Sign in

ELTX on Nasdaq

Elicio Therapeutics, Inc.

American pharmaceutical preparations company based in Boston1

In its 2026 annual report the company says: “We are a clinical-stage biotechnology company advancing novel immunotherapies for the treatment of cancer, including mutant Kirsten rat sarcoma viral oncogene homolog - positive pancreatic cancer, colorectal cancer, lung cancer and other mKRAS positive cancers.”3 Its shares trade on Nasdaq under the symbol ELTX.1

Price unavailable

Last updated Oct 21, 2026.

Overview

Compare with Apricus Biosciences, GeoVax Labs, Inc. or Korsana Biosciences, Inc., or pick any stock.

  • TickerELTX on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersBoston, Massachusetts1
  • Incorporated inDE2
  • Business address451 D Street, 5Th Floor, Boston, Ma 022102
  • Filer category, Emerging growth company2
  • Legal formCorporation

See how the biggest companies compare on our leaderboards

We are a clinical-stage biotechnology company advancing novel immunotherapies for the treatment of cancer, including mutant Kirsten rat sarcoma viral oncogene homolog (“mKRAS”) - positive pancreatic cancer, colorectal cancer (“CRC”), lung cancer and other mKRAS positive cancers. We intend to build on recent clinical successes in the personalized cancer immunotherapy space to develop effective, off-the-shelf immunotherapies. Our proprietary Amphiphile (“AMP”) technology aims to enhance the education, activation and amplification of cancer-specific T cells relative to conventional immunotherapy strategies, with the goal of promoting durable cancer immunosurveillance in patients. Recent advances have identified T cell responses as a key component of effective cancer immunotherapy and we believe our AMP technology can generate robust T cell responses in patients that can potentially translat…3 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 2022

-1031.4%Operating margin4
-1225.9%Net margin4
-91.9%Revenue growth, 20225
-$22.8MFree cash flow4

Where the money goes

Where each dollar of revenue went, fiscal 2022

  • Research and development83¢$18.1M
  • Interest17¢$3.6M

Out of $2.3M in revenue.54 The company lost money this year.

Financial statements

Revenue65$2.3M in 2022−20% since 2020
0$10.0M$20.0M$30.0M2020: $2.9M$2.9M20202021: $28.3M$28.3M2021+883%2022: $2.3M$2.3M2022−92%
Operating income654-$23.7M in 2022−57% since 2020
-$60.0M-$40.0M-$20.0M02020: -$55.3M-$55.3M20202021: -$39.3M-$39.3M2021−29%2022: -$23.7M-$23.7M2022−40%
Net income654-$28.2M in 2022−65% since 2020
-$100.0M-$75.0M-$50.0M-$25.0M02020: -$80.1M-$80.1M20202021: -$54.6M-$54.6M2021−32%2022: -$28.2M-$28.2M2022−48%

Every line of the income statement as filed: the last 2 fiscal years, latest first.9

Period ending2025-12-312024-12-31
Research and development$24.9M$33.7M
General and administrative$12.8M$11.3M
Total operating expenses$37.7M$45.0M
Loss from operations-$37.7M-$45.0M
Change in fair value of warrant liabilities-$1.9M-$3.9M
Loss on issuance of pre-funded warrants$0-$3.5M
Gain on sale of equipment$0$3.0K
Foreign exchange transaction gain$0$151.0K
Grant income$415.0K$0
Interest income$776.0K$777.0K
Interest expense-$1.1M-$455.0K
Total other expense, net-$1.9M-$6.9M
Provision for income taxes$0$0
Net loss-$39.6M-$51.9M
Foreign currency translation adjustment$48.0K$22.0K
Comprehensive loss-$39.5M-$51.9M
Net loss per common share, basic (in dollars per share)-$2.58-$4.25
Net loss per common share, diluted (in dollars per share)-$2.58-$4.25
Weighted average common shares outstanding, basic (in shares)15.3M shares12.2M shares
Weighted average common shares outstanding, diluted (in shares)15.3M shares12.2M shares

Compare Elicio Therapeutics, Inc. with another company

Corporate structure

Elicio Therapeutics, Inc. 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 Elicio Therapeutics, Inc.

  • Moti Investments LLC Filed SCHEDULE 13G on Elicio Therapeutics, Inc., latest Jul 16, 2026
  • Knoll Capital Management, LLC Filed SCHEDULE 13G/A on Elicio Therapeutics, Inc., latest Jul 8, 2026 (2 filings since Feb 5, 2025)
  • Actyus Private Equity SGIIC, S.A. Filed SCHEDULE 13G/A on Elicio Therapeutics, Inc., latest Oct 7, 2025 (3 filings since Jan 7, 2025)
  • GKCC, LLC Filed SCHEDULE 13D/A on Elicio Therapeutics, Inc., latest Jun 4, 2025 (6 filings since Jun 14, 2023)
  • Yekaterina Chudnovsky Filed SCHEDULE 13D/A on Elicio Therapeutics, Inc., latest Mar 7, 2025
  • Clal Biotechnology Industries Ltd Filed SC 13D/A on Elicio Therapeutics, Inc., latest Apr 10, 2024 (5 filings since Jun 12, 2023)
  • Vifor (International) Ltd Filed SC 13G/A on Elicio Therapeutics, Inc., latest Jul 7, 2023 (2 filings since Mar 30, 2022)
  • EISA-ABC LLC Filed SC 13G/A on Elicio Therapeutics, Inc., latest Feb 14, 2023 (2 filings since Feb 14, 2022)
  • Itzhak Goldberg Filed SC 13G/A on Elicio Therapeutics, Inc., latest Feb 14, 2023
  • Thomas A. Satterfield Jr. Filed SC 13G/A on Elicio Therapeutics, Inc., latest Feb 10, 2023 (2 filings since May 19, 2022)
  • Elicio Therapeutics, Inc. Boston, Massachusetts

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

What it owns

What Elicio Therapeutics, Inc. 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$2.1M9 Dec 31, 2025$2.0M9 Dec 31, 2024+0.8%
Accumulated depreciation$1.8M9 Dec 31, 2025$1.6M9 Dec 31, 2024+13.1%
Property and equipment, net$295.0K9 Dec 31, 2025$483.0K9 Dec 31, 2024−38.9%
Operating-lease assets (leased space)$4.8M9 Dec 31, 2025$5.7M9 Dec 31, 2024−16.2%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$18.6M9 Dec 31, 2025$17.6M9 Dec 31, 2024+5.4%

Properties, in its own words

In July 2021, we entered into a lease agreement for approximately 13,424 square feet of office and laboratory space in Boston, Massachusetts, which serves as our corporate headquarters. The lease commenced in February 2022. The lease term is for eight years and expires February 28, 2030 and does not contain an option to renew. The initial annual rent was $1,235,008 with a 3% annual increase. We believe substantially all of our property and equipment is in good condition and that we have sufficient capacity to meet our current operational needs. See Note 10 to our consolidated financial statements included in Item 8 of this Annual Report on Form 10-K for additional information.

Item 2 of the 10-K filed Mar 12, 2026.3

Leadership

Who has led Elicio Therapeutics, Inc., and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Robert Connelly2023–now

President

  1. Robert Connelly2023–now

Chief financial officer

  1. Brian Piekos2023–2024
2025
Board members and other officers (20)

Former names

  • Angion Biomedica Corp.Mar 4, 2014 to May 30, 20232

Timeline

  1. Sep 14, 20268-K Director nominations; Other events31
  2. Aug 13, 20268-K Results of operations32
  3. Jul 2, 20268-K Entered a material agreement; Other events33
  4. Jun 24, 20268-K Regulation FD disclosure34
  5. Jun 17, 20268-K Other events35
  6. Jun 15, 20268-K Other events36
  7. May 11, 20268-K Results of operations37
  8. Mar 16, 20268-K Entered a material agreement; Ended a material agreement38
  9. Mar 12, 20268-K Results of operations39
  10. Nov 13, 20258-K Results of operations40
  11. Sep 17, 20258-K Regulation FD disclosure; Other events41
  12. Aug 12, 20258-K Other events42
  13. Jun 7, 2023New chief executive Robert Connelly becomes CEO11

Calendar

Coming up

  1. Nov 12, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.60) a share, on Nov 13, 2025.43

When it reported results

  1. Aug 13, 2026Reported quarterly or annual results32
  2. May 11, 2026Reported quarterly or annual results37
  3. Mar 12, 2026Reported quarterly or annual results39
  4. Nov 13, 2025Reported quarterly or annual results40
  5. Aug 7, 2025Reported quarterly or annual results44
  6. May 13, 2025Reported quarterly or annual results45
  7. Mar 31, 2025Reported quarterly or annual results46
  8. Nov 13, 2024Reported quarterly or annual results47

Drug trials and FDA: recently

  1. Apr 20, 2026Phase 1/2 trial completed Phase 1/2 trial of ELI-002 7P in Pancreatic Ductal Adenocarcinoma: primary completion Apr 20, 2026, no results posted yet (ClinicalTrials.gov NCT05726864).48

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

296 filings to the SEC since October 2021: 8 annual reports, 15 quarterly reports, 73 major events, 98 insider forms, 28 large holders, 2 private raises, 72 other. The latest 20:

  1. Oct 9, 2026DEF 14A EDGAR
  2. Sep 14, 20268-K EDGAR
  3. Sep 2, 20264 EDGAR
  4. Sep 2, 20264 EDGAR
  5. Sep 2, 20264 EDGAR
  6. Sep 2, 20264 EDGAR
  7. Sep 2, 20264 EDGAR
  8. Sep 2, 20264 EDGAR
  9. Sep 2, 20264 EDGAR
  10. Aug 13, 202610-Q EDGAR
  11. Aug 13, 20268-K EDGAR
  12. Jul 17, 20264 EDGAR
  13. Jul 17, 20264 EDGAR
  14. Jul 17, 20264 EDGAR
  15. Jul 17, 20264 EDGAR
  16. Jul 16, 2026SCHEDULE 13G EDGAR
  17. Jul 8, 2026SCHEDULE 13G/A EDGAR
  18. Jul 2, 2026424B5 EDGAR
  19. Jul 2, 20268-K EDGAR
  20. Jun 24, 20268-K EDGAR

The 296 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

25 open-market trades by officers, directors and large owners since October 2021: 13 buys and 12 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Dec 22, 2023GKCC, LLC10% ownerBuy1,213,000$5.81$7.0MForm 4
May 25, 2022Venkatesan JayDirectorBuy11,313$1.25$14.1KForm 4
May 24, 2022Venkatesan JayDirectorBuy32,200$1.24$39.9KForm 4
May 20, 2022Nissenson AllenDirectorBuy2,037$1.18$2.4KForm 4
May 20, 2022Venkatesan JayDirectorBuy50,000$1.23$61.5KForm 4
May 19, 2022Nissenson AllenDirectorBuy7,346$1.16$8.5KForm 4
Dec 28, 2021Venkatesan JayDirectorBuy210,337$2.66$559.5KForm 4
Dec 27, 2021Venkatesan JayDirectorBuy66,907$2.55$170.6KForm 4
Dec 20, 2021Venkatesan JayDirectorBuy3,527$2.54$9.0KForm 4
Dec 20, 2021Neylan John F.See RemarksSale358$2.62$938Form 4
Dec 17, 2021Venkatesan JayDirectorBuy13,742$2.54$34.9KForm 4
Dec 16, 2021Venkatesan JayDirectorBuy27,883$2.55$71.1KForm 4
Dec 15, 2021Venkatesan JayDirectorBuy77,604$2.41$187.0KForm 4
Dec 15, 2021CURHAN GREGORY SSee RemarksBuy4,000$2.37$9.5KForm 4
Dec 14, 2021Rhodes Jennifer JSee RemarksSale451$2.42$1.1KForm 4
Dec 6, 2021Goldberg ItzhakDirectorSale32,118$3.35$107.6KForm 4
Dec 3, 2021Goldberg ItzhakDirectorSale40,215$3.39$136.3KForm 4
Dec 2, 2021Goldberg ItzhakDirectorSale38,800$3.51$136.2KForm 4
Dec 1, 2021Goldberg ItzhakDirectorSale38,867$3.54$137.6KForm 4
Nov 18, 2021Neylan John F.See RemarksSale374$4.13$1.5KForm 4

All 25 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
2025Robert ConnellyPresident, Chief Executive Officer, and Director66$632.7K$1.9M59
2025Preetam Shah, Ph.D.Chief Strategy and Financial Officer and Treasurer54$796.1K$1.4M59
2025Christopher Haqq, M.D., Ph.D.Executive Vice President, Head of Research and Development and Chief Medical Officer60$528.1K$1.1M59
2024Robert ConnellyPresident, Chief Executive Officer, and Director66$608.4K$2.0M59
2024Christopher Haqq, M.D., Ph.D.Executive Vice President, Head of Research and Development and Chief Medical Officer60$507.8K$926.5K59

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$13.0M 2023–2024
Money received by yearMoney received by year, 2023–2024: $13.0M in all. Private raises (Form D) $13.0M.$0$2M$4M$6M$8M2023 · Private raises (Form D): $7.0M20232024 · Private raises (Form D): $6.0M2024
Figures by year
YearPrivate raises (Form D)Total
2024$6.0M$6.0M
2023$7.0M$7.0M

Private raises

Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.

  1. Mar 19, 2024Raised $6 million in a private offering of securities60 Form D: 1 investor so far Form D
  2. Dec 22, 2023Raised $7 million in a private offering of equity61 Form D: 1 investor 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 48. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Knoll Capital Management, LLC1,211,957$4.7M2.6%+581,042
BlackRock, Inc.766,005$3.0M0.0%+715,408
Vanguard Capital Management LLC572,151$2.2M0.0%+53,513
Geode Capital Management, LLC311,354$1.2M0.0%+176,190
State Street Corp179,420$701.5K0.0%+128,800
Northern Trust Corp130,162$508.9K0.0%+70,428
Ikarian Capital, LLC100,000$391.0K0.1%New
Vanguard Portfolio Management LLC88,905$347.6K0.0%New
Vanguard Fiduciary Trust Co88,062$344.3K0.0%+18,873
Alliancebernstein L.P.81,280$317.8K0.0%New
UBS Group AG40,419$158.0K0.0%+6,650
Charles Schwab Investment Management Inc31,706$124.0K0.0%New
Boothbay Fund Management, LLC30,690$120.0K0.0%New
Morgan Stanley25,546$99.9K0.0%−6,858
Leonteq Securities AG20,000$78.2K0.0%New
Nuveen, LLC17,888$69.9K0.0%New
Citigroup Inc17,726$69.3K0.0%New
Bank of New York Mellon Corp15,884$62.1K0.0%New
New York State Common Retirement Fund14,200$55.5K0.0%New
Meyer Handelman Co13,899$54.3K0.0%No change
HighTower Advisors, LLC13,666$53.4K0.0%+2,500
Raymond James Financial Inc12,720$49.7K0.0%+1,620
Deutsche Bank Ag\12,652$49.5K0.0%New
Wells Fargo & Company/mn11,823$46.2K0.0%New
Wealth Enhancement Advisory Services, LLC11,972$41.7K0.0%New

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

SEC filer profile

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

  • Name on EDGARElicio Therapeutics, Inc.1
  • CIK0001601485
  • Employer ID (EIN)11-34300723
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company3
  • Incorporated inDelaware3
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address451 D Street, 5Th Floor, Boston, MA 022101
  • Phone(857) 209-00501
  • Shares outstanding26,281,882 as of Aug 11, 20268
  • Public float$81.8M as of Jun 30, 20253
  • AuditorBaker Tilly US, LLP, Tewksbury, Massachusetts PCAOB ID 23; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceMar 4, 20141
  • Filings382 in all: 4 (114), 8-K (79), 3 (21), 10-Q (17), CORRESP (15), UPLOAD (11), SC 13D/A (9), D (8)1
    All 43 form types

    EFFECT (8), 425 (7), S-8 (7), 10-K (6), 424B5 (6), S-3 (6), 4/A (4), DEF 14A (4), S-1/A (4), S-4/A (4), SC 13G (4), SC 13G/A (4), SEC STAFF LETTER (4), 10-K/A (3), 424B3 (3), S-3/A (3), SC 13D (3), SCHEDULE 13G (3), SCHEDULE 13G/A (3), ARS (2), DRS (2), DRS/A (2), DRSLTR (2), S-1 (2), SCHEDULE 13D/A (2), 3/A (1), 424B4 (1), 8-A12B (1), 8-A12B/A (1), 8-K/A (1), CERT (1), DEFA14A (1), PRE 14A (1), RW (1), S-4 (1)

  • Latest filingsAnnual report (10-K) Mar 12, 2026
    Quarterly report (10-Q) Aug 13, 2026
    Proxy statement (DEF 14A) Oct 9, 2026
    Latest 8-K (8-K) Sep 14, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.01ELTXNasdaq

From the cover page of the 10-K filed Mar 12, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks Elicio Therapeutics, Inc. names in Item 1A of its 10-K filed Mar 12, 2026: 74 risks under these headings, as written.3

  • Risks Related to Our Operating History, Financial Position and Capital Requirements
  • We will require substantial additional capital to finance our operations, 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 research and development programs, commercialization efforts or cease operations.
  • Our recurring losses from operations have raised substantial doubt regarding our ability to continue as a going concern.
  • We may be unsuccessful in raising the capital necessary to address our going concern issues, or if we are successful, it may be on terms that are highly dilutive to existing stockholders.
  • We have a history of operating losses that are expected to continue for the foreseeable future, and we are unable to predict the extent of future losses, or whether we will generate significant revenues or achieve or sustain profitability.
  • We have never generated revenue from product sales and may never become profitable.
  • We have a limited operating history and we expect a number of factors to cause our operating results to fluctuate on a quarterly and annual basis, which may make it difficult to predict our future performance.
  • We are obligated to develop and maintain proper and effective internal control over financial reporting. In the future, we may not complete our execution of our internal control over financial reporting in a timely manner, or these internal controls may not be determined to be effective, which may result in material misstatements in our consolidated financial statements and may adversely affect investor confidence in our company and, as a result, the value of our common stock.
  • We hold a portion of our cash and cash equivalents that we use to meet our working capital and operating expense needs in deposit accounts that could be adversely affected if the financial institutions holding such funds fail.
  • Changes in interpretation or application of U.S. GAAP may adversely affect our operating results.
  • Significant political, trade, regulatory developments, and other circumstances beyond our control, including as a result of recently announced tariffs, could have a material adverse effect on our financial condition or results of operations.
  • Risks Related to the Development of our Product Candidates
The other 64 risks
  • Our product candidates are at an early stage of clinical development and may not be successfully developed or commercialized.
  • Our product candidates are in various stages of development and we will not be able to commercialize our product candidates if our nonclinical and clinical studies do not produce successful results and/or our clinical trials do not
  • demonstrate the safety and efficacy of our product candidates; early results and early understanding of product candidate potential may not be predictive of later success. Any product candidates currently in clinical development or that we advance into clinical development are subject to extensive regulation, which can be costly and time-consuming, and we may experience unanticipated delays or be unable to receive the required approvals to commercialize our product candidates.
  • Preliminary results from our nonclinical studies and clinical trials that we announce or publish from time to time may change as more patient data becomes available and as the data undergoes audit and verification procedures.
  • The FDA or comparable foreign regulatory authorities may disagree with our regulatory plans and we may fail to obtain regulatory approval of our product candidates.
  • We may not be successful in our efforts to use and expand our discovery engine to build a pipeline of product candidates.
  • Relative to companies that are more established than we are or that have a larger footprint than we do, we have relatively limited experience as a company in completing preclinical studies to enable the filing of INDs, submitting INDs or commencing, enrolling and conducting clinical trials.
  • Our ELI-002 clinical trials are designed to require, as part of screening to determine whether patients meet inclusion criteria, the use of an investigational in vitro diagnostic device. If we are not able to successfully collaborate or partner with a third-party company for the development and authorization of such a device, we may not be able to receive marketing authorization for ELI-002.
  • We may seek designations under FDA programs designed to facilitate and potentially expedite product candidate development, such as fast track or breakthrough therapy designation. Our product candidates may not receive any such designations or if they do receive such designations it may not lead to faster development or regulatory review or approval and it does not increase the likelihood that our product candidates will receive marketing approval.
  • If we are unable to obtain approval via the accelerated approval pathway, we may be required to conduct additional nonclinical studies or clinical trials. Even if we receive accelerated approval from the FDA, the FDA may seek to withdraw accelerated approval.
  • If we apply for orphan drug designation from the FDA, there is no guarantee that we will be able to obtain or maintain this designation, receive this designation for any of our other product candidates, or receive or maintain any corresponding benefits, including periods of exclusivity.
  • We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • Any future product candidates for which we intend to seek approval as biological products may face competition sooner than anticipated.
  • If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • Any product candidate we advance into clinical trials may cause unacceptable adverse events or have other properties that may delay or prevent our regulatory approval or commercialization or limit our commercial potential.
  • We may form or seek strategic partnerships or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements.
  • We rely on CMOs to manufacture our nonclinical and clinical pharmaceutical supplies and expect to continue to rely on CMOs to produce commercial supplies of any approved product candidate, and our dependence on CMOs could adversely impact our business.
  • We rely on third parties to conduct some of our nonclinical studies and all of our clinical trials. If these third parties do not meet our deadlines or otherwise conduct the trials as required, our development programs could be delayed or unsuccessful and we may not be able to obtain regulatory approval for or commercialize our product candidates when expected or at all.
  • We rely on other third parties to store and distribute our product candidates for nonclinical studies and clinical trials that we conduct.
  • We may incur substantial product liability or indemnification claims relating to the clinical testing of our product candidates.
  • Risks Related to Our Business, Industry and Future Commercialization
  • If any product candidate that we successfully develop does not achieve broad market acceptance among physicians, patients, health care payors and the medical community, the revenues that we generate from sales will be limited.
  • If 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.
  • We face significant competition in an environment of rapid technological change, and there is a possibility that our competitors may achieve regulatory approval before us or develop therapies that are safer or more advanced or effective than ours, which may harm our financial condition and our ability to successfully market or commercialize any product candidates we may develop.
  • Corporate and academic collaborators may take actions to delay, prevent, or undermine the success of our products.
  • Data provided by collaborators and others upon which we rely that has not been independently verified could turn out to be false, misleading, or incomplete.
  • Even if we are able to commercialize any product candidates, such products may become subject to unfavorable pricing regulations, reimbursement practices, or health care reform initiatives, which would harm our business.
  • If the market opportunities for any of our product candidates are smaller than we believe they are, our potential revenues may be adversely affected, and our business may suffer. In addition, our estimates of the prevalence of our target populations may be inaccurate.
  • If we or any CMOs 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 the success of our business.
  • Our technologies are novel, and any product candidates we develop may be complex and difficult to manufacture on a clinical or commercial scale. We could experience delays in satisfying regulatory authorities or we could experience production problems that result in delays in our development or commercialization programs, limit the supply of our product candidates we may develop, or otherwise harm our business.
  • Our insurance policies are expensive and protect us only from some business risks, which will leave us exposed to significant uninsured liabilities.
  • Business interruptions could adversely affect future operations, revenues, and financial conditions, and may increase our costs and expenses.
  • Indemnity provisions in various agreements potentially expose us to substantial liability for intellectual property infringement, data protection, and other losses.
  • Risks Related to Our Intellectual Property
  • Our success will depend upon intellectual property and proprietary technologies, and we may be unable to protect our intellectual property.
  • We may be forced to litigate to enforce or defend our intellectual property rights, and/or the intellectual property rights of our licensors.
  • We have rights in some intellectual property that have been discovered through United States government funded programs and thus are subject to federal regulations such as “march-in” rights, certain reporting requirements, and a preference for U.S. industry.
  • We are substantially dependent on patents and patent applications under which we license rights from MIT, and if such licensed patent rights lack legal effect or if a dispute arises under such license agreement and our licensed rights are narrowed or this license is terminated, that could cause significant impairment to our ability to develop and commercialize certain of our product candidates.
  • If we or our partners are sued for infringing on the intellectual property rights of third parties, it could be costly and time-consuming, and an unfavorable outcome in any such litigation could have a material adverse effect on our business.
  • The biotechnology and pharmaceutical industries have experienced substantial litigation and other proceedings concerning intellectual property rights, and third parties may initiate legal proceedings alleging that we are infringing, misappropriating, or otherwise violating their intellectual property rights, the outcome of which could be uncertain and may prevent, delay or otherwise interfere with our product discovery and development efforts.
  • 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 patent law in the United States and in non-U.S. jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our technologies and product candidates.
  • Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
  • We may not be able to obtain PTE under the Drug Price Competition and Patent Term Restoration Act of 1984 in the United States and equivalent extension in other countries and, as a result, our product candidates, if approved, may not have patent protection for a sufficient period.
  • Weakening patent laws and enforcement by courts in the United States and foreign countries may impact our ability to protect our markets.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position could be harmed.
  • Third parties may assert that our employees, consultants, or advisors have wrongfully used or disclosed confidential information or misappropriated trade secrets.
  • Any trademarks we may obtain may be infringed or successfully challenged, resulting in harm to our business.
  • Intellectual property rights do not necessarily address all potential threats.
  • Risks Related to Regulatory and Compliance Matters
  • The FDA regulatory approval process is lengthy, time-consuming, and inherently unpredictable, and we may experience significant delays in the clinical development and regulatory approval, if any, of our product candidates.
  • Even if we receive regulatory approval of our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements.
  • Additional regulatory burdens and other risks and uncertainties in foreign markets may limit our growth.
  • Our relationships with health care providers, physicians, and third-party payors will be subject to applicable anti-kickback, fraud and abuse, anti-bribery and other health care laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, and diminished profits and future earnings.
  • Health care and other reform legislation may increase the difficulty and cost for us and any collaborators we may have to obtain marketing approval of and commercialize our product candidates and affect the prices we, or they, may obtain.
  • Our employees, principal investigators, consultants, and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.
  • Laws and regulations governing any international operations we may have in the future may preclude us from developing, manufacturing and selling certain product candidates outside of the United States and require us to develop and implement costly compliance programs.
  • We are subject to, and may in the future become subject to, U.S. federal and state, and foreign, stringent privacy laws, information security laws, regulations, policies and contractual obligations related to data privacy, artificial intelligence, and security and changes in such laws, regulations, policies and contractual obligations could adversely affect our business.
  • Inadequate funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent our product candidates from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business rely, which could negatively impact our business.
  • Risks Related to Employee and Operations Matters, Managing Growth and Information Technology
  • Our future success depends on our ability to retain our key executives and to attract, retain, and motivate qualified personnel.
  • If we are unable to hire additional qualified personnel, our ability to grow our business may be harmed.
  • We expect to expand our development, regulatory, and future sales and marketing capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
  • Our internal information technology systems, or those of our vendors, collaborators or other contractors or consultants, may fail or suffer cybersecurity incidents, loss of data, and other disruptions, which could result in a material disruption of our product development programs, compromise sensitive information related to our business or prevent us from accessing critical information, potentially exposing us to liability or otherwise adversely affecting our business.
  • Our use of new and evolving technologies, such as artificial intelligence, may present risks and challenges that can impact our business, including by posing cybersecurity and other risks to our confidential and/or proprietary information, including personal information, and as a result we may be exposed to reputational harm and liability.
  • Our business, operations and clinical development timelines and plans are subject to risks arising from epidemic or pandemic diseases.
  • General Risk Factors
  • Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price.

Legal proceedings

From time to time, we may be subject to various legal proceedings, claims and administrative proceedings that arise in the ordinary course of our business activities or otherwise. Although the results of any litigation and claims cannot be predicted with certainty, as of the date of this report, we do not believe we are party to any claim, proceeding or litigation the outcome of which, if determined adversely to us, would individually or in the aggregate be reasonably expected to have a material adverse effect on our business. The outcome of any future litigation is uncertain. Such litigation, if not resolved, could result in substantial costs to us, including any costs associated with the indemnification of directors and officers.

The opening of Item 3, Legal Proceedings.3

Sources

The numbers on this page point here. Each one links to the record it came from.

  1. 1
  2. 2
  3. 3
  4. 4
  5. 5
  6. 6
  7. 7
  8. 8
  9. 9
  10. 10
  11. 11
  12. 12
  13. 13
  14. 14
  15. 15
  16. 16
  17. 17
  18. 18
  19. 19
  20. 20
  21. 21
  22. 22
  23. 23
  24. 24
  25. 25
  26. 26
  27. 27
  28. 28
  29. 29
  30. 30
  31. 31
  32. 32
  33. 33
  34. 34
  35. 35
    SEC EDGAROther events
  36. 36
    SEC EDGAROther events
  37. 37
  38. 38
  39. 39
  40. 40
  41. 41
  42. 42
    SEC EDGAROther events
  43. 43
  44. 44
  45. 45
  46. 46
  47. 47
  48. 48
  49. 49
  50. 50
  51. 51
  52. 52
  53. 53
  54. 54
  55. 55
  56. 56
  57. 57
  58. 58
  59. 59
  60. 60
  61. 61