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ORKA on Nasdaq

Oruka Therapeutics, Inc.

Oruka Therapeutics, Inc. is an American pharmaceutical preparations company based in Westminster.2 Its shares trade on Nasdaq under the symbol ORKA.2

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Last updated Oct 21, 2026.

Overview

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  • TickerORKA on Nasdaq2
  • IndustryPharmaceutical Preparations2
  • HeadquartersWestminster, United States2
  • Incorporated inDE3
  • Business address855 Oak Grove Ave., Suite 100, Menlo Park, Ca 940253
  • Filer categoryNon-accelerated filer, Smaller reporting company3
  • Legal formCorporation2
  • LEI529900TG7O4ESUDMGI542
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressc/o THE CORPORATION TRUST COMPANY, CORPORATION TRUST CENTER 1209 ORANGE ST, 19801 Wilmington, United States2
  • Registered withDivision of Corporations, Department of State, 37779162

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PsO and will evaluate three dose levels of ORKA-001: 37.5 mg at Week 0, 300 mg at Weeks 0 and 4, and 600 mg at Weeks 0 and 4, versus placebo.5 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 2023

-14.4%Return on equity6
-$5.0MFree cash flow6

Financial statements

Revenue789106$0 in 2023
02019: $0$020192020: $0$020202021: $0$020212022: $0$020222023: $0$02023
Operating income89106-$7.3M in 2023+25% since 2019
-$20.0M-$15.0M-$10.0M-$5.0M02019: -$5.8M-$5.8M20192020: -$9.8M-$9.8M2020+68%2021: -$19.3M-$19.3M2021+98%2022: -$10.6M-$10.6M2022−45%2023: -$7.3M-$7.3M2023−31%
Net income89106-$5.3M in 2023−3% since 2019
-$20.0M-$15.0M-$10.0M-$5.0M02019: -$5.5M-$5.5M20192020: -$9.7M-$9.7M2020+78%2021: -$19.3M-$19.3M2021+98%2022: -$9.9M-$9.9M2022−49%2023: -$5.3M-$5.3M2023−46%

Every line of the income statement as filed: the last 2 fiscal years, latest first.13

Period ending2025-12-312024-12-31
Research and development$100.6M$75.1M
General and administrative$21.4M$13.1M
Total operating expenses$122.1M$88.1M
Loss from operations-$122.1M-$88.1M
Interest income$16.6M$5.9M
Interest expense-$1.5M
Other income (expense), net-$12.0K$4.0K
Total other income, net$16.6M$4.4M
Net loss-$105.4M-$83.7M

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Corporate structure

Oruka Therapeutics, Inc. sits at the top of its group. 2 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Oruka Therapeutics, Inc.

  • Oruka Therapeutics, Inc. Westminster, Colorado, United States
    • Oruka Therapeutics Operating Company, LLC Subsidiary · Delaware, United States

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Oruka 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$288.0K13 Dec 31, 2025$162.0K13 Dec 31, 2024+77.8%
Operating-lease assets (leased space)$1.8M13 Dec 31, 2025$876.0K13 Dec 31, 2024+108.9%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$46.9M13 Dec 31, 2025$61.6M13 Dec 31, 2024−23.8%
Marketable securities, current$290.1M13 Dec 31, 2025$314.1M13 Dec 31, 2024−7.6%
Marketable securities, non-current$142.5M13 Dec 31, 2025$18.1M13 Dec 31, 2024+688.9%
Debt securities available for sale$477.4M13 Dec 31, 2025$384.3M13 Dec 31, 2024+24.2%

Properties, in its own words

Our corporate headquarters are in Menlo Park, California and we have an additional office in Waltham, Massachusetts. Our lease for our Menlo Park headquarters expires on September 30, 2027 and our lease for our Waltham office expires on September 30, 2029. We believe our current facilities are sufficient for our needs for the foreseeable future.

Item 2 of the 10-K filed Mar 12, 2026.5

Leadership

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

Chief executive

  1. Richard B. Brewer2009
  2. Michael R. Bristow2009–2021
  3. Lawrence Otto Klein2024–now

President

  1. Ted W. Love2006
  2. Richard B. Brewer2009
  3. Michael R. Bristow2009–2015
  4. Lawrence Otto Klein2024

Chief financial officer

  1. Henry Ward Wolff2006–2007
  2. E. Lee Bendekgey2008–2009
  3. Kathryn E. Falberg2009
  4. Patrick M. Wheeler2009–2014
  5. C. Jeffrey Dekker2021–2022

Chief operating officer

  1. Kathryn E. Falberg2009
  2. Thomas A. Keuer2014–2022
  3. Laura Lee Sandler2025–now
2010201520202025
Board members and other officers (37)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Oruka Therapeutics Operating Company, LLC Delaware4

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Former names

  • ARCA biopharma, Inc.Jan 28, 2009 to Aug 30, 20243
  • NUVELO INCFeb 4, 2003 to Jan 27, 20093
  • HYSEQ INCJul 17, 1997 to Jan 28, 20033

Timeline

  1. Aug 24, 20268-K Executive or director change57
  2. Aug 10, 20268-K Results of operations58
  3. Jun 4, 20268-K Shareholder vote59
  4. Jun 1, 20268-K Other events60
  5. Apr 30, 20268-K Results of operations; Other events61
  6. Apr 27, 20268-K Regulation FD disclosure; Other events62
  7. Dec 11, 20258-K Executive or director change63
  8. Sep 22, 20258-K Entered a material agreement; Unregistered sale of shares; Regulation FD disclosure64
  9. Jul 1, 20258-K Executive or director change65
  10. Jun 3, 20258-K Shareholder vote66
  11. Feb 5, 20258-K Entered a material agreement67
  12. Dec 19, 20248-K Entered a material agreement68
  13. Sep 6, 2024New chief executive Lawrence Otto Klein becomes CEO14
  14. Oct 15, 2009New chief executive Michael R. Bristow becomes CEO16
  15. Feb 5, 2009New chief executive Richard B. Brewer becomes CEO15

Calendar

Coming up

  1. Nov 11, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.55) a share, on Nov 12, 2025.69

When it reported results

  1. Aug 10, 2026Reported quarterly or annual results58
  2. Apr 30, 2026Reported quarterly or annual results61
  3. Sep 5, 2024Reported quarterly or annual results70
  4. Aug 1, 2024Reported quarterly or annual results71
  5. Apr 25, 2024Reported quarterly or annual results72
  6. Feb 1, 2024Reported quarterly or annual results73
  7. Oct 18, 2023Reported quarterly or annual results74
  8. Jul 21, 2023Reported quarterly or annual results75

Drug trials and FDA: coming up

  1. Jun 2027Phase 2 trial readout expected Phase 2 trial of ORKA-001 in Plaque Psoriasis: primary completion expected Jun 2027 (ClinicalTrials.gov NCT07290569).76
  2. Oct 2027Phase 2 trial readout expected Phase 2 trial of ORKA-002 in Plaque Psoriasis: primary completion expected Oct 2027 (ClinicalTrials.gov NCT07474792).77

Drug trials and FDA: recently

  1. Mar 25, 2026Phase 2 trial completed Phase 2 trial of ORKA-001 Induction Dose and ORKA-001 Maintenance Dose in Plaque Psoriasis: primary completion Mar 25, 2026, no results posted yet (ClinicalTrials.gov NCT07090330).78

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

333 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 53 major events, 127 insider forms, 48 large holders, 85 other. The latest 20:

  1. Oct 15, 2026144 EDGAR
  2. Oct 15, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  3. Oct 13, 2026144 EDGAR
  4. Oct 13, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  5. Oct 2, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  6. Oct 1, 2026144 EDGAR
  7. Sep 21, 2026144 EDGAR
  8. Sep 21, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  9. Sep 21, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  10. Sep 15, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  11. Sep 15, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  12. Sep 15, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  13. Sep 15, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  14. Sep 15, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  15. Sep 1, 2026144 EDGAR
  16. Sep 1, 2026144 EDGAR
  17. Sep 1, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  18. Sep 1, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  19. Aug 28, 2026424B5 PROSPECTUS EDGAR
  20. Aug 27, 2026EFFECT EDGAR

The 333 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

83 open-market trades by officers, directors and large owners since October 2021: 42 buys and 41 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 21, 2026Agarwal ArjunSenior Vice President, FinanceSale533$95.75$51.0KForm 4
Sep 21, 2026Quinlan Paul TGeneral CounselSale10,000$93.64$936.4KForm 4
Sep 15, 2026Goncalves JoanaChief Medical OfficerSale7,947$92.38$734.2KForm 4
Sep 15, 2026Agarwal ArjunSenior Vice President, FinanceSale560$95.71$53.6KForm 4
Sep 15, 2026Klein Lawrence OttoChief Executive OfficerSale2,452$95.71$234.7KForm 4
Sep 15, 2026Quinlan Paul TGeneral CounselSale1,039$95.71$99.4KForm 4
Sep 15, 2026Sandler Laura LeeChief Operating OfficerSale906$95.71$86.7KForm 4
Sep 11, 2026Agarwal ArjunSenior Vice President, FinanceSale9,459$92.23$872.4KForm 4
Sep 1, 2026Sandler Laura LeeChief Operating OfficerSale5,000$91.82$459.1KForm 4
Sep 1, 2026Klein Lawrence OttoChief Executive OfficerSale75,000$91.84$6.9MForm 4
Aug 17, 2026Goncalves JoanaChief Medical OfficerSale7,000$111.84$782.9KForm 4
Aug 14, 2026Quinlan Paul TGeneral CounselSale52,000$108.49$5.6MForm 4
Aug 13, 2026Agarwal ArjunSenior Vice President, FinanceSale10,000$106.66$1.1MForm 4
Jul 15, 2026Goncalves JoanaChief Medical OfficerSale7,000$86.28$604.0KForm 4
Jul 13, 2026Agarwal ArjunSenior Vice President, FinanceSale9,999$84.63$846.2KForm 4
Jul 1, 2026Kiselak TomasDirectorSale3,553,410$84.43$300.0MForm 4
Jul 1, 2026Sandler Laura LeeChief Operating OfficerSale5,000$94.42$472.1KForm 4
Jun 22, 2026Agarwal ArjunSenior Vice President, FinanceSale1,587$80.95$128.5KForm 4
Jun 15, 2026Agarwal ArjunSenior Vice President, FinanceSale395$69.69$27.5KForm 4
Jun 15, 2026Goncalves JoanaChief Medical OfficerSale7,947$69.28$550.6KForm 4

All 83 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
2025Lawrence Klein43$624.0K$3.4M97
2025Joana Goncalves52$474.0K$2.3M97
2025Paul Quinlan63$474.0K$2.3M97
2024Chief Executive Officer$203.3K$520.9K97
2024Chief Medical Officer$155.9K$318.0K97
2024General Counsel$155.9K$318.0K97

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
Fmr LLC9,057,645$862.0M0.0%+1,626,242
BlackRock, Inc.4,990,181$474.9M0.0%+1,463,094
Venrock Adviser, LLC4,148,428$394.8M12.0%No change
Fairmount Funds Management LLC3,705,262$352.6M23.3%No change
Capital World Investors3,401,639$323.7M0.0%New
Rtw Investments, LP3,139,030$298.7M2.6%+1,080,882
State Street Corp2,673,090$254.4M0.0%+1,059,629
Vanguard Capital Management LLC2,360,971$224.7M0.0%+501,340
Paradigm Biocapital Advisors LP2,144,526$204.1M3.8%−175,790
Deep Track Capital, LP1,926,000$183.3M2.7%−108,203
Bellevue Group AG1,657,190$157.7M3.3%+1,150,182
Franklin Resources Inc1,621,451$154.3M0.0%+617,395
Remedium Capital Partners, LLC1,565,661$149.0M33.0%No change
Ra Capital Management, L.P.1,554,597$148.0M1.3%New
Viking Global Investors LP1,503,478$143.1M0.4%−1,163,212
Geode Capital Management, LLC1,429,954$136.1M0.0%+475,087
Jupiter Topco LLC1,375,844$131.0M0.1%New
Perceptive Advisors LLC1,345,063$128.0M2.0%−50,438
Polar Capital Holdings Plc1,228,609$116.9M0.3%+180,916
Citadel Advisors LLC1,119,011$106.5M0.1%+111,474
Bnp Paribas Financial Markets1,079,015$102.7M0.1%+1,068,087
Avidity Partners Management LP760,424$72.4M11.6%−760,424
Summit Partners Public Asset Management, LLC658,301$62.7M1.6%New
Aberdeen Group plc646,943$61.6M0.1%+571,263
UBS Group AG639,363$60.8M0.0%+427,092

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

SEC filer profile

How Oruka 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 EDGAROruka Therapeutics, Inc.1
  • CIK0000907654
  • Employer ID (EIN)36-38554895
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company5
  • Incorporated inDelaware5
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address855 Oak Grove Ave., Suite 100, Menlo Park, CA 940251
  • Phone650-606-79101
  • Shares outstanding66,209,699 as of Jul 31, 202612
  • Public float$371.5M as of Jun 30, 20255
  • AuditorPricewaterhouseCoopers LLP, Boston, Massachusetts PCAOB ID 238; no auditor attestation of internal control over financial reporting5
  • On EDGAR sinceJun 12, 19971
  • Filings1,532 in all: 4 (382), 8-K (376), 10-Q (88), SC 13G/A (65), 3 (64), 424B4 (47), 425 (47), SC 13G (44)1
    All 51 form types

    DEF 14A (31), 424B5 (28), 10-K (26), CT ORDER (23), DEFA14A (23), S-8 (23), CORRESP (21), S-3 (21), 8-K/A (18), 144 (17), EFFECT (17), 424B3 (16), UPLOAD (15), SC 13D/A (12), S-1/A (10), S-3/A (9), SCHEDULE 13G/A (9), ARS (8), D (8), POS AM (8), S-8 POS (8), SCHEDULE 13G (8), PRE 14A (7), SC 13D (7), S-4/A (5), 10-K/A (4), 4/A (4), S-1 (4), SCHEDULE 13D/A (4), 10-K405 (3), 10-Q/A (3), S-4 (3), 3/A (2), 5 (2), 8-A12G (2), PRER14A (2), SEC STAFF LETTER (2), 424B2 (1), 424B7 (1), RW (1), S-1MEF (1), S-3ASR (1), S-3MEF (1)

  • Latest filingsAnnual report (10-K) Mar 12, 2026
    Quarterly report (10-Q) Aug 10, 2026
    Proxy statement (DEF 14A) Apr 17, 2026
    Latest 8-K (8-K) Aug 24, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.001 per shareORKAThe Nasdaq Global Market

From the cover page of the 10-K filed Mar 12, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks Oruka Therapeutics, Inc. names in Item 1A of its 10-K filed Mar 12, 2026: 61 risks under these headings, as written.5

  • Risks Related to Our Financial Condition and Capital Requirements
  • Risks Related to Clinical Development, Regulatory Approval and Commercialization
  • Risks Related to Government Regulations
  • Risks Related to Our Intellectual Property
  • Risks Related to Our Reliance on Third Parties
  • Risks Related to Employee Matters, Managing Growth, Other Risks Related to Our Business, and Risks Related to Owning Our Common Stock
  • We are a clinical stage biopharmaceutical company with a limited operating history on which to assess our business; our clinical trials are ongoing, we have no products approved for commercial sale, we have historically incurred losses, and we anticipate that we will continue to incur significant losses for the foreseeable future. Moreover, we have never generated revenue from product sales and may never be profitable.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations, or require us to relinquish rights.
  • We face competition from entities that have developed or may develop programs for the diseases addressed by our product candidates.
  • Our product candidates may fail in development or suffer delays. We depend on the successful initiation and completion of clinical trials for our product candidates to advance our product development plans.
  • We are substantially dependent on the success of our two most advanced programs, ORKA-001 and ORKA-002, and our clinical trials of such programs may not be successful.
  • If we do not achieve our projected development goals in the time frames we announce or expect, the development and potential commercialization of our product candidates may be delayed and our expenses may increase and, as a result, our business may be materially harmed and our stock price may decline.
The other 54 risks
  • Any drug delivery device that we may use to deliver our product candidates may have its own regulatory, development, supply and other risks.
  • Our approach to the discovery and development of our lead programs is unproven, and we may not be successful in our efforts to build a pipeline of programs with commercial value.
  • Preclinical and clinical development involves a lengthy and expensive process that is subject to delays and uncertain outcomes and results of earlier studies and trials may not be predictive of future clinical trial results. Further, if our preclinical studies and clinical trials are not sufficient to support regulatory approval of any of our product candidates, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development of such product candidate.
  • Our clinical development activities could be delayed or otherwise adversely affected if we encounter difficulties enrolling and maintaining participants in our current and future clinical trials. We depend on the successful completion of clinical trials for our product candidates.
  • Preliminary, “topline”, or interim data from our clinical trials may change and are subject to audit and verification procedures, and should be viewed with caution until the final data are available. Our interpretation of such data is based on assumptions that may evolve as additional data become available, which could result in changes to conclusions regarding the safety, efficacy, timing, or likelihood of success of our clinical development programs.
  • Our clinical trials may reveal significant adverse events, undesirable side effects, or patient intolerance not seen in our preclinical studies or earlier clinical trials, and may result in a safety profile that could halt clinical development, inhibit regulatory approval, or limit commercial potential or market acceptance of any of our product candidates. We do not know whether any clinical trials we may conduct will demonstrate adequate efficacy and safety to result in regulatory approval to market any of our product candidates.
  • We may expend our limited resources to pursue a particular program and fail to capitalize on programs that may be more profitable or for which there is a greater likelihood of success.
  • Any approved products resulting from our programs may not achieve adequate market acceptance among clinicians, patients, healthcare third-party payors and others in the medical community necessary for commercial success and we may not generate any future revenue from the sale or licensing of such products.
  • Certain of our programs may compete with our other programs, which could negatively impact our business and reduce our future revenue.
  • We are conducting, and may conduct in the future, clinical trials for programs at sites outside the United States, subjecting us to additional risks that may delay or adversely affect our product development timelines.
  • Risks Related to Government and Regulatory Matters
  • The regulatory approval processes of the FDA and other comparable foreign regulatory authorities are lengthy, time-consuming and unpredictable. We may not be able to commercialize, or may be delayed in commercializing, our product candidates, and our ability to generate revenue may be materially impaired if we are not able to obtain, or if there are delays in obtaining, required regulatory approvals for our product candidates.
  • We may not be able to meet requirements for the chemistry, manufacturing, and control of our programs.
  • Our product candidates for which we intend to seek approval as biologics may face competition sooner than anticipated.
  • Even if our product candidates receive regulatory approval, we will remain subject to extensive ongoing regulatory obligations and continued regulatory review, which could result in restrictions on the use of the products, significant additional expenses, and penalties if we fail to comply with regulatory requirements or experience unanticipated issues with our product candidates.
  • Disruptions or changes at the FDA, the SEC and other government agencies and regulatory authorities could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner 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 legislative or regulatory reform measures.
  • Our business operations and current and future arrangements with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers will be subject to applicable healthcare regulatory laws, including conflicts of interest rules, which could expose us to penalties.
  • Even if we are able to commercialize any product candidates, we may be subject to unfavorable pricing regulations and/or third-party coverage and reimbursement policies, and we may not be able to offer such product candidates at competitive prices, which could seriously harm our business.
  • 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. We can face criminal liability and other serious consequences for violations, which can harm our business.
  • Governments outside the United States tend to impose strict price controls, which may adversely affect our revenue, if any.
  • Our ability to obtain, maintain, and protect our patents and other proprietary rights is uncertain, exposing us to the possible loss of competitive advantage.
  • We may not be successful in obtaining or maintaining necessary rights to our programs through acquisitions and in-licenses.
  • We may be subject to patent infringement claims or may need to file claims to protect our intellectual property, which could result in substantial costs and liability and prevent us from commercializing our potential products.
  • Changes to patent laws in the U.S. and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • Obtaining and maintaining patent protection depends on compliance with various procedural, document submissions, fee payment, and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance 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 subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • Patent terms may be inadequate to protect the competitive position of our product candidates for an adequate amount of time.
  • Our technology licensed from various third parties may be subject to retained rights.
  • We currently rely on licensing arrangements for a substantial portion of our product portfolio, including with Paragon for ORKA-001 and ORKA-002. If we are unable to maintain collaborations or licensing arrangements, or if our collaborations or licensing arrangements are not successful, our business could be negatively impacted.
  • We currently rely, and plan to rely in the future, on third parties to conduct and support our preclinical studies and clinical trials. If these third parties do not properly and successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval of or commercialize our product candidates.
  • We rely on the use of manufacturing suites in third-party facilities or on third parties to manufacture our product candidates, and we may rely on third parties to produce and process our products, if approved. Our business could be adversely affected if we are unable to use third-party manufacturing suites or if the third-party manufacturers encounter difficulties in production.
  • Risks Related to Employee Matters, Managing Growth and Other Risks Related to Our Business
  • In order to successfully implement our plans and strategies, we will need to grow the size of our organization and we may experience difficulties in managing this growth.
  • We are highly dependent on our key personnel and anticipate hiring new key personnel. If we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
  • We may be subject to claims that we have wrongfully hired an employee from a competitor or that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.
  • 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.
  • Our employees, independent contractors, consultants, advisors, commercial collaborators, principal investigators, CROs, CMOs, suppliers, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • Our internal information technology systems, or those of any of our third-party service providers, or potential future collaborators, may fail or suffer security or data privacy breaches 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, loss of revenue, significant liabilities, harm to our brand and material disruption of our operations.
  • We are subject to stringent and changing laws, regulations and standards, and contractual obligations relating to privacy, data protection, and data security. The actual or perceived failure to comply with such obligations could lead to government enforcement actions (which could include civil or criminal penalties), fines and sanctions, private litigation and/or adverse publicity and could negatively affect our operating results and business.
  • 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 may be subject to adverse U.S. legislative or regulatory tax changes that could negatively impact our financial condition.
  • We may acquire businesses or products, or form strategic alliances, in the future, and may not realize the benefits of such acquisitions.
  • We maintain our cash at financial institutions, often in balances that exceed federally-insured limits. The failure of financial institutions could adversely affect our ability to pay our operational expenses or make other payments.
  • General Risk Factors
  • Our estimates of market opportunity and forecasts of market growth may prove to be inaccurate, and even if the markets in which we compete achieve the forecasted growth, our business may not grow at similar rates, or at all.
  • We may become exposed to costly and damaging product liability claims and our insurance may not cover all damages from such claims.
  • Litigation costs and the outcome of litigation could have a material adverse effect on our business.
  • Our business could be adversely affected by economic downturns, inflation, fluctuation in interest rates, natural disasters, public health crises, political crises, geopolitical events or other macroeconomic conditions, which could have a material and adverse effect on our results of operations and financial condition.
  • Risks Related to Owning Our Stock
  • The market price of our common stock has been, and may continue to be, volatile.
  • Our certificate of incorporation and bylaws, as well as provisions under Delaware law, could make an acquisition of the company more difficult and may prevent attempts by our stockholders to replace or remove management.
  • Our governing documents 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.
  • Future sales of shares by existing stockholders, or the anticipation of such events, could cause our stock price to decline.
  • We do not anticipate that we will pay any cash dividends in the foreseeable future.
  • 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, our stock price and trading volume could decline.

Legal proceedings

From time to time, we may become involved in legal proceedings relating to claims arising from the ordinary course of business. Our management believes that there are currently no claims or actions pending against us, the ultimate disposition of which could reasonably be expected to have a material adverse effect on our results of operations, financial condition or cash flows.

The opening of Item 3, Legal Proceedings.5

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