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PLRX on Nasdaq

Pliant (United States)

In its 2026 annual report the company says: “We are a clinical-stage biopharmaceutical company focused on discovering and developing integrin-based therapeutics. Our lead program is focused on the development of treatments for solid tumors by inhibiting integrin-mediated activation of transforming growth factor-β (TGF-β). Our wholly owned lead product candidate, PLN-101095, is an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins in development for the treatment of solid tumors.”4 It was founded in 2016.1 It is headquartered in South San Francisco, California.1 Its shares trade on Nasdaq under the symbol PLRX.1

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Last updated Oct 21, 2026.

Overview

2016Founded1

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  • TickerPLRX on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersSouth San Francisco, California1
  • Websitepliantrx.com
  • Incorporated inDE3
  • Business address331 Oyster Point Boulevard, South San Francisco, Ca 940803
  • Filer categoryNon-accelerated filer, Smaller reporting company3

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We are a clinical-stage biopharmaceutical company focused on discovering and developing integrin-based therapeutics. Our lead program is focused on the development of treatments for solid tumors by inhibiting integrin-mediated activation of transforming growth factor-β (TGF-β). We have applied our deep understanding of integrin biology, along with our medicinal chemistry and translational medicine expertise to develop a proprietary drug discovery platform that we believe has broad applicability across multiple areas of disease.4 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

-82.4%Return on equity5
0.00×Debt to equity5
-$128.7MFree cash flow5

Financial statements

Revenue6785$0 in 2025
0$20.0M$40.0M$60.0M2019: $57.1M$57.1M20192020: $41.8M$41.8M2020−27%2021: $7.6M$7.6M2021−82%2022: $9.7M$9.7M2022+28%2023: $1.6M$1.6M2023−84%2024: $0$020242025: $0$02025
Operating income6785-$156.4M in 2025+12603% since 2019
-$300.0M-$200.0M-$100.0M02019: -$1.2M-$1.2M20192020: -$41.6M-$41.6M2020+3283%2021: -$97.5M-$97.5M2021+134%2022: -$127.2M-$127.2M2022+30%2023: -$184.1M-$184.1M2023+45%2024: -$228.4M-$228.4M2024+24%2025: -$156.4M-$156.4M2025−32%
Net income6785-$149.3M in 2025+23568% since 2019
-$300.0M-$200.0M-$100.0M02019: -$631.0K-$631.0K20192020: -$41.5M-$41.5M2020+6482%2021: -$97.3M-$97.3M2021+134%2022: -$123.3M-$123.3M2022+27%2023: -$161.3M-$161.3M2023+31%2024: -$210.3M-$210.3M2024+30%2025: -$149.3M-$149.3M2025−29%

Every line of the income statement as filed: the last 2 fiscal years, latest first.5

Period ending2025-12-312024-12-31
Revenue$0$0
Research and development-$109.2M-$169.3M
General and administrative-$47.2M-$59.1M
Total operating expenses-$156.4M-$228.4M
Loss from operations-$156.4M-$228.4M
Interest and other income (expense), net$11.4M$21.1M
Interest expense-$2.6M-$3.0M
Loss on extinguishment of debt (Note 7)-$1.8M$0
Net loss-$149.3M-$210.3M
Net loss per share - basic (USD per share)-$2.43-$3.47
Net loss per share - diluted (USD per share)-$2.43-$3.47
Weighted average shares used in computing net loss per share - basic (in shares)61.4M shares60.5M shares
Weighted average shares used in computing net loss per share - diluted (in shares)61.4M shares60.5M shares
Net unrealized loss on short-term investments-$336.0K-$24.0K
Total other comprehensive loss-$336.0K-$24.0K
Comprehensive loss-$149.7M-$210.3M

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Corporate structure

Pliant (United States) 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 Pliant (United States)

  • ADAR1 Capital Management, LLC Filed SCHEDULE 13G on Pliant (United States), latest Aug 14, 2026
  • CITADEL ADVISORS LLC Filed SCHEDULE 13G/A on Pliant (United States), latest Aug 14, 2026 (4 filings since Jan 22, 2026)
  • Point72 Asset Management, L.P. Filed SCHEDULE 13G/A on Pliant (United States), latest Feb 17, 2026 (2 filings since Sep 4, 2025)
  • Woodline Partners LP Filed SCHEDULE 13G/A on Pliant (United States), latest Feb 17, 2026 (2 filings since Nov 14, 2025)
  • Morgan Stanley Filed SCHEDULE 13G/A on Pliant (United States), latest Jan 8, 2026 (2 filings since Aug 6, 2025)
  • Deep Track Capital, LP Filed SCHEDULE 13G/A on Pliant (United States), latest Nov 14, 2025 (4 filings since Mar 20, 2023)
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on Pliant (United States), latest Jul 29, 2025 (2 filings since Feb 13, 2024)
  • BlackRock Filed SCHEDULE 13G/A on Pliant (United States), latest Jul 17, 2025 (2 filings since Jan 25, 2024)
  • Paradigm Biocapital Advisors LP Filed SCHEDULE 13G/A on Pliant (United States), latest May 15, 2025 (2 filings since Oct 4, 2024)
  • PRICE T ROWE ASSOCIATES INC /MD/ Filed SCHEDULE 13G/A on Pliant (United States), latest May 14, 2025 (3 filings since Feb 14, 2024)
  • TANG CAPITAL MANAGEMENT LLC Filed SCHEDULE 13D on Pliant (United States), latest Mar 10, 2025
  • FMR LLC Filed SCHEDULE 13G/A on Pliant (United States), latest Mar 7, 2025 (6 filings since Feb 9, 2022)
  • Pliant (United States) South San Francisco, California

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

What it owns

What Pliant (United States) 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$13.8M5 Dec 31, 2025$16.3M5 Dec 31, 2024−15.4%
Accumulated depreciation$10.9M5 Dec 31, 2025$10.8M5 Dec 31, 2024+0.6%
Property and equipment, net$2.9M5 Dec 31, 2025$5.5M5 Dec 31, 2024−46.8%
Operating-lease assets (leased space)$24.0M5 Dec 31, 2025$27.2M5 Dec 31, 2024−12.0%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$45.4M5 Dec 31, 2025$71.2M5 Dec 31, 2024−36.2%
Marketable securities, current$145.5M5 Dec 31, 2025$284.5M5 Dec 31, 2024−48.9%

Properties, in its own words

We lease premises consisting of approximately 100,904 square feet of office and laboratory space located at Oyster Point Blvd, South San Francisco, California pursuant to a lease agreement entered into on September 28, 2023 (the "Oyster Point Lease"), which is being used as a single unified Company headquarters. The lease term of approximately seven years started in the second quarter of 2024. Following the strategic restructuring of our operations in 2025, our current facilities provide ample space for our current and near-term needs for the business of developing and commercializing integrin-based therapeutics. We have begun to evaluate potential sub-lease opportunities in an effort to preserve capital.

Item 2 of the 10-K filed Mar 11, 2026.4

Leadership

Who has led Pliant (United States), and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Bernard Coulie2020–now

President

  1. Bernard Coulie2020–now

Chief operating officer

  1. Minnie Kuo2025–now
20202025
Board members and other officers (20)

Timeline

  1. Aug 11, 20268-K Results of operations34
  2. Jul 13, 20268-K Executive or director change35
  3. Jun 11, 20268-K Shareholder vote36
  4. May 11, 20268-K Results of operations37
  5. Apr 17, 20268-K Executive or director change38
  6. Mar 30, 20268-K Other events39
  7. Mar 11, 20268-K Results of operations40
  8. Mar 3, 20268-K Entered a material agreement; Change to shareholders' rights41
  9. Dec 16, 20258-K Executive or director change42
  10. Dec 8, 20258-K Executive or director change43
  11. Nov 6, 20258-K Results of operations44
  12. Oct 24, 20258-K Executive or director change45
  13. Jun 2, 2020New chief executive Bernard Coulie becomes CEO13
  14. 2016Founded Founded1

Calendar

Coming up

  1. Nov 5, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.43) a share, on Nov 6, 2025.46

When it reported results

  1. Aug 11, 2026Reported quarterly or annual results34
  2. May 11, 2026Reported quarterly or annual results37
  3. Mar 11, 2026Reported quarterly or annual results40
  4. Nov 6, 2025Reported quarterly or annual results44
  5. May 8, 2025Reported quarterly or annual results47
  6. Mar 3, 2025Reported quarterly or annual results48
  7. Nov 7, 2024Reported quarterly or annual results49
  8. Aug 7, 2024Reported quarterly or annual results50

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

Filings

325 filings to the SEC since October 2021: 7 annual reports, 15 quarterly reports, 58 major events, 158 insider forms, 48 large holders, 39 other. The latest 20:

  1. Oct 2, 20264 EDGAR
  2. Oct 2, 20263 EDGAR
  3. Aug 14, 2026SCHEDULE 13G EDGAR
  4. Aug 14, 2026SCHEDULE 13G/A EDGAR
  5. Aug 11, 20268-K EDGAR
  6. Aug 11, 202610-Q EDGAR
  7. Jul 13, 20263 EDGAR
  8. Jul 13, 20264 EDGAR
  9. Jul 13, 20268-K EDGAR
  10. Jul 13, 20263 EDGAR
  11. Jul 13, 20264 EDGAR
  12. Jun 12, 20264 EDGAR
  13. Jun 12, 20264 EDGAR
  14. Jun 12, 20264 EDGAR
  15. Jun 12, 20264 EDGAR
  16. Jun 12, 20264 EDGAR
  17. Jun 12, 20264 EDGAR
  18. Jun 11, 20268-K EDGAR
  19. May 11, 202610-Q EDGAR
  20. May 11, 20268-K EDGAR

The 325 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: 0 buys and 63 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jan 20, 2026Cummings Keith LamontChief Financial OfficerSale24,002$1.28$30.7KForm 4
Jan 20, 2026Cheung LilyChief Human Resource OfficerSale7,534$1.28$9.6KForm 4
Jan 20, 2026Coulie BernardPresident and CEOSale89,375$1.28$114.4KForm 4
Jan 20, 2026Kuo MinnieChief Operating OfficerSale6,917$1.28$8.9KForm 4
Jan 22, 2025Ouimette MikeGeneral Counsel & Corp. Sec'ySale10,230$10.99$112.4KForm 4
Jan 17, 2025Coulie BernardPresident and CEOSale52,419$11.20$587.1KForm 4
Jan 17, 2025Cummings Keith LamontChief Financial OfficerSale20,148$11.20$225.7KForm 4
Jan 17, 2025Hull HansChief Business OfficerSale15,936$11.20$178.5KForm 4
Jan 17, 2025Lefebvre EricChief Medical OfficerSale18,478$11.20$207.0KForm 4
Jan 17, 2025Cheung LilyChief Human Resource OfficerSale3,740$11.20$41.9KForm 4
Jan 17, 2025Ouimette MikeGeneral Counsel & Corp. Sec'ySale13,270$11.20$148.6KForm 4
Jul 10, 2024Lefebvre EricChief Medical OfficerSale12,319$11.56$142.4KForm 4
Jul 10, 2024Hull HansChief Business OfficerSale9,900$11.56$114.4KForm 4
Jul 10, 2024Cummings Keith LamontChief Financial OfficerSale10,911$11.56$126.1KForm 4
Jul 10, 2024Coulie BernardPresident and CEOSale38,710$11.56$447.5KForm 4
Jul 10, 2024Ouimette MikeGeneral Counsel & Corp. Sec'ySale7,656$11.56$88.5KForm 4
Jan 17, 2024Cummings Keith LamontChief Financial OfficerSale9,781$17.23$168.5KForm 4
Jan 17, 2024Hull HansChief Business OfficerSale9,786$17.23$168.6KForm 4
Jan 17, 2024Coulie BernardPresident and CEOSale25,721$17.23$443.2KForm 4
Jan 17, 2024Lefebvre EricChief Medical OfficerSale10,295$17.23$177.4KForm 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
2025Bernard Coulie, M.D., Ph.D., M.B.A.President, Chief Executive Officer and Director60$682.0K$5.5M71
2025Éric Lefebvre, M.D.Former Chief Medical Officer$571.9K$2.7M71
2025Keith Cummings, M.D., M.B.A.Chief Financial Officer49$503.9K$2.4M71
2025Minnie KuoChief Operating Officer45$470.7K$1.5M71
2024Bernard Coulie, M.D., Ph.D., M.B.A.President, Chief Executive Officer and Director60$640.8K$6.6M71
2024Keith Cummings, M.D., M.B.A.Chief Financial Officer49$484.5K$3.1M71
2024Éric Lefebvre, M.D.Former Chief Medical Officer$520.3K$2.6M71

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 85. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Tang Capital Management LLC6,141,261$7.0M0.3%−1,871
ADAR1 Capital Management, LLC5,509,724$6.3M0.3%+2,924,598
Vanguard Capital Management LLC2,440,351$2.8M0.0%+97,250
Two Sigma Investments, LP2,262,832$2.6M0.0%+9,694
Citadel Advisors LLC2,142,226$2.4M0.0%−1,084,373
Renaissance Technologies LLC2,049,874$2.3M0.0%+197,032
Monaco Asset Management SAM1,938,747$2.2M0.8%No change
Lynx1 Capital Management LP1,798,070$2.0M0.2%New
BML Capital Management, LLC1,546,137$1.8M1.0%No change
Prosight Management, LP1,370,233$1.6M0.3%−297,367
Peapod Lane Capital LLC1,309,013$1.5M1.0%+20,435
Woodline Partners LP1,296,534$1.5M0.0%−370,296
BlackRock, Inc.1,151,214$1.3M0.0%+54,784
Ikarian Capital, LLC1,000,000$1.1M0.2%New
Eversept Partners, LP891,425$1.0M0.1%No change
Marshall Wace, Llp835,124$952.0K0.0%−160,849
Redmile Group, LLC772,126$880.2K0.1%No change
Jpmorgan Chase & Co681,647$783.9K0.0%−180,176
Jacobs Levy Equity Management, Inc643,120$733.2K0.0%−75,423
Geode Capital Management, LLC578,577$660.0K0.0%+161,303
UBS Group AG571,760$651.8K0.0%−486,194
Millennium Management LLC559,447$637.8K0.0%−621,071
Bridgeway Capital Management, LLC553,630$631.1K0.0%No change
Connor, Clark & Lunn Investment Management Ltd.536,081$611.1K0.0%+18,628
DAFNA Capital Management LLC487,000$555.2K0.1%No change

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

SEC filer profile

How Pliant (United States) is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARPLIANT THERAPEUTICS, INC.2
  • CIK0001746473
  • Employer ID (EIN)47-42724814
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 312
  • Industry code (SIC)2834 Pharmaceutical Preparations2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address331 Oyster Point Boulevard, South San Francisco, CA 940802
  • Phone650-481-67702
  • Shares outstanding61,921,897 as of Aug 7, 202610
  • Public float$69.5M as of Jun 30, 20254
  • AuditorDeloitte & Touche LLP, San Francisco, California PCAOB ID 34; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceJul 20, 20182
  • Filings438 in all: 4 (189), 8-K (66), 3 (25), SC 13G/A (21), 10-Q (19), SC 13G (15), SCHEDULE 13G/A (12), UPLOAD (8)2
    All 40 form types

    CORRESP (7), S-8 (7), SCHEDULE 13G (7), 10-K (6), DEF 14A (6), DEFA14A (6), 424B5 (4), DRS/A (4), 144 (3), DRSLTR (3), EFFECT (3), 10-K/A (2), 8-A12B (2), D (2), D/A (2), S-1/A (2), S-3ASR (2), 4/A (1), 424B4 (1), 8-K/A (1), ARS (1), CERT (1), DRS (1), POS AM (1), POS EX (1), POSASR (1), PRE 14A (1), PRER14A (1), S-1 (1), S-3 (1), S-3MEF (1), SCHEDULE 13D (1)

  • Latest filingsAnnual report (10-K) Mar 11, 2026
    Quarterly report (10-Q) Aug 11, 2026
    Proxy statement (DEF 14A) Apr 22, 2026
    Latest 8-K (8-K) Aug 11, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.0001 per sharePLRXThe Nasdaq Stock Market LLC
Series A Junior Participating Preferred Purchase RightsThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Mar 11, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Pliant (United States) names in Item 1A of its 10-K filed Mar 11, 2026: 73 risks under these headings, as written.4

  • Our business faces significant risks. If any of the events or circumstances described in the following risks actually occurs, our business may suffer, the trading price of our common stock could decline and our financial condition or results of operations could be harmed. These risks should be read in conjunction with the other information set forth in this Report. The risks and uncertainties described below are not the only ones facing us. There may be additional risks faced by
  • our business. Other events that we do not currently anticipate or that we currently deem immaterial also may adversely affect our financial condition or results of operations.
  • Risks Related to Our Financial Position, Operations and Need for Additional Capital
  • We have incurred significant net losses since inception and we expect to continue to incur significant net losses for the foreseeable future.
  • Our pursuit of internal and external opportunities may not deliver the benefits we expect or enhance shareholder value.
  • We will require substantial additional capital to fund our operations. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and drug development programs, future commercialization efforts or other operations.
  • The amount of our future losses is uncertain and our quarterly operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts, each of which may cause our stock price to fluctuate or decline.
  • Risks Related to Research and Development and the Biopharmaceutical Industry
  • We have a limited operating history, which may make it difficult to evaluate our prospects and likelihood of success.
  • Our business is highly dependent on the success of the product candidates that we advance into the clinic. PLN-101095, our lead program, and our other product candidates will require significant additional development before we may be able to seek regulatory approval for and launch a product commercially.
  • Our approach to drug discovery and development of integrin-based therapeutics is unproven and may not result in a marketable product.
  • Clinical development involves a lengthy, complex, and expensive process, with an uncertain outcome.
The other 63 risks
  • We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of PLN-101095 or any other product candidates.
  • Our ongoing and future clinical trials may reveal significant adverse events or unexpected drug-drug interactions not seen in our preclinical studies and may result in a safety profile that could delay or prevent regulatory approval or market acceptance of PLN-101095 or any of our other product candidates.
  • If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • The design or execution of our ongoing and future clinical trials may not support marketing approval.
  • We may be unable to obtain and maintain orphan drug designation for our product candidates and, even if we obtain such designation, we may not be able to realize the benefits of such designation, including potential marketing exclusivity of our product candidates, if approved.
  • A Fast Track designation by the FDA, even if granted for current or future product candidates, may not lead to a faster development or regulatory review or approval process and does not increase the likelihood that PLN-101095 or our other product candidates will receive marketing approval.
  • Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
  • We may not be successful in our efforts to identify or discover additional product candidates in the future.
  • Due to our limited resources and access to capital, we must make decisions on the allocation of resources to certain programs and product candidates; these decisions may prove to be wrong and may adversely affect our business.
  • If product liability lawsuits are brought against us, we may incur substantial financial or other liabilities and may be required to limit commercialization of PLN-101095 or our other product candidates.
  • We face substantial competition, which may result in others discovering, developing, or commercializing products before or more successfully than us.
  • The biopharmaceutical industry is subject to extensive regulatory obligations and policies that may be subject to significant and abrupt change, including due to judicial challenges, election cycles, and resulting regulatory updates and changes in policy priorities.
  • Risks Related to Marketing, Reimbursement, Healthcare Regulations and Ongoing Regulatory Compliance
  • Even if a product candidate we develop receives marketing approval, it 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.
  • Coverage and reimbursement may be limited or unavailable or pricing unfavorable in certain market segments for our product candidates, if approved, which could make it difficult for us to sell PLN-101095 or any other product candidates profitably.
  • Even if we obtain FDA approval of PLN-101095 or any of our other product candidates, we may never obtain approval or commercialize such products outside of the United States, which would limit our ability to realize their full market potential.
  • We currently have no marketing and sales organization and have no experience as a company in commercializing products, and we may have to invest significant resources to develop these capabilities. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our products, we may not be able to generate product revenue.
  • Our relationships with healthcare providers, physicians, third-party payors, and other potential referral sources will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
  • Even if we receive regulatory approval of PLN-101095 or any other product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.
  • We are evaluating PLN-101095, and may continue to evaluate or develop current or future candidates, in combination with other therapies, which would expose us to additional risks.
  • Ongoing healthcare legislative and regulatory reform measures may have a material adverse effect on our business and results of operations.
  • Inadequate funding for the FDA, the SEC and other government agencies 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.
  • Drug marketing and reimbursement regulations may materially affect our ability to market and secure reimbursement for our products.
  • Additional laws and regulations governing international operations could negatively impact or restrict our operations.
  • We are subject to certain U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions, and other trade laws and regulations. We can face serious consequences for violations.
  • Risks Related to Our Intellectual Property
  • Our success depends in part on our ability to protect our intellectual property. It is difficult and costly to protect our proprietary rights and technology, and we may not be able to ensure their protection.
  • We may enter into license or other collaboration agreements that may impose certain obligations on us. If we fail to comply with our obligations under such agreements with third parties, we could lose license rights that may be important to our future business.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • Third-party claims of intellectual property infringement may prevent or delay our product discovery and development efforts.
  • Our future collaborators may assert ownership or commercial rights to inventions they develop from research we support or that we develop from our use of the tissue samples or other biological materials, which they provide to us, or otherwise arising from such collaboration.
  • Third parties may assert that we are employing their proprietary technology without authorization.
  • Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets.
  • We may not be successful in obtaining or maintaining necessary rights to develop any future product candidates on acceptable terms.
  • We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time consuming and unsuccessful.
  • 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.
  • Any patents covering our product candidates could be found invalid or unenforceable if challenged in court or the USPTO (or foreign patent offices).
  • Changes in patent law in the U.S. and in foreign jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.
  • Patent terms may be inadequate to protect our competitive position on PLN-101095 or our other product candidates for an adequate amount of time.
  • If we do not obtain patent term extension, data exclusivity and orphan exclusivity for PLN-101095 or any other product candidates we may develop, our business may be materially harmed.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
  • Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
  • Risks Related to Our Reliance on Third Parties
  • We rely on third parties to conduct certain aspects of our preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval of or commercialize PLN-101095 or any other potential product candidates.
  • We rely on third parties for tissue samples and other materials required for our research and development activities, and if we are unable to reach agreements with these third parties our research and development activities would be delayed.
  • Because we rely on third-party manufacturing and supply vendors, including single-source vendors and vendors in foreign jurisdictions, including China, our supply of research and development, preclinical and clinical development materials may become limited or interrupted or may not be of satisfactory quantity or quality.
  • If we are unable to enter into new collaborations, or if these collaborations are not successful, our business could be adversely affected.
  • Our suppliers and any future collaborators may need assurances that our financial resources and stability on a stand-alone basis are sufficient to satisfy their requirements for doing or continuing to do business with us.
  • Risks Related to Managing Our Business and Operations
  • As we continue to establish our business and operations at the appropriate scale, we may encounter difficulties in managing our long-term growth and any intervening changes and costs, which could adversely affect our operations.
  • If we lose key management personnel, or if we fail to recruit additional highly skilled personnel, our ability to develop PLN-101095 or other product candidates or identify and develop new product candidates will be impaired, could result in loss of markets or market share and could make us less competitive.
  • Our current operations are concentrated in one location, and we or the third parties upon whom we depend may be adversely affected by earthquakes or other natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster, including earthquakes, outbreak of disease or other natural disasters.
  • Our employees, independent contractors, consultants, commercial partners, collaborators and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • We use and generate materials that may expose us to material liability.
  • 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.
  • Compliance with governmental regulations regarding the treatment of animals used in research could increase our operating costs, which would adversely affect the commercialization of our products.
  • Our ability to use our net operating loss carryforwards and certain tax credit carryforwards may be subject to limitation.
  • Risks Related to Our Common Stock
  • The price of our stock may be volatile, and you could lose all or part of your investment.
  • We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock.
  • Our executive officers, directors and their affiliates and our principal stockholders own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.
  • If there are substantial sales of shares of our common stock, the price of our common stock could decline.
  • Anti-takeover provisions under our charter documents, our stockholder rights agreement, 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.
  • Shareholder activism could cause us to incur significant expense, disrupt our business, result in a proxy contest or litigation and impact our stock price.
  • Our bylaws designate certain courts as the exclusive forum for certain litigation that may be initiated by our stockholders, which could limit our stockholders’ ability to litigate disputes with us in a different judicial forum.
  • General Risk Factors
  • If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, stockholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our common stock.

Legal proceedings

As of the date of this Annual Report, we are not party to any material legal matters or claims. We may become party to legal matters and claims arising in the ordinary course of business. We cannot predict the outcome of any such legal matters or claims, and despite the potential outcomes, the existence thereof may have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.

The opening of Item 3, Legal Proceedings.4

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