What changed in this filing

/stocks — the workspaceLOADING

Item 7. Management’s Discussion and Analysis

2024-03-21 compared with 2023-03-15 · 94 added, 87 removed, 160 unchanged (53% of the section changed)

3 unchanged sentences

We are a clinical-stage biopharmaceutical company focused on developing medicines to target diseases driven by abnormally elevated aldosterone.

Our product candidate, lorundrostat, is a proprietary, orally administered, highly selective ASI that we are initially developing for the treatment of patients with uHTN or rHTN.

In the United States, there are over 115 million patients who have sustained elevated blood pressure (BP), or hypertension and more than half of this population fails to achieve their BP goals, defined as BP of below 130/80 mmHg, with currently available medications.

Our clinical-stage product candidate, lorundrostat, is a proprietary, orally administered, highly selective ASI that we are initially developing for the treatment of cardiorenal conditions affected by abnormally elevated aldosterone, including hypertension and CKD.

In the United States,

there are over 115 million patients who have sustained elevated BP, or hypertension, and more than half of this population fails to achieve their BP goals, defined as BP of below 130/80 mmHg, with currently available medications.

There are over 30 million treated patients who do not achieve their BP goal, of whom approximately 20 million have systolic BP levels greater than 140 mmHg.

Patients with hypertension that persists despite taking two or more medications have 1.8 and 2.5 times greater mortality risk due to either cardiovascular disease or stroke, respectively.

In a Phase 2 clinical trial evaluating 200 subjects with uHTN and rHTN, lorundrostat demonstrated a clinically meaningful and statistically significant reduction in BP with once-daily dosing and was well tolerated.

In addition to hypertension, we intend to develop lorundrostat for the treatment of CKD and believe that our product candidate holds promise to be an innovative solution for the rapidly growing unmet need in multiple cardiorenal disorders.

We plan to initiate our ADVANCE-HTN trial, a randomized, double-blind, placebo-controlled Phase 2 clinical trial in the first half of 2023 to evaluate the safety and efficacy of lorundrostat for the treatment of uHTN and rHTN, when used as an add-on therapy to standardized background treatment of two or three antihypertensive medications in up to approximately 300 adult subjects.

The topline data from this trial is expected in the first half of 2024.

We also plan to initiate a randomized, double-blind, placebo-controlled Phase 3 trial in the second half of 2023 to evaluate the safety and efficacy of lorundrostat for the treatment of uHTN and rHTN, when used as an add-on therapy to background treatment of two or more antihypertensive medications in up to approximately 1,000 adults.

The trial is expected to have a similar design as the planned Phase 2 trial.

The topline data from this trial is expected in mid-2025.

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

We plan to initiate a randomized, double-blind, placebo-controlled Phase 2 trial in mid-2023 to evaluate the safety and efficacy of lorundrostat for the treatment of uHTN and rHTN in a CKD population with expected topline data from this trial in the first half of 2024.

Uninhibited aldosterone is known to play a critical role in the progression of CKD, which affects over 23 million people in the United States.

Furthermore, we may expand the development of lorundrostat into additional cardiorenal indications.

In a Phase 2 proof-of-concept clinical trial evaluating 200 subjects with uHTN or rHTN, lorundrostat demonstrated a clinically meaningful and statistically significant reduction in BP with once-daily dosing and was well tolerated.

Abnormally elevated aldosterone levels are a key factor in driving hypertension in approximately 25% of hypertensive patients.

In addition to hypertension, we intend to investigate the benefits of lorundrostat in subjects with hypertension and CKD.

We believe that our product candidate holds promise to be an innovative solution for the rapidly growing unmet need in multiple cardiorenal metabolic disorders.

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 safety and efficacy 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 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.

The primary endpoint of the trial will be change in 24-hour ambulatory systolic BP at week twelve from baseline for active cohorts versus placebo.

Topline data from this trial is anticipated in the fourth quarter of 2024.

In December 2023, we also initiated our second pivotal trial, Launch-HTN, a randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate the safety and efficacy 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:

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.

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

Topline data from this trial is expected in the second half of 2025.

In mid-2023, we initiated an open-label extension trial to allow subjects to continue to receive lorundrostat and obtain long-term safety and efficacy 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 abnormal 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 is being modified 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.

We will also have all study participants stay on an SGLT2 inhibitor throughout the course of the trial.

We have also decided to lower the eGFR criteria for the proof-of-concept study from 45ml/

min/1.73m2 to 30ml/min/1.73m2 and have eliminated the original Part B profiling portion of the study.

Lastly, the study periods will be reduced from eight weeks to four weeks which we believe will provide ample time to demonstrate clinical benefit on BP reduction and kidney benefit.

The primary endpoint remains change in systolic BP and an exploratory endpoint is percent change from baseline in 24-hour urinary albumin creatinine ratio at week four.

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

Topline data from this trial continues to be anticipated between the fourth quarter of 2024 and the first quarter of 2025.

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 December 31, 2022, we had cash, cash equivalents, and marketable securities of $110.1 million.

From inception to December 31, 2022, we raised aggregate gross proceeds of approximately $158 million from the issuance of convertible promissory notes (the Convertible Notes) and convertible preferred stock.

As of December 31, 2023, we had cash, cash equivalents, and investments of $239.0 million.

From inception through the date of this Annual 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.

In February 2023, we completed our IPO of 13,800,000 shares of our common stock 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.

Including the option exercise, our aggregate net proceeds from the offering were approximately $202.0 million, net of underwriting discounts, commissions and estimated offering costs.

Including the option exercise, our aggregate net proceeds from the IPO were approximately $201.4 million, net of underwriting discounts, commissions, and offering costs.

In February 2024, we sold 8,339,169 shares of common stock and, to certain purchasers, 549,755 pre-funded warrants to purchase common stock for aggregate gross proceeds of approximately $120.0 million, before deducting offering expenses, in a private placement.

We do not have any products approved for sale, have not generated any revenue, and have incurred net losses since our inception.

1 unchanged sentence

Our net losses for the years ended December 31, 2023 and 2022 were $71.9 million and $29.8 million, respectively.

As of December 31, 2022 and 2021, we had an accumulated deficit of $52.8 million and $23.0 million, respectively.

As of December 31, 2023 and December 31, 2022, we had an accumulated deficit of $124.7 million and $52.8 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.

We expect our expenses and operating losses will increase substantially as we conduct our ongoing and planned clinical trials for lorundrostat, potentially seek regulatory approval for lorundrostat and any future product candidates we may develop, expand our clinical, regulatory, quality, manufacturing, and commercialization capabilities, obtain, maintain, protect and enforce our intellectual property, expand our general and administrative support functions, including hiring additional personnel, and incur additional costs associated with operating as a public company.

Based on our current operating plan, we believe that our existing cash, cash equivalents, and marketable securities, including the cash proceeds received from our IPO, will be sufficient to allow us to fund our operations for at least the next 12 months.

We have never generated any revenue and do not expect to generate any revenue from product sales unless and until we successfully complete development of, and obtain regulatory approval for, lorundrostat, which will not be for several years, if ever.

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

We have never generated any revenue and do not expect to generate any revenue from product sales unless and until we successfully complete the development of, and obtain regulatory approval for, lorundrostat, which will not be for several years, if ever.

Accordingly, until such time as we can generate significant revenue from sales of lorundrostat, if ever, we expect to finance our cash needs through equity offerings, debt financings, or other capital sources, including potential collaborations, licenses, and other similar arrangements.

2 unchanged sentences

For more information, see “ Liquidity and Capital Resources.

The global COVID-19 pandemic continues to evolve, and we will continue to monitor the COVID-19 situation closely.

We have not experienced a material impact from the COVID-19 pandemic to date;

however, the extent of the impact of the COVID-19 pandemic on our business, operations, and clinical development timelines and plans remains uncertain, and will depend on certain developments, including its impact on our clinical trial enrollment, trial sites, manufacturers, CROs, and other third parties with whom we do business, as well as its impact on regulatory authorities and our key scientific and management personnel.

The ultimate impact of the COVID-19 pandemic, including the impact of new variants of the virus that causes COVID-19, or a similar health pandemic is highly uncertain and subject to change.

To the extent possible, we are conducting business as usual, with necessary or advisable modifications to employee travel and most of our employees working remotely.

We will continue to actively monitor the evolving situation related to COVID-19 and may take further actions that alter our operations, including those that may be required by federal, state, or local authorities, or that we determine are in the best interests of our employees and other third parties with whom we do business.

At this point, the extent to which the COVID-19 pandemic may affect our business, operations, and development timelines and plans, including the resulting impact on our expenditures and capital needs, remains uncertain and is subject to change.

License Agreement with Mitsubishi Tanabe

In July 2020, we entered into a license agreement (the Mitsubishi License) with Mitsubishi Tanabe, pursuant to which Mitsubishi Tanabe granted us an exclusive, worldwide, royalty-bearing, sublicensable license under Mitsubishi Tanabe’s patent and other intellectual property rights to exploit products incorporating lorundrostat (formerly MT-4129) (Lorundrostat Products) for the prevention, treatment, diagnosis, detection, monitoring, or predisposition testing with respect to indications, diseases, and conditions in humans.

We paid Mitsubishi Tanabe a $1.0 million upfront fee, and we are obligated to pay Mitsubishi Tanabe development milestone payments of up to $9.0 million in the aggregate and commercial milestone payments of up to $155.0 million in the aggregate upon first commercial sale and upon meeting certain annual sales targets, as well as additional commercial milestone payments of up to $10.0 million for a second indication.

In July 2020, we entered into the Mitsubishi License with Mitsubishi Tanabe, pursuant to which Mitsubishi Tanabe granted us an exclusive, worldwide, royalty-bearing, sublicensable license under Mitsubishi Tanabe’s patent and other intellectual property rights to exploit Lorundrostat Products for the prevention, treatment, diagnosis, detection, monitoring, or predisposition testing with respect to indications, diseases, and conditions in humans.

Pursuant to the Mitsubishi License, we paid Mitsubishi Tanabe a $1.0 million upfront fee and development milestone payments of $9.0 million in the aggregate.

We have remaining obligations to pay Mitsubishi Tanabe commercial milestone payments of up to $155.0 million in the aggregate upon first commercial sale and upon meeting certain annual sales targets, as well as additional commercial milestone payments of up to $10.0 million for a second indication.

Additionally, we are obligated to pay Mitsubishi Tanabe tiered royalties at percentages ranging from the mid-single digits to ten percent (10%) of aggregate net sales of each Lorundrostat Product on a Lorundrostat Product-by-Lorundrostat Product and country-by-country basis, until the later of (i) the expiration of the last-to-expire valid Mitsubishi Tanabe patent claim covering a Lorundrostat Product, (ii) ten years from the first commercial sale of a Lorundrostat Product, or (iii) the expiration of regulatory exclusivity in such country.

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

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 to develop at least one Lorundrostat Product in a non-major market country.

If we elect to sublicense our rights under the Mitsubishi License to a third party with respect to exploitation of lorundrostat or any Lorundrostat Product in certain countries in Asia, Mitsubishi Tanabe has a right of first negotiation, for a specified period of time.

We incurred $9.0 million and $0 of research and development expenses related to the Mitsubishi License during the years ended December 31, 2023 and 2022, respectively.

The development milestones of $4.0 million and $5.0 million were achieved in March 2023 and December 2023, respectively, and related to the initiation of our pivotal clinical program of lorundrostat.

These payments satisfied in full the aggregate development milestone payments described above.

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.

If we elect to sublicense our rights under the Mitsubishi License to a third party with respect to exploitation of lorundrostat or any Lorundrostat Product in certain countries in Asia, we have agreed to negotiate such a sublicense first, for a specified period of time, with Mitsubishi Tanabe, if Mitsubishi Tanabe notifies us that it would like to obtain such a sublicense.

We also agreed not to commercialize any competing product prior to three years following the first commercial sale of the first Lorundrostat Product in any country without Mitsubishi Tanabe’s prior consent.

For additional information regarding the Mitsubishi License, including termination provisions, see “Business—Intellectual property—License agreement with Mitsubishi Tanabe.”

For additional information regarding the Mitsubishi License, including termination provisions, see “ Business—License Agreement with Mitsubishi Tanabe .”

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 (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 gross proceeds of approximately $120.0 million, before deducting offering expenses.

We expect to use 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.

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.

Pursuant to the Purchase Agreement, the Company agreed to file a registration statement with the SEC within 60 days after the closing of the Private Placement (subject to certain exceptions) for purposes of registering the resale of the Shares and the Warrant Shares, to use its reasonable best efforts to have such registration statement declared effective within the time period set forth in the Purchase Agreement, and to keep such registration statement effective until the earliest of (i) the time as all of the Shares and Warrant Shares purchased by the Purchasers pursuant to the terms of the Purchase Agreement have been sold pursuant to the registration statement, or (ii) such time as the Shares and Warrant Shares become eligible for resale by non-affiliates without any volume limitations or other restrictions pursuant to Rule 144 under the Securities Act or any other rule of similar effect.

Key Components of Results of Operations

12 unchanged sentences

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

modifications to clinical development plans based on feedback that we may receive from regulatory authorities;

• the initiation, type, number, scope, progress, expansions, results, costs, and timing of clinical trials and preclinical studies of lorundrostat and any future product candidates we may choose to pursue, including any modifications to clinical development plans based on feedback that we may receive from regulatory authorities;

• our ability and strategic decision to develop future product candidates other than lorundrostat, and the timing of such development, if any;

6 unchanged sentences

• the phase of development of the product candidate;

• the impact of any interruptions to our operations or to those of the third parties with whom we work due to the ongoing COVID-19 pandemic;

• the efficacy and safety profile of the relevant product candidate;

4 unchanged sentences

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 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 (Expense), Net

Interest Income (Expense)

Interest income during 2022 is associated with our investments in money market funds and U.S.

Interest expense during 2021 consisted of interest on our outstanding Convertible Notes described below prior to their conversion into shares of our Series A convertible preferred stock in February 2021.

Change in Fair Value of Convertible Notes

We issued Convertible Notes in 2019 and 2020 for which we elected the fair value option.

We adjusted the carrying value of our Convertible Notes to their estimated fair value as of December 31, 2021, with the change in fair value of the Convertible Notes recorded as an increase to change in fair value of Convertible Notes in our statements of operations.

All outstanding Convertible Notes and related accrued interest converted into shares of our Series A convertible preferred stock in February 2021.

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

Interest Income, Net

Interest income reported in each period is associated with our investments in money market funds and U.S.

treasuries, net of fees, or other related expenses.

Results of Operations

Comparison of the Years Ended December 31, 2023 and 2022

2023 2022 Change

(in thousands)

1 unchanged sentence

General and administrative expenses (14,296) (5,229) (9,067)

Total other income (expense), net 1,680 (683)

Total other income, net 12,759 1,680 11,079

Net loss $ (71,898) $ (29,799) $ (42,099)

Research and Development Expenses

Research and development expenses increased by $9.9 million for the year ended December 31, 2022, compared to the year ended December 31, 2021, which was primarily due to increases of $7.4 million in preclinical and clinical costs related to the research and development of lorundrostat, $1.7 million for clinical supply, manufacturing, and regulatory costs, and $0.9 million in personnel expenses for additional employees to support research and development.

We began a proof-of-concept Phase 2 clinical trial in the United States in mid-2021.

Costs related to executing our clinical trial was the primary driver of the increase in our research and development expense.

Research and development expenses increased by $44.1 million for the year ended December 31, 2023, compared to the year ended December 31, 2022, which was primarily due to increases of $21.4 million in preclinical and clinical costs, driven by the initiation of the lorundrostat pivotal program beginning in the second quarter of 2023, $9.0 million in license fees under the Mitsubishi License upon achieving a development milestones of lorundrostat in March and December of 2023, $7.8 million in clinical supply, manufacturing, and regulatory costs, $5.6 million in higher compensation expense resulting from additions to headcount and stock-based compensation, and $0.3 million in other research and development expenses.

General and Administrative Expenses

General and administrative expenses increased by $9.1 million for the year ended December 31, 2023, compared to the year ended December 31, 2022.

The increase was primarily due to higher professional fees of $1.7 million related to accounting, legal, and other support, and personnel expenses of $1.1 million associated with additional employees.

Total Other Income (Expense), Net

Total other income changed by $2.4 million for the year ended December 31, 2022, compared to total other expense for the year ended December 31, 2021 and was primarily attributable to an increase in interest income of $1.7 million related to interest earned on our investments in money market funds and U.S.

treasuries during the year ended December 31, 2022 and expense of $0.7 million for changes in fair value of our Convertible Notes during the year ended December 31, 2021.

The Convertible Notes were converted into Series A convertible preferred stock in February 2021, and no changes in fair value were recorded subsequent to that date.

The increase was primarily due to $3.8 million in higher professional fees associated with operating as a public company, $3.4 million in higher compensation expense resulting from additions to headcount and stock-based compensation, $1.1 million of higher insurance expense primarily associated with new director and officer insurance policies, and $0.8 million in higher other administrative expenses.

Total Other Income, Net

Total other income, net increased by $11.1 million for the year ended December 31, 2023, compared to the year ended December 31, 2022, which was primarily attributable to increased interest earned on our investments in money market funds and U.S.

Liquidity and Capital Resources

We have incurred net losses and negative cash flows from operations since our inception and anticipate we will continue to incur net losses and have negative cash flows from operations for the foreseeable future as we continue the development of, seek regulatory approval for, and potentially commercialize lorundrostat, seek to identify, assess, acquire, and in-license intellectual property related to or develop additional product candidates and operate as a public company.

From inception to December 31, 2022, we raised aggregate gross proceeds of approximately $158 million from the issuance of Convertible Notes and convertible preferred stock.

As of December 31, 2022, we had cash, cash equivalents, and marketable securities of $110.1 million.

Including the option exercise, our aggregate net proceeds from the offering were approximately $202.0 million, net of underwriting discounts, commissions and estimated offering costs.

Prior to our IPO, during the year ended December 31, 2022, we funded our operations primarily through private placements of our Series A and B convertible preferred stock with aggregate net proceeds of $129.6 million.

As of December 31, 2023, we had cash, cash equivalents, and investments of $239.0 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.

In February 2024, we sold 8,339,169 Shares and, to certain Purchasers, 549,755 Pre-Funded Warrants for aggregate gross proceeds of approximately $120.0 million, before deducting offering expenses, in a private placement.

Our primary uses of cash to date have been to fund our research and development activities, including with respect to lorundrostat, business planning, establishing and maintaining our intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these operations.

Funding Requirements

Based on our current operating plan, we believe that our cash, cash equivalents, and investments as of December 31, 2023 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.

8 unchanged sentences

• the costs, timing, and outcome of regulatory meetings and reviews of lorundrostat or any future product candidates;

• any delays and cost increases that may result from the COVID-19 or any future pandemic;

• any delays and cost increases that may result from any pandemic or other healthcare emergency;

• the costs of obtaining, maintaining, enforcing, and protecting our patents and other intellectual property and proprietary rights;

7 unchanged sentences

• costs associated with any products or technologies that we may in-license or acquire;

• the other risks and uncertainties described in “Risk Factors,” “Special Note Regarding Forward-Looking Statements and Market Data” and elsewhere in this Annual Report.

• the other risks and uncertainties described under the heading “ Risk Factors , ” “ Forward-Looking Statements and Market Data ,” and elsewhere in this Annual Report.

Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through equity offerings, debt financings, or other capital sources, including potential collaborations, licenses, and other similar arrangements.

We do not have any committed external source of funds.

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.

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.

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, the conflict between Russia and Ukraine and other factors, diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases in unemployment rates, and uncertainty about economic stability.

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.

If the equity and credit markets deteriorate, it may make any necessary debt or equity financing more difficult, more costly, and more dilutive.

2 unchanged sentences

Comparison of the Years Ended December 31, 2023 and 2022

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

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:

7 unchanged sentences

Net cash used in operating activities of $81.2 million during the year ended December 31, 2023 increased, compared to $29.2 million during the year ended December 31, 2022, 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 $14.7 million increase in cash used consisted of an increase in net loss of $10.4 million, the net effect of changes in working capital of $3.3 million, and a decrease in non-cash operating expenses of $1.0 million.

The $52.0 million increase in cash used consisted of an increase in net loss, adjusted for non-cash expenses of approximately $43.7 million and the net effect of changes in working capital of $8.3 million.

Investing Activities

Net cash used in investing activities of $21.8 million during the year ended December 31, 2022 increased, compared to zero during the year ended December 31, 2021, which was attributable to $71.8 million in our investments in short-term marketable securities during the year ended December 31, 2022 subsequent to our receipt of cash proceeds from the issuance of Series A and B convertible preferred stock in 2022, partially offset by maturities of these investments of $50.0 million during the year ended December 31, 2022.

Net cash used in investing activities of $160.5 million during the year ended December 31, 2023 increased, compared to $21.8 million during the year ended December 31, 2022, which was attributable to increased purchases of marketable securities of $276.2 million during the year ended December 31, 2023 subsequent to receiving cash proceeds from our IPO in February 2023, partially offset by increased maturities of marketable securities of $137.5 million during the year ended December 31, 2023.

Financing Activities

Net cash provided by financing activities of $203.2 million during the year ended December 31, 2023 increased, compared to $128.0 million during the year ended December 31, 2022.

During the year ended December 31, 2022, we received $129.6 million in aggregate net proceeds from the issuance of our Series A and B convertible preferred stock and

paid $1.6 million in deferred offering costs associated with the IPO.

During the year ended December 31, 2021, we received $23.8 million in net proceeds from the issuance and sale of our Series A convertible preferred stock.

During the year ended December 31, 2023, we received net proceeds of $203.0 million from the sale of our common stock in our IPO in February 2023.

During the year ended December 31, 2022, we received $129.6 million in net proceeds from the issuance and sale of our Series A and Series B convertible preferred stock.

Contractual Obligations and Commitments

Under the Mitsubishi License, we have milestone payment obligations that are contingent upon the achievement of certain development milestones and specified levels of product sales and are required to make certain royalty payments in connection with the sale of products developed under the agreement.

We are currently unable to estimate the timing or likelihood of achieving the milestones or making future product sales.

Under the Mitsubishi License, we have milestone payment obligations that are contingent upon the achievement of specified levels of product sales and are required to make certain royalty payments in connection with the sale of products developed under the agreement.

We are currently unable to estimate the timing or likelihood of achieving other future milestones or making future product sales.

See above and Note 4.

“ Commitments and Contingencies ” to our financial statements included elsewhere in this Annual Report for additional information regarding the Mitsubishi License.

For additional information regarding the Mitsubishi License, see “Business—Mineralys’ License Agreement with Mitsubishi Tanabe Pharma Corporation.”

We enter into contracts in the normal course of business for contract research services, contract manufacturing services, professional services, and other services and products for operating purposes.

These contracts generally provide for termination after a notice period, and, therefore, are cancelable contracts.

Critical Accounting Policies and Significant Judgments and Estimates

Critical Accounting Estimates

We have prepared the financial statements in accordance with accounting principles generally accepted in the United States of America.

The preparation of these financial statements requires us to make estimates, assumptions, and judgments that affect the reported amounts of assets, liabilities, expenses, and related disclosures at the date of the financial statements, and the reported amounts of expenses during the reporting period.

On an ongoing basis, management evaluates its critical estimates, including those related to accrued research and development expenses.

On an ongoing basis, management evaluates its critical estimates, including those related to prepaid and accrued research and development expenses.

We base our estimates on our historical experience and on assumptions that we believe are reasonable;

16 unchanged sentences

Payments under some of these contracts depend on factors such as the enrollment of patients and the completion of clinical trial milestones.

In accruing costs, we estimate the period over which services will be performed and the level of effort to be expended in each period based upon patient enrollment, clinical site activations, or information provided to us by our vendors on their actual costs incurred.

In accruing costs, we estimate the period over which services will be performed and the level of effort to be expended in each period based on patient enrollment, clinical site activations, or information provided to us by our vendors on their actual costs incurred.

Any estimates of the level of services performed or the costs of these services could differ from actual results.

To date, we have not experienced significant changes in our estimates of accrued research and development expenses after a reporting period.

However, due to the nature of estimates, we cannot assure that we will not make changes

to our estimates in the future as we become aware of additional information about the status or conduct of our clinical trials and other research activities.

Fair Value Option for Convertible Notes

We elected to account for our Convertible Notes at fair value in order to measure those liabilities at amounts that more accurately reflected the current economic environment in which the Company operates.

We recorded the Convertible Notes at fair value at the date of each issuance with changes in fair value recorded in earnings at each reporting period until their conversion into Series A convertible preferred stock in February 2021.

The fair value of the Convertible Notes was determined using a guideline transaction method valuation model.

Significant assumptions used to determine the fair value of the put feature include the estimated probability of exercise of the put option and the discount rate used to calculate fair value.

The estimated probability of exercise is based on management’s expectation for future equity financing transactions.

The discount rate is based on the weighted-average effective yield of notes previously issued by the Company, adjusted for changes in market yields of biotechnology sector CCC-rated debt.

However, due to the nature of estimates, we cannot assure that we will not make changes to our estimates in the future as we become aware of additional information about the status or conduct of our clinical trials and other research activities.

Determination of the Fair Value of our Common Stock

20 unchanged sentences

Changes in the assumptions can materially affect the fair value and ultimately how much stock-based compensation expense is recognized.

These inputs are subjective and generally require significant analysis and judgment to develop.

These inputs are

subjective and generally require significant analysis and judgment to develop.

“ Summary of Significant Accounting Policies ” of the notes to our financial statements included elsewhere in this Annual Report for information concerning certain of the specific assumptions we used in applying the Black-Scholes option pricing model to determine the estimated fair value of our stock options granted during 2023 and 2022.

The intrinsic value of all outstanding options as of December 31, 2022 was $20.5 million, based on the IPO price of $16.00 per share, of which approximately $3.8 million was related to vested options and approximately $16.7 million was related to unvested options.

JOBS Act and Smaller Reporting Company Status

2 unchanged sentences

We have elected to use the extended transition period for complying with new or revised accounting standards and as a result of this election, our financial statements may not be comparable to companies that comply with public company effective dates.

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 Sarbanes-Oxley.

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.

5 unchanged sentences

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-K

Item 7. Management’s Discussion and Analysis