Crinetics Pharmaceuticals, Inc.

Previous wording

We are a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors. We have built a highly productive drug discovery and development organization with extensive expertise in endocrine G protein coupled receptors, or GPCRs. We have discovered a pipeline of nonpeptide (small molecule) new chemical entities that target peptide GPCRs to address unmet needs for people with endocrine diseases and related tumors. Our lead product candidate is paltusotine, which is under review by the U.S. Food and Drug Administration, or FDA, in the United States, or U.S., for the treatment of acromegaly as PALSONIFYTM, under review by regulatory agencies in Europe for the treatment of acromegaly, and in clinical development for treatment of carcinoid syndrome associated with neuroendocrine tumors. Our second product candidate is atumelnant, which is in clinical development for congenital adrenal hyperplasia, or CAH and ACTH-Dependent Cushing’s Syndrome, or ADCS. We are advancing additional product candidates through preclinical discovery and development studies. Our vision is to build the premier, endocrine-rooted global pharmaceutical company dedicated to improving the lives of patients.

Current wording

Our first approved therapy is PALSONIFY™ (paltusotine), which has been approved by the U.S. Food and Drug Administration, or FDA, in the United States for the treatment of acromegaly. Additionally, PALSONIFY is under review by regulatory agencies in Europe for the treatment of acromegaly. Paltusotine is also in clinical development for treatment of carcinoid syndrome associated with neuroendocrine tumors. Atumelnant is in clinical development for congenital adrenal hyperplasia, or CAH, and ACTH-Dependent Cushing’s Syndrome, or ADCS. We are advancing additional product candidates through preclinical discovery and development studies in indications such as neuroendocrine tumors, Graves’ disease (including Graves’ hyperthyroidism and Graves’ orbitopathy, or thyroid eye disease), polycystic kidney disease, hyperparathyroidism, diabetes, obesity, and GPCR-targeted oncology indications. Our vision is to build the premier, endocrine-rooted global pharmaceutical company dedicated to improving the lives of patients.

Previous wording

Marketing authorization application, or MAA, validated by the European Medicines Agency, or EMA, for paltusotine for the treatment of acromegaly, consistent with a timeline for a potential EMA decision in the first half of 2026. The EMA also granted Orphan Drug Designation, or ODD, for paltusotine for the treatment of acromegaly, further highlighting the level of unmet need and the potential for paltusotine to offer significant benefit to patients.

Current wording

•Our marketing authorization application, or MAA, was validated by the European Medicines Agency, or EMA, for paltusotine for the treatment of acromegaly, consistent with a timeline for a potential EMA decision in the first half of 2026. The EMA also granted Orphan Drug Designation, or ODD, for paltusotine for the treatment of acromegaly, further highlighting the level of unmet need and the potential for paltusotine to offer significant benefit to patients.

Previous wording

Phase 2 TouCAHn open-label study of atumelnant in CAH reported positive results. Atumelnant administration was shown to result in rapid, substantial and sustained statistically significant reduction in androstenedione, or A4, levels, the key biomarker for disease control. Atumelnant was well-tolerated and demonstrated significant clinical improvements. We have also initiated an open-label extension study.

Current wording

•In January 2025, we reported positive results from the Phase 2 TouCAHn open-label study of atumelnant in CAH. Atumelnant administration was shown to result in rapid, substantial and sustained statistically significant reduction in androstenedione, or A4, levels, the key biomarker for disease control. Atumelnant was well-tolerated and demonstrated significant clinical improvements. We have also initiated an open-label extension study.

Previous wording

Phase 3 CALM-CAH study is designed with an uncompromising primary endpoint to demonstrate atumelnant’s potential ability to normalize A4 levels with physiological glucocorticoid, or GC, replacement.

Current wording

•In May 2025, we revealed the design of our Phase 3 CALM-CAH study with an uncompromising primary endpoint to demonstrate atumelnant’s potential ability to normalize A4 levels with physiological glucocorticoid, or GC, replacement.

Previous wording

Announced our pediatric trial design in CAH, BALANCE-CAH. BALANCE-CAH is designed as an operationally seamless three-part study (Phase 2/3/OLE). Part A is an open-label, semi-sequential cohort study to evaluate the safety, efficacy, and pharmacokinetics, or PK, of atumelnant treatment in pediatric participants with classic CAH. Part B is a double-blind, placebo controlled confirmatory portion of the study to evaluate the safety and efficacy of atumelnant in pediatric participants with classic CAH. Part C is a single-arm, open-label, long-term safety and efficacy study in pediatric participants that completed participation in either Part A or Part B of this study. We plan to initiate the BALANCE-CAH pediatric study in the second half of 2025.

Current wording

•Announced our pediatric trial design in CAH, BALANCE-CAH. BALANCE-CAH is designed as an operationally seamless three-part study (Phase 2/3/OLE). Part A is an open-label, semi-sequential cohort study to evaluate the safety, efficacy, and pharmacokinetics, or PK, of atumelnant treatment in pediatric participants with classic CAH. Part B is a double-blind, placebo controlled confirmatory portion of the study to evaluate the safety and efficacy of atumelnant in pediatric participants with classic CAH. Part C is a single-arm, open-label, long-term safety and efficacy study in pediatric participants that completed participation in either Part A or Part B of this study. We plan to initiate the BALANCE-CAH pediatric study in the fourth quarter of 2025.

Previous wording

Investigational New Drug, or IND, clearance for CRN09682, the first candidate from the nonpeptide drug conjugate, or NDC, platform. A “Study May Proceed” letter has been received to allow us to begin a Phase 1/2 dose escalation study of CRN09682 with an expansion phase for the treatment of metastatic or locally advanced SST2-positive neuroendocrine tumors and other SST2-expressing solid tumors.

Current wording

•Investigational New Drug, or IND, clearance for CRN09682, the first candidate from the nonpeptide drug conjugate, or NDC, platform. A “Study May Proceed” letter has been received to allow us to begin a Phase 1/2 dose escalation study of CRN09682 with an expansion phase for the treatment of metastatic or locally advanced SST2-positive neuroendocrine tumors and other SST2-expressing solid tumors. We expect the first patient to receive CRN09682 in the dose escalation phase of a Phase 1/2 study in the fourth quarter of 2025.

Previous wording

Revealed preclinical data on CRN12755 (a Thyroid Stimulating Hormone, or TSH, antagonist), CRN10329 (an SST3 agonist) and CRN09682 (an SST2+ nonpeptide drug conjugate) at our in-person and virtual Research and Development Day, or R&D Day, on June 26, 2025.

Current wording

•Revealed preclinical data on CRN09682 (an SST2+ nonpeptide drug conjugate), CRN12755 (a Thyroid Stimulating Hormone Receptor, or TSHR, antagonist), and CRN10329 (an SST3 agonist) at our in-person and virtual Research and Development Day, or R&D Day, on June 26, 2025.

Previous wording

The R&D Day presentation included the following updates on our pre-clinical development pipeline:

Current wording

•The R&D Day presentation included the following updates on our preclinical development pipeline:

Previous wording

We provided additional details regarding the trial design of BRAVESST2, our Phase 1/2 study of CRN09682 for the treatment of metastatic or locally advanced SST2-positive neuroendocrine tumors and other SST2-expressing solid tumors. In the Phase 1 dose escalation phase, we expect to enroll 3-6 patients per cohort until the minimum tolerated dose is confirmed. Data from the dose escalation will inform the recommended expansion dose for the Phase 2 dose expansion phase and confirm the tumor sub-types that will be enrolled in the expansion cohorts. We expect to enroll up to 150 participants across both Phase 1 and Phase 2 of the trial.

Current wording

•We provided additional details regarding the trial design of BRAVESST2, our Phase 1/2 study of CRN09682 for the treatment of metastatic or locally advanced SST2-positive neuroendocrine tumors and other SST2-expressing solid tumors. In the Phase 1 dose escalation phase, we expect to enroll 3-6 patients per cohort until the minimum tolerated dose is confirmed. Data from the dose escalation will inform the recommended expansion dose for the Phase 2 dose expansion phase and confirm the tumor sub-types that will be enrolled in the expansion cohorts.

Previous wording

CRN10329: We identified CRN10329 as a preclinical leading development candidate for a selective SST3 nonpeptide agonist for the treatment of autosomal dominant polycystic kidney disease, or ADPKD. CRN10329 was observed to decrease cystic index, cellular proliferation, kidney weight and aberrant expression of renal tubular injury markers in a mouse model of ADPKD. We also shared data highlighting that SST3 is highly and consistently expressed in cyst-lining cells in ADPKD.

Current wording

•CRN10329: We identified CRN10329 as a preclinical leading development candidate for a selective somatostatin receptor type 3 (SST3) nonpeptide agonist for the treatment of autosomal dominant polycystic kidney disease, or ADPKD. CRN10329 was observed to decrease cystic index, cellular proliferation, kidney weight and aberrant expression of renal tubular injury markers in a mouse model of ADPKD. We also shared data highlighting that SST3 is highly and consistently expressed in cyst-lining cells in ADPKD.

Previous wording

We continued international expansion activities in parallel with the continuing review of our marketing authorization application, or MAA, for paltusotine by the European Medicines Agency.

Current wording

•We continued international expansion activities in parallel with the ongoing review of our MAA for PALSONIFY by the European Medicines Agency.

Previous wording

To date, we have devoted substantially all of our resources to drug discovery, conducting preclinical studies and clinical trials, obtaining and maintaining patents related to our product candidates, licensing activities, and the provision of selling, general and administrative support for these operations and commercial preparedness. We have recognized revenues from various research and development grants and license and collaboration agreements, but do not have any products approved for sale and have not generated any product sales. We have funded our operations primarily through our grant and license revenues, and offerings of our preferred and common stock.

Current wording

To date, we have devoted substantially all of our resources to drug discovery, conducting preclinical studies and clinical trials, obtaining and maintaining patents related to our product candidates, licensing activities, and the provision of selling, general and administrative support for these operations and commercial preparedness. We have recognized revenues from various research and development grants and license and collaboration agreements. We received FDA approval on PALSONIFY on September 25, 2025, but have not yet generated any product revenue during the quarter ended September 30, 2025. We have funded our operations primarily through license revenues and offerings of our preferred and common stock.

Previous wording

We have incurred cumulative net losses since our inception. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials and preclinical studies and our expenditures on other research and development activities. We expect our expenses and operating losses will increase substantially as we conduct our ongoing and planned clinical trials, continue our research and development activities and conduct preclinical studies, hire additional personnel, protect our intellectual property and incur costs associated with being a public company, including audit, legal, regulatory, and tax-related services associated with maintaining compliance with exchange listing and Securities and Exchange Commission, or SEC, requirements, director and officer insurance premiums, and investor relations costs.

Current wording

We have incurred cumulative net losses since our inception. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on our ability to successfully commercialize PALSONIFY and the associated costs, the timing of our revenues, our clinical trials and preclinical studies, our expenditures on other research and development activities, and other expenditures to support our on-going activities, including international expansion. While the FDA approved PALSONIFY on September 25, 2025, we have not yet generated product revenues from sales of PALSONIFY as of September 30, 2025 and we expect operating expenses to increase in future periods as product revenues increase. We also expect our expenses will increase substantially as we conduct our ongoing and planned clinical trials, continue our research and development activities and conduct preclinical studies, commercialize PALSONIFY and other potential approved product candidates, if any, and incur general and administrative costs to support our on-going growth. We expect our operating losses will increase in future periods until such time, if ever, we can generate substantial product revenues to support our cost structure.

Previous wording

We do not expect to generate any revenues from product sales unless and until we successfully obtain regulatory approval for one or more of our product candidates. If we obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. Accordingly, until such time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our cash needs through equity offerings, debt financings or other sources as may be required, including potentially, collaborations, licenses and other similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. Our failure to raise capital or enter into such other arrangements when needed would have a negative impact on our financial condition and could force us to delay, scale back or discontinue the development of our existing product candidates, our commercialization efforts or our efforts to expand our product pipeline.

Current wording

As a new commercial-stage company, we are continuing to build our market presence We expect product revenues to increase as we continue to expand our commercial activities. However, we do not anticipate generating significant or sustained revenues from product sales until our product achieves broader market acceptance and, in some cases, until we obtain additional regulatory approvals for our product candidates in the pipeline. We expect to incur significant commercialization expenses related to product sales, marketing, manufacturing, and distribution. Accordingly, until such time as we can generate significant revenue from PALSONIFY along with other product candidates in the pipeline, if ever, we expect to finance our cash needs through equity offerings, debt financings or other sources as may be required, including potentially, collaborations, licenses and other similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. Our failure to raise capital or enter into such other arrangements when needed would have a negative impact on our financial condition and could force us to delay, scale back or discontinue the development of our existing product candidates, our commercialization efforts or our efforts to expand our product pipeline.

Previous wording

To date, our revenues have been mainly derived from research grant awards and licenses, including our Collaboration and License Agreement with Radionetics Oncology, Inc., or the Radionetics License, our license agreement with Sanwa Kagaku Kenkyusho Co., Ltd., or the Sanwa License, and our license agreement with Cellular Longevity, Inc. doing business as Loyal, or the Loyal License. We have also entered into a clinical supply agreement, or the Sanwa Clinical Supply Agreement, whereby we are responsible for manufacturing and supplying certain materials to Sanwa Kagaku Kenkyusho Co., Ltd. for specified activities under the Sanwa License. As our data exchange performance obligation under the Sanwa License is fulfilled, we expect to recognize as revenues the deferred revenue amounts included in the accompanying condensed consolidated balance sheets as of June 30, 2025. We will recognize royalty and milestone revenues under our license agreements if and when appropriate under the relevant accounting rules (see Note 7 to our condensed consolidated financial statements). Our revenues of $1.0 million and $0.4 million for the three months ended June 30, 2025 and 2024, respectively, and $1.4 million and $1.0 million for the six months ended June 30, 2025 and 2024, respectively, were derived from the Sanwa License and the Sanwa Clinical Supply Agreement. We have not generated any revenues from the commercial sale of approved products, and we may never generate revenues from the commercial sale of our product candidates for at least the foreseeable future, if ever. However, we submitted a New Drug Application, or NDA, to the FDA, for PALSONIFY for the proposed treatment and long-term maintenance therapy of acromegaly and subsequently received notification of acceptance from the FDA on the status of the NDA submission and were granted a Prescription Drug User Fee Act, or PDUFA, Target Action Date of September 25, 2025.

Current wording

To date, our revenues have been mainly derived from licenses, including our collaboration and license agreement with Radionetics Oncology, Inc., or the Radionetics License, our license agreement with Sanwa Kagaku Kenkyusho Co., Ltd., or the Sanwa License, and our license agreement with Cellular Longevity, Inc. doing business as Loyal, or the Loyal License. We have also entered into a clinical supply agreement, or the Sanwa Clinical Supply Agreement, whereby we are responsible for manufacturing and supplying certain materials to Sanwa Kagaku Kenkyusho Co., Ltd. for specified activities under the Sanwa License. As our data exchange performance obligation under the Sanwa License is fulfilled, we expect to recognize as revenues the deferred revenue amounts included in our condensed consolidated balance sheets. We will recognize royalty and milestone revenues under our license agreements if and when appropriate under the relevant accounting rules (see Note 7 to our condensed consolidated financial statements).

Previous wording

To date, our research and development expenses have related primarily to discovery efforts and preclinical and clinical development of our product candidates. Research and development expenses are recognized as incurred and payments made prior to the receipt of goods or services to be used in research and development are capitalized until the goods or services are received.

Current wording

Our research and development expenses have related primarily to discovery efforts and preclinical and clinical development of our product candidates. Research and development expenses are recognized as incurred and payments made prior to the receipt of goods or services to be used in research and development are capitalized until the goods or services are received.

Previous wording

Our direct research and development expenses consist principally of external costs, such as fees paid to CROs, investigative sites and consultants in connection with our clinical trials, preclinical and non-clinical studies, and costs related to manufacturing clinical trial materials. The majority of our third-party expenses during the three and six months ended June 30, 2025 and 2024 related to the research and development of paltusotine, atumelnant, and discovery. We deploy our personnel and facility related resources across all of our research and development activities.

Current wording

Our direct research and development expenses consist principally of external costs, such as fees paid to CROs, investigative sites and consultants in connection with our clinical trials, preclinical and non-clinical studies, and costs related to manufacturing clinical trial materials. The majority of our third-party expenses during the three and nine months ended September 30, 2025 and 2024 related to the research and development of paltusotine, atumelnant, and discovery. We deploy our personnel and facility related resources across all of our research and development activities.

Previous wording

Selling, general and administrative expenses consist primarily of salaries and employee-related costs, including stock-based compensation, for personnel in executive, finance and other administrative functions. Other significant costs include facility-related costs, legal fees relating to intellectual property and corporate matters, professional fees for accounting and consulting services, insurance costs, and commercial planning expenses. We also incur expenses related to audit, legal, regulatory, and tax-related services associated with maintaining compliance with exchange listing and SEC requirements, director and officer insurance premiums, as well as corporate strategy and business development, corporate communications, and investor relations costs associated with operating as a public company. We anticipate that our selling, general and administrative expenses will increase in the future to support our continued research and development activities and, if any of our product candidates receive marketing approval, commercialization activities.

Current wording

Selling, general and administrative expenses consist primarily of salaries and employee-related costs, including stock-based compensation, for personnel in executive, commercial, finance, and other administrative functions. Other significant costs include sales and marketing, facility-related costs, legal fees relating to intellectual property and corporate matters, professional fees for accounting and consulting services, insurance costs, and commercial planning expenses. We also incur expenses related to audit, legal, regulatory, and tax-related services associated with maintaining compliance with exchange listing and Securities and Exchange Commission, or SEC, requirements, director and officer insurance premiums, as well as corporate strategy and business development, corporate communications, and investor relations costs associated with operating as a public company. We anticipate that our selling, general and administrative expenses will increase in the future to support our continued research and development activities, the commercialization of PALSONIFY and the commercialization of any of our other product candidates in the pipeline if and when such products receive marketing approval.

Previous wording

Our management's discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which we have prepared in accordance with U.S. generally accepted accounting principles, or GAAP. The preparation of these condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues, and expenses and the disclosure of contingent assets and liabilities at the date of our condensed consolidated financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses and leases. We base our estimates on historical experience, known trends and events, information received from third parties and various other factors that we believe are reasonable under the circumstances at the time the estimates are made, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. Our critical accounting policies are those accounting principles generally accepted in the United States that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. For a description of our critical accounting policies, please see the section entitled

Current wording

Our management's discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which we have prepared in accordance with U.S. generally accepted accounting principles, or GAAP. The preparation of these condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues, and expenses and the disclosure of contingent assets and liabilities at the date of our condensed consolidated financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses and leases. We base our estimates on historical experience, known trends and events, information received from third parties and various other factors that we believe are reasonable under the circumstances at the time the estimates are made, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. Our critical accounting policies are those accounting principles generally accepted in the United States that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. For a description of our critical accounting policies, please see the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Critical Accounting Estimates” contained in our Annual Report on Form 10-K for the year ended December 31, 2024. There have been no material changes to our critical accounting estimates discussed therein.

Previous wording

Comparison of the three and six months ended June 30, 2025 and 2024

Current wording

Comparison of the three and nine months ended September 30, 2025 and 2024

Previous wording

The following table summarizes our results of operations for the three and six months ended June 30, 2025 and 2024 (in thousands):

Current wording

The following table summarizes our results of operations for the three and nine months ended September 30, 2025 and 2024 (in thousands):

Previous wording

Revenues. Revenues during the three and six months ended June 30, 2025 and the three and six months ended June 30, 2024 related to the Sanwa License and the Sanwa Clinical Supply Agreement.

Current wording

Revenues. Revenues during the nine months ended September 30, 2025 and September 30, 2024 related to the Sanwa License and the Sanwa Clinical Supply Agreement. Revenues during the three months ended September 30, 2025 were derived from the Sanwa License. There were no revenues for the three months ended September 30, 2024.

Previous wording

Research and development expenses. The increase of $22.0 million and $44.9 million in research and development expenses during the three and six months ended June 30, 2025, respectively, compared to the prior year periods was primarily due to an increase in headcount, manufacturing activities and increased clinical costs driven by the advancement of our clinical programs and the expansion of our preclinical portfolio, as outlined below.

Current wording

Research and development expenses. The increase of $28.6 million and $73.4 million in research and development expenses during the three and nine months ended September 30, 2025, respectively, compared to the prior year periods was primarily due to an increase in headcount, manufacturing activities and increased clinical costs driven by the advancement of our clinical programs and the advancement of our preclinical portfolio, as outlined below.

Previous wording

The following table summarizes our primary external and internal research and development expenses for the three and six months ended June 30, 2025 and 2024 (in thousands):

Current wording

The following table summarizes our primary external and internal research and development expenses for the three and nine months ended September 30, 2025 and 2024 (in thousands):

Previous wording

The increase in the majority of the categories above for the three and six months ended June 30, 2025 since the corresponding prior period is as a result of the advancement of our clinical programs and the expansion of our preclinical portfolio.

Current wording

The increase in the majority of the categories above for the three and nine months ended September 30, 2025 since the corresponding prior period is as a result of the advancement of our clinical programs and the advancement of our preclinical portfolio.

Previous wording

The following table summarizes our research and development expenses by program for the three and six months ended June 30, 2025 and 2024 (in thousands):

Current wording

The following table summarizes our research and development expenses by program for the three and nine months ended September 30, 2025 and 2024 (in thousands):

Previous wording

The increase in research and development programs for the three and six months ended June 30, 2025 as compared to the prior year periods was primarily due to clinical and manufacturing costs associated with paltusotine for the treatment of carcinoid syndrome and atumelnant, pre-clinical and manufacturing costs for early research and development programs, and increase in headcount and other increases to support the overall increased activities in various programs.

Current wording

The increase in research and development programs for the three and nine months ended September 30, 2025 as compared to the prior year periods was primarily due to clinical, manufacturing, and outside services costs associated with paltusotine for the treatment of carcinoid syndrome and atumelnant, preclinical, clinical, manufacturing, and outside services costs for early research and development programs, and increase in headcount and other increases to support the overall increased activities in various programs.

Previous wording

Selling, general and administrative expenses. The increase of $25.0 million and $39.7 million in selling, general and administrative expenses during the three and six months ended June 30, 2025 , respectively, compared to the prior year periods was primarily due to the increase in personnel expenses of $12.0 million (including $5.6 million of stock-based compensation expense) and $20.0 million (including $8.3 million of stock-based compensation expense) for the three and six months ended June 30, 2025, respectively, when compared to the same periods in 2024. The remainder of the increase is primarily attributable to an increase in outside services of $10.3 million and $16.0 million for the three months and six months ended June 30, 2025, respectively, as compared to the prior year periods. These increases are attributable to the increase in headcount and increase in selling and other general and administrative costs to support our overall growth and the planned commercial launch of PALSONIFY.

Current wording

Selling, general and administrative expenses. The increase of $26.4 million and $66.1 million in selling, general and administrative expenses during the three and nine months ended September 30, 2025, respectively, compared to the prior year periods was primarily due to the increase in personnel expenses of $10.2 million (including $2.1 million of stock-based compensation expense) and $29.1 million (including $10.4 million of stock-based compensation expense) for the three and nine months ended September 30, 2025, respectively, when compared to the same periods in 2024. The remainder of the increase is primarily attributable to an increase in outside services of $12.0 million and $29.0 million for the three and nine months ended September 30, 2025, respectively, as compared to the prior year periods. These increases are attributable to the increase in headcount and increase in selling and other general and administrative costs to support our overall growth and the commercial launch of PALSONIFY.

Previous wording

Other income, net. The increase of $4.7 million and $12.3 million in other income during the three and six months ended June 30, 2025 since the corresponding periods in the prior year was primarily due to an increase in income generated by our investment securities.

Current wording

Other income, net. The increase of $1.5 million and $13.8 million in other income during the three and nine months ended September 30, 2025 since the corresponding periods in the prior year was primarily due to an increase in income generated by our investment securities.

Previous wording

Our financial condition is summarized as follows:

Current wording

Our financial condition is summarized as follows (in thousands):

Previous wording

the type, number, scope, progress, expansions, results, costs and timing of our preclinical studies and clinical trials of our product candidates which we are pursuing or may choose to pursue in the future;

Current wording

•the type, number, scope, progress, results, costs and timing of our preclinical studies and clinical trials of our product candidates which we are pursuing or may choose to pursue in the future;

Previous wording

our ability to generate revenues through future licensing arrangements and product sales after commercialization;

Current wording

•our ability to generate revenues through product sales of PALSONIFY and other potential product candidates once approved, if ever, and future licensing arrangements;

Previous wording

the costs and timing of manufacturing for our product candidates, including commercial manufacturing if any product candidate is approved;

Current wording

•the costs and timing of manufacturing for our product candidates, including commercial manufacturing;

Previous wording

our efforts to enhance operational systems and hire additional personnel to satisfy our obligations as a public company, including enhanced internal controls over financial reporting;

Current wording

•our efforts to enhance operational systems and hire additional personnel to satisfy our obligations as a public company with a commercial pharmaceutical product, including enhanced internal controls over financial reporting, government price reporting and establishing and maintaining an effective compliance program;

Previous wording

the costs associated with hiring additional personnel and consultants as our preclinical and clinical activities increase;

Current wording

•the costs associated with hiring additional personnel and consultants as our preclinical, clinical and commercial activities increase;

Previous wording

our ability to achieve sufficient market acceptance, adequate coverage and reimbursement from third-party payors and adequate market share and revenue for any approved products;

Current wording

•our ability to achieve sufficient market acceptance, adequate coverage and reimbursement from third-party payers and adequate market share and revenue for any approved products;

Previous wording

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

Current wording

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

Previous wording

the funding of any co-development arrangements we enter into; and

Current wording

•the funding of any co-development arrangements we enter into.

Previous wording

Until such time, if ever, as we can generate substantial product revenues to support our cost structure, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, including potential collaborations, licenses, and other similar arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. In addition, our ability to access financing on the terms we anticipate, or at all, may be impacted by volatility in global credit and financial markets, including as a result of inflation, rising interest rates, fluctuation in the value of the U.S. dollar and the effects, if any, of evolving international trade policies and government actions relating to tariffs. Debt financing and preferred 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.

Current wording

Until such time, if ever, as we can generate substantial product revenues to support our cost structure, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, including potential collaborations, licenses, and other similar arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. In addition, our ability to access financing on the terms we anticipate, or at all, may be impacted by volatility in global credit and financial markets, including as a result of inflation, rising interest rates, fluctuation in the value of the U.S. dollar and the effects, if any, of evolving international trade policies and government actions relating to tariffs. Further, the U.S. federal government has been shut down since October 1, 2025, and the impact of a prolonged government shutdown on business and economic conditions generally, and on our financial position specifically, is uncertain. Debt financing and preferred 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.

Previous wording

On June 21, 2024, we entered into a Sales Agreement, or the 2024 Sales Agreement, with SVB Leerink LLC and Cantor Fitzgerald & Co., or the Sales Agents, under which we may, from time to time, sell up to $350.0 million of shares of our common stock through the Sales Agents, or the 2024 ATM Offering. We are not obligated to, and we cannot provide any assurances that we will continue to, make any sales of the shares under the 2024 Sales Agreement. The 2024 Sales Agreement may be terminated by either Sales Agent (with respect to itself) or us at any time upon 10 days’ notice to the other parties, or by either Sales Agent, with respect to itself, at any time in certain circumstances, including the occurrence of a material adverse change. We will pay the Sales Agents a commission for their services in acting as agent in the sale of common stock in an amount equal to 3% of the gross sales price per share sold. During the three and six months ended June 30, 2025 and as of date of this report, no shares of common stock had been sold under the 2019 ATM Offering or the 2024 ATM Offering Agreement.

Current wording

On June 21, 2024, we entered into a Sales Agreement, or the 2024 Sales Agreement, with SVB Leerink LLC and Cantor Fitzgerald & Co., or the Sales Agents, under which we may, from time to time, sell up to $350.0 million of shares of our common stock through the Sales Agents, or the 2024 ATM Offering. We are not obligated to, and we cannot provide any assurances that we will continue to, make any sales of the shares under the 2024 Sales Agreement. The 2024 Sales Agreement may be terminated by either Sales Agent (with respect to itself) or us at any time upon 10 days’ notice to the other parties, or by either Sales Agent, with respect to itself, at any time in certain circumstances, including the occurrence of a material adverse change. We will pay the Sales Agents a commission for their services in acting as agent in the sale of common stock in an amount equal to 3% of the gross sales price per share sold. During the three and nine months ended September 30, 2025 and as of date of this report, no shares of common stock had been sold under the 2024 ATM Offering Agreement.