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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, 2025



 

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

Crinetics Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

26-3744114

(State or other jurisdiction

of incorporation or organization)

(I.R.S. Employer

Identification No.)

 

 

 

6055 Lusk Boulevard,

San Diego, California

92121

(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

Common Stock, par value $0.001 per share

 

CRNX

 

Nasdaq Global Select Market

 

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.

 

Large accelerated filer

 

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 May 2, 2025, the registrant had 93,680,130 shares of common stock ($0.001 per share par value) outstanding.

 

 

 


 

CRINETICS PHARMACEUTICALS, INC. QUARTERLY REPORT ON FORM 10-Q

For the Quarter Ended March 31, 2025

TABLE OF CONTENTS

 

 

 

 

Page

 

PART I – FINANCIAL INFORMATION

 

 

 

 

 

 

Item 1.

 

Condensed Consolidated Financial Statements (unaudited):

 

2

 

 

Condensed Consolidated Balance Sheets as of March 31, 2025 and December 31, 2024

 

2

 

 

Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended March 31, 2025 and 2024

 

3

 

 

Condensed Consolidated Statements of Stockholders’ Equity for the three months ended March 31, 2025 and 2024

 

4

 

 

Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2025 and 2024

 

5

 

 

Notes to Condensed Consolidated Financial Statements

 

6

Item 2.

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

18

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

 

29

Item 4.

 

Controls and Procedures

 

29

 

 

 

 

 

PART II — OTHER INFORMATION

 

 

 

 

 

 

Item 1.

 

Legal Proceedings

 

30

Item 1A.

 

Risk Factors

 

30

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

 

30

Item 3.

 

Defaults Upon Senior Securities

 

30

Item 4.

 

Mine Safety Disclosures

 

30

Item 5.

 

Other Information

 

30

Item 6.

 

Exhibits

 

31

 

1


 

PART I — FINANCIAL INFORMATION

Item 1. Condensed Financial Statements

Crinetics Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except per share data)

 

 

 

March 31,

 

 

December 31,

 

 

 

2025

 

 

2024

 

 

 

(Unaudited)

 

 

 

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

94,569

 

 

$

264,545

 

Restricted cash

 

 

500

 

 

 

500

 

Investment securities, amortized cost of $1,177,559 at March 31, 2025 and $1,088,561 at December 31, 2024

 

 

1,179,555

 

 

 

1,089,524

 

Prepaid expenses and other current assets

 

 

16,431

 

 

 

20,819

 

Total current assets

 

 

1,291,055

 

 

 

1,375,388

 

Property and equipment, net

 

 

12,628

 

 

 

12,068

 

Operating lease right-of-use assets

 

 

42,694

 

 

 

43,507

 

Restricted cash, net of current portion

 

 

800

 

 

 

800

 

Other assets

 

 

14,150

 

 

 

2,829

 

Total assets

 

$

1,361,327

 

 

$

1,434,592

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable and accrued expenses

 

$

31,616

 

 

$

21,469

 

Accrued compensation and related expenses

 

 

16,606

 

 

 

28,887

 

Deferred revenue

 

 

2,206

 

 

 

2,176

 

Operating lease liabilities

 

 

6,883

 

 

 

7,152

 

Total current liabilities

 

 

57,311

 

 

 

59,684

 

Operating lease liabilities, non-current

 

 

43,936

 

 

 

44,570

 

Deferred revenue, non-current

 

 

4,313

 

 

 

4,704

 

Other non-current liabilities

 

 

1,767

 

 

 

829

 

Total liabilities

 

 

107,327

 

 

 

109,787

 

Commitments and contingencies (Note 7)

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Preferred stock, $0.001 par; 10,000 shares authorized; no shares issued
     or outstanding at March 31, 2025 or December 31, 2024

 

 

 

 

 

 

Common stock and paid-in capital, $0.001 par; 200,000 shares authorized;
    
93,525 shares issued and outstanding at March 31, 2025;
    
92,926 shares issued and outstanding at December 31, 2024

 

 

2,300,882

 

 

 

2,275,952

 

Accumulated other comprehensive income

 

 

2,002

 

 

 

963

 

Accumulated deficit

 

 

(1,048,884

)

 

 

(952,110

)

Total stockholders’ equity

 

 

1,254,000

 

 

 

1,324,805

 

Total liabilities and stockholders’ equity

 

$

1,361,327

 

 

$

1,434,592

 

 

See the accompanying notes to these unaudited condensed consolidated financial statements.

2


 

Crinetics Pharmaceuticals, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except per share data)

(unaudited)

 

 

 

Three months ended March 31,

 

 

 

2025

 

 

2024

 

Revenues

 

$

361

 

 

$

640

 

Operating expenses:

 

 

 

 

 

 

Research and development

 

 

76,240

 

 

 

53,341

 

Selling, general and administrative

 

 

35,526

 

 

 

20,828

 

Total operating expenses

 

 

111,766

 

 

 

74,169

 

Loss from operations

 

 

(111,405

)

 

 

(73,529

)

Other income (expense):

 

 

 

 

 

 

Interest income

 

 

14,834

 

 

 

7,320

 

Other expense, net

 

 

(203

)

 

 

(251

)

Total other income, net

 

 

14,631

 

 

 

7,069

 

Loss before equity method investment

 

 

(96,774

)

 

 

(66,460

)

Loss on equity method investment

 

 

 

 

 

(470

)

Net loss

 

$

(96,774

)

 

$

(66,930

)

Net loss per share:

 

 

 

 

 

 

Net loss per share - basic and diluted

 

$

(1.04

)

 

$

(0.93

)

Weighted average shares - basic and diluted

 

 

93,102

 

 

 

72,289

 

Other comprehensive income (loss):

 

 

 

 

 

 

Unrealized gain (loss) on investment securities

 

$

1,033

 

 

$

(827

)

Unrealized gain on foreign currency

 

 

6

 

 

 

 

Total other comprehensive income (loss)

 

 

1,039

 

 

 

(827

)

Comprehensive loss

 

$

(95,735

)

 

$

(67,757

)

 

See the accompanying notes to these unaudited condensed consolidated financial statements.

3


 

Crinetics Pharmaceuticals, Inc.

Condensed Consolidated Statements of Stockholders’ Equity

(in thousands)

(unaudited)

 

 

 

Common Stock

 

 

Common Stock
and Paid-In

 

 

Accumulated
Other
Comprehensive

 

 

Accumulated

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Capital

 

 

Income (loss)

 

 

Deficit

 

 

Equity

 

Balance at January 1, 2025

 

 

92,926

 

 

$

2,275,952

 

 

$

963

 

 

$

(952,110

)

 

$

1,324,805

 

Exercise of stock options

 

 

215

 

 

 

4,452

 

 

 

 

 

 

 

 

 

4,452

 

Issuance of common stock upon vesting of restricted stock units

 

 

384

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

20,478

 

 

 

 

 

 

 

 

 

20,478

 

Other comprehensive income

 

 

 

 

 

 

 

 

1,039

 

 

 

 

 

 

1,039

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(96,774

)

 

 

(96,774

)

Balance at March 31, 2025

 

 

93,525

 

 

$

2,300,882

 

 

$

2,002

 

 

$

(1,048,884

)

 

$

1,254,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance on January 1, 2024

 

 

68,175

 

 

$

1,191,831

 

 

$

977

 

 

$

(653,702

)

 

$

539,106

 

Issuance of common stock, net of $15,810 of transaction costs

 

 

9,557

 

 

 

378,890

 

 

 

 

 

 

 

 

 

378,890

 

Exercise of stock options

 

 

605

 

 

 

11,240

 

 

 

 

 

 

 

 

 

11,240

 

Issuance of common stock upon vesting of restricted stock units

 

 

202

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

13,454

 

 

 

 

 

 

 

 

 

13,454

 

Other comprehensive loss

 

 

 

 

 

 

 

 

(827

)

 

 

 

 

 

(827

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

(66,930

)

 

 

(66,930

)

Balance at March 31, 2024

 

 

78,539

 

 

$

1,595,415

 

 

$

150

 

 

$

(720,632

)

 

$

874,933

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

See the accompanying notes to these unaudited condensed consolidated financial statements.

4


 

Crinetics Pharmaceuticals, Inc.

Condensed Consolidated Statements of Cash Flows

(in thousands)

(unaudited)

 

 

Three months ended

 

 

 

March 31,

 

 

 

2025

 

 

2024

 

Operating activities:

 

 

 

 

 

 

Net loss

 

$

(96,774

)

 

$

(66,930

)

Reconciliation of net loss to net cash used in operating activities:

 

 

 

 

 

 

Stock-based compensation

 

 

20,478

 

 

 

13,454

 

Depreciation and amortization

 

 

925

 

 

 

474

 

Noncash lease expense

 

 

813

 

 

 

789

 

Accretion of purchase discounts and amortization
   of premiums on investment securities, net

 

 

(4,376

)

 

 

(3,847

)

Loss on disposal of property and equipment

 

 

19

 

 

 

42

 

Loss on equity method investment

 

 

 

 

 

470

 

Increase (decrease) in cash resulting from changes in:

 

 

 

 

 

 

Prepaid expenses and other assets

 

 

(6,917

)

 

 

212

 

Accounts payable and accrued expenses, compensation and related expenses

 

 

(1,356

)

 

 

1,306

 

Deferred revenue

 

 

(361

)

 

 

398

 

Operating lease liabilities

 

 

(903

)

 

 

776

 

Net cash used in operating activities

 

 

(88,452

)

 

 

(52,856

)

Investing activities:

 

 

 

 

 

 

Purchases of investment securities

 

 

(391,204

)

 

 

(99,741

)

Maturities of investment securities

 

 

306,482

 

 

 

101,382

 

Purchases of property and equipment

 

 

(1,239

)

 

 

(1,332

)

Net cash (used in) provided by investing activities

 

 

(85,961

)

 

 

309

 

Financing activities:

 

 

 

 

 

 

Proceeds from issuance of common stock, net of $0 (2025) and $17,300 (2024) of transaction costs

 

 

 

 

 

383,215

 

Proceeds from exercise of stock options

 

 

4,437

 

 

 

10,359

 

Net cash provided by financing activities

 

 

4,437

 

 

 

393,574

 

Net change in cash, cash equivalents and restricted cash

 

 

(169,976

)

 

 

341,027

 

Cash, cash equivalents and restricted cash at beginning of period

 

 

265,845

 

 

 

56,197

 

Cash, cash equivalents and restricted cash at end of period

 

$

95,869

 

 

$

397,224

 

Components of cash, cash equivalents and restricted cash:

 

 

 

 

 

 

Cash and cash equivalents

 

$

94,569

 

 

$

395,924

 

Restricted cash

 

 

1,300

 

 

 

1,300

 

Cash, cash equivalents and restricted cash at end of period

 

$

95,869

 

 

$

397,224

 

Noncash investing and financing activities:

 

 

 

 

 

 

Stock options exercised receivable

 

$

15

 

 

$

881

 

Amounts accrued for purchases of property and equipment

 

$

264

 

 

$

168

 

Accrued financing costs

 

$

 

 

$

4,325

 

 

See the accompanying notes to these unaudited condensed consolidated financial statements.

5


 

Crinetics Pharmaceuticals, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

1. ORGANIZATION AND BASIS OF PRESENTATION

Description of Business

Crinetics Pharmaceuticals, Inc. (the “Company”) is a clinical-stage pharmaceutical company incorporated in Delaware on November 18, 2008 and based in San Diego, California. The Company is focused on the discovery, development, and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors. In January 2017, the Company established a wholly-owned Australian subsidiary, Crinetics Australia Pty Ltd (“CAPL”), in order to conduct various preclinical and clinical activities for its development candidates. In September 2024, the Company established Crinetics Pharmaceuticals Europe GmbH ("CPEG"), a wholly-owned Swiss subsidiary which was formed, among other things, to conduct various development, regulatory, and pre-commercialization activities for our product candidates in Europe.

Our lead product candidate is paltusotine, which is in clinical development for the treatment of acromegaly and carcinoid syndrome associated with neuroendocrine tumors ("NETs"). Our second product candidate is atumelnant (formerly CRN04894), which is in clinical development for congenital adrenal hyperplasia ("CAH"), and patients with either Cushing's disease or Ectopic ACTH Syndrome ("EAS").

Unaudited Interim Financial Information

The accompanying interim condensed consolidated balance sheet as of March 31, 2025, the condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2025 and 2024, the condensed consolidated statements of stockholders’ equity for the three months ended March 31, 2025 and 2024, and the condensed consolidated statements of cash flows for the three months ended March 31, 2025 and 2024, and the related disclosures are unaudited. In management’s opinion, the unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements and include all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of March 31, 2025 and the results of its operations and cash flows for the three months ended March 31, 2025 and 2024 in accordance with accounting principles generally accepted in the United States of America (“GAAP”). The results for the three months ended March 31, 2025 are not necessarily indicative of the results expected for the full fiscal year or any other interim period.

These condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2024, included in the Company's Annual Report on Form 10-K filed with the SEC on February 27, 2025. The condensed consolidated balance sheet as of December 31, 2024, has been derived from the audited consolidated financial statements as of that date, but does not include all of the information and footnotes required by GAAP for complete financial statements.

Liquidity

From inception, the Company has devoted substantially all of its efforts to drug discovery and development and conducting preclinical studies and clinical trials. The Company has a limited operating history and the sales and income potential of the Company’s business and market are unproven. Successful transition to attaining profitable operations is dependent upon achieving a level of revenues adequate to support the Company’s cost structure. The Company has experienced net losses and negative cash flows from operating activities since its inception and has an accumulated deficit of $1.0 billion as of March 31, 2025.

As of March 31, 2025, the Company had $1.3 billion in unrestricted cash, cash equivalents and investment securities, which the Company believes is sufficient to meet its funding requirements for at least the next 12 months.

The Company expects to continue to incur net losses for the foreseeable future and believes it will need to raise substantial additional capital to accomplish its business plan over the next several years. The Company plans to continue to fund its losses from operations and capital funding needs through a combination of equity offerings, debt financings or other sources, including potential collaborations, licenses and other similar arrangements. If the Company is not able to secure adequate additional funding, the Company 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 the Company’s 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.

6


 

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

During the three months ended March 31, 2025, there were no changes to our significant accounting policies as described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024.

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. Dilutive common stock equivalents are comprised of common stock subject to repurchase and stock options outstanding under the Company’s stock option plan. 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 (in thousands):

 

 

 

As of March 31,

 

 

2025

 

 

2024

 

Stock options

 

 

15,286

 

 

 

14,457

 

Restricted stock units

 

 

1,979

 

 

 

1,478

 

Employee stock purchase plan

 

 

164

 

 

 

292

 

Total

 

 

17,429

 

 

 

16,227

 

Recent Accounting Pronouncements Not Yet Adopted

ASU 2023-09

In December 2023, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") No. 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures” (“ASU 2023-09”). ASU 2023-09 requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid. ASU 2023-09 is effective for public entities for annual periods beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact that this guidance will have on the presentation of its condensed consolidated financial statements and accompanying notes.

ASU 2024-03

On November 4, 2024, the FASB issued ASU No. 2024-03, “Income Statement–Reporting Comprehensive Income–Expense disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses” (“ASU 2024-03”), which requires disaggregated disclosure of income statement expenses for public business entities ("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. The Company is currently evaluating the impact that this guidance will have on the presentation of its condensed consolidated financial statements and accompanying notes.

 

3. INVESTMENT SECURITIES

 

The Company reports its available-for-sale investment securities at their estimated fair values. The following is a summary of the available-for-sale investment securities held by the Company as of March 31, 2025 and December 31, 2024 (in thousands):

 

 

As of March 31, 2025

 

 

 

Amortized
Cost

 

 

Gross
Unrealized
Gains

 

 

Gross
Unrealized
Losses

 

 

Fair
Market
Value

 

Available-for-sale investment securities:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. government obligations

 

$

587,384

 

 

$

731

 

 

$

(12

)

 

$

588,103

 

Agency obligations

 

 

62,992

 

 

 

7

 

 

 

(42

)

 

 

62,957

 

Corporate debt securities

 

 

527,183

 

 

 

1,345

 

 

 

(33

)

 

 

528,495

 

Total

 

$

1,177,559

 

 

$

2,083

 

 

$

(87

)

 

$

1,179,555

 

 

7


 

 

 

As of December 31, 2024

 

 

 

Amortized
Cost

 

 

Gross
Unrealized
Gains

 

 

Gross
Unrealized
Losses

 

 

Fair
Market
Value

 

Available-for-sale investment securities:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. government obligations

 

$

542,962

 

 

$

417

 

 

$

(35

)

 

$

543,344

 

Agency obligations

 

 

57,986

 

 

 

2

 

 

 

(57

)

 

 

57,931

 

Corporate debt securities

 

 

487,613

 

 

 

818

 

 

 

(182

)

 

 

488,249

 

Total

 

$

1,088,561

 

 

$

1,237

 

 

$

(274

)

 

$

1,089,524

 

 

As of March 31, 2025 and December 31, 2024, available-for-sale investment securities by contractual maturity were as follows (in thousands):

 

 

As of March 31, 2025

 

 

As of December 31, 2024

 

 

 

Amortized
Cost

 

 

Fair
Market
Value

 

 

Amortized
Cost

 

 

Fair
Market
Value

 

Available-for-sale investment securities:

 

 

 

 

 

 

 

 

 

 

 

 

Due in one year or less

 

$

730,000

 

 

$

730,706

 

 

$

621,499

 

 

$

622,161

 

Due after one year through five years

 

 

447,559

 

 

 

448,849

 

 

 

467,062

 

 

 

467,363

 

Total

 

$

1,177,559

 

 

$

1,179,555

 

 

$

1,088,561

 

 

$

1,089,524

 

 

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, 2025 and December 31, 2024 (in thousands):

 

 

As of March 31, 2025

 

 

 

Less Than 12 Months

 

 

More Than 12 Months

 

 

Total

 

 

 

Fair
Market
Value

 

 

Gross
Unrealized
Losses

 

 

Fair
Market
Value

 

 

Gross
Unrealized
Losses

 

 

Fair
Market
Value

 

 

Gross
Unrealized
Losses

 

Available-for-sale investment securities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

U.S. government obligations

 

$

162,923

 

 

$

(12

)

 

$

 

 

$

 

 

$

162,923

 

 

$

(12

)

Agency obligations

 

 

57,953

 

 

 

(42

)

 

 

 

 

 

 

 

 

57,953

 

 

 

(42

)

Corporate debt securities

 

 

53,054

 

 

 

(33

)

 

 

 

 

 

 

 

 

53,054

 

 

 

(33

)

Total

 

$

273,930

 

 

$

(87

)

 

$

 

 

$

 

 

$

273,930

 

 

$

(87

)

 

 

 

As of December 31, 2024

 

 

 

Less Than 12 Months

 

 

More Than 12 Months

 

 

Total

 

 

 

Fair
Market
Value

 

 

Gross
Unrealized
Losses

 

 

Fair
Market
Value

 

 

Gross
Unrealized
Losses

 

 

Fair
Market
Value

 

 

Gross
Unrealized
Losses

 

Available-for-sale investment securities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

U.S. government obligations

 

$

19,953

 

 

$

(35

)

 

$

 

 

$

 

 

$

19,953

 

 

$

(35

)

Agency obligations

 

 

47,936

 

 

 

(57

)

 

 

 

 

 

 

 

 

47,936

 

 

 

(57

)

Corporate debt securities

 

 

165,032

 

 

 

(182

)

 

 

 

 

 

 

 

 

165,032

 

 

 

(182

)

Total

 

$

232,921

 

 

$

(274

)

 

$

 

 

$

 

 

$

232,921

 

 

$

(274

)

 

The Company reviewed its investment holdings as of March 31, 2025 and December 31, 2024 and determined that the decrease in fair value is attributable to changes in interest rates and not credit quality, and as the Company does not intend to sell the investments and it is not more likely than not that the Company will be required to sell the investments before recovery of their amortized cost basis, which may be maturity. Therefore, there were no allowances for credit losses as of March 31, 2025 and December 31, 2024. Realized net gains (losses) were immaterial for the three months ended March 31, 2025 and March 31, 2024.

Accrued interest receivable on available-for-sale securities was $7.2 million and $8.3 million at March 31, 2025 and December 31, 2024, respectively. The Company did not write off any accrued interest receivable in any of the periods presented in the condensed consolidated financial statements.

8


 

4. FAIR VALUE MEASUREMENTS

Investment Securities

The Company holds investment securities that consist of highly liquid, investment grade debt securities. The Company determines the fair value of its investment securities based upon one or more valuations reported by its investment accounting and reporting service provider. The investment service provider values the securities using a hierarchical security pricing model that relies primarily on valuations provided by an industry-recognized valuation service. Such valuations 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, 2025 and December 31, 2024 were as follows (in thousands):

 

 

 

As of March 31, 2025

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

86,241

 

 

$

 

 

$

 

 

$

86,241

 

Investment securities:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. government obligations

 

 

588,103

 

 

 

 

 

 

 

 

 

588,103

 

Agency obligations

 

 

 

 

 

62,957

 

 

 

 

 

 

62,957

 

Corporate debt securities

 

 

 

 

 

528,495

 

 

 

 

 

 

528,495

 

Total assets measured at fair value

 

$

674,344

 

 

$

591,452

 

 

$

 

 

$

1,265,796

 

 

 

 

As of December 31, 2024

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

249,116

 

 

$

 

 

$

 

 

$

249,116

 

Corporate debt securities

 

 

 

 

 

5,314

 

 

 

 

 

 

5,314

 

Investment securities:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. government obligations

 

 

543,344

 

 

 

 

 

 

 

 

 

543,344

 

Agency obligations

 

 

 

 

 

57,931

 

 

 

 

 

 

57,931

 

Corporate debt securities

 

 

 

 

 

488,249

 

 

 

 

 

 

488,249

 

Total assets measured at fair value

 

$

792,460

 

 

$

551,494

 

 

$

 

 

$

1,343,954

 

 

The Company’s policy is to recognize transfers between levels of the fair value hierarchy on the date of the event or change in circumstances that caused the transfer. There were no transfers into or out of Level 3 during the three months ended March 31, 2025 and 2024.

5. BALANCE SHEET DETAILS

Prepaid expenses and other current assets consisted of the following (in thousands):

 

 

 

March 31,
2025

 

 

December 31,
2024

 

Prepaid clinical costs

 

$

1,556

 

 

$

6,842

 

Prepaid research and development costs

 

 

1,167

 

 

 

714

 

Australian tax incentive receivable

 

 

74

 

 

 

74

 

Prepaid insurance

 

 

535

 

 

 

1,025

 

Prepaid subscriptions

 

 

3,157

 

 

 

2,561

 

Interest receivable

 

 

7,225

 

 

 

8,310

 

Receivable for common stock issued

 

 

15

 

 

 

76

 

Other

 

 

2,702

 

 

 

1,217

 

Total

 

$

16,431

 

 

$

20,819

 

 

9


 

Property and equipment, net consisted of the following (in thousands):

 

 

 

March 31,
2025

 

 

December 31,
2024

 

Leasehold improvements

 

$

12,986

 

 

$

11,900

 

Lab equipment

 

 

6,027

 

 

 

5,693

 

Office equipment

 

 

2,195

 

 

 

2,147

 

Computers and software

 

 

60

 

 

 

60

 

Property and equipment at cost

 

 

21,268

 

 

 

19,800

 

Less accumulated depreciation and amortization

 

 

(8,640

)

 

 

(7,732

)

Total

 

$

12,628

 

 

$

12,068

 

Accounts payable and accrued expenses consisted of the following (in thousands):

 

 

 

March 31,
2025

 

 

December 31,
2024

 

Accounts payable

 

$

9,842

 

 

$

5,853

 

Accrued clinical trial costs

 

 

5,194

 

 

 

3,076

 

Accrued research and development costs

 

 

8,350

 

 

 

6,067

 

Accrued outside services and professional fees

 

 

6,565

 

 

 

5,572

 

Other accrued expenses

 

 

1,665

 

 

 

901

 

Total

 

$

31,616

 

 

$

21,469

 

 

6. OPERATING LEASES

In February 2018, the Company entered into a non-cancellable operating lease, as amended in March 2018, for a facility in San Diego, California (the "2018 Lease"). The 2018 Lease has an initial term of seven years which expires in August 2025, and the Company has an option to extend the term of the 2018 Lease for an additional five years, a termination option subject to early termination fees and an option to sublease the facility. The 2018 Lease is subject to base lease payments and additional charges for common area maintenance and other costs and includes certain lease incentives and tenant improvement allowances. The Company’s estimated incremental fully collateralized borrowing rate of 8.0% was used in its present value calculation as the 2018 Lease does not have a stated rate and the implicit rate was not readily determinable.

In 2022, the Company entered into a lease agreement for laboratory and office space in San Diego, California (the "2022 Lease"). Under the terms of the 2022 Lease, the Company has expected future monthly minimum lease payments of $0.5 million and the term expires on the date immediately preceding the one hundred thirty-seventh (137th) monthly anniversary of the lease payment start date. Lease payments are subject to annual 3% increases. The Company is also responsible for certain operating expenses and taxes during the term of the 2022 Lease. The 2022 Lease provides the Company with specified tenant improvement and landlord work allowances. The Company has (i) two options to extend the term of the 2022 Lease for an additional period of five (5) years each, and (ii) a right of first offer on adjacent space to the new facility, subject to the terms and conditions of the 2022 Lease. The 2022 Lease commenced in 2023 when the building was ready and available for its intended use. As of the date of the recording of the 2022 Lease, the Company is not reasonably certain that these options will be exercised. In September 2023, the Company recorded a right-of-use asset and corresponding lease liability in the accompanying condensed consolidated balance sheets in connection with the 2022 Lease. The Company recorded $47.0 million for the right-of-use asset obtained in exchange for the 2022 Lease.

In December 2023, the Company entered into a lease amendment to the 2022 Lease that moved the initial payment date and start of the hundred thirty-seventh month from September 2023 to November 2023. The amendment was a modification that did not result in a new contract as the modification did not provide the Company additional right-of-use assets. As a result, the Company recorded a $0.7 million reduction to right-of-use assets and lease liabilities in the accompanying condensed consolidated balance sheets.

The Company’s estimated incremental fully collateralized borrowing rate of 8.6% was used in its present value calculation as the 2022 Lease does not have a stated rate and the implicit rate was not readily determinable. The rate was determined using a synthetic credit rating analysis.

Under the terms of the 2018 Lease and 2022 Lease, the Company provided the lessors with irrevocable letters of credit in the amounts of $0.5 million and $0.8 million, respectively, which are included in restricted cash and restricted cash, net of current portion, respectively, in the accompanying consolidated balance sheets. The lessors are entitled to draw on the letters of credit in the event of any default by the Company under the terms of the leases.

10


 

As of March 31, 2025, the Company's future minimum payments under non-cancellable operating leases, were as follows (in thousands):

 

Year ending December 31,

 

Minimum
Payments

 

2025 (nine months)

 

$

5,496

 

2026

 

 

6,795

 

2027

 

 

6,999

 

2028

 

 

7,209

 

2029

 

 

7,425

 

Thereafter

 

 

43,550

 

Total future minimum lease payments

 

 

77,474

 

Less imputed interest

 

 

(26,655

)

Total operating lease liabilities

 

 

50,819

 

Less operating lease liabilities, current

 

 

(6,883

)

Operating lease liabilities, non-current

 

$

43,936

 

 

Operating lease cost was $2.2 million and $2.0 million for the three months ended March 31, 2025 and 2024, respectively. As of March 31, 2025 and December 31, 2024, the Company’s weighted average remaining term was 10.0 years and 10.1 years, respectively. As of March 31, 2025 and December 31, 2024, the Company’s weighted-average discount rate was 8.6%.

Cash paid for amounts included in the measurement of lease liabilities for operating cash flow from operating leases was $2.0 million and $0.3 million for the three months ended March 31, 2025 and 2024, respectively.

7. COMMITMENTS AND CONTINGENCIES

Litigation

From time to time, the Company may be subject to various claims and suits arising in the ordinary course of business. The Company does not expect that the resolution of these matters will have a material adverse effect on its financial position or results of operations.

8. REVENUE RECOGNITION

Sanwa Kagaku Kenkyusho Co., Ltd

On February 25, 2022, the Company and Sanwa Kagaku Kenkyusho Co., Ltd. ("Sanwa"), entered into a license agreement (the “Sanwa License”) whereby the Company granted Sanwa an exclusive license to develop and commercialize paltusotine in Japan.

Under the Sanwa License, Sanwa has the right to receive data obtained by the Company through certain paltusotine studies. The Company assessed the Sanwa License and concluded that Sanwa is a customer within the agreement. Sanwa will assume all costs associated with clinical trials and regulatory applications associated with these processes in Japan. Further, the Company retains all rights to develop and commercialize the product outside Japan. The Company also granted Sanwa 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.

The Company determined that its performance obligations under the Sanwa License comprised the license and data exchange. Certain professional services, such as the Company's participation on committees, were deemed to be immaterial to the context of the contract.

In exchange, the Company received a $13.0 million nonrefundable, upfront payment and will be eligible to receive up to an additional $25.5 million in milestone payments related to the achievement of certain development, regulatory and commercial goals. In addition, upon market approval of paltusotine in Japan, the Company will be eligible to receive certain sales-based royalties. Initially, the Company determined that the transaction price amounted to the upfront payment of $13.0 million.

During the three months ended March 31, 2024, the Company achieved a $1.0 million milestone for the first indication of the development milestones. As of March 31, 2024, the Company updated its estimated transaction price to $14.0 million and recorded a cumulative catch-up adjustment of $0.4 million during the three months ended March 31, 2024. As there have been no sales to date, no sales-based milestones or royalties were recognized to date. Further, using the most-likely-method, the other developmental milestone payments continue to be considered fully constrained.

The control of the license was transferred to Sanwa at the inception of the contract and the Company does 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 the ongoing paltusotine studies in the U.S. and related data transfer. Revenue is recognized on a gross basis as the Company is the principal.

11


 

Deferred revenue consisted of the following (in thousands):

 

 

 

Three months ended March 31,

 

 

 

 

2025

 

 

2024

 

 

Deferred revenues at beginning of period

 

$

6,880

 

 

$

6,806

 

 

Unearned revenue from cash received during the period, excluding amounts recognized as revenue during the period

 

 

 

 

 

576

 

 

Revenue recognized that was included in deferred revenues as of the beginning of the period

 

 

(361

)

 

 

(178

)

 

Deferred revenues at end of period

 

$

6,519

 

 

$

7,204

 

 

 

 

 

 

 

 

 

 

 

During the three months ended March 31, 2025 and 2024, $0.4 million and $0.6 million, respectively, of the $14.0 million estimated transaction price was recognized as revenues in the accompanying condensed consolidated statements of operations and comprehensive loss. Deferred revenues are expected to be recognized over the duration of certain paltusotine studies conducted by the Company.

On June 14, 2022, the Company and Sanwa, entered into a clinical supply agreement (the "Sanwa Clinical Supply Agreement") whereby the Company is responsible for manufacturing and supplying certain materials to Sanwa for specified activities under the Sanwa License. During the three months ended March 31, 2025 and 2024, the Company recognized $0 and $38,000, respectively, of revenues from the Sanwa Clinical Supply Agreement in the accompanying condensed consolidated statements of operations and comprehensive loss. No significant supply purchases were made by Sanwa through the Sanwa Clinical Supply Agreement during each of the three months ended March 31, 2025 and 2024.

Cellular Longevity, Inc., doing business as Loyal

On March 24, 2023, the Company and Cellular Longevity Inc., doing business as Loyal ("Loyal") entered into a license agreement (the “Loyal License”) whereby the Company granted Loyal an exclusive license to develop and commercialize CRN01941, a somatostatin receptor type 2 agonist, for veterinary use. In exchange the Company received a $0.1 million nonrefundable, upfront payment and preferred stock in Loyal valued at approximately $2.0 million. The Company will also be eligible to receive certain single-digit sales-based royalties if the licensed intellectual property is approved for veterinary use.

No revenue was recognized during the three months ended March 31, 2025 and 2024 from the Loyal License in the accompanying condensed consolidated statements of operations and comprehensive loss. As of March 31, 2025, the shares of Loyal preferred stock issued and to be issued to the Company valued at $2.0 million is included in other assets in the accompanying condensed consolidated balance sheets. The Loyal preferred stock does not have a readily determinable fair value and is recorded at cost less impairment. The Company assesses equity securities without a readily determinable fair value for changes in observable prices each period, noting none for the three months ended March 31, 2025.

9. STOCKHOLDERS’ EQUITY

Stock Offerings

On March 1, 2024, the Company completed a private placement of 8,333,334 shares of its common stock at a price of $42.00 per share (the "Private Placement"). Net proceeds from the Private Placement were approximately $335.5 million, after offering costs of approximately $14.5 million. On March 19, 2024, the Company registered for resale the shares issued and sold in the Private Placement, pursuant to the Registration Rights Agreement entered into with the Purchasers, dated February 27, 2024.

On October 10, 2024, the Company completed an underwritten public offering of 11,500,000 shares of its common stock at a price to the public of $50.00 per share, which included 1,500,000 shares of common stock issued pursuant to the underwriters' option to purchase additional shares. Net proceeds from the offering were approximately $542.8 million, after underwriting discounts and commissions and other offering costs of approximately $32.2 million.

ATM Offerings

On August 13, 2019, the Company entered into a Sales Agreement (as amended, the “2019 Sales Agreement”) with SVB Leerink LLC and Cantor Fitzgerald & Co. (collectively, the “Sales Agents”), under which the Company could, from time to time, sell up to $150.0 million of shares of its common stock through the Sales Agents (the “2019 ATM Offering”). The 2019 ATM Offering was terminated upon the filing by the Company of its Registration Statement on Form S-3ASR on June 21, 2024.

On June 21, 2024, the Company entered into a Sales Agreement (the “2024 Sales Agreement”) with the Sales Agents under which the Company may, from time to time, sell up to $350.0 million of shares of its common stock through the Sales Agents (the “2024 ATM Offering”).

During the three months ended March 31, 2024, the Company issued 1,223,775 shares of common stock pursuant to the 2019 ATM Offering for net proceeds of approximately $43.4 million, after deducting commissions.

12


 

During the three months ended March 31, 2025 and as of date of this Report, no shares of common stock had been sold under the 2019 ATM Offering or the 2024 ATM Offering Agreement.

10. EQUITY INCENTIVE PLANS

2021 Employment Inducement Incentive Award Plan

The Company adopted the 2021 Employment Inducement Incentive Award Plan (the "2021 Inducement Plan") in December 2021. The Company initially reserved 1,500,000 shares of the Company’s common stock for issuance pursuant to awards granted under the 2021 Inducement Plan. The terms of the 2021 Inducement Plan are substantially similar to the terms of the Company’s 2018 Incentive Award Plan with the exception that awards may only be made to an employee who has not previously been an employee or member of the board of directors of the Company if the award is in connection with commencement of employment. In 2022, the Company amended the 2021 Inducement Plan to increase the number of shares of the Company’s common stock available for future issuance under the 2021 Inducement Plan to 5,000,000 shares. In November 2023, the Company amended the 2021 Inducement Plan to increase the number of shares of the Company’s common stock available for future issuance under the 2021 Inducement Plan to 7,500,000 shares. In December 2024, the Company amended the 2021 Inducement Plan to increase the number of shares of the Company’s common stock available for future issuance under the 2021 Inducement Plan to 9,500,000 shares. As of March 31, 2025, 2,787,184 shares of common stock were available for future issuance under the 2021 Inducement Plan.

2018 Incentive Award Plan

The Company adopted the 2018 Incentive Award Plan (the “2018 Plan”) in July 2018. Under the 2018 Plan, which expires in July 2028, the Company may grant equity-based awards to individuals who are employees, officers, directors or consultants of the Company. Options issued under the 2018 Plan will generally expire ten years from the date of grant and vest over a four-year period. As of March 31, 2025, 5,221,327 shares of common stock were available for future issuance under the 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 the Company’s common stock outstanding on December 31 of the immediately preceding calendar year, or (ii) such lesser amount determined by the Company. Under this evergreen provision, on January 1, 2025, an additional 4,646,320 shares became available for future issuance under the 2018 Plan.

2015 Stock Incentive Plan

The Company adopted the 2015 Stock Incentive Plan (the “2015 Plan”) in February 2015, which provided for the issuance of equity awards to the Company’s employees, members of its board of directors and consultants. In general, options issued under this plan vest over four years and expire after 10 years. Subsequent to the adoption of the 2018 Plan, no additional equity awards can be made under the 2015 Plan.

2018 Employee Stock Purchase Plan

The Company adopted the 2018 Employee Stock Purchase Plan (the “ESPP”) in July 2018. The ESPP permits participants to purchase common stock through payroll deductions of up to 20% of their eligible compensation. As of March 31, 2025, 2,980,072 shares of common stock were available for issuance under the 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 the Company’s common stock outstanding on December 31 of the immediately preceding calendar year, or (ii) such lesser amount determined by the Company. Under this evergreen provision, on January 1, 2025, an additional 929,264 shares became available for future issuance under the ESPP.

13


 

Stock Awards

Stock Options

Activity under the Company’s stock option plans during the three months ended March 31, 2025 was as follows:

 

 

 

 

 

 

Weighted-

 

 

Weighted-

 

 

Aggregate

 

 

 

 

 

 

Average

 

 

Average

 

 

Intrinsic

 

 

 

Options

 

 

Exercise

 

 

Remaining

 

 

Value

 

 

 

Outstanding

 

 

Price

 

 

Term

 

 

(000’s)

 

Balance at December 31, 2024

 

 

13,665,771

 

 

$

26.57

 

 

 

 

 

 

 

Granted

 

 

2,149,003

 

 

$

36.95

 

 

 

 

 

 

 

Exercised

 

 

(215,439

)

 

$

20.67

 

 

 

 

 

 

 

Forfeited and expired

 

 

(312,840

)

 

$

33.24

 

 

 

 

 

 

 

Balance at March 31, 2025

 

 

15,286,495

 

 

$

27.98

 

 

 

7.6

 

 

$

136,422

 

Vested and expected to vest at March 31, 2025

 

 

15,286,495

 

 

$

27.98

 

 

 

7.6

 

 

$

136,422

 

Exercisable at March 31, 2025

 

 

7,020,057

 

 

$

20.88

 

 

 

6.2

 

 

$

94,797

 

 

Aggregate intrinsic value is calculated as the difference at a specific point in time between the closing price of the Company’s common stock on March 31, 2025, the last trading day of the quarter, and the exercise price of stock options that had exercise prices below the closing price. The aggregate intrinsic value of options exercised during the three months ended March 31, 2025 and 2024 was $4.1 million and $13.8 million, respectively.

Restricted Stock Units

The Company’s restricted stock unit activity during the three months ended March 31, 2025, was as follows:

 

 

 

 

 

 

Weighted-

 

 

 

 

Restricted Stock

 

 

Average

 

 

 

 

Units

 

 

Grant Date

 

 

 

Outstanding

 

 

 

 

 

Balance at December 31, 2024

 

 

1,334,635

 

 

$

34.30

 

 

Granted

 

 

1,053,048

 

 

$

36.58

 

 

Vested

 

 

(383,464

)

 

$

31.91

 

 

Forfeited

 

 

(25,653

)

 

$

37.54

 

 

Balance at March 31, 2025

 

 

1,978,566

 

 

$

35.94

 

 

The total fair value of restricted stock units that vested during the three months ended March 31, 2025 and 2024 was $13.2 million and $7.9 million, respectively.

Fair Value of Stock Awards

The Company estimates the fair value of all stock option grants and the ESPP using the Black-Scholes option pricing model and recognizes forfeitures as they occur. The following table summarizes the weighted average assumptions used to estimate the fair value of stock options granted under the Company’s stock option plans for the periods presented below:

 

Stock Option Awards

 

Three months ended March 31,

 

 

2025

 

2024

Expected option term

 

6.0 years

 

6.0 years

Expected volatility

 

64%

 

67%

Risk free interest rate

 

4.4%

 

4.2%

Expected dividend yield

 

%

 

%

The weighted-average fair value of stock options awarded was $22.97 and $27.38 per share during the three months ended March 31, 2025 and 2024, respectively.

 

There were no ESPP awards during the three months ended March 31, 2025 and 2024.

The key assumptions used in determining the fair value of equity awards, and the Company’s rationale, were as follows: (i) Expected term - the expected term for stock options represents the period that the stock options are expected to be outstanding and has been estimated using the simplified method, due to limited historical exercise behavior. The expected term using the simplified method is an average of the contractual option term and its vesting period; the expected term for awards granted under the ESPP represents the

14


 

term the awards are expected to be outstanding; (ii) Expected volatility - the expected volatility assumption is based on the historical volatility of the Company's common stock; (iii) Risk-free interest rate - the risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for zero coupon U.S. Treasury notes with maturities that approximate the expected terms of awards; and (iv) Expected dividend yield - the expected dividend yield assumption is zero as the Company has never paid dividends and has no present intention to do so in the future.

Restricted stock units are valued using the closing sale price of our common stock on the date of grant.

Stock-Based Compensation Expense

Stock-based compensation expense for the equity awards issued by the Company to employees and non-employees for the periods presented below was as follows (in thousands):

 

 

Three months ended March 31,

 

 

 

2025

 

 

2024

 

 

Included in research and development

$

11,819

 

 

$

7,565

 

 

Included in selling, general and administrative

 

8,659

 

 

 

5,889

 

 

Total stock-based compensation expense

$

20,478

 

 

$

13,454

 

 

 

As of March 31, 2025, unrecognized stock-based compensation cost related to option awards, restricted stock units, and ESPP was $169.5 million, $68.4 million and $1.9 million, respectively, which is expected to be recognized over a remaining weighted-average period of 2.7 years, 3.3 years and 1.3 years, respectively.

11. INVESTMENT IN RADIONETICS

Investment in Radionetics

In October 2021, the Company entered into a Collaboration and License Agreement (the "Radionetics License") with Radionetics Oncology, Inc. ("Radionetics"), in which the Company granted Radionetics an exclusive worldwide license to its technology for the development of radiotherapeutics and related radio-imaging agents in exchange for 50,500,000 shares of common stock of Radionetics, which represented an initial majority stake in Radionetics of 64%, and a warrant (the "Radionetics Warrant") to purchase the greater of 3,407,285 additional shares of Radionetics common stock or the number of additional shares of Radionetics common stock that would allow the Company to maintain an aggregate equity interest of 22% of the fully diluted capitalization of Radionetics.

In August 2023, Radionetics completed a refinancing that included a number of transactions that were negotiated by the Company as a package (the “August 2023 Radionetics Transaction”). In connection with the August 2023 Radionetics Transaction, (1) the Company exercised the Radionetics Warrant to purchase 3,407,285 shares of Radionetics common stock with an exercise price of $0.00001 per share, (2) the Company exchanged 32,344,371 shares of Radionetics common stock for Radionetics preferred stock on a one-for-one basis, (3) the Company invested $5.0 million to purchase 14,404,656 shares of preferred stock in Radionetics along with other new and existing investors who participated in the financing, and (4) the Company and Radionetics agreed to amend the Radionetics License to include additional sales milestones of up to $15 million. Radionetics’ convertible notes held by other investors were also converted to Radionetics preferred stock and certain Radionetics common shares held by other investors were cancelled in connection with the August 2023 Radionetics Transaction.

Radionetics is a variable interest entity ("VIE") due to having insufficient equity to finance its activities without additional subordinated financial support. The Company evaluated whether it is the primary beneficiary of Radionetics by evaluating Radionetics’ key activities: (1) conducting research and development, (2) making financing decisions, and (3) determining the strategic direction of Radionetics. Decisions about research and development activities are made by unanimous vote of members of the research and development committee, in which no individual party has unilateral decision-making power. Decisions about financing and strategic direction rest with Radionetics’ board of directors, and no party was determined to be in control, given the Radionetics board of directors is comprised of six members. Crinetics, 5AM and Frazier are each entitled to appoint and replace, as needed, their board designee, the fourth member is Radionetics’ CEO, and the fifth and sixth members must be mutually agreed upon by the other four board members. All changes to board composition are subject to shareholder approval with common and preferred shareholders having equal votes. Radionetics’ management continues to be entirely separate from the Company and determined by the Radionetics’ board of directors. As the Company did not control any of Radionetics' key activities, it was not the primary beneficiary of the VIE and did not consolidate the financial results of Radionetics.

The Company determined that its preferred stock investment in Radionetics represents in-substance common stock. The preferred stock investment is substantially similar to common stock in that it does not have a substantive liquidation preference since the preferred stock will participate in substantially all of Radionetics losses, the conversion ratio for preferred stock into common stock is on a one-for-one basis without any significant restrictions or contingencies, and the preferred stock lacks redemption features, among other factors. The Company is not obligated to fund losses incurred by Radionetics. The Company’s $5.0 million purchase of preferred stock in the August 2023 Radionetics Transaction was alongside new and existing investors and did not fund previous losses.

15


 

In June 2024, the Company amended the Radionetics License to reduce the number of development targets. Following the amendment to the Radionetics License, ownership of the non-licensed targets reverted back to the Company and the Company is eligible to receive total potential sales milestones in excess of $300.0 million and single-digit royalties on net sales. In July 2024, Radionetics announced the formation of a strategic partnership with Eli Lilly and Company, or Lilly. Under the terms of the agreement, Radionetics was entitled to receive a $140.0 million upfront cash payment and Lilly obtained the exclusive right to acquire Radionetics for $1.0 billion upon conclusion of an exercise period. During the exercise period, Radionetics will continue to build out a proprietary pipeline of therapeutic assets. As of March 31, 2025, the Company owned approximately 25% of Radionetics consisting of common and preferred stock.

The Company accounts for its investment in Radionetics common stock under the equity method of accounting due to its ability to exercise significant influence. The Company records its share of Radionetics income (loss) outside of operations in the statements of operations and comprehensive loss on a quarterly lag. The Company's equity method investment in Radionetics was written down to zero during a prior period as a result of the allocation of the Company’s share of losses of the investee. There were no equity method losses recorded during the three months ended March 31, 2025. During the three months ended March 31, 2024, the Company recorded equity method losses of $0.5 million, in the accompanying condensed consolidated statements of operations and comprehensive loss, as a result of the allocation of the Company’s share of Radionetics eligible losses, which is recorded on a quarterly lag. As of March 31, 2025, the Company's investment in Radionetics was written down to zero.

Other Items

R. Scott Struthers, Ph.D., the Company’s President and Chief Executive Officer, serves as chairman of the Radionetics board of directors. Pursuant to such arrangement, Dr. Struthers receives consideration in the form of both equity and a $50,000 annual retainer for his service as a board member of Radionetics. As of March 31, 2025, Dr. Struthers has an approximately 1.3% ownership stake in Radionetics consisting of common stock.

Reimbursements from Radionetics were immaterial during the three months ended March 31, 2025 and 2024.

12. SEGMENT REPORTING

Operating segments are identified as components of an enterprise for which separate discrete financial information is available for evaluation by the chief operating decision maker ("CODM") in making decisions regarding the allocation of resources, assessing performance and monitoring budget versus actuals. The Company's CODM is its founder and chief executive officer. The Company views its operations and manages its business as one operating and reportable segment as the Company has devoted substantially all of its resources to drug discovery and development activities through conducting preclinical studies and clinical trials associated with its programs, all of which aim to discover, develop and commercialize novel therapeutics for rare endocrine diseases and endocrine-related tumors, as outlined in the table below. The Company's operating segment derives its revenues from licensing arrangements (see Note 8). The CODM assesses performance based on condensed consolidated net loss as reported on the condensed consolidated statement of operations and comprehensive loss. The measure of segment assets is reported on the condensed consolidated balance sheet as total consolidated assets. Further, segment depreciation expense and segment asset additions are consistent with consolidated amounts reported within the condensed consolidated statement of cash flows given the Company's operations are aggregated within a single reportable segment. Substantially all of the Company’s assets and sources of revenues are located in the United States. The total segment amount of equity method investments for the segment is also consistent with the consolidated amount of equity method investments reported within the condensed consolidated balance sheet.

Segment revenue and significant segment expenses which are regularly reported to the CODM are included within the table below and are reconciled to condensed consolidated net loss:

16


 

 

 

Three Months ended March 31,

 

 

 

2025

 

 

2024

 

Revenue

 

$

361

 

 

$

640

 

Less:

 

 

 

 

 

 

Research and development expenses

 

 

 

 

 

 

  Paltusotine

 

 

(16,491

)

 

 

(12,952

)

  Atumelnant

 

 

(7,195

)

 

 

(3,932

)

  Early research and development programs

 

 

(7,065

)

 

 

(4,787

)

  Research and development personnel expenses

 

 

(27,473

)

 

 

(18,427

)

  Research and development stock-based compensation

 

 

(11,819

)

 

 

(7,565

)

  Other research and development (1)

 

 

(6,197

)

 

 

(5,678

)

Total research and development expenses

 

 

(76,240

)

 

 

(53,341

)

Selling, general and administrative

 

 

 

 

 

 

  External selling, general and administrative expenses

 

 

(14,041

)

 

 

(7,185

)

  Selling, general and administrative personnel expenses

 

 

(12,826

)

 

 

(7,754

)

  Selling, general and administrative stock-based compensation

 

 

(8,659

)

 

 

(5,889

)

Total selling, general and administrative expenses

 

 

(35,526

)

 

 

(20,828

)

Total other income, net

 

 

14,631

 

 

 

7,069

 

Loss on equity method investment

 

 

 

 

 

(470

)

Segment and consolidated net loss

 

$

(96,774

)

 

$

(66,930

)

(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.

17


 

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 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.

Forward Looking Statements

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.

Overview

We are a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors. Endocrine pathways function to maintain homeostasis and commonly use peptide hormones acting through G protein coupled receptors, or GPCRs, to regulate many aspects of physiology including growth, energy, metabolism, gastrointestinal function and stress responses. We have built a highly productive drug discovery and development organization with extensive expertise in endocrine GPCRs. We have discovered a pipeline of oral nonpeptide (small molecule) new chemical entities that target peptide GPCRs to treat a variety of endocrine diseases where treatment options have significant efficacy, safety and/or tolerability limitations. Our lead product candidate is paltusotine, which is in clinical development for the treatment of acromegaly and carcinoid syndrome associated with neuroendocrine tumors, or NETs. Our second product candidate is atumelnant (formerly CRN04894), which is in clinical development for congenital adrenal hyperplasia, or CAH, and patients with either Cushing’s disease or Ectopic ACTH Syndrome, or EAS. We are advancing additional product candidates through preclinical discovery and development studies. Our vision is to build a premier, endocrine-focused, global biopharmaceutical company that consistently pioneers new therapeutics that improve the lives of patients.

 

We focus on the discovery and development of nonpeptide therapeutics that target peptide GPCRs with well-understood biological functions, validated biomarkers and the potential to substantially improve the treatment of endocrine diseases and endocrine-related tumors. Our pipeline consists of the following product candidates:

 

Paltusotine (SST2 Agonist Program)

 

Paltusotine, our lead product candidate, establishes a new class of oral selective nonpeptide somatostatin receptor type 2, or SST2, agonists designed for the treatment of acromegaly and carcinoid syndrome associated with NETs. Somatostatin is a neuropeptide hormone that broadly inhibits the secretion of other hormones, including growth hormone, or GH, from the pituitary gland. Acromegaly arises from a benign pituitary tumor that secretes excess GH that, in turn, causes excess secretion of insulin-like growth factor-1, or IGF-1, by the liver. This loss of homeostasis in the GH axis results in excess tissue growth and other adverse metabolic effects throughout the body. We estimate that up to 27,000 people in the United States have been diagnosed with acromegaly, and depending on surgical success, we estimate that approximately 11,000 are candidates for chronic pharmacological intervention, of which somatostatin peptide analog depot injections are the primary pharmacotherapy. Carcinoid syndrome occurs when NETs, which originate from neuroendocrine cells commonly found in the gut, lung or pancreas, secrete hormones or other chemical substances into the bloodstream that cause severe flushing or diarrhea, among other symptoms. Approximately 175,000 adults in the United States are diagnosed with NETs. Of these, it is estimated that approximately 33,000 patients have carcinoid syndrome. Most NETs overexpress SST2 receptors and injected depots of peptide somatostatin analogs have become the first-line standard of care as detailed in National Comprehensive Cancer Network, or NCCN, guidelines. These drugs require painful monthly or daily injections and, in the case of somatostatin peptide drugs, often fail to fully control the disease in many acromegaly or carcinoid syndrome patients.

 

To date, our clinical trials have shown that paltusotine was generally well tolerated among healthy adults and patients with acromegaly and with carcinoid syndrome. The drug substance for paltusotine is synthesized in India and then undergoes a bioavailability optimization step in Portugal. Subsequently, the drug substance is tabulated in the United States.

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Acromegaly

 

Our Phase 3 development program for paltusotine in acromegaly consisted of two placebo-controlled clinical trials, PATHFNDR-1 and PATHFNDR-2. The PATHFNDR-1 trial was designed as a double-blind, placebo-controlled, nine-month clinical trial of paltusotine in acromegaly patients with average IGF-1 levels less than or equal to 1.0 times the upper limit of normal, or ULN, and who had been on stable doses of somatostatin receptor ligand monotherapy (octreotide LAR or lanreotide depot). We also conducted a second study, the PATHFNDR-2 trial, which was designed as a double-blind, placebo-controlled, six-month clinical trial of acromegaly patients who were not on pharmacological treatment and had elevated IGF-1 levels. The primary endpoint of both PATHFNDR studies was the proportion of patients with IGF-1 ≤ 1.0 ×ULN at the end of the treatment period on paltusotine as compared to placebo.

 

Positive topline data from the randomized controlled portion of the PATHFNDR-1 study was reported in September 2023, where the primary endpoint and all secondary endpoints of the study were achieved. Additionally, in the PATHFNDR-1 study, paltusotine was well tolerated and no serious or severe adverse events were reported in participants treated with paltusotine.

 

In March 2024, we reported positive topline results from the PATHFNDR-2 study. The study met statistical significance (p<0.0001) on the primary endpoint, and all secondary endpoints. Additionally, in PATHFNDR-2, paltusotine was generally well-tolerated and no serious adverse events were reported in participants treated with paltusotine.

 

The open label extension phases of both PATHFNDR trials are ongoing.

 

We believe that the results of the two trials could support global marketing applications for the use of paltusotine for all acromegaly patients who require pharmacotherapy, including untreated patients and those switching from other therapies. We submitted a New Drug Application, or NDA, to the U.S. Food and Drug Administration, or FDA, for paltusotine for the proposed treatment and long-term maintenance therapy of acromegaly. We subsequently received notification of acceptance from the FDA on the status of the NDA submission and were granted a Prescription Drug User Fee Act, or PDUFA, Target Action Date of September 25, 2025. The FDA has granted orphan drug designation for paltusotine for the treatment of acromegaly. In February 2025, the European Medicines Agency, or EMA, granted paltusotine orphan drug designation for the treatment of acromegaly. Designation was given following a positive recommendation from the EMA Committee for Orphan Medicinal Products, highlighting the potential impact of paltusotine for acromegaly patients in the European Union. The EMA validated the Marketing Authorization Application, or MAA, in March 2025 consistent with a timeline for potential EMA decision in the first half of 2026.

 

Carcinoid Syndrome

 

In March 2024, we reported positive topline results from our randomized, open-label, parallel group, multi-center Phase 2 study to assess safety, tolerability, pharmacokinetics, and efficacy of paltusotine in people living with carcinoid syndrome. A total of 36 participants were randomized to receive either 40 mg (n=18) or 80 mg (n=18) of paltusotine for eight weeks, with the ability to adjust dose based on tolerability or inadequate control of symptoms during the first four weeks of treatment. Results demonstrated that administration of paltusotine resulted in rapid and sustained reductions in bowel movement frequency and flushing episodes. Paltusotine was generally well-tolerated with a safety profile consistent with prior clinical studies, with no treatment-related severe or serious adverse events.

 

We have begun site activation activities for the CAREFNDR Phase 3 clinical trial in patients with carcinoid syndrome and expect to initiate the trial in the second half of 2025. CAREFNDR is designed as a double-blind, placebo-controlled, sixteen-week clinical trial to enroll carcinoid syndrome patients who are not on pharmacological treatment at baseline and are actively symptomatic. The primary endpoint of the CAREFNDR trial is the percentage change in the frequency of flushing episodes at week 12. In addition, a key secondary endpoint measures the change in bowel movement frequency at week 12. The CAREFNDR trial is designed to capture other efficacy endpoints including severity of flushing and urgency of bowel movements. Following the 16-week randomized controlled period, the trial will include a 104-week open-label extension, or OLE, to evaluate long-term efficacy, safety and additional clinical outcomes. The OLE will include an exploratory assessment of tumor control.

 

Atumelnant (ACTH Antagonist)

 

Atumelnant (formerly CRN04894) is our investigational, orally available, nonpeptide product candidate designed to antagonize the adrenocorticotrophic hormone, or ACTH, receptor. It is intended for the treatment of diseases caused by excess ACTH, including CAH and ACTH-dependent Cushing’s Syndrome, or ADCS, which includes patients with either Cushing's disease or EAS. CAH encompasses a set of disorders that are caused by genetic mutations that result in impaired cortisol synthesis. A lack of cortisol leads to a breakdown of feedback mechanisms and results in persistently high levels of ACTH, which, in turn, causes overstimulation of the adrenal cortex. The resulting adrenal hyperplasia and over-secretion of other steroids (particularly androgens) and steroid precursors

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can lead to a variety of effects from improper gonadal development to life-threatening dysregulation of mineralocorticoids. Cushing’s disease results from a pituitary tumor that secretes excess ACTH, and EAS results from non-pituitary ectopic tumors which secrete ACTH. The excess secretion of ACTH causes the downstream synthesis and over-secretion of cortisol by the adrenal glands. Cortisol is the body’s main stress hormone and excess amounts can cause significant increases in mortality and morbidity. We estimate that approximately 17,000 patients in the United States are potential candidates for treatment with atumelnant. We estimate there are over 11,000 patients with Cushing’s disease in the United States, of which approximately 5,000 patients are potential candidates for treatment with atumelnant.

 

We conducted a double-blind, randomized, placebo-controlled Phase 1 study of atumelnant in healthy volunteers to assess the safety and tolerability of single and multiple doses of atumelnant. In addition, the study was designed to measure the effect of atumelnant on suppression of cortisol, cortisol precursors, and adrenal androgens following exogenous ACTH stimulation. In May 2022, we announced positive topline data from the Phase 1 study in healthy volunteers which showed atumelnant was well tolerated and demonstrated dose-dependent increases in atumelnant plasma concentrations. We believe atumelnant demonstrated pharmacologic proof-of-concept, as the Phase 1 results showed dose-dependent reductions of both basal cortisol and elevated cortisol following an ACTH challenge. All adverse events were considered mild to moderate and there were no serious adverse events.

 

Congenital Adrenal Hyperplasia

 

We conducted the TouCAHn Phase 2 study of atumelnant in adult CAH patients. This open-label study was designed to evaluate the safety, efficacy, and pharmacokinetics of different doses of atumelnant. In addition, biomarkers, including serum androstenedione (A4) and 17-hydroxyprogesterone (17-OHP), were measured to evaluate the potential efficacy of atumelnant. We reported positive initial findings from our Phase 2 study in June 2024 and topline data from 28 patients in January 2025. We recently added a final cohort of patients to the Phase 2 study to study morning dosing of atumelnant at 80 mg as well as glucocorticoid reduction.

CALM-CAH is designed as a Phase 3 double-blind, placebo-controlled, thirty two-week clinical trial to enroll patients with CAH. The primary endpoint of the CALM-CAH trial is the proportion of participants with androstenedione (A4) ≤ULN (upper limit of normal) who are on physiologic GC replacement at week 32. The CALM-CAH trial is also designed to evaluate the impact of atumelnant on the clinical signs, symptoms, co-morbidities and outcomes of CAH. In addition we have initiated our open-label extension study which will enroll patients from both Phase 2 and 3. We plan to initiate the CALM-CAH Phase 3 study in adults with CAH in the second half of 2025. We also plan to initiate a Phase 2/3 pediatric study in the second half of 2025.

ACTH-Dependent Cushing’s Syndrome (ADCS)

 

We are conducting a clinical trial of atumelnant in patients with ADCS, including those with Cushing’s disease and Ectopic ACTH Syndrome. We entered into a clinical trial agreement with the National Institute of Diabetes and Digestive and Kidney Diseases, or NIDDK, of the National Institutes of Health, or NIH, to collaborate on a company-sponsored multiple-ascending dose trial of atumelnant in ADCS. This open-label study is designed to evaluate safety, tolerability, and pharmacokinetics of different doses of atumelnant in patients with ADCS as well as to measure 24-hour urinary-free cortisol and serum cortisol as indicators of efficacy. We reported positive initial findings from our ongoing open-label Phase 1b/2a study in June 2024. Planning for the next trial of atumelnant in ACTH-dependent Cushing’s syndrome is underway, and we expect to initiate a Phase 2/3 study in the second half of 2025.

 

CRN09682 (nonpeptide drug conjugate for SST2 positive solid tumors)

We have developed a first-in-class, non-radioactive, nonpeptide drug conjugate, or NDC, linking an SST2 agonist with the cytotoxic drug monomethyl auristatin E, or MMAE, via a spacer and a cleavable linker for the treatment of NETs and potentially for use in other solid tumors that express SST2, or SST+ tumors. The SST2 ligand on the NDC molecule binds to SST2 on the tumor cell surface and is internalized by the cell where enzymes cleave the MMAE and release it. MMAE is a payload that causes microtubule disruption leading to cell arrest and death. Approximately 140,000 adults in the United States have SST2+ NETs, and many other tumor types express SST2. NETs are generally incurable when metastatic, regardless of tumor grade. Overall survival rates vary significantly by stage, grade, age at diagnosis, primary site, and time period of diagnosis. While somatostatin analogs have typically been used as first-line treatment, other therapies commonly used for advanced, metastatic disease include peptide receptor radionuclide therapy, or PRRT, targeted therapies like tyrosine kinase inhibitors, or TKIs, and chemotherapies like platinum/etoposide. We believe our NDC therapy has the potential to improve treatment of SST2+ NETs by stopping tumor progression and/or shrinking tumors. 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.

 

 

 

 

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Parathyroid Hormone Antagonist

 

We are developing antagonists of the parathyroid hormone, or PTH, receptor for the treatment of primary hyperparathyroidism, or PHPT and humoral hypercalcemia of malignancy, or HHM, and other diseases of excess PTH. PTH regulates calcium and phosphate homeostasis in bone and kidney through activation of its receptor, PTHR1. Increased activation of PTHR1, either via PTH or PTH-related peptide (PTHrP, PTHLH) can affect bone metabolism and calcium regulation. Primary hyperparathyroidism arises from a small, benign tumor on one or more of the parathyroid glands, which results in over-secretion of PTH, leading to increased blood calcium levels, or hypercalcemia, increased urine-calcium levels, or hypercalciuria, as well as decreased phosphate levels, or hypophosphatemia. Many patients experience no symptoms. Surgery is indicated in symptomatic patients and asymptomatic patients with target organ involvement to remove the tumor and/or hyperactive gland(s). For patients who decline or cannot undergo surgery, management with medical therapy is recommended. Symptomatic PHPT is characterized by skeletal, renal, cardiovascular, gastrointestinal, neurobehavioral and neuromuscular manifestations with increased mortality. PHPT incidence in the U.S. has been highly influenced by changes in medical practice with the emergence of increased serum calcium and PTH screening and is now estimated to be approximately 200,000 cases. HHM is caused by over-secretion of PTHrP by a malignant tumor and results in bone resorption and calcium reabsorption in the kidney, leading to hypercalcemia. Patients with HHM typically have advanced-stage cancers, present severely symptomatic and tend to have limited survival of several months. HHM occurs in approximately 20% of all cancer patients during their clinical course. We have identified multiple investigational, orally available nonpeptide PTH antagonists that show activity and drug-like properties in preclinical models. Based on emerging data from IND-enabling studies, our PTH antagonist candidate in preclinical development has been substituted with another candidate expected to exhibit an improved profile. This new candidate is in IND-enabling studies, which we intend to complete next year.

 

Thyroid Stimulating Hormone Receptor Antagonist

 

We are developing thyroid-stimulating hormone receptor, or TSHR, antagonists for the treatment of Graves’ disease and Thyroid Eye Disease, or TED, or Grave’s orbitopathy. Graves’ disease is an autoimmune condition that affects approximately 3 million people in the United States. It is characterized by the production of autoantibodies against TSHR, and the pathology of Graves’ disease is driven by these TSHR stimulatory antibodies, or TSAb, that result in heightened activation of TSHR. This overstimulation results in hyperthyroidism due to excessive production of thyroid hormones which causes symptoms including weight loss, rapid or irregular heartbeat, anxiety, sweating or muscle weakness. Some Graves’ disease patients also develop TED due to overactivation of TSHR in orbital fibroblasts leading to excessive production of hyaluronic acid, adipogenesis, cytokine production, and fibrosis. This causes a constellation of debilitating symptoms including pain, swelling, blurry vision, diplopia, and proptosis. Several treatments for Graves’ hyperthyroidism are available including anti-thyroid drugs, radioactive iodine, or RAI, and surgery. RAI and surgery are definitive treatments for Graves’ hyperthyroidism, but result in permanent hypothyroidism requiring life long thyroid hormone replacement. In addition, none of the current treatments for Graves’ hyperthyroidism are effective in treating TED and, in some cases, such as with RAI, the treatments worsen the condition. Blocking TSHR activation directly via a TSHR antagonist may provide an important new therapeutic mechanism to treat patients with Graves’ disease that would effectively treat both the hyperthyroidism and TED. We have identified investigational, orally available nonpeptide TSHR antagonists that demonstrate activity in preclinical models and possess good drug-like properties. We have selected a development candidate and are conducting first-in-human enabling activities.

SST3 Agonist Program for the Treatment for Autosomal Dominant Polycystic Kidney Disease

Autosomal Dominant Polycystic Kidney Disease, or ADPKD, is the most frequent genetic cause of chronic kidney disease, affecting more than 300,000 individuals, and is the fourth leading cause of end-stage renal disease. ADPKD is caused by mutations in the PKD1 or PKD2 genes, which encode the polycystin 1 or 2 proteins (PC1 and PC2) and is characterized by the growth of numerous fluid-filled cysts causing kidney injury and progressive loss of kidney functions. Increasing evidence points toward a model where loss of polycystin function in cilia of kidney epithelial cells might be the driver of cystogenesis observed in ADPKD. In healthy individuals, PC1 and PC2 form channels in the cilia of epithelial cells that contribute to maintain high calcium levels in this cellular compartment. In ADPKD, a decrease in ciliary calcium levels due to the loss of PC1 or PC2 function activates adenylyl cyclase 5/6, increasing ciliary cAMP, a molecule that plays a key role in cell differentiation and proliferation. Somatostatin receptor type 3 (SST3) is expressed in cyst lining cells in ADPKD patients and localizes in cilia. A selective SST3 agonist will decrease adenylyl cyclase activity and cAMP levels, thus potentially reducing cystogenesis in ADPKD. We have identified an investigational, orally available selective SST3 nonpeptide agonist for the treatment of ADPKD and are conducting first-in-human enabling activities.

 

Research Discovery

 

Patients with many other debilitating endocrine diseases and endocrine related tumors await new therapeutic options, and we continuously evaluate and prioritize where to deploy our drug discovery efforts. We plan to continue to expand our drug discovery efforts and leverage our expertise in the evaluation of additional unmet medical needs. Our drug discovery and development efforts are focused on endocrine, metabolism, and targeted therapies.

 

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Endocrine: Our deep understanding of endocrine systems and patient needs have produced a robust pipeline of transformative novel molecules that are purposefully designed to meet the needs of patients. We focus on developing innovative nonpeptide drug candidates with unique methods of action, targeting particular endocrine pathways, including non-traditional ones, where modulating irregular hormone secretion can lead to improving conditions that significantly impact patients’ lives.

 

Metabolism: Metabolic disorders including diabetes, obesity, and others impact the lives of hundreds of millions of people across the world and their effects on patients are significant and varied. Many of these disorders are a result of the dysregulation of key metabolic hormones, including insulin, glucagon, glucagon-like peptide-1, gastric inhibitory polypeptide, and others. Crinetics’ understanding of these hormonal pathways and the GPCRs that control them coupled with our expertise in developing nonpeptides with specific pharmacologies allows us to create new molecules with the chance to improve the lives of patients with metabolic diseases.

 

Targeted Therapies: Our efforts in precision oncology began with developing nonpeptide, GPCR-targeted radioligands for the imaging and treatment of a broad range of endocrine receptor-driven cancers, ultimately leading to the formation of Radionetics Oncology, Inc. in 2021. Our continued dedication to this concept has led to our latest novel development program that is exploring a new modality known as NDCs, a unique therapeutic approach that leverages endocrine receptors for highly selective targeting of anti-tumor agents.

 

All of our product candidates have been discovered, characterized and developed internally and are the subject of composition of matter patent applications. We do not have any royalty obligations and have retained worldwide rights to commercialize our product candidates, except with respect to the exclusive right to develop and commercialize paltusotine in Japan pursuant to the Sanwa License (as defined below), the exclusive right to certain radiotherapeutics technology pursuant to the Radionetics License (as defined below), and the exclusive right to develop and commercialize CRN01941, a separate SST2 agonist licensed to Cellular Longevity Inc., doing business as Loyal, for veterinary use, or the Loyal License.

 

Radionetics Oncology, Inc.

 

We formed Radionetics Oncology, Inc., or Radionetics, in October 2021 together with 5AM Ventures and Frazier Healthcare Partners. Radionetics aims to develop a deep pipeline of novel, targeted, nonpeptide radiopharmaceuticals for the treatment of a broad range of oncology indications. In connection with the formation of Radionetics, we entered into a Collaboration and License Agreement with Radionetics, or the Radionetics License, granting Radionetics an exclusive world-wide license to certain targets for the development of radiotherapeutics and related radio-imaging agents. As of March 31, 2025, we had an approximate 25% ownership stake in Radionetics consisting of common and preferred stock. In addition to our equity stake in Radionetics, Crinetics is eligible to receive total potential sales milestones in excess of $300.0 million and single-digit royalties on net sales of the licensed targets. In July 2024, Radionetics announced the formation of a strategic partnership with Eli Lilly and Company, or Lilly. Under the terms of the agreement, Radionetics was entitled to receive an upfront cash payment of $140 million and Lilly obtained the exclusive right to acquire Radionetics for $1.0 billion upon conclusion of an exercise period. During the exercise period, Radionetics will continue to build out a proprietary pipeline of therapeutic assets.

 

Australian operations

 

In January 2017, we established Crinetics Australia Pty Ltd, or CAPL, a wholly-owned subsidiary which was formed to conduct various preclinical and clinical activities for our product and development candidates. CAPL is eligible for certain financial incentives made available by the Australian government for research and development expenses. Specifically, the Australian Taxation Office provides a refundable tax credit in the form of a cash refund equal to 43.5% of qualified research and development expenditures under the Australian Research and Development Tax Incentive Program, or the Australian Tax Incentive, to Australian companies that operate the majority of their research and development activities associated with such projects in Australia. A wholly-owned Australian subsidiary of a non-Australian parent company is eligible to receive the refundable tax credit, provided that the Australian subsidiary retains the rights to the data and intellectual property generated in Australia, and provided that the total revenues of the parent company and its consolidated subsidiaries during the period for which the refundable tax credit is claimed are less than $20.0 million Australian dollars. If we lose our ability to operate CAPL in Australia, or if we are ineligible or unable to receive the research and development tax credit, or the Australian government significantly reduces or eliminates the tax credit, the actual refund amounts we receive may differ from our estimates.

 

Financial operations overview

 

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

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any product sales. We have funded our operations primarily through our grant and license revenues, and offerings of our preferred and common stock. As of March 31, 2025, we had unrestricted cash, cash equivalents, and investment securities of $1.3 billion.

We have incurred cumulative net losses since our inception and, as of March 31, 2025, we had an accumulated deficit of $1.0 billion. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials and preclinical studies and our expenditures on other research and development activities. We expect our expenses and operating losses will increase substantially as we conduct our ongoing and planned clinical trials, continue our research and development activities and conduct preclinical studies, hire additional personnel, protect our intellectual property and incur costs associated with being a public company, including audit, legal, regulatory, and tax-related services associated with maintaining compliance with exchange listing and Securities and Exchange Commission, or SEC, requirements, director and officer insurance premiums, and investor relations costs.

We do not expect to generate any revenues from product sales unless and until we successfully complete development and obtain regulatory approval for one or more of our product candidates. If we obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. Accordingly, until such time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, 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 or our efforts to expand our product pipeline.

 

Revenues

 

To date, our revenues have been mainly derived from research grant awards and licenses, including the Radionetics License, the Sanwa License, and the Loyal License. As our data exchange performance obligation under the Sanwa License is fulfilled, we expect to recognize as revenues the deferred revenue amounts included in the accompanying condensed consolidated balance sheets as of March 31, 2025. We will recognize royalty and milestone revenues under our license agreements if and when appropriate under the relevant accounting rules (see Note 8 to our condensed consolidated financial statements). We have not generated any revenues from the commercial sale of approved products, and we may never generate revenues from the commercial sale of our product candidates for at least the foreseeable future, if ever. However, we submitted a New Drug Application, or NDA, to the U.S. Food and Drug Administration, or FDA, for paltusotine for the proposed treatment and long-term maintenance therapy of acromegaly and subsequently received notification of acceptance from the FDA on the status of the NDA submission and were granted a Prescription Drug User Fee Act, or PDUFA, Target Action Date of September 25, 2025.

 

License revenues

 

In February 2022, we and Sanwa entered into a license agreement, or the Sanwa License, pursuant to which whereby we granted Sanwa an exclusive license to develop and commercialize paltusotine in Japan.

 

License revenues of $0.4 million and $0.6 million, respectively, for the three months ended March 31, 2025 and 2024 were primarily derived from the Sanwa License.

 

Clinical supply revenues

 

On June 14, 2022, we and Sanwa entered into a clinical supply agreement, or the Sanwa Clinical Supply Agreement, whereby we are responsible for manufacturing and supplying certain materials to Sanwa for specified activities under the Sanwa License. No significant supply purchases were made by Sanwa through the Sanwa Clinical Supply Agreement during each of the three months ended March 31, 2025 and 2024.

 

Research and development

 

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

Research and development expenses include:

salaries, payroll taxes, employee benefits, and stock-based compensation charges for those individuals involved in research and development efforts;
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;
costs related to manufacturing our product candidates for clinical trials and preclinical studies, including fees paid to third-party manufacturers;
costs related to compliance with regulatory requirements;

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laboratory supplies; and
facilities, depreciation and other allocated expenses for rent, facilities maintenance, insurance, equipment and other supplies.

We recognize the Australian Tax Incentive as a reduction of research and development expense. The amounts are determined based on eligible research and development expenditures. The Australian Tax Incentive is recognized when there is reasonable assurance that the Australian Tax Incentive will be received, the relevant expenditure has been incurred, and the amount of the Australian Tax Incentive can be reliably measured.

Our direct research and development expenses consist principally of external costs, such as fees paid to CROs, investigative sites and consultants in connection with our clinical trials, preclinical and non-clinical studies, and costs related to manufacturing clinical trial materials. The majority of our third-party expenses during the three months ended March 31, 2025 and 2024 related to the research and development of paltusotine, atumelnant, and discovery. We deploy our personnel and facility related resources across all of our research and development activities.

Our clinical development costs may vary significantly based on factors such as:

per patient trial costs;
the number of trials required for approval;
the number of sites included in the trials;
the countries in which the trials are conducted;
the length of time required to enroll eligible patients;
the number of patients that participate in the trials;
number of doses that patients receive;
drop-out or discontinuation rates of patients;
potential additional safety monitoring requested by regulatory agencies;
the duration of patient participation in the trials and follow-up;
the cost and timing of manufacturing our product candidates;
the number of product candidates;
the phase of development of our product candidates; and
the efficacy and safety profile of our product candidates.

 

We plan to increase our research and development expenses for the foreseeable future as we continue the development of our product candidates and the discovery of new product candidates. We cannot determine with certainty the timing of initiation, the duration or the completion costs of current or future preclinical studies and clinical trials of our product candidates due to the inherently unpredictable nature of preclinical and clinical development. Clinical and preclinical development timelines, the probability of success and development costs can differ materially from expectations. We anticipate that we will make determinations as to which product candidates to pursue and how much funding to direct to each product candidate on an ongoing basis in response to the results of ongoing and future preclinical studies and clinical trials, regulatory developments and our ongoing assessments as to each product candidate’s commercial potential. We will need to raise substantial additional capital in the future. In addition, we cannot forecast which product candidates may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.

 

Selling, general and administrative

 

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

 

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Critical Accounting Estimates

 

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

Results of Operations

Comparison of the three months ended March 31, 2025 and 2024

The following table summarizes our results of operations for the three months ended March 31, 2025 and 2024 (in thousands):

 

 

 

Three months ended March 31,

 

 

Dollar

 

 

 

2025

 

 

2024

 

 

Change

 

Revenues

 

$

361

 

 

$

640

 

 

$

(279

)

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

 

76,240

 

 

 

53,341

 

 

 

22,899

 

Selling, general and administrative

 

 

35,526

 

 

 

20,828

 

 

 

14,698

 

Total operating expenses

 

 

111,766

 

 

 

74,169

 

 

 

37,597

 

Loss from operations

 

 

(111,405

)

 

 

(73,529

)

 

 

(37,876

)

Other income, net

 

 

14,631

 

 

 

7,069

 

 

 

7,562

 

Loss before equity method investment

 

 

(96,774

)

 

 

(66,460

)

 

 

(30,314

)

Loss on equity method investment

 

 

 

 

 

(470

)

 

 

470

 

Net loss

 

$

(96,774

)

 

$

(66,930

)

 

$

(29,844

)

Revenues. Revenues during the three months ended March 31, 2025 and the three months ended March 31, 2024 related to the Sanwa License.

Research and development expenses. Research and development expenses were $76.2 million and $53.3 million for the three months ended March 31, 2025 and 2024, respectively. The change was primarily due to an increase in personnel costs of $13.3 million, increased manufacturing activities costs of $2.5 million, and increased outside services costs of $4.1 million, all of which were driven by the advancement of our clinical programs and the expansion of our preclinical portfolio.

25


 

The following table summarizes our primary external and internal research and development expenses for the three months ended March 31, 2025 and 2024 (in thousands):

 

 

 

Three Months ended March 31,

 

 

Dollar

 

 

 

2025

 

 

2024

 

 

Change

 

External research and development expenses:

 

 

 

 

 

 

 

 

 

Clinical trials

 

$

11,501

 

 

$

10,389

 

 

$

1,112

 

Contract manufacturing

 

 

8,752

 

 

 

6,253

 

 

 

2,499

 

Preclinical studies

 

 

2,592

 

 

 

1,845

 

 

 

747

 

Outside services

 

 

9,317

 

 

 

5,220

 

 

 

4,097

 

Other external research and development

 

 

15

 

 

 

4

 

 

 

11

 

Total external research and development expenses

 

 

32,177

 

 

 

23,711

 

 

 

8,466

 

Internal expenses:

 

 

 

 

 

 

 

 

 

Payroll and benefits

 

 

27,473

 

 

 

18,427

 

 

 

9,046

 

Stock-based compensation

 

 

11,819

 

 

 

7,565

 

 

 

4,254

 

Facilities and related

 

 

3,010

 

 

 

2,557

 

 

 

453

 

Other internal research and development

 

 

1,761

 

 

 

1,081

 

 

 

680

 

Total internal research and development expenses

 

 

44,063

 

 

 

29,630

 

 

 

14,433

 

  Total research and development expenses

 

$

76,240

 

 

$

53,341

 

 

$

22,899

 

 

The following table summarizes our research and development expenses by program for the three months ended March 31, 2025 and 2024 (in thousands):

 

 

 

Three Months ended March 31,

 

 

Dollar

 

 

 

2025

 

 

2024

 

 

Change

 

Paltusotine

 

$

16,491

 

 

$

12,952

 

 

$

3,539

 

Atumelnant

 

 

7,195

 

 

 

3,932

 

 

 

3,263

 

Early research and development programs

 

 

7,065

 

 

 

4,787

 

 

 

2,278

 

Payroll and benefits

 

 

27,473

 

 

 

18,427

 

 

 

9,046

 

Stock-based compensation

 

 

11,819

 

 

 

7,565

 

 

 

4,254

 

Other

 

 

6,197

 

 

 

5,678

 

 

 

519

 

  Total research and development expenses

 

$

76,240

 

 

$

53,341

 

 

$

22,899

 

 

Research and development expenses for our paltusotine program were $16.5 million and $13.0 million for the three months ended March 31, 2025 and 2024, respectively. The change was primarily due to increased spending on manufacturing activities of $0.9 million and an increase in outside services costs of $2.9 million.

Research and development expenses for our atumelnant program were $7.2 million and $3.9 million for the three months ended March 31, 2025 and 2024, respectively. The change was primarily due to increased spending on manufacturing activities of $1.2 million, an increase in outside services costs of $0.6 million, and an increase of $1.3 million in clinical and regulatory costs.

Research and development expenses for our early research and development programs were $7.1 million and $4.8 million for the three months ended March 31, 2025 and 2024, respectively. The change was primarily due to an increase in spending in manufacturing activities of $1.3 million, an increase in outside services costs of $0.6 million, and an increase in spending on nonclinical activities of $0.5 million as a result of the expansion of our discovery efforts across new therapeutic targets.

Research and development expenses for payroll and benefits were $27.5 million and $18.4 million for the three months ended March 31, 2025 and 2024, respectively. The change was primarily due to an increase in headcount to support our ongoing programs as well as for the expansion of our discovery efforts across new therapeutic targets.

Research and development expenses for stock-based compensation were $11.8 million and $7.6 million for the three months ended March 31, 2025 and 2024, respectively. The change was primarily due to an increase in headcount to support our ongoing programs as well as for the expansion of our discovery efforts across new therapeutic targets.

Other research and development expenses were $6.2 million and $5.7 million for the three months ended March 31, 2025 and 2024, respectively. The change was primarily due to an increase in facilities expenditures of $0.5 million and an increase in spending on nonclinical activities of $0.1 million, offset by a decrease in manufacturing activities of $0.2 million.

Selling, general and administrative expenses. Selling, general and administrative expenses were $35.5 million and $20.8 million for the three months ended March 31, 2025 and 2024, respectively. The change was primarily due to increases in personnel costs of $7.8

26


 

million and an increase in outside services costs of $5.6 million. When compared to the three months ended March 31, 2024, personnel expenses for the three months ended March 31, 2025 reflected a higher headcount, and an increase of $2.8 million in non-cash stock-based compensation expense. The increase in headcount was primarily due to the continued overall growth of the Company to support our ongoing programs and the planned commercial launch of paltusotine. The increase in outside services costs is primarily driven by costs associated with commercial planning for paltusotine.

Other income, net. Other income, net was $14.7 million and $7.1 million for the three months ended March 31, 2025 and 2024, respectively. The increase was primarily due to income generated by our investment securities.

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, 2025, we had unrestricted cash, cash equivalents and investment securities of $1.3 billion and an accumulated deficit of $1.0 billion.

The following table provides information regarding our cash flows for the three months ended March 31, 2025 and 2024 (in thousands):

 

 

 

Three months ended March 31,

 

 

 

2025

 

 

2024

 

Net cash used in operating activities

 

$

(88,452

)

 

$

(52,856

)

Net cash (used in) provided by investing activities

 

 

(85,961

)

 

 

309

 

Net cash provided by financing activities

 

 

4,437

 

 

 

393,574

 

Net change in cash, cash equivalents and restricted cash

 

$

(169,976

)

 

$

341,027

 

Operating Activities. Net cash used in operating activities was $88.5 million and $52.9 million for the three months ended March 31, 2025 and 2024, respectively. The increase in cash used in operations was primarily attributable to higher net loss due to higher personnel costs. The net cash used in operating activities during the three months ended March 31, 2025 was primarily due to our net loss of $96.8 million adjusted for $17.9 million of noncash charges, primarily for stock-based compensation, and a $9.5 million change in operating assets and liabilities. Net cash used in operating activities during the three months ended March 31, 2024 was primarily due to our net loss of $66.9 million adjusted for $11.4 million of noncash charges, primarily for stock-based compensation, and a $2.7 million change in operating assets and liabilities.

Investing activities. Investing activities consist primarily of purchases and maturities of investment securities and, to a lesser extent, the cash outflow associated with purchases of property and equipment. Such activities resulted in a net outflow of funds of approximately $86.0 million during the three months ended March 31, 2025, compared to a net inflow of funds of approximately $0.3 million during the three months ended March 31, 2024.

Financing activities. Net cash provided by financing activities was $4.4 million and $393.6 million for the three months ended March 31, 2025 and 2024, respectively. The net cash provided by financing activities during 2025 resulted from proceeds received from the exercise of stock options 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.

Liquidity and Capital Resources

As of March 31, 2025, we had unrestricted cash, cash equivalents and investment securities of $1.3 billion. Based on our current and anticipated level of operations, we believe that our existing capital resources, together with investment income, 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, expansions, results, costs and timing of our preclinical studies and clinical trials of our product candidates which we are pursuing or may choose to pursue in the future;
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 if any product candidate is approved;
the costs, timing and outcome of regulatory review of our product candidates;
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, including enhanced internal controls over financial reporting;

27


 

the costs associated with hiring additional personnel and consultants as our preclinical and clinical activities increase;
the timing and the extent of any Australian Tax Incentive refund and future grant revenues that we receive;
the costs and timing of establishing or securing sales and marketing capabilities if any product candidate is approved;
our ability to achieve sufficient market acceptance, adequate coverage and reimbursement from third-party payors and adequate market share and revenue for any approved products;
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;
our ability to generate revenues through future licensing arrangements and product sales after commercialization;
the funding of any co-development arrangements we enter into; and
our ability to participate in future equity offerings by Radionetics.

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

ATM Offerings

In August 2019, we entered into the 2019 Sales Agreement with the Sales Agents, under which we could, from time to time, sell up to $150.0 million of shares of our common stock through the Sales Agents pursuant to the 2019 ATM Offering. During the three months ended March 31, 2024, the Company issued 1,223,775 shares of common stock in the 2019 ATM Offering for net proceeds of approximately $43.4 million, after deducting commissions. The 2019 ATM Offering was terminated upon the filing of our Registration Statement on Form S-3ASR on June 21, 2024.

On June 21, 2024, we entered into the 2024 Sales Agreement with 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 pursuant to 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 nine months ended September 30, 2024, the Company issued 928,912 shares of common stock pursuant to the 2024 ATM Offering for net proceeds of approximately $48.3 million, after deducting commissions. During the three months ended March 31, 2025 and as of date of this Report, no shares of common stock had been sold under the 2019 ATM Offering or the 2024 ATM Offering Agreement.

Equity Offerings

On February 27, 2024, we entered into a stock purchase agreement with certain investors named therein, or the Purchasers, pursuant to which we agreed to issue and sell to the Purchasers in the Private Placement an aggregate of 8,333,334 shares of its common stock at a price of $42.00 per share for aggregate gross proceeds of approximately $350.0 million, before deducting offering expenses payable by us. The Private Placement closed on March 1, 2024. On March 19, 2024, we registered the resale of the shares issued and sold in the Private Placement, pursuant to the Registration Rights Agreement entered into with the Purchasers, dated February 27, 2024.

On October 10, 2024, we completed an underwritten public offering of 11,500,000 shares of its common stock at a price to the public of $50.00 per share, which included 1,500,000 shares of common stock issued pursuant to the underwriters' option to purchase additional shares. Net proceeds from the offering were approximately $542.8 million, after underwriting discounts and commissions and other offering costs of approximately $32.2 million.

Headquarters Lease

On September 9, 2022, we entered into a lease agreement for laboratory and office space in San Diego, California, or the 2022 Lease (see Note 6 to the condensed consolidated financial statements). On December 18, 2023, we moved our corporate headquarters to the new facility.

28


 

 

Item 3. Quantitative and Qualitative Disclosures about Market Risk

Interest Rate Risk

Our cash, cash equivalents and investment securities consist of cash held in readily available checking and money market accounts as well as short-term debt securities. We are exposed to market risk related to fluctuations in interest rates and market prices. Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of United States interest rates. However, because of the short-term nature of the instruments in our portfolio, a sudden hypothetical 10% change in market interest rates would not be expected to have a material impact on our financial condition or results of operations.

Foreign Currency

We conduct a portion of our business in currencies other than our U.S. dollar functional currency. These transactions give rise to cash flows and monetary assets and liabilities that are denominated in currencies other than the U.S. dollar; the value of these amounts are exposed to changes in currency exchange rates from the time the transactions are forecasted or originated until the time the cash settlement is converted into U.S. dollars.

We contract with vendors, CROs and investigational sites in several foreign countries, including countries in South America, Europe and the Asia Pacific. As such, we have exposure to fluctuations in foreign currency rates in connection with these agreements. We do not hedge our foreign currency exchange rate risk. Additionally, our subsidiaries expose us to foreign currency exchange risk. We believe this exposure to be immaterial and, to date, we have not incurred any material adverse effects from foreign currency changes on these contracts. As of March 31, 2025 and 2024, the impact of a theoretical 10% change in the exchange rates of our subsidiaries would not result in a material gain or loss.

Inflation Risk

Inflationary factors, such as increases in the cost of our materials, supplies, and overhead costs may continue to adversely affect our operating results. Although we do not believe that inflation has had a material impact on our financial position or results of operations to date, we may experience some adverse effect if inflation rates continue to rise. Significant adverse changes in inflation and prices in the future could result in material losses.

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 SEC’s rules 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 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 SEC 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, 2025 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.

29


 

PART II — OTHER INFORMATION

We are not currently a party to any material legal proceedings. From time to time, we may be 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 Annual Report on Form 10-K for the year ended December 31, 2024.

 

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

On March 13, 2025, Stephen Betz, Chief Scientific Officer, adopted a Rule 10b5-1 trading arrangement that is intended to satisfy the affirmative defense of Rule 10b5-1(c) for the sale of up to 97,483 shares of our common stock until September 15, 2025. None of our officers (as defined in Rule 16a–1(f)) or directors terminated any Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement, as each such term is defined in Item 408 of Regulation S-K.



 

30


 

Item 6. Exhibits

EXHIBIT INDEX

 

Exhibit

 

Incorporated by Reference

Filed

Number

Exhibit Description

Form

File No.

Exhibit

Filing Date

Herewith

3.1

Amended and Restated Certificate of Incorporation

8-K

001-38583

3.3

7/20/2018

 

3.2

Amended and Restated Bylaws

8-K

001-38583

3.1

12/12/2023

 

4.1

Specimen Stock Certificate Evidencing the Shares of Common Stock

S-1/A

333-225824

4.1

7/9/2018

 

10.1

Consulting Agreement, effective as of April 1, 2025, between Crinetics Pharmaceuticals, Inc. and Marc Wilson

8-K

001-38583

10.1

4/4/2025

 

10.2†#

Employment Agreement, effective as of February 21, 2025, between Crinetics Pharmaceuticals, Inc. and Tobin Schilke

 

 

 

 

X

31.1

Certification of Chief Executive Officer pursuant to Rule 13(a)-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes Oxley Act of 2002

 

 

 

 

X

31.2

Certification of Chief Financial Officer pursuant to Rule 13(a)-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes Oxley Act of 2002

 

 

 

 

X

32.1*

Certification of Chief Executive Officer and Chief Financial Officer pursuant 18. U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes Oxley Act of 2002

 

 

 

 

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

 

 

† Portions of this exhibit have been omitted in compliance with Regulation S-K Item 601(b)(10)(iv).

# Indicates management contract or compensatory plan.

* The certification attached as Exhibit 32.1 that accompanies this Quarterly Report on Form 10-Q is not deemed filed with the SEC and is not to be incorporated by reference into any filing of Crinetics Pharmaceuticals, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Form 10-Q, irrespective of any general incorporation language contained in such filing.

 

31


 

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 8, 2025

By:

 

/s/ R. Scott Struthers, Ph.D.

 

 

 

R. Scott Struthers, Ph.D.

 

 

 

 

President and Chief Executive Officer

 

 

 

 

(Principal executive officer)

 

 

 

 

 

Date: May 8, 2025

By:

 

/s/ Tobin Schilke

 

 

 

Tobin Schilke

 

 

 

 

Chief Financial Officer

 

 

 

 

(Principal financial and accounting officer)

 

 

32