What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2026-08-11 compared with 2026-05-06 · 139 added, 79 removed, 160 unchanged (58% of the section changed)

4 unchanged sentences

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 (including the anticipated timing of any U.S.

Food and Drug Administration’s (FDA) approval of our new drug application (NDA) that was submitted to the FDA for lorundrostat for the treatment of hypertension when used in combination with other antihypertensive drugs in December 2025) 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, plans and objectives of management for future operations and future results of anticipated product development efforts, and the sufficiency of our cash, cash equivalents and investments to fund our operations, are forward-looking statements.

Food and Drug Administration’s (FDA) approval of our new drug application (NDA) that was submitted to the FDA for lorundrostat for the treatment of hypertension when used in combination with other antihypertensive drugs in December 2025) 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, plans and objectives of management for future operations and future results of anticipated product development efforts, and the sufficiency of our cash, cash equivalents, and investments to fund our operations and satisfy our debt obligations, 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 the timing, volume, and nature of feedback or requests from the FDA in connection with our NDA submission, macroeconomic trends and uncertainty with regard to high interest rates, elevated inflation, tariffs and other trade policies, geopolitical conflict, and the potential for a local and/or global economic recession.

11 unchanged sentences

Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances, or otherwise.

All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

All forward-looking statements are qualified in their entirety by this cautionary

statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

This Quarterly Report includes trademarks, trade names, and service marks that are the property of other organizations.

Solely for convenience, trademarks and trade names referred to in this Quarterly Report appear without the ® and ™ symbols, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights, or that the applicable owner will not assert its rights, to these trademarks and trade names.

We are a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA), and other diseases driven by dysregulated aldosterone.

Our initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor.

We have now completed six clinical trials of lorundrostat supporting its efficacy and safety profile while also validating aldosterone as an integral therapeutic target in uncontrolled hypertension (uHTN) and resistant hypertension (rHTN).

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

Our initial product candidate, lorundrostat, is an investigational, proprietary, orally administered, highly selective aldosterone synthase inhibitor that we are developing for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), as well as related comorbidities, such as chronic kidney disease (CKD), obstructive sleep apnea (OSA), and other diseases driven by dysregulated aldosterone.

We have completed six clinical trials of lorundrostat supporting its efficacy and safety profile while also validating aldosterone as an integral therapeutic target in uHTN and rHTN.

The clinical program includes two pivotal, registrational trials, the Phase 3 Launch-HTN trial and Phase 2 Advance-HTN trial, which support the robust, durable, and clinically meaningful reductions in systolic blood pressure (BP) by lorundrostat.

9 unchanged sentences

Transform-HTN is an open-label extension trial that is ongoing and enables participants to continue to receive lorundrostat and allows us to gather additional long-term safety and efficacy 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.

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

On March 9, 2026, we announced topline data from our exploratory Phase 2 Explore-OSA trial that evaluated the effect of lorundrostat in the treatment of overweight and obese participants with moderate-to-severe OSA and hypertension.

After four weeks of treatment, lorundrostat 50 mg dosed in the evening did not demonstrate a clinically meaningful difference relative to placebo on the apnea-hypopnea index, the primary endpoint.

The trial demonstrated a clinically meaningful reduction in BP at week four, with an 11.1 mmHg (p <

0.0001) and a 1.0 mmHg (p = NS) BP reduction with lorundrostat and placebo, respectively, in the pre-planned parallel arm analysis of the first period.

After four weeks of treatment, lorundrostat 50 mg dosed in the evening did not demonstrate a clinically meaningful difference relative to placebo on the apnea-hypopnea index, the primary

The trial demonstrated a clinically meaningful reduction in BP at week four, with an 11.1 mmHg (p < 0.0001) and a 1.0 mmHg (p = NS) BP reduction with lorundrostat and placebo, respectively, in the pre-planned parallel arm analysis of the first period.

There was a 6.2 mmHg placebo-adjusted reduction (p < 0.0003) in BP in the crossover analysis.

3 unchanged sentences

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, 2026, we had cash, cash equivalents, and investments of $646.1 million.

Since inception, we have raised aggregate gross proceeds of approximately $1.1 billion from the sale of common stock, convertible preferred stock, pre-funded warrants, and convertible notes.

Our net losses for the three months ended March 31, 2026 and 2025 were $39.3 million and $42.2 million, respectively.

As of March 31, 2026 and December 31, 2025, we had an accumulated deficit of $496.5 million and $457.2 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 commenced our operations in May 2019 and have devoted substantially all of our resources to date to fund research and development activities, business planning, establishing and maintaining our intellectual property portfolio, advancing regulatory activities, staffing our company, initiating commercial-readiness activities, raising capital, and providing general and administrative support for our operations.

As of June 30, 2026, we had cash, cash equivalents, and investments of $661.4 million.

Since inception, we have raised aggregate gross proceeds of approximately $1.4 billion from sales of common stock, convertible preferred stock, pre-funded warrants, and convertible notes, as well as borrowings under the Loan Agreement (as defined and further described below).

Our net losses for the six months ended June 30, 2026 and 2025 were $280.4 million and $85.5 million, respectively.

As of June 30, 2026 and December 31, 2025, we had an accumulated deficit of $737.6 million and $457.2 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, the timing and outcome of the regulatory review of our NDA for lorundrostat by the FDA, and the extent of our commercial-readiness activities in anticipation of potential FDA approval.

We anticipate that certain expenses will increase substantially as we prepare for a potential approval and launch of lorundrostat, including the following:

• conducting ongoing regulatory activities, including responding to FDA information requests, supporting a potential advisory committee meeting (not anticipated currently), preparing for potential approval and post-marketing commitments, and commercial launch of lorundrostat;

• continuing to expand our pre-commercial organization, including building out medical affairs, market access, health economics and outcomes research, regulatory, quality, manufacturing, and commercial functions;

• continuing to expand our pre-commercial organization, including building out our sales, medical affairs, market access, health economics and outcomes research, regulatory, quality, manufacturing, and other commercial functions;

• obtaining, maintaining, protecting, and enforcing our intellectual property;

5 unchanged sentences

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 .”

Tanabe License Agreement

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

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

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

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

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

We have no remaining development milestone obligations under the Tanabe License and did not incur any development or commercial expenses pursuant to the Tanabe License during the three months ended March 31, 2026 and 2025.

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

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

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

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

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

On June 2, 2026, we entered into a fourth amendment to the Tanabe License (the Fourth Amendment), pursuant to which our obligation to pay Tanabe royalties on net sales of Lorundrostat Products was terminated, the license was amended and restated to grant us an exclusive, worldwide, royalty-free, sublicensable, perpetual, irrevocable license, and our diligence obligations with respect to the ongoing development and commercialization of lorundrostat were eliminated.

As consideration, we made an upfront cash payment to Tanabe of $200.0 million and agreed to pay additional commercial milestone payments of up to $100.0 million in the aggregate (the New Milestones).

As a result of the Fourth Amendment, we have remaining obligations to pay Tanabe commercial milestone payments, including the New Milestones, of up to $255.0 million in the aggregate upon first commercial sale and upon meeting certain annual sales targets, as well as up to $10.0 million related to commercialization for a potential second indication.

The New Milestones become immediately due and payable by us upon certain change-of-control transactions.

Within a specified period following execution of the Fourth Amendment, the parties agreed to enter into an agreement to terminate the Tanabe License, pursuant to which, among other things, Tanabe will assign to us all of Tanabe’s rights in the licensed intellectual property.

Senior Secured Term Loan

On June 2, 2026, we entered into a senior secured term loan agreement (the Loan Agreement) with BioPharma Credit PLC, as collateral agent, and each of BPCR Limited Partnership and BioPharma Credit Investments V (Master) LP, which are funds managed by Pharmakon Advisors, LP, as lenders.

The Loan Agreement provides for a five‑year senior secured term loan of up to $500.0 million, maturing on June 3, 2031 (the Maturity Date), consisting of the following tranches (collectively, the Term Loans):

(i) a Tranche A Loan of $100.0 million, which was drawn on June 2, 2026;

(ii) a Tranche B Loan of $150.0 million, which is required to be drawn no later than April 30, 2027, subject to approval by the FDA of the lorundrostat NDA (the Tranche B Approval Condition);

(iii) a Tranche C Loan of $150.0 million, which is available at our election until December 14, 2028, subject to the occurrence of the Tranche B Approval Condition and the achievement of certain net sales milestones;

and (iv) a Tranche D Loan of $100.0 million, which is available at our election until June 14, 2029, subject to the draw of the Tranche C Loan and the achievement of certain net sales milestones.

As of June 30, 2026, we had drawn the $100.0 million Tranche A Loan, and the Tranche B Loan, Tranche C Loan, and Tranche D Loan were undrawn.

The Maturity Date is subject to acceleration to June 30, 2028 if the Tranche B Approval Condition is not satisfied on or before September 30, 2027.

The Term Loans bear interest at a rate per annum equal to the three‑month secured overnight financing rate (SOFR) (subject to a 3.25% floor) plus 5.50%, payable quarterly in arrears.

At inception of the Tranche A Loan, the applicable interest rate was 9.15%.

We are required to pay a funding fee equal to 2.00% of the funding amount on the funding date of each Term Loan, and paid a funding fee of $2.0 million in connection with the Tranche A Loan.

We may elect to prepay the Term Loans in whole or, subject to certain conditions, in part prior to the Maturity Date, subject to certain prepayment, make‑whole, and exit fees.

The Term Loans are subject to certain mandatory prepayments, including a repayment of all Term Loans in four equal installments commencing on September 30, 2027 to the extent the Tranche B Approval Condition is not met on or prior to September 30, 2027.

Each Term Loan requires us to pay a final fee equal to 1.5% of the original principal

amount of such Term Loan (the Final Fee), due upon the earlier of the Maturity Date or prepayment of the applicable Term Loan.

The Final Fee associated with the Tranche A Loan is fixed at $1.5 million and will not increase.

However, the aggregate Final Fee payable under the Loan Agreement will increase if additional Term Loan tranches are drawn, as each additional tranche would be subject to its own Final Fee.

Borrowings under the Term Loans are secured by substantially all of our assets, subject to certain exceptions.

The Loan Agreement contains financial covenants, including a minimum liquidity requirement and, with respect to the fiscal year ending December 31, 2028 and then tested quarterly commencing with the fiscal quarter ending March 31, 2029, a minimum trailing twelve-month consolidated net product revenue covenant.

As of June 30, 2026, we were in compliance with all covenants under the Loan Agreement.

Upon the occurrence of an event of default under the Loan Agreement, the lenders may, among other things, accelerate our obligations under the Loan Agreement, and upon an event of default relating to certain insolvency, liquidation, bankruptcy, or similar events, all outstanding obligations under the Loan Agreement will be automatically accelerated.

In connection with the Tranche A Loan, we received gross proceeds of $100.0 million.

We recognized a debt discount of $2.0 million and incurred $2.1 million in debt issuance costs, which were comprised of amounts paid to third parties and lenders.

We allocated a portion of the debt issuance costs to the undrawn future Term Loans and recognized a long-term deferred asset in the amount of $1.7 million, which will be amortized to interest expense on a straight-line basis over the period to which the related borrowing capacity is available.

As of June 30, 2026, the unamortized debt discounts and debt issuance costs of approximately $2.0 million and $0.4 million, respectively, were recorded as a reduction of the carrying amount of the Tranche A Loan and are being amortized to interest expense over the term of the Tranche A Loan using the effective interest method.

The effective interest rate on the Tranche A Loan was 9.91% as of June 30, 2026.

Public Offerings

On March 11, 2025, we entered into an underwriting agreement relating to the issuance and sale of 14,907,406 shares of our 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 offering expenses.

On June 3, 2026, we entered into an underwriting agreement with BofA Securities, Inc., Goldman Sachs & Co.

LLC, and Evercore Group L.L.C., relating to the issuance and sale of 5,660,378 shares of our common stock at a price of $26.50 per share for net proceeds of approximately $143.6 million after deducting underwriting discounts and 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.

333-291435 ), filed with the SEC on November 10, 2025, and a prospectus supplement and accompanying prospectus filed with the SEC on June 3, 2026.

We used the net proceeds from the offering to fund a portion of the $200.0 million upfront payment made on June 2, 2026 to Tanabe upon execution of the Fourth Amendment (as further described above).

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, 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.

2 unchanged sentences

LLC, pursuant to which we may sell shares of our common stock having an aggregate offering price of up to $300.0 million from time to time.

During the three months ended March 31, 2026, we sold pursuant to the ATM Agreement an aggregate of 568,320 shares of common stock at a weighted-average price of $35.66 per share for aggregate net proceeds of approximately $20.2 million after deducting commissions and offering expenses.

There were no sales of common stock pursuant to the ATM Agreement during the three months ended March 31, 2025.

From inception of the ATM Agreement and through March 31, 2026, we sold an aggregate of 2,720,508 shares of common stock at a weighted-average price of $41.45 per share for aggregate net proceeds of approximately $112.4 million after deducting commissions and offering expenses.

As of March 31, 2026, approximately $187.2 million of shares remained available for sale pursuant to the ATM Agreement.

During the six months ended June 30, 2026, we sold pursuant to the ATM Agreement an aggregate

of 568,320 shares of common stock at a weighted-average price of $35.66 per share for aggregate net proceeds of approximately $20.2 million after deducting commissions and offering expenses.

No shares of common stock were sold pursuant to the ATM Agreement during the three months ended June 30, 2026, or during the three and six months ended June 30, 2025.

From inception of the ATM Agreement and through June 30, 2026, we sold an aggregate of 2,720,508 shares of common stock at a weighted-average price of $41.45 per share for aggregate net proceeds of approximately $112.4 million after deducting commissions and offering expenses.

As of June 30, 2026, approximately $187.2 million of shares remained available for sale pursuant to the ATM Agreement.

On March 21, 2024, we entered into an ATM Equity Offering Sales Agreement (the Prior ATM Agreement) with BofA Securities, Inc.

1 unchanged sentence

Effective November 9, 2025, the Prior ATM Agreement was terminated in connection with the execution of the ATM Agreement.

There were no sales of common stock pursuant to the Prior ATM Agreement during each of the three months ended March 31, 2026 and March 31, 2025.

There were no sales of common stock pursuant to the Prior ATM Agreement during each of the three and six months ended June 30, 2026.

During the three and six months ended June 30, 2025, we sold pursuant to the Prior ATM Agreement an aggregate of 674,518 shares of common stock at a weighted-average price of $14.15 per share for aggregate net proceeds of approximately $9.5 million after deducting commissions and offering expenses.

From inception of the Prior ATM Agreement and through its termination effective November 9, 2025, we sold an aggregate of 1,914,040 shares of common stock at a weighted-average price of $14.32 per share for aggregate net proceeds of approximately $27.3 million after deducting commissions and offering expenses.

8 unchanged sentences

• costs related to advancing our commercial-readiness activities in preparation for a potential launch of lorundrostat for patients with hypertension, if approved by the FDA;

• fees incurred under the Tanabe License;

• allocated overhead.

2 unchanged sentences

However, we anticipate that certain other expenses will increase substantially as we:

• conduct ongoing regulatory activities, including responding to FDA information requests, supporting a potential advisory committee meeting (not anticipated currently), preparing for potential approval and post-marketing commitments, and commercial launch of lorundrostat;

• conduct ongoing regulatory activities, including responding to FDA information requests, supporting a potential advisory committee meeting (not anticipated currently), preparing for

potential approval and post-marketing commitments, and potential commercial launch of lorundrostat;

• continue the Transform-HTN open-label extension trial and conduct any required post-approval studies;

7 unchanged sentences

• our ability to receive timely regulatory approvals for lorundrostat, any future product candidates, and any 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, changes in international trade policies and tariffs, any supply chain issues, or component shortages;

• the costs and timing of manufacturing lorundrostat to support a potential commercial launch 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 the timing of seeking approval in such jurisdictions;

3 unchanged sentences

(ii) professional fees for legal, audit, tax, and other consulting or advisory services;

(iii) costs associated with building our pre-commercial organization, including medical affairs, market access, and health economics;

(iii) costs associated with building our pre-commercial organization, including sales, medical affairs, market access, and health economics;

(iv) fees relating to intellectual property and corporate matters;

7 unchanged sentences

treasuries, net of fees, or other related expenses.

Comparison of the Three Months Ended March 31, 2026 and 2025

Following the disbursement of the Tranche A Loan on June 2, 2026, we also began recording interest expense and amortization of debt discounts and issuance costs associated with our Term Loans.

Results of Operations

Comparison of the Three Months Ended June 30, 2026 and 2025

Three Months Ended,

6 unchanged sentences

Research and Development Expenses

Research and development expenses decreased by $13.5 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025.

The decrease was primarily driven by a $15.5 million reduction in preclinical and clinical costs following the conclusion of the lorundrostat pivotal program in the second quarter of 2025.

This decrease was partially offset by $1.1 million of increased clinical supply, manufacturing, and regulatory costs, and $0.8 million of increased personnel-related expenses resulting from headcount growth and increased compensation.

Research and development expenses increased by $183.1 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025.

The increase was primarily due to the $200.0 million upfront payment to Tanabe in June 2026 in connection with the Fourth Amendment.

The increase was also due to $0.6 million of increased personnel-related expenses resulting from headcount growth and increased compensation and $0.2 million of increased clinical supply, manufacturing, regulatory, and other costs.

These increases were partially offset by $17.8 million of lower preclinical and clinical costs, primarily due to the conclusion of the lorundrostat pivotal program in the second quarter of 2025.

General and Administrative Expenses

General and administrative expenses increased by $14.4 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025.

The increase was primarily driven by $7.9 million of higher professional fees, $6.1 million of increased personnel-related expenses resulting from headcount growth and increased compensation, and $0.4 million of other general and administrative expenses.

General and administrative expenses increased by $16.2 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025.

The increase was primarily due to $8.0 million in higher professional fees, $8.0 million of increased personnel-related expenses resulting from headcount growth and increased compensation, and $0.2 million of increased other administrative expenses.

Total Other Income, Net

Total other income, net increased by $3.8 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025.

The increase reflects higher interest earned on investments in money market funds and U.S.

Treasuries due to higher average cash balances invested during the three months ended March 31, 2026.

Total other income, net increased by $1.5 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025, which was primarily attributable to $2.3 million of increased interest earned on our investments as a result of higher average cash balances during the three months ended June 30, 2026, partially offset by $0.8 million of interest and amortization expense related to the Loan Agreement entered into during the three months ended June 30, 2026.

Comparison of the Six Months Ended June 30, 2026 and 2025

Six Months Ended,

2026 2025 Change

(in thousands)

Research and development expenses $ (245,742) $ (76,157) $ (169,585)

General and administrative expenses (45,638) (15,036) (30,602)

Total other income, net 10,970 5,708 5,262

Net loss $ (280,410) $ (85,485) $ (194,925)

Research and Development Expenses

Research and development expenses increased by $169.6 million for the six months ended June 30, 2026, compared to the six months ended June 30, 2025.

The increase was primarily due to the $200.0 million upfront payment to Tanabe in June 2026 in connection with the Fourth Amendment.

The increase was also due to $1.5 million of increased personnel-related expenses resulting from headcount growth and increased compensation and $1.4 million of increased clinical supply, manufacturing, regulatory, and other costs.

These increases were partially offset by $33.3 million of lower preclinical and clinical costs, primarily due to the conclusion of the lorundrostat pivotal program in the six months ended June 30, 2025.

General and Administrative Expenses

General and administrative expenses increased by $30.6 million for the six months ended June 30, 2026, compared to the six months ended June 30, 2025.

The increase was primarily due to $15.9 million in higher professional fees, $14.1 million of increased personnel-related expenses resulting from headcount growth and increased compensation, and $0.6 million of increased other administrative expenses.

Total Other Income, Net

Total other income, net increased by $5.3 million for the six months ended June 30, 2026, compared to the six months ended June 30, 2025, which was primarily attributable to $6.1 million of increased interest earned on our investments as a result of higher average cash balances during the six months ended June 30, 2026, partially offset by $0.8 million of interest and amortization expense related to the Loan Agreement entered into during the six months ended June 30, 2026.

Liquidity and Capital Resources

We have incurred net losses and negative cash flows from operations since our inception and we expect to continue to incur significant expenses and operating losses for the foreseeable future.

Since inception, we have raised aggregate gross proceeds of approximately $1.1 billion from the sale of common stock, convertible preferred stock, pre-funded warrants, and convertible notes.

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.

As of March 31, 2026, we had cash, cash equivalents, and investments of $646.1 million and an accumulated deficit of $496.5 million.

During the three months ended March 31, 2026, we sold an aggregate of 568,320 shares of common stock under the ATM Agreement at a weighted-average price of $35.66 per share for aggregate net proceeds of approximately $20.2 million after deducting commissions and offering expenses.

As of March 31, 2026, approximately $187.2 million of shares remained available for sale pursuant to the ATM Agreement, subject to the terms and conditions of the ATM Agreement and applicable securities laws.

Since inception, we have incurred net losses and negative cash flows from operations.

We expect to continue to incur significant expenses and, until we begin generating substantial product revenue from product sales, we anticipate continuing to incur operating losses for the foreseeable future.

Our primary uses of cash to date have been to fund our research and development activities, business planning, establishing and maintaining our intellectual property portfolio, advancing regulatory activities, staffing our company, initiating commercial-readiness activities, raising capital, and providing general and administrative support for these operations.

As of June 30, 2026, we had cash, cash equivalents, and investments of $661.4 million and an accumulated deficit of $737.6 million.

During the six months ended June 30, 2026:

• we sold 5,660,378 shares of our common stock at a price of $26.50 per share for net proceeds of approximately $143.6 million after deducting underwriting discounts and offering expenses;

• we borrowed $100.0 million under the Loan Agreement;

• we sold an aggregate of 568,320 shares of common stock under the ATM Agreement at a weighted-average price of $35.66 per share for aggregate net proceeds of approximately $20.2 million after deducting commissions and offering expenses.

As of June 30, 2026, approximately $187.2 million of shares remained available for sale pursuant to the ATM Agreement, subject to the terms and conditions of the ATM Agreement and applicable securities laws, and up to $400.0 million of Term Loans remained available under the Loan Agreement, subject to certain conditions.

Funding Requirements

Based on our current operating plan, we believe that our cash, cash equivalents, and investments as of March 31, 2026 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, 2026 will be sufficient to allow us to fund our planned operations, including the commercial launch of lorundrostat, 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.

2 unchanged sentences

Our future capital requirements will depend on many factors, including, but not limited to:

candidates we may choose to pursue, including any modifications to clinical development plans based on feedback that we may receive from regulatory authorities;

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

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

6 unchanged sentences

• the costs associated with hiring additional personnel and consultants as our business grows, including additional executive officers and clinical development, regulatory, manufacturing, quality, and commercial personnel;

• the timing and amount of the milestone, royalty, or other payments we must make to Tanabe, from whom we have in-licensed lorundrostat, or any future licensors;

• the timing and amount of the milestone or other payments we must make to Tanabe, from whom we have in-licensed lorundrostat, or any future licensors;

• the costs and timing of establishing or securing sales and marketing capabilities if lorundrostat or any future product candidate is approved;

5 unchanged sentences

• 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.

We do not have any committed external source of funds.

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

4 unchanged sentences

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, 2026 and 2025

Comparison of the Six Months Ended June 30, 2026 and 2025

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

2026 2025 Change

5 unchanged sentences

Operating Activities

Net cash used in operating activities was $39.5 million during the three months ended March 31, 2026, compared to $45.5 million during the three months ended March 31, 2025, resulting in a decrease that was primarily attributable to a decrease 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 $6.0 million decrease in cash used consisted of the net effect of a decrease in net loss, adjusted for non-cash expenses, of approximately $2.2 million and changes in working capital of $3.8 million.

Net cash used in operating activities was $72.0 million during the six months ended June 30, 2026, compared to $75.7 million during the six months ended June 30, 2025.

The $3.6 million decrease in net cash used was primarily due to a $4.9 million decrease in net loss adjusted for non-cash items, partially offset by $1.3 million of net changes in working capital.

Cash used in operating activities continued to reflect expenditures related to the development of lorundrostat, including clinical trial expenses, personnel related costs, legal and professional fees, and general working capital requirements.

Investing Activities

Net cash used in investing activities was $44.9 million for the three months ended March 31, 2026, compared to $92.9 million for the three months ended March 31, 2025.

Net cash used in investing activities

during the three months ended March 31, 2026 and 2025 was primarily driven by the timing and volume of maturities and purchases of marketable securities in each period.

During the three months ended March 31, 2026, there was a $267.5 million increase in maturities of previously purchased marketable securities and a $219.6 million increase in purchases of marketable securities, compared to the three months ended March 31, 2025.

Net cash used in investing activities was $230.2 million for the six months ended June 30, 2026, compared to $135.8 million for the six months ended June 30, 2025.

The increase in net cash used in investing activities was primarily attributable to the $200.0 million payment made pursuant to the Tanabe License during the six months ended June 30, 2026, for which there was no comparable payment in the prior-year period.

This increase was partially offset by the timing and volume of purchases and maturities of marketable securities.

Compared to the six months ended June 30, 2025, maturities of previously purchased marketable securities increased by $517.5 million and purchases of marketable securities increased by $411.9 million during the six months ended June 30, 2026.

Financing Activities

Net cash provided by financing activities was $24.3 million during the three months ended March 31, 2026, compared to $189.3 million during the three months ended March 31, 2025.

During the three months ended March 31, 2026, we received net proceeds of $20.2 million from the sale of common stock pursuant to the ATM Agreement, net of issuance costs, and 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, net of offering costs.

Additionally, during the three months ended March 31, 2026, we received increased proceeds of $3.9 million from stock option exercises as compared to the three months ended March 31, 2025.

Net cash provided by financing activities was $267.5 million during the six months ended June 30, 2026, compared to $199.1 million during the six months ended June 30, 2025.

During the six months ended June 30, 2026, financing proceeds consisted primarily of $143.9 million of net proceeds from a public offering of common stock, $96.5 million of net proceeds borrowed under the Loan Agreement, and $20.2 million of net proceeds from sales of common stock under the ATM Agreement.

During the six months ended June 30, 2025, financing proceeds consisted primarily of $188.9 million of net proceeds from a public offering of common stock and $8.9 million of net proceeds from sales of common stock under the Prior ATM Agreement.

In addition, during the six months ended June 30, 2026, proceeds from stock option exercises increased by $5.5 million and proceeds from issuances of common stock under the 2023 Employee Stock Purchase Plan increased by $0.2 million, compared to the prior year period.

Contractual Obligations and Commitments

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

Under the Tanabe License, we have commercial milestone payment obligations that are contingent upon the achievement of specified levels of product sales in connection with the sale of products developed

under the agreement.

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

See above and Note 4.

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

See above and Note 5, “ Commitments and Contingencies ” to our condensed financial statements included elsewhere in this Quarterly Report for additional information regarding the Tanabe License.

In June 2026, we borrowed $100.0 million related to the Tranche A Loan under the Loan Agreement.

The Loan Agreement provides for a five‑year senior secured term loan of up to $500.0 million, maturing on June 3, 2031, consisting of the following additional tranches:

(i) a Tranche B Loan of $150.0 million, which is required to be drawn no later than April 30, 2027, subject to approval by the FDA of the lorundrostat NDA;

(ii) a Tranche C Loan of $150.0 million, which is available at our election until December 14, 2028, subject to the occurrence of the Tranche B Approval Condition and the achievement of certain net sales milestones;

and (iii) a Tranche D Loan of $100.0 million, which is available at our election until June 14, 2029, subject to the draw of the Tranche C Loan and the achievement of certain net sales milestones.

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.

6 unchanged sentences

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, 2026 to our critical accounting estimates as disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025.

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

“ Summary of Significant Accounting Policies ” within our Annual Report on Form 10-K for the year ended December 31, 2025.

There were no changes during the six months ended June 30, 2026 to our critical accounting estimates as disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025.

For information on our significant accounting policies, please refer to Note 2, “ Summary of Significant Accounting Policies ” within our Annual Report on Form 10-K for the year ended December 31, 2025.

JOBS Act and Smaller Reporting Company Status

1 unchanged sentence

This allows an emerging growth company to delay the adoption of certain accounting standards until those standards would otherwise apply to private companies.

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

We intend to rely on other exemptions provided by the JOBS Act, including, without

limitation, not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act of 2002.

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

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 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.

5 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis