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APRE on Nasdaq

Aprea Therapeutics, Inc.

In its 2026 annual report the company says: “We are a clinical-stage precision medicine oncology company focused on the discovery and development of targeted therapies for patients with biomarker-defined cancers. Our approach focuses on matching treatments to specific cancer-related genetic mutations to potentially maximize effectiveness and minimize side effects.”3 It is headquartered in Doylestown, Pennsylvania.1 Its shares trade on Nasdaq under the symbol APRE.1

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Last updated Oct 21, 2026.

Overview

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  • TickerAPRE on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersDoylestown, Pennsylvania1
  • Incorporated inDE2
  • Business address3805 Old Easton Road, Doylestown, Pa 189022
  • Filer categoryNon-accelerated filer, Smaller reporting company2
  • Legal formCorporation

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We are a clinical-stage precision medicine oncology company focused on the discovery and development of targeted therapies for patients with biomarker-defined cancers. Our approach focuses on matching treatments to specific cancer-related genetic mutations to potentially maximize effectiveness and minimize side effects. Specifically, we develop small molecule inhibitors designed to exploit genetic mutations in cancer to widen the therapeutic window and intended to make treatments more effective at destroying cancer cells while sparing healthy tissue. We have assembled a team with extensive experience in the discovery, development, and commercialization of oncology drugs to support our mission of developing novel synthetic lethality-based cancer therapeutics.3 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 income456-$13.2M in 2025−65% since 2021
-$150.0M-$100.0M-$50.0M02021: -$37.4M-$37.4M20212022: -$113.4M-$113.4M2022+203%2023: -$15.5M-$15.5M2023−86%2024: -$14.3M-$14.3M2024−7%2025: -$13.2M-$13.2M2025−8%
Net income78456-$12.6M in 2025−55% since 2019
-$150.0M-$100.0M-$50.0M02019: -$28.1M-$28.1M20192020: -$53.5M-$53.5M2020+91%2021: -$37.1M-$37.1M2021−31%2022: -$112.7M-$112.7M2022+203%2023: -$14.3M-$14.3M2023−87%2024: -$13.0M-$13.0M2024−9%2025: -$12.6M-$12.6M2025−3%

Every line of the income statement as filed: the last 2 fiscal years, latest first.6

Period ending2025-12-312024-12-31
Grant revenue$285.8K$1.5M
Research and development$7.0M$9.4M
General and administrative$6.5M$6.5M
Total operating expenses$13.5M$15.8M
Loss from operations-$13.2M-$14.3M
Interest income, net$652.1K$1.3M
Other income$77.5K
Foreign currency (loss) gain-$95.3K$71.8K
Total other income$634.3K$1.4M
Net loss-$12.6M-$13.0M
Foreign currency translation-$7.3K-$16.1K
Total comprehensive loss-$12.6M-$13.0M
Net loss per share attributable to common stockholders, basic (in dollars per share)-$1.93-$2.35
Net loss per share attributable to common stockholders, diluted (in dollars per share)-$1.93-$2.35
Weighted-average common shares outstanding, basic (in shares)6.5M shares5.5M shares
Weighted-average common shares outstanding, diluted (in shares)6.5M shares5.5M shares

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Corporate structure

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

Major holders of Aprea Therapeutics, Inc.

  • Aprea Therapeutics, Inc. Doylestown, Pennsylvania

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

What it owns

What Aprea 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$154.0K6 Dec 31, 2025$154.0K6 Dec 31, 20240%
Accumulated depreciation$94.2K6 Dec 31, 2025$72.4K6 Dec 31, 2024+30.0%
Property and equipment, net$59.8K6 Dec 31, 2025$81.5K6 Dec 31, 2024−26.6%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$14.6M6 Dec 31, 2025$22.8M6 Dec 31, 2024−36.1%

Properties, in its own words

We have a facility in Doylestown, Pennsylvania which consists of office and laboratory space of approximately 1,550 square feet under an operating lease agreement that expires in October 2026. We believe that our current facilities are suitable and adequate to meet our current needs. We believe that suitable additional or substitute space will be available as needed to accommodate any potential expansion of our operations.

Item 2 of the 10-K filed Mar 16, 2026.3

Leadership

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

Chief executive

  1. Christian S. Schade2019–2022
  2. Oren Gilad2022–now

Chair

  1. Christian S. Schade2021–2022

President

  1. Christian S. Schade2019–2020
  2. Oren Gilad2022–now

Chief financial officer

  1. Scott M. Coiante2019–2022

Chief operating officer

  1. Gregory Alan Korbel2022
20202025
Board members and other officers (23)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive OfficerJohn P. Hamill named Dec 29, 202539
  • DirectorRichard P. Peters named Dec 29, 202539

Timeline

  1. Aug 28, 20268-K Other events40
  2. Aug 12, 20268-K Results of operations; Other events41
  3. Jul 23, 20268-K Listing notice or transfer42
  4. Jun 17, 20268-K Shareholder vote43
  5. May 13, 20268-K Results of operations; Other events44
  6. Apr 1, 20268-K Regulation FD disclosure45
  7. Mar 30, 20268-K Entered a material agreement; Unregistered sale of shares; Regulation FD disclosure46
  8. Mar 16, 20268-K Results of operations; Other events47
  9. Feb 18, 20268-K Other events48
  10. Jan 29, 20268-K Entered a material agreement; Unregistered sale of shares; Regulation FD disclosure49
  11. Jan 23, 20268-K Listing notice or transfer50
  12. Jan 9, 20268-K Other events51
  13. Aug 1, 2022New chief executive Oren Gilad becomes CEO12
  14. Oct 2, 2019New chief executive Christian S. Schade becomes CEO13

Calendar

Coming up

  1. Nov 11, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.47) a share, on Nov 12, 2025.52

When it reported results

  1. Aug 12, 2026Reported quarterly or annual results41
  2. May 13, 2026Reported quarterly or annual results44
  3. Mar 16, 2026Reported quarterly or annual results47
  4. Nov 12, 2025Reported quarterly or annual results53
  5. Aug 12, 2025Reported quarterly or annual results54
  6. May 14, 2025Reported quarterly or annual results55
  7. Mar 25, 2025Reported quarterly or annual results56
  8. Jan 13, 2025Reported quarterly or annual results57

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

Filings

278 filings to the SEC since October 2021: 7 annual reports, 15 quarterly reports, 74 major events, 99 insider forms, 26 large holders, 1 private raises, 56 other. The latest 20:

  1. Aug 28, 20268-K EDGAR
  2. Aug 13, 2026SCHEDULE 13G/A EDGAR
  3. Aug 12, 202610-Q EDGAR
  4. Aug 12, 20268-K EDGAR
  5. Jul 23, 20268-K EDGAR
  6. Jun 17, 20264 OWNERSHIP DOCUMENT EDGAR
  7. Jun 17, 20264 OWNERSHIP DOCUMENT EDGAR
  8. Jun 17, 20264 OWNERSHIP DOCUMENT EDGAR
  9. Jun 17, 20264 OWNERSHIP DOCUMENT EDGAR
  10. Jun 17, 20264 OWNERSHIP DOCUMENT EDGAR
  11. Jun 17, 20264 OWNERSHIP DOCUMENT EDGAR
  12. Jun 17, 20264 OWNERSHIP DOCUMENT EDGAR
  13. Jun 17, 20264 OWNERSHIP DOCUMENT EDGAR
  14. Jun 17, 20268-K EDGAR
  15. May 15, 2026424B7 EDGAR
  16. May 15, 2026SCHEDULE 13G EDGAR
  17. May 13, 202610-Q EDGAR
  18. May 13, 20268-K EDGAR
  19. Apr 30, 2026ARS EDGAR
  20. Apr 30, 2026DEFA14A EDGAR

The 278 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

28 open-market trades by officers, directors and large owners since October 2021: 22 buys and 6 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jan 30, 2026Gilad OrenPresident/CEOBuy28,100$0.89$25.0KForm 4
Jan 30, 2026Hamill John P.SrVP/CFO/Prin Fin & Acct OfcrBuy5,700$0.89$5.1KForm 4
Dec 10, 2025Duey MarcDirectorBuy21,459$1.17$25.1KForm 4
Dec 10, 2025Hamill John P.SrVP/CFO/Prin Fin & Acct OfcrBuy5,000$1.17$5.8KForm 4
Apr 3, 2025Gilad OrenPresident/CEOBuy5,500$1.84$10.1KForm 4
Oct 23, 2024Gilad OrenPresident/CEOBuy500$3.92$2.0KForm 4
Oct 18, 2024Duey MarcDirectorSale6,462$4.58$29.6KForm 4
Oct 16, 2024Duey MarcDirectorBuy30,000$4.39$131.7KForm 4
Oct 15, 2024Gilad OrenPresident/CEOBuy250$2.90$725Form 4
Oct 14, 2024Duey MarcDirectorBuy190$2.58$490Form 4
Oct 14, 2024Gilad OrenPresident/CEOBuy1,000$2.59$2.6KForm 4
Oct 11, 2024Hamill John P.SrVP/CFO/Prin Fin & Acct OfcrBuy50$2.46$123Form 4
Oct 11, 2024Seizinger Bernd R.DirectorBuy10,000$2.68$26.8KForm 4
Oct 10, 2024Gilad OrenPresident/CEOBuy150$2.54$381Form 4
Oct 10, 2024Hamill John P.SrVP/CFO/Prin Fin & Acct OfcrBuy450$2.61$1.2KForm 4
Mar 13, 2024Hamill John P.SrVP/CFO/Prin Fin & Acct OfcrBuy1,010$7.29$7.4KForm 4
Mar 13, 2024Seizinger Bernd R.DirectorBuy6,860$7.29$50.0KForm 4
Mar 13, 2024HENNEMAN JOHN B IIIDirectorBuy6,860$7.29$50.0KForm 4
Mar 13, 2024Gilad OrenPresident/CEOBuy2,000$7.29$14.6KForm 4
Jun 7, 2023Seizinger Bernd R.DirectorBuy6,029$3.68$22.2KForm 4

All 28 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.

Money raised

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

  1. Dec 10, 2025Raised $3.1 million in a private offering of equity Form D: $5.8 million offered in all 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 28. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
AIGH Capital Management LLC1,015,541$814.8K0.1%No change
Nantahala Capital Management, LLC411,520$330.2K0.0%+205,760
Vestal Point Capital, LP350,000$280.8K0.0%No change
Sphera Funds Management Ltd.270,000$216.6K0.0%No change
Renaissance Technologies LLC105,800$84.9K0.0%+80,700
Geode Capital Management, LLC74,869$60.1K0.0%−44,262
Citadel Advisors LLC58,600$47.0K0.0%New
Bnp Paribas Financial Markets45,211$36.3K0.0%+5,394
Diadema Partners LP44,907$36.0K0.0%New
Vanguard Fiduciary Trust Co38,464$30.8K0.0%No change
Susquehanna International Group, Llp34,939$28.0K0.0%+21,921
Morgan Stanley25,830$20.7K0.0%+3,500
Vanguard Capital Management LLC22,882$18.4K0.0%+3,260
LPL Financial LLC16,052$12.9K0.0%−5,000
HighTower Advisors, LLC13,864$11.1K0.0%No change
Northern Trust Corp13,705$11.0K0.0%New
Persistent Asset Partners Ltd11,490$9.2K0.0%New
XTX Topco Ltd10,565$8.5K0.0%New
BlackRock, Inc.7,173$5.8K0.0%−1,331
Tower Research Capital LLC (TRC)3,590$2.9K0.0%−1,537
Group One Trading LLC577$4630.0%No change
Barclays PLC473$3790.0%New
Osaic Holdings, Inc.295$2360.0%No change
WealthCollab, LLC158$1270.0%No change
Fmr LLC45$360.0%New

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

SEC filer profile

How Aprea 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 EDGARAprea Therapeutics, Inc.1
  • CIK0001781983
  • Employer ID (EIN)84-22467693
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company3
  • Incorporated inDelaware3
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address3805 Old Easton Road, Doylestown, PA 189021
  • Phone215-948-41191
  • Shares outstanding12,591,136 as of Aug 12, 202610
  • Public float$8.6M as of Jun 30, 20253
  • AuditorEisnerAmper LLP, Philadelphia, Pennsylvania PCAOB ID 274; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceJul 12, 20191
  • Filings444 in all: 4 (152), 8-K (93), 3 (28), 10-Q (21), SC 13G/A (12), CORRESP (11), SC 13G (11), SCHEDULE 13G/A (11)1
    All 37 form types

    S-8 (9), DEF 14A (8), SC 13D/A (8), UPLOAD (8), 10-K (7), EFFECT (7), 424B3 (6), S-3 (6), DEFA14A (5), SCHEDULE 13G (5), 424B5 (4), ARS (4), S-1/A (4), SEC STAFF LETTER (4), PRE 14A (3), 10-K/A (2), S-3/A (2), SC 13D (2), 424B4 (1), 424B7 (1), 8-A12B (1), CERT (1), D (1), DRS (1), DRS/A (1), DRSLTR (1), FWP (1), S-1 (1), S-1MEF (1)

  • Latest filingsAnnual report (10-K) Mar 16, 2026
    Quarterly report (10-Q) Aug 12, 2026
    Proxy statement (DEF 14A) Apr 30, 2026
    Latest 8-K (8-K) Aug 28, 2026

Securities registered for trading

ClassSymbolExchange
Common stock, par value $0.001 per shareAPREThe NASDAQ Stock Market LLC

From the cover page of the 10-K filed Mar 16, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks Aprea Therapeutics, Inc. names in Item 1A of its 10-K filed Mar 16, 2026: 72 risks under these headings, as written.3

  • Risks related to our financial position and the need for additional capital
  • Risks related to the discovery, development and commercialization of our product candidates
  • Risks related to our dependence on third parties
  • Risks related to our intellectual property
  • Risks related to regulatory and marketing approval and other legal compliance matters
  • Risks related to our common stock
  • Risks related to our financial position and need for additional capital
  • We have incurred significant losses in each year since inception. We expect to incur losses for the foreseeable future and may never achieve or maintain profitability.
  • We have identified conditions and events that raise substantial doubt regarding our ability to continue as a going concern.
  • Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability. We have never generated commercial revenues and may never be profitable.
  • We will need substantial additional funding, which may not be available to us on acceptable terms or at all. If we are unable to raise capital when needed, we may be forced to delay, reduce and/or eliminate our research and drug development programs or future commercialization efforts.
  • Raising additional capital may cause dilution to our stockholders and restrict our operations or require us to relinquish rights to our product candidates.
The other 66 risks
  • We are currently operating in a period of global economic uncertainty and capital markets disruption, which has been significantly impacted by geopolitical conflicts, natural and man-made disasters, global health emergencies and uncertainties in regulatory developments and legislative actions, which could adversely affect our business, financial condition and results of operations.
  • The political and economic environment in the United States could materially impact our business operations and financial performance, and uncertainty surrounding the potential legal, regulatory and policy changes by the U.S. administration may directly affect us and the global economy.
  • 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.
  • We are substantially dependent on the success of APR-1051 and ATRN-119 which are in clinical development. Our clinical trials of APR-1051 and ATRN-119 may not be successful. If we are unable to obtain approval for and commercialize APR-1051 and ATRN-119 or experience significant delays in doing so, our business will be materially harmed.
  • We are in the early stages of testing APR-1051 and ATRN-119 in Phase 1 clinical trials and we have not tested APR-1051 or ATRN-119 in later phase clinical trials. The results of preclinical studies and early-stage clinical trials may not be predictive of future results in later studies or trials. Initial success in clinical trials may not be indicative of results obtained when these trials are completed or in later-stage clinical trials.
  • 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 may not permit us to proceed.
  • We have limited experience as a company conducting clinical trials and may be unable to complete pivotal clinical trials for any product candidates we may develop.
  • We may find it difficult to enroll patients in our clinical trials. If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary marketing approvals could be delayed or prevented.
  • Leveraging synthetic lethality in therapeutic targeting of DDR represents an emerging strategy to treat a broad spectrum of cancers, and negative perceptions of the efficacy, safety, or tolerability of this class of targets, including any that we develop, could adversely affect our ability to conduct our business, advance our product candidates or obtain regulatory approvals.
  • If serious adverse or unacceptable side effects are identified during the development of our product candidates or we observe limited efficacy of our product candidates, we may need to abandon or limit the development of one or more of our product candidates.
  • The outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, interim results of a clinical trial do not necessarily predict final results, and the results of our clinical trials may not satisfy the requirements of the FDA or comparable foreign regulatory authorities.
  • Clinical drug development is a lengthy and expensive process, with an uncertain outcome. 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, we may incur additional costs, experience delays in completing, or ultimately be unable to complete, the development of our product candidates or be unable to obtain marketing approval.
  • We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • If we are required to in the future and if we are unable to successfully develop companion diagnostic tests for our product candidates that require such tests, or experience significant delays in doing so, we may not realize the full commercial potential of these product candidates.
  • We may not be successful in our efforts to identify or discover additional potential product candidates.
  • If any of our product candidates receives marketing approval and we, or others, later discover that the drug is less safe or effective than previously believed or causes undesirable side effects that were not previously identified, our ability, or that of any future collaborators, to market the drug could be compromised.
  • Even if any of our product candidates receive marketing approval, they may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors and others in the medical community necessary for commercial success.
  • We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.
  • Our business and operations would suffer in the event of IT system failures, cybersecurity attacks, data breaches, or vulnerabilities in our or our third-party vendors’ information security program or defenses.
  • If, in the future, we are unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and market our product candidates, we may not be successful in commercializing our product candidates if and when they are approved.
  • If the FDA or comparable foreign regulatory authorities approve generic versions of any of our product candidates that receive marketing approval, or such authorities do not grant our product candidates appropriate periods of data or market exclusivity before approving generic versions of our product candidates, the sales of our product candidates could be adversely affected.
  • Even if we obtain regulatory approval of any product candidate, the approved product may be subject to post-approval studies and will remain subject to ongoing regulatory requirements. If we fail to comply, or if concerns are identified in subsequent studies, our approval could be withdrawn, and our product sales could be suspended.
  • Even if we are able to commercialize any product candidate, such product candidate may become subject to unfavorable pricing regulations, third-party coverage and reimbursement policies or healthcare reform initiatives, which could harm our business.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any drugs that we may develop. Our insurance policies may be inadequate and may potentially expose us to unrecoverable risk.
  • Governments outside of the United States tend to impose strict price controls, which may adversely affect our revenues from the sales of our products, if any.
  • The reactivation of p53 is a novel and unproven therapeutic approach and our development of eprenetapopt may never lead to a marketable product.
  • We rely on third parties to conduct our clinical trials and some aspects of our research and preclinical studies, and those third parties may not perform satisfactorily, including failing to conduct their operations in compliance with regulatory requirements or to meet deadlines for the completion of such trials, research and studies.
  • Although we currently plan to retain all commercial rights to our product candidates, we may enter into strategic collaborations for the development, marketing and commercialization of our product candidates. If those collaborations are not successful, the development, marketing and/or commercialization of our product candidates that are the subject of such collaborations would be harmed.
  • We are currently dependent on a single third party manufacturer for the manufacture of the active pharmaceutical ingredient for our product candidates. This reliance on a single third party increases the risk that we will not have sufficient quantities of our product candidates or drugs or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
  • If we are unable to obtain and maintain intellectual property protection for our product candidates or for our technology, our competitors could develop and commercialize products or technology similar or identical to ours, and our ability to successfully commercialize any product candidates we may develop, and our technology may be adversely affected.
  • Our proprietary position for eprenetapopt depends upon patents that consist of formulation patent claims, which may not prevent a competitor or other third party from using the same product candidate for another use or in another formulation.
  • Issued patents covering our product candidates and other technologies could be narrowed or found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad.
  • We may be subject to other claims challenging the inventorship of our patents and other intellectual property.
  • If we do not obtain patent term extension or data exclusivity for any product candidates we may develop, our business may be materially harmed.
  • We may not be successful in obtaining, through acquisitions, in-licenses or otherwise, rights that may be necessary to our product candidates or other technologies.
  • Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates and technology.
  • 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 we are sued for infringing, misappropriating or otherwise violating patents or other intellectual property rights of third parties, it will be costly and time consuming, and an unfavorable outcome in that litigation would have a material adverse effect on our business.
  • We may not be able to protect our intellectual property rights with patents throughout the world.
  • Obtaining and maintaining our patent protection depends upon compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • 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.
  • Confidentiality agreements with employees and third parties may not prevent unauthorized disclosure of trade secrets and other proprietary information.
  • Intellectual property rights do not necessarily address all potential threats.
  • If trademarks, brand names and trade names are not adequately protected or available, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
  • We have never obtained marketing approval for a product candidate and we may be unable to obtain, or may be delayed in obtaining, marketing approval for any of our product candidates.
  • Even if we complete the necessary preclinical studies and clinical trials, the marketing approval process is expensive, time-consuming and uncertain and may prevent us, or any future collaborators, from obtaining approvals for the commercialization of some or all of our product candidates. As a result, we cannot predict when or if, and in which territories, we, or any future collaborators, will obtain marketing approval to commercialize a product candidate.
  • Failure to obtain marketing approval in foreign jurisdictions would prevent our product candidates from being marketed abroad. Any approval we are granted for our product candidates in the United States would not assure approval of our product candidates in foreign jurisdictions.
  • We, or any future collaborators, may not be able to obtain or maintain orphan drug exclusivity for our product candidates and, even if we do, that exclusivity may not prevent the FDA or the European Commission from approving competing products.
  • Even if we, or any collaborators we may have in the future, obtain marketing approvals for our product candidates, the terms of approvals and ongoing regulation of our product candidates could require substantial expenditure of resources and may limit how we, or they, manufacture and market our product candidates, which could materially impair our ability to generate revenue.
  • The FDA’s and other comparable regulatory authorities’ policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates, which would impact our ability to generate revenue.
  • Any of our product candidates for which we, or our future collaborators, obtain marketing approval in the future will be subject to substantial penalties if we, or they, fail to comply with regulatory requirements or if we, or they, experience unanticipated problems with our product candidates following approval.
  • Recently enacted and future legislation, and any change in existing government regulations and policies, may increase the difficulty and cost for us and our future collaborators to obtain marketing approval of and commercialize our product candidates and affect the prices we, or they, may obtain.
  • We may seek a breakthrough therapy designation for APR-1051 or ATRN-119, or one or more of our other product candidates, but we might not receive such designation, and even if we do, such designation may not lead to a faster development or regulatory review or approval process.
  • A fast track designation by the FDA for APR-1051, ATRN-119, or any of our other product candidates may not actually lead to a faster development or regulatory review or approval process.
  • We may seek priority review designation for one or more of our product candidates, but we might not receive such designation, and even if we do, such designation may not lead to a faster development or regulatory review or approval process.
  • Our relationships with healthcare providers, physicians 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 penalties, including criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
  • Our employees and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements, which could cause significant liability for us and harm our reputation.
  • 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 our business.
  • Laws and regulations governing any international operations we may have in the future may preclude us from developing, manufacturing and selling certain product candidates outside of the United States and require us to develop and implement costly compliance programs.
  • Security breaches, loss of data and other disruptions could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability, which could adversely affect our business and our reputation.
  • Any clinical trial programs we conduct or research collaborations we enter into in the European Economic Area (“EEA”)/UK may subject us to the EU General Data Protection Regulation 2016/679 (the “EU GDPR”) as implemented by countries within the EEA. In addition, where we conduct programs and collaborations in the UK we may be subject to the UK Data Protection Act 2018 and the UK General Data Protection Regulation, (together the “UK GDPR”).
  • Risks related to employee matters and managing growth
  • Our future success depends on our ability to retain our President and Chief Executive Officer and our Senior Vice President and Chief Financial Officer, and to attract, retain and motivate qualified personnel.
  • We expect to expand our development and regulatory capabilities and potentially our sales and marketing capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
  • We will need to expand our organization, and may experience difficulties in managing this growth, which could disrupt operations.
  • Our employees, independent contractors, principal investigators, consultants, commercial collaborators, service providers and other vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have an adverse effect on our results of operations.
  • Risks related to tax matters
  • We have significant deferred tax assets, which may become devalued if we do not generate sufficient future taxable income, applicable corporate tax rates are reduced or if we experience an ownership change.

Legal proceedings

There are no matters which constitute material pending legal proceedings to which we are a party other than those incorporated into this item by reference to Note 9 of the section of this Annual Report on Form 10-K in Item 8, entitled “Financial Statements and Supplementary Data.”

The opening of Item 3, Legal Proceedings.3

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