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Sutro Biopharma

Logo: Sutro Biopharma, Public domain, via Wikimedia Commons6

Biotechnology company based in South San Francisco, California

Sutro Biopharma, Inc. is a publicly traded biotechnology company headquartered in South San Francisco, California focused on clinical-stage drug discovery, development and manufacturing. Using a proprietary cell-free protein synthesis platform, Sutro is working on oncology therapeutics using protein engineering and rational design. Founded in 2003 under the name Fundamental Applied Biology, the company name changed to Sutro Biopharma in 2009.3 Its shares trade on Nasdaq under the symbol STRO.1 Wikipedia text CC BY-SA 4.0

$11.28 up 0.76 (7.22%)Price as of Oct 15, 2026 at 17:33 UTC

Last updated Oct 21, 2026.

Overview

2003Founded1

Compare with Century Therapeutics (United States), ImmunityBio, Inc. or Acceleron Pharma, or pick any stock.

  • TickerSTRO on Nasdaq1
  • Industrybiotechnology1
  • HeadquartersSouth San Francisco1
  • Websitewww.sutrobio.com
  • Legal formprivately held company1
  • Business address111 Oyster Point Blvd., South San Francisco, Ca 940807
  • Filer categoryNon-accelerated filer, Smaller reporting company7
  • LEI5493005U6P15VD25P8514
  • StatusActive4
  • LEI statusLapsed (not renewed)4
  • Registered addressC/O The Corporation Trust Company, 19801 Wilmington, United States4
  • Registered withDivision of Corporations, Department of State, 36438244

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111 Oyster Point Blvd
Photo: Coolcaesar, CC BY 4.0, via Wikimedia Commons9

Sutro Biopharma, Inc. is a publicly traded biotechnology company headquartered in South San Francisco, California focused on clinical-stage drug discovery, development and manufacturing. Using a proprietary cell-free protein synthesis platform, Sutro is working on oncology therapeutics using protein engineering and rational design. Founded in 2003 under the name Fundamental Applied Biology, the company name changed to Sutro Biopharma in 2009. William Newell, CEO as of 2024, joined Sutro in January 2009.3

Financials

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

Key numbers, fiscal 2025

-154.5%Operating margin10
-186.5%Net margin10
65.2%Revenue growth, 202510

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development100¢$166.4M
  • Income tax0¢$93.0K

Out of $102.5M in revenue.10 The company lost money this year.

Financial statements

Revenue1112131410$102.5M in 2025+140% since 2019
0$50.0M$100.0M$150.0M$200.0M2019: $42.7M$42.7M20192020: $42.7M$42.7M2020−0%2021: $61.9M$61.9M2021+45%2022: $67.8M$67.8M2022+10%2023: $153.7M$153.7M2023+127%2024: $62.0M$62.0M2024−60%2025: $102.5M$102.5M2025+65%
Operating income1112131410-$158.4M in 2025+186% since 2019
-$300.0M-$200.0M-$100.0M02019: -$55.5M-$55.5M20192020: -$71.1M-$71.1M2020+28%2021: -$98.5M-$98.5M2021+39%2022: -$128.9M-$128.9M2022+31%2023: -$89.3M-$89.3M2023−31%2024: -$238.5M-$238.5M2024+167%2025: -$158.4M-$158.4M2025−34%
Net income12131410-$191.1M in 2025+60% since 2019
-$300.0M-$200.0M-$100.0M02019: -$119.2M-$119.2M20192020: -$32.1M-$32.1M2020−73%2021: -$105.5M-$105.5M2021+228%2022: -$119.2M-$119.2M2022+13%2023: -$106.8M-$106.8M2023−10%2024: -$227.5M-$227.5M2024+113%2025: -$191.1M-$191.1M2025−16%

Every line of the income statement as filed: the last 2 fiscal years, latest first.10

Period ending2025-12-312024-12-31
Revenue$102.5M$62.0M
Research and development$166.4M$252.0M
General and administrative$41.0M$48.5M
Restructuring and related costs$53.4M
Total operating expenses$260.9M$300.5M
Loss from operations-$158.4M-$238.5M
Interest income$9.3M$18.6M
Non-cash interest expense related to the sale of future royalties-$38.2M-$31.1M
Interest and other income (expense), net-$3.9M$25.8M
Loss before provision for income taxes-$191.2M-$225.1M
Provision for income taxes-$93.0K$2.4M
Net loss-$191.1M-$227.5M
Net loss per share, basic-$22.49-$29.40
Net loss per share, diluted-$22.49-$29.40
Weighted-average shares used in computing basic net loss per share8.5M shares7.7M shares
Weighted-average shares used in computing diluted net loss per share8.5M shares7.7M shares

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Corporate structure

Sutro Biopharma 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 Sutro Biopharma

  • Sutro Biopharma South San Francisco, 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 Sutro Biopharma 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$38.0M10 Dec 31, 2025$66.8M10 Dec 31, 2024−43.1%
Accumulated depreciation$27.4M10 Dec 31, 2025$48.6M10 Dec 31, 2024−43.8%
Property and equipment, net$10.6M10 Dec 31, 2025$18.2M10 Dec 31, 2024−41.5%
Operating-lease assets (leased space)$10.9M10 Dec 31, 2025$17.7M10 Dec 31, 2024−38.3%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$58.1M10 Dec 31, 2025$190.3M10 Dec 31, 2024−69.5%
Marketable securities, current$83.3M10 Dec 31, 2025$126.6M10 Dec 31, 2024−34.2%
Marketable securities, non-current$010 Dec 31, 2025$010 Dec 31, 2024
Debt securities available for sale$134.6M10 Dec 31, 2025$313.4M10 Dec 31, 2024−57.0%

Properties, in its own words

Our principal executive office is located in South San Francisco, California, where we lease approximately 115,466 square feet for our corporate headquarters and to conduct, or expand, research and development activities. The lease expires in December 2027.

We also have a manufacturing facility and manufacturing-support facility in San Carlos, California, where we lease a total of approximately 29,600 square feet of space in two buildings. In June 2021, we extended the lease of the manufacturing facility and manufacturing-support facility for a period of five years. The lease on such facilities will expire in July 2026 and June 2026, respectively, and both lease terms include the option to renew the lease for an additional five years. We wound down our manufacturing activities in our San Carlos facility in 2025 and do not intend to renew these leases.

Item 2 of the 10-K filed Mar 23, 2026.18

Leadership

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

Chief executive

  1. William J. Newell2018–2025
  2. Jane Chung2025–now

President

  1. William J. Newell2018
  2. Jane Chung2023–2025

Chief financial officer

  1. Edward C. Albini2018–2025
  2. Gregory K. Chow2025–now

Chief operating officer

  1. Jane Chung2023–2025
20052010201520202025
Board members and other officers (27)

Products and brands

Sutro's Xpress CF Platform is based on Stanford Professor James R. Swartz's patented Open Cell-Free Synthesis (OCFS) technology. XpressCF technology enables the parallel expression of hundreds of protein variants in less than 24 hours, providing a platform for the discovery and development of a wide variety of protein classes including cytokines, vaccine carrier-proteins, antibodies, and novel antibody-based proteins. The XpressCF+ platform allows for precise incorporation of non-natural amino acids into a protein sequence, and Sutro is using this technology to develop homogeneous site-specific antibody-drug conjugates (ADCs). Once identified, production of protein drug candidates can be scaled in Sutro's cGMP manufacturing facility located in San Carlos, CA.

Sutro's technology has also contributed to the formation of SutroVax, a vaccine spin off founded in 2015 that has raised over US$170 million in capital.

From Wikipedia’s article on Sutro Biopharma, shared under CC BY-SA 4.0.8

Former names

  • SUTRO BIOPHARMA INCMar 11, 2009 to Nov 8, 20187
  • Fundamental Applied Biology IncNov 8, 2006 to Oct 24, 20077

Timeline

  1. Aug 12, 20268-K Results of operations; Regulation FD disclosure49
  2. Jun 8, 20268-K Shareholder vote50
  3. May 14, 20268-K Results of operations51
  4. Mar 23, 20268-K Ended a material agreement; Results of operations52
  5. Feb 10, 20268-K Entered a material agreement; Regulation FD disclosure53
  6. Dec 17, 20258-K Other events54
  7. Dec 3, 20258-K Change to shareholders' rights; Bylaws or fiscal year changed; Other events55
  8. Nov 6, 20258-K Results of operations56
  9. Sep 29, 20258-K Exit or restructuring costs57
  10. Aug 7, 20258-K Results of operations58
  11. Jun 25, 20258-K Listing notice or transfer59
  12. Jun 10, 20258-K Shareholder vote60
  13. Apr 8, 2025New chief executive Jane Chung becomes CEO19
  14. Sep 26, 2018New chief executive William J. Newell becomes CEO20
  15. 2003Founded Founded1

Calendar

Coming up

  1. Nov 5, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($6.70) a share, on Nov 6, 2025.61

When it reported results

  1. Aug 12, 2026Reported quarterly or annual results49
  2. May 14, 2026Reported quarterly or annual results51
  3. Mar 23, 2026Reported quarterly or annual results52
  4. Nov 6, 2025Reported quarterly or annual results56
  5. Aug 7, 2025Reported quarterly or annual results58
  6. May 8, 2025Reported quarterly or annual results62
  7. Mar 13, 2025Reported quarterly or annual results63
  8. Nov 13, 2024Reported quarterly or annual results64

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

Filings

352 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 57 major events, 182 insider forms, 50 large holders, 43 other. The latest 20:

  1. Sep 22, 20264 EDGAR
  2. Aug 14, 2026SCHEDULE 13G/A EDGAR
  3. Aug 14, 2026SCHEDULE 13G/A EDGAR
  4. Aug 12, 202610-Q EDGAR
  5. Aug 12, 20268-K EDGAR
  6. Jul 30, 2026SCHEDULE 13G EDGAR
  7. Jun 9, 20264 EDGAR
  8. Jun 9, 20264 EDGAR
  9. Jun 9, 20264 EDGAR
  10. Jun 9, 20264 EDGAR
  11. Jun 9, 20264 EDGAR
  12. Jun 9, 20264 EDGAR
  13. Jun 9, 20264 EDGAR
  14. Jun 9, 20264 EDGAR
  15. Jun 8, 20268-K EDGAR
  16. Jun 2, 20264 EDGAR
  17. May 15, 2026SCHEDULE 13G/A EDGAR
  18. May 15, 2026SCHEDULE 13G EDGAR
  19. May 14, 202610-Q EDGAR
  20. May 14, 20268-K EDGAR

The 352 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

9 open-market trades by officers, directors and large owners since October 2021: 6 buys and 3 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Oct 15, 2025Pauling DavidChief Admin. Ofcr. & GCBuy12,504$0.80$10.0KForm 4
Oct 15, 2025Gerber Hans-PeterCHIEF SCIENTIFIC OFFICERBuy17,000$0.80$13.6KForm 4
Oct 15, 2025Chung JaneChief Executive OfficerBuy12,500$0.80$10.0KForm 4
Oct 15, 2025Chow Gregory K.CFOBuy19,750$0.81$16.0KForm 4
Oct 15, 2025MATSUI CONNIEDirectorBuy50,000$0.80$40.0KForm 4
Jan 29, 2024Vasquez NickiCHIEF PORT. STRAT & ALNCE OFCRSale12,185$5.00$60.9KForm 4
Aug 28, 2023Shtylla BrunildaChief Business OfficerSale15,428$4.71$72.7KForm 4
Aug 25, 2023Shtylla BrunildaChief Business OfficerSale11,613$4.59$53.3KForm 4
Mar 14, 2022NEWELL WILLIAM JCEOBuy10,000$7.75$77.5KForm 4

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
2025Former ChiefExecutive Officer$239.7K$1.7M82
2025Chief Executive Officer$652.0K$1.6M82
2025Chief Scientific Officer$527.5K$942.9K82
2025Chief Financial Officer$277.1K$854.5K82
2024Former ChiefExecutive Officer$707.5K$2.3M82
2024Chief Executive Officer$560.0K$1.4M82
2024Chief Scientific Officer$512.5K$1.2M82

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 95. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Perceptive Advisors LLC1,304,846$43.3M0.7%+589,539
Bvf Inc/il1,251,788$41.6M1.1%No change
Affinity Asset Advisors, LLC1,172,487$38.9M1.9%+102,968
BlackRock, Inc.1,122,655$37.3M0.0%+889,971
Samsara Biocapital, LLC1,062,872$35.3M2.9%No change
Kynam Capital Management, LP872,558$29.0M1.6%No change
Orbimed Advisors LLC743,944$24.7M0.5%−57,200
Balyasny Asset Management L.P.711,162$23.6M0.0%+245,370
Vanguard Capital Management LLC694,219$23.0M0.0%−26,223
Eventide Asset Management, LLC585,262$19.4M0.3%−130,045
Velan Capital Investment Management LP512,160$17.0M10.4%No change
Woodline Partners LP458,029$15.2M0.0%+588
ADAR1 Capital Management, LLC404,014$13.4M0.6%−120,427
Geode Capital Management, LLC389,692$12.9M0.0%+218,306
Millennium Management LLC365,972$12.2M0.0%+155,594
State Street Corp305,979$10.2M0.0%+253,861
Merck & Co., Inc.272,351$9.0M1.7%New
Acuta Capital Partners, LLC270,251$9.0M6.3%+826
Ameriprise Financial Inc244,669$8.1M0.0%New
Point72 Asset Management, L.P.237,827$7.9M0.0%−454,284
KVP Capital Advisors, LP226,575$7.5M5.5%No change
UBS Group AG208,512$6.9M0.0%−184,359
Two Sigma Investments, LP201,688$6.7M0.0%+136,512
Vanguard Portfolio Management LLC197,562$6.6M0.0%New
Marshall Wace, Llp175,246$5.8M0.0%−47,388

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

SEC filer profile

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

  • Name on EDGARSUTRO BIOPHARMA, INC.2
  • CIK0001382101
  • Employer ID (EIN)47-092618618
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company18
  • Incorporated inDelaware18
  • Fiscal year endsDecember 312
  • Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address111 Oyster Point Blvd., South San Francisco, CA 940802
  • Phone650-392-84122
  • Shares outstanding16,581,171 as of Aug 7, 202616
  • Public float$60.0M as of Jun 30, 202518
  • AuditorErnst & Young LLP, San Mateo, California PCAOB ID 42; no auditor attestation of internal control over financial reporting18
  • On EDGAR sinceNov 8, 20062
  • Filings624 in all: 4 (297), 8-K (92), 3 (34), SC 13G/A (30), 10-Q (24), SC 13G (19), SCHEDULE 13G/A (13), S-8 (12)2
    All 44 form types

    SCHEDULE 13G (9), 10-K (8), 424B5 (8), CORRESP (8), DEF 14A (8), DEFA14A (7), UPLOAD (7), EFFECT (5), ARS (4), 144 (3), 4/A (3), DRSLTR (3), REGDEX (3), S-3 (3), PRE 14A (2), REGDEX/A (2), 10-K/A (1), 3/A (1), 424B3 (1), 424B4 (1), 8-A12B (1), CERT (1), CT ORDER (1), D (1), D/A (1), DRS (1), DRS/A (1), POS AM (1), POS EX (1), POSASR (1), S-1 (1), S-1/A (1), S-1MEF (1), S-3ASR (1), S-3MEF (1), SC 13D (1)

  • Latest filingsAnnual report (10-K) Mar 23, 2026
    Quarterly report (10-Q) Aug 12, 2026
    Proxy statement (DEF 14A) Apr 22, 2026
    Latest 8-K (8-K) Aug 12, 2026

Securities registered for trading

ClassSymbolExchange
Common stock, $0.001 par valueSTROThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Mar 23, 2026 (Section 12(b) of the Exchange Act).18

Risk factors and legal proceedings

The risks Sutro Biopharma names in Item 1A of its 10-K filed Mar 23, 2026: 75 risks under these headings, as written.18

  • Risks Related to Our Business
  • We are a clinical stage oncology company with no products approved for commercial sale. We have a history of significant losses, 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 our product candidates and failure to obtain sufficient funding may force us to delay, limit or terminate our product development programs, commercialization efforts or other operations. We may have difficulty accessing additional capital on reasonable, or even any, terms to continue our product and platform development or other operations and have made and may have to make again in the future difficult prioritization decisions regarding development and potential partnering of our clinical and preclinical product candidates.
  • Our product candidates are in varying development stages and may fail in development or be impacted by competitive products or suffer delays that materially and adversely affect their commercial viability. If we or our collaborators are unable to complete development of or commercialize our product candidates or experience significant delays in doing so, our business will be materially harmed.
  • Our business is dependent on the success of our product candidates, including STRO-004, STRO-006 and STRO-227, which are generated from our proprietary XpressCF® and XpressCF+® platforms. Existing and future preclinical studies and clinical trials of our product candidates may not be successful. If we are unable to commercialize our product candidates or experience significant delays in doing so, our business will be materially harmed.
  • If we do not achieve our projected development goals in the timeframes we anticipate and project, the commercialization of our products may be delayed and our stock price may decline.
  • Our approach to the discovery and development of our therapeutic treatments is based on novel technologies, including unprecedented dual-payload ADC technology, which includes Immunostimulatory ADCs, that are unproven and may not result in marketable products.
  • Results of preclinical studies and early clinical trials may not be predictive of results of future clinical trials.
  • Interim, top-line, or preliminary data from our clinical trials that we announce may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • The market may not be receptive to our product candidates, and we may not generate any future revenue from the sale or licensing of product candidates.
  • Dual-payload ADC technology is novel, which makes it difficult to predict the time, risks and cost of development and of subsequently obtaining regulatory approval of these potential product candidates.
  • We have entered, and may in the future seek to enter, into collaborations with third parties for the development and commercialization of our product candidates using our XpressCF® and XpressCF+® platforms. If we fail to enter into such collaborations, or such collaborations are not successful, we may not be able to capitalize on the market potential of our XpressCF® and XpressCF+® platforms and resulting product candidates.
The other 64 risks
  • Our existing collaborations with Astellas and Vaxcyte are important to our business. If our collaborators cease development efforts under our existing or future collaboration agreements, fail to fulfill their contract obligations, or if any of those agreements are terminated, these collaborations may fail to lead to commercial products and we may never receive milestone payments or future royalties under these agreements.
  • We may not successfully engage in strategic transactions, including any additional collaborations we seek, which could adversely affect our ability to develop and commercialize product candidates, impact our cash position, increase our expenses and present significant distractions to our management.
  • To date, no product developed on a cell-free manufacturing platform has received approval from the FDA, so the requirements for the manufacturing of products using our XpressCF® and XpressCF+® platforms are uncertain.
  • We expect to rely on third parties to conduct certain of our preclinical studies or clinical trials. If those third parties do not perform as contractually required, fail to satisfy regulatory or legal requirements or
  • miss expected deadlines, our development program could be delayed with potentially material and adverse effects on our business, financial condition, results of operations and prospects.
  • We expect to rely on third parties to manufacture our drug supplies. If those third-parties are unable to manufacture sufficient quantities of our product candidates, or we lose such suppliers, or they fail to comply with applicable regulatory requirements or to supply sufficient quantities at acceptable quality levels or prices, or at all, our business would be materially and adversely affected.
  • U.S.-China trade relations may adversely impact our supply chain operations and business.
  • Our third-party manufacturers may be unable to successfully scale-up manufacturing of our product candidates or materials used to manufacture components of our product candidates in sufficient quality and quantity, which would delay or prevent us from developing our product candidates and commercializing approved products, if any.
  • The manufacture of biologics is complex and our third-party manufacturers may encounter difficulties in production. If any of our third-party manufacturers encounter such difficulties, our ability to provide supply of our product candidates for clinical trials, our ability to obtain marketing approval, or our ability to provide supply of our products, if approved, for patients, could be delayed or stopped.
  • We may not be successful in our efforts to use our XpressCF® and XpressCF+® platforms to expand our pipeline of product candidates and develop marketable products.
  • 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.
  • Failure to successfully validate, develop and obtain regulatory approval for companion diagnostics for our product candidates could harm our drug development strategy and operational results.
  • We face competition from entities that have developed or may develop product candidates for cancer, including companies developing novel treatments and technology platforms. If these companies develop technologies or product candidates more rapidly than we do or their technologies are perceived to be
  • more effective, our ability to develop and successfully commercialize product candidates may be adversely affected.
  • Any inability to attract and retain qualified key management and technical personnel would impair our ability to implement our business plan.
  • We expect we will need to grow our organization in the future, and we may experience difficulties in managing our growth and expanding our operations.
  • If any of our product candidates are approved for marketing and commercialization 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 commercialize successfully any such future products.
  • 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.
  • Price controls imposed in either the U.S. or foreign markets may adversely affect our future profitability.
  • Our business entails a significant risk of product liability and our ability to obtain sufficient insurance coverage could have a material and adverse effect on our business, financial condition, results of operations and prospects.
  • Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • We depend on our information technology systems, and any failure of these systems, or those of our CROs, CDMOs, third-party vendors, or other contractors or consultants we may utilize, could adversely affect our business. Security breaches, cyber-attacks, loss of data, and other disruptions could compromise sensitive information related to our business or other personal information or prevent us from accessing critical information and expose us to liability, which could adversely affect our business, reputation, results of operations, financial condition and prospects.
  • Our information technology systems could face serious disruptions that could adversely affect our business.
  • If we do not comply with laws regulating the protection of the environment and health and human safety, our business could be affected adversely.
  • 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.
  • Our current operations are in the San Francisco Bay Area, and we, or the third parties upon whom we depend, may be adversely affected by earthquakes, other natural disasters, pandemics, or other catastrophic events and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
  • 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 flows, financial condition or results of operations.
  • Our ability to use net operating loss carryforwards to offset taxable income could be limited.
  • Our cash and investments could be adversely affected if the financial institutions in which we hold our cash and investments fail.
  • Our financial results may be adversely affected by changes in accounting principles generally accepted in the United States.
  • Risks Related to Intellectual Property
  • If we are not able to obtain, maintain and enforce sufficient patent and other intellectual property protection for our technologies or product candidates, development and commercialization of our product candidates may be adversely affected.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • Other companies or organizations may challenge our or our licensors’ patent rights or may assert patent rights that prevent us from developing and commercializing our products.
  • We may not be able to protect our intellectual property rights throughout the world.
  • We, our licensors or collaborators, or any future strategic partners may need to resort to litigation to protect or enforce our patents or other proprietary rights, all of which could be costly, time-consuming, delay or prevent the development and commercialization of our product candidates, or put our patents and other proprietary rights at risk.
  • We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market our therapeutics.
  • Intellectual property rights of third parties could adversely affect our ability to commercialize our product candidates, and we, our licensors or collaborators, or any future strategic partners may become subject to third party claims or litigation alleging infringement of patents or other proprietary rights or seeking to invalidate patents or other proprietary rights. We might be required to litigate or obtain licenses from third parties in order to develop or market our product candidates. Such litigation or licenses could be costly or not available on commercially reasonable terms.
  • Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
  • 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 product candidates or we could lose certain rights to grant sublicenses.
  • We may be subject to claims that we or our employees or consultants have wrongfully used or disclosed alleged trade secrets of our employees’ or consultants’ former employers or their clients. These claims may be costly to defend and if we do not successfully do so, we may be required to pay monetary damages and may lose valuable intellectual property rights or personnel.
  • Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • Changes in U.S. patent and ex-U.S. patent laws could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • 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.
  • Risks Related to Government Regulation
  • We and/or our collaborators may be unable to obtain, or may be delayed in obtaining, U.S. or foreign regulatory approval and, as a result, unable to commercialize our product candidates.
  • Delays in obtaining regulatory approval of our manufacturing process may delay or disrupt our commercialization efforts. To date, no product using a cell-free manufacturing process in the United States has received marketing approval from the FDA.
  • Even if we receive regulatory approval for any of our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expenses. Additionally, our product candidates, if approved, could be subject to labeling and other restrictions and market withdrawal. We may also be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our products.
  • We may face difficulties from healthcare legislative reform measures.
  • Our operations and relationships with healthcare providers, healthcare organizations, customers and third-party payors will be subject to applicable anti-bribery, anti-kickback, fraud and abuse, transparency and other healthcare laws and regulations, which could expose us to, among other things, enforcement actions, criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.
  • Our failure to comply with privacy and data security laws, regulations and standards may cause our business to be materially adversely affected.
  • If in the future we are unable to establish U.S. or global sales and marketing capabilities or enter into agreements with third parties to sell and market our product candidates, we may not be successful in commercializing our product candidates if they are approved and we may not be able to generate any revenue.
  • Our product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated.
  • If any of our product candidates receives marketing approval and we or others later identify undesirable side effects caused by the product candidates, our ability to market and derive revenue from the product candidates could be compromised.
  • If we decide to seek Fast Track Designation or Breakthrough Therapy Designation by the FDA for any product candidate, even if successful, it may not lead to a faster development or regulatory review or approval process.
  • If we decide to seek Orphan Drug Designation for some of our product candidates, we may be unsuccessful or may be unable to maintain the benefits associated with Orphan Drug Designation, including the potential for orphan drug exclusivity.
  • If we decide to pursue accelerated approval for any of our product candidates, it may not lead to a faster development or regulatory review or approval process and does not increase the likelihood that our product candidates will receive marketing approval.
  • Risks Related to Our Common Stock
  • Our quarterly and annual 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.
  • Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
  • The exclusive forum provision in our organizational documents may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or any of our directors, officers or other employees, or the underwriters of any offering giving rise to such claim, which may discourage lawsuits with respect to such claims.
  • 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.
  • The market price of our stock may be volatile, and you could lose all or part of your investment.
  • If we fail to maintain compliance with Nasdaq’s minimum listing requirements, our common stock will be subject to delisting. Our ability to publicly or privately sell equity securities and the liquidity of our common stock could be adversely affected if our common stock is delisted.
  • The future sale and issuance of equity or of debt securities that are convertible into equity will dilute our share capital.
  • A sale of a substantial number of shares of our common stock may cause the price of our common stock to decline.
  • General Risk Factors

Legal proceedings

From time to time, we may be involved in legal proceedings arising in the ordinary course of our business. We are not presently a party to any legal proceedings that, in the opinion of management, would have a material adverse effect on our business. Regardless of outcome, litigation can have an adverse impact on us due to defense and settlement costs, diversion of management resources, negative publicity and reputational harm, and other factors.

The opening of Item 3, Legal Proceedings.18

Sources

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