What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-05-12 compared with 2024-11-12 · 146 added, 105 removed, 154 unchanged (62% of the section changed)

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The following discussion and analysis and the unaudited interim financial statements included in this Quarterly Report on Form 10-Q (Quarterly Report) should be read in conjunction with the financial statements and notes thereto for the year ended December 31, 2024 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in the Annual Report on Form 10-K for the year ended December 31, 2024.

Forward-Looking Statements

Special Note Regarding Forward-Looking Statements

This Quarterly Report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act).

All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding our future results of operations and financial position, business strategy, research and development plans, the anticipated timing, costs, design, and conduct of our ongoing and planned preclinical studies and planned clinical trials for lorundrostat and any future product candidates, the timing and likelihood of regulatory filings and approvals for lorundrostat and any future product candidates, our ability to commercialize our product candidates, if approved, the potential to develop future product candidates, the potential benefits of strategic collaborations and our intent to enter into any strategic arrangements, the timing and likelihood of success, and plans and objectives of management for future operations and future results of anticipated product development efforts, are forward-looking statements.

These statements involve known and unknown risks, uncertainties, and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements, including macroeconomic trends and uncertainty with regard to high interest rates, elevated inflation, tariffs, and the potential for a local and/or global economic recession.

This Quarterly Report also contains estimates and other statistical data made by independent parties and by us relating to market size and growth and other data about our industry.

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

Our clinical-stage product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor (ASI) that we are initially developing for the treatment of cardiorenal conditions affected by dysregulated aldosterone, including hypertension and chronic kidney disease (CKD).

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 aldosterone synthase inhibitor (ASI) that we are developing for the treatment of cardiorenal conditions affected by dysregulated aldosterone, including hypertension, chronic kidney disease (CKD), and obstructive sleep apnea (OSA).

In the United States, there are approximately 120 million patients with sustained elevated blood pressure (BP), or hypertension, and more than half of this population fails to achieve their BP goals, defined as BP 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 proof-of-concept clinical trial evaluating 200 subjects with uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), lorundrostat demonstrated a clinically meaningful and statistically significant reduction in BP with once-daily dosing and was well tolerated.

Dysregulated aldosterone levels are a key factor in driving hypertension in approximately 30% of hypertensive patients.

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

In March 2025, we announced that our pivotal trials Launch-HTN and Advance-HTN, both of which evaluated the efficacy and safety of lorundrostat for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), successfully achieved statistical significance and were clinically meaningful in their primary efficacy endpoints and demonstrated a favorable safety and tolerability profile.

Based on the outcome of Launch-HTN and Advance-HTN, we anticipate a pre-new drug application (NDA) meeting with the U.S.

Food and Drug Administration (FDA) in the fourth quarter of 2025 as we prepare the NDA for lorundrostat for the treatment of uHTN and rHTN.

We also believe the Launch-HTN and Advance-HTN results demonstrate the opportunity for lorundrostat in third-line or later treatment of patients with hypertension.

Our ongoing Transform-HTN open-label extension trial allows subjects to continue to receive lorundrostat and generate additional safety and efficacy data.

In addition to hypertension, we are investigating the potential benefits of lorundrostat in subjects with hypertension and CKD and in subjects with hypertension and OSA.

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

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.

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.

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

Clinical Program Highlights

Launch-HTN was a large, global, randomized, double-blind, placebo-controlled Phase 3 clinical trial that evaluated 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.

Subjects were randomized into three cohorts for twelve weeks receiving one of the following treatments:

lorundrostat 50 mg once daily (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 was 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.

We announced the results of our pivotal trials in March 2025, which are summarized in detail below.

The Launch-HTN trial has been accepted as a late-breaking presentation at the 2025 European Society of Hypertension Meeting on Hypertension and Cardiovascular Protection, which is being held in Milan, Italy on May 23-26, 2025.

Advance-HTN was a randomized, double-blind, placebo-controlled Phase 2 clinical trial that evaluated 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.

Subjects who met screening criteria 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 receiving one of the following treatments:

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 Advance-HTN was change in 24-hour ambulatory systolic BP at week twelve from baseline for each active cohort versus placebo.

We announced the results of our pivotal trials in March 2025, which are summarized in detail below.

The Advance-HTN trial results were recently presented in a late-breaking presentation at the American College of Cardiology’s ACC.25 and published on May 8th in the New England Journal of Medicine.

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 (estimated glomerular filtration rate (eGFR) greater than or equal to 30 mL/min/1.73m 2 ) and albuminuria despite receiving stable treatment with an angiotensin-converting enzyme inhibitor 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.

Randomization of 60 subjects was completed in the first quarter of 2025, 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.

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.

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.

Lorundrostat has been developed to address dysregulated aldosterone, and we believe this mechanism may be applicable to other indications where dysregulated aldosterone biology plays a role.

Most recently, we have begun to explore lorundrostat for patients with OSA and hypertension.

In January 2025, we announced that the FDA cleared our investigational new drug application for Explore-OSA to evaluate the effect of lorundrostat in the treatment of overweight and obese subjects with moderate-to-severe OSA and hypertension.

Explore-OSA is a placebo-controlled, crossover trial that will evaluate the safety and efficacy of lorundrostat 50 mg QD in the evening in approximately 40 subjects with hypertension and moderate-to-severe OSA.

Subjects will be at least 18 years old, with a systolic BP ≥ 130 mmHg and ≤ 160 mmHg, with a body mass index (BMI) ≥27 kg/m 2 , and the trial will be conducted across approximately 40 sites.

The key objective of this trial is to evaluate the hypothesis that lorundrostat both alleviates the severity of upper airway obstruction and reduces nocturnal hypertension.

The primary outcome measure is absolute change in the frequency of apnea-hypopnea episodes compared to placebo.

The key secondary objective is to quantify BP throughout the night using continuous BP monitoring during performance of a standard sleep study without the use of CPAP.

Standard patient-reported outcomes specific to OSA will also be assessed.

We initiated Explore-OSA in the first quarter of 2025, and enrollment is ongoing.

Pivotal Program Clinical Trial Results

Efficacy Results

The Launch-HTN trial was a global, randomized, double-blinded, placebo-controlled Phase 3 trial, which enrolled eligible adult participants who failed to achieve their BP goal despite being on two to five antihypertensive medications.

Launch-HTN reflects the real-world setting for clinicians by utilizing automated office blood pressure measurement and allowing participants to stay on their existing medications.

The trial met its endpoints demonstrating clinically meaningful, statistically significant mean reduction from baseline in placebo-adjusted systolic BP at week six, and the benefit was sustained with potential further reduction through week 12.

Launch-HTN Phase 3 Trial

(automated office systolic BP measure, n=1,083 randomized)

Week 6 (50 mg pooled)

Placebo-Adjusted

50 mg -16.9 mmHg -9.1 mmHg

(p<0.0001)* -19.0 mmHg

50 to100 mg -15.7 mmHg

* Primary endpoint

Key characteristics of subjects enrolled in the Launch-HTN trial include:

approximately 63% had a BMI greater than or equal to 30kg/m2, approximately 47% were women, and approximately 29% were Black or African American.

The Advance-HTN trial was a randomized, double-blind, placebo-controlled Phase 2 pivotal trial that evaluated the efficacy and safety of lorundrostat for the treatment of confirmed uHTN or rHTN, when used as add-on therapy to an optimized background treatment of two or three antihypertensive medications in adult subjects.

The trial was designed to evaluate lorundrostat in an uHTN or rHTN population at the highest risk and which would normally be treated by a specialist given severity of their condition.

The trial met its primary endpoint as well as additional prespecified outcome measures, including measures of efficacy in the dose-escalation cohort, safety, and tolerability, and were consistent with those observed in the Launch-HTN trial.

Advance-HTN Phase 2 Trial

(24-hour ambulatory systolic BP, n=285 randomized)

Week 4 (50 mg pooled)

Placebo-Adjusted

50 mg -11.5 mmHg

50 to100 mg -13.9 mmHg

* Primary endpoint

Key characteristics of subjects enrolled in the Advance-HTN trial include:

approximately 66% had a BMI greater than or equal to 30kg/m2, approximately 40% were women, and approximately 53% were Black or African American.

Safety and Tolerability Results

We believe clinical safety findings in the two pivotal trials, including adrenocorticotropic hormone (ACTH)-stimulated and serum cortisol, change in serum potassium, serum sodium, and eGFR, as well as incidence of hypotension, support a favorable benefit-risk profile.

In the two active treatment arms of the Launch-HTN trial, 50 mg and 50 mg with optional dose escalation to 100 mg, the incidence of treatment-emergent serious adverse events (SAEs) was twelve subjects (2.2%) and two subjects (0.7%), respectively, compared with eight subjects (3.0%) in the placebo arm.

There was only one subject (0.1%) in the trial with treatment-related SAE that occurred in the 50 mg arm.

The incidence of hyperkalemia (serum potassium >6.0 mmol/L) at the scheduled study visit was 1.1% and 1.5% in the 50 mg and 50 to 100 mg arms, respectively.

The per-protocol procedure for validation of suspected factitious hyperkalemia (most often due to phlebotomy-related hemolysis and release of potassium from red blood cells) specified a repeat potassium measurement within 72 hours while still taking study medication to

confirm validity and provide an accurate determination of the true incidence of hyperkalemia.

After exclusion of the spurious results, the incidence of confirmed hyperkalemia was 0.6% and 1.1%, respectively.

In the Advance-HTN trial, there were six subjects (6.4%) and eight subjects (8.4%) with treatment-emergent SAEs in the lorundrostat 50 mg and lorundrostat 50 to 100 mg, respectively, compared to two subjects (2.1%) in the placebo arm.

Treatment-related SAEs occurred in 2%, 1%, and 0% of subjects in the lorundrostat 50 mg, lorundrostat 50 to 100 mg, and placebo arms, respectively.

The incidence of hyperkalemia (serum potassium >6.0 mmol/L) at the scheduled study visit was 5.3% and 7.4% in the 50 mg and 50 to 100 mg arms, respectively.

After exclusion of the spurious results, the incidence of confirmed hyperkalemia was 2.1% and 3.2%, respectively.

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

As of March 31, 2025, we had cash, cash equivalents, and investments of $343.0 million.

From inception through the date of this Quarterly Report, we raised aggregate gross proceeds of approximately $700.0 million from the sale of common stock, convertible preferred stock, convertible notes, and pre-funded warrants.

In February 2023, we completed our initial public offering (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 IPO were approximately $201.4 million, net of underwriting discounts, commissions, and offering costs.

In March 2025, we sold 14,907,406 shares of common stock for net proceeds of approximately $188.7 million after deducting an underwriting discount of 6% and other offering expenses.

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 net proceeds of approximately $116.1 million, net of offering expenses, in a private placement offering (the Private Placement).

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

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

Our net losses for the three months ended March 31, 2025 and 2024 were $42.2 million and $31.5 million, respectively.

As of March 31, 2025 and December 31, 2024, we had an accumulated deficit of $344.7 million and $302.5 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.

We expect our expenses and operating losses will increase substantially as we conduct our ongoing and planned clinical trials for lorundrostat, seek regulatory approval for lorundrostat and potentially 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 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.

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.

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 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 have no remaining development milestone obligations under the Mitsubishi License and did not incur any development or commercial expenses pursuant to the Mitsubishi License during the three months ended March 31, 2025 and 2024.

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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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.

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.

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.

We registered the resale of the Shares and the Warrant Shares on a shelf registration statement on Form S-3 (Registration No.

333-278122), which was declared effective by the SEC on April 11, 2024 (the Registration Statement).

Pursuant to the Purchase Agreement, we agreed to use our reasonable best efforts to keep the 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.

Public Offering

In March 2025, we entered into an underwriting agreement (the Underwriting Agreement) with BofA Securities, Inc., Evercore Group L.L.C.

and Goldman Sachs & Co.

LLC as representatives of the several underwriters named therein (collectively, the Underwriters), relating to the issuance and sale of 14,907,406 shares of the Company’s common stock at a price of $13.50 per share for net proceeds of approximately $188.7 million after deducting an underwriting discount of 6% and other offering expenses.

The offering was made pursuant to our shelf registration statement on Form S-3 (Registration Statement No.

333-278122) previously filed with and declared effective by the SEC (the Registration Statement), and a prospectus supplement and accompanying prospectus filed with the SEC.

We are using the net proceeds from this offering to fund the clinical development of lorundrostat, including research and development, manufacturing, and pre-commercialization activities, as well as for working capital and general corporate purposes.

At Market Equity Offering Sales Agreement

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Pursuant to the terms of the ATM Agreement, we may sell from time to time through the Agents shares of our common stock having an aggregate offering price of up to $100,000,000 (the ATM Shares).

Any ATM Shares will be issued pursuant to the Registration Statement.

Sales of the ATM Shares, if any, will be made by means of ordinary brokers’ transactions on the Nasdaq Global Select Market or as otherwise agreed by us and the Agents.

Any ATM Shares

will be issued pursuant to the Registration Statement.

Sales of the ATM Shares will be made by means of ordinary brokers’ transactions on the Nasdaq Global Select Market or as otherwise agreed by us and the Agents.

Under the terms of the ATM Agreement, we may also sell the ATM Shares from time to time to an Agent as principal for its own account at a price to be agreed upon at the time of sale.

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 September 30, 2024.

As of March 31, 2025, we had not yet sold any ATM Shares.

Private Placement Offering

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.

We registered the resale of the Shares and the Warrant Shares on the Registration Statement.

Key Components of Results of Operations

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• salaries, bonuses, employee benefits, and stock-based compensation charges for those individuals involved in research and development efforts;

• external research and development expenses incurred under agreements with contract research organizations (CROs) and consultants to conduct and support our clinical trials of lorundrostat, and payments made under the Mitsubishi License;

• external research and development expenses incurred under agreements with contract research organizations (CROs) and consultants to conduct and support our clinical trials of lorundrostat;

• costs related to manufacturing lorundrostat for our clinical trials;

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.

• costs related to advancing our commercial readiness activities in preparation for a potential launch of lorundrostat for patients with uHTN or rHTN, if approved by the FDA.

We have increased 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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• our ability to receive timely regulatory approvals for lorundrostat, any future product candidates, and additional indications of lorundrostat and any future product candidates, in the jurisdictions in which we or any future partners apply for such approvals;

• the costs and timing of manufacturing lorundrostat or any future product candidates for use in our trials, including as a result of inflation, any supply chain issues, or component shortages;

• the costs and timing of manufacturing lorundrostat or any future product candidates for use in our trials, including as a result of inflation, changes in international trade policies and tariffs, any supply chain issues, or component shortages;

• any additional jurisdictions in which we may seek approval for lorundrostat and any future product candidates and timing of seeking approval in such jurisdictions;

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Other significant general and administrative expenses include legal fees relating to intellectual property and corporate matters, professional fees for accounting, tax and consulting services, and insurance costs.

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.

associated with operating as a public company.

Other Income, Net

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Results of Operations

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

Comparison of the Three Months Ended March 31, 2025 and 2024

Three Months Ended,

September 30,

2025 2024 Change

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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 $2.3 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 $0.3 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

(in thousands)

Research and development expenses $ (124,012) $ (46,676) $ (77,336)

General and administrative expenses (16,624) (10,270) (6,354)

Total other income, net 11,772 9,437 2,335

Net loss $ (128,864) $ (47,509) $ (81,355)

Research and Development Expenses

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.

Research and development expenses increased by $7.1 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024, which was primarily due to increases of $4.8 million in preclinical and clinical costs and $2.8 million in compensation expense resulting from additions to headcount, increases in salaries and accrued bonuses, and increased stock-based compensation, partially offset by $0.5 million in lower clinical supply, manufacturing, and regulatory costs.

General and Administrative Expenses

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.

General and administrative expenses increased by $2.0 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024.

The increase was primarily due to $1.2 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 higher professional fees.

Total Other Income, Net

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.

Total other income, net decreased by $1.6 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024, which was primarily attributable to decreased 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 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.

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.

In February 2024, we sold 8,339,169 Shares and, to certain Purchasers, 549,755 Pre-Funded Warrants for aggregate net proceeds of approximately $116.1 million 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.

From inception through the date of this Quarterly Report, we raised aggregate gross proceeds of approximately $700.0 million from the sale of common stock, convertible

preferred stock, convertible notes, and pre-funded warrants.

As of March 31, 2025, we had cash, cash equivalents, and investments of $343.0 million.

In March 2025, we sold 14,907,406 shares of common stock for net proceeds of approximately $188.7 million after deducting an underwriting discount of 6% and other offering expenses.

In February 2024, we sold 8,339,169 Shares and, to certain Purchasers, 549,755 Pre-Funded Warrants for aggregate net proceeds of approximately $116.1 million in the Private Placement.

Our primary uses of cash to date have been to fund our research and development and other 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 September 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 March 31, 2025 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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• 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 any pandemic or other healthcare emergency;

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

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

• the other risks and uncertainties described under the heading “ Risk Factor s” in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2023 and in “ Forward-Looking Statements ” and elsewhere in this Quarterly Report.

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

• the other risks and uncertainties described under the heading “ Risk Factor s ,” “ Special Note Regarding Forward-Looking Statements , ” and elsewhere in this Quarterly 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.

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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.

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.

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, geopolitical conflict in and around Ukraine, Israel, and other areas of the world, inflation, changes in international trade policies and tariffs, 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.

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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 Nine Months Ended September 30, 2024 and 2023

Comparison of the Three Months Ended March 31, 2025 and 2024

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 (in thousands):

Nine Months Ended

September 30,

Three Months Ended

2025 2024 Change

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Operating Activities

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.

Net cash used in operating activities was $45.5 million during the three months ended March 31, 2025, compared to $19.1 million during the three months ended March 31, 2024, resulting in an increase that 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 $26.3 million increase in cash used consisted of the net effect of changes in working capital of $18.6 million and an increase in net loss, adjusted for non-cash expenses, of approximately $7.8 million.

Investing Activities

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.

Net cash used in investing activities was $92.9 million for the three months ended March 31, 2025, compared to $56.0 million for the three months ended March 31, 2024.

The increase in cash used was primarily driven by the timing and volume of purchases and maturities of marketable securities in each period.

There was a $32.5 million decrease in maturities of previously purchased marketable securities, partially offset by a $4.5 million increase in purchases of marketable securities during the three months ended March 31, 2025 compared to the three months ended March 31, 2024.

Financing Activities

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.

Net cash provided by financing activities of $189.3 million during the three months ended March 31, 2025 increased, compared to $116.2 million during the three months ended March 31, 2024.

During the three months ended March 31, 2025, we received net proceeds of $189.2 million from the sale of common stock in a public offering, and during the three months ended March 31, 2024, we received net proceeds of $116.1 million from the sale of Shares and Pre-Funded Warrants in the Private Placement.

Contractual Obligations and Commitments

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See above and Note 4.

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

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

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.

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The preparation of these condensed 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 condensed 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 prepaid and accrued research and development expenses and stock-based compensation.

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;

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

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.

There were no changes during the three months ended March 31, 2025 to our critical accounting estimates as disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024.

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

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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.

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 initial public offering in February 2023, (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.

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

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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