Crinetics Pharmaceuticals, Inc.
For the period ended Mar 31, 2026. Filed May 7, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2026 · Filed May 7, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-06.
0001658247-25-000019
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-07.
0001658247-26-000040
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 109 previous paragraphs and 91 current paragraphs.
23 unchanged; 19 reworded; 48 added; 67 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 5 previous and 7 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (48)
Current report
We are a pharmaceutical company committed to transforming the treatment of endocrine diseases and endocrine-related tumors through science rooted in patient needs. We are focused on discovering, developing, and commercializing novel therapies, with a core expertise in targeting GPCRs with small molecules that have specifically tailored pharmacology and properties.
Current report
Recent Developments
Current report
PALSONIFY
Current report
•Key metrics for the first quarter 2026 reflect broad and deep uptake from patients and healthcare providers as well as favorable feedback from payers.
Current report
•Received 232 Enrollment Forms during the first quarter of 2026. Breadth and depth of PALSONIFY prescribers continued to grow, with 263 unique HCPs having prescribed PALSONIFY within the first two quarters of launch. Approximately 70% of patients treated with PALSONIFY at the end of the first quarter of 2026 were on reimbursed therapy, as payers have increasingly provided coverage.
Current report
•In February 2026, the CHMP of the EMA adopted a positive opinion and in April 2026, the EC approved PALSONIFY for the medical treatment of adults with acromegaly.
Current report
•In March 2026, we submitted a MAA to Brazil’s ANVISA for PALSONIFY for the treatment of acromegaly in adults.
Current report
•Paltusotine is also in development for acromegaly in Japan through our licensing agreement with SKK. In April 2026, SKK submitted an NDA in Japan for paltusotine for the treatment of acromegaly.
Current report
•In January 2026, we provided an update, including data on the fourth cohort of the Phase 2 TouCAHn study and data from the separate OLE study. Participants in all four cohorts were eligible to enroll in the OLE.
Current report
•In January 2026, the first participant in the BALANCE-CAH study was dosed.
Current report
•In February 2026, we announced the design of our operationally seamless Phase 2/3 EQUILIBRIUM study of atumelnant in ADCS. The first participant in the EQUILIBRIUM study is expected to be randomized in the second quarter of 2026.
Current report
During the three months ended March 31, 2026, our financial results continued to reflect the commercialization of PALSONIFY following the FDA approval in September 2025 and the launch of PALSONIFY in the fourth quarter of 2025. As a result, our results of operations for the three months ended March 31, 2026 include product revenue, alongside collaboration and license revenue that historically represented our primary sources of revenue.
Current report
Following the PALSONIFY launch in late 2025, we continued to incur cost of product revenue and invested in commercial infrastructure to support ongoing commercial operations. These changes resulted in increased operating expenses, including commercialization-related selling, general and administrative expenses, while we also maintained investments in manufacturing readiness and supply chain activities.
Current report
Research and development expenses increased as we progressed clinical development programs and supported earlier-stage research initiatives to advance our pipeline of product candidates.
Current report
There have been no material changes in our critical accounting policies and estimates compared to those disclosed in Item 7 in our FY 2025 Form 10-K.
Current report
Beginning in the first quarter of 2026, we compare our results of operations for the current quarter to the immediately preceding fiscal quarter and the same period from the previous fiscal year, rather than only the same period from the previous fiscal year. We believe this presentation provides investors with a more meaningful analysis of changes in our results of operations over time following our transition from a clinical-stage company to a commercial company in late 2025, which impacted the comparability of quarter-to-quarter results.
Current report
N/M - changes not meaningful
Current report
Revenue
Current report
We have been recognizing net product sales in the U.S. since the commercial launch of PALSONIFY in October 2025. PALSONIFY is a newly launched product and current results may not be indicative of future results. Collaboration and license revenue is attributable to the timing of the revenue recognition for the data exchange performance obligation under the SKK License.
Current report
The increase in revenue during the three months ended March 31, 2026 as compared to the sequential period primarily relates to PALSONIFY net product revenue which increased in volume due to continued gains on patient activations. The increase as compared to the prior year-to-date period relates to PALSONIFY net product revenue.
Current report
Cost of product revenue
Current report
The following table summarizes our cost of product revenue for the three months ended March 31, 2026, December 31, 2025, and March 31, 2025:
Current report
N/M - changes not meaningful
Current report
Product revenue during the three months ended March 31, 2026 was derived from zero-cost inventory containing inventory manufactured prior to regulatory approval of PALSONIFY which had a zero cost basis as the related manufacturing costs were previously expensed as research and development in accordance with U.S. GAAP. As a result, cost of product revenue during this early commercialization period is not directly correlated with product revenue and does not reflect our expected cost structure for future periods.
Current report
For the three months ended March 31, 2026, the cost of product revenue would have increased by less than $0.1 million if we included zero-cost inventory.
Current report
The decrease for the three months ended March 31, 2026 as compared to the sequential period is due to the initial launch distribution charges and commercial supplier qualification costs in the fourth quarter of 2025. No amounts were incurred in the prior year-to-date period as PALSONIFY was commercialized in the fourth quarter of 2025.
Current report
Research and development expenses
Current report
Research and development expenses consist of costs incurred to support our research and the discovery, preclinical development and clinical development of PALSONIFY and our product candidates. These expenses include personnel-related costs for employees engaged in research and development activities, external costs incurred under agreements with CROs, investigative sites and consultants, costs to manufacture drug supply for preclinical studies and clinical trials, regulatory compliance costs, laboratory supplies, outside services, and allocated facility and overhead expenses.
Current report
Research and development expenses are expensed as incurred. Costs incurred to manufacture PALSONIFY prior to FDA approval were recorded as research and development expenses, resulting in zero-cost inventory upon approval.
Current report
Research and development expenses are driven by the scope, timing and progress of our clinical trials, including trial design, patient enrollment rates, trial duration, manufacturing requirements and regulatory activities. As a result, research and development spending may vary from period to period based on these factors and our strategic prioritization of programs.
Current report
We expect research and development expenses to increase as we continue to advance our pipeline and conduct ongoing and planned clinical and preclinical studies. However, the timing, duration and costs of these activities are subject to the inherent uncertainty associated with pharmaceutical research and development.
Current report
The increase in research and development expenses for the three months ended March 31, 2026 compared to the sequential and year-over-year periods was primarily driven by higher clinical supply manufacturing and external services costs associated with atumelnant and increased investment across other research and development programs. These increases were partially offset by a reduction in paltusotine-related research and development expenses following the commercialization of PALSONIFY in the fourth quarter of 2025. Research and development personnel and stock‑based compensation expenses also increased to support ongoing programs and due to a stock‑based compensation modification related to an executive’s departure.
Current report
Selling, general and administrative expenses
Current report
Selling, general and administrative expenses primarily include personnel‑related costs, including stock‑based compensation, across commercial and administrative functions, as well as sales and marketing expenses, facility and information technology costs, legal fees related to intellectual property, professional fees, insurance, business development activities, and costs associated with operating as a public company.
Current report
We expect these selling, general and administrative expenses, excluding commercial launch expenses, to increase as we continue commercialization efforts, expand our infrastructure, and support potential future product launches and geographic expansion.
Current report
The following table summarizes our selling, general and administrative expenses for the three months ended March 31, 2026, December 31, 2025, and March 31, 2025:
Current report
Other income, net
Current report
Other income, net was $12.5 million, $11.0 million, and $14.6 million for the three months ended March 31, 2026, December 31, 2025, and March 31, 2025, respectively. The changes in other income, net were primarily driven by higher yields in the current quarter compared to the sequential period and lower yields in the current quarter compared to the prior-year period, as well as fluctuations in invested balances from period to period.
Current report
We have funded our operations through equity financings, supplemented by license, collaboration and initial product revenue.
Current report
•general economic, industry and market conditions or other events or factors, many of which are beyond our control, such as the impact of any natural disasters, including related to climate change, or public health emergencies, and the impacts of inflation, interest rates, actual or anticipated bank failures, actual or anticipated government tariffs, and international military or geopolitical conflicts, including between Russia and Ukraine and in the Middle East.
Showing the first 40 of 48 passages. Open the source sections for the rest.
Removed paragraphs (67)
Previous report
We are a 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.
Previous report
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 report
Key Pipeline Updates
Previous report
The following represents a summary of notable business updates and events:
Previous report
•On September 25, 2025, the FDA approved PALSONIFY for the first-line treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option.
Previous report
•Our research suggests that there are approximately 36,000 people living with acromegaly in the United States, of which 17,000 or more are undiagnosed, 7,500 are not in active follow-up for treatment, and 11,500 are actively managed. Our research further suggests that of the 11,500 actively managed patients in the United States, 40% are treatment naïve, 25% are on injectable somatostatin receptor ligands, 20% are on other therapies, and 15% have discontinued treatment. Our research also indicates that there are approximately 1,500 newly diagnosed patients per year, 500 of which are candidates to initiate pharmaceutical treatment.
Previous report
•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 report
•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 report
•Continued progress on the development program for atumelnant across multiple trials, including enrollment completion of Cohort 4 of the adult Phase 2 study with data expected early in 2026.
Previous report
•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 report
•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 report
•Announced that we expect to initiate the Phase 2/3 trial of atumelnant in ADCS in the first half of 2026.
Previous report
Early-Stage Pipeline:
Previous report
•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 report
•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 report
•The R&D Day presentation included the following updates on our preclinical development pipeline:
Previous report
•CRN09682:
Previous report
•We shared data on CRN09682 previously presented at medical conferences that show the potency, selectivity and internalization of CRN09682. CRN09682 in tumor and plasma and free monomethyl auristatin E, or MMAE, in plasma are not observed after 24 hours in a mouse tumor model, while free MMAE cleaved from CRN09682 persists within the tumor for at least 240 hours. We also demonstrated that CRN09682 induced anti-tumor activity in a dose-dependent manner in different mouse tumor growth models without a decrease in body weight.
Previous report
•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 report
We expect to enroll up to 150 participants across both Phase 1 and Phase 2 of the trial.
Previous report
•CRN12755: We provided preclinical data on our lead candidate, CRN12755, in the TSHR antagonist program for the treatment of Graves’ disease, including the two major manifestations Graves’ hyperthyroidism and Graves’ orbitopathy (Thyroid Eye Disease, or TED). CRN12755 was observed to decrease TSAb-stimulated thyroid hormone (T4) in a rat model, and was observed to decrease hyaluronic acid and IL-6 production in Graves Orbital Fibroblasts, or GOFs from TED patients. We also provided an overview of the clinical development strategy for CRN12755, including key biomarkers and other data to be captured in the Phase 1 trial.
Previous report
•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 report
•Based on emerging data from IND enabling studies, focus of the TSHR antagonist program has shifted to bringing forward an alternative candidate with a superior profile. There is also follow-up preclinical work needed on the IND-enabling studies for the SST3 program that will postpone its IND submission.
Previous report
International Expansion:
Previous report
•We continued international expansion activities in parallel with the ongoing review of our MAA for PALSONIFY by the European Medicines Agency.
Previous report
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 report
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 report
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 report
Revenues
Previous report
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 report
Our revenues during the nine months ended September 30, 2025 and September 30, 2024 were derived from the Sanwa License and the Sanwa Clinical Supply Agreement. Our 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. We did not generate any revenues from the commercial sale of PALSONIFY during the third quarter of 2025. Further, we may never generate revenues from the commercial sale of our other product candidates in the pipeline for at least the foreseeable future, if ever.
Previous report
Research and development
Previous report
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 report
Research and development expenses include:
Previous report
•salaries, payroll taxes, employee benefits, and stock-based compensation charges for those individuals involved in research and development efforts;
Previous report
•external research and development expenses incurred under agreements with contract research organizations, or CROs, investigative sites and consultants to conduct our clinical trials and preclinical and nonclinical studies;
Previous report
•costs related to manufacturing our product candidates for clinical trials and preclinical studies, including fees paid to third-party manufacturers;
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•costs related to compliance with regulatory requirements;
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•laboratory supplies; and
Previous report
•facilities, depreciation and other allocated expenses for rent, facilities maintenance, insurance, equipment and other supplies.
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Reworded paragraphs (19)
Previous wording
You should read the following discussion of our financial condition and results of operations in conjunction with the unaudited condensed consolidated financial statements and the notes thereto included elsewhere in this Quarterly Report on Form 10-Q and with our audited financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2024.
Current wording
You should read the following discussion of our financial condition and results of operations in conjunction with the unaudited condensed consolidated financial statements and the notes thereto included elsewhere in this Report and with our audited financial statements and notes thereto included in our FY 2025 Form 10-K . Unless otherwise indicated, all dollar amounts are presented in thousands, with the exception of per share amounts.
Previous wording
The following discussion and other parts of this quarterly report contain forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. All statements other than statements of historical facts contained in this quarterly report, including statements regarding our future results of operations and financial position, business strategy, the impact of international conflicts, prospective products, product approvals, research and development costs, timing and likelihood of success, plans and objectives of management for future operations and future results of anticipated products, are forward-looking statements. These statements are often identified by the use of words such as “may,” “will,” “expect,” “believe,” “anticipate,” “intend,” “could,” “should,” “estimate,” or “continue,” and similar expressions or variations. The forward-looking statements in this quarterly report are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, operating results, business strategy, short-term and long-term business operations and objectives. These forward-looking statements speak only as of the date of this quarterly report and are subject to a number of risks, uncertainties and assumptions, including those described in Part II, Item 1A, “Risk Factors.” The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. 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.
Current wording
The following discussion and other parts of this Report contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act and Section 21E of the Exchange Act. All statements other than statements of historical facts contained in this Report, including statements regarding our future results of operations and financial position, business strategy, commercialization efforts, prospective products, product approvals, research and development costs, timing and likelihood of success, plans and objectives of management for future operations and future results of anticipated products, are forward-looking statements. These statements are often identified by the use of words such as “may,” “will,” "should," “expect,” "plan," “anticipate,” “intend,” “target,” “goal,” “aspire,” “project,” “lead to,” “contemplates,” “believes,” “estimates,” “predicts,” “forecast,” “potential,”or “continue,” and similar expressions or variations. In particular, forward-looking statements in this Report relate to, among other things: our ability to successfully commercialize PALSONIFY for the treatment of acromegaly; expected insurance coverage for PALSONIFY; our expectations regarding the timing, duration and costs of advancing our pipeline and conducting ongoing and planned clinical and preclinical studies, including future product launches and geographic expansion; anticipated future results and expenses; our expectations regarding our ability to raise additional capital as needed, and our ability to achieve or maintain profitability; and our expectations regarding the impact of general economic, industry and market conditions globally that may affect us. The forward-looking statements in this Report are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, operating results, business strategy, short-term and long-term business operations and objectives. These forward-looking statements speak only as of the date of this Report and are subject to a number of risks, uncertainties and assumptions, including those described in the “Risk Factors” section contained in our FY 2025 10-K . The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. 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.
Previous wording
Comparison of the three and nine months ended September 30, 2025 and 2024
Current wording
Comparison of the three months ended March 31, 2026, December 31, 2025, and March 31, 2025
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The following table summarizes our results of operations for the three and nine months ended September 30, 2025 and 2024 (in thousands):
Current wording
The following table summarizes our results of operations for the three months ended March 31, 2026, December 31, 2025, and March 31, 2025:
Previous 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):
Current wording
The following table summarizes our primary external and internal research and development expenses for the three months ended March 31, 2026, December 31, 2025, and March 31, 2025:
Previous 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):
Current wording
The following table summarizes our research and development expenses by program for the three months ended March 31, 2026, December 31, 2025, and March 31, 2025:
Previous 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.
Current wording
The decrease in selling, general and administrative expenses during the three months ended March 31, 2026 as compared to the sequential period was primarily due to the initial commercial launch expenses to support the commercialization of PALSONIFY in the fourth quarter of 2025. The increase in selling, general and administrative expenses during the three months ended March 31, 2026 as compared to the prior year period was primarily due to the increase in personnel expenses, including stock-based compensation, and professional services to support our growth, following the commercial launch of PALSONIFY in the fourth quarter of 2025.
Previous wording
Our financial condition is summarized as follows (in thousands):
Current wording
Our financial condition is summarized as follows:
Previous wording
Based on our current and anticipated level of operations, we believe that our existing capital resources, together with income generated by our investment securities, will be sufficient to satisfy our current and projected funding requirements for at least the next twelve months. However, our forecast of the period 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. We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we expect. Additionally, the process of testing product candidates in clinical trials is costly, and the timing of progress and expenses in these trials is uncertain.
Current wording
Based on our current and anticipated level of operations, we believe that our existing capital resources, together with income generated by our investment securities and product revenue, will be sufficient to satisfy our current and projected funding requirements for at least the next twelve months. However, our forecast of the period 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. We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we expect. Additionally, the process of testing product candidates in clinical trials is costly, and the timing of progress and expenses in these trials is uncertain.
Previous wording
•our ability to generate revenues through product sales of PALSONIFY and other potential product candidates once approved, if ever, and future licensing arrangements;
Current wording
•our ability to generate revenue through product sales of PALSONIFY and other potential product candidates once approved, if ever, and future licensing arrangements;
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•the costs and timing of establishing or securing sales and marketing capabilities if any product candidate is approved;
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•the costs and timing of establishing or securing sales and marketing capabilities if any additional product candidates are approved;
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•costs associated with any products or technologies that we may in-license or acquire; and
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•costs associated with any products or technologies that we may in-license or acquire;
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•the funding of any co-development arrangements we enter into.
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•the funding of any co-development arrangements we enter into; and
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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.
Current wording
Until such time, if ever, as we can generate substantial product revenue to support our cost structure, we expect to finance our cash needs through our capital resources, 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, disruptions of the global supply chain and energy markets as a result of geopolitical conflicts, 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.
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 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.
Current wording
Pursuant to the 2024 Sales Agreement, we may, from time to time, sell up to $350.0 million shares of our common stock through the Sales Agents.
Previous wording
We have incurred cumulative net losses and negative cash flows from operations since our inception and anticipate we will continue to incur net losses for the foreseeable future. As of September 30, 2025, we had unrestricted cash, cash equivalents and investment securities of $1.1 billion and an accumulated deficit of $1.3 billion.
Current wording
We have incurred cumulative net losses and negative cash flows from operations since our inception and anticipate we will continue to incur net losses for the foreseeable future. As of March 31, 2026, we had unrestricted cash, cash equivalents and investment securities of $1.3 billion and an accumulated deficit of $1.5 billion.
Previous wording
The following table provides information regarding our cash flows for the nine months ended September 30, 2025 and 2024 (in thousands):
Current wording
The following table provides information regarding our cash flows for the three months ended March 31, 2026 and 2025:
Previous wording
Financing activities. The net cash provided by financing activities during the nine months ended September 30, 2025 resulted from proceeds received from the exercise of stock options and shares issued under the ESPP, and the net cash provided by financing activities during the same period in 2024 resulted from proceeds received from the sale of common stock and cash received from the exercise of stock options and shares issued under the ESPP.
Current wording
Cash flows from financing activities consist of net proceeds from the sale of common stock, exercises of stock options, and shares issued under the ESPP. The increase in cash provided by financing activities is due to the net proceeds received from the sale of common stock in January 2026 and a net increase in proceeds from stock option exercises.
Previous wording
As of October 28, 2025, outstanding shares of common stock were 94.9 million, outstanding stock options were 14.3 million, unvested restricted stock units were 2.3 million, and shares expected to be purchased under the 2018 Employee Stock Purchase Plan, or ESPP, were 0.4 million.
Current wording
As of April 23, 2026, outstanding shares of common stock were 105.4 million, outstanding stock options were 14.6 million, unvested restricted stock units were 2.8 million, and shares expected to be purchased under the ESPP were 0.7 million.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
During the three months ended March 31, 2026 and 2025, and as of the date of this Report, no shares of common stock have been issued pursuant to the 2024 Sales Agreement.