ALEC on Nasdaq

Alector (United States)

In its 2026 annual report the company says: “We are a clinical-stage biotechnology company developing therapies for neurodegenerative diseases, with a focus on areas of high unmet medical need. Our work is informed by advances in disease biology, including the roles of misfolded or deficient proteins, lysosomal dysfunction, and immune and neuronal pathway disruption. Our objective is to develop product candidates that address disease through targeted mechanisms, such as removing pathogenic proteins, replacing deficient proteins, and restoring normal cellular function.”4 It was founded in 2013.1 It is headquartered in South San Francisco, California.1 Its shares trade on Nasdaq under the symbol ALEC.1

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Last updated Oct 21, 2026.

Overview

2013Founded1

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  • TickerALEC on Nasdaq1
  • IndustryBiological Products, (No Diagnostic Substances)1
  • HeadquartersSouth San Francisco, California1
  • Websitewww.alector.com
  • Business address131 Oyster Point Blvd., Suite 600, South San Francisco, Ca 940803
  • Filer categoryAccelerated filer, Smaller reporting company3

We are a clinical-stage biotechnology company developing therapies for neurodegenerative diseases, with a focus on areas of high unmet medical need. Our work is informed by advances in disease biology, including the roles of misfolded or deficient proteins, lysosomal dysfunction, and immune and neuronal pathway disruption.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

-741.3%Operating margin5
-679.2%Net margin5
-79.1%Revenue growth, 20255
-466.3%Return on equity5
0.30×Debt to equity5
-$184.1MFree cash flow5

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development100¢$123.1M
  • Income tax0¢$168.0K

Out of $21.0M in revenue.5 The company lost money this year.

Financial statements

Revenue67895$21.0M in 2025−1% since 2019
0$100.0M$200.0M$300.0M2019: $21.2M$21.2M20192020: $21.1M$21.1M2020−1%2021: $207.1M$207.1M2021+882%2022: $133.6M$133.6M2022−35%2023: $97.1M$97.1M2023−27%2024: $100.6M$100.6M2024+4%2025: $21.0M$21.0M2025−79%
Operating income67895-$156.0M in 2025+36% since 2019
-$200.0M-$150.0M-$100.0M-$50.0M02019: -$114.4M-$114.4M20192020: -$195.2M-$195.2M2020+71%2021: -$37.4M-$37.4M2021−81%2022: -$137.8M-$137.8M2022+269%2023: -$151.7M-$151.7M2023+10%2024: -$145.0M-$145.0M2024−4%2025: -$156.0M-$156.0M2025+8%
Net income67895-$142.9M in 2025+36% since 2019
-$200.0M-$150.0M-$100.0M-$50.0M02019: -$105.4M-$105.4M20192020: -$190.2M-$190.2M2020+81%2021: -$36.3M-$36.3M2021−81%2022: -$133.3M-$133.3M2022+267%2023: -$130.4M-$130.4M2023−2%2024: -$119.0M-$119.0M2024−9%2025: -$142.9M-$142.9M2025+20%

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

Period ending2025-12-312024-12-31
Collaboration revenue$21.0M$100.6M
Research and development$123.1M$185.9M
General and administrative$54.0M$59.6M
Total operating expenses$177.1M$245.6M
Loss from operations-$156.0M-$145.0M
Other income, net$13.2M$26.1M
Loss before income taxes-$142.8M-$118.9M
Income tax expense$168.0K$128.0K
Net loss-$142.9M-$119.0M
Unrealized gain (loss) on marketable securities-$95.0K$77.0K
Comprehensive loss-$143.0M-$119.0M
Net loss per share, basic-$1.39-$1.23
Net loss per share, diluted-$1.39-$1.23
Shares used in computing net loss per share, basic103.0M shares96.6M shares
Shares used in computing net loss per share, diluted103.0M shares96.6M shares

Compare Alector (United States) with another company

Corporate structure

Alector (United States) sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Alector (United States)

  • BIOTECHNOLOGY VALUE FUND L P Filed SCHEDULE 13G on Alector (United States), latest Sep 18, 2026
  • Polaris Venture Partners VI, L.P. Filed SCHEDULE 13G/A on Alector (United States), latest May 14, 2026 (6 filings since Feb 11, 2022)
  • BlackRock Filed SCHEDULE 13G on Alector (United States), latest Apr 27, 2026 (7 filings since Feb 3, 2022)
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on Alector (United States), latest Mar 26, 2026 (5 filings since Feb 9, 2022)
  • RTW INVESTMENTS, LP Filed SCHEDULE 13G/A on Alector (United States), latest Feb 17, 2026 (2 filings since Nov 14, 2025)
  • Arnon Rosenthal Filed SCHEDULE 13G/A on Alector (United States), latest Feb 6, 2026 (4 filings since Feb 14, 2022)
  • TCG Crossover GP II, LLC Filed SCHEDULE 13G on Alector (United States), latest Nov 14, 2025
  • FMR LLC Filed SCHEDULE 13G/A on Alector (United States), latest Nov 7, 2025 (5 filings since Feb 9, 2022)
  • RA CAPITAL MANAGEMENT, L.P. Filed SCHEDULE 13G/A on Alector (United States), latest Aug 14, 2025 (2 filings since Dec 6, 2024)
  • Morgan Stanley Filed SC 13G/A on Alector (United States), latest Nov 7, 2024 (2 filings since Feb 12, 2024)
  • EcoR1 Capital, LLC Filed SC 13G/A on Alector (United States), latest Feb 10, 2023 (2 filings since Feb 14, 2022)
  • Federated Hermes Filed SC 13G/A on Alector (United States), latest Feb 9, 2023 (3 filings since Feb 14, 2022)
  • Alector (United States) South San Francisco, California

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

What it owns

What Alector (United States) reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$48.3M5 Dec 31, 2025$50.1M5 Dec 31, 2024−3.5%
Accumulated depreciation$37.5M5 Dec 31, 2025$32.9M5 Dec 31, 2024+13.8%
Property and equipment, net$10.8M5 Dec 31, 2025$17.1M5 Dec 31, 2024−36.8%
Operating-lease assets (leased space)$13.7M5 Dec 31, 2025$20.0M5 Dec 31, 2024−31.3%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$65.8M5 Dec 31, 2025$33.0M5 Dec 31, 2024+99.3%
Marketable securities, current$190.2M5 Dec 31, 2025$380.4M5 Dec 31, 2024−50.0%

Properties, in its own words

Our corporate headquarters are currently located in South San Francisco, California, where we lease approximately 105,000 square feet of office and laboratory space. The term of the lease agreement expires in May 2029, with an option to extend the term of the lease for an additional 10 years. The lease agreement also provides us a right of first offer to expand into available office space in the building. We subleased approximately 9,300 square feet of our corporate headquarters in February 2023 with a lease term that expired in July 2025. We also subleased approximately 13,000 square feet of the corporate headquarters in February 2025 and expanded the sublease to 15,200 square feet in August 2025, with a lease term that will expire in March 2029. We also subleased approximately 7,700 square feet of the corporate headquarters in December 2025, with a lease term that will expire in July 2027. We lease approximately 18,700 square feet of additional office and laboratory space in Newark, California. In August 2024, we approved a plan to transition operations from our laboratory and office space in Newark, California to our South San Francisco headquarters. Our intention is to sublease the Newark facility. If required, we believe that suitable additional or alternative space would be available in the future on commercially reasonable terms.

Item 2 of the 10-K filed Feb 25, 2026.4

Leadership

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

Board members and other officers (15)

Former names

  • Alector LLCSep 16, 2015 to Sep 16, 20153

Timeline

  1. Oct 14, 20268-K Executive or director change32
  2. Oct 5, 20268-K Entered a material agreement; Results of operations; Regulation FD disclosure33
  3. Aug 6, 20268-K Results of operations34
  4. Jul 8, 20268-K Ended a material agreement35
  5. Jun 17, 20268-K Shareholder vote36
  6. May 7, 20268-K Results of operations37
  7. May 7, 20268-K Entered a material agreement38
  8. Feb 25, 20268-K Results of operations39
  9. Dec 12, 20258-K Executive or director change40
  10. Nov 6, 20258-K Results of operations41
  11. Oct 21, 20258-K Results of operations; Exit or restructuring costs; Executive or director change42
  12. Aug 7, 20258-K Results of operations43
  13. Feb 6, 2019New chief executive Arnon Rosenthal becomes CEO13
  14. 2013Founded Founded1

Calendar

Coming up

  1. Nov 5, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.34) a share, on Nov 6, 2025.44

When it reported results

  1. Oct 5, 2026Reported quarterly or annual results33
  2. Aug 6, 2026Reported quarterly or annual results34
  3. May 7, 2026Reported quarterly or annual results37
  4. Feb 25, 2026Reported quarterly or annual results39
  5. Nov 6, 2025Reported quarterly or annual results41
  6. Oct 21, 2025Reported quarterly or annual results42
  7. Aug 7, 2025Reported quarterly or annual results43
  8. May 8, 2025Reported quarterly or annual results45

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

Filings

381 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 51 major events, 170 insider forms, 40 large holders, 100 other. The latest 20:

  1. Oct 15, 20264 EDGAR
  2. Oct 15, 20264 EDGAR
  3. Oct 15, 20264 EDGAR
  4. Oct 14, 20268-K EDGAR
  5. Oct 5, 20268-K EDGAR
  6. Sep 18, 2026SCHEDULE 13G EDGAR
  7. Sep 4, 2026144 EDGAR
  8. Sep 4, 20264 EDGAR
  9. Sep 4, 20264 EDGAR
  10. Sep 4, 20264 EDGAR
  11. Sep 2, 2026144 EDGAR
  12. Sep 1, 2026144 EDGAR
  13. Sep 1, 2026144 EDGAR
  14. Sep 1, 2026144 EDGAR
  15. Aug 21, 20264 EDGAR
  16. Aug 6, 202610-Q EDGAR
  17. Aug 6, 20268-K EDGAR
  18. Jul 9, 20264 EDGAR
  19. Jul 8, 20268-K EDGAR
  20. Jun 17, 20264 EDGAR

The 381 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

88 open-market trades by officers, directors and large owners since October 2021: 0 buys and 88 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 4, 2026Wong-Sarad GracePrincipal Accounting OfficerSale3,625$2.51$9.1KForm 4
Sep 3, 2026Wong-Sarad GracePrincipal Accounting OfficerSale5,165$2.67$13.8KForm 4
Sep 3, 2026Rosenthal ArnonChief Executive OfficerSale72,606$2.66$193.1KForm 4
Sep 3, 2026Berkley Neil LindsayCFO & Chief Business OfficerSale29,251$2.66$77.8KForm 4
Sep 2, 2026Wong-Sarad GracePrincipal Accounting OfficerSale656$2.75$1.8KForm 4
Jun 3, 2026Wong-Sarad GracePrincipal Accounting OfficerSale3,475$1.88$6.5KForm 4
Jun 2, 2026Rosenthal ArnonChief Executive OfficerSale87,216$1.97$171.8KForm 4
Jun 2, 2026Wong-Sarad GracePrincipal Accounting OfficerSale5,709$1.97$11.2KForm 4
Jun 2, 2026Berkley Neil LindsayCFO & Chief Business OfficerSale19,360$1.97$38.1KForm 4
Apr 16, 2026Wong-Sarad GracePrincipal Accounting OfficerSale1,820$2.65$4.8KForm 4
Mar 10, 2026Wong-Sarad GracePrincipal Accounting OfficerSale1,000$2.65$2.6KForm 4
Mar 3, 2026Wong-Sarad GracePrincipal Accounting OfficerSale3,367$2.08$7.0KForm 4
Mar 2, 2026Berkley Neil LindsayCFO & Chief Business OfficerSale29,649$2.12$62.9KForm 4
Mar 2, 2026Wong-Sarad GracePrincipal Accounting OfficerSale8,071$2.12$17.1KForm 4
Mar 2, 2026Rosenthal ArnonChief Executive OfficerSale81,864$2.12$173.6KForm 4
Feb 26, 2026Wong-Sarad GracePrincipal Accounting OfficerSale4,079$2.50$10.2KForm 4
Dec 5, 2025Wong-Sarad GracePrincipal Accounting OfficerSale4,753$1.21$5.8KForm 4
Dec 3, 2025Berkley Neil LindsayCFO & Chief Business OfficerSale37,261$1.12$41.7KForm 4
Dec 3, 2025Wong-Sarad GracePrincipal Accounting OfficerSale8,056$1.12$9.0KForm 4
Dec 3, 2025Kenkare-Mitra SaraPresident and Head of R&DSale41,687$1.12$46.7KForm 4

All 88 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
2025Arnon RosenthalPh.D.$678.1K$2.0M58
2025Sara Kenkare-MitraPh.D.$614.3K$1.6M58
2025Neil Berkley52$455.0K$1.1M58
2024Co-founderChief Executive Officer$674.8K$3.7M58
2024Former President and Head of$624.4K$2.5M58
2024Chief Financial Officer and Chief Business Officer$350.0K$2.3M58

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
TCG Crossover Management, LLC10,000,000$20.1M0.5%No change
Nantahala Capital Management, LLC8,636,218$17.4M0.5%+5,820,235
BlackRock, Inc.7,847,879$15.8M0.0%+106,634
Vanguard Capital Management LLC4,009,340$8.1M0.0%+330,618
Kynam Capital Management, LP3,808,494$7.7M0.4%+1,808,494
Merck & Co., Inc.3,545,719$7.1M1.4%No change
Balyasny Asset Management L.P.3,247,426$6.5M0.0%+312,173
683 Capital Management, LLC3,200,000$6.4M0.6%No change
D. E. Shaw & Co., Inc.2,959,983$5.9M0.0%−372,852
ADAR1 Capital Management, LLC2,883,583$5.8M0.3%+1,833,583
Vanguard Portfolio Management LLC2,820,493$5.7M0.0%+236,951
Geode Capital Management, LLC2,454,271$4.9M0.0%+168,053
Spruce Street Capital LP2,101,068$4.2M0.8%No change
Millennium Management LLC1,988,835$4.0M0.0%+9,609
Ikarian Capital, LLC1,982,606$4.0M0.7%−100,000
State Street Corp1,879,765$3.8M0.0%+14,239
Jacobs Levy Equity Management, Inc1,765,929$3.5M0.0%−388,432
Medici Capital LLC1,652,520$3.3M6.5%No change
Affinity Asset Advisors, LLC1,510,000$3.0M0.2%+1,010,000
Eversept Partners, LP1,423,873$2.9M0.2%+72,767
Fmr LLC1,396,398$2.8M0.0%−399,706
Aqr Capital Management LLC1,309,577$2.6M0.0%+598,243
Euclidean Capital LLC1,307,858$2.6M0.6%No change
Mackenzie Financial Corp1,109,770$2.2M0.0%+252,416
Deutsche Bank Ag\1,098,388$2.2M0.0%+5,485

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

SEC filer profile

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

  • Name on EDGARAlector, Inc.2
  • CIK0001653087
  • Employer ID (EIN)82-29333434
  • Filer statusAccelerated filer not an emerging growth company; a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • 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 address131 Oyster Point Blvd., Suite 600, South San Francisco, CA 940802
  • Phone415-231-56602
  • Shares outstanding111,656,919 as of Jul 31, 202611
  • Public float$115.4M as of Jun 30, 20254
  • AuditorErnst & Young LLP, San Mateo, California PCAOB ID 42; it also attests to the company’s internal control over financial reporting4
  • On EDGAR sinceSep 16, 20152
  • Filings624 in all: 4 (274), 8-K (82), 144 (71), 3 (25), 10-Q (23), SC 13G/A (23), SC 13G (12), SCHEDULE 13G/A (11)2
    All 38 form types

    S-8 (10), SC 13D/A (9), 10-K (8), CORRESP (8), DEF 14A (8), DEFA14A (8), UPLOAD (6), 424B5 (5), EFFECT (5), DRSLTR (4), SCHEDULE 13G (4), ARS (3), S-1/A (3), 4/A (2), 424B4 (2), DRS (2), S-1 (2), S-3 (2), 10-K/A (1), 8-A12B (1), CERT (1), CT ORDER (1), D (1), DEFR14A (1), DRS/A (1), FWP (1), POS AM (1), S-1MEF (1), S-3ASR (1), SC 13D (1)

  • Latest filingsAnnual report (10-K) Feb 25, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Apr 28, 2026
    Latest 8-K (8-K) Oct 14, 2026

Securities registered for trading

ClassSymbolExchange
Common StockALECThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Feb 25, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Alector (United States) names in Item 1A of its 10-K filed Feb 25, 2026: 74 risks under these headings, as written.4

  • Risks Related to Our Business, Financial Condition, and Capital Requirements
  • We are in various stages of drug development and have a limited operating history and no products approved for commercial sale, which may make it difficult to evaluate our current business and predict our future success and viability.
  • We have incurred significant net losses in each year since our inception and anticipate that we will continue to incur net losses for the foreseeable future.
  • Drug development is a highly uncertain undertaking and involves a substantial degree of risk.
  • We will need to obtain substantial additional financing to complete the development and any commercialization of our product candidates, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce, or terminate our commercialization efforts, product development, or other operations.
  • Due to the significant resources required for the development of our product candidates, and depending on our ability to access capital, we must prioritize development of certain product candidates. Moreover, we may expend our limited resources on programs that do not yield a successful product candidate or fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • Our Loan Agreement requires us to comply with specified operating covenants and places restrictions on our operating and financial flexibility.
  • Risks Related to the Discovery, Development, and Commercialization of Our Product Candidates
  • Research and development of biopharmaceutical products is inherently risky. Our business is heavily dependent on the successful development of our product candidates, which are in various stages of preclinical and clinical development. We cannot give any assurance that any of our product candidates will receive regulatory, including marketing, approval, which is necessary before they can be commercialized.
  • We may not be successful in our efforts to continue to create a pipeline of product candidates from our research and drug discovery platform or to develop commercially successful products. If we fail to successfully identify and develop additional product candidates from our research and drug discovery platform, our commercial opportunity may be limited.
  • We may not be successful in our efforts to obtain approval for additional or expanded indications for any product candidates that receive approval for a given indication.
  • We have concentrated a substantial portion of our research and development efforts on the treatment of neurodegenerative diseases, a field that has seen limited success in drug development. Further, our product candidates are based on innovative approaches and technologies to address the complex mechanisms underlying neurodegeneration, which makes it difficult to predict the time and cost of product candidate development and to subsequently obtain regulatory approval.
The other 63 risks
  • We may encounter substantial delays in our clinical trials or may not be able to conduct or complete our clinical trials on the timelines we expect, if at all.
  • We may encounter difficulties enrolling patients in our clinical trials, and our clinical development activities could thereby be delayed or otherwise adversely affected.
  • Our clinical trials may reveal significant adverse events, toxicities, or other side effects and may fail to demonstrate substantial evidence of the safety and efficacy of our product candidates, which would prevent, delay, or limit the scope of regulatory approval and commercialization.
  • We face significant competition in an environment of rapid technological and scientific change. Some competitors have achieved, and there is a possibility that other competitors will achieve, regulatory approval before us. Our competitors’ therapies may be safer, more advanced, or more effective than ours, which may negatively impact our ability to successfully market or commercialize any product candidates we may develop and ultimately harm our financial condition.
  • The manufacture of our product candidates is complex, and we may encounter difficulties in production. If we or any of our third-party manufacturers encounter such difficulties, or fail to meet rigorously enforced regulatory standards, our ability to provide supply of our product candidates for clinical trials or our products, if approved for patients, could be delayed or stopped, or we may be unable to maintain a commercially viable cost structure.
  • If, in the future, we are unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and market any product candidates we may develop, we may not be successful in commercializing those product candidates if and when they are approved.
  • Even if any product candidates we develop receive marketing approval, they may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors, and others in the medical community necessary for commercial success.
  • Any products we or a collaboration partner commercialize may become subject to unfavorable pricing regulations, third-party reimbursement practices, or healthcare reform initiatives, which would harm our business.
  • Our product candidates for which we intend to seek approval may face biosimilar competition sooner than anticipated.
  • Any legal proceedings or claims involving or against us could be costly and time-consuming to defend and could harm our reputation regardless of the outcome.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.
  • Risks Related to Regulatory Approval and Other Legal Compliance Matters
  • The regulatory approval processes of the FDA, EMA, and comparable foreign regulatory authorities are lengthy, time consuming, and inherently unpredictable. If we are ultimately unable to obtain regulatory approval for our product candidates, we will be unable to generate product revenue and our business will be substantially harmed.
  • Our product candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval, limit their commercial potential, or result in significant negative consequences.
  • Data on our current and future product candidates resulting from clinical trials conducted outside the United States may not be accepted by the FDA, EMA, and applicable foreign regulatory authorities.
  • Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.
  • Even if we obtain regulatory approval for a product candidate, our products will remain subject to extensive post-marketing requirements and regulatory scrutiny.
  • We may seek orphan drug designation for our product candidates, but we may be unable to obtain such designations or to maintain the benefits associated with orphan drug status, including market exclusivity, which may cause our revenue, if any, to be reduced.
  • Healthcare legislative and executive measures aimed at reducing healthcare costs may have a material adverse effect on our business and results of operations.
  • Our employees, independent contractors, consultants, commercial partners, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • If we fail to comply with healthcare laws, we could face substantial penalties and our business, operations, and financial conditions could be adversely affected.
  • If we or any contract manufacturers and suppliers we engage 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 our business.
  • Changes or reductions in the FDA’s or other government agencies’ management and personnel, or changes in such agencies’ funding, could impact their ability to hire and retain key leadership and other personnel, impact the timing for development or commercialization of new products and services, or otherwise impact those agencies’ performance of historically typical business functions on which the operation of our business may rely, which could negatively impact our business.
  • Our business activities may be subject to the Foreign Corrupt Practices Act (FCPA), similar anti-bribery and anti-corruption laws, and other regulations.
  • Risks Related to Our Reliance on Third Parties
  • We expect to depend on collaborations with third parties for the research, development, and commercialization of certain of the product candidates we may develop. If any such collaborations are not successful, we may not be able to realize the market potential of those product candidates.
  • We expect to rely on third parties to conduct our clinical trials and some aspects of our research and preclinical testing, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research, or testing.
  • We, and the CDMO partners on which we rely, depend on third-party suppliers for key raw materials used in our manufacturing processes, and the loss of these third-party suppliers or their inability to supply us with adequate raw materials, could harm our business.
  • Risks Related to Our Intellectual Property
  • If we are unable to obtain and maintain patent protection for any product candidates we develop, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize any product candidates we may develop may be adversely affected.
  • If any of our patent applications, or those of our collaborators, do not issue as patents in any jurisdiction, we may not be able to compete effectively.
  • If the scope of any patent protection we obtain is not sufficiently broad, or if we lose any of our patent protection, our ability to prevent our competitors from commercializing similar or identical technology and product candidates would be adversely affected.
  • Our rights to develop and commercialize are subject, in part, to the terms and conditions of agreements with others, including terms and conditions regarding intellectual property rights.
  • If we fail to comply with our obligations in the agreements under which we option or license intellectual property rights from our collaborators or future licensors or otherwise experience disruptions to our business relationships with our collaborators or future licensors, we could lose intellectual property rights that are important to our business.
  • We may not be able to protect our intellectual property and proprietary rights throughout the world.
  • 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.
  • Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • Issued patents covering our product candidates and other technologies could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad.
  • If we do not obtain patent term extension and data exclusivity for any product candidates we may develop, our business may be materially harmed.
  • We may be subject to claims challenging the inventorship of our patents and other intellectual property.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • We may not be successful in obtaining, through acquisitions or otherwise, necessary rights to our product candidates or other technologies.
  • We may be subject to claims that our employees, consultants, or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property.
  • Third-party claims of intellectual property infringement, misappropriation, or other violation against us or our collaborators may prevent or delay the development and commercialization of our product candidates and other technologies.
  • We may become involved in lawsuits to protect or enforce our patents and other intellectual property rights or to defend against allegations of patent infringement, which could be expensive, time consuming, and unsuccessful.
  • 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.
  • Risks Related to Our Operations
  • We are highly dependent on our key personnel, and if we are not successful in attracting, motivating, and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
  • We will need to effectively manage the size and capabilities of our organization.
  • We have engaged in strategic collaborations and may in the future engage in acquisitions, collaborations, or strategic partnerships, which may increase our capital requirements, dilute our stockholders, cause us to incur additional debt or assume contingent liabilities, and subject us to other risks.
  • The use of new and evolving technologies, such as AI, in our operations may require us to expend resources and may present risks and challenges that can impact our business, including by posing security and other risks to our proprietary and personal information, any of which may result in reputational harm and liability, or otherwise adversely affect our business.
  • Business disruptions, including as a result of geopolitical events, could seriously harm our future revenue and financial condition and increase our costs and expenses.
  • Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
  • Changes in tax laws or in their implementation or interpretation may adversely affect our business and financial condition.
  • General Risk Factors
  • The market price of our common stock may continue to be volatile, which could result in substantial losses for investors.
  • If securities analysts do not publish research or reports about our business or if they publish negative evaluations of our stock, the price of our stock could decline.
  • Sales of substantial amounts of our common stock in the public markets, or the perception that such sales might occur, could cause the market price of our common stock to decline significantly, even if our business is doing well.
  • If we fail to comply with the continued listing requirements of the Nasdaq Stock Market, it could result in our common stock being delisted, which could adversely affect the market price and liquidity of our securities and could have other adverse effects.
  • Raising additional capital may cause dilution to our existing stockholders, restrict our operations, or require us to relinquish rights to our technologies or product candidates.
  • Our principal stockholders and management own a significant percentage of our stock and will be able to exercise significant influence over matters subject to stockholder approval.
  • We have incurred and will continue to incur significant additional costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives and corporate governance practices.
  • If we are unable to maintain effective internal controls, our business, financial position, and results of operations could be adversely affected.
  • Our operations are subject to the effects of inflation.
  • Market conditions and changing circumstances, some of which may be beyond our control, could impair our ability to access our existing cash, cash equivalents and investments and to timely pay key vendors and others.
  • We do not expect to pay any dividends for the foreseeable future. Investors may never obtain a return on their investment.
  • Delaware law and provisions in our amended and restated certificate of incorporation and bylaws might discourage, delay, or prevent a change in control of our company or changes in our management and, therefore, depress the trading price of our common stock.

Legal proceedings

From time to time, we may become involved in litigation or other legal proceedings. We are not currently a party to any litigation or legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business. Regardless of outcome, litigation, or other legal proceedings can have an adverse impact on us because of legal fees and settlement costs, diversion of management resources, and other factors.

The opening of Item 3, Legal Proceedings.4

Sources

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