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SYRE on Nasdaq

Aeglea BioTherapeutics

Aeglea BioTherapeutics is a business enterprise in the United States founded in 2013.1 It is headquartered in Austin.1 Its shares trade on Nasdaq under the symbol SYRE.1

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Last updated Oct 21, 2026.

Overview

Jan 1, 2013Founded1

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  • TickerSYRE on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersAustin1
  • Websiteaegleabio.com
  • Incorporated inDE3
  • Business address221 Crescent Street, Building 23, Suite 105, Waltham, Ma 024533
  • Filer categoryLarge accelerated filer3
  • Legal formCorporation

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Spyre Therapeutics, Inc. (NASDAQ: SYRE) is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre’s pipeline includes extended half-life antibodies targeting α4β7, TL1A, and IL-23 in development as monotherapies and pair-wise combinations.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

-21.7%Return on equity5

Financial statements

Revenue67895$0 in 2025
0$5.0M$10.0M$15.0M$20.0M2019: $0$020192020: $0$020202021: $18.7M$18.7M20212022: $2.3M$2.3M2022−88%2023: $886.0K$886.0K2023−62%2024: $0$020242025: $0$02025
Operating income67895-$209.6M in 2025+161% since 2019
-$300.0M-$200.0M-$100.0M02019: -$80.3M-$80.3M20192020: -$81.5M-$81.5M2020+1%2021: -$65.6M-$65.6M2021−19%2022: -$84.8M-$84.8M2022+29%2023: -$242.3M-$242.3M2023+186%2024: -$208.6M-$208.6M2024−14%2025: -$209.6M-$209.6M2025+0%
Net income67895-$155.2M in 2025+98% since 2019
-$400.0M-$300.0M-$200.0M-$100.0M02019: -$78.3M-$78.3M20192020: -$80.9M-$80.9M2020+3%2021: -$65.8M-$65.8M2021−19%2022: -$83.8M-$83.8M2022+27%2023: -$338.8M-$338.8M2023+304%2024: -$208.0M-$208.0M2024−39%2025: -$155.2M-$155.2M2025−25%

Every line of the income statement as filed: the last 3 fiscal years, latest first.5

Period ending2025-12-312024-12-312023-12-31
Total revenue$0$0$886.0K
Acquired in-process research and development$0$0$130.2M
Gain on sale of in-process research and development asset-$10.0M$0-$16.4M
Total operating expenses$209.6M$208.6M$243.2M
Loss from operations-$209.6M-$208.6M-$242.3M
Interest income$24.9M$21.3M$6.1M
Other income (expense), net$29.5M-$20.7M-$19.1M
Total other income (expense)$54.3M$599.0K-$96.5M
Loss before income tax expense-$155.2M-$208.0M-$338.8M
Income tax benefit (expense)$15.0K-$51.0K$26.0K
Net loss-$155.2M-$208.0M-$338.8M
Research and development$171.7M$162.8M$89.5M
General and administrative$47.9M$45.8M$39.9M

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Corporate structure

Aeglea BioTherapeutics 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 Aeglea BioTherapeutics

  • Fairmount Funds Management LLC Filed SCHEDULE 13D/A on Aeglea BioTherapeutics, latest Oct 9, 2026 (9 filings since Jun 30, 2023)
  • Paradigm Biocapital Advisors LP Filed SCHEDULE 13G on Aeglea BioTherapeutics, latest Oct 1, 2026
  • PERCEPTIVE ADVISORS LLC Filed SCHEDULE 13G/A on Aeglea BioTherapeutics, latest Aug 14, 2026 (6 filings since Dec 13, 2023)
  • RTW INVESTMENTS, LP Filed SCHEDULE 13G/A on Aeglea BioTherapeutics, latest Aug 14, 2026 (3 filings since Feb 14, 2024)
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on Aeglea BioTherapeutics, latest Mar 27, 2026 (2 filings since Jul 29, 2025)
  • TANG CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G/A on Aeglea BioTherapeutics, latest Feb 17, 2026 (2 filings since May 1, 2025)
  • BlackRock Filed SCHEDULE 13G/A on Aeglea BioTherapeutics, latest Jul 16, 2025 (5 filings since Feb 3, 2022)
  • Venrock Healthcare Capital Partners III, L.P. Filed SCHEDULE 13G/A on Aeglea BioTherapeutics, latest Feb 14, 2025 (4 filings since Jul 10, 2023)
  • Avoro Capital Advisors LLC Filed SC 13G/A on Aeglea BioTherapeutics, latest Nov 14, 2024 (3 filings since Feb 14, 2024)
  • Commodore Capital LP Filed SC 13G/A on Aeglea BioTherapeutics, latest Nov 14, 2024 (3 filings since Dec 1, 2023)
  • Deep Track Capital, LP Filed SC 13G/A on Aeglea BioTherapeutics, latest Nov 14, 2024 (3 filings since Jun 30, 2023)
  • FMR LLC Filed SC 13G/A on Aeglea BioTherapeutics, latest Nov 12, 2024 (5 filings since Feb 9, 2024)
  • Aeglea BioTherapeutics Austin

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

What it owns

What Aeglea BioTherapeutics 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.

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$85.7M5 Dec 31, 2025$89.4M5 Dec 31, 2024−4.1%
Marketable securities, current$670.8M5 Dec 31, 2025$513.7M5 Dec 31, 2024+30.6%

Properties, in its own words

We do not maintain physical corporate offices. Our employees work remotely. We believe these arrangements support our current needs. We maintain a mailing address at 221 Crescent St., Building 23, Suite 105, Waltham, MA 02453. As we expand, we believe that suitable additional alternative spaces will be available in the future on commercially reasonable terms, if required.

Item 2 of the 10-K filed Feb 19, 2026.4

Leadership

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

Chief executive

  1. David George Lowe2016–2017
  2. Anthony Quinn2017–2022
  3. James Paul Kastenmayer2022
  4. Cameron Turtle2023–now

President

  1. David George Lowe2016–2017
  2. Anthony Quinn2018–2022
  3. Jonathan Alspaugh2023

Chief financial officer

  1. Charles N. York Ii.2016–2020
  2. Jonathan Alspaugh2021–2023
  3. Scott L. Burrows2023–now

Chief operating officer

  1. Leslie Sloan2019–2022
201520202025
Board members and other officers (38)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive OfficerCortney Caudill named Jul 6, 202355
  • DirectorIvana J. Magovcevic-Liebisch named Jul 6, 202355

Former names

  • Aeglea BioTherapeutics, Inc.Mar 24, 2015 to Nov 24, 20233

Timeline

  1. Oct 7, 20268-K Entered a material agreement56
  2. Sep 8, 20268-K Regulation FD disclosure; Other events57
  3. Aug 25, 20268-K Regulation FD disclosure; Other events58
  4. Aug 4, 20268-K Results of operations59
  5. Jun 15, 20268-K Regulation FD disclosure; Other events60
  6. Jun 1, 20268-K Other events61
  7. May 29, 20268-K Executive or director change; Shareholder vote62
  8. May 5, 20268-K Results of operations63
  9. Apr 16, 20268-K Entered a material agreement64
  10. Apr 13, 20268-K Regulation FD disclosure; Other events65
  11. Apr 13, 20268-K Results of operations; Other events66
  12. Feb 19, 20268-K Results of operations67
  13. Nov 27, 2023New chief executive Cameron Turtle becomes CEO13
  14. Aug 25, 2022New chief executive James Paul Kastenmayer becomes CEO14
  15. Sep 1, 2017New chief executive Anthony Quinn becomes CEO15
  16. Apr 6, 2016New chief executive David George Lowe becomes CEO16
  17. Jan 1, 2013Founded Founded1

Calendar

Coming up

  1. Nov 3, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.15) a share, on Nov 4, 2025.68

When it reported results

  1. Aug 4, 2026Reported quarterly or annual results59
  2. May 5, 2026Reported quarterly or annual results63
  3. Apr 13, 2026Reported quarterly or annual results66
  4. Feb 19, 2026Reported quarterly or annual results67
  5. Nov 4, 2025Reported quarterly or annual results69
  6. Oct 14, 2025Reported quarterly or annual results70
  7. Aug 5, 2025Reported quarterly or annual results71
  8. May 8, 2025Reported quarterly or annual results72

Drug trials and FDA: recently

  1. Dec 15, 2022Phase 2 trial completed Phase 2 trial of AEB1102 in Arginase I Deficiency, run by Immedica Pharma AB: primary completion Dec 15, 2022, results posted Sep 24, 2026 (ClinicalTrials.gov NCT03378531).73

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar

Filings

455 filings to the SEC since October 2021: 7 annual reports, 18 quarterly reports, 90 major events, 132 insider forms, 80 large holders, 2 private raises, 126 other. The latest 20:

  1. Oct 9, 2026SCHEDULE 13D/A EDGAR
  2. Oct 7, 20268-K EDGAR
  3. Oct 6, 2026424B5 EDGAR
  4. Oct 5, 2026424B5 EDGAR
  5. Oct 2, 20264 EDGAR
  6. Oct 2, 20264 EDGAR
  7. Oct 2, 20264 EDGAR
  8. Oct 1, 2026144 EDGAR
  9. Oct 1, 2026144 EDGAR
  10. Oct 1, 2026SCHEDULE 13G EDGAR
  11. Sep 30, 2026144 EDGAR
  12. Sep 8, 20268-K EDGAR
  13. Sep 3, 20264 EDGAR
  14. Sep 3, 20264 EDGAR
  15. Sep 3, 20264 EDGAR
  16. Sep 1, 2026144 EDGAR
  17. Aug 25, 20268-K EDGAR
  18. Aug 14, 2026SCHEDULE 13G/A EDGAR
  19. Aug 14, 2026SCHEDULE 13G/A EDGAR
  20. Aug 10, 20264 EDGAR

The 455 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

47 open-market trades by officers, directors and large owners since October 2021: 13 buys and 34 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 2, 2026King-Jones HeidySee RemarksSale400$90.00$36.0KForm 4
Sep 2, 2026Burrows Scott LChief Financial OfficerSale18,232$89.35$1.6MForm 4
Sep 1, 2026King-Jones HeidySee RemarksSale27,999$87.31$2.4MForm 4
Sep 1, 2026Burrows Scott LChief Financial OfficerSale7,500$87.31$654.8KForm 4
Sep 1, 2026Turtle CameronChief Executive OfficerSale15,000$87.29$1.3MForm 4
Aug 7, 2026Albers Jeffrey W.DirectorSale23,000$104.53$2.4MForm 4
Aug 3, 2026Burrows Scott LChief Financial OfficerSale7,500$95.57$716.8KForm 4
Aug 3, 2026Turtle CameronChief Executive OfficerSale15,000$95.51$1.4MForm 4
Jul 1, 2026Burrows Scott LChief Financial OfficerSale7,500$87.74$658.0KForm 4
Jul 1, 2026Sloan SheldonChief Medical OfficerSale8,334$87.70$730.9KForm 4
Jul 1, 2026Turtle CameronChief Executive OfficerSale15,000$87.69$1.3MForm 4
Jun 25, 2026Burrows Scott LChief Financial OfficerSale15,000$87.13$1.3MForm 4
Jun 23, 2026Fairmount Funds Management LLCDirectorSale4,684,781$85.31$399.7MForm 4
Jun 22, 2026HENDERSON MICHAEL THOMASDirectorSale20,000$100.00$2.0MForm 4
Jun 3, 2026Sloan SheldonChief Medical OfficerSale8,333$75.00$625.0KForm 4
Jun 1, 2026Turtle CameronChief Executive OfficerSale15,000$70.43$1.1MForm 4
Jun 1, 2026Burrows Scott LChief Financial OfficerSale7,500$71.06$532.9KForm 4
May 8, 2026HENDERSON MICHAEL THOMASDirectorSale80,000$74.40$6.0MForm 4
May 1, 2026Sloan SheldonChief Medical OfficerSale78,333$71.50$5.6MForm 4
May 1, 2026Burrows Scott LChief Financial OfficerSale12,500$71.37$892.1KForm 4

All 47 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
2025Cameron Turtle36$665.0K$6.7M103
2025Sheldon Sloan68$503.0K$2.2M103
2025Heidy King-Jones43$490.0K$2.2M103
2025Scott Burrows49$490.0K$2.2M103
2024Chief Medical Officer$124.0K$9.4M103
2024Chief Executive Officer$625.0K$7.0M103
2024Chief Financial Officer$475.0K$2.2M103
2024Chief Legal Officer and Corporate Secretary$480.0K$2.1M103
2023Chief Executive Officer$272.9K$15.9M103
2023Chief Financial Officer$154.6K$7.6M103
2023Chief Legal Officer and Corporate Secretary$168.7K$6.6M103

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$390.0M 2023–2023
Money received by yearMoney received by year, 2023–2023: $390.0M in all. Private raises (Form D) $390.0M.$0$100M$200M$300M$400M2023 · Private raises (Form D): $390.0M2023
Figures by year
YearPrivate raises (Form D)Total
2023$390.0M$390.0M

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. Dec 11, 2023Raised $180 million in a private offering of equity104 Form D: 30 investors so far Form D
  2. Jun 26, 2023Raised $210 million in a private offering of equity55 Form D: 41 investors so far Form D

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Fmr LLC13,026,187$1.2B0.1%+1,245,163
BlackRock, Inc.6,506,605$577.7M0.0%+985,384
Perceptive Advisors LLC4,319,496$383.5M6.0%+536,271
Rtw Investments, LP4,251,996$377.5M3.2%+80,000
Paradigm Biocapital Advisors LP3,840,778$341.0M6.4%+1,883,512
Vanguard Capital Management LLC3,448,681$306.2M0.0%+391,280
State Street Corp3,057,416$271.4M0.0%+450,385
Venrock Adviser, LLC2,985,448$265.0M8.0%−700,000
Driehaus Capital Management LLC2,799,166$248.5M1.4%+8,381
Geode Capital Management, LLC2,562,265$239.3M0.0%+841,353
Vanguard Portfolio Management LLC2,330,098$206.9M0.0%+1,744,968
Capital World Investors2,315,553$205.6M0.0%+1,648,989
Jupiter Topco LLC2,206,936$195.9M0.1%New
TCG Crossover Management, LLC1,900,582$168.7M4.1%No change
Tang Capital Management LLC1,892,200$168.0M7.7%No change
Bank Of America Corp /de/1,777,854$157.8M0.0%+549,761
Adage Capital Partners Gp, L.l.c.1,722,300$152.9M0.2%New
Wellington Management Group Llp1,581,505$140.4M0.0%−243,306
Goldman Sachs Group Inc1,478,059$131.2M0.0%+1,208,121
Franklin Resources Inc1,472,943$130.8M0.0%+590,110
Remedium Capital Partners, LLC1,464,169$130.0M28.8%+7,938
Affinity Asset Advisors, LLC1,279,134$113.6M5.6%No change
Jpmorgan Chase & Co1,093,026$98.9M0.0%+113,727
Holocene Advisors, LP1,015,170$90.1M0.2%New
Marshall Wace, Llp991,693$88.0M0.1%+852,434

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

SEC filer profile

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

  • Name on EDGARSpyre Therapeutics, Inc.2
  • CIK0001636282
  • Employer ID (EIN)46-43127874
  • Filer statusLarge accelerated filer not an emerging growth company; not 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 address221 Crescent Street, Building 23, Suite 105, Waltham, MA 024532
  • Phone61765159402
  • Shares outstanding88,173,762 as of Jul 28, 202611
  • Public float$1.1B as of Jun 30, 20254
  • AuditorKPMG LLP, San Diego, California PCAOB ID 185; it also attests to the company’s internal control over financial reporting4
  • On EDGAR sinceMar 24, 20152
  • Filings821 in all: 4 (223), 8-K (170), SC 13G/A (66), 3 (42), SC 13G (37), 10-Q (32), CORRESP (29), 424B5 (23)2
    All 44 form types

    UPLOAD (22), 144 (20), EFFECT (16), S-8 (14), DEF 14A (12), S-1/A (11), 10-K (10), S-3 (9), SCHEDULE 13G/A (8), 424B3 (6), CT ORDER (6), POS AM (6), SC 13D/A (6), ARS (4), DEFA14A (4), SCHEDULE 13D/A (4), SCHEDULE 13G (4), 10-Q/A (3), 3/A (3), CERTNAS (3), D (3), PRE 14A (3), S-1 (3), 10-K/A (2), 4/A (2), 8-K/A (2), S-3/A (2), SC 13D (2), SEC STAFF LETTER (2), 424B4 (1), 5 (1), 8-A12B (1), DRS (1), FWP (1), PRER14A (1), S-3ASR (1)

  • Latest filingsAnnual report (10-K) Feb 19, 2026
    Quarterly report (10-Q) Aug 4, 2026
    Proxy statement (DEF 14A) Apr 10, 2026
    Latest 8-K (8-K) Oct 7, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.0001 Par Value Per ShareSYRENasdaq

From the cover page of the 10-K filed Feb 19, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Aeglea BioTherapeutics names in Item 1A of its 10-K filed Feb 19, 2026: 72 risks under these headings, as written.4

  • Risks Related to Our Financial Condition and Capital Requirements
  • Risks Related to Discovery, Development and Commercialization
  • Risks Related to Government Regulation
  • Risks Related to Our Intellectual Property
  • Risks Related to Our Reliance on Third Parties
  • Risks Related to Employee Matters, Managing Growth and Other Risks Related to Our Business
  • Risks Related to Our Common Stock
  • General Risk Factors
  • We will need to raise additional capital, and if we are unable to do so when needed, we will not be able to continue as a going concern.
  • We have never generated any revenue from product sales and may never be profitable.
  • We have historically incurred losses, have a limited operating history on which to assess our business, and anticipate that we will continue to incur significant losses for the foreseeable future.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations, or require us to relinquish rights.
The other 68 risks
  • We face competition from entities that have developed or may develop programs for the diseases and/or mechanisms of action targeted by our product candidates.
  • Our product candidates are in clinical and preclinical stages of development and may fail in development or suffer delays that materially and adversely affect their commercial viability. If we or our current or future 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.
  • We are substantially dependent on the success of our SPY001, SPY002, SPY072 and SPY003 programs, alone or in combination, and our current and planned clinical trials of such programs may not be successful.
  • If we do not achieve our projected development goals in the time frames we announce and expect, the commercialization of our product candidates may be delayed and our expenses may increase and, as a result, our stock price may decline.
  • Any drug delivery device that we potentially use to deliver our product candidates may have its own regulatory, development, supply and other risks.
  • Our approach to the discovery and development of our programs is unproven, and we may not be successful in our efforts to build a pipeline of programs with commercial value.
  • Preclinical and clinical development involve lengthy and expensive processes that are subject to delays and may result in uncertain outcomes, and results of earlier studies and trials may not be predictive of future clinical trial results. If our preclinical studies and clinical trials are not sufficient to support regulatory approval of any of our product candidates, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development of such product candidate.
  • A key element of our strategy is the development of intra-portfolio investigational drug combinations. If we are not successful in discovering, developing and commercializing investigational products that take advantage of different mechanisms of action to achieve superior outcomes relative to the use of monotherapies or other combinations, our ability to achieve our strategic objectives would likely be impaired.
  • Development of combination therapies may present more or different challenges than development of monotherapies.
  • If we encounter difficulties enrolling participants in our current and future clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • Preliminary, “topline” or interim data from our clinical trials that we announce or publish from time to time may change as more participant data become available and are subject to audit and verification procedures.
  • Our current and future clinical trials or those of our future collaborators may reveal significant adverse events or undesirable side effects not seen in our clinical and nonclinical studies and may result in a safety profile that could halt clinical development, inhibit regulatory approval or limit commercial potential or market acceptance of any of our product candidates.
  • We may expend our limited resources to pursue a particular program and fail to capitalize on programs that may be more profitable or for which there is a greater likelihood of success.
  • Any approved products resulting from our current programs or any future program may not achieve adequate market acceptance among clinicians, patients, healthcare third-party payors and others in the medical community necessary for commercial success and we may not generate any future revenue from the sale or licensing of such products.
  • Some of our programs may compete with our other programs, which could negatively impact our business and reduce our future revenue.
  • We are conducting and may conduct future clinical trials for our programs at sites in the United States and various other jurisdictions, and the FDA and comparable foreign regulatory authorities may not accept data from such trials.
  • The regulatory approval processes of the FDA and other comparable foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable. If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals for our product candidates, we will not be able to commercialize, or will be delayed in commercializing, our product candidates, and our ability to generate revenue will be materially impaired.
  • We may not be able to meet requirements for the chemistry, manufacturing and control of our programs.
  • Our product candidates for which we intend to seek approval as biologics may face competition sooner than anticipated.
  • Even if we receive regulatory approval of our product candidates, we will be subject to extensive ongoing post marketing 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 post marketing regulatory requirements or experience unanticipated problems with our products.
  • We may be negatively impacted by changes in law or other policy, including healthcare reform initiatives.
  • Our business operations and current and future arrangements with investigators, healthcare professionals, consultants, third-party payors, patient organizations, patients and others will be subject to applicable healthcare regulatory laws, which could expose us to penalties.
  • Even if we are able to commercialize any product candidates, due to unfavorable pricing regulations and/or third-party coverage and reimbursement policies, we may not be able to offer such product candidates at competitive prices, which would seriously harm our business.
  • We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations. We can face criminal liability and other serious consequences for violations, which can harm our business.
  • Governments outside the United States tend to impose strict price controls, which may adversely affect our revenue, if any.
  • A breakthrough therapy, fast track, or other expedited designation for our product candidates may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that those product candidates will receive marketing approval.
  • Disruptions at the FDA and other government agencies, including as a result of the government shutdown, could negatively affect the review of our regulatory submissions, which could negatively impact our business.
  • Our ability to obtain and protect our patents and other proprietary rights is uncertain, exposing us to the possible loss of competitive advantage.
  • We may not be successful in obtaining or maintaining necessary rights to our programs through acquisitions and in-licenses.
  • We may be subject to patent infringement claims or may need to file claims to protect our intellectual property, which could result in substantial costs and liability and prevent us from commercializing our potential products.
  • We may be subject to claims that we have wrongfully hired an employee from a competitor or that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.
  • Changes to patent laws in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • Obtaining and maintaining patent protection depends on compliance with various procedural, document submissions, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market our products.
  • We may become subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • Patent terms may be inadequate to protect the competitive position of our product candidates for an adequate amount of time.
  • Our technology licensed from various third parties may be subject to retained rights or may be affected by our failure to comply with obligations under license agreements or other disruptions to business relationships with licensors resulting in loss of license rights that are important to our business.
  • We have limited foreign intellectual property rights and may not be able to protect our intellectual property and proprietary rights throughout the world.
  • The intellectual property landscape around engineered antibodies is highly dynamic, and third parties may initiate legal proceedings alleging that we are infringing, misappropriating, or otherwise violating
  • their intellectual property rights, the outcome of which would be uncertain and may prevent, delay or otherwise interfere with our product discovery and development efforts.
  • We rely on collaborations and licensing arrangements with third parties, including our arrangement with Paragon. If we are unable to maintain these collaborations or licensing arrangements, or if these collaborations or licensing arrangements are not successful, our business could be negatively impacted.
  • We currently rely, and plan to rely in the future, on third parties to conduct and support our nonclinical studies and clinical trials. If these third parties do not properly and successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval of or commercialize our product candidates.
  • We currently rely and expect to rely in the future on the use of manufacturing suites in third-party facilities or on third parties to manufacture our product candidates, and we may rely on third parties to produce and process our products, if approved. Our business could be adversely affected if we are unable to use third-party manufacturing suites or if the third-party manufacturers encounter difficulties in production.
  • In order to successfully implement our plans and strategies, we will need to grow the size of our organization and we may experience difficulties in managing this growth.
  • We are highly dependent on our key personnel and anticipate hiring new key personnel. If we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
  • Our future growth may depend, in part, on our ability to operate in foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.
  • Our estimates of market opportunity and forecasts of market growth may prove to be inaccurate, and even if the markets in which we compete achieve the forecasted growth, our business may not grow at similar rates, or at all.
  • Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, CMOs, suppliers and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • Our internal information technology systems, as well as those of any of our CROs, manufacturers, other contractors or consultants, third-party service providers, and potential future collaborators, are subject to the risk of failure, security breaches, data privacy incidents, or other unauthorized or improper
  • access to, use of, or destruction of proprietary, confidential, employee, or personal data, which could result in additional costs, loss of revenue, significant liabilities, harm to our brand, and material disruption to our business.
  • Our expanding use of AI exposes us to operational, regulatory, legal, and ethical risks that could adversely affect our business, reputation, financial condition, and results of operations.
  • Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
  • We are subject to stringent and changing laws, regulations and standards, and contractual obligations relating to privacy, data protection, and data security. The actual or perceived failure to comply with such obligations could lead to government enforcement actions (which could include civil or criminal penalties), fines and sanctions, private litigation and/or adverse publicity and could negatively affect our operating results and business.
  • If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
  • We may be subject to adverse legislative or regulatory tax changes that could negatively impact our financial condition.
  • We may acquire businesses or products, or form strategic alliances, in the future, and may not realize the benefits of such acquisitions.
  • We maintain our cash at financial institutions, often in balances that exceed federally-insured limits. The failure of financial institutions could adversely affect our ability to pay our operational expenses or make other payments.
  • The market price of our common stock has historically been volatile, and the market price of our common stock may decline in the future.
  • Anti-takeover provisions in our charter documents and under Delaware law and the terms of some of our contracts could make an acquisition of us more difficult and may prevent attempts by our stockholders to replace or remove our management.
  • Our Certificate of Incorporation and Bylaws provide that the Court of Chancery of the State of Delaware is the exclusive forum certain types of actions and proceedings that may be initiated by our stockholders, and our Bylaws designate the federal courts of the United States as the exclusive forum for actions arising under the Securities Act, each of which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, employees or agents.
  • We do not anticipate that we will pay any cash dividends in the foreseeable future.
  • Future sales of shares by existing stockholders could cause our stock price to decline.
  • Future sales and issuances of equity and debt could result in additional dilution to our stockholders.
  • Our principal stockholders own a significant percentage of our stock and are able to exert significant control over matters subject to stockholder approval.
  • We may become exposed to costly and damaging liability claims, either when testing our programs in the clinic or at the commercial stage, and our product liability insurance may not cover all damages from such claims.
  • Litigation costs and the outcome of litigation could have a material adverse effect on our business.
  • We continue to incur significant costs and demands upon management as a result of complying with the laws and regulations regulating public companies.
  • We are no longer a “smaller reporting company” within the meaning of the Securities Act and as a result we are or will be subject to certain enhanced disclosure requirements which will require us to incur significant expenses and expend time and resources.

Legal proceedings

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

The opening of Item 3, Legal Proceedings.4

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