KURA on Nasdaq

Kura Oncology

In its 2026 annual report the company says: “We are a biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer.”5 It was founded in 2014.1 It is headquartered in La Jolla.1 Its shares trade on Nasdaq under the symbol KURA.1

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Last updated Oct 21, 2026.

Overview

2014Founded1

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  • TickerKURA on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersLa Jolla1
  • Websitewww.kuraoncology.com
  • Incorporated inDE4
  • Business address4930 Directors Place, Suite 500, San Diego, Ca 921214
  • Filer categoryNon-accelerated filer, Smaller reporting company4
  • Legal formCorporation3
  • LEI5493005QORQTZCZYOP393
  • StatusActive3
  • LEI statusIssued and current3
  • Registered addressc/o NATIONAL REGISTERED AGENTS, INC., 1209 ORANGE STREET, 19801 Wilmington, United States3
  • Registered withDivision of Corporations, Department of State, 57055943

We are a biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. Since our founding in 2014, we have transformed from a research and development company to a fully-integrated commercial-stage organization with a diversified pipeline of product candidates. Our pipeline consists of small molecules designed to target cancer signaling pathways and address significant unmet needs in oncology and hematology.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 2025

-449.9%Operating margin6
-412.9%Net margin6
25.2%Revenue growth, 20256
-160.0%Return on equity6
0.06×Debt to equity6
-$70.7MFree cash flow6

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

Collaboration revenue brought in 50% of the revenue Kura Oncology broke down this way in fiscal 2025.

  1. Collaboration revenue$65.3M650%up 21% from 2024
  2. Collaboration Revenue$65.3M650%up 21% from 2024
Products and services by year
Products and services202320242025
Collaboration revenue$0$53.9M$65.3M
Collaboration Revenue$53.9M$65.3M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development68¢$251.1M
  • Selling, general and admin32¢$120.0M
  • Income tax0¢$297.0K

Out of $67.5M in revenue.6 The company lost money this year.

Financial statements

Revenue6$67.5M in 2025
0$20.0M$40.0M$60.0M$80.0M2023: $0$020232024: $53.9M$53.9M20242025: $67.5M$67.5M2025+25%
Operating income76-$303.6M in 2025+117% since 2022
-$400.0M-$300.0M-$200.0M-$100.0M02022: -$139.9M-$139.9M20222023: -$165.8M-$165.8M2023+19%2024: -$193.2M-$193.2M2024+17%2025: -$303.6M-$303.6M2025+57%
Net income891076-$278.7M in 2025+341% since 2019
-$300.0M-$200.0M-$100.0M02019: -$63.1M-$63.1M20192020: -$89.6M-$89.6M2020+42%2021: -$130.5M-$130.5M2021+46%2022: -$135.8M-$135.8M2022+4%2023: -$152.6M-$152.6M2023+12%2024: -$174.0M-$174.0M2024+14%2025: -$278.7M-$278.7M2025+60%

Every line of the income statement as filed: the last 3 fiscal years, latest first.6

Period ending2025-12-312024-12-312023-12-31
Total revenue$67.5M$53.9M$0
Cost of product sales$57.0K$0$0
Research and development$251.1M$170.0M$115.2M
Selling, general and administrative$120.0M$77.1M$50.6M
Total operating expenses$371.1M$247.1M$165.8M
Loss from operations-$303.6M-$193.2M-$165.8M
Interest and other income, net$26.8M$22.8M$14.7M
Interest expense-$1.5M-$1.6M-$1.5M
Total other income, net$25.3M$21.2M$13.2M
Loss before income taxes-$278.4M-$172.0M-$152.6M
Income tax expense$297.0K$2.0M$0
Net Loss-$278.7M-$174.0M-$152.6M
Net loss per share, basic-$3.18-$2.02-$2.08
Net loss per share, diluted-$3.18-$2.02-$2.08
Weighted average number of shares used in computing net loss per share, basic87.7M shares86.2M shares73.2M shares
Weighted average number of shares used in computing net loss per share, diluted87.7M shares86.2M shares73.2M shares
Unrealized gain on short-term investments$260.0K$2.0M$6.8M
Comprehensive loss-$278.4M-$171.9M-$145.9M

Compare Kura Oncology with another company

Corporate structure

Kura Oncology 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 Kura Oncology

  • Kura Oncology La Jolla, California, United States

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

What it owns

What Kura Oncology 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$10.8M6 Dec 31, 2025$5.0M6 Dec 31, 2024+117.0%
Accumulated depreciation$2.9M6 Dec 31, 2025$3.3M6 Dec 31, 2024−11.5%
Property and equipment, net$7.9M6 Dec 31, 2025$1.7M6 Dec 31, 2024+367.0%
Operating-lease assets (leased space)$7.3M6 Dec 31, 2025$5.8M6 Dec 31, 2024+25.8%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$149.1M6 Dec 31, 2025$224.5M6 Dec 31, 2024−33.6%
Marketable securities, current$518.1M6 Dec 31, 2025$502.9M6 Dec 31, 2024+3.0%

Inventory

ItemLatestA year beforeChange
Inventory, total$413.0K6 Dec 31, 2025$06 Dec 31, 2024

Properties, in its own words

We occupy approximately 32,512 square feet of office space for our corporate headquarters in San Diego, California under a lease that expires in May 2033. We also occupy approximately 16,541 square feet of office space in Boston, Massachusetts under a lease that expires in July 2031.

Item 2 of the 10-K filed Mar 5, 2026.5

Leadership

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

Board members and other officers (23)

Former names

  • ZETA ACQUISITION CORP IIIFeb 1, 2008 to Mar 10, 20154

Timeline

  1. Sep 9, 20268-K Other events42
  2. Sep 8, 20268-K Executive or director change43
  3. Aug 12, 20268-K Results of operations44
  4. Jul 29, 20268-K Executive or director change45
  5. Jun 4, 20268-K Executive or director change; Shareholder vote46
  6. May 12, 20268-K Results of operations47
  7. Mar 5, 20268-K Results of operations48
  8. Jan 29, 20268-K Bylaws or fiscal year changed49
  9. Jan 12, 20268-K Results of operations50
  10. Dec 2, 20258-K Other events51
  11. Nov 13, 20258-K Other events52
  12. Nov 4, 20258-K Results of operations53
  13. Mar 16, 2015New chief executive Troy Edward Wilson becomes CEO14
  14. 2014Founded Founded1

Calendar

Coming up

  1. Nov 3, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.85) a share, on Nov 4, 2025.54

When it reported results

  1. Aug 12, 2026Reported quarterly or annual results44
  2. May 12, 2026Reported quarterly or annual results47
  3. Mar 5, 2026Reported quarterly or annual results48
  4. Jan 12, 2026Reported quarterly or annual results50
  5. Nov 4, 2025Reported quarterly or annual results53
  6. Aug 7, 2025Reported quarterly or annual results55
  7. May 1, 2025Reported quarterly or annual results56
  8. Feb 26, 2025Reported quarterly or annual results57

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

Filings

358 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 62 major events, 138 insider forms, 52 large holders, 1 private raises, 85 other. The latest 20:

  1. Sep 29, 2026144 EDGAR
  2. Sep 29, 2026144 EDGAR
  3. Sep 29, 2026144 EDGAR
  4. Sep 29, 20264 EDGAR
  5. Sep 29, 20264 EDGAR
  6. Sep 29, 20264 EDGAR
  7. Sep 29, 20264 EDGAR
  8. Sep 29, 20264 EDGAR
  9. Sep 28, 2026144 EDGAR
  10. Sep 28, 2026144 EDGAR
  11. Sep 28, 2026144 EDGAR
  12. Sep 28, 2026144 EDGAR
  13. Sep 28, 2026144 EDGAR
  14. Sep 28, 2026144 EDGAR
  15. Sep 25, 20264 EDGAR
  16. Sep 24, 2026144 EDGAR
  17. Sep 10, 20264 EDGAR
  18. Sep 10, 20263 EDGAR
  19. Sep 9, 20268-K EDGAR
  20. Sep 8, 20268-K EDGAR

The 358 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

63 open-market trades by officers, directors and large owners since October 2021: 6 buys and 57 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 29, 2026FORD KATHLEENChief Operating OfficerSale3,668$10.75$39.4KForm 4
Sep 29, 2026Leoni MollieChief Medical OfficerSale28,802$10.75$309.6KForm 4
Sep 29, 2026Powl Brian T.Chief Commercial OfficerSale15,430$10.75$165.9KForm 4
Sep 28, 2026Bair Teresa BrophyChief Legal OfficerSale8,442$10.50$88.6KForm 4
Sep 28, 2026FORD KATHLEENChief Operating OfficerSale6,906$10.50$72.5KForm 4
Sep 28, 2026Leoni MollieChief Medical OfficerSale12,448$10.50$130.7KForm 4
Sep 28, 2026DOYLE THOMAS JAMESSVP, Finance & AccountingSale4,607$10.50$48.4KForm 4
Sep 28, 2026Powl Brian T.Chief Commercial OfficerSale17,020$10.53$179.2KForm 4
Sep 24, 2026Burrows FrancisChief Scientific OfficerSale20,726$10.83$224.5KForm 4
Aug 24, 2026WILSON TROY EDWARDPresident and CEOBuy100,000$12.39$1.2MForm 4
Aug 21, 2026Powl Brian T.Chief Commercial OfficerSale4,345$11.89$51.7KForm 4
Aug 19, 2026Bair Teresa BrophyChief Legal OfficerSale31,487$12.63$397.7KForm 4
Aug 17, 2026WILSON TROY EDWARDPresident and CEOBuy100,000$11.12$1.1MForm 4
Jun 18, 2026Leoni MollieChief Medical OfficerSale84,929$9.82$834.0KForm 4
May 21, 2026Powl Brian T.Chief Commercial OfficerSale10,000$11.00$110.0KForm 4
May 19, 2026FORD KATHLEENChief Operating OfficerSale2,257$9.08$20.5KForm 4
May 19, 2026Powl Brian T.Chief Commercial OfficerSale339$9.21$3.1KForm 4
May 18, 2026Bair Teresa BrophyChief Legal OfficerSale2,256$9.38$21.2KForm 4
Jan 27, 2026Burrows FrancisChief Scientific OfficerSale1,311$8.46$11.1KForm 4
Jan 27, 2026Powl Brian T.Chief Commercial OfficerSale6,414$8.46$54.3KForm 4

All 63 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
2025Troy E. WilsonPh.D., J.D.$700.0K$4.7M72
2025Brian Powl52$506.3K$2.7M72
2025Kathleen Ford79$539.9K$1.9M72
2024President and Chief Executive Officer$671.7K$6.2M72
2024Chief Operating Officer$519.2K$2.5M72

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$150.0M 2024–2024
Money received by yearMoney received by year, 2024–2024: $150.0M in all. Private raises (Form D) $150.0M.$0$50M$100M$150M$200M2024 · Private raises (Form D): $150.0M2024
Figures by year
YearPrivate raises (Form D)Total
2024$150.0M$150.0M

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. Jan 26, 2024Raised $150 million in a private offering of equity73 Form D: 10 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
BlackRock, Inc.10,509,233$115.3M0.0%+871,702
Montanova Capital, LLC8,575,422$94.1M2.0%No change
Bvf Inc/il8,445,769$92.7M2.4%No change
State Street Corp5,329,208$58.5M0.0%+817,317
Vanguard Capital Management LLC3,916,164$43.0M0.0%+130,479
Armistice Capital, LLC3,678,000$40.3M1.1%−58,000
Aqr Capital Management LLC3,126,727$34.3M0.0%+1,002,247
Goldman Sachs Group Inc2,265,171$24.8M0.0%+831,700
Geode Capital Management, LLC2,229,958$24.5M0.0%+195,682
Alethea Capital Management, LLC2,167,938$23.8M9.9%+638,569
Prosight Management, LP2,021,964$22.2M3.8%−1,334,736
Deep Track Capital, LP1,978,565$21.7M0.3%−664,977
Renaissance Technologies LLC1,663,765$18.3M0.0%+81,197
Arrowstreet Capital, Limited Partnership1,410,275$15.5M0.0%New
Vanguard Portfolio Management LLC1,329,941$14.6M0.0%+99,139
Nan Fung Trinity (hk) Ltd1,174,880$12.9M1.3%+110,000
Qube Research & Technologies Ltd1,169,884$12.8M0.0%−466,849
Dimensional Fund Advisors LP1,169,189$12.8M0.0%−256,756
Bank Of America Corp /de/1,160,921$12.7M0.0%−69,210
Morgan Stanley1,160,310$12.7M0.0%−3,667
Connor, Clark & Lunn Investment Management Ltd.996,114$10.9M0.0%+195,517
UBS Group AG964,636$10.6M0.0%−75,597
Jacobs Levy Equity Management, Inc948,974$10.4M0.0%+346,743
Northern Trust Corp831,160$9.1M0.0%+74,887
Millennium Management LLC711,332$7.8M0.0%−853,811

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

Members of Congress who traded it

1 trades disclosed by members of Congress. “Vs S&P since” is the stock’s change since the trade minus the S&P 500’s.

DateMemberTradeAmountVs S&P sinceFiling
Dec 12, 2022Christopher L. Jacobs, HouseBuy$1,001 - $15,000−119.8%Report

Members report amounts as ranges, not exact figures. Returns are price-only (no dividends).

SEC filer profile

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

  • Name on EDGARKura Oncology, Inc.2
  • CIK0001422143
  • Employer ID (EIN)61-15478515
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company5
  • Incorporated inDelaware5
  • Fiscal year endsDecember 312
  • Industry code (SIC)2834 Pharmaceutical Preparations2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address4930 Directors Place, Suite 500, San Diego, CA 921212
  • Phone(858) 500-88002
  • Shares outstanding88,960,619 as of Aug 7, 202612
  • Public float$496.1M as of Jun 30, 20255
  • AuditorErnst & Young LLP, San Diego, CA USA PCAOB ID 42; no auditor attestation of internal control over financial reporting5
  • On EDGAR sinceFeb 1, 20082
  • Filings805 in all: 4 (237), 8-K (149), SC 13G/A (61), 10-Q (54), 144 (48), 3 (33), SC 13G (24), 10-K (18)2
    All 43 form types

    424B5 (18), 424B3 (16), S-8 (16), SCHEDULE 13G/A (16), CORRESP (14), DEFA14A (12), CT ORDER (11), DEF 14A (11), EFFECT (9), UPLOAD (8), S-3 (6), SCHEDULE 13G (5), ARS (4), 5 (3), S-1/A (3), SC 13D (3), 10QSB (2), 8-K/A (2), D (2), PRE 14A (2), S-1 (2), S-3/A (2), S-3ASR (2), 10SB12G (1), 3/A (1), 4/A (1), 424B4 (1), 8-A12B (1), CERTNAS (1), DEF 14C (1), POS AM (1), POS EX (1), PRE 14C (1), S-3MEF (1), SC 14F1 (1)

  • Latest filingsAnnual report (10-K) Mar 5, 2026
    Quarterly report (10-Q) Aug 12, 2026
    Proxy statement (DEF 14A) Apr 10, 2026
    Latest 8-K (8-K) Sep 9, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.0001 per shareKURAThe Nasdaq Global Select Market

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

Risk factors and legal proceedings

The risks Kura Oncology names in Item 1A of its 10-K filed Mar 5, 2026: 72 risks under these headings, as written.5

  • Risks Related to the Commercialization of KOMZIFTI and Our Product Candidates
  • Our ability to generate revenue is highly dependent on the successful commercialization of KOMZIFTI in the United States and continued global development of ziftomenib. If we are unable to successfully commercialize KOMZIFTI in the United States, or to expand ziftomenib’s indications of use or market opportunity, our ability to generate meaningful revenue or achieve profitability will be materially and adversely affected.
  • KOMZIFTI may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
  • If the market opportunities for KOMZIFTI are smaller than we believe, our revenue may be adversely affected, and our business may suffer.
  • If we are unable to execute on our sales, marketing and distribution plans to commercialize KOMZIFTI, we may be unable to generate meaningful product revenue.
  • If competitors develop products, product candidates or technologies that are superior to or more favorable than KOMZIFTI or our product candidates, such development would significantly impact the development and commercial viability of KOMZIFTI and our product candidates, which would severely and adversely affect our financial results, business and business prospects, and might cause us to cease operations.
  • Post-approval results for KOMZIFTI in larger numbers of patients, broader populations or real world clinical practice may not be consistent with the results from our clinical trials.
  • We have limited experience as a commercial company and our sales, marketing and distribution of KOMZIFTI may be unsuccessful or less successful than anticipated.
  • The insurance coverage and reimbursement status of newly-approved products are uncertain. Failure to obtain or maintain coverage and adequate reimbursement for KOMZIFTI or any product candidates for which we receive marketing approval could limit our ability to market those products and decrease our ability to generate revenue.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of KOMZIFTI or any other approved products.
  • Risks Related to Regulatory Approval of Our Product and Product Candidates and Other Legal Compliance Matters
  • We may be unable to maintain FDA approval of KOMZIFTI for adult patients with relapsed or refractory NPM1-mutated AML, which would severely and adversely affect our business and business prospects.
The other 61 risks
  • If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals in some or all planned regions, whether due to actual or perceived deficiencies in our applications, changes in regulatory requirements, evolving agency guidance or interpretation, resource constraints at regulatory authorities, or other factors, we will not be able to commercialize, or may be delayed in commercializing, our product candidates, and our ability to generate revenue will be materially impaired.
  • Our marketing approval for KOMZIFTI in the United States for adult patients with relapsed or refractory NPM1-mutated AML is subject to post-approval regulatory requirements and commitments, and we may be subject to penalties, restrictions or withdrawal from the market if we fail to comply with these requirements and commitments or if we experience unanticipated problems with KOMZIFTI.
  • Failure to obtain marketing approval in international jurisdictions would prevent our product candidates from being marketed abroad.
  • Although the FDA has granted Orphan Drug Designation to ziftomenib for the treatment of AML, we may not be able to obtain orphan drug exclusivity, and even if obtained, such exclusivity may not effectively protect ziftomenib from competition, which could limit the potential profitability of ziftomenib.
  • Our relationships with healthcare professionals, customers and third-party payors and our general business operations are subject to applicable fraud and abuse laws, including anti-kickback and false claims laws, transparency laws, privacy laws and other healthcare laws and regulations, which could expose us to significant penalties, including criminal sanctions, administrative and civil penalties, contractual damages, reputational harm and diminished profits and future earnings, among other penalties.
  • Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of our product candidates and commercialize our products, and may affect the prices we may obtain.
  • Governments outside the United States tend to impose strict price controls, which may adversely affect our revenues, if any.
  • 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 harm our business.
  • Risks Related to the Discovery and Development of Our Product Candidates
  • Our discovery, preclinical and clinical development activities are primarily focused on the development of targeted therapeutics for patients with genetically defined cancers, which is a rapidly evolving area of science, and the approach we are taking to discover and develop drugs may not lead to new marketable products or new approved disease indications.
  • Clinical drug development involves a lengthy and expensive process with an uncertain outcome. The results of preclinical studies and early clinical trials of our product candidates may not be predictive of the results of subsequent clinical trials, and preliminary or interim results of a clinical trial do not necessarily predict final results. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
  • We anticipate that our current product candidates and any future product candidates may be used in combination with third-party drugs or biologics, some of which may still be in development, and we have limited or no control over the supply, regulatory status, or regulatory approval of such drugs or biologics.
  • Our product candidates may cause serious adverse events or have unacceptable side effects that could delay, limit or prevent their development.
  • Failure by us or our third-party collaborators to develop, validate and obtain regulatory approval for a diagnostic testing platform could harm our drug development strategy and operational results.
  • We may find it difficult to enroll patients in our clinical trials. Difficulty in enrolling patients could delay or prevent clinical trials of our product candidates.
  • We may expend our limited resources to pursue a specific product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • Risks Related to Our Financial Position and Need for Additional Capital
  • We have incurred losses since our inception, expect to incur losses over the next several years and may never achieve or maintain profitability.
  • We have limited historical product revenue, and we expect that our financial and operating results will vary significantly from period to period.
  • We may need to obtain substantial additional capital in connection with our continuing operations. If we are required to raise additional capital, doing so may cause dilution to our stockholders, restrict our operations or require us to relinquish certain rights to our technologies or product candidates.
  • Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
  • Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults or non-performance by financial institutions could adversely affect our current financial condition and projected business operations.
  • Risks Related to Our Dependence on Third Parties
  • Our collaboration with Kyowa Kirin is important to our business. If Kyowa Kirin ceases development efforts under the Kyowa License Agreement, or if the Kyowa License Agreement is terminated, we may not receive future milestone payments or royalties under the Kyowa License Agreement and our business could be adversely affected. If Kyowa Kirin does not fulfill its obligations under the Kyowa Co-Promotion Agreement, our business could be adversely affected.
  • We rely on third-party contractors and organizations to conduct, and/or to supply materials to conduct, our clinical trials and provide commercial supply, and those third parties may not perform satisfactorily, including failing to meet deadlines for the supply of materials and/or the completion of such clinical trials or to meet the demands of our commercial supply.
  • We depend on third parties for the manufacture of our product candidates for preclinical and clinical testing and for the manufacture of commercial supplies of KOMZIFTI. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or KOMZIFTI at an acceptable cost and quality, which could delay, prevent or impair our development or commercialization efforts.
  • Risks Related to Our Intellectual Property
  • If we are unable to, or if we do not, obtain and maintain intellectual property protection for our product and product candidates, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our product and product candidates may be impaired.
  • We depend on our licensors to prosecute and maintain patents and patent applications that are material to our business. Any failure by our licensors to effectively protect these intellectual property rights could adversely impact our business and operations.
  • Patent terms may be inadequate to protect our competitive position on our product and product candidates for a commercially meaningful length of time.
  • We may not be successful in obtaining or maintaining necessary third-party intellectual property rights for our development pipeline through acquisitions and in-licenses.
  • If we are unable to maintain the confidentiality of our trade secrets or other confidential information, our business and competitive position would be harmed.
  • If we breach any of the agreements under which we license from third parties the development and/or commercialization rights to our product candidates, we could lose license rights that are important to our business and our operations could be materially harmed.
  • The patent applications of pharmaceutical and biotechnology companies involve highly complex legal and factual questions, which, if determined adversely to us, could negatively impact our patent position.
  • Changes in U.S. patent law, or laws in other countries, could diminish the value of patents in general, thereby impairing our ability to protect our product and product candidates.
  • 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 non-compliance with these requirements.
  • We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful.
  • Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.
  • Intellectual property discovered through government-funded programs may be subject to federal regulations such as “march-in” rights, certain reporting requirements and a preference for use of U.S.-based manufacturing companies. Compliance with such regulations may limit our exclusive rights and limit our ability to contract with non-U.S. manufacturers.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Risks Related to Employee Matters, Managing Growth and Macroeconomic Conditions
  • We are highly dependent on our Chief Executive Officer. Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
  • We have expanded our development, regulatory, operations, medical affairs, and commercial capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
  • Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations.
  • If our information technology systems, or those of third parties with whom we work, or our data are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; and other adverse consequences.
  • Our business and operations would suffer in the event of system failures.
  • Actual or threatened public health epidemics or outbreaks may adversely impact our industry, including our clinical trials, our supply chain, our liquidity and access to capital markets and our business development activities.
  • Our operations are vulnerable to interruption by natural disasters, power loss, terrorist activity and other events beyond our control, the occurrence of which could materially harm our business.
  • International trade policies, including tariffs, sanctions and trade barriers, may adversely affect our business, financial condition, results of operations and prospects.
  • Risks Related to Ownership of our Common Stock
  • Our stock price may fluctuate significantly and you may have difficulty selling your shares based on current trading volumes of our stock.
  • The price of our common stock may be volatile and may be influenced by numerous factors, some of which are beyond our control.
  • We have broad discretion in the use of our cash and may not use our cash effectively, which could adversely affect our results of operations.
  • FINRA sales practice requirements may limit a stockholder’s ability to buy and sell our stock.
  • The resale of shares covered by our effective shelf registration statements could adversely affect the market price of our common stock in the public market, which result would in turn negatively affect our ability to raise additional equity capital.
  • We will incur increased costs and demands upon management as a result of complying with the laws and regulations affecting public companies, which could harm our operating results.
  • If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired, which could harm our operating results, our ability to operate our business and investors’ views of us.
  • We are a “smaller reporting company” and any decision on our part to comply only with certain reduced reporting and disclosure requirements applicable to smaller reporting companies could make our common stock less attractive to investors.
  • Future sales and issuances of our common stock or rights to purchase or acquire common stock, including pursuant to our equity incentive plans, outstanding stock options, restricted stock units, performance-based restricted stock units, warrants, pre-funded warrants or otherwise, could result in dilution to the percentage ownership of our stockholders and could cause our stock price to fall.
  • Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a change of control which could limit the market price of our common stock and may prevent or frustrate attempts by our stockholders to replace or remove our current management.
  • Our charter documents provide that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
  • Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition or results of operations.
  • Our ability to use net operating loss carryforwards and certain other tax attributes to offset future taxable income or taxes may be limited.
  • We do not intend to pay cash dividends on our capital stock in the foreseeable future.
  • General Risk Factors
  • If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about us, our business or our market, our stock price and trading volume could decline.
  • Our business could be negatively affected as a result of actions of activist stockholders, and such activism could impact the trading value of our securities.
  • Securities class action litigation could divert our management’s attention and harm our business and could subject us to significant liabilities.

Legal proceedings

We are not currently a party to, nor is our property the subject of, any material legal proceedings.

The opening of Item 3, Legal Proceedings.5

Sources

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