SEC Form 10-Q filed by Crinetics Pharmaceuticals Inc.
$CRNX
Biotechnology: Pharmaceutical Preparations
Health Care
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
___________________________________________________________________________________________
FORM 10-Q
___________________________________________________________________________________________
(Mark One)
| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |||||
For the quarterly period ended March 31, 2026
| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |||||
For the transition period from ______ to
Commission File Number: 001-38583
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | ||||
| (Address of principal executive offices) | (Zip code) | ||||
Registrant’s telephone number, including area code: (858 ) 450-6464
___________________________________________________________________________________________
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days. Yes ☑ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☑ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| ☑ | Accelerated filer | ☐ | ||||||||||||
| Non-accelerated filer | ☐ | Smaller reporting company | ||||||||||||
| Emerging growth company | ||||||||||||||
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☑
As of April 23, 2026, the registrant had 105,440,208 shares of common stock ($0.001 per share par value) outstanding.
GLOSSARY OF DEFINED TERMS
Unless expressly indicated or the context requires otherwise, the terms “Crinetics,” “Company,” “we,” “us,” and “our,” in this Quarterly Report on Form 10-Q (this “Report”) refer to Crinetics Pharmaceuticals, Inc., a Delaware corporation, and, where appropriate, its wholly-owned subsidiaries. We also have used several other terms in this Report, most of which are explained or defined below.
“2018 Plan” means our 2018 Incentive Award Plan.
“2021 Inducement Plan” means our 2021 Employment Inducement Incentive Award Plan.
“2022 Lease” means our operating lease for our headquarters in San Diego, California.
“2024 Sales Agreement” means the Sales Agreement entered into by and between Crinetics and the Sales Agents on June 21, 2024.
“ADCS” means ACTH-Dependent Cushing’s Syndrome.
“ANVISA” means Agência Nacional de Vigilância Sanitária, or the Brazilian Health Regulatory Agency.
“ASC” means Accounting Standards Codification.
“ASU” means Accounting Standards Update.
“ATM” means at-the-market.
“CAH” means congenital adrenal hyperplasia.
“CHMP” means the Committee for Medicinal Products for Human Use.
“CODM” means chief operating decision maker.
“CROs” means contract research organizations.
“CS” means carcinoid syndrome.
“EC” means the European Commission.
“EMA” means the European Medicines Agency.
“Enrollment Form” means an official document containing both HCP and patient consent, submitted to CrinetiCARE or specialty pharmacies to initiate a patient on PALSONIFY. Enrollment forms metric also includes direct dispenses from pituitary treatment centers or community practices to patients.
“ESPP” means our 2018 Employee Stock Purchase Plan.
“Exchange Act” means the U.S. Securities Exchange Act of 1934, as amended.
“FASB” means the Financial Accounting Standards Board.
“FDA” means the U.S. Food and Drug Administration.
“FY 2025 Form 10-K” means our Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the SEC on February 26, 2026.
“GPCRs” means G-protein coupled receptors.
“HCP” means healthcare professionals.
“Lilly” means Eli Lilly and Company.
“Loyal” means Cellular Longevity Inc., doing business as Loyal.
“MAA” means Marketing Authorization Application.
“NETs” means neuroendocrine tumors.
“OLE” means open-label extension.
“PBEs” means public business entities.
“Quickstart” means a program that provides eligible patients with a temporary supply of PALSONIFY at no cost while insurance coverage is pending or under appeal. This program is designed to ensure continuity of care during delays in insurance coverage determination.
i
“Radionetics” means Radionetics Oncology, Inc.
“Radionetics License” means the collaboration and license agreement entered into with Radionetics in October 2021.
“Radionetics Warrant” means the warrant issued to the Company by Radionetics pursuant to the Radionetics License.
“RSUs” means restricted stock units.
“Sales Agents” means SVB Leerink LLC and Cantor Fitzgerald & Co.
“SEC” means the U.S. Securities and Exchange Commission.
“SKK” means Sanwa Kagaku Kenkyusho Co., Ltd.
“SKK License” means the license agreement entered into with SKK on February 25, 2022.
“SST2” means the somatostatin receptor type 2.
“SEC” means the Securities and Exchange Commission.
“U.S.” means United States.
“U.S. GAAP” means U.S. Generally Accepted Accounting Principles.
“VIE” means variable interest entity.
ii
CRINETICS PHARMACEUTICALS, INC. QUARTERLY REPORT ON FORM 10-Q
For the Quarter Ended March 31, 2026
TABLE OF CONTENTS
| Page | ||||||||
1
PART I — FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements (Unaudited)
2
Crinetics Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except per share data)
| March 31, 2026 | December 31, 2025 | ||||||||||
| (Unaudited) | |||||||||||
| ASSETS | |||||||||||
CURRENT ASSETS | |||||||||||
| Cash and cash equivalents | $ | $ | |||||||||
Investment securities, amortized cost of $ | |||||||||||
Trade accounts receivable, net | |||||||||||
Inventory | |||||||||||
| Prepaid expenses and other current assets | |||||||||||
| Total current assets | |||||||||||
| Property and equipment, net | |||||||||||
| Operating lease right-of-use assets | |||||||||||
| Restricted cash, net of current portion | |||||||||||
| Prepaid expenses and other assets, net of current portion | |||||||||||
TOTAL ASSETS | $ | $ | |||||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||||
| CURRENT LIABILITIES | |||||||||||
| Accounts payable and accrued expenses | $ | $ | |||||||||
| Accrued compensation and related expenses | |||||||||||
| Deferred revenue | |||||||||||
| Operating lease liabilities | |||||||||||
| Total current liabilities | |||||||||||
| Operating lease liabilities, non-current | |||||||||||
| Deferred revenue, non-current | |||||||||||
| Other liabilities | |||||||||||
| TOTAL LIABILITIES | |||||||||||
| STOCKHOLDERS’ EQUITY | |||||||||||
Preferred stock, $ | |||||||||||
Common stock and paid-in capital, $ | |||||||||||
Accumulated other comprehensive (loss) income | ( | ||||||||||
| Accumulated deficit | ( | ( | |||||||||
| Stock held in trust | ( | ( | |||||||||
| TOTAL STOCKHOLDERS’ EQUITY | |||||||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | $ | |||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
Crinetics Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except per share data)
(unaudited)
| Three months ended March 31, | |||||||||||
| 2026 | 2025 | ||||||||||
| Revenue: | |||||||||||
| Product revenue, net | $ | $ | |||||||||
| Collaboration and license revenue | |||||||||||
| Total revenue | |||||||||||
| Operating expenses: | |||||||||||
| Cost of product revenue | |||||||||||
| Research and development | |||||||||||
| Selling, general and administrative | |||||||||||
| Total operating expenses | |||||||||||
| Loss from operations | ( | ( | |||||||||
| Other income (expense): | |||||||||||
| Interest income | |||||||||||
| Other expense, net | ( | ( | |||||||||
| Total other income, net | |||||||||||
| Net loss | ( | ( | |||||||||
| Net loss per share: | |||||||||||
| Net loss per share — basic and diluted | $ | ( | $ | ( | |||||||
| Weighted average shares — basic and diluted | |||||||||||
| Other comprehensive income (loss): | |||||||||||
| Unrealized gain (loss) on investment securities | $ | ( | $ | ||||||||
| Unrealized gain on foreign currency | |||||||||||
| Total other comprehensive income (loss) | ( | ||||||||||
| Comprehensive loss | $ | ( | $ | ( | |||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
Crinetics Pharmaceuticals, Inc.
Condensed Consolidated Statements of Stockholders’ Equity
(in thousands)
(unaudited)
| Common Stock Shares | Common Stock and Paid-In Capital | Accumulated Other Comprehensive Income (loss) | Accumulated Deficit | Stock Held in Trust | Total Stockholders’ Equity | ||||||||||||||||||||||||||||||
| Balance at January 1, 2026 | $ | $ | $ | ( | $ | ( | $ | ||||||||||||||||||||||||||||
| Exercise of stock options | — | — | — | ||||||||||||||||||||||||||||||||
Issuance of common stock, net of transaction costs | — | — | — | ||||||||||||||||||||||||||||||||
| Issuance of common stock upon vesting of RSUs | — | — | — | — | — | ||||||||||||||||||||||||||||||
| Stock-based compensation | — | — | — | — | |||||||||||||||||||||||||||||||
| Stock held in trust under deferred compensation plan | — | — | — | ( | |||||||||||||||||||||||||||||||
| Other comprehensive loss | — | — | ( | — | — | ( | |||||||||||||||||||||||||||||
| Net loss | — | — | — | ( | — | ( | |||||||||||||||||||||||||||||
| Balance at March 31, 2026 | $ | $ | ( | $ | ( | $ | ( | $ | |||||||||||||||||||||||||||
| Balance on January 1, 2025 | $ | $ | $ | ( | $ | $ | |||||||||||||||||||||||||||||
| Exercise of stock options | — | — | — | ||||||||||||||||||||||||||||||||
Issuance of common stock upon vesting of RSUs | — | — | — | — | — | ||||||||||||||||||||||||||||||
| Stock-based compensation | — | — | — | — | |||||||||||||||||||||||||||||||
| Other comprehensive income | — | — | — | — | |||||||||||||||||||||||||||||||
| Net loss | — | — | — | ( | — | ( | |||||||||||||||||||||||||||||
| Balance at March 31, 2025 | $ | $ | $ | ( | $ | $ | |||||||||||||||||||||||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5
Crinetics Pharmaceuticals, Inc.
Condensed Consolidated Statements of Cash Flows
(in thousands)
(unaudited)
| Three months ended | |||||||||||
| March 31, | |||||||||||
| 2026 | 2025 | ||||||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | |||||||||||
| Net loss | $ | ( | $ | ( | |||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||
| Stock-based compensation | |||||||||||
| Depreciation and amortization | |||||||||||
| Noncash lease expense | |||||||||||
| Accretion of purchase discounts and amortization of premiums on investment securities, net | ( | ( | |||||||||
| Loss on disposal of property and equipment | |||||||||||
| Changes in operating assets and liabilities: | |||||||||||
| Trade accounts receivable | ( | ||||||||||
| Inventory | ( | ||||||||||
| Prepaid expenses and other assets | ( | ( | |||||||||
| Accounts payable and accrued expenses, compensation and related expenses, and other liabilities | ( | ( | |||||||||
| Deferred revenue | ( | ( | |||||||||
| Operating lease liabilities | ( | ( | |||||||||
| Net cash used in operating activities | ( | ( | |||||||||
| CASH FLOWS FROM INVESTING ACTIVITIES | |||||||||||
| Purchases of investment securities | ( | ( | |||||||||
| Proceeds from sales and maturities of investment securities | |||||||||||
| Purchases of property and equipment | ( | ( | |||||||||
| Net cash used in investing activities | ( | ( | |||||||||
| CASH FLOWS FROM FINANCING ACTIVITIES | |||||||||||
| Proceeds from issuance of common stock, net of commissions | |||||||||||
| Offering costs related to issuance of common stock | ( | ||||||||||
| Proceeds from exercise of stock options | |||||||||||
| Net cash provided by financing activities | |||||||||||
| Net change in cash, cash equivalents and restricted cash | ( | ||||||||||
Exchange rate changes in cash, cash equivalents and restricted cash | ( | ||||||||||
| Cash, cash equivalents and restricted cash - beginning of period | |||||||||||
| Cash, cash equivalents and restricted cash - end of period | $ | $ | |||||||||
| COMPONENTS OF CASH, CASH EQUIVALENTS AND RESTRICTED CASH | |||||||||||
| Cash and cash equivalents | $ | $ | |||||||||
| Restricted cash | |||||||||||
| Cash, cash equivalents and restricted cash at end of period | $ | $ | |||||||||
| NONCASH INVESTING AND FINANCING ACTIVITIES | |||||||||||
| Stock options exercised receivable | $ | $ | |||||||||
| Amounts accrued for purchases of property and equipment | $ | $ | |||||||||
Amounts accrued for offering costs | $ | $ | |||||||||
| Stock held in trust | $ | $ | |||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
6
Crinetics Pharmaceuticals, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements
(Unless otherwise indicated, all dollar amounts are presented in thousands, except per share amounts)
1. Organization and Basis of Presentation
Description of Business
Crinetics Pharmaceuticals, Inc. is 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.
Basis of Presentation and Principles of Consolidation
The accompanying condensed consolidated financial statements are unaudited, and reflect all adjustments which are, in the opinion of management, of a normal recurring nature and necessary for a fair statement of the results for the interim periods presented in accordance with U.S. GAAP.
Our condensed consolidated balance sheet for the year ended December 31, 2025 was derived from our audited consolidated financial statements, but does not include all disclosures required by U.S. GAAP. The interim results presented herein are not necessarily indicative of the results expected for the full fiscal year or any other interim period. Our condensed consolidated financial statements should be read in conjunction with the FY 2025 Form 10-K.
Our condensed consolidated financial statements include our accounts and those of our wholly-owned subsidiaries, and have been prepared in conformity with U.S. GAAP. All intercompany transactions and balances have been eliminated.
Liquidity
From inception, we have devoted substantially all of our efforts to drug discovery and development, conducting preclinical studies and clinical trials, building the infrastructure necessary for commercial operations, and launching PALSONIFY in the U.S. We have a limited operating history and the sales and income potential of our business and market are unproven. While we have received FDA and EMA approval for our lead product, we may continue to incur substantial operating losses even as we generate revenue from PALSONIFY, and a successful transition to attaining profitable operations is dependent upon achieving a level of revenue adequate to support our cost structure.
We have experienced net losses and negative cash flows from operating activities since our inception and have an accumulated deficit of $1.5 billion as of March 31, 2026. As of March 31, 2026, we had $1.3 billion in cash, cash equivalents and investment securities, which we believe is sufficient to fund our operating cash needs for at least the next 12 months from the date of issuance of these unaudited condensed consolidated financial statements.
Our future long-term liquidity requirements will be substantial and will depend on many factors, including our ability to effectively commercialize PALSONIFY and other product candidates. We expect to continue to incur net losses for the foreseeable future and may need to raise substantial additional capital to accomplish our business objectives. We plan to continue to fund our losses from operations and capital funding needs through a combination of existing capital resources, product sales, equity offerings, debt financings or other sources, including potential collaborations, licenses and other similar arrangements. If we are not able to secure adequate additional funding, we may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, or suspend or curtail planned programs. Any of these actions could materially harm our business, results of operations and prospects. There can be no assurance as to the availability or terms upon which such financing and capital might be available in the future.
7
Significant Accounting Policies
There have been no material changes to our significant accounting policies from the FY 2025 Form 10-K.
Use of Estimates
The preparation of our condensed consolidated financial statements requires us to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenue and expenses and the disclosure of contingent assets and liabilities in our condensed consolidated financial statements and accompanying notes. The estimates in our condensed consolidated financial statements include, but are not limited to, accrual of research and development expenses, valuation of stock-based awards, fair values of financial instruments, inventory valuation, and revenue recognition.
As of the date of issuance of these condensed consolidated financial statements, we are not aware of any specific event or circumstance that would require us to update our estimates, judgments or revise the carrying value of our assets or liabilities. These estimates may change as new events occur and additional information is obtained, and are recognized in the condensed consolidated financial statements as soon as they become known. Actual results could differ from those estimates and any such differences may be material to our condensed consolidated financial statements.
Recent Accounting Pronouncements Not Yet Adopted
ASU 2024-03
In November 2024, the FASB issued ASU 2024-03, Income Statement–Reporting Comprehensive Income–Expense disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires disaggregated disclosure of income statement expenses for PBEs. ASU 2024-03 does not change the expense captions an entity presents on the face of the income statement; rather, it requires disaggregation of certain expense captions into specified categories in disclosures within the footnotes to the financial statements. ASU 2024-03 is effective for all PBEs for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. We are currently evaluating the impact that this guidance will have on the presentation of our condensed consolidated financial statements and accompanying notes.
ASU 2025-03
In May 2025, the FASB issued ASU 2025-03, Business Combinations (Topic 805) and Consolidation (Topic 810): Determining the Accounting Acquirer in the Acquisition of a Variable Interest Entity, which provides guidance for identifying the accounting acquirer in business combinations in which the legal acquiree is a VIE that meets the definition of a business. Under the ASU, the acquirer is determined using the factors in ASC 805, Business Combinations, rather than assuming the primary beneficiary is the acquirer. ASU 2025‑03 is effective for fiscal years beginning after December 15, 2026, and interim periods within those years, with early adoption permitted. We are currently evaluating the impact of this guidance on the presentation of our condensed consolidated financial statements and accompanying notes.
2. Investment Securities
We report our available-for-sale investment securities at their estimated fair values. The following is a summary of our available-for-sale investment securities as of March 31, 2026 and December 31, 2025:
| As of March 31, 2026 | As of December 31, 2025 | ||||||||||||||||||||||||||||||||||||||||||||||
| Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Market Value | Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Market Value | ||||||||||||||||||||||||||||||||||||||||
| Available-for-sale investment securities: | |||||||||||||||||||||||||||||||||||||||||||||||
| U.S. government obligations | $ | $ | $ | ( | $ | $ | $ | $ | $ | ||||||||||||||||||||||||||||||||||||||
| Agency obligations | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||
| Corporate debt securities | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||
| Total | $ | $ | $ | ( | $ | $ | $ | $ | ( | $ | |||||||||||||||||||||||||||||||||||||
8
As of March 31, 2026 and December 31, 2025, available-for-sale investment securities by contractual maturity were as follows:
| As of March 31, 2026 | As of December 31, 2025 | ||||||||||||||||||||||
| Amortized Cost | Fair Market Value | Amortized Cost | Fair Market Value | ||||||||||||||||||||
| Available-for-sale investment securities: | |||||||||||||||||||||||
| Due in one year or less | $ | $ | $ | $ | |||||||||||||||||||
| Due after one year through five years | |||||||||||||||||||||||
| Total | $ | $ | $ | $ | |||||||||||||||||||
The following is a summary of the available-for-sale investment securities by length of time in a net loss position as of March 31, 2026 and December 31, 2025:
| As of March 31, 2026 | As of December 31, 2025 | ||||||||||||||||||||||
| Less Than 12 Months | Less Than 12 Months | ||||||||||||||||||||||
| Fair Market Value | Gross Unrealized Losses | Fair Market Value | Gross Unrealized Losses | ||||||||||||||||||||
| Available-for-sale investment securities: | |||||||||||||||||||||||
| U.S. government obligations | $ | $ | ( | $ | $ | ||||||||||||||||||
| Agency obligations | ( | ( | |||||||||||||||||||||
| Corporate debt securities | ( | ( | |||||||||||||||||||||
| Total | $ | $ | ( | $ | $ | ( | |||||||||||||||||
As of March 31, 2026 and December 31, 2025, all available-for-sale investment securities in a continuous unrealized loss position had been in a loss position for less than 12 months.
We reviewed our investment holdings as of March 31, 2026 and December 31, 2025 and determined that the decrease in fair value is attributable to changes in interest rates and not credit quality. Therefore, there were no
Accrued interest receivable on available-for-sale securities was $9.0 million and $7.8 million at March 31, 2026 and December 31, 2025, respectively.
3. Fair Value Measurements
Fair value measurements may be based on trade prices in active markets for identical assets or liabilities (Level 1 inputs) or valuation models using inputs that are observable either directly or indirectly (Level 2 inputs), such as quoted prices for similar assets or liabilities, yield curves, volatility factors, credit spreads, default rates, loss severity, current market and contractual prices for the underlying instruments or debt, and broker and dealer quotes, as well as other relevant economic measures.
Financial assets measured at fair value on a recurring basis as of March 31, 2026 and December 31, 2025 were as follows:
| As of March 31, 2026 | |||||||||||||||||||||||
| Level 1 | Level 2 | Level 3 | Total | ||||||||||||||||||||
| Cash equivalents: | |||||||||||||||||||||||
| Money market funds | $ | $ | $ | $ | |||||||||||||||||||
| U.S. government obligations | |||||||||||||||||||||||
| Total cash equivalents | |||||||||||||||||||||||
| Investment securities: | |||||||||||||||||||||||
| U.S. government obligations | |||||||||||||||||||||||
| Agency obligations | |||||||||||||||||||||||
| Corporate debt securities | |||||||||||||||||||||||
| Total investment securities | |||||||||||||||||||||||
| Other non-current assets: | |||||||||||||||||||||||
| Deferred compensation plan (1) | |||||||||||||||||||||||
| Total assets measured at fair value | $ | $ | $ | $ | |||||||||||||||||||
9
| As of December 31, 2025 | |||||||||||||||||||||||
| Level 1 | Level 2 | Level 3 | Total | ||||||||||||||||||||
| Cash equivalents: | |||||||||||||||||||||||
| Money market funds | $ | $ | $ | $ | |||||||||||||||||||
| Total cash equivalents | |||||||||||||||||||||||
| Investment securities: | |||||||||||||||||||||||
| U.S. government obligations | |||||||||||||||||||||||
| Agency obligations | |||||||||||||||||||||||
| Corporate debt securities | |||||||||||||||||||||||
| Total investment securities | |||||||||||||||||||||||
| Other non-current assets: | |||||||||||||||||||||||
| Deferred compensation plan (1) | |||||||||||||||||||||||
| Total assets measured at fair value | $ | $ | $ | $ | |||||||||||||||||||
(1)Consists of mutual fund investments held in the Rabbi Trust related to our non-qualified deferred compensation plan.
4. Balance Sheet Details
Inventory
Inventory consisted of the following:
| March 31, 2026 | December 31, 2025 | ||||||||||
| Work-in-process | $ | $ | |||||||||
| Finished goods | |||||||||||
| $ | $ | ||||||||||
Inventory balances include the capitalization of PALSONIFY manufacturing costs following the regulatory approval in September 2025. PALSONIFY inventory produced prior to approval was expensed as research and development. We did not hold any raw materials inventory as of March 31, 2026 or December 31, 2025.
There were no write-downs of inventory during the three months ended March 31, 2026 and 2025.
Prepaid expenses and other assets
Prepaid expenses and other assets consisted of the following:
| March 31, 2026 | December 31, 2025 | ||||||||||
| Prepaid clinical costs | $ | $ | |||||||||
| Interest receivable | |||||||||||
| Deferred compensation plan | |||||||||||
| Prepaid research and development costs | |||||||||||
| Prepaid subscriptions | |||||||||||
| Other | |||||||||||
| Total prepaid expenses and other assets | |||||||||||
| Less prepaid expenses and other current assets | ( | ( | |||||||||
| Prepaid expenses and other assets, net of current portion | $ | $ | |||||||||
10
Property and Equipment, net
Property and equipment, net consisted of the following:
| March 31, 2026 | December 31, 2025 | ||||||||||
| Leasehold improvements | $ | $ | |||||||||
| Lab equipment | |||||||||||
| Office equipment | |||||||||||
| Computers and software | |||||||||||
| Property and equipment at cost | |||||||||||
| Less accumulated depreciation and amortization | ( | ( | |||||||||
| Total | $ | $ | |||||||||
Accounts Payable and Accrued Expenses
Accounts payable and accrued expenses consisted of the following:
| March 31, 2026 | December 31, 2025 | ||||||||||
| Accounts payable | $ | $ | |||||||||
| Accrued clinical trial costs | |||||||||||
| Accrued outside services and professional fees | |||||||||||
| Accrued research and development costs | |||||||||||
| Other accrued expenses | |||||||||||
| Total | $ | $ | |||||||||
5. Operating Leases
The Company entered into the 2022 Lease in April 2022. The 2022 Lease is a non-cancellable operating lease and expires in April 2035.
Under the terms of the 2022 Lease, we provided the lessor with an irrevocable letter of credit in the amount of $0.8 million, which is included as restricted cash in the accompanying condensed consolidated balance sheets. The lessor is entitled to draw on the letter of credit in the event of any default by us under the terms of the 2022 Lease.
As of March 31, 2026, our future minimum payments under the 2022 Lease were as follows:
| Year ending December 31, | Minimum Payments | |||||||
| 2026 (nine months) | $ | |||||||
| 2027 | ||||||||
| 2028 | ||||||||
| 2029 | ||||||||
| 2030 | ||||||||
| Thereafter | ||||||||
| Total future minimum lease payments | ||||||||
| Less imputed interest | ( | |||||||
| Total operating lease liabilities | ||||||||
| Less operating lease liabilities, current | ( | |||||||
| Operating lease liabilities, non-current | $ | |||||||
Operating lease cost was $1.9 million and $2.2 million for the three months ended March 31, 2026 and 2025, respectively. Short-term lease expenses for the three months ended March 31, 2026 and 2025 were not significant.
Remaining lease terms and discount rates for our operating lease are as follows:
| As of March 31, 2026 | As of December 31, 2025 | ||||||||||
| Weighted-average remaining lease term (years) | |||||||||||
| Weighted-average discount rate | |||||||||||
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Supplemental cash flow information related to leases was as follows:
| Three months ended March 31, | |||||||||||
| 2026 | 2025 | ||||||||||
| Operating cash flow used for operating leases | $ | $ | |||||||||
6. Commitments and Contingencies
Litigation
From time to time, we may be subject to various claims and suits arising in the ordinary course of business. We do not expect that the resolution of these matters will have a material adverse effect on our financial position or results of operations.
7. Revenue Recognition
Product Revenue
Following the regulatory approval in September 2025, we launched PALSONIFY and began recognizing product revenue in the U.S. from the sales to specialty distributors and specialty pharmacies.
The following table summarizes customers that represented 10% or greater of our consolidated gross product revenue:
| Three months ended March 31, 2026 | |||||
| Customer A | % | ||||
| Customer B | % | ||||
Collaboration and License Revenue
Sanwa Kagaku Kenkyusho Co., Ltd
In February 2022, we entered into the SKK License, pursuant to which we granted SKK an exclusive license to develop and commercialize paltusotine in Japan. Under the SKK License, SKK is responsible for clinical development and regulatory activities in Japan, and we retain all rights outside Japan. We also granted SKK the right to purchase supply of paltusotine for clinical and commercial requirements at cost plus a pre-negotiated percentage which was a market rate and therefore not a material right.
Pursuant to the SKK License, we received a $13.0 million nonrefundable upfront payment and would be eligible to receive up to $25.5 million in development, regulatory, and commercial milestone payments, as well as sales-based royalties upon market approval in Japan. In 2024, we updated the estimated transaction price to $14.0 million following the achievement of a development milestone. In April 2026, we achieved $1.5 million of development milestones related to SKK's NDA submission in Japan for paltusotine for the treatment of acromegaly.
Our performance obligations under the SKK License comprised the license and data exchange. Control of the license transferred to SKK at contract inception and we do not have an ongoing performance obligation to support or maintain the licensed intellectual property. Revenue allocated to the data exchange obligation is recognized over time using the cost-to-cost measure as this method represents a faithful depiction of progress toward certain ongoing paltusotine studies and related data transfer. Revenue is recognized on a gross basis as we are the principal. Deferred revenues represent the data exchange obligation and are expected to be recognized over the duration of certain paltusotine studies conducted by us.
As of March 31, 2026, no sales-based milestones or royalties have been recognized as there have been no sales of paltusotine in Japan to date, and remaining milestone payments are constrained.
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Deferred revenue consisted of the following:
| Three months ended March 31, | |||||||||||
| 2026 | 2025 | ||||||||||
| Balance at beginning of period | $ | $ | |||||||||
| Deferred revenue additions, excluding amounts recognized as revenue during the period | |||||||||||
| Revenue recognized | ( | ( | |||||||||
| Balance at end of period | |||||||||||
| Less deferred revenue, current | ( | ( | |||||||||
| Deferred revenue, non-current | $ | $ | |||||||||
Cellular Longevity, Inc., doing business as Loyal
On March 24, 2023, we granted Loyal an exclusive license to develop and commercialize CRN01941, a somatostatin receptor type 2 agonist, for veterinary use. In return, we received a $0.1 million upfront payment and Loyal preferred stock valued at $2.0 million. We may also earn single-digit sales-based royalties if the product is approved.
8. Stockholders’ Equity
Stock Offering
On January 8, 2026, we completed an underwritten public offering of 8,763,000 shares of our common stock at a price to the public of $45.95 per share, which included 1,143,000 shares of common stock issued pursuant to the underwriters' option to purchase additional shares. Net proceeds from the offering were approximately $380 million, after underwriting discounts and commissions and other offering costs.
ATM Offering
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.
During the three months ended March 31, 2026 and 2025, and as of the date of this Report, no
9. Equity Incentive Plans
2021 Inducement Plan
As of March 31, 2026, 2,026,223 shares of common stock were available for future issuance under the 2021 Inducement Plan.
2018 Plan
As of March 31, 2026, 7,411,539 shares of common stock were available for future issuance under our 2018 Plan.
The 2018 Plan contains a provision that allows annual increases in the number of shares available for issuance on the first day of each calendar year through January 1, 2028, in an amount equal to the lesser of: (i) 5 % of the aggregate number of shares of our common stock outstanding on December 31 of the immediately preceding calendar year, or (ii) such lesser amount determined by us. Under this evergreen provision, on January 1, 2026, an additional 4,778,774 shares became available for future issuance under the 2018 Plan.
ESPP
As of March 31, 2026, 2,773,650 shares of common stock were available for issuance under our ESPP.
The ESPP contains a provision that allows annual increases in the number of shares available for issuance on the first day of each calendar year through January 1, 2028, in an amount equal to the lesser of: (i) 1 % of the aggregate number of shares of our common stock outstanding on December 31 of the immediately preceding calendar year, or (ii) such lesser amount determined by us. We elected to not increase the number of shares available for issuance under the ESPP on January 1, 2026.
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Stock Awards
Stock Options
Our stock option activity during the three months ended March 31, 2026 was as follows:
| Options Outstanding | Weighted- Average Exercise Price | Weighted- Average Remaining Term (in years) | Aggregate Intrinsic Value (000’s) | ||||||||||||||||||||
| Balance at December 31, 2025 | $ | ||||||||||||||||||||||
| Granted | $ | ||||||||||||||||||||||
| Exercised | ( | $ | |||||||||||||||||||||
| Forfeited and expired | ( | $ | |||||||||||||||||||||
| Balance at March 31, 2026 | $ | $ | |||||||||||||||||||||
| Exercisable at March 31, 2026 | $ | $ | |||||||||||||||||||||
RSUs
Our RSU activity during the three months ended March 31, 2026, was as follows:
| Restricted Stock Units Outstanding | Weighted-Average Grant Date Fair Value | ||||||||||
| Balance at December 31, 2025 | $ | ||||||||||
| Granted | $ | ||||||||||
| Vested | ( | $ | |||||||||
| Forfeited | ( | $ | |||||||||
| Balance at March 31, 2026 | $ | ||||||||||
Stock-Based Compensation Expense
Stock-based compensation expense for all equity awards is reported in the condensed consolidated statements of operations and comprehensive income (loss) as follows:
| Three months ended March 31, | |||||||||||
| 2026 | 2025 | ||||||||||
| Research and development | $ | $ | |||||||||
| Selling, general and administrative | |||||||||||
| Total stock-based compensation expense (exclusive of capitalized stock-based compensation expense) | |||||||||||
| Capitalized stock-based compensation expense | |||||||||||
| Total stock-based compensation expense | $ | $ | |||||||||
A summary of our total unrecognized stock-based compensation expense, as of March 31, 2026, is as follows:
| Unrecognized Stock-Based Compensation Expense | Average Remaining Vesting Period (in years) | ||||||||||
| Stock option awards | $ | ||||||||||
| RSU awards | $ | ||||||||||
| ESPP | $ | ||||||||||
10. Investment In Radionetics
In October 2021, we entered into the Radionetics License with Radionetics, whereby we licensed our radiotherapeutics technology to Radionetics in exchange for 50,500,000 shares of Radionetics' common stock, equivalent to a 64 % initial stake, and the Radionetics Warrant, which was exercisable for a number of shares of Radionetics common stock that would allow us to maintain up to 22 % equity in Radionetics on a fully diluted basis.
In August 2023, we participated in a refinancing transaction, exercising the Radionetics Warrant to purchase 3,407,285 shares of Radionetics common stock, exchanging 32,344,371 shares of Radionetics common stock for Radionetics
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preferred stock, and investing $5.0 million for an additional 14,404,656 shares of Radionetics preferred stock. The Radionetics License was also amended to include up to $15.0 million in new sales milestones.
In June 2024, the Radionetics License was amended to reduce development targets and revert certain rights to us. Under the amended Radionetics License, we are eligible to receive potential sales milestones in excess of $300.0 million and single-digit royalties on net sales. In July 2024, Radionetics formed a strategic partnership with Lilly, receiving a $140.0 million upfront payment and granting Lilly the exclusive right to acquire Radionetics for $1.0 billion.
Although Radionetics is a VIE, we determined we are not the primary beneficiary and do not consolidate Radionetics’ results due to lack of control over key decisions, which rests with Radionetics’ independent board and management. We account for our investment in Radionetics under the equity method.
As of March 31, 2026, we held a 25 % ownership in Radionetics consisting of common and preferred stock. The investment asset was previously written down to zero in the first quarter of 2024 with no gains or losses recorded thereafter.
11. Segment Reporting
We operate in a single reportable segment. The CODM, our President and Chief Executive Officer, assesses performance based on condensed consolidated net loss as reported on the condensed consolidated statement of operations and comprehensive loss, supplemented by certain additional significant expense details reflected in the table below. There have been no changes in the determination of segments or the measurements used to determine reported segment loss or segment total assets discussed in our FY 2025 Form 10-K.
Segment revenue and significant segment expenses regularly reported to the CODM are included within the table below and are reconciled to condensed consolidated net loss:
| Three months ended March 31, | |||||||||||
| 2026 | 2025 | ||||||||||
| Revenue: | |||||||||||
| Product revenue, net | $ | $ | |||||||||
| Collaboration and license revenue | |||||||||||
| Total revenue | |||||||||||
| Less: | |||||||||||
| Cost of product revenue | ( | ||||||||||
| Research and development | |||||||||||
| Paltusotine | ( | ( | |||||||||
| Atumelnant | ( | ( | |||||||||
| Other research and development programs | ( | ( | |||||||||
| Research and development personnel expenses | ( | ( | |||||||||
| Research and development stock-based compensation | ( | ( | |||||||||
| Other research and development (1) | ( | ( | |||||||||
| Total research and development expenses | ( | ( | |||||||||
| Selling, general and administrative | |||||||||||
| Other selling, general and administrative expenses (2) | ( | ( | |||||||||
| Selling, general and administrative personnel expenses | ( | ( | |||||||||
| Selling, general and administrative stock-based compensation | ( | ( | |||||||||
| Total selling, general and administrative expenses | ( | ( | |||||||||
| Total other income, net | |||||||||||
| Segment and consolidated net loss | $ | ( | $ | ( | |||||||
(1)Other research and development is comprised of non-personnel related research and development indirect costs incurred for the benefit of multiple research and development programs, including depreciation, and other facility-based expenses, such as rent expense.
(2)Other selling, general and administrative expenses is comprised of non-personnel related indirect costs incurred for the benefit of multiple administrative functions, including sales and marketing expenses, facility-related costs, legal and professional fees, insurance costs and costs to operate a public company.
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During the second quarter of 2025, the company updated the presentation of certain segment expenses. The information for the period ended March 31, 2025 presented in the footnote has been updated to conform.
12. Net Loss Per Share
Basic net loss per share is computed by dividing the net loss by the weighted-average number of common shares outstanding for the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of shares of common stock and dilutive common stock equivalents outstanding for the period determined using the treasury-stock and if-converted methods. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding as inclusion of the potentially dilutive securities on loss per share would be antidilutive.
Potentially dilutive securities (in common stock equivalent shares) not included in the calculation of diluted net loss per share because to do so would be anti-dilutive are as follows:
| Three months ended March 31, | |||||||||||
| 2026 | 2025 | ||||||||||
| Stock options | |||||||||||
| Unvested RSUs | |||||||||||
| Estimated shares of common stock expected to be purchased under the ESPP | |||||||||||
| Stock held in trust under deferred compensation plan | |||||||||||
| Total | |||||||||||
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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
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.
Forward Looking Statements
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.
Overview
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.
Recent Developments
PALSONIFY
•Key metrics for the first quarter 2026 reflect broad and deep uptake from patients and healthcare providers as well as favorable feedback from payers.
•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.
Paltusotine
•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.
•In March 2026, we submitted a MAA to Brazil’s ANVISA for PALSONIFY for the treatment of acromegaly in adults.
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•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.
Atumelnant
•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.
•In January 2026, the first participant in the BALANCE-CAH study was dosed.
•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.
Financial operations overview
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.
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.
Research and development expenses increased as we progressed clinical development programs and supported earlier-stage research initiatives to advance our pipeline of product candidates.
Critical Accounting Estimates
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.
Results of Operations
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.
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Comparison of the three months ended March 31, 2026, December 31, 2025, and March 31, 2025
The following table summarizes our results of operations for the three months ended March 31, 2026, December 31, 2025, and March 31, 2025:
| Three months ended | $ Change | ||||||||||||||||||||||||||||
| March 31, 2026 | December 31, 2025 | March 31, 2025 | Sequential | Year-over-year | |||||||||||||||||||||||||
| Revenue: | |||||||||||||||||||||||||||||
| Product revenue, net | $ | 10,306 | $ | 5,420 | $ | — | $ | 4,886 | N/M | ||||||||||||||||||||
| Collaboration and license revenue | 428 | 741 | 361 | (313) | 67 | ||||||||||||||||||||||||
| Total revenue | 10,734 | 6,161 | 361 | 4,573 | 10,373 | ||||||||||||||||||||||||
| Operating expenses: | |||||||||||||||||||||||||||||
| Cost of product revenue | 200 | 1,076 | — | (876) | N/M | ||||||||||||||||||||||||
| Research and development | 100,081 | 85,053 | 76,240 | 15,028 | 23,841 | ||||||||||||||||||||||||
| Selling, general and administrative | 50,831 | 53,698 | 35,526 | (2,867) | 15,305 | ||||||||||||||||||||||||
| Total operating expenses | 151,112 | 139,827 | 111,766 | 11,285 | 39,346 | ||||||||||||||||||||||||
| Loss from operations | (140,378) | (133,666) | (111,405) | (6,712) | (28,973) | ||||||||||||||||||||||||
| Other income, net | 12,533 | 11,031 | 14,631 | 1,502 | (2,098) | ||||||||||||||||||||||||
| Loss before income taxes | (127,845) | (122,635) | (96,774) | (5,210) | (31,071) | ||||||||||||||||||||||||
| Income tax expense | — | 180 | — | N/M | N/M | ||||||||||||||||||||||||
| Net loss | $ | (127,845) | $ | (122,815) | $ | (96,774) | $ | (5,030) | $ | (31,071) | |||||||||||||||||||
N/M - changes not meaningful
Revenue
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.
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.
Cost of product revenue
The following table summarizes our cost of product revenue for the three months ended March 31, 2026, December 31, 2025, and March 31, 2025:
| Three months ended | $ Change | ||||||||||||||||||||||||||||
| March 31, 2026 | December 31, 2025 | March 31, 2025 | Sequential | Year-over-year | |||||||||||||||||||||||||
| Commercial manufacturing readiness and supplier qualification costs | $ | — | $ | 826 | $ | — | $ | (826) | N/M | ||||||||||||||||||||
| Packaging, distribution, and other fulfillment costs | 200 | 250 | — | (50) | N/M | ||||||||||||||||||||||||
| Total cost of product revenue | $ | 200 | $ | 1,076 | $ | — | $ | (876) | N/M | ||||||||||||||||||||
N/M - changes not meaningful
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.
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.
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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.
Research and development expenses
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.
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.
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.
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.
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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:
| Three months ended | $ Change | ||||||||||||||||||||||||||||
| March 31, 2026 | December 31, 2025 | March 31, 2025 | Sequential | Year-over-year | |||||||||||||||||||||||||
| External research and development expenses: | |||||||||||||||||||||||||||||
| Clinical trials | $ | 20,791 | $ | 20,602 | $ | 11,501 | $ | 189 | $ | 9,290 | |||||||||||||||||||
| Clinical supply manufacturing | 9,519 | 7,240 | 8,752 | 2,279 | 767 | ||||||||||||||||||||||||
| Preclinical studies | 2,415 | 3,144 | 2,592 | (729) | (177) | ||||||||||||||||||||||||
| Outside services | 11,789 | 10,003 | 11,163 | 1,786 | 626 | ||||||||||||||||||||||||
| Other external research and development | 7 | 17 | 15 | (10) | (8) | ||||||||||||||||||||||||
| Total external research and development expenses | 44,521 | 41,006 | 34,023 | 3,515 | 10,498 | ||||||||||||||||||||||||
| Internal expenses: | |||||||||||||||||||||||||||||
| Personnel expenses | 30,649 | 25,850 | 25,627 | 4,799 | 5,022 | ||||||||||||||||||||||||
| Stock-based compensation | 19,328 | 12,423 | 11,819 | 6,905 | 7,509 | ||||||||||||||||||||||||
| Depreciation and amortization | 473 | 420 | 237 | 53 | 236 | ||||||||||||||||||||||||
| Facilities and related | 2,512 | 2,259 | 2,773 | 253 | (261) | ||||||||||||||||||||||||
| Other internal research and development | 2,598 | 3,095 | 1,761 | (497) | 837 | ||||||||||||||||||||||||
| Total internal research and development expenses | 55,560 | 44,047 | 42,217 | 11,513 | 13,343 | ||||||||||||||||||||||||
| Total research and development expenses | $ | 100,081 | $ | 85,053 | $ | 76,240 | $ | 15,028 | $ | 23,841 | |||||||||||||||||||
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:
| Three months ended | $ Change | ||||||||||||||||||||||||||||
| March 31, 2026 | December 31, 2025 | March 31, 2025 | Sequential | Year-over-year | |||||||||||||||||||||||||
| Paltusotine | $ | 11,869 | $ | 17,785 | $ | 17,251 | $ | (5,916) | $ | (5,382) | |||||||||||||||||||
| Atumelnant | 20,267 | 14,149 | 7,749 | 6,118 | 12,518 | ||||||||||||||||||||||||
| Other research and development programs | 9,667 | 7,394 | 7,058 | 2,273 | 2,609 | ||||||||||||||||||||||||
| Personnel expenses | 30,649 | 25,850 | 25,627 | 4,799 | 5,022 | ||||||||||||||||||||||||
| Stock-based compensation | 19,328 | 12,423 | 11,819 | 6,905 | 7,509 | ||||||||||||||||||||||||
| Depreciation and amortization | 473 | 420 | 237 | 53 | 236 | ||||||||||||||||||||||||
| Other | 7,828 | 7,032 | 6,499 | 796 | 1,329 | ||||||||||||||||||||||||
| Total research and development expenses | $ | 100,081 | $ | 85,053 | $ | 76,240 | $ | 15,028 | $ | 23,841 | |||||||||||||||||||
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.
Selling, general and administrative expenses
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.
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.
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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:
| Three months ended | $ Change | ||||||||||||||||||||||||||||
| March 31, 2026 | December 31, 2025 | March 31, 2025 | Sequential | Year-over-year | |||||||||||||||||||||||||
| Selling, general and administrative (excluding personnel expenses, stock-based compensation, depreciation and amortization) | $ | 19,755 | $ | 25,686 | $ | 14,086 | $ | (5,931) | $ | 5,669 | |||||||||||||||||||
| Personnel expenses | 20,037 | 18,141 | 12,093 | 1,896 | 7,944 | ||||||||||||||||||||||||
| Stock-based compensation | 10,352 | 9,297 | 8,659 | 1,055 | 1,693 | ||||||||||||||||||||||||
| Depreciation and amortization | 687 | 574 | 688 | 113 | (1) | ||||||||||||||||||||||||
| Total selling, general and administrative expenses | $ | 50,831 | $ | 53,698 | $ | 35,526 | $ | (2,867) | $ | 15,305 | |||||||||||||||||||
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.
Other income, net
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.
Liquidity and Capital Resources
Our financial condition is summarized as follows:
| March 31, 2026 | December 31, 2025 | $ Change | % Change | ||||||||||||||||||||
| Cash and cash equivalents | $ | 114,341 | $ | 101,536 | $ | 12,805 | 13 | % | |||||||||||||||
| Investment securities | 1,176,965 | 926,353 | 250,612 | 27 | % | ||||||||||||||||||
| Cash, cash equivalents and investment securities | $ | 1,291,306 | $ | 1,027,889 | $ | 263,417 | 26 | % | |||||||||||||||
| Working capital | $ | 1,251,328 | $ | 963,270 | $ | 288,058 | 30 | % | |||||||||||||||
| Accumulated deficit | $ | (1,545,272) | $ | (1,417,427) | $ | (127,845) | 9 | % | |||||||||||||||
We have funded our operations through equity financings, supplemented by license, collaboration and initial product revenue.
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.
Our future capital requirements will depend on many factors, including:
•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;
•our ability to generate revenue through product sales of PALSONIFY and other potential product candidates once approved, if ever, and future licensing arrangements;
•the costs, timing and outcome of regulatory review of our product candidates;
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•the costs associated with hiring additional personnel and consultants as our preclinical, clinical and commercial activities increase;
•the costs of and our ability to obtain clinical and commercial supplies for our current product candidates and any other product candidates we may identify and develop;
•the costs and timing of manufacturing for our product candidates, including commercial manufacturing;
•the costs of obtaining, maintaining and enforcing our patents and other intellectual property rights;
•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;
•the costs and timing of establishing or securing sales and marketing capabilities if any additional product candidates are approved;
•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;
•the terms and timing of establishing and maintaining collaborations, licenses and other similar arrangements;
•costs associated with any products or technologies that we may in-license or acquire;
•the funding of any co-development arrangements we enter into; and
•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.
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.
If we raise funds through collaborations, licenses, and other similar arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.
Stock Offering
On January 8, 2026, we completed an underwritten public offering of 8,763,000 shares of our common stock at a price to the public of $45.95 per share, which included 1,143,000 shares of common stock issued pursuant to the underwriters' option to purchase additional shares. Net proceeds from the offering were approximately $380.0 million, after underwriting discounts and commissions and other offering costs.
ATM Offering
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.
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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.
Cash Flows
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.
The following table provides information regarding our cash flows for the three months ended March 31, 2026 and 2025:
| Three months ended March 31, | $ Change | % Change | |||||||||||||||||||||
| 2026 | 2025 | ||||||||||||||||||||||
| Net cash used in operating activities | $ | (124,703) | $ | (88,452) | $ | (36,251) | 41 | % | |||||||||||||||
| Net cash used in investing activities | (252,359) | (85,961) | (166,398) | 194 | % | ||||||||||||||||||
| Net cash provided by financing activities | 389,875 | 4,437 | 385,438 | 8,687 | % | ||||||||||||||||||
| Net change in cash, cash equivalents and restricted cash | $ | 12,813 | $ | (169,976) | $ | 182,789 | (108) | % | |||||||||||||||
Cash Flows from Operating Activities
Cash used in operating activities is driven by personnel costs; clinical, manufacturing, and facility expenses; sales and marketing activities; and general and administrative support, partially offset by revenue generated from net product sales of PALSONIFY and our collaboration and license revenue. Our cash flows from operating activities will continue to be affected principally by our working capital requirements and the extent to which we increase spending on personnel, commercial activities, and research and development as our business grows.
The increase in cash used in operating activities was primarily due to expenditures related to supporting our commercial growth and the advancement of our clinical programs offset by cash receipts from net product sales.
Cash Flows from Investing Activities
Cash flows from investing activities are driven by fluctuations in the timing of purchases and maturities of investments and, to a lesser extent, purchases of property and equipment. The increase in cash used in investing activities is primarily due to differences in the mix and timing of investment purchases and maturities.
Cash Flows from Financing Activities
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.
Common Stock and Common Stock Equivalents
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.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
For a discussion of our market risks, refer to Item 7A, “Quantitative and Qualitative Disclosures about Market Risk,” included in our Annual Report on Form 10-K. There have been no material changes to any of these risks since December 31, 2025.
ITEM 4. CONTROLS AND PROCEDURES
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the rules of the SEC and forms and that such information is accumulated and communicated to our management, including our chief executive officer and chief financial officer, as appropriate, to allow for timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. In addition, the design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, control may become inadequate because of changes in conditions, or the degree
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of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
As required by Exchange Act Rule 13a-15(b), we carried out an evaluation, under the supervision and with the participation of our management, including our chief executive officer and chief financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered by this Report. Based on the foregoing, our chief executive officer and chief financial officer concluded that our disclosure controls and procedures were effective as of March 31, 2026 at the reasonable assurance level.
There has been no change in our internal control over financial reporting during our most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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PART II — OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
We are not currently a party to any material legal proceedings. From time to time, we are involved in legal proceedings or subject to claims incident to the ordinary course of business. Regardless of the outcome, such proceedings or claims can have an adverse impact on us because of defense and settlement costs, diversion of resources and other factors, and there can be no assurances that favorable outcomes will be obtained.
ITEM 1A. RISK FACTORS
We do not believe that there have been any material changes to the risk factors set forth in Part I, Item 1A of our FY 2025 Form 10-K.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5. OTHER INFORMATION
Rule 10b5-1 Trading Plans
During the three months ended March 31, 2026, the following members of our Board of Directors and/or officers adopted , modified, terminated
| Name | Title of Director or Officer | Action | Date of Action | Duration of Plan | Total Shares of Common Stock to be Sold | |||||||||||||||||||||||||||
2/19/26 - | Up to | |||||||||||||||||||||||||||||||
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ITEM 6. EXHIBITS
EXHIBIT INDEX
| Exhibit Number | Incorporated by Reference | Filed Herewith | ||||||||||||||||||
| Exhibit Description | Form | File No. | Exhibit | Filing Date | ||||||||||||||||
| 3.1 | 8-K | 001-38583 | 3.3 | 7/20/2018 | ||||||||||||||||
| 3.2 | 8-K | 001-38583 | 3.1 | 12/12/2023 | ||||||||||||||||
| 4.1 | S-1/A | 333-225824 | 4.1 | 7/9/2018 | ||||||||||||||||
| 31.1 | X | |||||||||||||||||||
| 31.2 | X | |||||||||||||||||||
| 32.1* | X | |||||||||||||||||||
| 101.INS | Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the inline XBRL document | X | ||||||||||||||||||
| 101.SCH | Inline XBRL Taxonomy Extension Schema Document. | X | ||||||||||||||||||
| 104 | Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101) | X | ||||||||||||||||||
*The certification attached as Exhibit 32.1 that accompanies this Report is not deemed filed with the SEC and is not to be incorporated by reference into any filing of Crinetics under the U.S. Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date of this Report, irrespective of any general incorporation language contained in such filing.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Crinetics Pharmaceuticals, Inc. | ||||||||
Date: May 7, 2026 | By: | /s/ R. Scott Struthers, Ph.D. | ||||||
| R. Scott Struthers, Ph.D. | ||||||||
| President and Chief Executive Officer | ||||||||
| (Principal executive officer) | ||||||||
Date: May 7, 2026 | By: | /s/ Tobin Schilke | ||||||
| Tobin Schilke | ||||||||
| Chief Financial Officer | ||||||||
| (Principal financial and accounting officer) | ||||||||
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