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SRZN on Nasdaq

Surrozen, Inc./DE

In its 2026 annual report the company says: “We are a biotechnology company committed to discovering and developing product candidates to selectively modulate the Wnt pathway, a critical mediator of tissue repair. Our current strategic focus is ophthalmology, where Wnt signaling plays a central role in retinal vascular integrity, barrier function, and tissue maintenance. We are located in South San Francisco, California.”4 Its shares trade on Nasdaq under the symbol SRZN.1

$24.85 up 1.10 (4.63%)Price as of Oct 15, 2026 at 17:33 UTC

Last updated Oct 21, 2026.

Overview

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  • TickerSRZN on Nasdaq1
  • IndustryBiological Products, (No Diagnostic Substances)1
  • HeadquartersSouth San Francisco, California1
  • Incorporated inDE3
  • Business address171 Oyster Point Blvd, Suite 400, South San Francisco, Ca 940803
  • Filer categoryNon-accelerated filer, Smaller reporting company3
  • Legal formCorporation

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We are a biotechnology company committed to discovering and developing product candidates to selectively modulate the Wnt pathway, a critical mediator of tissue repair. Our current strategic focus is ophthalmology, where Wnt signaling plays a central role in retinal vascular integrity, barrier function, and tissue maintenance. We are located in South San Francisco, California.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

-1210.6%Operating margin5
-6960.8%Net margin5
-67.4%Revenue growth, 20255
-$30.4MFree cash flow5

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development100¢$29.4M

Out of $3.5M in revenue.5 The company lost money this year.

Financial statements

Revenue6785$3.5M in 2025
0$5.0M$10.0M$15.0M2021: $0$020212022: $12.5M$12.5M20222023: $0$020232024: $10.7M$10.7M20242025: $3.5M$3.5M2025−67%
Operating income96785-$42.1M in 2025+28% since 2020
-$60.0M-$40.0M-$20.0M02020: -$32.8M-$32.8M20202021: -$54.4M-$54.4M2021+66%2022: -$44.3M-$44.3M2022−18%2023: -$45.8M-$45.8M2023+3%2024: -$25.5M-$25.5M2024−44%2025: -$42.1M-$42.1M2025+65%
Net income96785-$242.0M in 2025+640% since 2020
-$300.0M-$200.0M-$100.0M02020: -$32.7M-$32.7M20202021: -$54.6M-$54.6M2021+67%2022: -$36.0M-$36.0M2022−34%2023: -$43.0M-$43.0M2023+20%2024: -$63.6M-$63.6M2024+48%2025: -$242.0M-$242.0M2025+281%

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

Period ending2025-12-312024-12-31
Revenue$3.5M$10.7M
Total Revenue$3.5M$10.7M
Research and development$29.4M$21.1M
General and administrative$16.2M$15.1M
Total operating expenses$45.6M$36.2M
Loss from operations-$42.1M-$25.5M
Interest income$3.0M$1.7M
Loss on issuance of common stock, pre-funded warrants and warrants in the 2024 PIPE$0-$20.4M
Loss on amendment and cancellation of warrants-$2.1M$0
Loss on execution of the 2025 PIPE-$71.1M$0
Loss on change in fair value of tranche liability-$104.8M$0
Gain on settlement of tranche liability$1.4M$0
Other expense, net-$26.3M-$19.3M
Net loss and comprehensive loss-$242.0M-$63.6M
Net loss per share attributable to common stockholders, basic-$32.37-$21.67
Net loss per share attributable to common Stockholders, diluted-$32.37-$21.67
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic7.5K shares2.9K shares
Weighted-average shares used in computing net loss per share attributable to common stockholders, diluted7.5K shares2.9K shares

Compare Surrozen, Inc./DE with another company

Corporate structure

Surrozen, Inc./DE 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 Surrozen, Inc./DE

  • Surrozen, Inc./DE 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 Surrozen, Inc./DE 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$8.8M5 Dec 31, 2025$8.4M5 Dec 31, 2024+4.7%
Accumulated depreciation$8.4M5 Dec 31, 2025$7.8M5 Dec 31, 2024+6.7%
Property and equipment, net$433.0K5 Dec 31, 2025$562.0K5 Dec 31, 2024−23.0%
Operating-lease assets (leased space)$6.0M5 Dec 31, 2025$7.8M5 Dec 31, 2024−23.1%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$89.2M5 Dec 31, 2025$34.6M5 Dec 31, 2024+158.2%

Properties, in its own words

Our principal executive office is located in South San Francisco, California, pursuant to a lease that expires in April 2029. We believe that our current facility is adequate to meet our ongoing needs and, if we require additional space, we will be able to obtain additional facilities on commercially reasonable terms.

Item 2 of the 10-K filed Mar 23, 2026.4

Leadership

Who has led Surrozen, Inc./DE, and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Craig C. Parker2021–now

Chief financial officer

  1. Kevin Harold Livingston2020–2021
  2. Andrew Pedrum Maleki2025–now
2025
Board members and other officers (18)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive OfficerCharles Williams named Apr 19, 2024 to Apr 8, 202532
  • Executive OfficerYang J. Li, Ph.D. named Apr 8, 202532
  • DirectorDavid J. Woodhouse, Ph.D. named Apr 19, 2024 to Apr 8, 202532
  • DirectorMace J. Rothenberg, M.D. named Apr 19, 2024 to Apr 8, 202532
  • DirectorMary J. Haak-Frendscho, Ph.D. named Apr 19, 2024 to Apr 8, 202532
  • DirectorShao-Lee J. Lin, M.D., Ph.D. named Apr 19, 2024 to Apr 8, 202532
  • DirectorTim J. Kutzkey, Ph.D. named Apr 19, 2024 to Apr 8, 202532

Former names

  • Consonance-HFW Acquisition Corp.Sep 18, 2020 to Aug 11, 20213

Timeline

  1. Oct 2, 20268-K Other events33
  2. Aug 6, 20268-K Results of operations34
  3. May 14, 20268-K Shareholder vote35
  4. May 6, 20268-K Results of operations36
  5. Mar 23, 20268-K Results of operations37
  6. Jan 30, 20268-K Executive or director change38
  7. Nov 7, 20258-K Results of operations; Executive or director change39
  8. Oct 17, 20258-K Ended a material agreement40
  9. Aug 29, 20258-K Entered a material agreement41
  10. Aug 8, 20258-K Results of operations42
  11. May 15, 20258-K Shareholder vote43
  12. May 9, 20258-K Results of operations44
  13. Aug 16, 2021New chief executive Craig C. Parker becomes CEO12

Calendar

Coming up

  1. Nov 6, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($3.61) a share, on Nov 7, 2025.45

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results34
  2. May 6, 2026Reported quarterly or annual results36
  3. Mar 23, 2026Reported quarterly or annual results37
  4. Nov 7, 2025Reported quarterly or annual results39
  5. Aug 8, 2025Reported quarterly or annual results42
  6. May 9, 2025Reported quarterly or annual results44
  7. Mar 31, 2025Reported quarterly or annual results46
  8. Nov 6, 2024Reported quarterly or annual results47

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

Filings

355 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 48 major events, 128 insider forms, 65 large holders, 2 private raises, 92 other. The latest 20:

  1. Oct 7, 2026SCHEDULE 13G/A EDGAR
  2. Oct 2, 20268-K EDGAR
  3. Oct 1, 2026SCHEDULE 13G EDGAR
  4. Aug 14, 2026SCHEDULE 13G/A EDGAR
  5. Aug 14, 2026SCHEDULE 13G EDGAR
  6. Aug 14, 2026SCHEDULE 13G/A EDGAR
  7. Aug 11, 2026SCHEDULE 13G/A EDGAR
  8. Aug 7, 202625-NSE EDGAR
  9. Aug 6, 202610-Q EDGAR
  10. Aug 6, 20268-K EDGAR
  11. Jul 24, 2026SCHEDULE 13G/A EDGAR
  12. Jul 24, 20264 EDGAR
  13. Jun 16, 20264 EDGAR
  14. Jun 16, 20264 EDGAR
  15. Jun 16, 20264 EDGAR
  16. Jun 16, 20264 EDGAR
  17. May 19, 20264 EDGAR
  18. May 18, 2026SCHEDULE 13D/A EDGAR
  19. May 15, 2026SCHEDULE 13G/A EDGAR
  20. May 15, 2026SCHEDULE 13G/A EDGAR

The 355 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

44 open-market trades by officers, directors and large owners since October 2021: 35 buys and 9 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jul 22, 2026Yu Chen-Ming10% ownerSale325,000$21.25$6.9MForm 4
May 4, 2026Li YangExec. Vice President, ResearchSale1,584$33.33$52.8KForm 4
May 4, 2026Williams Charles OChief Operating OfficerSale2,036$33.33$67.9KForm 4
May 4, 2026Parker Craig CChief Executive OfficerSale4,524$33.33$150.8KForm 4
Mar 24, 2026TCG Crossover Fund II, L.P.10% ownerBuy106,658$24.69$2.6MForm 4
Mar 23, 2026TCG Crossover Fund II, L.P.10% ownerBuy15,223$24.90$379.1KForm 4
Mar 16, 2026TCG Crossover Fund II, L.P.10% ownerBuy1,190$24.99$29.7KForm 4
Mar 13, 2026TCG Crossover Fund II, L.P.10% ownerBuy35,433$24.88$881.6KForm 4
Mar 12, 2026TCG Crossover Fund II, L.P.10% ownerBuy12,374$24.99$309.2KForm 4
Feb 12, 2026TCG Crossover Fund II, L.P.10% ownerBuy1,093$23.86$26.1KForm 4
Feb 11, 2026TCG Crossover Fund II, L.P.10% ownerBuy17,763$23.58$418.9KForm 4
Feb 3, 2026TCG Crossover GP III, LLC10% ownerBuy4,355$21.94$95.5KForm 4
Feb 2, 2026TCG Crossover GP III, LLC10% ownerBuy731$21.38$15.6KForm 4
Jan 30, 2026TCG Crossover GP III, LLC10% ownerBuy4,271$21.39$91.4KForm 4
Jan 20, 2026Column Group Opportunity III GP, LP10% ownerBuy18,052$19.60$353.8KForm 4
Jan 20, 2026Kutzkey TimDirectorBuy18,052$19.60$353.8KForm 4
Jan 16, 2026Column Group Opportunity III GP, LP10% ownerBuy2,562$20.00$51.2KForm 4
Jan 16, 2026Kutzkey TimDirectorBuy2,562$20.00$51.2KForm 4
Jan 15, 2026Column Group Opportunity III GP, LP10% ownerBuy11,893$19.89$236.6KForm 4
Jan 15, 2026Kutzkey TimDirectorBuy11,893$19.89$236.6KForm 4

All 44 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
2025Craig Parker$630.0K$2.8M75
2025Charles Williams$485.0K$1.5M75
2025Yang LiPh.D.$456.5K$1.3M75
2024President and ChiefExecutive Officer$605.0K$1.5M75
2024Chief Operating Officer and Corporate Secretary$463.3K$1.0M75
2024Executive Vice PresidentResearch$415.0K$847.2K75

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$269.4M 2024–2025
Money received by yearMoney received by year, 2024–2025: $269.4M in all. Private raises (Form D) $269.4M.$0$50M$100M$150M$200M2024 · Private raises (Form D): $193.0M20242025 · Private raises (Form D): $76.4M2025
Figures by year
YearPrivate raises (Form D)Total
2025$76.4M$76.4M
2024$193.0M$193.0M

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. Mar 26, 2025Raised $76.4 million in a private offering of equity32 Form D: $175 million offered in all Form D
  2. Apr 4, 2024Raised $193 million in a private offering of equity76 Form D: 18 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 69. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
TCG Crossover Management, LLC1,473,101$38.2M0.9%No change
Boxer Capital Management, LLC1,105,683$27.0M2.0%+339,365
Kalehua Capital Management LLC770,356$20.0M6.4%No change
Millennium Management LLC683,079$17.7M0.0%−48,059
Point72 Asset Management, L.P.664,272$17.2M0.0%New
Venrock Adviser, LLC632,931$16.4M0.5%No change
Stempoint Capital LP602,798$13.8M2.4%−118,822
Perceptive Advisors LLC503,985$13.1M0.2%+274,592
Spruce Street Capital LP432,040$11.2M2.2%No change
BlackRock, Inc.394,864$10.2M0.0%+367,013
Vanguard Capital Management LLC392,550$10.2M0.0%+223,458
Braidwell LP390,753$10.1M0.4%−5,347
Vestal Point Capital, LP304,669$7.9M0.2%−33,942
5AM Venture Management, LLC271,250$7.0M2.4%−116,250
Vivo Capital, LLC260,000$6.7M0.6%No change
Balyasny Asset Management L.P.205,032$5.3M0.0%+1,144
Geode Capital Management, LLC201,652$5.2M0.0%+135,803
Acuta Capital Partners, LLC173,395$4.5M3.1%+548
Regents Of The University Of California133,207$3.5M0.1%No change
State Street Corp133,084$3.5M0.0%+105,358
Goldman Sachs Group Inc113,531$2.9M0.0%+87,680
Adage Capital Partners Gp, L.l.c.88,653$2.3M0.0%No change
Euclidean Capital LLC87,696$2.3M0.5%No change
Two Sigma Investments, LP71,119$1.8M0.0%+31,637
Northern Trust Corp63,609$1.7M0.0%+51,344

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

SEC filer profile

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

  • Name on EDGARSurrozen, Inc./DE1
  • CIK0001824893
  • Employer ID (EIN)30-13748894
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 311
  • Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address171 Oyster Point Blvd, Suite 400, South San Francisco, CA 940801
  • Phone650-475-28201
  • Shares outstanding11,753,558 as of Aug 4, 202611
  • Public float$59.7M as of Jun 30, 20254
  • AuditorErnst & Young LLP, San Francisco, California PCAOB ID 42; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceSep 18, 20201
  • Filings492 in all: 4 (142), 8-K (58), 424B3 (29), 3 (27), SCHEDULE 13G/A (26), CORRESP (19), 10-Q (18), SCHEDULE 13G (14)1
    All 44 form types

    SC 13G (13), EFFECT (12), SC 13G/A (11), 4/A (10), 425 (10), 3/A (8), UPLOAD (8), 424B5 (7), S-8 (7), SC 13D/A (7), 10-K (6), DEF 14A (6), DEFA14A (6), S-1/A (6), S-3 (5), ARS (4), CERT (3), POS AM (3), S-1 (3), SCHEDULE 13D/A (3), 10-K/A (2), 8-A12B (2), D (2), S-4/A (2), SC 13D (2), 10-Q/A (1), 25 (1), 25-NSE (1), 424B4 (1), 8-A12B/A (1), DEFM14A (1), DRS (1), NT 10-K (1), NT 10-Q (1), PRE 14A (1), S-4 (1)

  • Latest filingsAnnual report (10-K) Mar 23, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Apr 1, 2026
    Latest 8-K (8-K) Oct 2, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.0001 par value per shareSRZNNasdaq
Redeemable warrants, each whole warrant exercisable for one-fifteenth of a share of Common StockSRZNWNasdaq

From the cover page of the 10-K filed Mar 23, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Surrozen, Inc./DE names in Item 1A of its 10-K filed Mar 23, 2026: 76 risks under these headings, as written.4

  • Risks Related to Our Business
  • We are a biopharmaceutical company with a history of losses. We expect to continue to incur significant losses for the foreseeable future and may never achieve or maintain profitability, which could result in a decline in the market value of our common stock.
  • We will need substantial additional funds to advance development of product candidates of our Wnt therapeutics platform, and we cannot guarantee that we will have sufficient funds available in the future to develop and commercialize our current or potential future product candidates.
  • None of our product candidates have received regulatory approval; our ability to achieve and sustain profitability depends on obtaining regulatory approval and successfully commercializing product candidates, either alone or with collaborators.
  • Our product candidates that are tested in humans may not demonstrate the safety, purity and potency, or efficacy, necessary to become approvable or commercially viable.
  • We may not be successful in our efforts to use and expand our Wnt therapeutics platform to build a pipeline of product candidates.
  • Although we intend to explore other therapeutic opportunities, in addition to the product candidates that we are currently developing, we may fail to identify viable new product candidates for clinical development for a number of reasons. If we fail to identify additional potential product candidates, our business could be materially harmed.
  • The market may not be receptive to our current or potential future product candidates, and we may not generate any revenue from the sale or licensing of our product candidates.
  • If any current or future product candidate, after it begins clinical trials or receives marketing approval, demonstrates undesirable safety or tolerability side effects or safety concerns, our ability to market and derive revenue from the product candidate could be compromised.
  • We have incurred significant operating losses since inception and anticipate that we will incur continued losses for the foreseeable future.
  • Any future equity or debt issuances or other financing transactions may have dilutive or adverse effects on our existing stockholders.
  • We may expend our limited resources to pursue a particular product candidate and fail to capitalize on product candidates that may be more profitable or for which there is a greater likelihood of success.
The other 65 risks
  • Interim, topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available or as additional analyses are conducted, and as the data are subject to audit and verification procedures that could result in material changes in the final data.
  • We may not be able to enter into strategic transactions on acceptable terms, if at all, which could adversely affect our ability to develop and commercialize current and potential future product candidates, impact our cash position, increase our expense, and present significant distractions to our management.
  • We rely on third parties to conduct our preclinical studies and clinical trials, and those third parties may not perform satisfactorily.
  • We and our collaborators may not achieve projected discovery and development milestones and other anticipated key events in the time frames that such collaborators announce, which could have an adverse impact on our business and could cause our stock price to decline.
  • Clinical trials are expensive, time-consuming and difficult to design and implement, which may cause delays in our development timelines, increase costs, and limit our ability to timely complete our trials.
  • Our clinical development activities could be delayed or otherwise adversely affected for various reasons.
  • We may not be able to conduct, or contract with others to conduct, animal testing in the future, which could harm our research and development activities.
  • The manufacturing of our product candidates is complex. We and our third-party manufacturers may encounter difficulties in production. If we encounter any such difficulties, our ability to supply our product candidates for clinical trials or, if approved, for commercial sale, could be delayed or halted entirely.
  • Because we may rely on third parties for manufacturing and supply of our product candidates, some of which may be sole source vendors, for preclinical and clinical development materials and commercial supplies, our supply may become limited or interrupted or may not be of satisfactory quantity or quality.
  • Our third-party manufacturers may be unable to successfully scale manufacturing of our lead product candidates in sufficient quality and quantity, which would delay or prevent us from developing our current and future product candidates and, if approved, commercializing product candidates.
  • We or the third parties upon whom we depend may be adversely affected by natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
  • Changes in methods of product candidate manufacturing or formulation may result in the need to perform new clinical trials, which would require additional costs and cause delay.
  • If the market opportunities for our current and potential future product candidates are smaller than we believe they are, our future product revenues may be adversely affected and our business may suffer.
  • We face competition from entities that have developed or may develop product candidates for the treatment of the diseases that we may target, including companies developing novel treatments and therapeutic platforms. If these companies develop therapeutics or product candidates more rapidly than we do, or if their therapeutics or product candidates are more effective or have fewer side effects, our ability to develop and successfully commercialize product candidates may be adversely affected.
  • If we are unable to maintain proper and effective internal controls over financial reporting, the accuracy and timeliness of our financial reporting and the market price of our common stock may be adversely affected.
  • Our ability to use net operating loss carryforwards, or NOLs, to offset future taxable income may be subject to certain limitations.
  • Any inability to attract and retain qualified key management, technical personnel and employees would impair our ability to implement our business plan.
  • We may experience difficulties in managing growth and expanding operations.
  • If any of our product candidates is approved for marketing and commercialization in the future and we are unable to develop sales, marketing and distribution capabilities on our own or enter into agreements with third parties to perform these functions on acceptable terms, we will be unable to successfully commercialize any such future products.
  • Our international operations may expose us to business, political, operational and financial risks associated with doing business outside of the United States.
  • 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.
  • International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects.
  • Our business entails a significant risk of product liability, and our inability to obtain sufficient insurance coverage could have a material and adverse effect on our business, financial condition, results of operations and prospects.
  • Our employees, principal investigators, consultants and commercial collaborators may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • Failure to comply with health and data protection laws and regulations could lead to government enforcement actions (which could include civil or criminal penalties), private litigation or adverse publicity and could negatively affect our operating results and business.
  • We depend on sophisticated information technology systems and data processing to operate our business. If we experience 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, we may face costs, significant liabilities, harm to our brand and business disruption.
  • If we do not comply with laws regulating the protection of the environment and health and human safety, our business could be adversely affected.
  • Our business, operations and clinical development plans and timelines could be adversely affected by the effects of health epidemics, natural disasters and other events on the manufacturing, clinical trial and other business activities performed by us or by third parties with whom it conducts business, including contract manufacturers, CROs, shippers and others.
  • To the extent we enter into any other collaborations, we may depend on such collaborations for the development and commercialization of our product candidates. If those collaborations are not successful, we may not be able to capitalize on the market potential of our product candidates.
  • Collaborations are complex and time-consuming to negotiate and document, and if we fail to enter into new strategic relationships, our business, financial condition, commercialization prospects and results of operations may be materially adversely affected.
  • Risks Related to Our Intellectual Property
  • If we are unable to obtain or protect intellectual property rights related to our technology and current or future product candidates, or if our intellectual property rights are inadequate, we may not be able to compete effectively.
  • The patent protection and patent prosecution for some of our product candidates may be dependent on third parties.
  • In the future, we may enter into agreements involving licenses or collaborations that provide for access or sharing of intellectual property. If we fail to comply with our obligations under any license, collaboration or other agreements, we may be required to pay damages and could lose intellectual property rights that are necessary for developing and protecting our current and future product candidates.
  • If we fail to comply with our obligations under any license, collaboration or other intellectual property-related agreements, we may be required to pay damages and could lose intellectual property rights that may be necessary for developing, commercializing and protecting our current or future technologies or product candidates or we could lose certain rights to grant sublicenses.
  • Patent terms may not be able to protect our competitive position for an adequate period of time with respect to our current or future technologies or product candidates.
  • Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our current or any future technologies or product candidates.
  • Other companies or organizations may challenge our or our licensors’ patent rights, which could require significant time and attention of our management, require costs to defend, and could have a material and adverse impact on our profitability, financial condition, and prospects.
  • We may not be able to protect our intellectual property rights throughout the world, which could negatively impact our business.
  • Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or violating their intellectual property rights, the outcome of which would be uncertain and could have a material adverse impact on the success of our business.
  • Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of our common stock to decline.
  • Intellectual property rights of third parties could adversely affect our ability to commercialize our current or future technologies or product candidates, and we might be required to litigate or obtain licenses from third parties to develop or market our current or future technologies or product candidates, which may not be available on commercially reasonable terms or at all.
  • If, in the future, we develop trade secrets and are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • We may be subject to claims that we or our employees or consultants have wrongfully used or disclosed alleged trade secrets or other proprietary information of our employees’ or consultants’ former employers or their clients.
  • We may be subject to claims challenging the inventorship of our patents and other intellectual property.
  • We may not be successful in obtaining or maintaining necessary rights to our product candidates through acquisitions and in-licenses.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • Some intellectual property that we have in-licensed may have been discovered through government funded programs and thus may be subject to federal regulations such as “march-in” rights, certain reporting requirements and a preference for U.S.-based companies. Compliance with such regulations may limit our exclusive rights and limit our ability to contract with non-U.S. manufacturers.
  • 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 business.
  • Risks Related to Government Regulation
  • Clinical development includes a lengthy and expensive process with an uncertain outcome, we may have negative results and results of earlier studies and trials may not be predictive of future trial results.
  • We may be unable to obtain U.S. or foreign regulatory approval and, as a result, be unable to commercialize current or potential future product candidates.
  • Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that it will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.
  • Even if we receive regulatory approval for any of our current or potential future product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense. Additionally, our current or potential future product candidates, if approved, could be subject to labeling and other restrictions and market withdrawal and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our products.
  • Healthcare legislative reform measures may have a material adverse effect on our business and results of operations.
  • If we or our existing or potential future collaborators, manufacturers or service providers fail to comply with healthcare laws and regulations, we or they could be subject to enforcement actions, which could affect our ability to develop, market and sell our product candidates and may harm our reputation.
  • If we fail to comply with U.S. and foreign regulatory requirements, regulatory authorities could limit or withdraw any marketing or commercialization approvals we may receive and subject us to other penalties that could materially harm its business.
  • Even if we are able to commercialize any product candidate, such product candidate may become subject to unfavorable pricing regulations or third-party coverage and reimbursement policies, which would harm our business.
  • We are subject to U.S. and foreign anti-corruption and anti-money laundering laws with respect to our operations and non-compliance with such laws can subject us to criminal or civil liability and harm its business.
  • 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 product candidates 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 its business.
  • Risks Related to Ownership of Our Shares
  • Our stock price may be volatile and purchasers of our common stock could incur substantial losses.
  • Because our management will have flexibility in allocating our cash, you may not agree with how we use our cash and it may not be invested successfully.
  • We may issue additional shares of common stock or other equity securities without your approval, including pursuant to our employee stock plans, and holders of warrants and options may choose to exercise their warrants and options requiring us to issue shares of common stock; all of these actions would dilute your ownership interest and may depress the market price of our common stock.
  • A few stockholders, including one of our directors, control the voting rights with respect to a large number of shares of our common stock and could exercise their voting power in a manner that adversely affects us or our stockholders.
  • Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.
  • Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of our company, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.

Legal proceedings

From time to time, we may be subject to legal proceedings. We are not currently a party to or aware of any proceedings that we believe will have, individually or in the aggregate, a material adverse effect on our business, financial condition or results of operations. Regardless of outcome, litigation can 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

Sources

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