOBS Act, including without limitation, not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act of 2002.

We will remain an emerging growth company until the earliest of (i) the last day of the fiscal year following the fifth anniversary of the consummation of our IPO, (ii) the last day of the fiscal year in which we have total annual gross revenue of at least $1.235 billion, (iii) the last day of the fiscal year in which we are deemed to be a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, which would occur if, among other factors, the market value of our common stock held by non-affiliates exceeded $700.0 million as of the last business day of the second fiscal quarter of such year (subject to certain conditions), or (iv) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period.

if, among other factors, the market value of our common stock held by non-affiliates exceeded $700.0 million as of the last business day of the second fiscal quarter of such year (subject to certain conditions), or (iv) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period.

We are also a smaller reporting company as defined in the Exchange Act.

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Recently Issued Accounting Pronouncements

We have reviewed all recently issued accounting pronouncements and have determined that, other than as disclosed elsewhere in this Quarterly Report, such standards do not have a material impact on our consolidated financial statements or do not otherwise apply to our operations.

We have reviewed all recently issued accounting pronouncements and have determined that, other than as disclosed elsewhere in this Quarterly Report, such standards do not have a material impact on our condensed financial statements or do not otherwise apply to our operations.

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