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CGON on Nasdaq

CG Oncology, Inc.

American biological products company, incorporated in Delaware1

In its 2026 annual report the company says: “We are a late-stage clinical biopharmaceutical company focused on developing and commercializing cretostimogene grenadenorepvec (cretostimogene), an investigational oncolytic immunotherapy with a dual mechanism of action designed both to eliminate cancer cells directly by selective replication and indirectly by activating an anti-tumor immune response, as a potential backbone therapy in a broad range of patients afflicted with bladder cancer.”4 It is headquartered in Dallas, Texas.1 Its shares trade on Nasdaq under the symbol CGON.1

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Last updated Oct 21, 2026.

Overview

Compare with Ocugen, Prime Medicine, Inc. or CRISPR Therapeutics, or pick any stock.

  • TickerCGON on Nasdaq1
  • IndustryBiological Products, (No Diagnostic Substances)1
  • HeadquartersDallas, Texas1
  • Incorporated inDE2
  • Business address3000 Pegasus Park Drive, Suite 1640, Dallas, Tx 752472
  • Filer categoryLarge accelerated filer2

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We are a late-stage clinical biopharmaceutical company focused on developing and commercializing cretostimogene grenadenorepvec (cretostimogene), an investigational oncolytic immunotherapy with a dual mechanism of action designed both to eliminate cancer cells directly by selective replication and indirectly by activating an anti-tumor immune response, as a potential backbone therapy in a broad range of patients afflicted with bladder cancer. Cretostimogene is currently in clinical development for the treatment of patients with high-risk and intermediate-risk non-muscle invasive bladder cancer (NMIBC), which potentially represents up to 150,000 addressable patients.4 From its latest annual report

Financials

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

Key numbers, fiscal 2025

-4722.1%Operating margin5
-3985.0%Net margin5
254.7%Revenue growth, 20255
-21.4%Return on equity5
0.00×Debt to equity5
-$132.5MFree cash flow5

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

Commercial And Development Revenue brought in 80% of the revenue CG Oncology, Inc. broke down this way in fiscal 2025.

  1. Commercial And Development Revenue$3.2M580%
  2. License And Collaboration Revenue$806.0K520%down 29% from 2024
Products and services by year
Products and services202320242025
Commercial And Development Revenue$0$0$3.2M
License And Collaboration Revenue$204.0K$1.1M$806.0K

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development100¢$116.6M
  • Income tax0¢$270.0K

Out of $4.0M in revenue.5 The company lost money this year.

Financial statements

Revenue5$4.0M in 2025+1880% since 2023
0$2.0M$4.0M$6.0M2023: $204.0K$204.0K20232024: $1.1M$1.1M2024+458%2025: $4.0M$4.0M2025+255%
Operating income5-$190.8M in 2025+244% since 2023
-$200.0M-$150.0M-$100.0M-$50.0M02023: -$55.4M-$55.4M20232024: -$114.7M-$114.7M2024+107%2025: -$190.8M-$190.8M2025+66%
Net income5-$161.0M in 2025+231% since 2023
-$200.0M-$150.0M-$100.0M-$50.0M02023: -$48.6M-$48.6M20232024: -$88.0M-$88.0M2024+81%2025: -$161.0M-$161.0M2025+83%

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

Period ending2025-12-312024-12-312023-12-31
Total revenues$4.0M$1.1M$204.0K
Cost of sales$4.6M
Research and development$116.6M$82.1M$45.8M
General and administrative$73.5M$33.7M$9.9M
Total operating costs and expenses$194.8M$115.8M$55.7M
Loss from operations-$190.8M-$114.7M-$55.4M
Interest income, net$29.9M$26.6M$6.9M
Other (expense) income, net-$152.0K$3.0K-$62.0K
Total other income, net$29.8M$26.6M$6.8M
Net loss and comprehensive loss-$161.0M-$88.0M-$48.6M
Deemed dividend on redeemable convertible preferred stock issuances$0$0-$410.0K
Cumulative redeemable convertible preferred stock dividends$0$0-$18.8M
Net loss attributable to common stockholders-$161.0M-$88.0M-$67.8M
Net loss per share , basic-$2.08-$1.41-$15.65
Net loss per share , diluted-$2.08-$1.41-$15.65
Weighted average shares of common stock outstanding, basic77.3M shares62.5M shares4.3M shares
Weighted average shares of common stock outstanding, diluted77.3M shares62.5M shares4.3M shares

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Corporate structure

CG Oncology, Inc. sits at the top of its group. 4 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of CG Oncology, Inc.

  • CG Oncology, Inc. Dallas, Texas
    • Biovire, Inc. Subsidiary · Delaware, United States
    • SafeGuard Healthcare, LLC Subsidiary · Delaware, United States
    • SP Healthcare SPV I, LLC 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 CG Oncology, 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$17.1M5 Dec 31, 2025$359.0K5 Dec 31, 2024+4654.9%
Accumulated depreciation$1.5M5 Dec 31, 2025$87.0K5 Dec 31, 2024+1594.3%
Property and equipment, net$15.6M5 Dec 31, 2025$272.0K5 Dec 31, 2024+5633.8%
Operating-lease assets (leased space)$4.0M5 Dec 31, 2025$221.0K5 Dec 31, 2024+1696.8%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$32.5M5 Dec 31, 2025$257.1M5 Dec 31, 2024−87.4%
Marketable securities, current$709.7M5 Dec 31, 2025$484.9M5 Dec 31, 2024+46.3%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$10.3M5 Dec 31, 2025$05 Dec 31, 2024
Finite-lived intangibles, gross$600.0K5 Dec 31, 2025
Accumulated amortization$25.0K5 Dec 31, 2025
Finite-lived intangibles, net$575.0K5 Dec 31, 2025$05 Dec 31, 2024

Inventory

ItemLatestA year beforeChange
Inventory, total$1.6M5 Dec 31, 2025$05 Dec 31, 2024

Properties, in its own words

Our principal executive offices are located in Irvine, California and consist of approximately 1,249 square feet of office space leased until August 2026. We also lease additional office space in Emeryville, California and Branchburg, New Jersey, under leases which end in August 2028 and January 2030, respectively. In December 2025, we entered into a lease for additional office space in Dallas, Texas, which will commence in 2026 and has a term of approximately eight years. In addition, a lease was acquired in connection with the Conversion Event in July 2025 for office, manufacturing, and warehouse space, which ends in February 2030.We believe that our existing and planned facilities will be adequate for the foreseeable future and that suitable additional or substitute space will be available as and when needed.

Item 2 of the 10-K filed Feb 27, 2026.4

Leadership

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

Chief executive

  1. Arthur Kuan2024–now

President

  1. Ambaw Bellete2024–now

Chief financial officer

  1. Corleen M. Roche2024–2026
  2. James M. Detore2026–now

Chief operating officer

  1. Ambaw Bellete2024–now
2025
Board members and other officers (10)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Biovire, Inc. Delaware3
  • SP Healthcare SPV I, LLC Delaware3
  • SafeGuard Healthcare, LLC Delaware3

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

Timeline

  1. Aug 6, 20268-K Results of operations; Other events22
  2. Jun 8, 20268-K Shareholder vote23
  3. May 26, 20268-K Executive or director change24
  4. May 8, 20268-K Results of operations25
  5. Apr 13, 20268-K Executive or director change26
  6. Feb 27, 20268-K Results of operations27
  7. Jan 13, 20268-K Other events28
  8. Jan 9, 20268-K Regulation FD disclosure; Other events29
  9. Nov 26, 20258-K Executive or director change30
  10. Nov 14, 20258-K Results of operations31
  11. Nov 14, 20258-K Executive or director change32
  12. Sep 9, 20258-K Regulation FD disclosure33
  13. Jan 24, 2024New chief executive Arthur Kuan becomes CEO9

Calendar

Coming up

  1. Nov 13, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.57) a share, on Nov 14, 2025.34

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results22
  2. May 8, 2026Reported quarterly or annual results25
  3. Feb 27, 2026Reported quarterly or annual results27
  4. Nov 14, 2025Reported quarterly or annual results31
  5. Aug 8, 2025Reported quarterly or annual results35
  6. May 13, 2025Reported quarterly or annual results36
  7. Mar 28, 2025Reported quarterly or annual results37
  8. Nov 12, 2024Reported quarterly or annual results38

Drug trials and FDA: coming up

  1. Nov 2026Phase 3 trial readout expected Phase 3 trial of Cretostimogene Grenadenorepvec in Non Muscle Invasive Bladder Cancer: primary completion expected Nov 2026 (ClinicalTrials.gov NCT06111235).39
  2. Mar 31, 2027Phase 2 trial readout expected Phase 2 trial of Cretostimogene Grenadenorepvec in High-Risk Non-Muscle-Invasive Bladder Cancer: primary completion expected Mar 31, 2027 (ClinicalTrials.gov NCT06567743).40

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

240 filings to the SEC since October 2021: 3 annual reports, 8 quarterly reports, 29 major events, 90 insider forms, 27 large holders, 83 other. The latest 20:

  1. Oct 15, 2026144 EDGAR
  2. Sep 21, 2026144 EDGAR
  3. Sep 17, 2026144 EDGAR
  4. Sep 17, 20264 EDGAR
  5. Sep 11, 2026144 EDGAR
  6. Sep 2, 2026144 EDGAR
  7. Aug 31, 2026144 EDGAR
  8. Aug 27, 2026144 EDGAR
  9. Aug 25, 2026144 EDGAR
  10. Aug 24, 2026144 EDGAR
  11. Aug 19, 2026144 EDGAR
  12. Aug 18, 20264 EDGAR
  13. Aug 17, 2026144 EDGAR
  14. Aug 14, 2026144 EDGAR
  15. Aug 14, 2026SCHEDULE 13G/A EDGAR
  16. Aug 14, 2026SCHEDULE 13G/A EDGAR
  17. Aug 13, 2026144 EDGAR
  18. Aug 13, 2026SCHEDULE 13G/A EDGAR
  19. Aug 12, 2026144 EDGAR
  20. Aug 11, 2026144 EDGAR

The 240 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

39 open-market trades by officers, directors and large owners since October 2021: 7 buys and 32 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 15, 2026POST LEONARD EDirectorSale1,000$72.98$73.0KForm 4
Aug 14, 2026POST LEONARD EDirectorSale1,000$74.54$74.5KForm 4
Jul 15, 2026POST LEONARD EDirectorSale1,000$71.17$71.2KForm 4
Jul 10, 2026Mulay JamesDirectorSale24,165$75.16$1.8MForm 4
Jun 25, 2026Liu Brian Guan-ChyunDirectorBuy371,085$66.87$24.8MForm 4
Jun 24, 2026POST LEONARD EDirectorSale5,000$70.00$350.0KForm 4
Jun 22, 2026POST LEONARD EDirectorSale5,000$65.00$325.0KForm 4
Jun 15, 2026Mulay JamesDirectorSale1,964$60.12$118.1KForm 4
Jun 4, 2026POST LEONARD EDirectorSale1,000$54.50$54.5KForm 4
Apr 17, 2026Mulay JamesDirectorSale15,600$73.01$1.1MForm 4
Mar 16, 2026Mulay JamesDirectorSale1,964$63.50$124.7KForm 4
Jan 9, 2026Mulay JamesDirectorSale11,145$52.47$584.8KForm 4
Nov 17, 2025POST LEONARD EDirectorSale1,000$41.43$41.4KForm 4
Oct 13, 2025POST LEONARD EDirectorSale1,000$43.25$43.2KForm 4
Oct 9, 2025Mulay JamesDirectorSale5,903$43.99$259.7KForm 4
Sep 30, 2025POST LEONARD EDirectorSale5,000$40.09$200.4KForm 4
Sep 29, 2025Mulay JamesDirectorSale12,755$39.19$499.9KForm 4
Sep 19, 2025Mulay JamesDirectorSale3,574$38.99$139.3KForm 4
Sep 18, 2025Mulay JamesDirectorSale19,112$39.01$745.6KForm 4
Sep 15, 2025POST LEONARD EDirectorSale1,000$35.10$35.1KForm 4

All 39 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
2025Arthur KuanChief Executive Officer35$690.0K$11.9M55
2025Ambaw BelletePresident and Chief Operating Officer56$537.9K$4.8M55
2025Vijay KasturiChief Medical Officer58$502.9K$3.6M55
2025Joshua F. PattersonGeneral Counsel, Chief Compliance Officer, and Secretary50$461.5K$2.4M55
2025Corleen RochePrior Chief Financial Officer$288.9K$2.3M55
2025Robert Lapetina (Prior Interim Principal Financial and Accounting Officer)$310.2K$645.3K55
2025Jim DeToreChief Financial Officer61$96.0K55
2024Arthur KuanChief Executive Officer35$653.5K$11.2M55
2024Corleen RochePrior Chief Financial Officer$446.4K$9.8M55
2024Ambaw BelletePresident and Chief Operating Officer56$511.9K$5.2M55
2023Arthur KuanChief Executive Officer35$449.0K$3.9M55
2023Ambaw BelletePresident and Chief Operating Officer56$322.0K$3.0M55

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
Rtw Investments, LP8,514,590$605.0M5.2%+1,529,782
Decheng Capital LLC6,371,669$452.7M61.9%No change
BlackRock, Inc.6,256,288$444.5M0.0%+1,192,108
Wellington Management Group Llp5,324,751$378.3M0.1%−46,481
Fmr LLC4,161,493$295.7M0.0%+396,649
TCG Crossover Management, LLC3,670,206$260.8M6.3%No change
Vanguard Portfolio Management LLC3,465,197$246.2M0.0%+370,099
State Street Corp3,437,590$244.2M0.0%+790,536
Vanguard Capital Management LLC3,316,793$235.7M0.0%+283,168
Foresite Capital Management VI LLC2,369,574$168.4M26.2%+148,100
Geode Capital Management, LLC2,153,277$153.0M0.0%+556,413
Seven Fleet Capital Management LP1,886,236$134.0M22.1%+1,810,478
EcoR1 Capital, LLC1,494,300$106.2M5.3%+392,300
DV Trading LLC1,439,393$102.3M8.5%No change
Avidity Partners Management LP1,398,948$99.4M15.9%+110,000
Franklin Resources Inc1,312,880$93.3M0.0%−194,125
Alliancebernstein L.P.1,374,149$93.0M0.0%+84,062
Morgan Stanley1,177,109$83.6M0.0%+656,896
Acorn Capital Advisors, LLC1,131,500$80.4M21.9%+999
Foresite Capital Management V, LLC1,079,050$76.7M21.2%+75,000
Logos Global Management LP1,000,000$71.0M3.1%+425,000
Bank Of America Corp /de/984,918$70.0M0.0%−464,446
UBS Group AG977,695$69.5M0.0%−334,283
Orbimed Advisors LLC972,800$69.1M1.3%+24,533
Goldman Sachs Group Inc857,713$60.9M0.0%−301,526

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

SEC filer profile

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

  • Name on EDGARCG Oncology, Inc.1
  • CIK0001991792
  • Employer ID (EIN)37-16114994
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 311
  • Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address3000 Pegasus Park Drive, Suite 1640, Dallas, TX 752471
  • Phone(949) 409-37001
  • Shares outstanding88,640,375 as of Aug 5, 20267
  • Public float$1.7B as of Jun 30, 20254
  • AuditorErnst & Young LLP, Irvine, California PCAOB ID 42; it also attests to the company’s internal control over financial reporting4
  • On EDGAR sinceOct 27, 20231
  • Filings240 in all: 4 (74), 144 (45), 8-K (29), 3 (15), SCHEDULE 13G/A (9), 10-Q (8), SC 13G (8), CORRESP (6)1
    All 32 form types

    SCHEDULE 13G (4), 10-K (3), S-1/A (3), SC 13G/A (3), UPLOAD (3), 424B4 (2), 424B5 (2), ARS (2), DEF 14A (2), DEFA14A (2), DRS (2), EFFECT (2), S-1 (2), S-8 (2), SCHEDULE 13D (2), SEC STAFF LETTER (2), 4/A (1), 8-A12B (1), CERT (1), DRS/A (1), DRSLTR (1), S-1MEF (1), S-3ASR (1), SCHEDULE 13D/A (1)

  • Latest filingsAnnual report (10-K) Feb 27, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Apr 24, 2026
    Latest 8-K (8-K) Aug 6, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.0001 par value per shareCGONNasdaq

From the cover page of the 10-K filed Feb 27, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks CG Oncology, Inc. names in Item 1A of its 10-K filed Feb 27, 2026: 73 risks under these headings, as written.4

  • Risks Related to the Development and Regulatory Approval of Our Product Candidates
  • We currently depend entirely on the success of cretostimogene, which is our only product candidate. If we are unable to advance cretostimogene in clinical development, obtain regulatory approval and ultimately commercialize cretostimogene, or experience significant delays in doing so, our business will be materially harmed.
  • Cretostimogene is 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.
  • Clinical and preclinical drug development involves a lengthy and expensive process with uncertain timelines and outcomes, and the results of preclinical studies and early clinical trials are not necessarily predictive of future results. Cretostimogene or any future product candidates may not achieve favorable results in clinical trials or preclinical studies or receive regulatory approval on a timely basis, if at all.
  • Any difficulties or delays in the commencement or completion, or the termination or suspension, of our current or planned clinical trials or preclinical studies could result in increased costs to us, delay or limit our ability to generate revenue or adversely affect our commercial prospects.
  • We may find it difficult to enroll patients in our clinical trials. If we encounter difficulties or delays enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • Use of cretostimogene or any future product candidates could be associated with adverse side effects, adverse events or other properties or safety risks, which could delay or preclude regulatory approval, cause us to suspend or discontinue clinical trials, abandon cretostimogene or any future product candidate, limit the commercial profile of an approved label or result in other significant negative consequences that could severely harm our business, financial condition, results of operations and prospects.
  • We have not as an organization completed submission of a BLA, and we may be unable to do so for cretostimogene or any future product candidates.
  • We are developing cretostimogene in combination with other therapies, which exposes us to additional risks.
  • Negative developments in the field of immuno-oncology and, in particular, viral immunotherapy, could damage public perception of any cretostimogene or any future oncolytic product candidates and negatively affect our business.
  • We may not be successful in our efforts to investigate cretostimogene in additional indications. We may expend our limited resources to pursue a new product candidate or a particular indication for cretostimogene and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • We are currently conducting and may in the future conduct certain of our clinical trials for cretostimogene or any future product candidate outside of the United States. However, the FDA and other foreign equivalents may not accept data from such trials, in which case our development plans will be delayed, which could materially harm our business.
The other 62 risks
  • Interim, topline and preliminary data from our clinical trials and preclinical studies that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • Changes in methods of the manufacturing or formulation of cretostimogene or any future product candidates may result in additional costs or delay.
  • A Breakthrough Therapy designation from the FDA may not lead to a faster development or regulatory review or approval process for cretostimogene, and it does not increase the likelihood that cretostimogene or any future product candidates will receive FDA approval.
  • Fast track designation by the FDA for cretostimogene may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that cretostimogene or any future product candidate which may receive fast track designation will receive regulatory approval.
  • We may attempt to secure approval from the FDA through the use of the accelerated approval pathway. If we are unable to obtain such approval, we may be required to conduct additional clinical trials beyond those that we contemplate, which could increase the expense of obtaining, and delay the receipt of, necessary regulatory approvals. Even if we receive accelerated approval from the FDA, if our confirmatory trials do not verify clinical benefit, or if we do not comply with rigorous post-marketing requirements, the FDA may seek to withdraw any accelerated approval we have obtained.
  • Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.
  • Risks Related to Our Reliance on Third Parties
  • We rely on third parties to conduct our clinical trials and preclinical studies. If these third parties do not successfully carry out their contractual duties, comply with applicable regulatory requirements, or meet expected deadlines, cretostimogene or any future product candidate and our ability to seek or obtain regulatory approval for or commercialize cretostimogene or any future product candidates may be delayed.
  • We rely on Biovire and third parties for the manufacture and shipping of cretostimogene for clinical development and, if approved by the FDA, will rely on third parties for the manufacture, supply and shipping of cretostimogene for commercialization, and expect to do so for the foreseeable future. This reliance increases the risk that we will not have sufficient quantities of cretostimogene or future product candidates or such quantities at an acceptable cost, which could delay, prevent, or impair our development or commercialization efforts.
  • Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor or other third party will discover them or that our trade secrets will be misappropriated or disclosed.
  • We have entered into, and may in the future enter into, collaboration agreements and strategic alliances to maximize the potential of cretostimogene, and we may not realize the anticipated benefits of such collaborations or alliances. We may continue to form collaborations or alliances in the future with respect to cretostimogene or any future product candidates, but may be unable to do so or to realize the potential benefits of such transactions, which may cause us to alter or delay our development and commercialization plans.
  • Risks Related to Commercialization of Cretostimogene and any Future Product Candidates
  • Even if we receive regulatory approval for cretostimogene or any future product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense.
  • The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
  • Any product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated.
  • The commercial success of cretostimogene or any future product candidates will depend upon the degree of market acceptance of such product candidates by physicians, patients, healthcare payors, and others in the medical community.
  • The successful commercialization of cretostimogene or any future product candidates, if approved, will depend in part on the extent to which governmental authorities and health insurers establish coverage, adequate reimbursement levels and favorable pricing policies. Failure to obtain or maintain coverage and adequate reimbursement for our products could limit our ability to market those products and decrease our ability to generate revenue.
  • We face significant competition from entities that have developed or may develop product candidates for cancer, including companies developing novel treatments and technology platforms. If our competitors develop and commercialize their product candidates more rapidly than we do, or their technologies or product candidates are more effective, safer, or less expensive than cretostimogene or any future product candidates we develop, our business and our ability to develop and successfully commercialize products may be adversely affected.
  • If the market opportunities for cretostimogene or any future product candidates are smaller than we believe they are, our revenue may be adversely affected, and our business may suffer.
  • We are in the early stages of building our internal marketing and sales organization and have no experience as a company in commercializing products, and we will need to invest significant resources to develop these capabilities. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market, sell and distribute our products, we may not be able to generate product revenue.
  • Our future growth may depend, in part, on our ability to operate in foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.
  • Risks Related to Our Limited Operating History, Financial Position and Capital Requirements
  • We have a relatively limited operating history, have incurred significant operating losses since our inception, and expect to incur significant losses for the foreseeable future. We may never generate any revenue from our product candidates or become profitable or, if we achieve profitability, we may not be able to sustain it.
  • 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 development programs, commercialization efforts or other operations.
  • Raising additional capital may cause dilution to our stockholders restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • Risks Related to Our Business Operations and Industry
  • 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 any guidance we may provide.
  • Our success is dependent on our ability to attract and retain highly qualified management and other clinical and scientific personnel.
  • We may encounter difficulties in managing our growth and expanding our operations successfully, which could disrupt our operations.
  • We are subject to various U.S. federal, state and foreign healthcare laws and regulations, which could increase compliance costs, and our failure to comply with these laws and regulations could harm our reputation, subject us to significant fines and liability or otherwise adversely affect our business.
  • Current and future healthcare reform legislation or regulation may increase the difficulty and cost for us to obtain coverage for and commercialize cretostimogene or any future product candidates and may adversely affect the prices we may set.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit, delay or cease commercialization of our products.
  • Our insurance policies are expensive and protect us from only some business risks, which will leave us exposed to significant uninsured liabilities.
  • We and any of our current or potential future collaborators will be required to report to regulatory authorities if any of our approved products cause or contribute to adverse medical events, and any failure to do so would result in sanctions that would materially harm our business.
  • We and our service providers are subject to a variety of stringent and evolving U.S. and foreign data protection, privacy and security obligations, including laws, regulations, standards and contractual provisions, which could increase compliance costs, and any actual or perceived failure by us or our service providers to comply with such laws and obligations could subject us to potentially significant liability, fines or penalties and otherwise harm our business.
  • If our information technology systems or those third parties with whom we work or our data, are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to material disruption of our development programs, compromise of sensitive information related to our business, inability to access critical information, potentially exposing us to liability or otherwise adversely affecting our business.
  • Our business could be affected by litigation, government investigations and enforcement actions.
  • Our employees and independent contractors, including collaborators, principal investigators, CROs, consultants and vendors, may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • We may engage in strategic transactions that could impact our liquidity, increase our expenses, and present significant distractions to our management.
  • We acquired a controlling interest in Biovire, Inc., a contract manufacturing organization that provides our clinical supply and, if any of our product candidates are approved, we expect will provide our commercial supply of cretostimogene. We do not have experience operating a contract manufacturing organization, which organizations are highly regulated and provide services and offerings that are exacting and complex, and failure to operate Biovire’s business effectively may result in a material and adverse impact to our business.
  • Our ability to use net operating loss carryforwards and other tax attributes may be limited.
  • Risks Related to Our Intellectual Property
  • If we are unable to obtain, maintain, defend and enforce patent or other intellectual property protection for cretostimogene or any future product candidates or technology, or if the scope of the patent or other intellectual property protection obtained is not sufficiently broad, our competitors or other third parties could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize cretostimogene or any future product candidates may be adversely affected.
  • We may not be able to protect our intellectual property and proprietary rights throughout the world.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • Changes in patent laws or their interpretations could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • Issued patents covering cretostimogene or any future product candidates could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad.
  • Patent terms may be inadequate to protect the competitive position of cretostimogene or any future product candidates for an adequate amount of time.
  • If we do not obtain patent term extension and equivalent extensions outside of the United States for cretostimogene or any future product candidates, our business may be materially harmed.
  • We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • We may be subject to claims that our employees, consultants, or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property.
  • We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market cretostimogene or any future product candidates.
  • Third-party claims of intellectual property infringement, misappropriation, or other violations against us or our collaborators could be expensive and time consuming and may prevent or delay the development and commercialization of cretostimogene or any future product candidates.
  • We may become involved in lawsuits to protect or enforce our patents and other intellectual property rights, which could be expensive, time-consuming, and unsuccessful.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
  • Intellectual property rights do not necessarily address all potential threats.
  • We may not be successful in obtaining or maintaining necessary rights to product components and processes for our development pipeline through acquisitions and in-licenses.
  • Risks Related to Ownership of Our Common Stock
  • Prior to our initial public offering, there was no public market for our common stock. An active, liquid and orderly market for our common stock may not be sustained, or we may in the future fail to satisfy the continued listing requirements of Nasdaq.
  • The trading price of the shares of our common stock could be highly volatile, and purchasers of our common stock could incur substantial losses.
  • Our executive officers, directors, and principal stockholders, if they choose to act together, have the ability to significantly influence all matters submitted to stockholders for approval.
  • We do not currently intend to pay dividends on our common stock, so any returns on your investment will be limited to the value of our common stock.
  • Sales of a substantial number of shares of our common stock by our existing stockholders in the public market could cause our stock price to fall.
  • Provisions in our charter documents and under Delaware law could discourage a takeover that stockholders may consider favorable and may lead to entrenchment of management.
  • Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders and that the federal district courts shall be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees or the underwriters or any offering giving rise to such claim.
  • General Risk Factors
  • We incur significant costs as a result of operating as a public company, and our management is required to devote substantial time to new compliance initiatives.

Legal proceedings

From time to time, we may be subject to other legal proceedings. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources, and other factors.

On March 4, 2024, ANI Pharmaceuticals, Inc. (ANI) filed a complaint against the Company in the Superior Court of the State of Delaware seeking (i) a declaratory judgment that a provision in an assignment and technology transfer agreement between the Company and ANI, dated November 15, 2010 (the ANI Agreement), obligates the Company to pay ANI a royalty on certain “net sales” of cretostimogene, and (ii) compensatory damages alleging the Company was unjustly enriched by obtaining the benefit of certain non-patent assets under the ANI Agreement without paying adequate consideration to ANI. On July 16, 2025, the Superior Court granted the Company’s motion for summary judgment with respect to ANI’s request for a declaratory judgment to receive royalty payments from the potential sale of cretostimogene but denied the Company’s motion for summary judgment with respect to ANI’s unjust enrichment claim. On July 29, 2025, a jury entered a verdict in favor of the Company, unanimously rejecting all of ANI's claims for unjust enrichment damages. As a result and subject to the outcome of any post-trial motions or appeals brought by ANI, the Company will not owe ANI a future royalty of 5% on commercial sales of cretostimogene, no damages have been awarded to ANI, and there are no further payments due to ANI under the ANI Agreement. The Company will continue to vigorously defend any post-trial motions and appeals brought by ANI.

The opening of Item 3, Legal Proceedings.4

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