Sign in

OKUR on Nasdaq

OnKure Therapeutics, Inc.

American pharmaceutical preparations company based in Boulder1

In its 2026 annual report the company says: “OnKure Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the discovery and development of precision medicines that target biologically validated drivers of cancers and other diseases that are underserved by available therapies.”3 Its shares trade on Nasdaq under the symbol OKUR.1

Price unavailable

Last updated Oct 21, 2026.

Overview

Compare with another stock.

  • TickerOKUR on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersBoulder, Colorado1
  • Incorporated inDE2
  • Business address6707 Winchester Circle, Suite 400, Boulder, Co 803012
  • Filer category, Emerging growth company2
  • Legal formCorporation

See how the biggest companies compare on our leaderboards

OnKure Therapeutics, Inc. (“OnKure”, “we”, “us” or the “Company”) is a clinical-stage biopharmaceutical company focused on the discovery and development of precision medicines that target biologically validated drivers of cancers and other diseases that are underserved by available therapies. Using a structure-based drug design platform, we are committed to improving clinical outcomes for patients by building a pipeline of small molecule drugs designed to achieve optimal efficacy and tolerability by selectively targeting specific mutations shown to be key drivers of cancer and other diseases. By selectively sparing the wild-type enzyme and preferentially targeting the mutated form of the protein, which is oncogenic and drives disease processes in both cancer and vascular overgrowth syndromes, we aim to discover and develop drugs with improved safety and efficacy by sparing toxicity that …3 From its latest annual report

Financials

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

Key numbers, fiscal 2024

-50.7%Return on equity4
-$51.2MFree cash flow4

Financial statements

Operating income67854-$54.4M in 2024+178% since 2020
-$60.0M-$40.0M-$20.0M02020: -$19.6M-$19.6M20202021: -$39.8M-$39.8M2021+104%2022: -$53.8M-$53.8M2022+35%2023: -$36.9M-$36.9M2023−31%2024: -$54.4M-$54.4M2024+47%
Net income67854-$52.7M in 2024+171% since 2020
-$60.0M-$40.0M-$20.0M02020: -$19.5M-$19.5M20202021: -$39.8M-$39.8M2021+104%2022: -$52.0M-$52.0M2022+31%2023: -$35.3M-$35.3M2023−32%2024: -$52.7M-$52.7M2024+49%

Every line of the income statement as filed: the last 2 fiscal years, latest first.4

Period ending2025-12-312024-12-31
Research and development$48.3M$43.8M
General and administrative$14.7M$10.6M
Total operating expenses$63.0M$54.4M
Loss from operations-$63.0M-$54.4M
Interest income$3.4M$2.0M
Interest and other expense-$8.0K-$300.0K
Total other income (expense)$3.4M$1.7M
Net loss and comprehensive loss-$59.5M-$52.7M
Net loss per share attributable to common stockholders: Basic-$4.40-$15.28
Net loss per share attributable to common stockholders: diluted-$4.40-$15.28
Weighted average shares outstanding: Basic13.5M shares3.4M shares
Weighted average shares outstanding: diluted13.5M shares3.4M shares

Compare OnKure Therapeutics, Inc. with another company

Corporate structure

OnKure Therapeutics, Inc. 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 OnKure Therapeutics, Inc.

  • OnKure Therapeutics, Inc. Boulder, Colorado

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

What it owns

What OnKure 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, before depreciation$2.1M4 Dec 31, 2025$2.1M4 Dec 31, 2024−3.0%
Accumulated depreciation$1.5M4 Dec 31, 2025$1.1M4 Dec 31, 2024+30.6%
Property and equipment, net$618.0K4 Dec 31, 2025$1.0M4 Dec 31, 2024−39.7%
Operating-lease assets (leased space)$387.0K4 Dec 31, 2025$770.0K4 Dec 31, 2024−49.7%

Real estate and locations

ItemLatestA year beforeChange
Area of real estate14,790 sq ft4 Dec 31, 202514,790 sq ft5 Dec 31, 20240%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$59.0M4 Dec 31, 2025$110.8M4 Dec 31, 2024−46.7%
Debt securities available for sale$04 Dec 31, 2025$04 Dec 31, 2024

Properties, in its own words

We lease approximately 14,790 square feet of office space for our headquarters in Boulder, Colorado, and consists of office and laboratory space pursuant to a lease that expires in December 2026. In the Merger, we assumed the lease of approximately 5,100 square feet of office space for the former Reneo headquarters in Irvine, California under a non-cancelable operating lease through November 2026. In January 2025, we subleased this space for the remaining duration of the lease. We believe that our existing facilities are adequate to meet our current needs.

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

Leadership

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

Chief executive

  1. Gregory J. Flesher2021–2022
  2. Nicholas A. Saccomano2024–now

Chair

  1. Michael G. Grey2021–2023

President

  1. Gregory J. Flesher2021–2022
  2. Nicholas A. Saccomano2024–now

Chief financial officer

  1. Vineet R. Jindal2021
  2. Jason A. Leverone2024–now

Chief operating officer

  1. Michael Cruse2022
2025
Board members and other officers (24)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • DirectorR. Michael Carruthers named Oct 21, 202440

Former names

  • Reneo Pharmaceuticals, Inc.Jan 8, 2018 to Oct 2, 20242

Timeline

  1. Aug 13, 20268-K Executive or director change41
  2. Aug 4, 20268-K Results of operations42
  3. Jun 4, 20268-K Executive or director change; Shareholder vote43
  4. May 5, 20268-K Results of operations44
  5. Mar 30, 20268-K Entered a material agreement; Unregistered sale of shares; Executive or director change45
  6. Mar 12, 20268-K Results of operations46
  7. Nov 6, 20258-K Results of operations47
  8. Nov 6, 20258-K Entered a material agreement48
  9. Aug 12, 20258-K Results of operations49
  10. Jun 26, 20258-K Regulation FD disclosure50
  11. May 28, 20258-K Shareholder vote51
  12. May 6, 20258-K Results of operations52
  13. Oct 8, 2024New chief executive Nicholas A. Saccomano becomes CEO12
  14. Apr 8, 2021New chief executive Gregory J. Flesher becomes CEO13

Calendar

Coming up

  1. Nov 5, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($1.09) a share, on Nov 6, 2025.53

When it reported results

  1. Aug 4, 2026Reported quarterly or annual results42
  2. May 5, 2026Reported quarterly or annual results44
  3. Mar 12, 2026Reported quarterly or annual results46
  4. Nov 6, 2025Reported quarterly or annual results47
  5. Aug 12, 2025Reported quarterly or annual results49
  6. May 6, 2025Reported quarterly or annual results52
  7. Mar 10, 2025Reported quarterly or annual results54
  8. Aug 13, 2024Reported quarterly or annual results55

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

Filings

330 filings to the SEC since October 2021: 6 annual reports, 15 quarterly reports, 49 major events, 127 insider forms, 58 large holders, 1 private raises, 74 other. The latest 20:

  1. Oct 7, 2026SCHEDULE 13G EDGAR
  2. Sep 23, 20264 EDGAR
  3. Sep 23, 20264 EDGAR
  4. Aug 14, 2026SCHEDULE 13G/A EDGAR
  5. Aug 14, 2026SCHEDULE 13G/A EDGAR
  6. Aug 14, 2026SCHEDULE 13G/A EDGAR
  7. Aug 13, 20264/A EDGAR
  8. Aug 13, 20268-K EDGAR
  9. Aug 11, 20264 EDGAR
  10. Aug 11, 20264 EDGAR
  11. Aug 11, 20264 EDGAR
  12. Aug 11, 20264 EDGAR
  13. Aug 11, 20264 EDGAR
  14. Aug 11, 20264 EDGAR
  15. Aug 11, 20264 EDGAR
  16. Aug 11, 20264 EDGAR
  17. Aug 11, 20264 EDGAR
  18. Aug 11, 20264 EDGAR
  19. Aug 11, 20264 EDGAR
  20. Aug 10, 2026SCHEDULE 13G/A EDGAR

The 330 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

36 open-market trades by officers, directors and large owners since October 2021: 16 buys and 20 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 21, 2026Leverone Jason A.Chief Financial OfficerSale302$2.97$897Form 4
Sep 21, 2026Saccomano Nicholas APresident and CEOSale87$2.97$258Form 4
Jun 22, 2026Leverone Jason A.Chief Financial OfficerSale303$4.40$1.3KForm 4
Jun 22, 2026Saccomano Nicholas APresident and CEOSale86$4.40$378Form 4
Mar 23, 2026Leverone Jason A.Chief Financial OfficerSale301$4.16$1.3KForm 4
Mar 23, 2026Saccomano Nicholas APresident and CEOSale86$4.16$358Form 4
Dec 22, 2025Leverone Jason A.Chief Financial OfficerSale302$2.97$897Form 4
Dec 22, 2025Saccomano Nicholas APresident and CEOSale87$2.97$258Form 4
Sep 22, 2025Leverone Jason A.Chief Financial OfficerSale303$2.62$794Form 4
Sep 22, 2025Saccomano Nicholas APresident and CEOSale88$2.62$231Form 4
Jun 23, 2025Saccomano Nicholas APresident and CEOSale88$2.38$209Form 4
Jun 23, 2025Leverone Jason A.Chief Financial OfficerSale303$2.38$721Form 4
May 15, 2025ACORN CAPITAL ADVISORS GP, LLC10% ownerBuy1,400,000$1.85$2.6MForm 4
May 15, 2025Cormorant Private Healthcare Fund III LPSale1,813,439$1.85$3.4MForm 4
May 12, 2025Cormorant Global Healthcare Master Fund, LPSale24,300$1.99$48.4KForm 4
Apr 7, 2025Saccomano Nicholas APresident and CEOSale516$2.67$1.4KForm 4
Apr 7, 2025Leverone Jason A.Chief Financial OfficerSale1,844$2.67$4.9KForm 4
Apr 4, 2025Saccomano Nicholas APresident and CEOSale358$3.33$1.2KForm 4
Apr 4, 2025Leverone Jason A.Chief Financial OfficerSale1,278$3.33$4.3KForm 4
Sep 25, 2024Leonard Braden MichaelBuy68,746$1.50$103.1KForm 4

All 36 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
2025Nicholas A. Saccomano, Ph.D.President and Chief Executive Officer67$600.0K$1.5M83
2025Jason Leverone, C.P.A.Chief Financial Officer52$444.0K$896.2K83
2025Samuel Agresta, M.D.Chief Medical Officer53$482.0K$851.7K83
2024Nicholas A. Saccomano, Ph.D.President and Chief Executive Officer67$462.1K$9.5M83
2024Samuel Agresta, M.D.Chief Medical Officer53$416.7K$2.8M83
2024Jason Leverone, C.P.A.Chief Financial Officer52$383.0K$2.7M83

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$65.0M 2024–2024
Money received by yearMoney received by year, 2024–2024: $65.0M in all. Private raises (Form D) $65.0M.$0$20M$40M$60M$80M2024 · Private raises (Form D): $65.0M2024
Figures by year
YearPrivate raises (Form D)Total
2024$65.0M$65.0M

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. Oct 4, 2024Raised $65 million in a private offering of equity40 Form D: 20 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 75. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Ra Capital Management, L.P.3,998,333$18.2M0.2%No change
Bvf Inc/il3,235,778$14.8M0.4%+1,256,806
Acorn Capital Advisors, LLC2,839,674$12.9M3.5%No change
StepStone Group LP2,660,612$12.1M0.6%No change
ADAR1 Capital Management, LLC2,238,684$10.2M0.5%−196,257
Vivo Capital, LLC1,927,710$8.8M0.8%No change
Vestal Point Capital, LP1,825,699$8.3M0.2%−14,120
BlackRock, Inc.1,499,845$6.8M0.0%+1,450,258
Trails Edge Capital Partners, LP1,438,456$6.6M1.0%New
Vanguard Capital Management LLC1,437,039$6.6M0.0%+854,562
Adage Capital Partners Gp, L.l.c.1,204,819$5.5M0.0%No change
Citadel Advisors LLC1,187,047$5.4M0.0%+1,149,460
Sio Capital Management, LLC1,078,965$4.9M0.8%No change
Prosight Management, LP978,992$4.5M0.8%−1,175,389
Logos Global Management LP963,855$4.4M0.2%New
Geode Capital Management, LLC724,438$3.3M0.0%+625,688
NEA Management Company, LLC478,548$2.2M0.1%No change
State Street Corp463,662$2.1M0.0%+450,200
Ensign Peak Advisors, Inc431,631$2.0M0.0%New
Renaissance Technologies LLC358,738$1.6M0.0%−18,512
Sofinnova Investments, Inc.321,692$1.5M0.1%+179,992
Carlyle Group Inc.269,895$1.2M0.0%No change
Affinity Asset Advisors, LLC240,963$1.1M0.1%No change
Dv Equities, LLC240,963$1.1M0.2%New
Seven Fleet Capital Management LP240,963$1.1M0.2%New

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

SEC filer profile

How OnKure 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 EDGAROnKure Therapeutics, Inc.1
  • CIK0001637715
  • Employer ID (EIN)47-23095153
  • 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 address6707 Winchester Circle, Suite 400, Boulder, CO 803011
  • Phone(720) 307-28921
  • Shares outstanding40,496,309 as of Aug 3, 202611
  • Public float$28.0M as of Jun 30, 20253
  • AuditorKPMG LLP, Denver, CO PCAOB ID 185; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceJan 8, 20181
  • Filings402 in all: 4 (133), 8-K (54), 3 (35), 10-Q (17), SCHEDULE 13G/A (14), SCHEDULE 13G (12), 424B3 (11), CORRESP (11)1
    All 39 form types

    SC 13G (11), SC 13D/A (10), EFFECT (9), S-8 (8), UPLOAD (8), SC 13G/A (6), 10-K (5), S-3 (5), SC 13D (5), 424B5 (4), 425 (4), D (4), DEF 14A (4), DEFA14A (4), ARS (3), S-4/A (3), 144 (2), 4/A (2), POS AM (2), S-1 (2), SCHEDULE 13D (2), SCHEDULE 13D/A (2), SEC STAFF LETTER (2), 10-K/A (1), 3/A (1), 424B4 (1), 8-A12B (1), CERT (1), DRS (1), S-1/A (1), S-4 (1)

  • Latest filingsAnnual report (10-K) Mar 12, 2026
    Quarterly report (10-Q) Aug 4, 2026
    Proxy statement (DEF 14A) Apr 21, 2026
    Latest 8-K (8-K) Aug 13, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.0001 Par Value per ShareOKURThe 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 OnKure Therapeutics, Inc. names in Item 1A of its 10-K filed Mar 12, 2026: 72 risks under these headings, as written.3

  • Risks Related to Our Operating History, Financial Position and Need for Additional Capital
  • We are early in our development efforts and have no products approved for commercial sale, which may make it difficult for you to evaluate our current business and likelihood of success and future viability.
  • Our management has concluded that due to our need for additional capital, and the uncertainties surrounding our ability to raise such funding, substantial doubt exists as to our ability to continue as a going concern.
  • We have incurred significant net losses in each period since inception, and we expect to continue to incur significant net losses for the foreseeable future.
  • We have never generated revenue from product sales and may never achieve or maintain profitability.
  • We will need substantial additional funding before we can complete the development of our product candidates. If we are unable to obtain such additional capital on favorable terms, on a timely basis or at all, we would be forced to delay, reduce or eliminate our product development and clinical programs and may not have the capital required to otherwise operate our business.
  • Risks Related to Our Development and Commercialization of Our Product Candidates
  • We are substantially dependent on OKI-219. If we are unable to advance OKI-219 through clinical development, obtain regulatory approval and ultimately commercialize such product candidate, or experience significant delays in doing so, our business will be materially harmed.
  • We have limited resources and are currently focusing our efforts on OKI-219 for development in particular indications and advancing our other preclinical and discovery research programs. As a result, we may fail to capitalize on programs, product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • If clinical trials of our product candidates fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities or do not otherwise produce positive results, we would incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
  • The regulatory approval processes of the FDA, EMA and other comparable foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable. If we are ultimately unable to obtain regulatory approval of our product candidates, we will be unable to generate product revenue and our business will be substantially harmed.
  • Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.
The other 62 risks
  • If we experience delays or difficulties in the enrollment or retention of subjects in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.
  • Our product candidates may cause significant adverse events, toxicities or other undesirable side effects when used alone or in combination with other approved products or investigational new drugs that may result in a safety profile that could prevent regulatory approval, prevent market acceptance, limit their commercial potential, or result in significant negative consequences.
  • The outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and the results of our clinical trials may not satisfy the requirements of the FDA, EMA, or other comparable foreign regulatory authorities.
  • Interim, initial, “top-line,” and preliminary data from clinical trials that we announce or publish from time to time may change as more patient 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 delay.
  • We may develop programs in combination with other therapies, which exposes us to additional risks.
  • We face substantial competition which may result in others discovering, developing, or commercializing products before or more successfully than we do.
  • Even if OKI-219 or any other product candidate receives marketing approval, they may fail to achieve market acceptance among physicians, patients, third-party payors, and others in the medical community.
  • If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and market our product candidates on acceptable terms, we may be unable to successfully commercialize our product candidates that obtain regulatory approval.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our products, if approved.
  • Any product candidates we develop may become subject to unfavorable third-party coverage and reimbursement practices, as well as pricing regulations.
  • A variety of risks associated with marketing our product candidates internationally could materially adversely affect our business.
  • Increased tariffs on imports, including tariffs imposed by the United States and China, trade sanctions, other trade restrictions, or a global trade war could increase our costs and materially and adversely affect our business operations and financial condition.
  • Risks Related to Our Intellectual Property
  • If we are unable to obtain and maintain sufficient intellectual property protection for our technology and products and product candidates we may develop, or if the scope of the 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 develop and, if approved, commercialize our product candidates may be adversely affected.
  • Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements.
  • 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.
  • We may become involved in third-party claims of intellectual property infringement, which may delay or prevent the development and commercialization of OKI-219 and any future product candidate.
  • We may become involved in lawsuits to protect or enforce our patents or other intellectual property rights, or the patents or other intellectual property rights of any licensors, which could be expensive, time-consuming, and unsuccessful.
  • Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties.
  • Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • We may not be able to protect our intellectual property rights throughout the world, which could impair our business.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • We may become subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of their former employers or other third parties or claims asserting ownership of what we regard as our own intellectual property.
  • If our future 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.
  • Our intellectual property rights do not necessarily address all potential threats to our competitive advantage.
  • Any collaboration or partnership arrangements that we may enter into in the future may not be successful, which could adversely affect our ability to develop and commercialize our products.
  • If we fail to comply with our obligations under any license, collaboration or other agreement, such agreements may be terminated, we may be required to pay damages and could lose intellectual property rights that are necessary for developing and protecting our product candidates.
  • We may not be able to license or acquire new or necessary intellectual property rights or technology from third parties.
  • Risks Related to Our Regulatory Approval and Other Legal Compliance Matters
  • Even if we receive regulatory approval of our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory oversight, which may result in significant additional expense, and we may experience unanticipated problems with our product candidates or be subject to penalties if we fail to comply with regulatory requirements.
  • Disruptions at the FDA, the SEC or other government agencies caused by funding shortages, global health concerns, government shutdown, or a lapse of U.S. government appropriations could hinder their ability to hire and retain 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, or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • We may face difficulties from changes to current regulations and future legislation. Healthcare legislative measures aimed at reducing healthcare costs may have a material adverse effect on our business and results of operations.
  • We may be subject to federal and state healthcare fraud and abuse laws, false claims laws, transparency laws and health information privacy and security laws, which could expose us to, among other things, criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens, and diminished profits and future earnings.
  • Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
  • We are subject to certain U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions and other trade laws and regulations and can face serious consequences for violations.
  • Restrictive laws and regulations govern the collection, use, transfer, and other processing of personal information.
  • Risks Related to Our Reliance on Third Parties
  • We rely, and expect to continue to rely, on third parties, including independent clinical investigators and CROs, to conduct, supervise and monitor certain aspects of our clinical trials and preclinical studies. If these third parties do not successfully carry out their contractual duties, comply with applicable regulatory requirements and meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our product candidates, or such approval or commercialization may be delayed, and our business could be substantially harmed.
  • We contract with third parties for the manufacture of our product candidates for preclinical studies and clinical trials, and expect to continue to do so for additional clinical trials and ultimately for commercialization. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
  • The manufacture of drugs is complex, and our third-party manufacturers may encounter difficulties in production. If any of our third-party manufacturers encounters such difficulties, our ability to provide adequate supply of our product candidates for clinical trials or our products for patients, if approved, could be delayed or prevented.
  • Risks Related to Our Business Operations
  • Our success is highly dependent on our ability to attract and retain highly skilled executive officers and employees.
  • If we engage in acquisitions, in-licensing or strategic partnerships, this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities, and subject us to other risks.
  • Our internal computer systems, or those of any of our CROs, manufacturers, other contractors or consultants, or potential future collaborators, may fail or suffer actual or suspected security or privacy breaches or incidents or other unauthorized or improper access to, use of, or destruction of our proprietary or confidential data, employee data, or personal data, which could result in additional costs, significant liabilities, harm to our brand and material disruption of our operations, and potentially significant delays in our delivery to market.
  • Risks Related to Ownership of Our Class A Common Stock
  • The market price of our Class A Common Stock has been and is expected to continue to be volatile.
  • We expect to incur losses for the foreseeable future and might never achieve profitability.
  • If we fail to attract and retain management and other key personnel, we may be unable to continue to successfully develop or commercialize our product candidates or otherwise implement our business plan.
  • We will incur additional costs and increased demands upon management as a result of complying with the laws and regulations affecting public companies.
  • We will continue to be an emerging growth company and a smaller reporting company, and it cannot be certain if the reduced reporting requirements applicable to emerging growth companies and smaller reporting companies will make our Class A Common Stock less attractive to investors.
  • If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired.
  • Our Amended and Restated Certificate of Incorporation and our Amended and Restated Bylaws and provisions of Delaware law could make acquiring us more difficult and may prevent attempts by our stockholders to replace or remove our management.
  • Our Amended Bylaws provide that, unless we consent in writing to the selection of an alternative forum, certain designated courts will be the sole and exclusive forum for certain legal actions between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, employees or agents.
  • Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us.
  • We do not anticipate that we will pay any cash dividends in the foreseeable future.
  • A robust trading market for our Class A Common Stock may not develop, and the holders of our Class A Common Stock may not be able to resell their shares of our Class A Common Stock for a profit, if at all.
  • We could be subject to securities class action litigation, which is expensive and could divert management attention.
  • Reneo’s winddown of its historical operations, the suspension of development activities and the Merger, resulting in the conversion of Legacy OnKure into a public company, made us subject to the SEC requirements applicable to reporting shell company business combinations. As a result, we are subject to more stringent reporting requirements, offering limitations and resale restrictions than some other companies.
  • Future sales of shares by existing stockholders could cause our Class A Common Stock price to decline.
  • Our executive officers, directors and principal stockholders have the ability to control or significantly influence all matters submitted to our stockholders for approval.
  • If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, the stock price and trading volume of our Class A Common Stock could decline.
  • We may be subject to adverse legislative or regulatory tax changes that could negatively impact our financial condition.
  • Our ability to use net operating loss carryforwards and other tax attributes may be limited, including as a result of the Merger.
  • Unfavorable global economic conditions could adversely affect our business, financial condition, results of operations or cash flows.

Legal proceedings

From time to time, we may become involved in legal proceedings relating to claims arising from the ordinary course of business. Information pertaining to legal proceedings is described in Item 8, “Financial Statements and Supplementary Data - Note 13: Commitments and Contingencies,” and incorporated by reference herein.

The opening of Item 3, Legal Proceedings.3

Sources

The numbers on this page point here. Each one links to the record it came from.

  1. 1
  2. 2
  3. 3
  4. 4
  5. 5
  6. 6
  7. 7
  8. 8
  9. 9
  10. 10
  11. 11
  12. 12
  13. 13
  14. 14
  15. 15
  16. 16
  17. 17
  18. 18
  19. 19
  20. 20
  21. 21
  22. 22
  23. 23
  24. 24
  25. 25
  26. 26
  27. 27
  28. 28
  29. 29
  30. 30
  31. 31
  32. 32
  33. 33
  34. 34
  35. 35
  36. 36
  37. 37
  38. 38
  39. 39
  40. 40
  41. 41
  42. 42
  43. 43
  44. 44
  45. 45
  46. 46
  47. 47
  48. 48
  49. 49
  50. 50
  51. 51
  52. 52
  53. 53
  54. 54
  55. 55
  56. 56
  57. 57
  58. 58
  59. 59
  60. 60
  61. 61
  62. 62
  63. 63
  64. 64
  65. 65
  66. 66
  67. 67
  68. 68
  69. 69
  70. 70
  71. 71
  72. 72
  73. 73
  74. 74
  75. 75
  76. 76
  77. 77
  78. 78
  79. 79
  80. 80
  81. 81
  82. 82
  83. 83