MLYS on Nasdaq

Mineralys Therapeutics, Inc.

In its 2026 annual report the company says: “We are a biopharmaceutical company focused on developing medicines to target diseases driven by dysregulated aldosterone. Our product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor (ASI) that we are developing for the treatment of cardiorenal conditions affected by dysregulated aldosterone, including hypertension and related comorbidities such as chronic kidney disease (CKD) and obstructive sleep apnea (OSA).”3 It is headquartered in Radnor, Pennsylvania.1 Its shares trade on Nasdaq under the symbol MLYS.1

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Last updated Oct 21, 2026.

Overview

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  • TickerMLYS on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersRadnor, Pennsylvania1
  • Business address150 N. Radnor Chester Road, Suite F200, Radnor, Pa2
  • Filer categoryNon-accelerated filer, Smaller reporting company, Emerging growth company2
  • Legal formCorporation

We are a biopharmaceutical company focused on developing medicines to target diseases driven by dysregulated aldosterone. Our product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor (ASI) that we are developing for the treatment of cardiorenal conditions affected by dysregulated aldosterone, including hypertension and related comorbidities such as chronic kidney disease (CKD) and obstructive sleep apnea (OSA).3 From its latest annual report

Financials

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

Financial statements

Operating income456-$170.6M in 2025+442% since 2022
-$200.0M-$150.0M-$100.0M-$50.0M02022: -$31.5M-$31.5M20222023: -$84.7M-$84.7M2023+169%2024: -$192.4M-$192.4M2024+127%2025: -$170.6M-$170.6M2025−11%
Net income456-$154.7M in 2025+419% since 2022
-$200.0M-$150.0M-$100.0M-$50.0M02022: -$29.8M-$29.8M20222023: -$71.9M-$71.9M2023+141%2024: -$177.8M-$177.8M2024+147%2025: -$154.7M-$154.7M2025−13%

Every line of the income statement as filed: the last 2 fiscal years, latest first.6

Period ending2025-12-312024-12-31
Research and development$132.0M$168.6M
General and administrative$38.6M$23.8M
Total operating expenses$170.6M$192.4M
Loss from operations-$170.6M-$192.4M
Interest income, net$16.0M$14.6M
Other income$0$5.0K
Total other income, net$16.0M$14.6M
Net loss-$154.7M-$177.8M
Net loss per share attributable to common stockholders - basic (in USD per share)-$2.29-$3.66
Net loss per share attributable to common stockholders - diluted (in USD per share)-$2.29-$3.66
Weighted-average shares used to compute net loss per share attributable to common stockholders - basic (in shares)67.7M shares48.5M shares
Weighted-average shares used to compute net loss per share attributable to common stockholders - diluted (in shares)67.7M shares48.5M shares

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Corporate structure

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

Major holders of Mineralys Therapeutics, Inc.

  • FMR LLC Filed SCHEDULE 13G/A on Mineralys Therapeutics, Inc., latest Aug 6, 2026 (2 filings since Feb 5, 2026)
  • Catalys Pacific Fund, LP Filed SCHEDULE 13G/A on Mineralys Therapeutics, Inc., latest Feb 13, 2026 (4 filings since Feb 13, 2024)
  • BlackRock Filed SCHEDULE 13G on Mineralys Therapeutics, Inc., latest Jan 21, 2026
  • RA CAPITAL MANAGEMENT, L.P. Filed SCHEDULE 13D/A on Mineralys Therapeutics, Inc., latest Sep 8, 2025 (4 filings since Feb 24, 2023)
  • Samsara BioCapital, L.P. Filed SCHEDULE 13D/A on Mineralys Therapeutics, Inc., latest Sep 8, 2025 (4 filings since Feb 24, 2023)
  • Andera Partners Filed SCHEDULE 13G/A on Mineralys Therapeutics, Inc., latest Aug 14, 2025 (2 filings since Feb 24, 2023)
  • ADAMS STREET PARTNERS LLC Filed SCHEDULE 13G/A on Mineralys Therapeutics, Inc., latest Feb 14, 2025 (2 filings since Feb 14, 2024)
  • HBM Healthcare Investments (Cayman) Ltd. Filed SC 13G/A on Mineralys Therapeutics, Inc., latest Nov 13, 2024 (2 filings since Feb 13, 2024)
  • TCG Crossover GP II, LLC Filed SC 13G/A on Mineralys Therapeutics, Inc., latest Nov 13, 2024 (2 filings since Feb 15, 2024)
  • Mineralys Therapeutics, Inc. Radnor, Pennsylvania

Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Mineralys Therapeutics, Inc. 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, net$38.0K6 Dec 31, 2025$53.0K6 Dec 31, 2024−28.3%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$172.9M6 Dec 31, 2025$114.1M6 Dec 31, 2024+51.6%
Marketable securities, non-current$05 Dec 31, 2024$2.5M5 Dec 31, 2023−100.0%

Properties, in its own words

We maintain our corporate offices at 150 N. Radnor Chester Road, Suite F200, Radnor, PA 19087 under a virtual office lease. We lease our corporate and other office premises under monthly rental agreements with terms of twelve months or less at a nominal cost. We consider our current office space adequate for our current operations.

Item 2 of the 10-K filed Mar 12, 2026.3

Leadership

Who has led Mineralys Therapeutics, Inc., and when. Pick a name to see everywhere that person has worked.

2025
Board members and other officers (15)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive OfficerAdam Levy named Jun 13, 202223

Timeline

  1. Aug 11, 20268-K Results of operations; Executive or director change24
  2. Jun 3, 20268-K Entered a material agreement; New debt or obligation25
  3. Jun 3, 20268-K Other events26
  4. May 22, 20268-K Shareholder vote27
  5. May 6, 20268-K Results of operations28
  6. Mar 12, 20268-K Results of operations29
  7. Mar 9, 20268-K Regulation FD disclosure; Other events30
  8. Jan 6, 20268-K Regulation FD disclosure; Other events31
  9. Nov 10, 20258-K Results of operations32
  10. Sep 3, 20258-K Other events33
  11. Sep 2, 20258-K Other events34
  12. Aug 12, 20258-K Results of operations35
  13. Feb 9, 2023New chief executive Jon Congleton becomes CEO9

Calendar

Coming up

  1. Nov 9, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.52) a share, on Nov 10, 2025.36

When it reported results

  1. Aug 11, 2026Reported quarterly or annual results24
  2. May 6, 2026Reported quarterly or annual results28
  3. Mar 12, 2026Reported quarterly or annual results29
  4. Nov 10, 2025Reported quarterly or annual results32
  5. Aug 12, 2025Reported quarterly or annual results35
  6. May 12, 2025Reported quarterly or annual results37
  7. Feb 12, 2025Reported quarterly or annual results38
  8. Nov 12, 2024Reported quarterly or annual results39

Drug trials and FDA: recently

  1. Dec 30, 2025Phase 3 trial completed Phase 3 trial of lorundrostat in Hypertension: primary completion Dec 30, 2025, no results posted yet (ClinicalTrials.gov NCT05968430).40
  2. Dec 17, 2025Phase 2 trial completed Phase 2 trial of Lorundrostat in Obstructive Sleep Apnea: primary completion Dec 17, 2025, no results posted yet (ClinicalTrials.gov NCT06785454).41
  3. Feb 27, 2025Phase 2 trial completed Phase 2 trial in Chronic Kidney Disease: primary completion Feb 27, 2025, results posted Jun 3, 2026 (ClinicalTrials.gov NCT06150924).42

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar

Filings

400 filings to the SEC since October 2021: 4 annual reports, 11 quarterly reports, 46 major events, 176 insider forms, 23 large holders, 1 private raises, 139 other. The latest 20:

  1. Oct 13, 2026144 EDGAR
  2. Oct 2, 20264 EDGAR
  3. Sep 30, 2026144 EDGAR
  4. Sep 24, 20264 EDGAR
  5. Sep 22, 2026144 EDGAR
  6. Sep 22, 20264 EDGAR
  7. Sep 21, 2026144 EDGAR
  8. Sep 17, 2026144 EDGAR
  9. Sep 17, 20264 EDGAR
  10. Sep 15, 2026144 EDGAR
  11. Sep 14, 2026144 EDGAR
  12. Sep 9, 2026144 EDGAR
  13. Aug 25, 20264 EDGAR
  14. Aug 21, 2026144 EDGAR
  15. Aug 17, 2026144 EDGAR
  16. Aug 13, 2026144 EDGAR
  17. Aug 12, 20264 EDGAR
  18. Aug 12, 20263 EDGAR
  19. Aug 12, 20264 EDGAR
  20. Aug 11, 202610-Q EDGAR

The 400 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

108 open-market trades by officers, directors and large owners since October 2021: 18 buys and 90 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 22, 2026Slingsby Brian TaylorDirectorSale104,320$28.81$3.0MForm 4
Sep 21, 2026Warren EricChief Commercial OfficerSale7,438$28.12$209.2KForm 4
Sep 15, 2026Karydas DaphneDirectorSale3,000$28.58$85.7KForm 4
Aug 21, 2026Warren EricChief Commercial OfficerSale7,437$25.98$193.2KForm 4
Aug 10, 2026Rodman David MalcomChief Medical OfficerSale2,170$27.09$58.8KForm 4
Jul 21, 2026Warren EricChief Commercial OfficerSale7,438$26.87$199.9KForm 4
Jul 17, 2026Rodman David MalcomChief Medical OfficerSale416$26.53$11.0KForm 4
Jul 15, 2026Rodman David MalcomChief Medical OfficerSale6,349$26.61$168.9KForm 4
Jul 13, 2026Congleton JonChief Executive OfficerSale10,700$27.24$291.5KForm 4
Jul 13, 2026Rodman David MalcomChief Medical OfficerSale14,058$27.58$387.7KForm 4
Jul 9, 2026Rodman David MalcomChief Medical OfficerSale2,171$30.30$65.8KForm 4
Jun 30, 2026Congleton JonChief Executive OfficerSale75,000$26.14$2.0MForm 4
Jun 26, 2026Warren EricChief Commercial OfficerSale104,124$25.90$2.7MForm 4
Jun 17, 2026Rodman David MalcomChief Medical OfficerSale4,584$25.00$114.6KForm 4
Jun 17, 2026Karydas DaphneDirectorSale3,000$25.00$75.0KForm 4
Jun 15, 2026Rodman David MalcomChief Medical OfficerSale9,890$23.81$235.5KForm 4
Jun 12, 2026Rodman David MalcomChief Medical OfficerSale6,349$23.93$151.9KForm 4
Jun 10, 2026Rodman David MalcomChief Medical OfficerSale2,170$25.00$54.2KForm 4
May 18, 2026Rodman David MalcomChief Medical OfficerSale417$27.55$11.5KForm 4
May 13, 2026Rodman David MalcomChief Medical OfficerSale14,056$28.58$401.7KForm 4

All 108 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
2025Jon Congleton62$636.5K$5.5M52
2025David RodmanM.D.$533.0K$2.2M52
2025Adam Levy$532.0K$2.2M52
2024President and Chief Executive Officer$580.0K$5.4M52
2024Chief Medical Officer$520.0K$2.9M52
2024Chief Financial Officer and Secretary$500.0K$2.8M52

Funding

Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.

Money received by year$118.0M 2022–2022
Money received by yearMoney received by year, 2022–2022: $118.0M in all. Private raises (Form D) $118.0M.$0$50M$100M$150M2022 · Private raises (Form D): $118.0M2022
Figures by year
YearPrivate raises (Form D)Total
2022$118.0M$118.0M

Private raises

Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.

  1. Jun 1, 2022Raised $118 million in a private offering of equity23 Form D: 23 investors so far Form D

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Catalys Pacific, LLC7,903,838$213.2M92.9%No change
Ra Capital Management, L.P.7,692,750$207.6M1.8%No change
BlackRock, Inc.5,887,038$158.8M0.0%+1,405,456
Samsara Biocapital, LLC5,871,018$158.4M13.0%No change
Fmr LLC4,511,689$121.7M0.0%−349,415
State Street Corp4,141,636$111.7M0.0%+1,205,696
Deerfield Management Company, L.P.3,958,000$106.8M1.3%New
Vanguard Capital Management LLC2,756,770$74.4M0.0%+302,407
Laurion Capital Management LP2,506,152$67.6M5.1%+274,112
Orbimed Advisors LLC2,110,300$56.9M1.1%+57,400
Capital World Investors1,997,607$53.9M0.0%+1,599,428
Armistice Capital, LLC1,736,000$46.8M1.3%+560,000
Troluce Capital Advisors LLC1,728,753$46.6M17.5%+1,073,753
Nantahala Capital Management, LLC1,640,962$44.3M1.3%+745,481
Franklin Resources Inc1,635,520$44.1M0.0%−149,142
Andera Partners1,591,917$42.9M20.8%No change
Geode Capital Management, LLC1,584,326$42.8M0.0%+283,191
SR One Capital Management, LP1,563,966$42.2M4.1%No change
Bank Of America Corp /de/1,505,547$40.6M0.0%+405,175
Sphera Funds Management Ltd.1,469,971$39.7M5.7%+130,000
Goldman Sachs Group Inc1,458,676$39.4M0.0%+673,633
Pictet Asset Management Holding SA1,430,649$38.6M0.0%+396,211
Polar Capital Holdings Plc1,420,854$38.3M0.1%−79,895
Millennium Management LLC1,221,758$33.0M0.0%+696,498
Ghisallo Capital Management LLC1,125,000$30.4M0.7%New

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

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

  • Name on EDGARMineralys Therapeutics, Inc.1
  • CIK0001933414
  • Employer ID (EIN)84-19668873
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company3
  • Incorporated inDelaware3
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address150 N. Radnor Chester Road, Suite F200, Radnor, PA1
  • Phone(888) 378-62401
  • Shares outstanding88,406,885 as of Aug 3, 20268
  • Public float$676.0M as of Jun 30, 20253
  • AuditorErnst & Young LLP, Denver, Colorado PCAOB ID 42; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceJun 13, 20221
  • Filings400 in all: 4 (160), 144 (94), 8-K (46), 3 (16), 10-Q (11), 424B5 (6), SC 13G (5), SCHEDULE 13G/A (5)1
    All 37 form types

    10-K (4), S-8 (4), SCHEDULE 13D/A (4), ARS (3), CORRESP (3), DEF 14A (3), DEFA14A (3), SC 13G/A (3), UPLOAD (3), DRS/A (2), DRSLTR (2), EFFECT (2), SC 13D (2), SC 13D/A (2), SCHEDULE 13G (2), SEC STAFF LETTER (2), 144/A (1), 424B4 (1), 8-A12B (1), CERT (1), D (1), DRS (1), S-1 (1), S-1/A (1), S-1MEF (1), S-3 (1), S-3/A (1), S-3ASR (1), S-3MEF (1)

  • Latest filingsAnnual report (10-K) Mar 12, 2026
    Quarterly report (10-Q) Aug 11, 2026
    Proxy statement (DEF 14A) Apr 8, 2026
    Latest 8-K (8-K) Aug 11, 2026

Securities registered for trading

ClassSymbolExchange
0.0001MLYSThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Mar 12, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks Mineralys Therapeutics, Inc. names in Item 1A of its 10-K filed Mar 12, 2026: 73 risks under these headings, as written.3

  • 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 incur significant losses for the foreseeable future. We may never generate any revenue or become profitable or, if we achieve profitability, we may not be able to sustain it.
  • We will require substantial additional capital to finance our goals, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce, or terminate our development programs, commercialization efforts, or other operations.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations, or require us to relinquish rights to our technologies or product candidates.
  • Risks Related to the Development and Regulatory Approval of Our Product Candidates
  • We currently depend entirely on the success of lorundrostat, which is our only product candidate. If we are unable to obtain regulatory approval for, and ultimately commercialize, lorundrostat, or experience significant delays in doing so, our business will be materially harmed.
  • Clinical and preclinical development involves a lengthy and expensive process with uncertain timelines and outcomes, and results of prior clinical trials and studies of lorundrostat are not necessarily predictive of future results. Lorundrostat may not achieve favorable results in our ongoing or future nonclinical studies or clinical trials or receive regulatory approval on a timely basis, if at all.
  • Any difficulties or delays in the commencement or completion, or the termination or suspension, of our current or future clinical trials or preclinical studies could result in increased costs to us, delay or limit our ability to generate revenue, or adversely affect our commercial prospects.
  • We may find it difficult to enroll participants in our future clinical trials. If we encounter difficulties or delays enrolling participants in our future clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • Use of lorundrostat or any future product candidates could be associated with adverse side effects, adverse events, or other properties or safety risks, which could delay or preclude regulatory approval, cause us to suspend or discontinue clinical trials, abandon a product candidate, limit the commercial profile of an approved label, or result in other significant negative consequences that could severely harm our business, prospects, operating results, and financial condition.
  • We may not be successful in our efforts to investigate lorundrostat in additional indications. We may expend our limited resources to pursue, acquire, or license a new product candidate or a particular indication for lorundrostat and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • We are conducting and intend to conduct some of our clinical trials for lorundrostat outside of the United States. However, the FDA and other foreign equivalents may not accept data from such trials, in which case our development plans will be delayed, which could materially harm our business.
The other 62 risks
  • Interim, topline, and preliminary data from our clinical trials and preclinical studies that we announce or publish from time to time may change as more participant data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • Changes in methods of product candidate manufacturing or formulation may result in additional costs or delays.
  • Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns 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.
  • Risks Related to Our Reliance on Third Parties
  • We heavily rely on our exclusive Tanabe License with Tanabe to provide us with intellectual property rights to develop and commercialize lorundrostat. If the Tanabe License is terminated, we would lose our rights to develop and commercialize lorundrostat.
  • We rely on and intend to continue to rely on third parties to conduct, supervise, and monitor our clinical trials and preclinical studies. If these third parties do not successfully carry out their contractual duties, comply with applicable regulatory requirements, or meet expected deadlines, our development programs and our ability to seek or obtain regulatory approval for or commercialize lorundrostat and any future product candidates may be delayed or subject to increased costs, each of which may have an adverse effect on our business and prospects.
  • We currently rely on a third party for the manufacture of lorundrostat and expect to continue to rely on third parties for the foreseeable future. This reliance on third parties increases the risk that we will not have sufficient quantities of lorundrostat or such quantities at an acceptable cost, which could delay, prevent, or impair our development or potential commercialization efforts.
  • Our reliance on third parties requires us to share potential trade secrets, which increases the possibility that a competitor or other third party will discover them or that potential trade secrets will be misappropriated or disclosed.
  • We may seek to enter into collaborations, license agreements, and other similar arrangements and may not be successful in doing so, and even if we are, we may relinquish valuable rights and may not realize the benefits of such relationships, and our collaborations would be subject to other risks attendant to third party relationships, including inability to prevent or control actions taken or not taken by such third parties which may adversely impact us.
  • Risks Related to Commercialization of Lorundrostat and any Future Product Candidates
  • Even if we receive regulatory approval for lorundrostat or any future product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense. Additionally, lorundrostat and any future product candidates, if approved, 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 with our product candidates, when and if any of them are approved.
  • The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
  • The commercial success of lorundrostat or any future product candidates will depend upon the degree of market acceptance of such product candidates by healthcare providers, product recipients, healthcare payors, and others in the medical community. If lorundrostat or any future product candidates fail to achieve the broad degree of adoption by the medical community necessary for commercial success, our operating results and financial condition will be adversely affected, which may delay, prevent, or limit our ability to generate revenue and continue our business.
  • The successful commercialization of lorundrostat or any future product candidates, if approved, 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 significant competition, and if our competitors develop and commercialize technologies or product candidates more rapidly than we do, or their technologies or product candidates are more effective, safer, or less expensive than lorundrostat and any future product candidates we develop, our business and our ability to develop and successfully commercialize products will be adversely affected.
  • We currently have a limited marketing and sales organization and have no experience as a company in commercializing products, and we may need to invest significant resources to develop these capabilities. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our products, we may not be able to generate product revenue.
  • If the market opportunities for lorundrostat and any future product candidates are smaller than we believe they are, our revenue may be adversely affected, and our business may suffer.
  • 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 Business Operations and Industry
  • 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 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 will need to develop and expand our organization, and we may encounter difficulties in managing our growth and expanding our operations successfully, which could disrupt our operations.
  • We are subject to various U.S. federal, state, and foreign healthcare laws and regulations, which could increase compliance costs, and our failure to comply with these laws and regulations could harm our results of operations and financial condition.
  • Recently enacted legislation, future legislation, and healthcare reform measures may increase the difficulty and cost for us to obtain marketing approval for and commercialize lorundrostat and any future product candidates and may affect the prices we may set.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit, delay, or cease commercialization of our products.
  • Our insurance policies are expensive and only protect us from some business risks, which will leave us exposed to significant uninsured liabilities.
  • 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.
  • We and our service providers may be subject to a variety of privacy and data security laws and contractual obligations, which could increase compliance costs, and our actual or perceived failure to comply with such laws and obligations could subject us to potentially significant liability, fines, or penalties and otherwise harm our business.
  • Our internal information technology systems, or those of any of our service providers, may fail or suffer security breaches, loss or leakage of data, and other disruptions, which could result in a material disruption of our product development programs, compromise sensitive information related to our business or prevent us from accessing critical information, potentially exposing us to liability or otherwise adversely affecting our business.
  • Our business could be affected by litigation, government investigations, and enforcement actions.
  • Our employees and independent contractors, including principal investigators, CROs, consultants, and vendors, may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading, which could harm our business, financial condition, and results of operations.
  • We may engage in strategic transactions that could increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities, subject us to other risks, adversely affect our liquidity, increase our expenses, and present significant distractions to our management.
  • Our ability to use net operating loss carryforwards and other tax attributes may be limited.
  • Changes in trade policy and inflation could adversely affect our business and results of operations.
  • Risks Related to Our Intellectual Property
  • If we are unable to obtain, maintain, and enforce patent or other intellectual property protection for lorundrostat or any future product candidates or technology, or if the scope of the patent or other intellectual property protection obtained is not sufficiently broad, our competitors or other third parties could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize lorundrostat or any future product candidates may be adversely affected.
  • We may not be able to protect our intellectual property and proprietary rights throughout the world.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • Changes in patent laws or their interpretations could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • Issued patents covering our product candidates could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad.
  • We cannot ensure that patent rights relating to inventions described and claimed in our pending patent applications will issue or that patents based on our patent applications will not be challenged and rendered invalid and/or unenforceable.
  • Patent terms may be inadequate to protect the competitive position of our product candidates for an adequate amount of time.
  • If we do not obtain patent term extension and equivalent extensions outside of the United States for our product candidates, our business may be materially harmed.
  • We may be subject to claims challenging the inventorship of our patents and other intellectual property.
  • If we are unable to protect the confidentiality of any potential trade secrets, our business and competitive position would be harmed.
  • We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope, or expiration of a third-party patent, which might adversely affect our ability to develop and market our products and product candidates.
  • We may be subject to claims asserting that our employees, consultants, or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property.
  • Third-party claims of intellectual property infringement, misappropriation, or other violations against us or our collaborators could be expensive and time-consuming and may prevent or delay the development and commercialization of our product candidates.
  • We may become involved in lawsuits to protect or enforce our patent and other intellectual property rights, which could be expensive, time-consuming, and unsuccessful.
  • 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.
  • Intellectual property rights do not necessarily address all potential threats.
  • We partially depend on intellectual property licensed from third parties, and our licensors may not always act in our best interest. If we fail to comply with our obligations under our intellectual property licenses, if the licenses are terminated, or if disputes regarding these licenses arise, we could lose significant rights that are important to our business.
  • We may not be successful in obtaining or maintaining necessary rights to product components and processes for our development pipeline through acquisitions and in-licenses.
  • Our intellectual property licensed from third parties may be subject to retained rights.
  • Risks Related to Our Common Stock
  • 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, will have the ability to significantly influence all matters submitted to stockholders for approval and may prevent new investors from influencing significant corporate decisions.
  • We are an emerging growth company and a smaller reporting company, and the reduced disclosure requirements applicable to emerging growth companies and smaller reporting companies may make our common stock less attractive to investors.
  • 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 provides 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 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.
  • General Risk Factors
  • 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 could face criminal liability and other serious consequences for violations, which could harm our business.
  • Our third-party manufacturers or 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.
  • Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
  • Unstable market and economic conditions may have serious adverse consequences on our business, financial condition, and stock price.
  • Changes in tax laws or in their implementation or interpretation may materially adversely affect our financial condition, results of operations, and cash flows, or adversely impact the value of an investment in our common stock.
  • If we fail to maintain proper and effective internal control over financial reporting, our ability to produce accurate and timely financial statements could be impaired, investors may lose confidence in our financial reporting, and the trading price of our common stock may decline.
  • We could be subject to securities class action litigation.

Legal proceedings

We are not currently a party to any material proceeding. From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. Regardless of outcome, litigation can have an adverse impact on us due to defense and settlement costs, diversion of management resources, negative publicity, reputational harm, and other factors.

The opening of Item 3, Legal Proceedings.3

Sources

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