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CADL on Nasdaq

Candel Therapeutics

In its 2026 annual report the company says: “We are a clinical stage biopharmaceutical company focused on developing off-the-shelf viral immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Our engineered viruses are designed to induce a systemic anti-tumor response due to induction of immunogenic cell death within the tumor microenvironment, thus releasing tumor neo-antigens and creating a pro-inflammatory microenvironment at the site of injection.”4 It is headquartered in Auburndale.1 Its shares trade on Nasdaq under the symbol CADL.1

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Last updated Oct 21, 2026.

Overview

Compare with VivoSim Labs, INC., Instil Bio, Inc. or Zivo Bioscience, Inc., or pick any stock.

  • TickerCADL on Nasdaq1
  • Industrypharmaceutical industry1
  • HeadquartersAuburndale1
  • Websitewww.candeltx.com
  • Incorporated inDE3
  • Business address117 Kendrick Street, Suite 450, Needham, Ma 024943
  • Filer category, Emerging growth company3

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We are a clinical stage biopharmaceutical company focused on developing off-the-shelf viral immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Our engineered viruses are designed to induce a systemic anti-tumor response due to induction of immunogenic cell death within the tumor microenvironment, thus releasing tumor neo-antigens and creating a pro-inflammatory microenvironment at the site of injection. This is intended to lead to in-situ immunization against the injected tumor and uninjected distant metastases. Local administration is designed to achieve these therapeutic effects while minimizing systemic exposure and associated toxicity.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 2022

-27777.6%Operating margin5
-15035.2%Net margin5
0.0%Revenue growth, 20225
-39.4%Return on equity6
-$32.7MFree cash flow5

Where the money goes

Where each dollar of revenue went, fiscal 2022

  • Research and development92¢$20.8M
  • Interest8¢$1.7M

Out of $125.0K in revenue.5 The company lost money this year.

Financial statements

Revenue785$125.0K in 2022+0% since 2020
0$50.0K$100.0K$150.0K2020: $125.0K$125.0K20202021: $125.0K$125.0K2021+0%2022: $125.0K$125.0K2022+0%
Operating income785-$34.7M in 2022+151% since 2020
-$40.0M-$30.0M-$20.0M-$10.0M02020: -$13.8M-$13.8M20202021: -$25.7M-$25.7M2021+86%2022: -$34.7M-$34.7M2022+35%
Net income785-$18.8M in 2022+6% since 2020
-$40.0M-$30.0M-$20.0M-$10.0M02020: -$17.7M-$17.7M20202021: -$36.1M-$36.1M2021+104%2022: -$18.8M-$18.8M2022−48%

Every line of the income statement as filed: the last 2 fiscal years, latest first.11

Period ending2025-12-312024-12-31
Research and development$30.5M$19.3M
General and administrative$17.8M$14.1M
Total operating expenses$48.3M$33.4M
Loss from operations-$48.3M-$33.4M
Grant income$89.0K
Interest income$3.9M$1.1M
Interest expense-$2.1M-$2.1M
Change in fair value of warrant liabilities$8.2M-$20.8M
Total other income (expense), net$10.1M-$21.8M
Net loss and comprehensive loss-$38.2M-$55.2M
Net loss per share - basic-$0.72-$1.74
Net loss per share - diluted-$0.72-$1.74
Weighted-average common shares outstanding, basic53.0M shares31.7M shares
Weighted-average common shares outstanding, diluted53.0M shares31.7M shares

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Corporate structure

Candel Therapeutics 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 Candel Therapeutics

  • BlackRock Filed SCHEDULE 13G on Candel Therapeutics, latest Jul 27, 2026 (3 filings since Jan 21, 2026)
  • RTW INVESTMENTS, LP Filed SCHEDULE 13G on Candel Therapeutics, latest May 15, 2026
  • Paul B. Manning Filed SCHEDULE 13D/A on Candel Therapeutics, latest Mar 18, 2026 (2 filings since Feb 14, 2022)
  • ACORN BIOVENTURES, L.P. Filed SCHEDULE 13G on Candel Therapeutics, latest Jun 30, 2025
  • BAKER BROS. ADVISORS LP Filed SCHEDULE 13G/A on Candel Therapeutics, latest May 15, 2025 (2 filings since Feb 14, 2025)
  • Northpond Ventures, LP Filed SCHEDULE 13G/A on Candel Therapeutics, latest Feb 14, 2025 (2 filings since Feb 14, 2022)
  • CVI Investments, Inc. Filed SCHEDULE 13G/A on Candel Therapeutics, latest Feb 7, 2025 (2 filings since Dec 17, 2024)
  • FMR LLC Filed SCHEDULE 13G/A on Candel Therapeutics, latest Feb 7, 2025 (4 filings since Feb 9, 2022)
  • Candel Therapeutics Auburndale

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

What it owns

What Candel Therapeutics 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$5.2M11 Dec 31, 2025$5.3M11 Dec 31, 2024−1.3%
Accumulated depreciation$3.6M11 Dec 31, 2025$3.1M11 Dec 31, 2024+15.7%
Property and equipment, net$1.6M11 Dec 31, 2025$2.2M11 Dec 31, 2024−25.1%
Operating-lease assets (leased space)$1.7M11 Dec 31, 2025$542.0K11 Dec 31, 2024+206.5%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$119.7M11 Dec 31, 2025$102.7M11 Dec 31, 2024+16.6%

Properties, in its own words

Our principal office is located at 117 Kendrick St, Suite 450, Needham, Massachusetts 02494, where we lease approximately 15,000 square feet of office and laboratory space. We lease this space under a lease that terminates on August 31, 2029.

Item 2 of the 10-K filed Mar 12, 2026.4

Leadership

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

Chief executive

  1. Paul Peter Tak2021–now

President

  1. Paul Peter Tak2021

Chief financial officer

  1. John J. Canepa2021–2022
  2. Jason Amello2022–2023
  3. Charles Schoch2025–now
2025
Board members and other officers (23)

Timeline

  1. Sep 10, 20268-K Executive or director change; Regulation FD disclosure37
  2. Sep 9, 20268-K Regulation FD disclosure38
  3. Aug 13, 20268-K Results of operations39
  4. Jun 24, 20268-K Shareholder vote40
  5. Jun 16, 20268-K Executive or director change41
  6. May 15, 20268-K Regulation FD disclosure42
  7. May 14, 20268-K Results of operations43
  8. Mar 12, 20268-K Results of operations44
  9. Feb 23, 20268-K Entered a material agreement; Other events45
  10. Feb 19, 20268-K Entered a material agreement; Results of operations; Regulation FD disclosure46
  11. Dec 5, 20258-K Regulation FD disclosure47
  12. Nov 13, 20258-K Results of operations48
  13. Jul 26, 2021New chief executive Paul Peter Tak becomes CEO12

Calendar

Coming up

  1. Nov 12, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.21) a share, on Nov 13, 2025.49

When it reported results

  1. Aug 13, 2026Reported quarterly or annual results39
  2. May 14, 2026Reported quarterly or annual results43
  3. Mar 12, 2026Reported quarterly or annual results44
  4. Feb 19, 2026Reported quarterly or annual results46
  5. Nov 13, 2025Reported quarterly or annual results48
  6. Oct 14, 2025Reported quarterly or annual results50
  7. Aug 14, 2025Reported quarterly or annual results51
  8. May 13, 2025Reported quarterly or annual results52

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

Filings

366 filings to the SEC since October 2021: 7 annual reports, 15 quarterly reports, 82 major events, 177 insider forms, 17 large holders, 68 other. The latest 20:

  1. Oct 2, 20264 EDGAR
  2. Oct 2, 20264 EDGAR
  3. Oct 2, 20264 EDGAR
  4. Sep 11, 20264 EDGAR
  5. Sep 10, 2026144 EDGAR
  6. Sep 10, 20264 EDGAR
  7. Sep 10, 20263 EDGAR
  8. Sep 10, 20268-K EDGAR
  9. Sep 9, 20268-K EDGAR
  10. Aug 19, 20264 EDGAR
  11. Aug 17, 2026144 EDGAR
  12. Aug 13, 202610-Q EDGAR
  13. Aug 13, 20268-K EDGAR
  14. Jul 27, 2026SCHEDULE 13G EDGAR
  15. Jul 8, 20264 EDGAR
  16. Jul 8, 20263 EDGAR
  17. Jul 1, 20264 EDGAR
  18. Jul 1, 20264 EDGAR
  19. Jul 1, 20264 EDGAR
  20. Jul 1, 20264 EDGAR

The 366 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

59 open-market trades by officers, directors and large owners since October 2021: 15 buys and 44 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 11, 2026Tak Paul PeterChief Executive OfficerSale59,379$10.46$621.1KForm 4
Sep 10, 2026Tak Paul PeterChief Executive OfficerSale220,866$11.50$2.5MForm 4
Aug 17, 2026Tyagarajan SeshuChief Technology OfficerSale7,000$12.00$84.0KForm 4
Jun 29, 2026Tyagarajan SeshuChief Technology OfficerSale7,000$10.02$70.1KForm 4
Jun 29, 2026Barone FrancescaChief Scientific OfficerSale23,447$10.06$235.9KForm 4
Feb 23, 2026Manning Paul BDirectorBuy550,458$5.45$3.0MForm 4
Jul 28, 2025Nichols William GarrettChief Medical OfficerSale937$6.98$6.5KForm 4
Jun 30, 2025Nichols William GarrettChief Medical OfficerSale781$5.04$3.9KForm 4
Mar 19, 2025Tak Paul PeterChief Executive OfficerSale400$9.00$3.6KForm 4
Mar 18, 2025Nichols William GarrettChief Medical OfficerSale45,316$8.76$397.0KForm 4
Mar 18, 2025Barone FrancescaChief Scientific OfficerSale32,146$8.76$281.6KForm 4
Mar 18, 2025Tak Paul PeterChief Executive OfficerSale25,772$8.77$226.0KForm 4
Mar 17, 2025Tyagarajan SeshuChief Technology OfficerSale31,278$8.82$275.9KForm 4
Mar 17, 2025Tyagarajan SeshuChief Technology OfficerSale31,278$8.82$275.9KForm 4
Mar 17, 2025Schoch CharlesChief Financial OfficerSale5,000$8.83$44.1KForm 4
Jan 15, 2025Tyagarajan SeshuChief Technology OfficerSale14,322$7.23$103.5KForm 4
Jan 15, 2025Barone FrancescaChief Scientific OfficerSale13,534$7.23$97.9KForm 4
Jan 15, 2025Schoch CharlesChief Financial OfficerSale9,511$7.23$68.8KForm 4
Jan 15, 2025Tak Paul PeterChief Executive OfficerSale21,704$7.23$156.9KForm 4
Jan 15, 2025Nichols William GarrettChief Medical OfficerSale10,428$7.23$75.4KForm 4

All 59 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
2025Paul Peter Tak, M.D.Ph.D., FMedSci, Chief Executive Officer$743.6K$5.3M61
2025Francesca Barone, M.D.Ph.D. Chief Scientific Officer$483.3K$1.6M61
2025Charles SchochChief Financial Officer41$398.5K$1.5M61
2024Paul Peter Tak, M.D.Ph.D., FMedSci, Chief Executive Officer$688.9K$1.4M61
2024Francesca Barone, M.D.Ph.D. Chief Scientific Officer$443.3K$726.2K61

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 LLC10,990,535$113.2M0.0%+3,518
Rtw Investments, LP6,422,018$66.1M0.6%No change
BlackRock, Inc.4,969,040$51.2M0.0%+1,859,998
State Street Corp3,549,823$36.6M0.0%+2,731,265
Acorn Capital Advisors, LLC3,497,948$36.0M9.8%No change
Portolan Capital Management, LLC3,490,398$36.0M1.3%+596,073
Saturn V Capital Management LP3,303,686$34.0M4.9%+407,098
Vanguard Capital Management LLC2,694,040$27.7M0.0%+231,283
Geode Capital Management, LLC1,571,021$16.2M0.0%+535,586
Millennium Management LLC1,093,905$11.3M0.0%+33,819
Halter Ferguson Financial Inc.772,461$8.0M1.3%−131,590
Northern Trust Corp492,465$5.1M0.0%+169,311
Kennedy Capital Management LLC488,291$5.0M0.1%+395,666
Vanguard Portfolio Management LLC437,150$4.5M0.0%+168,901
Vanguard Fiduciary Trust Co412,109$4.2M0.0%+131,658
Sands Capital Alternatives, LLC405,837$4.2M0.7%No change
Goldman Sachs Group Inc305,216$3.1M0.0%+77,695
Marshall Wace, Llp300,641$3.1M0.0%New
Bank Of America Corp /de/278,944$2.9M0.0%+231,542
Susquehanna International Group, Llp227,939$2.3M0.0%+114,966
Wellington Management Group Llp205,745$2.1M0.0%New
Charles Schwab Investment Management Inc199,454$2.1M0.0%+87,738
Tanager Wealth Management LLP198,175$2.0M0.2%No change
Bank of New York Mellon Corp191,701$2.0M0.0%+55,435
UBS Group AG169,271$1.7M0.0%+19,416

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

SEC filer profile

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

  • Name on EDGARCandel Therapeutics, Inc.2
  • CIK0001841387
  • Employer ID (EIN)52-22148514
  • Filer statusNon-accelerated filer 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 address117 Kendrick Street, Suite 450, Needham, MA 024942
  • Phone617-916-54452
  • Shares outstanding76,518,565 as of Aug 6, 202610
  • Public float$245.3M as of Jun 30, 20254
  • AuditorKPMG LLP, Boston, Massachusetts PCAOB ID 185; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceFeb 16, 20212
  • Filings416 in all: 4 (169), 8-K (85), 144 (36), 3 (25), 10-Q (16), CORRESP (9), 424B5 (7), S-8 (6)2
    All 33 form types

    SCHEDULE 13G (6), UPLOAD (6), 10-K (5), DEF 14A (5), SCHEDULE 13G/A (5), ARS (4), 4/A (3), DEFA14A (3), EFFECT (3), S-1/A (3), SC 13G (3), 10-K/A (2), 5 (2), S-3 (2), 424B4 (1), 5/A (1), 8-A12B (1), CERT (1), DRS (1), DRS/A (1), DRSLTR (1), S-1 (1), SC 13D (1), SC 13G/A (1), SCHEDULE 13D/A (1)

  • Latest filingsAnnual report (10-K) Mar 12, 2026
    Quarterly report (10-Q) Aug 13, 2026
    Proxy statement (DEF 14A) Apr 29, 2026
    Latest 8-K (8-K) Sep 10, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.01 per shareCADLThe Nasdaq Global Market

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

Risk factors and legal proceedings

The risks Candel Therapeutics names in Item 1A of its 10-K filed Mar 12, 2026: 73 risks under these headings, as written.4

  • Risks Related to Our Business, Financial Position and Capital Requirements
  • We are a biopharmaceutical company with a limited operating history and have not generated any revenue to date from product sales.
  • We have incurred significant operating losses since our inception and anticipate that we will incur continued losses for the foreseeable future.
  • We have no products approved for commercial sale and have not generated any revenue from product sales.
  • We will need to raise substantial additional funding, which may not be available on acceptable terms, or at all. If we are unable to raise capital when needed, we would be forced to delay, reduce or eliminate some of our product development programs or commercialization efforts or initiate steps to cease operations.
  • We have incurred indebtedness, and we may incur additional indebtedness, which could adversely affect our financial condition.
  • The terms of the RTW Purchase Agreement place restrictions on our operating and financial flexibility, and if we fail to comply with certain covenants in the RTW Purchase Agreement, our results of operations and financial condition may be harmed.
  • Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults, or non-performance by financial institutions or transactional counterparties, could adversely affect our current and projected business operations and our financial condition and results of operations.
  • Risks Related to Product Development
  • Our business is dependent on the success of our most advanced product candidate, aglatimagene, as well as linoserpaturev and any other product candidates that we advance into the clinic. All of our product candidates will require additional development before we may be able to seek regulatory approval for and launch a product commercially.
  • Our preclinical studies and clinical trials may fail to demonstrate adequately the safety and efficacy of any of our product candidates, which would prevent or delay development, regulatory approval, and commercialization.
  • Interim, topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to regulatory audit and verification procedures that could result in material changes in the final data.
The other 63 risks
  • We may not be successful in our efforts to identify additional product candidates or indications. Due to our limited resources and access to capital, we must prioritize development of certain product candidates and indications; these decisions may prove to be wrong and may adversely affect our business.
  • Results of earlier studies and trials of our product candidates may not be predictive of future trial results.
  • Our product candidates are based on a novel approach to the treatment of cancer, which makes it difficult to predict the time and cost of product candidate development and subsequently obtaining regulatory approval, if at all.
  • We are developing, and in the future may develop, other product candidates, in combination with other therapies, which exposes us to additional risks related to any prodrugs or any agents used in combination with our product candidates.
  • Negative developments in the field of immuno-oncology and, in particular, viral immunotherapy, could damage public perception of any of our product candidates and negatively affect our business.
  • Difficulty in enrolling patients could delay or prevent clinical trials of our product candidates, and ultimately delay or prevent regulatory approval.
  • If we experience delays in the completion of, or termination of, any clinical trial of our product candidates, the commercial prospects of our product candidates will be harmed, and our ability to generate product revenue from any of these product candidates could be delayed or prevented.
  • We face substantial competition, which may result in others discovering, developing or commercializing product candidates before or more successfully than we do.
  • Risks Related to Government Regulation and Commercialization of Our Product Candidates
  • The regulatory approval processes of the FDA and comparable foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable. If we are not able to obtain, or experience delays in obtaining, required regulatory approvals, we will not be able to commercialize aglatimagene, linoserpaturev and future product candidates as expected, and our ability to generate revenue may be materially impaired.
  • The FDA’s agreement to a Special Protocol Assessment with respect to the study design of our pivotal phase 3 clinical trial of aglatimagene in newly diagnosed localized prostate cancer in intermediate and high-risk patients does not guarantee any particular outcome from regulatory review, including ultimate approval, and may not lead to a successful review or approval process.
  • A Fast Track Designation by the FDA, even though granted for some indications for aglatimagene and linoserpaturev, or if received for any other future 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 for the designated indications.
  • A Breakthrough Therapy Designation by the FDA, even if granted for some indications of our product candidates, may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval for the designated indications.
  • We have received Orphan Drug Designation from the FDA and the EMA for aglatimagene for the treatment of pancreatic cancer and for linoserpaturev for the treatment of recurrent HGG. We may seek Orphan Drug Designation from regulatory authorities in other jurisdictions for aglatimagene and linoserpaturev, and we may seek Orphan Drug Designation for our other product candidates. In any of these instances, we may not receive the requested designation or we may be unable to realize the benefits associated with Orphan Drug Designation, including the potential for market exclusivity.
  • We have received Regenerative Medicine Advanced Therapy Designation from the FDA for aglatimagene for the treatment of newly diagnosed localized prostate cancer in patients with intermediate- to high-risk disease. This may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that aglatimagene, or any other product candidates that receive such designation, will receive marketing approval for the designated indications.
  • Accelerated approval by the FDA, even if granted for certain of our current or future product candidates, may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval.
  • Changes in product candidate manufacturing or formulation may result in additional costs or delay.
  • Inadequate funding for the FDA, the SEC, patent offices and other government agencies could hinder their ability to hire and retain key personnel, and substantial changes in leadership, personnel, and policy could prevent new products and services 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 may rely, which could negatively impact our business.
  • Even if aglatimagene, linoserpaturev or any future product candidates receive regulatory approval, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense and limit how we manufacture and market our products.
  • Regulatory approval by the FDA or comparable foreign regulatory authorities is limited to those specific indications and conditions for which approval has been granted, and we may be subject to substantial fines, criminal penalties, injunctions or other enforcement actions if we are determined to be promoting the use of our products for unapproved or “off-label” uses, or in a manner inconsistent with the approved labeling, resulting in damage to our reputation and business.
  • We may not be able to file INDs or IND amendments to commence additional clinical trials on the timelines we expect, and even if we are able to, the FDA or a comparable foreign regulatory authority may not permit us to proceed.
  • If approved, our investigational products regulated as biologics may face competition from biosimilars approved through an abbreviated regulatory pathway.
  • The size of the potential market for our product candidates is difficult to estimate and, if any of our assumptions are inaccurate, the actual markets for our product candidates may be smaller than our estimates.
  • Healthcare reform measures may have a material adverse effect on our business and results of operations.
  • If, in the future, we are unable to establish sales and marketing and patient support capabilities or enter into agreements with third parties to sell and market our current or future product candidates, we may not be successful in commercializing our current or future product candidates if and when they are approved, and we may not be able to generate any revenue.
  • If any product candidate for which we receive regulatory approval does not achieve broad market acceptance among physicians, patients, healthcare payors, and the medical community, the revenues that we generate from its sales will be limited.
  • If we fail to develop additional product candidates, our commercial opportunity could be limited.
  • Our relationships with customers and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, exclusion from government healthcare programs, contractual damages, reputational harm and diminished profits and future earnings.
  • We may face potential liability if we obtain identifiable patient health information from clinical trials sponsored by us.
  • 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.
  • 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.
  • Risks Related to Employee Matters, Managing Growth and General Business Operations
  • Any future public health crisis may affect our ability to complete our ongoing clinical trials and initiate and complete other preclinical studies, planned clinical trials or future clinical trials, disrupt regulatory activities, disrupt our manufacturing and supply chain or have other adverse effects on our business and operations. In addition, any future public health crisis may cause substantial disruption in the financial markets and may adversely impact economies worldwide, both of which could result in adverse effects on our business, operations and ability to raise capital.
  • Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
  • We expect to expand our development, manufacturing and regulatory capabilities and potentially implement sales, marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
  • The increasing use of social media platforms presents new risks and challenges.
  • Our internal computer systems, or those of our third-party CROs that we may use in the future, or other contractors or consultants, may fail or suffer cybersecurity incidents or data breaches, which could result in a material disruption of our product candidates’ development programs.
  • Our operations or those of the third parties upon whom we depend might be affected by the occurrence of a natural disaster, pandemic, war or other catastrophic event.
  • Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
  • If we identify material weaknesses in our internal control over financial reporting in the future or otherwise fail to maintain an effective system of internal controls, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect our business and the market price of our common stock.
  • If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, stockholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our common stock.
  • Risks Related to Legal and Compliance Matters
  • We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability and have to limit the commercialization of any approved products and/or our product candidates.
  • We are subject to the U.S. Foreign Corrupt Practices Act and other anti-corruption laws, as well as import and export control laws, customs laws, sanctions laws and other laws governing our operations. If we fail to comply with these laws, we could be subject to civil or criminal penalties, other remedial measures, and legal expenses, which could adversely affect our business, financial condition, results of operations, stock price and prospects.
  • If we fail to comply with federal and state healthcare laws, including fraud and abuse and health and other information privacy and security laws, we could face substantial penalties and our business, financial condition, results of operations, stock price and prospects will be materially harmed.
  • Changes in tax laws or in their implementation or interpretation may adversely affect our business and financial condition.
  • Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
  • If third-party payors fail to provide adequate coverage, reimbursement and payment rates for our product candidates, or if health maintenance organizations or long-term care facilities choose to use therapies that are less expensive or considered a better value, our revenue and prospects for profitability will be limited.
  • Our employees, independent contractors, consultants, commercial partners, principal investigators, CROs or CDMOs may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading, which could have a material adverse effect on our business.
  • Violations of, or liabilities under, environmental, health and safety laws and regulations could subject us to fines, penalties or other costs that could have a material adverse effect on the success of our business.
  • Risks Related to Our Reliance on Third Parties
  • For certain product candidates, we depend, or will depend, on development and commercialization collaborators to develop and conduct clinical trials with, obtain regulatory approvals for, and if approved, market and sell product candidates. If such collaborators fail to perform as expected, the potential for us to generate future revenue from such product candidates would be significantly reduced and our business would be harmed.
  • If conflicts arise with our development and commercialization collaborators or licensors, they may act in their own self-interest, which may be adverse to the interests of our company.
  • We rely on third parties, including independent clinical investigators and CROs to conduct and sponsor some of the clinical trials of our product candidates. Any failure by a third party to meet its obligations with respect to the clinical development of our product candidates may delay or impair our ability to obtain regulatory approval for our product candidates.
  • If the manufacturers upon which we may rely fail to produce our product candidates in the volumes that we require on a timely basis, or fail to comply with stringent regulations applicable to biopharmaceutical manufacturers, we may face delays in the development and commercialization of, or be unable to meet demand for, our product candidates and may lose potential revenues.
  • Some of our product candidates are being, and may continue to be, studied in third-party research and clinical trials sponsored by organizations or agencies other than us, or in investigator-sponsored clinical trials, which means we will have minimal or no control over the conduct of such trials and which may adversely affect our ability to obtain marketing approval or certain regulatory exclusivities.
  • Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
  • Risks Related to Intellectual Property
  • Our rights to develop and commercialize certain of our product candidates are subject and may in the future be subject, in part, to the terms and conditions of licenses granted to us by third parties. If we fail to comply with our obligations under our current or future intellectual property license agreements or otherwise experience disruptions to our business relationships with our current or any future licensors, we could lose intellectual property rights that are important to our business.
  • Our success depends in part on our ability to protect our intellectual property. It is difficult and costly to protect our proprietary rights and technology, and we may not be able to ensure their protection.
  • We may enter into license or other collaboration agreements in the future that may impose certain obligations on us. If we fail to comply with our obligations under such future agreements with third parties, we could lose license rights that may be important to our future business.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • Third-party claims of intellectual property infringement may prevent or delay our product discovery and development efforts.
  • Our collaborators may assert ownership or commercial rights to inventions they develop from research we support or that we develop from our use of the tissue samples or other biological materials, which they provide to us, or otherwise arising from the collaboration.
  • Third parties may assert that we are employing their proprietary technology without authorization.
  • Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information, misappropriated trade secrets, or are in breach of non-competition or non-solicitation agreements with our competitors.
  • We may not be successful in obtaining or maintaining necessary rights to develop any future product candidates on acceptable terms.
  • We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful.

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 probable to have a material adverse effect on our business. Regardless of outcome, litigation can have an adverse impact on our business, financial condition, results of operations and prospects because of defense and settlement costs, diversion of management resources and other factors.

The opening of Item 3, Legal Proceedings.4

Sources

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