Mineralys Therapeutics, Inc.

Previous wording

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. Lorundrostat was well tolerated in both trials with a favorable safety profile. We submitted our NDA to the FDA in December 2025 for lorundrostat for the treatment of hypertension in combination with other antihypertensive drugs. The FDA accepted the NDA submission and provided us with a Prescription Drug User Fee Act (PDUFA) target date of December 22, 2026 for lorundrostat.

Current wording

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 durable, and clinically meaningful reductions in systolic blood pressure (BP) by lorundrostat. Lorundrostat was well tolerated in both trials with a favorable safety profile. We submitted our NDA to the FDA in December 2025 for lorundrostat for the treatment of hypertension in combination with other antihypertensive drugs. The FDA accepted the NDA submission and provided us with a Prescription Drug User Fee Act (PDUFA) target date of December 22, 2026 for lorundrostat.

Previous wording

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. There was a 6.2 mmHg placebo-adjusted reduction (p < 0.0003) in BP in the crossover analysis. Lorundrostat demonstrated a favorable safety profile and was well tolerated, with no serum potassium excursions above 5.5 mmol/L. Analysis is ongoing for other endpoints in the trial and may be reported in future publications or medical meetings. Detailed results of our trials are set forth in Part I, Item 1, “Business” in our Annual Report on Form 10-K for the year ended December 31, 2025.

Current wording

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. There was a 6.2 mmHg placebo-adjusted reduction (p < 0.0003) in BP in the crossover analysis. Lorundrostat demonstrated a favorable safety profile and was well tolerated, with no serum potassium excursions above 5.5 mmol/L. Analysis is ongoing for other endpoints in the trial and may be reported in future publications or medical meetings.

Previous wording

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.

Current wording

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, conducting commercial-readiness activities, raising capital, and providing general and administrative support for our operations. As of September 30, 2026, we had cash, cash equivalents, and investments of $624.7 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 nine months ended September 30, 2026 and 2025 were $337.7 million and $122.4 million, respectively. As of September 30, 2026 and December 31, 2025, we had an accumulated deficit of $794.9 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.

Previous wording

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.

Current wording

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 would assign to us all of Tanabe’s rights in the licensed intellectual property.

Previous wording

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.

Current wording

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 9.16%. 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.

Previous wording

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.

Current wording

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 is being amortized to interest expense on a straight-line basis over the applicable maturity period to which the related borrowing capacity is available. As of September 30, 2026, the unamortized debt discounts and debt issuance costs of approximately $1.6 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 applicable maturity period of the Tranche A Loan using the effective interest method. The effective interest rate on the Tranche A Loan was 11.38% as of September 30, 2026.

Previous wording

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 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, 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.

Current wording

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 underwriting discounts and offering expenses. The offering was made pursuant to our shelf registration statement on Form S-3 (Registration Statement No. 333-278122) 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.

Previous wording

On November 10, 2025, we entered into an ATM Equity Offering Sales Agreement (the ATM Agreement) with BofA Securities, Inc., Evercore Group L.L.C., and Goldman Sachs & Co. 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 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.

Current wording

On November 10, 2025, we entered into an ATM Equity Offering Sales Agreement (the ATM Agreement) with BofA Securities, Inc., Evercore Group L.L.C., and Goldman Sachs & Co. 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 nine months ended September 30, 2026, we sold an aggregate of 568,320 shares of common stock pursuant to 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. No shares of common stock were sold pursuant to the ATM Agreement during the nine months ended September 30, 2025. From inception of the ATM Agreement and through September 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 September 30, 2026, shares of common stock having an aggregate offering price of approximately $187.2 million remained available for sale pursuant to the ATM Agreement.

Previous wording

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

Current wording

On March 21, 2024, we entered into an ATM Equity Offering Sales Agreement (the Prior ATM Agreement) with BofA Securities, Inc. and Evercore Group L.L.C. Effective November 9, 2025, the Prior ATM Agreement was terminated in connection with us entering into the ATM Agreement. There were no sales of common stock pursuant to the Prior ATM Agreement during the nine months ended September 30, 2026. During the nine months ended September 30, 2025, we sold an aggregate of 1,914,040 shares of common stock pursuant to the Prior ATM Agreement 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. No additional shares of common stock were sold pursuant to the Prior ATM Agreement following September 30, 2025.

Previous wording

•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;

Current wording

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

Previous wording

Interest income reported in each period is associated with our investments in money market funds and U.S. treasuries, net of fees, or other related expenses. 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.

Current wording

Interest income reported in each period is associated with our investments in money market funds and U.S. treasuries, net of fees, or other related expenses. Following the disbursement of the Tranche A Loan in June 2026, we also began recording interest expense associated with our Term Loans.

Previous wording

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.

Current wording

Research and development expenses decreased by $8.8 million for the three months ended September 30, 2026, compared to the three months ended September 30, 2025. The decrease was primarily due to $8.5 million of lower preclinical and clinical costs resulting from the conclusion of the lorundrostat pivotal program in the second quarter of 2025 and $0.3 million of decreased clinical supply, manufacturing, regulatory, and other costs.

Previous wording

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.

Current wording

General and administrative expenses increased by $27.7 million for the three months ended September 30, 2026, compared to the three months ended September 30, 2025. The increase was primarily due to investments to expand our operations in preparation for commercialization, including $15.4 million in higher professional fees and $11.4 million in increased personnel-related expenses resulting from headcount growth and increased compensation, as well as $0.9 million of increased other administrative expenses.

Previous wording

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.

Current wording

Total other income, net decreased by $1.4 million for the three months ended September 30, 2026, compared to the three months ended September 30, 2025, which was primarily attributable to $3.2 million of increased interest expense related to the Loan Agreement entered into in June 2026, partially offset by

Previous wording

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.

Current wording

Research and development expenses increased by $160.8 million for the nine months ended September 30, 2026, compared to the nine months ended September 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 $1.1 million of increased clinical supply, manufacturing, regulatory, and other costs. These increases were partially offset by $41.8 million of lower preclinical and clinical costs resulting from the conclusion of the lorundrostat pivotal program during the nine months ended September 30, 2025.

Previous wording

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.

Current wording

General and administrative expenses increased by $58.3 million for the nine months ended September 30, 2026, compared to the nine months ended September 30, 2025. The increase was primarily due to investments to expand our operations in preparation for commercialization, including $31.2 million in higher professional fees and $25.6 million in increased personnel-related expenses resulting from headcount growth and increased compensation, as well as $1.5 million of increased other administrative expenses.

Previous wording

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.

Current wording

Total other income, net increased by $3.8 million for the nine months ended September 30, 2026, compared to the nine months ended September 30, 2025, which was primarily attributable to $7.8 million of increased interest earned on our investments as a result of higher average cash balances during the nine months ended September 30, 2026, partially offset by $4.0 million of increased interest expense related to the Loan Agreement entered into in June 2026.

Previous wording

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. 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. 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.

Current wording

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. 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. 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, conducting commercial-readiness activities, raising capital, and providing general and administrative support for these operations.

Previous wording

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:

Current wording

As of September 30, 2026, we had cash, cash equivalents, and investments of $624.7 million and an accumulated deficit of $794.9 million. During the nine months ended September 30, 2026:

Previous wording

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.

Current wording

As of September 30, 2026, shares of common stock having an aggregate offering price of approximately $187.2 million 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.

Previous wording

•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;

Current wording

•the timing and amount of the milestone payments we must make to Tanabe;

Previous wording

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.

Current wording

Net cash used in operating activities was $115.1 million during the nine months ended September 30, 2026, compared to $104.5 million during the nine months ended September 30, 2025. The increase in net cash used in operating activities was primarily due to a $15.2 million increase in net loss adjusted for non-cash items, partially offset by $4.6 million of net changes in working capital. Cash used in operating activities reflects expenditures related to the development of lorundrostat, activities supporting potential regulatory approval, and commercial-readiness initiatives, including personnel related costs, legal and professional fees, and general working capital requirements.

Previous wording

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.

Current wording

Net cash used in investing activities was $225.5 million for the nine months ended September 30, 2026, compared to $286.3 million for the nine months ended September 30, 2025. The decrease in net cash used in investing activities was primarily due to a net increase in cash provided by marketable securities activity, reflecting higher maturities of marketable securities, partially offset by higher purchases of marketable securities. This decrease was partially offset by the $200.0 million payment made pursuant to the Fourth Amendment during the nine months ended September 30, 2026, for which there was no comparable payment in the prior-year period.

Previous wording

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.

Current wording

Net cash provided by financing activities was $268.9 million during the nine months ended September 30, 2026, compared to $494.3 million during the nine months ended September 30, 2025. The decrease in net cash provided by financing activities was primarily attributable to a $322.6 million reduction in net proceeds from shares of common stock in public offerings and under the ATM Agreement compared to the prior-year period. This decrease was partially offset by $95.9 million of net proceeds borrowed under the Loan Agreement, a $1.2 million increase in proceeds from stock option exercises, and a $0.2 million increase in proceeds from issuances of common stock under the 2023 Employee Stock Purchase Plan, compared to the prior year period.

Previous wording

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

Current wording

Under the Payment Obligation Agreement, 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 5, “Commitments and Contingencies” to our condensed financial statements included elsewhere in this Quarterly Report for additional information regarding our agreements with Tanabe.

Previous wording

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.

Current wording

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. If the Tranche B Approval Condition is not satisfied on or before September 30, 2027, we would be required to make four equal quarterly principal payments of approximately $25.0 million each beginning on September 30, 2027, and the Maturity Date would accelerate to June 30, 2028.

Previous wording

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.

Current wording

There were no changes during the nine months ended September 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.