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ELVN on Nasdaq

Enliven Therapeutics, Inc.

In its 2026 annual report the company says: “We are a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics to help people not only live longer, but live better. Our discovery process combines deep insights into clinically validated biological targets and differentiated chemistry with the goal of designing therapies for unmet needs.”4 It is headquartered in Burlingame, California.1 Its shares trade on Nasdaq under the symbol ELVN.1

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Last updated Oct 21, 2026.

Overview

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  • TickerELVN on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersBurlingame, California1
  • Incorporated inDE2
  • Business address205 Park Road, Burlingame, Ca 940102
  • Filer categoryNon-accelerated filer2
  • Legal formCorporation

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We are a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics to help people not only live longer, but live better. We aim to address existing and emerging unmet needs with a precision medicine approach that improves survival and enhances overall well-being. Our discovery process combines deep insights into clinically validated biological targets and differentiated chemistry with the goal of designing therapies for unmet needs. By combining clinically validated targets and specific target product profiles with disciplined clinical trial design and regulatory strategy, we aim to develop drugs that address unmet needs with an increased probability of clinical and commercial success. Validated targets are those whose role in disease pathology have been demonstrated by mechanistic and clinical studies. We are currently advancing ELV…4 From its latest annual report

Financials

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

Financial statements

Operating income5678910-$119.7M in 2025+396% since 2019
-$150.0M-$100.0M-$50.0M02019: -$24.1M-$24.1M20192020: -$41.7M-$41.7M2020+73%2021: -$51.4M-$51.4M2021+23%2022: -$38.8M-$38.8M2022−25%2023: -$83.5M-$83.5M2023+115%2024: -$104.6M-$104.6M2024+25%2025: -$119.7M-$119.7M2025+14%
Net income5678910-$103.7M in 2025+342% since 2019
-$150.0M-$100.0M-$50.0M02019: -$23.5M-$23.5M20192020: -$41.4M-$41.4M2020+76%2021: -$51.4M-$51.4M2021+24%2022: -$37.7M-$37.7M2022−27%2023: -$71.6M-$71.6M2023+90%2024: -$89.0M-$89.0M2024+24%2025: -$103.7M-$103.7M2025+16%

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

Period ending2025-12-312024-12-31
Research and development$85.9M$80.8M
General and administrative$33.8M$23.8M
Total operating expenses$119.7M$104.6M
Loss from operations-$119.7M-$104.6M
Interest income$16.0M$14.9M
Change in fair value of contingent value right liability$0$873.0K
Income tax expense$0-$232.0K
Other expense-$49.0K-$2.0K
Total other income (expense), net$16.0M$15.5M
Net loss-$103.7M-$89.0M
Net unrealized gains (losses) on marketable securities$279.0K-$86.0K
Comprehensive loss-$103.4M-$89.1M
Net loss per share, basic-$1.83-$1.89
Net loss per share, diluted-$1.83-$1.89
Weighted-average shares outstanding, basic56.7M shares47.1M shares
Weighted-average shares outstanding, diluted56.7M shares47.1M shares

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Corporate structure

Enliven Therapeutics, Inc. sits at the top of its group. 2 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Enliven Therapeutics, Inc.

  • FMR LLC Filed SCHEDULE 13G/A on Enliven Therapeutics, Inc., latest Aug 6, 2026 (6 filings since Feb 9, 2022)
  • ORBIMED ADVISORS LLC Filed SCHEDULE 13D/A on Enliven Therapeutics, Inc., latest Jun 24, 2026 (6 filings since Feb 28, 2023)
  • Polar Capital Holdings Plc Filed SCHEDULE 13G/A on Enliven Therapeutics, Inc., latest Jun 22, 2026 (6 filings since Nov 13, 2024)
  • Commodore Capital LP Filed SCHEDULE 13G/A on Enliven Therapeutics, Inc., latest May 15, 2026 (9 filings since Oct 24, 2022)
  • Fairmount Funds Management LLC Filed SCHEDULE 13G/A on Enliven Therapeutics, Inc., latest May 15, 2026 (6 filings since Apr 27, 2023)
  • Venrock Healthcare Capital Partners III, L.P. Filed SCHEDULE 13G/A on Enliven Therapeutics, Inc., latest May 15, 2026 (5 filings since Mar 13, 2023)
  • Vestal Point Capital, LP Filed SCHEDULE 13G/A on Enliven Therapeutics, Inc., latest May 15, 2026 (2 filings since Feb 17, 2026)
  • BlackRock Filed SCHEDULE 13G/A on Enliven Therapeutics, Inc., latest Jul 17, 2025 (3 filings since Oct 24, 2024)
  • CITADEL ADVISORS LLC Filed SC 13G/A on Enliven Therapeutics, Inc., latest Nov 14, 2024 (3 filings since Mar 6, 2023)
  • RA CAPITAL MANAGEMENT, L.P. Filed SC 13G/A on Enliven Therapeutics, Inc., latest Nov 14, 2024 (4 filings since Oct 24, 2022)
  • 5AM Ventures VI, L.P. Filed SC 13D/A on Enliven Therapeutics, Inc., latest Jul 29, 2024 (6 filings since Mar 6, 2023)
  • Pfizer Filed SC 13G/A on Enliven Therapeutics, Inc., latest Feb 14, 2024
  • Enliven Therapeutics, Inc. Burlingame, California
    • Enliven Inc. Subsidiary · Delaware, United States

Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Enliven 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$263.0K10 Dec 31, 2025$1.4M10 Dec 31, 2024−80.9%
Accumulated depreciation$229.0K10 Dec 31, 2025$919.0K10 Dec 31, 2024−75.1%
Property and equipment, net$34.0K10 Dec 31, 2025$458.0K10 Dec 31, 2024−92.6%
Operating-lease assets (leased space)$383.0K10 Dec 31, 2025$700.0K10 Jan 31, 2025−45.3%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$98.9M10 Dec 31, 2025$124.1M10 Dec 31, 2024−20.3%
Marketable securities, current$363.7M10 Dec 31, 2025$189.3M10 Dec 31, 2024+92.1%
Debt securities available for sale$363.7M10 Dec 31, 2025$189.3M10 Dec 31, 2024+92.1%

Properties, in its own words

Our corporate headquarters are located in Boulder, Colorado. In September 2024, we entered into a lease (the “Lease”) with Crestview, LLC for approximately 20,011 rentable square feet of office and laboratory space from January 1, 2025 through December 31, 2026, with a renewal option for an additional term of five years. The Lease replaced our prior sublease for more space in the same location. We believe that our facility is adequate to meet our current needs and that suitable additional alternative spaces will be available in the future on commercially reasonable terms, if required.

Item 2 of the 10-K filed Mar 3, 2026.4

Leadership

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

Chief executive

  1. Rahul D. Ballal2020–2023
  2. Samuel Kintz2023–2025
  3. Richard A. Fair2025–now

President

  1. Rahul D. Ballal2020
  2. Samuel Kintz2023–2025
  3. Richard A. Fair2025–now

Chief financial officer

  1. Benjamin Hohl2023–now

Chief operating officer

  1. Anish Patel2023–now
2025
Board members and other officers (28)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Enliven Inc. Delaware3

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Former names

  • IMARA Inc.Apr 21, 2016 to Feb 23, 20232

Timeline

  1. Oct 14, 20268-K Executive or director change; Regulation FD disclosure42
  2. Aug 5, 20268-K Results of operations43
  3. Jun 12, 20268-K Entered a material agreement; Regulation FD disclosure44
  4. Jun 11, 20268-K Regulation FD disclosure; Other events45
  5. Jun 10, 20268-K Bylaws or fiscal year changed; Shareholder vote46
  6. May 7, 20268-K Results of operations47
  7. Mar 3, 20268-K Results of operations48
  8. Jan 7, 20268-K Executive or director change49
  9. Dec 12, 2025New chief executive Richard A. Fair becomes CEO13
  10. Dec 11, 20258-K Executive or director change; Regulation FD disclosure50
  11. Nov 13, 20258-K Results of operations51
  12. Nov 12, 20258-K Results of operations52
  13. Aug 13, 20258-K Results of operations53
  14. Feb 27, 2023New chief executive Samuel Kintz becomes CEO14
  15. Mar 11, 2020New chief executive Rahul D. Ballal becomes CEO15

Calendar

Coming up

  1. Nov 11, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.32) a share, on Nov 12, 2025.54

When it reported results

  1. Aug 5, 2026Reported quarterly or annual results43
  2. May 7, 2026Reported quarterly or annual results47
  3. Mar 3, 2026Reported quarterly or annual results48
  4. Nov 13, 2025Reported quarterly or annual results51
  5. Nov 12, 2025Reported quarterly or annual results52
  6. Aug 13, 2025Reported quarterly or annual results53
  7. May 14, 2025Reported quarterly or annual results55
  8. Mar 13, 2025Reported quarterly or annual results56

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

Filings

664 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 47 major events, 314 insider forms, 64 large holders, 1 private raises, 218 other. The latest 20:

  1. Oct 14, 20268-K EDGAR
  2. Oct 5, 20264 EDGAR
  3. Oct 1, 2026144 EDGAR
  4. Sep 21, 20264 EDGAR
  5. Sep 21, 20264 EDGAR
  6. Sep 17, 2026144 EDGAR
  7. Sep 4, 2026144 EDGAR
  8. Aug 19, 20264 EDGAR
  9. Aug 19, 20264 EDGAR
  10. Aug 6, 20264 EDGAR
  11. Aug 6, 2026SCHEDULE 13G/A EDGAR
  12. Aug 5, 202610-Q EDGAR
  13. Aug 5, 20268-K EDGAR
  14. Aug 4, 2026144 EDGAR
  15. Jul 21, 20264 EDGAR
  16. Jul 21, 20264 EDGAR
  17. Jul 17, 2026144 EDGAR
  18. Jul 8, 20264 EDGAR
  19. Jun 24, 20264 EDGAR
  20. Jun 24, 2026SCHEDULE 13D/A EDGAR

The 664 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

284 open-market trades by officers, directors and large owners since October 2021: 28 buys and 256 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 17, 2026Hohl BenjaminCHIEF FINANCIAL OFFICERSale6,018$50.35$303.0KForm 4
Sep 17, 2026Collins Helen LouiseCHIEF MEDICAL OFFICERSale5,000$50.35$251.8KForm 4
Aug 17, 2026Hohl BenjaminCHIEF FINANCIAL OFFICERSale6,018$58.58$352.5KForm 4
Aug 17, 2026Collins Helen LouiseCHIEF MEDICAL OFFICERSale5,000$58.59$292.9KForm 4
Aug 4, 2026Derynck Mika KDirectorSale158,795$60.21$9.6MForm 4
Jul 17, 2026Hohl BenjaminCHIEF FINANCIAL OFFICERSale6,018$52.64$316.8KForm 4
Jul 17, 2026Collins Helen LouiseCHIEF MEDICAL OFFICERSale5,000$52.67$263.4KForm 4
Jul 6, 2026Kunkel Lori AnneDirectorSale10,000$50.49$504.9KForm 4
Jun 22, 2026ORBIMED ADVISORS LLC10% ownerSale860,123$45.36$39.0MForm 4
Jun 17, 2026Hohl BenjaminCHIEF FINANCIAL OFFICERSale6,018$43.80$263.6KForm 4
Jun 17, 2026Collins Helen LouiseCHIEF MEDICAL OFFICERSale5,000$43.80$219.0KForm 4
Jun 15, 2026ORBIMED ADVISORS LLC10% ownerSale281,408$45.02$12.7MForm 4
Jun 5, 2026Kunkel Lori AnneDirectorSale10,000$34.54$345.4KForm 4
May 18, 2026Collins Helen LouiseCHIEF MEDICAL OFFICERSale5,000$39.79$199.0KForm 4
Apr 17, 2026Collins Helen LouiseCHIEF MEDICAL OFFICERSale5,000$47.67$238.4KForm 4
Mar 25, 2026Collins Helen LouiseCHIEF MEDICAL OFFICERSale40,000$35.10$1.4MForm 4
Mar 17, 2026Collins Helen LouiseCHIEF MEDICAL OFFICERSale5,000$27.76$138.8KForm 4
Mar 10, 2026Collins Helen LouiseCHIEF MEDICAL OFFICERSale10,129$30.19$305.8KForm 4
Mar 9, 2026Collins Helen LouiseCHIEF MEDICAL OFFICERSale29,871$30.02$896.7KForm 4
Mar 6, 2026Hohl BenjaminCHIEF FINANCIAL OFFICERSale10,000$29.58$295.8KForm 4

All 284 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
2025President and Chief Executive Officer$38.1K$11.9M71
2025Sam KintzM.B.A.$624.2K$8.9M71
2025Helen CollinsM.D.63$523.0K$3.5M71
2025Chief Financial Officer$480.0K$3.4M71
2024Former President and Chief Executive Officer$600.0K$5.5M71
2024Chief Medical Officer$495.0K$2.8M71

Money raised

Private offerings the company reported to the SEC on Form D.

  1. Mar 21, 2024Raised $90 million in a private offering of equity Form D: 20 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 LLC10,025,017$508.8M0.0%+3,195,771
Orbimed Advisors LLC6,776,632$343.9M6.5%−1,182,906
Polar Capital Holdings Plc6,430,636$326.4M0.9%+1,364,703
BlackRock, Inc.4,359,704$221.3M0.0%+674,997
Vestal Point Capital, LP4,000,000$203.0M4.7%+750,000
Commodore Capital LP3,275,000$166.2M9.9%No change
Vanguard Capital Management LLC2,569,002$130.4M0.0%+400,840
Citadel Advisors LLC2,068,992$105.0M0.1%+325,077
Fairmount Funds Management LLC1,855,644$94.2M6.2%No change
Siren, L.L.C.1,774,411$90.1M1.8%+1,028,185
Bellevue Group AG1,490,000$75.6M1.6%−830,867
Geode Capital Management, LLC1,407,202$71.4M0.0%+340,782
First Light Asset Management, LLC1,360,750$69.1M4.2%+1,158,883
State Street Corp1,213,616$61.6M0.0%+122,510
Pictet Asset Management Holding SA1,161,784$59.0M0.1%+232,240
Adage Capital Partners Gp, L.l.c.1,083,313$55.0M0.1%New
Novo Holdings A/s1,000,000$50.8M2.9%−280,000
First Turn Management, LLC954,360$48.4M5.2%+330,521
Samlyn Capital, LLC912,637$46.3M0.8%New
Baker Bros. Advisors LP905,191$45.9M0.2%No change
Candriam S.C.A.905,674$45.9M0.2%+311,595
Tri Locum Partners LP866,716$44.0M5.4%New
Alliancebernstein L.P.896,161$35.1M0.0%+124,276
Dimensional Fund Advisors LP671,412$34.1M0.0%−10,303
Assenagon Asset Management S.A.613,148$31.1M0.0%New

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

SEC filer profile

How Enliven 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 EDGAREnliven Therapeutics, Inc.1
  • CIK0001672619
  • Employer ID (EIN)81-15238494
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address205 Park Road, Burlingame, CA 940101
  • Phone650-547-58141
  • Shares outstanding73,270,761 as of Jul 28, 202612
  • Public float$836.0M as of Jun 30, 20254
  • AuditorDeloitte & Touche LLP, San Francisco, California PCAOB ID 34; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceApr 21, 20161
  • Filings789 in all: 4 (323), 144 (156), 8-K (56), 3 (44), SC 13G/A (23), 10-Q (20), SCHEDULE 13G/A (15), SC 13G (14)1
    All 44 form types

    SC 13D/A (13), CORRESP (12), 4/A (10), S-8 (9), 424B5 (8), DEFA14A (8), UPLOAD (8), 10-K (6), DEF 14A (6), 425 (5), EFFECT (5), SC 13D (5), 8-K/A (4), ARS (4), D (3), S-3 (3), SCHEDULE 13D/A (3), 144/A (2), 424B3 (2), PRE 14A (2), S-1/A (2), S-4/A (2), SCHEDULE 13G (2), SEC STAFF LETTER (2), 424B4 (1), 8-A12B (1), CERT (1), DEFM14A (1), DRS (1), DRS/A (1), DRSLTR (1), PREM14A (1), S-1 (1), S-3ASR (1), S-3MEF (1), S-4 (1)

  • Latest filingsAnnual report (10-K) Mar 3, 2026
    Quarterly report (10-Q) Aug 5, 2026
    Proxy statement (DEF 14A) Apr 27, 2026
    Latest 8-K (8-K) Oct 14, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.001 par value per shareELVNThe Nasdaq Global Select Market

From the cover page of the 10-K filed Mar 3, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Enliven Therapeutics, Inc. names in Item 1A of its 10-K filed Mar 3, 2026: 76 risks under these headings, as written.4

  • Risks Related to Our Limited Operating History, Financial Position and Need for Additional Capital
  • We are early in our development efforts, with a limited operating history, and we have no products approved for commercial sale, which may make it difficult for you to evaluate our current business and likelihood of success and future viability.
  • We have incurred significant net losses and we expect to continue to incur significant net losses for the foreseeable future.
  • We have never generated revenue from product sales and may never achieve or maintain profitability.
  • Risks Related to the Discovery, Development and Commercialization of Our Product Candidates
  • We are very early in our development efforts. In addition, we are substantially dependent on ELVN-001. If we are unable to advance ELVN-001 through clinical development, obtain regulatory approval and ultimately commercialize or license ELVN-001, or experience significant delays in doing so, our business will be materially harmed.
  • The outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and the results of our clinical trials may not satisfy the requirements of the FDA, EMA or other comparable foreign regulatory authorities.
  • We have limited resources and are currently focusing our efforts on ELVN-001 for development in particular indications and advancing our other research programs. As a result, we may fail to capitalize on programs, product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • Our prospects depend in large part upon developing and commercializing and/or otherwise licensing ELVN-001 and discovering, developing and commercializing product candidates from our other research programs, and failure to successfully identify, develop and commercialize additional product candidates could impair our ability to grow.
  • If clinical trials of our product candidates fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities or do not otherwise produce positive results, or if FDA disagrees with our clinical trial design or our interpretation of the data, we would incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
  • The regulatory approval processes of the FDA, EMA and other comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable. If we are ultimately unable to obtain regulatory approval of our product candidates, we will be unable to generate product revenue and our business will be substantially harmed.
  • If we are required by the FDA or comparable regulatory authorities to obtain approval of a companion diagnostic in connection with approval of any of our product candidates or a group of therapeutic products, and we do not obtain or we face delays in obtaining approval of a companion diagnostic, we will not be able to commercialize the product candidate and our ability to generate revenue will be materially impaired.
The other 64 risks
  • We have limited experience as a company in designing and conducting clinical trials.
  • Any delays in the commencement or completion, or termination or suspension of our planned or future clinical trials could result in increased costs, delay or limit our ability to generate revenue and adversely affect our commercial prospects. We may not be able to file INDs to commence clinical trials on the timelines we expect, and even if we are able to, the FDA, EMA or other comparable foreign regulatory authorities may not permit us to proceed.
  • Interim, topline and preliminary data from our preclinical studies and clinical trials that we announce or publish from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • If we experience delays or difficulties in the enrollment or maintenance of participants that meet the protocol criteria in clinical trials, our regulatory submissions or receipt of necessary marketing approvals could be delayed or prevented.
  • We face substantial competition which may result in others discovering, developing or commercializing products before or more successfully than we do.
  • The manufacture of drugs is complex, and our third-party manufacturers may encounter difficulties in production. If any of our third-party manufacturers encounter such difficulties, our ability to provide adequate supply of our product candidates for clinical trials or our products for patients, if approved, could be delayed or prevented.
  • Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
  • Our product candidates may not achieve adequate market acceptance among physicians, patients, healthcare payors and others in the medical community necessary for commercial success.
  • The market opportunities for any product candidates we develop, if approved, may be limited to certain smaller patient subsets and may be smaller than we estimate them to be.
  • We face risks related to public health emergencies, health epidemics (including COVID-19) or other outbreaks, which could significantly disrupt our operations or otherwise result in material adverse impacts to us.
  • Any product candidates we develop may become subject to unfavorable third-party coverage and reimbursement practices, as well as pricing regulations.
  • Our business entails a significant risk of product liability and if we are unable to obtain sufficient insurance coverage such inability could have an adverse effect on our business and financial condition.
  • Risks Related to Regulatory Approval and Other Legal Compliance Matters
  • We may develop our current or future product candidates in combination with other therapies, which would expose us to additional risks.
  • We have never commercialized a product candidate as a company before and currently lack the necessary expertise, personnel and resources to successfully commercialize any products on our own or together with suitable collaborators.
  • The FDA, EMA and other comparable foreign regulatory authorities may not accept data from trials conducted in locations outside of their jurisdiction.
  • 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 our product candidates receive regulatory approval, they will be subject to significant post-marketing regulatory requirements and oversight.
  • The FDA, EMA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
  • Where possible, we plan to seek Fast Track designation from the FDA for one or more of our product candidates. Even if one or more of our product candidates receive Fast Track designation, we may be unable to obtain or maintain the benefits associated with the Fast Track designation.
  • Where possible, we plan to seek Breakthrough Therapy designation from the FDA, which even if granted for any of our product candidates, may not lead to a faster development or regulatory review or approval process and does not increase the likelihood that our product candidates will receive marketing approval.
  • We received orphan drug designation for ELVN-001. We may not be able to obtain additional orphan drug designations or obtain or maintain orphan drug exclusivity for our product candidates and, even if we do, that exclusivity may not prevent the FDA, EMA or other comparable foreign regulatory authorities, from approving competing products.
  • We may face difficulties from changes to current regulations and future legislation. Healthcare legislative measures aimed at reducing healthcare costs may have a material adverse effect on our business and results of operations.
  • Our relationships with employees, independent contractors, consultants, commercial collaborators, healthcare professionals, clinical investigators, CROs, suppliers, vendors and third-party payors in connection with our current and future business activities may be subject to federal and state healthcare fraud and abuse laws, false claims laws, transparency laws, government price reporting, and health information privacy and security laws, which could expose us to significant losses, including, among other
  • things, criminal sanctions, civil penalties, contractual damages, exclusion from governmental healthcare programs, reputational harm, administrative burdens and diminished profits and future earnings.
  • We are subject to stringent and changing privacy, data protection and data security laws, regulations and standards as well as policies, contracts and other obligations related to data privacy, data protection and data security. Our actual or perceived failure to comply with such obligations could lead to enforcement or litigation (that could result in fines or penalties), a disruption or cancellation of clinical trials or commercialization of products, reputational harm, or other adverse business effects.
  • Our business activities may be subject to the U.S. Foreign Corrupt Practices Act (“FCPA”) and similar anti-bribery and anti-corruption laws and anti-money laundering laws, including laws of other countries in which we operate, as well as U.S. and certain foreign export controls, trade sanctions, and import laws and regulations. Compliance with these legal requirements could limit our ability to compete in foreign markets and subject us to liability if we violate them.
  • 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.
  • Any legal proceedings or claims against us could be costly and time-consuming to defend and could harm our reputation regardless of the outcome.
  • Risks Related to Employee Matters, Managing Our Growth and Other Risks Related to Our Business
  • Our success is highly dependent on our ability to attract, hire and retain highly skilled executive officers and employees.
  • Our reliance on a limited number of employees who provide various administrative, research and development, and other services across our organization presents operational challenges that may adversely affect our business.
  • We will need to grow the size and capabilities of our organization, and we may experience difficulties in managing this growth.
  • If we are unable to establish sales or marketing capabilities or enter into agreements with third parties to sell or market our product candidates, we may not be able to successfully sell or market our product candidates that obtain regulatory approval.
  • A variety of risks associated with marketing our product candidates internationally could materially adversely affect our business.
  • Risks Related to Our Intellectual Property
  • Our success depends on our ability to protect our intellectual property and our proprietary technologies.
  • 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 product candidates would be adversely affected.
  • Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
  • Our commercial success depends significantly on our ability to operate without infringing the patents and other proprietary rights of third parties. Claims by third parties that we infringe their proprietary rights may result in liability for damages or prevent or delay our developmental and commercialization efforts.
  • Because our development programs may in the future require the use of proprietary rights held by third parties, the growth of our business may depend in part on our ability to acquire, in-license, or use these third-party proprietary rights.
  • We may be involved in lawsuits to protect or enforce our patents or our future licensors’ patents, which could be expensive, time consuming and unsuccessful. Further, our issued patents or our future licensors’ patents could be found invalid or unenforceable if challenged in court.
  • Changes in United States patent law, or laws in other countries, could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
  • Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
  • If we do not obtain patent term extension for our product candidates, our business may be materially harmed.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, documentary, fee payment and other requirements imposed by regulations and governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • 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.
  • We may be subject to claims that we or our employees have wrongfully used or disclosed alleged confidential information or trade secrets.
  • We may be subject to claims that we have wrongfully hired an employee from a competitor or that we or our employees have wrongfully used or disclosed alleged confidential information or trade secrets of their former employers.
  • Our rights to develop and commercialize our technology and product candidates may be subject, in part, to the terms and conditions of licenses granted to us by others.
  • If we fail to comply with our obligations in the agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our future licensors, we could lose license rights that are important to our business.
  • Intellectual property discovered through government funded programs may be subject to federal regulations such as “march-in” rights, certain reporting requirements and a preference for United States-based companies. Compliance with such regulations may limit our exclusive rights and limit our ability to contract with non-United States manufacturers.
  • Risks Related to Our Dependence on Third Parties
  • We rely on third parties to conduct preclinical studies and clinical trials and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research and studies.
  • We contract with third parties for the manufacture of our product candidates for preclinical studies and clinical trials and expect to do so ultimately for commercialization, and the loss of these third parties or their inability to supply us with sufficient quality and quantities of our product candidates or such quantities at an acceptable cost could delay, prevent or impair our development or commercialization efforts.
  • Our manufacturing process needs to comply with FDA regulations relating to the quality and reliability of such processes. Any failure to comply with relevant regulations could result in delays in or termination of our clinical programs and suspension or withdrawal of any regulatory approvals.
  • If our third-party manufacturers use hazardous materials in a manner that causes injury or violates applicable law, we may be liable for damages.
  • If we engage in future acquisitions or strategic partnerships, this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities, and subject us to other risks.
  • If we decide to establish collaborations but are not able to establish those collaborations on commercially reasonable terms, we may have to alter our development and commercialization plans.
  • We may enter into collaborations with third parties for the development and commercialization of product candidates. If those collaborations are not successful, we may not be able to capitalize on the market potential of these product candidates.
  • Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or our guidance.
  • Risks Related to Our Common Stock
  • The market price of our common stock may be volatile and may drop.
  • We will need substantial additional funding before we can complete the development of our product candidates. If we are unable to obtain such additional capital on favorable terms, on a timely basis or at all, we would be forced to delay, reduce or eliminate our product development and clinical programs and may not have the capital required to otherwise operate our business.
  • 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 marketable securities and to timely pay key vendors and others.
  • We have incurred and will continue to incur additional costs and increased demands upon management as a result of complying with the laws and regulations affecting public companies.
  • We ceased to be an emerging growth company on December 31, 2025 and will cease to be eligible to use the requirements for smaller reporting companies until our Form 10-Q for the first fiscal quarter of 2026. Once we are no longer a smaller reporting company or otherwise no longer qualify for applicable exemptions, we will be subject to additional laws and regulations affecting public companies that will increase our costs and the demands on management and could harm our operating results.

Legal proceedings

From time to time, we may become involved in litigation or other legal proceedings arising in the ordinary course of our business. We are not currently a party to any material 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 can have an adverse impact on us because of defense and settlement costs, diversion of management resources, negative publicity, reputational harm and other factors.

The opening of Item 3, Legal Proceedings.4

Sources

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