Private company

Crinetics Pharmaceuticals

Logo: https://crinetics.com/, Non-free logo, via Wikipedia5

American pharmaceutical company

Crinetics Pharmaceuticals was a global pharmaceutical company known for developing drugs for the treatment of endocrine-related diseases. It was founded by Scott Struthers, Frank Zhu, Ana Kusnetzow, and Stephen F. Betz in 2008 and is headquartered in San Diego, California. It went public on NASDAQ in 2018.3 Wikipedia text CC BY-SA 4.0

Last updated Oct 20, 2026.

Overview

Nov 18, 2008Founded1
  • IndustryPharmaceutical Preparations1
  • HeadquartersSan Diego1
  • Websitecrinetics.com
  • Legal formDelaware corporation1
  • Incorporated inDE6
  • Business address6055 Lusk Blvd., San Diego, Ca 921216
  • Filer categoryLarge accelerated filer6
  • LEI549300Q1CNFXK5P31D284
  • StatusActive4
  • LEI statusLapsed (not renewed)4
  • Registered addressC/O Corporation Service Company, 19808 Wilmington, United States4
  • Registered withDivision of Corporations, Department of State, 46243104

Crinetics Pharmaceuticals was a global pharmaceutical company known for developing drugs for the treatment of endocrine-related diseases. It was founded by Scott Struthers, Frank Zhu, Ana Kusnetzow, and Stephen F. Betz in 2008 and is headquartered in San Diego, California. It went public on NASDAQ in 2018.3

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

-6714.8%Operating margin8
-6046.2%Net margin8
640.7%Revenue growth, 20258
-46.9%Return on equity8
-$383.7MFree cash flow8

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue0¢$1.1M
  • Research and development63¢$332.1M
  • Selling, general and admin36¢$191.3M
  • Income tax0¢$180.0K

Out of $7.7M in revenue.8 The company lost money this year.

Financial statements

Revenue9108$7.7M in 2025+545% since 2019
0$2.0M$4.0M$6.0M$8.0M2019: $1.2M$1.2M20192020: $71.0K$71.0K2020−94%2021: $0$020212022: $0$020222023: $4.0M$4.0M20232024: $1.0M$1.0M2024−74%2025: $7.7M$7.7M2025+641%
Operating income91011128-$516.8M in 2025+860% since 2019
-$600.0M-$400.0M-$200.0M02019: -$53.8M-$53.8M20192020: -$75.0M-$75.0M2020+39%2021: -$107.7M-$107.7M2021+44%2022: -$167.9M-$167.9M2022+56%2023: -$222.6M-$222.6M2023+33%2024: -$338.9M-$338.9M2024+52%2025: -$516.8M-$516.8M2025+53%
Net income91011128-$465.3M in 2025+823% since 2019
-$600.0M-$400.0M-$200.0M02019: -$50.4M-$50.4M20192020: -$73.8M-$73.8M2020+46%2021: -$107.6M-$107.6M2021+46%2022: -$163.9M-$163.9M2022+52%2023: -$214.5M-$214.5M2023+31%2024: -$298.4M-$298.4M2024+39%2025: -$465.3M-$465.3M2025+56%
Fiscal year2019202020212022202320242025
Revenue$1.2M9$71.0K10$010$010$4.0M8$1.0M8$7.7M8
Cost of revenue$08$08$1.1M8
Research and development$41.5M9$57.0M10$84.3M11$130.2M12$168.5M8$240.2M8$332.1M8
Selling, general and admin$58.1M8$99.7M8$191.3M8
Operating expenses$108.8M11$172.6M12$226.6M12$339.9M12$524.5M8
Operating income-$53.8M9-$75.0M10-$107.7M11-$167.9M12-$222.6M8-$338.9M8-$516.8M8
Interest
Income before tax-$107.6M11-$163.9M12-$214.5M12-$298.4M12-$465.1M8
Income tax$09$010$011$012$08$08$180.0K8
Net income-$50.4M9-$73.8M10-$107.6M11-$163.9M12-$214.5M8-$298.4M8-$465.3M8
Earnings per share-$2.4210-$2.8011-$3.1512-$3.698-$3.698-$4.958
Earnings per share (diluted)-$2.4210-$2.8011-$3.1512-$3.698-$3.698-$4.958
Shares (weighted, basic)38.4M shares1152.0M shares1258.1M shares880.8M shares894.1M shares8
Shares (weighted, diluted)38.4M shares1152.0M shares1258.1M shares880.8M shares894.1M shares8

Compare Crinetics Pharmaceuticals with another company

Corporate structure

Crinetics Pharmaceuticals sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Crinetics Pharmaceuticals

  • Wellington Management Company Filed SCHEDULE 13G/A on Crinetics Pharmaceuticals, latest Aug 13, 2026 (8 filings since Feb 6, 2023)
  • FMR LLC Filed SCHEDULE 13G/A on Crinetics Pharmaceuticals, latest Aug 7, 2026 (7 filings since Jan 10, 2022)
  • FARALLON CAPITAL MANAGEMENT, L.L.C. Filed SCHEDULE 13G/A on Crinetics Pharmaceuticals, latest Aug 3, 2026
  • DRIEHAUS CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G/A on Crinetics Pharmaceuticals, latest May 15, 2026 (4 filings since Jan 10, 2022)
  • PRICE T ROWE ASSOCIATES INC /MD/ Filed SCHEDULE 13G/A on Crinetics Pharmaceuticals, latest May 15, 2026 (2 filings since Nov 14, 2024)
  • VANGUARD CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G on Crinetics Pharmaceuticals, latest Apr 29, 2026
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on Crinetics Pharmaceuticals, latest Mar 26, 2026 (6 filings since Feb 13, 2024)
  • Farallon Capital Partners, L.P. Filed SCHEDULE 13G/A on Crinetics Pharmaceuticals, latest Feb 5, 2026 (2 filings since Sep 8, 2025)
  • EcoR1 Capital, LLC Filed SC 13G/A on Crinetics Pharmaceuticals, latest Nov 14, 2024 (2 filings since Mar 11, 2024)
  • Point72 Asset Management, L.P. Filed SC 13G/A on Crinetics Pharmaceuticals, latest Nov 14, 2024 (3 filings since Sep 18, 2023)
  • State Street Corporation Filed SC 13G/A on Crinetics Pharmaceuticals, latest Oct 17, 2024 (2 filings since Jan 24, 2024)
  • PERCEPTIVE ADVISORS LLC Filed SC 13D/A on Crinetics Pharmaceuticals, latest Mar 1, 2024 (3 filings since Apr 21, 2022)
  • Crinetics Pharmaceuticals San Diego, California, United States

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Crinetics Pharmaceuticals reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$22.2M8 Dec 31, 2025$19.8M8 Dec 31, 2024+12.4%
Accumulated depreciation$8.0M8 Dec 31, 2025$7.7M8 Dec 31, 2024+2.8%
Property and equipment, net$14.3M8 Dec 31, 2025$12.1M8 Dec 31, 2024+18.5%
Operating-lease assets (leased space)$40.5M8 Dec 31, 2025$43.5M8 Dec 31, 2024−6.9%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$101.5M8 Dec 31, 2025$264.5M8 Dec 31, 2024−61.6%
Marketable securities, current$926.4M8 Dec 31, 2025$1.1B8 Dec 31, 2024−15.0%
Debt securities available for sale$1.1B12 Dec 31, 2024$503.7M12 Dec 31, 2023+116.3%

Inventory

ItemLatestA year beforeChange
Inventory, total$2.0M8 Dec 31, 2025$08 Dec 31, 2024
Raw materials$08 Dec 31, 2025$08 Dec 31, 2024
Work in process$2.0M8 Dec 31, 2025$08 Dec 31, 2024
Finished goods$18.0K8 Dec 31, 2025$08 Dec 31, 2024

Properties, in its own words

Our corporate headquarters consists of approximately 94,000 square feet of leased laboratory and office space in San Diego, California, which expires in April 2035.

We use our corporate headquarters to support our corporate, research and development, and commercial operations. We believe that our facilities are adequate to meet our current needs, and that suitable additional alternative spaces will be available in the future on commercially reasonable terms, if required.

Item 2 of the 10-K filed Feb 26, 2026.16

The story

Struthers, Zhu, Kusnetzow, and Betz founded Crinetics in 2008 after previously working together on a small molecule drug for the treatment of endometriosis at Neurocrine Biosciences.

Crinetics expanded into a larger laboratory in 2010. After receiving NIH grant funding, Crinetics moved into its second laboratory.

In 2011, Crinetics Pharmaceuticals competed for the Michelson Prize, a competition sponsored by the Found Animals Foundation to develop a low-cost, non-surgical method for sterilizing dogs and cats, which would later lead to the licensing of a molecule for the treatment of acromegaly in large breed dogs.

Crinetics first synthesized its lead drug candidate to treat acromegaly. The drug was named paltusotine, in 2016. Crinetics Pharmaceuticals went public with an IPO in 2018. It conducted Phase II trials for paltusotine from 2019 to 2020. It conducted Phase III trials for paltusotine from 2021 to 2024. After the drug succeeded in a second Phase III study, the FDA accepted the company's new drug application for paltusotine and the company announced it was planning for a 2025 launch for the drug. The FDA set a Prescription Drug User Fee Act for the drug on September 25, 2025.

In 2021, Crinetics, together with 5AM Ventures and Frazier Healthcare Partners, formed an independently operated new company, Radionetics Oncology, aimed to develop a deep pipeline of novel, targeted, nonpeptide radiopharmaceuticals for the treatment of a broad range of oncology indications.

Crinetics partnered with the veterinary medicine company Loyal to develop a pill to extend the lifespans of large dogs in 2023.

In 2024, Scott Struthers received the Ernst & Young Entrepreneur of the Year Award for his work with Crinetics. In 2024, Crinetics was reported to have patent activity in rare diseases, health technology, and addiction therapies.

In 2024, Radionetics formed a strategic relationship with Eli Lilly and Company to take forward Radionetics’ proprietary GPCR targeting small molecule radiopharmaceuticals. Under the terms of the agreement, Radionetics received a $140 million upfront cash payment. As part of the strategic agreement, Lilly obtained the exclusive right to acquire Radionetics upon conclusion of an exercise period for $1 billion.

Read the full text

Crinetics also established its first office outside the United States in Zug, Switzerland in 2024.

In 2025, Crinetics Pharmaceuticals plans to file an Investigational New Drug for an oral thyroid stimulating hormone receptor antagonist and its nonpeptide drug conjugate (CRN09682). A total of four development candidates are currently in IND-enabling studies, including a PTH antagonist (Hyperparathyrodism), non-peptide drug conjugate (NETs and SST2-expressing solid tumors), TSH antagonist (Graves’ disease & TED) and SST3 agonist (ADPKD).

In July 2026, Vertex Pharmaceuticals agreed to acquire Crinetics for $10 billion.

From Wikipedia’s article on Crinetics Pharmaceuticals, shared under CC BY-SA 4.0.7

Leadership

Who has led Crinetics Pharmaceuticals, and when. Pick a name to see everywhere that person has worked.

Chief financial officer

  1. Tobin Schilke2025–now

Chief operating officer

  1. Jeff E. Knight2021–now
2010201520202025
Board members and other officers (19)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive OfficerMARC SCOTT WILSON named Mar 11, 202438
  • DirectorMATTHEW SCOTT FUST named Mar 11, 202438
  • DirectorROGERIO VIVALDI COELHO, M.D. named Mar 11, 202438

Timeline

  1. Sep 1, 20268-K Ended a material agreement; Completed an acquisition or sale; Listing notice or transfer39
  2. Aug 28, 20268-K Shareholder vote40
  3. Aug 19, 20268-K Other events41
  4. Aug 14, 20268-K Other events42
  5. Aug 3, 20268-K Results of operations43
  6. Jul 10, 20268-K Entered a material agreement; Executive or director change44
  7. Jul 6, 20268-K Entered a material agreement; Other events45
  8. Jun 22, 20268-K Shareholder vote46
  9. May 7, 20268-K Results of operations47
  10. Apr 10, 20268-K Executive or director change48
  11. Mar 23, 20268-K Executive or director change49
  12. Mar 3, 20268-K Change of auditor50
  13. Mar 12, 2019New chief executive Richard Scott Struthers becomes CEO17
  14. Nov 18, 2008Founded Founded1

Calendar

Coming up

  1. Around Oct 30, 2026Next results, estimated About a quarter after its last report. The company hasn't announced the date.

When it reported results

  1. Aug 3, 2026Reported quarterly or annual results43
  2. May 7, 2026Reported quarterly or annual results47
  3. Feb 26, 2026Reported quarterly or annual results51
  4. Jan 13, 2026Reported quarterly or annual results52
  5. Jan 5, 2026Reported quarterly or annual results53
  6. Nov 6, 2025Reported quarterly or annual results54
  7. Aug 7, 2025Reported quarterly or annual results55
  8. May 8, 2025Reported quarterly or annual results56

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

526 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 85 major events, 232 insider forms, 53 large holders, 1 private raises, 135 other. The latest 20:

  1. Sep 11, 202615-12G EDGAR
  2. Sep 1, 20264 EDGAR
  3. Sep 1, 20264 EDGAR
  4. Sep 1, 20264 EDGAR
  5. Sep 1, 20264 EDGAR
  6. Sep 1, 20264 EDGAR
  7. Sep 1, 20264 EDGAR
  8. Sep 1, 20264 EDGAR
  9. Sep 1, 20264 EDGAR
  10. Sep 1, 20264 EDGAR
  11. Sep 1, 20264 EDGAR
  12. Sep 1, 20264 EDGAR
  13. Sep 1, 2026S-8 POS EDGAR
  14. Sep 1, 2026S-8 POS EDGAR
  15. Sep 1, 2026S-8 POS EDGAR
  16. Sep 1, 2026S-8 POS EDGAR
  17. Sep 1, 2026S-8 POS EDGAR
  18. Sep 1, 2026S-8 POS EDGAR
  19. Sep 1, 2026S-8 POS EDGAR
  20. Sep 1, 2026S-8 POS EDGAR

The 526 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

118 open-market trades by officers, directors and large owners since October 2021: 3 buys and 115 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jul 2, 2026Vivaldi Coelho RogerioDirectorSale3,000$40.00$120.0KForm 4
Jun 17, 2026Okey StephanieDirectorSale6,900$35.67$246.1KForm 4
Apr 8, 2026Knight Jeff E.Chief Dev. & Operating OfficerSale85,163$40.10$3.4MForm 4
Mar 16, 2026Knight Jeff E.Chief Dev. & Operating OfficerSale9,911$37.37$370.4KForm 4
Mar 16, 2026Betz Stephen F.Chief Scientific OfficerSale10,612$37.37$396.6KForm 4
Mar 16, 2026Struthers Richard ScottPresident & CEOSale21,981$37.37$821.5KForm 4
Mar 12, 2026Vivaldi Coelho RogerioDirectorSale5,000$36.15$180.8KForm 4
Mar 3, 2026Okey StephanieDirectorSale3,000$39.67$119.0KForm 4
Mar 3, 2026Schilke TobinChief Financial & Infra. Ofcr.Sale6,713$39.67$266.3KForm 4
Jan 5, 2026Kalofonos IsabelChief Commercial OfficerSale2,500$55.00$137.5KForm 4
Dec 1, 2025Pizzuti DanaChief Med and Dev OfficerSale5,000$45.02$225.1KForm 4
Nov 3, 2025Pizzuti DanaChief Med and Dev OfficerSale5,000$42.66$213.3KForm 4
Oct 1, 2025Pizzuti DanaChief Med and Dev OfficerSale5,000$41.81$209.1KForm 4
Sep 26, 2025Struthers Richard ScottPresident & CEOSale4,000$45.00$180.0KForm 4
Sep 26, 2025Fust Matthew KDirectorSale16,000$44.75$716.0KForm 4
Sep 2, 2025Pizzuti DanaChief Med and Dev OfficerSale5,000$32.10$160.5KForm 4
Aug 22, 2025Pizzuti DanaChief Med and Dev OfficerSale30,000$30.43$912.9KForm 4
Aug 20, 2025Pizzuti DanaChief Med and Dev OfficerSale6,492$29.18$189.4KForm 4
Jun 12, 2025Betz Stephen F.Chief Scientific OfficerSale97,483$32.23$3.1MForm 4
Mar 19, 2025Pizzuti DanaChief Med and Dev OfficerSale2,515$34.20$86.0KForm 4

All 118 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025R. Scott StruthersPh.D.$718.5K$11.6M76
2025Tobin Schilke51$452.2K$4.4M76
2025Dana PizzutiM.D.$573.3K$3.9M76
2025Stephen F. BetzPh.D.$520.0K$3.8M76
2025Jeff Knight$511.7K$3.8M76
2025Marc Wilson$119.8K$3.3M76
2024President and Chief Executive Officer$653.8K$10.5M76
2024Former Chief Financial Officer$468.9K$4.4M76
2024Chief Medical and Development Officer$550.8K$4.2M76
2024Chief Scientific Officer$491.7K$4.1M76
2024Chief Operating Officer$490.0K$4.1M76
2023President and Chief Executive Officer$614.0K$5.7M76
2023Former Chief Financial Officer$450.5K$2.5M76
2023Chief Scientific Officer$471.9K$2.5M76
2023Chief Operating Officer$459.2K$2.4M76
2023Chief Medical and Development Officer$529.2K$1.1M76

Money raised

Private offerings the company reported to the SEC on Form D.

  1. Mar 1, 2024Raised $350 million in a private offering of equity Form D: 36 investors so far Form D

SEC filer profile

How Crinetics Pharmaceuticals is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARCrinetics Pharmaceuticals, Inc.2
  • CIK0001658247
  • Employer ID (EIN)26-374411416
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company16
  • Incorporated inDelaware16
  • Fiscal year endsDecember 312
  • Industry code (SIC)2834 Pharmaceutical Preparations2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address6055 Lusk Blvd., San Diego, CA 921212
  • Phone858-450-64642
  • Shares outstanding106,065,229 as of Jul 22, 202614
  • Public float$2.7B as of Jun 30, 202516
  • AuditorBDO USA, P.C., San Diego PCAOB ID 243; it also attests to the company’s internal control over financial reporting16
  • On EDGAR sinceNov 16, 20152
  • Filings726 in all: 4 (272), 8-K (120), 144 (77), SC 13G/A (37), 10-Q (25), 3 (25), SC 13G (21), 5 (16)2
    All 41 form types

    SCHEDULE 13G/A (16), 424B5 (14), DEFA14A (12), S-8 POS (10), CORRESP (9), S-8 (9), 10-K (8), DEF 14A (8), UPLOAD (7), SC 13D/A (5), ARS (4), 4/A (3), D (3), S-3ASR (3), EFFECT (2), POSASR (2), SCHEDULE 13G (2), 15-12G (1), 25-NSE (1), 424B4 (1), 8-A12B (1), CERT (1), DEFM14A (1), DRS (1), DRS/A (1), DRSLTR (1), PREM14A (1), S-1 (1), S-1/A (1), S-1MEF (1), S-3 (1), S-3/A (1), SC 13D (1)

  • Latest filingsAnnual report (10-K) Feb 26, 2026
    Quarterly report (10-Q) Aug 3, 2026
    Proxy statement (DEF 14A) Apr 29, 2026
    Latest 8-K (8-K) Sep 1, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.001 per shareCRNXNasdaq Global Select Market

From the cover page of the 10-K filed Feb 26, 2026 (Section 12(b) of the Exchange Act).16

Risk factors and legal proceedings

The risks Crinetics Pharmaceuticals names in Item 1A of its 10-K filed Feb 26, 2026: 74 risks under these headings, as written.16

  • Risks related to our limited operating history, financial position and capital requirements
  • We have a limited operating history, have incurred significant operating losses since our inception and expect to continue to incur losses. We may never become profitable or, if we achieve profitability, we may not be able to sustain it.
  • We will require substantial additional financing to achieve our goals, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could lead us to delay, limit, reduce, abandon or terminate our product development programs, commercialization efforts or other operations.
  • Risks related to the discovery and development and regulatory approval of our product candidates and the commercialization of PALSONIFY
  • We currently primarily depend on the success of paltusotine, approved as PALSONIFY in the U.S., and have other product candidates in clinical development, and all of our other research programs are still in the preclinical or discovery stage. If we are unable to successfully commercialize PALSONIFY or develop other product candidates or experience significant delays in doing so, our business will be materially harmed.
  • We cannot assure you that we will be able to successfully discover and develop additional product candidates.
  • Preclinical and clinical drug development involves a lengthy and expensive process with an uncertain outcome, and the results of preclinical studies and early clinical trials are not necessarily predictive of future results. Our product candidates that we develop may not have favorable results in later clinical trials, if any, or receive regulatory approval, and we may choose to terminate development for strategic reasons.
  • We may find it difficult to enroll and retain patients in our clinical trials given the limited number of patients who have the diseases for which our product candidates are being developed. If we encounter difficulties enrolling subjects in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • Use of our products and product candidates could be associated with side effects or adverse events during their development or commercialization, which could severely harm our business, reputation, prospects, operating results and financial condition.
  • Our product candidates are subject to extensive regulation and compliance, which is costly and time consuming and which may cause unanticipated delays or prevent the receipt of the required approvals to commercialize our product candidates.
  • We have obtained orphan drug designation from the FDA for paltusotine for the treatment of acromegaly. We also plan to seek orphan drug designations for certain of our other product candidates. However, we may not be able to obtain or maintain orphan drug designations for paltusotine or any of our other product candidates, and we may be unable to maintain the benefits associated with orphan drug designation, including the potential for market exclusivity.
  • We have conducted, and continue to conduct, clinical trials for our current product candidates outside of the U.S., and we may do so for our other product candidates. However, conducting trials outside of the U.S. exposes us to additional risks, which could materially harm our business.
The other 62 risks
  • Changes in U.S. and international trade policies, particularly with respect to China, Europe and India may adversely impact our business and operating results.
  • Initial, interim, topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data becomes available and is subject to audit and verification procedures that could result in material changes in the final data.
  • Risks related to commercialization of PALSONIFY and our product candidates
  • We are subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense. Additionally, PALSONIFY and, if approved, our other product candidates could be subject to labeling and other restrictions on marketing or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems.
  • Disruptions at the FDA and other government agencies could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved, or commercialized in a timely manner or at all, which could negatively impact our business.
  • The commercial success of PALSONIFY and our other product candidates, if approved, will depend upon the degree of market acceptance by physicians, patients, health care payors and others in the medical community.
  • The successful commercialization of PALSONIFY and, if approved, our other product candidates, will depend in part on the extent to which governmental authorities and health insurers establish coverage, adequate reimbursement levels and favorable pricing policies. Failure to obtain or maintain coverage and adequate reimbursement for our products could limit our ability to market those products and decrease our ability to generate revenue.
  • We face competition from entities that have developed or may develop somatostatin agonist products and other competitive candidates. If these companies develop competing technologies or product candidates more rapidly than we do or their technologies are more effective, our ability to develop and successfully commercialize products may be adversely affected.
  • The numbers of patients suffering from the rare endocrine diseases and endocrine-related tumors that we target is small and have not been established with precision. If the market opportunities for our products are smaller than we believe they are, our revenue may be adversely affected, and our business may suffer.
  • We have sought and may continue to seek to enter into collaborations, licenses and other similar arrangements of our product and may not be successful in doing so, and even if we are, we may not realize the benefits of such relationships.
  • We obtained regulatory approval from the FDA for PALSONIFY but have limited demonstration of conducting commercial activities.
  • Our future growth may depend, in part, on our ability to operate in foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.
  • Risks related to our reliance on third parties
  • We rely on third parties to conduct many of our preclinical studies and clinical trials. Any failure by a third party to conduct the clinical trials according to GCPs and in a timely manner may delay or prevent our ability to seek or obtain regulatory approval for or commercialize our product candidates.
  • We rely on third parties for raw materials, active pharmaceutical ingredients, and drug product intermediates for the manufacture of our product candidates for preclinical and clinical development and expect to continue to do so for the foreseeable future. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or products or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
  • We are dependent on an international third-party licensee for the development and commercialization of paltusotine in Japan, and we may enter into similar agreements in other geographic regions. The failure of this and other third parties to meet their contractual, regulatory or other obligations could adversely affect our business.
  • Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
  • Risks related to our business operations and industry
  • We are dependent on the services of our management and other clinical and scientific personnel, and if we are not able to retain these individuals or recruit additional management or clinical and scientific personnel, our business will suffer.
  • We may encounter difficulties in managing our growth and expanding our operations successfully.
  • We are subject to various foreign, federal and state healthcare laws and regulations, and our failure to comply with these laws and regulations could harm our results of operations and financial condition.
  • Actual or perceived failures to comply with applicable data protection, privacy and security laws, regulations, standards and other requirements could have a material adverse effect on our business, financial condition or results of operations.
  • Recently enacted legislation, future legislation and healthcare reform measures may increase the difficulty and cost for us to obtain marketing approval for and commercialize our products and product candidates and may affect the prices we may set.
  • If product liability or state consumer protection act lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our products.
  • We and any of our potential future collaborators will be required to report to regulatory authorities if any of our approved products cause or contribute to adverse medical events, and any failure to do so would result in sanctions that would materially harm our business.
  • Our employees and independent contractors, including principal investigators, CROs, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • We may not realize any benefits from our relationship with Radionetics.
  • The increasing use of social media and artificial intelligence-based platforms presents new risks and challenges.
  • Risks related to our intellectual property
  • Our success depends on our ability to protect our intellectual property and our proprietary technologies, and if we are unable to protect our intellectual property and technologies, our business will suffer.
  • If the scope of any patent protection we obtain is not sufficiently broad, or if we lose any of our patent protection, our ability to prevent our competitors from commercializing similar or identical product candidates would be material and adversely affected.
  • Some of our intellectual property has been discovered through government funded programs and thus may be subject to federal regulations such as “march-in” rights, certain reporting requirements and a preference for U.S.-based companies. Compliance with such regulations may limit our exclusive rights and limit our ability to contract with non-U.S. manufacturers.
  • We may be involved in lawsuits to protect or enforce our patents, which could be expensive, time consuming and unsuccessful. Further, our issued patents could be found invalid or unenforceable if challenged in court.
  • Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
  • Our commercial success depends significantly on our ability to operate without infringing the patents and other proprietary rights of third parties. Claims by third parties that we infringe their proprietary rights may result in liability for damages or prevent or delay our developmental and commercialization efforts.
  • Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of our common shares to decline.
  • Derivation proceedings may be necessary to determine priority of inventions, and an unfavorable outcome may require us to cease using the related technology or to attempt to license rights from the prevailing party.
  • Changes in U.S. patent law, or laws in other countries or jurisdictions, could diminish the value of patents in general, thereby impairing our ability to protect our products and product candidates.
  • We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
  • If we do not obtain patent term extension for our product candidates, our business may be materially harmed.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, documentary, fee payment and other requirements imposed by regulations and governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • We may be subject to claims that we have wrongfully hired an employee from a competitor or that we or our employees have wrongfully used or disclosed alleged confidential information or trade secrets of their former employers.
  • Risks related to our common stock
  • An active, liquid and orderly market for our common stock may not be maintained.
  • The trading price of the shares of our common stock could be highly volatile, and purchasers of our common stock could incur substantial losses.
  • Our executive officers, directors and principal stockholders, if they choose to act together, have the ability to control or significantly influence all matters submitted to stockholders for approval.
  • We do not currently intend to pay dividends on our common stock, and, consequently, your ability to achieve a return on your investment will depend on appreciation, if any, in the price of our common stock.
  • Sales of a substantial number of shares of our common stock by our existing stockholders in the public market could cause our stock price to fall.
  • Provisions in our charter documents and under Delaware law could discourage a takeover that stockholders may consider favorable and may lead to entrenchment of management.
  • Our amended and restated certificate of incorporation and amended and restated bylaws provide that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, and our amended and restated bylaws provide that the federal district courts shall be the exclusive forum
  • for the resolution of any complaint asserting a cause of action arising under the Securities Act, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
  • Our ability to use net operating loss carryforwards and other tax attributes may be limited.
  • General risk factors
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • We may engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management.
  • Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide.
  • We and any of our third-party manufacturers and suppliers may use potent chemical agents and hazardous materials, and any claims relating to improper handling, storage or disposal of these materials could be time consuming or costly.
  • Our information technology systems, or those of any of our CROs, manufacturers, other contractors or consultants or potential future collaborators, may fail or suffer security breaches, which could result in a material disruption of our product development programs.
  • Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
  • Unfavorable global economic conditions could adversely affect our business, financial condition and stock price.
  • We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws and anti-money laundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic and international markets. We can face criminal liability and other serious consequences for violations, which can harm our business.
  • If securities or industry analysts do not publish research or reports or publish unfavorable research or reports about our business, our stock price and trading volume could decline.
  • The increasing focus and evolving expectations with respect to on environmental sustainability and social initiatives could increase our costs, harm our reputation and adversely impact our financial results.
  • Changes in tax laws may impact our financial condition and results of operations.

Legal proceedings

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.

The opening of Item 3, Legal Proceedings.16

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