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Item 2. Management’s Discussion and Analysis

2025-08-12 compared with 2025-05-12 · 136 added, 78 removed, 222 unchanged (49% of the section changed)

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

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 and related comorbidities such as 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.

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

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.

Our research and development has been committed to clinical trials researching the benefits of lorundrostat for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN) and hypertensive patients with CKD and OSA.

In the first half of 2025, we announced the positive results of our pivotal program for lorundrostat (Advance-HTN and Launch-HTN) and our Phase 2 Explore-CKD trial, which are described further below.

Research to date has demonstrated the opportunities for lorundrostat as a solution for patients in the treatment of hypertension, including hypertensive patients with CKD and OSA.

We also believe, based on available clinical data, that our product candidate holds promise to be an innovative solution for the rapidly growing unmet need in multiple cardiorenal metabolic disorders.

Clinical Program Highlights

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 uHTN or 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 are planning to conduct 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 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.

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

The Launch-HTN trial results were presented in a late-breaking presentation at the 2025 European Society of Hypertension Meeting on Hypertension and Cardiovascular Protection in May 2025 and published in the June 30, 2025 issue of the Journal of the American Medical Association (JAMA, DOI:10.1001/jama.9413).

The Advance-HTN trial results were presented in a late-breaking presentation at the American College of Cardiology’s Annual Scientific Session & Expo (ACC.25) held in March 2025 and published in the April 23, 2025 issue of the New England Journal of Medicine (NEJM, DOI:

10.1056/NEJMoa2501440).

In June 2025, we announced positive topline data from our Phase 2 Explore-CKD trial evaluating the safety and efficacy of 25 mg of lorundrostat in addition to a sodium-glucose cotransporter 2 (SGLT2) inhibitor for the treatment of hypertension in participants with hypertension and comorbid CKD.

The trial was highly statistically significant and was clinically meaningful in both endpoints and demonstrated a favorable safety and tolerability profile.

Greater detail of the results of these trials is described below.

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

All participants in the pivotal hypertension

program, including the Advance-HTN and Launch-HTN trials, as well as the Explore-CKD trial, were given the opportunity to participate in the extension trial.

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.

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 participants 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 once daily (QD) in the evening in approximately 40 participants with hypertension and moderate-to-severe OSA.

Participants will be at least 18 years old, with a systolic BP ≥ 130 mmHg and ≤ 180 mmHg, with a body mass index (BMI) ≥27 kg/m 2 , and the trial will be conducted across approximately 35 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.

The key secondary objective is to quantify BP throughout the night using continuous BP monitoring during the 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.

We anticipate reporting topline results from Explore-OSA in the first half of 2026.

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 was a large, global, randomized, double-blinded, placebo-controlled Phase 3 clinical 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.

Participants were 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 six based on defined criteria or placebo.

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.

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* Primary endpoint

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

Key characteristics of participants 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.

add-on therapy to a standardized background treatment of two or three antihypertensive medications in adult participants.

Participants 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.

Participants 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.

The trial was designed to evaluate lorundrostat in a 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.

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* Primary endpoint

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

Key characteristics of participants 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.

We believe clinical safety findings in the two pivotal trials, including adrenocorticotropic hormone-stimulated and serum cortisol, change in serum potassium, serum sodium, and estimated glomerular filtration rate (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 participants (2.2%) and two participants (0.7%), respectively, compared with eight participants (3.0%) in the placebo arm.

There was only one participant (0.1%) in the trial with a 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.

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

After exclusion of the spurious results, the incidence of confirmed hyperkalemia was 0.6% and 1.1% in the 50 mg and 50 to 100 mg arms, respectively.

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

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

Explore-CKD Clinical Trial Results

Efficacy, Safety, and Tolerability Results

The Explore-CKD trial was a randomized, double-blind, placebo controlled, two-period, two-sequence (2x2) crossover trial.

This phase 2 trial was designed to evaluate efficacy in terms of systolic BP and urine albumin-to-creatinine ratio (UACR) reduction, and safety of four-week 25 mg QD lorundrostat added to a background treatment that included an SGLT2 inhibitor and an angiotensin-converting enzyme inhibitor (ACEi) or an ARB in CKD participants with an eGFR ≥ 30 mL/min/1.73m 2 and albuminuria (UACR of 200-5,000 mg/g).

The primary endpoint was placebo-adjusted change from baseline in systolic BP at week four, and an exploratory endpoint was placebo-adjusted percent change from baseline in UACR at week four.

The trial was highly statistically significant and was clinically meaningful in both of these endpoints and demonstrated a favorable safety and tolerability profile.

Explore-CKD Phase 2 Trial (N=59)

Placebo Lorundrostat 25 mg

Placebo-Adjusted

Change in systolic BP (mmHg)* -1.76 -9.25 -7.5 (p=0.0024)

Change in spot UACR (mg/g) -6.60% -30.51% -25.60% (p=0.0015)

Change in eGFR** (mL/min/1.73m 2 )

-2.20% -6.78% -4.58% (p=0.0362)

Treatment Emergent Adverse Events (TEAEs) leading to discontinuation of study drug

Confirmed hyperkalemia*** (K + >6.0 mmol/L)

0/59 (0%) 3/58 (5%)

BP, blood pressure;

UACR, Urine albumin-to-creatinine ratio;

TEAE, Treatment-emergent adverse event

* Primary endpoint.

** Cystatin-C formula, a surrogate biomarker of renal function not subject to MATE1 transport and elimination in the glomeruli of the kidney.

*** Per protocol Systolic BP, UACR, and eGFR estimates and p values from Mixed Effects Model for a crossover trial with multiple baselines.

SAEs were reported in two participants (3%) during the lorundrostat treatment period and none during the placebo treatment period.

TEAEs leading to discontinuation occurred in one participant (2%) during the placebo treatment period and in two participants (3%) during the lorundrostat treatment period.

During lorundrostat treatment, one participant discontinued treatment due to elevation of potassium associated with reduced eGFR, and one participant discontinued treatment due to reduction in eGFR alone.

During the lorundrostat treatment period, an anticipated, modest decrease in mean eGFR was observed (-6.8% lorundrostat, -4.6% mL/min/1.73m 2 placebo-adjusted).

Reduction in eGFR is also seen with other renin-angiotensin-aldosterone pathway inhibitors, including ACE inhibitors, ARBs and mineralocorticoid receptor antagonists.

This is the result of a reduction in the deleterious over-perfusion of glomeruli due, in part, to reduced BP.

These findings add to a growing body of evidence supporting the efficacy and safety of aldosterone synthase inhibitors in addressing the underlying mechanisms of hypertension, including in individuals with

reduced kidney function and albuminuria.

The reduction in UACR observed in this trial is consistent with the potential of lorundrostat to have renal protective effects.

The Explore-CKD trial was designed to provide data that augments the antihypertensive profile of lorundrostat by evaluating the efficacy and safety of lorundrostat in participants with compromised renal function.

We had already completed three trials of lorundrostat for the treatment of participants with uHTN, including rHTN, the pivotal Phase 3 Launch-HTN and Phase 2 Advance-HTN trials, and the Phase 2, dose-ranging, Target-HTN trial, which demonstrated clinically meaningful reductions in systolic BP and a favorable safety and tolerability profile.

We continue to study lorundrostat in the ongoing, open-label Transform-HTN extension trial, which is evaluating long-term efficacy, safety, and tolerability.

Additionally, the Explore-OSA trial, initiated in the first quarter of 2025, continues to enroll participants with OSA and uHTN, and we anticipate topline results in the first half of 2026.

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 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.

As of June 30, 2025, we had cash, cash equivalents, and investments of $324.9 million.

Since inception, we have raised aggregate gross proceeds of approximately $717.4 million from the sale of common stock, convertible preferred stock, convertible notes, and pre-funded warrants.

Beginning in April 2025 and through August 12, 2025, we have sold an aggregate of 1,237,944 ATM Shares for aggregate net proceeds of approximately $17.4 million after deducting commission to the Agents and other related 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.

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Our operations to date have been limited to business planning, raising capital, in-licensing and developing lorundrostat, conducting clinical trials, and other research and development 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 for the six months ended June 30, 2025 and 2024 were $85.5 million and $72.5 million, respectively.

As of June 30, 2025 and December 31, 2024, we had an accumulated deficit of $388.0 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.

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

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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as our sales agents (the Agents) and/or principals.

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

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 $100.0 million (the ATM Shares).

The 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.

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

Beginning in April 2025 and through June 30, 2025, we sold an aggregate of 674,518 ATM Shares at a weighted-average price of $14.15 per share for aggregate net proceeds of approximately $9.5 million after deducting commissions to the Agents and other related costs.

As of June 30, 2025, we had approximately $90.5 million of ATM Shares remaining available for sale pursuant to the ATM Agreement.

Subsequent to June 30, 2025 and through August 12, 2025, we sold an additional 563,426 ATM Shares at a weighted-average price of $14.03 per share for aggregate net proceeds of approximately $7.9 million after deducting commissions to the Agents.

Private Placement Offering

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• 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;

• the drop-out or discontinuation rates of clinical trial patients;

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

• the drop-out or discontinuation rates of clinical trial participants;

• potential additional safety monitoring requested by regulatory agencies;

• the duration of patient participation in the trials and follow-up;

• the duration of participant participation in the trials and follow-up;

• the phase of development of the product candidate;

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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, investor and public relations costs, business development, and medical affairs.

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Results of Operations

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

Comparison of the Three Months Ended June 30, 2025 and 2024

Three Months Ended,

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Research and Development Expenses

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.

Research and development expenses decreased by $1.0 million for the three months ended June 30, 2025, compared to the three months ended June 30, 2024, which was primarily due to a decrease of $4.5 million in preclinical and clinical costs driven by the conclusion of the lorundrostat pivotal program in the second quarter of 2025, partially offset by increases of $2.7 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 clinical supply, manufacturing, regulatory, and other costs.

General and 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.

General and administrative expenses increased by $2.6 million for the three months ended June 30, 2025, compared to the three months ended June 30, 2024.

The increase was primarily due to $1.9 million in higher compensation expense resulting from additions to headcount, increases in salaries and accrued bonuses, and increased stock-based compensation, $0.6 million in higher professional fees, and $0.1 million in other administrative expenses.

Total Other Income, Net

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.

Total other income, net decreased by $0.7 million for the three months ended June 30, 2025, compared to the three months ended June 30, 2024, which was primarily attributable to decreased interest earned on our

investments in money market funds and U.S.

treasuries as a result of lower average cash balances invested during the three months ended June 30, 2025.

Results of Operations

Comparison of the Six Months Ended June 30, 2025 and 2024

Six Months Ended,

2025 2024 Change

(in thousands)

Research and development expenses $ (76,157) $ (70,027) $ (6,130)

General and administrative expenses (15,036) (10,503) (4,533)

Total other income, net 5,708 8,008 (2,300)

Net loss $ (85,485) $ (72,522) $ (12,963)

Research and Development Expenses

Research and development expenses increased by $6.1 million for the six months ended June 30, 2025, compared to the six months ended June 30, 2024, which was primarily due to an increase of $5.6 million in compensation expense resulting from additions to headcount, increases in salaries and accrued bonuses, and increased stock-based compensation, $0.3 million in higher preclinical and clinical costs, and $0.2 million in clinical supply, manufacturing, and regulatory costs.

General and Administrative Expenses

General and administrative expenses increased by $4.5 million for the six months ended June 30, 2025, compared to the six months ended June 30, 2024.

The increase was primarily due to $3.1 million in higher compensation expense resulting from additions to headcount, increases in salaries and accrued bonuses, and increased stock-based compensation, $1.3 million in higher professional fees, and $0.1 million in other administrative expenses.

Total Other Income, Net

Total other income, net decreased by $2.3 million for the six months ended June 30, 2025, compared to the six months ended June 30, 2024, which was primarily attributable to decreased interest earned on our investments in money market funds and U.S.

treasuries as a result of lower average cash balances invested during the six months ended June 30, 2025.

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 $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.

Since inception, we have raised aggregate gross proceeds of approximately $717.4 million from the sale of common stock, convertible preferred stock, convertible notes, and pre-funded warrants.

As of June 30, 2025, we had cash, cash equivalents, and investments of $324.9 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.

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Funding Requirements

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.

Based on our current operating plan, we believe that our cash, cash equivalents, and investments as of June 30, 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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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.

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, Iran 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 Three Months Ended March 31, 2025 and 2024

Comparison of the Six Months Ended June 30, 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):

Three Months Ended

Six Months Ended

2025 2024 Change

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Operating Activities

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.

Net cash used in operating activities was $75.7 million during the six months ended June 30, 2025, compared to $49.3 million during the six months ended June 30, 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 $26.4 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 $7.7 million.

Investing Activities

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.

Net cash used in investing activities was $135.8 million for the six months ended June 30, 2025, compared to $48.2 million for the six months ended June 30, 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.

There was a $92.5 million decrease in maturities of previously purchased marketable securities, partially offset by a $4.9 million decrease in purchases of marketable securities during the six months ended June 30, 2025 compared to the six months ended June 30, 2024.

Financing Activities

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.

Net cash provided by financing activities of $199.1 million during the six months ended June 30, 2025, increased compared to $116.1 million during the six months ended June 30, 2024.

During the six months ended June 30, 2025, we received net proceeds of $188.9 million from the sale of common stock in a public offering and $8.9 million from the sale of ATM Shares, and during the six months ended June 30, 2024, we received net proceeds of $116.1 million from the sale of Shares and Pre-Funded Warrants in the Private Placement.

Additionally, during the six months ended June 30, 2025, we received increased proceeds of $1.0 million from stock option exercises as compared to the six months ended June 30, 2024.

Contractual Obligations and Commitments

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

There were no changes during the 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.

There were no changes during the six months ended June 30, 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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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