Sign in

ACRV on Nasdaq

Acrivon Therapeutics, Inc.

Pharmaceutical preparations company based in Watertown, listed on Nasdaq (ACRV)1

In its 2026 annual report the company says: “We are a clinical-stage biopharmaceutical company discovering and developing precision medicines utilizing our proprietary Generative Phosphoproteomics Acrivon Predictive Precision Proteomics, or AP3, platform designed to quantify compound-specific, drug-regulated pathway activity levels inside the intact cell in an unbiased manner, yielding terabytes of proprietary data and delivering rapid, actionable insights. Our company name, Acrivon, is derived from Greek for “accurate” or “precise”.”4

Price unavailable

Last updated Oct 21, 2026.

Overview

Compare with another stock.

  • TickerACRV on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersWatertown, Massachusetts1
  • Business address480 Arsenal Way, Suite 100, Watertown, Ma 024722
  • Filer category, Emerging growth company2
  • Legal formCorporation

See how the biggest companies compare on our leaderboards

We are a clinical-stage biopharmaceutical company discovering and developing precision medicines utilizing our proprietary Generative Phosphoproteomics Acrivon Predictive Precision Proteomics, or AP3, platform designed to quantify compound-specific, drug-regulated pathway activity levels inside the intact cell in an unbiased manner, yielding terabytes of proprietary data and delivering rapid, actionable insights. Our company name, Acrivon, is derived from Greek for “accurate” or “precise”. We chose it to embody how our AP3 platform can, among other highly actionable discovery and development applications, accurately match our therapies with patients who will benefit. Recently approved precision oncology treatments, such as kinase inhibitors, have transformed the cancer treatment landscape, and while the therapeutic benefit of these agents has provided significant benefit to patients, the…4 From its latest annual report

Financials

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

Financial statements

Operating income5678-$84.1M in 2025+420% since 2021
-$100.0M-$75.0M-$50.0M-$25.0M02021: -$16.2M-$16.2M20212022: -$32.7M-$32.7M2022+102%2023: -$67.1M-$67.1M2023+105%2024: -$89.2M-$89.2M2024+33%2025: -$84.1M-$84.1M2025−6%
Net income5678-$77.9M in 2025+380% since 2021
-$100.0M-$75.0M-$50.0M-$25.0M02021: -$16.2M-$16.2M20212022: -$31.2M-$31.2M2022+92%2023: -$60.4M-$60.4M2023+94%2024: -$80.6M-$80.6M2024+33%2025: -$77.9M-$77.9M2025−3%

Every line of the income statement as filed: the last 2 fiscal years, latest first.8

Period ending2025-12-312024-12-31
Research and development$60.0M$64.0M
General and administrative$24.1M$25.2M
Total operating expenses$84.1M$89.2M
Loss from operations-$84.1M-$89.2M
Interest income$6.5M$9.2M
Other expense, net-$270.0K-$558.0K
Total other income, net$6.2M$8.6M
Net loss-$77.9M-$80.6M
Net loss per sharebasic-$2.02-$2.38
Net loss per sharediluted-$2.02-$2.38
Weighted-average common stock outstandingbasic38.5M shares33.8M shares
Weighted-average common stock outstandingdiluted38.5M shares33.8M shares
Unrealized (loss) gain on available-for-sale investments, net of tax-$336.0K$530.0K
Comprehensive loss-$78.2M-$80.0M

Compare Acrivon Therapeutics, Inc. with another company

Corporate structure

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

Major holders of Acrivon Therapeutics, Inc.

  • Acrivon Therapeutics, Inc. Watertown, Massachusetts
    • Acrivon AB, a joint stock company incorporated under the laws of Subsidiary · Sweden

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 Acrivon 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$8.2M8 Dec 31, 2025$6.4M8 Dec 31, 2024+27.6%
Accumulated depreciation$3.3M8 Dec 31, 2025$2.0M8 Dec 31, 2024+69.1%
Property and equipment, net$4.9M8 Dec 31, 2025$4.5M8 Dec 31, 2024+9.3%
Operating-lease assets (leased space)$2.5M8 Dec 31, 2025$3.6M8 Dec 31, 2024−28.9%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$41.5M8 Dec 31, 2025$39.8M8 Dec 31, 2024+4.2%
Marketable securities, current$77.1M8 Dec 31, 2025$139.7M8 Dec 31, 2024−44.8%
Debt securities available for sale$77.1M8 Dec 31, 2025$144.8M8 Dec 31, 2024−46.7%
Long-term investments$5.1M8 Dec 31, 2024$41.9M6 Dec 31, 2022−87.8%

Properties, in its own words

Our principal office is located in Watertown, Massachusetts, where we lease 13,711 square feet of office and laboratory space under a lease that expires in 2028, with an option to extend the term for an additional five years at then-market rental rates. We also occupy 529 square meters of office space located in Lund, Sweden under a lease that expires in December 2026 and will automatically renew for an additional term of three years unless we provide written notice of termination nine months prior to the termination date. In July 2024, we entered into a lease for additional office and laboratory space adjacent to our existing leased space located in Lund, Sweden. The term of the lease commenced in September 2024, has an initial term of three years, and will automatically renew for an additional term of three years unless we provide written notice of termination nine months prior to the termination date. We believe that our current and future planned facilities are sufficient to meet our current and near-term needs and that, should it be needed, suitable additional space will be available.

Item 2 of the 10-K filed Mar 19, 2026.4

Leadership

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

Chief executive

  1. Peter Blume-Jensen2022–now

President

  1. Peter Blume-Jensen2022–now

Chief financial officer

  1. Rasmus Holm-Jorgensen2022–now

Chief operating officer

  1. Eric Devroe2022–now
2025
Board members and other officers (15)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • DirectorMarcin Czernik named Nov 23, 202126

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Acrivon AB, a joint stock company incorporated under the laws of Sweden3

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

Timeline

  1. Aug 12, 20268-K Results of operations27
  2. Jun 17, 20268-K Executive or director change; Shareholder vote28
  3. May 13, 20268-K Results of operations29
  4. Mar 19, 20268-K Results of operations; Regulation FD disclosure30
  5. Mar 2, 20268-K Ended a material agreement31
  6. Feb 27, 20268-K Regulation FD disclosure32
  7. Jan 8, 20268-K Results of operations; Regulation FD disclosure; Other events33
  8. Jan 8, 20268-K Regulation FD disclosure34
  9. Nov 13, 20258-K Results of operations35
  10. Sep 5, 20258-K Regulation FD disclosure36
  11. Aug 13, 20258-K Results of operations37
  12. Jun 13, 20258-K Shareholder vote38
  13. Nov 9, 2022New chief executive Peter Blume-Jensen becomes CEO11

Calendar

Coming up

  1. Nov 12, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.47) a share, on Nov 13, 2025.39

When it reported results

  1. Aug 12, 2026Reported quarterly or annual results27
  2. May 13, 2026Reported quarterly or annual results29
  3. Mar 19, 2026Reported quarterly or annual results30
  4. Jan 8, 2026Reported quarterly or annual results33
  5. Nov 13, 2025Reported quarterly or annual results35
  6. Aug 13, 2025Reported quarterly or annual results37
  7. May 14, 2025Reported quarterly or annual results40
  8. Mar 25, 2025Reported quarterly or annual results41

Drug trials and FDA: coming up

  1. May 30, 2027Phase 2 trial readout expected Phase 2 trial of ACR-368 and Gemcitabine in Endometrial Adenocarcinoma: primary completion expected May 30, 2027 (ClinicalTrials.gov NCT05548296).42
  2. Aug 12, 2027Phase 1/2 trial readout expected Phase 1/2 trial of ACR-2316 in Specific Advanced Solid Tumors: primary completion expected Aug 12, 2027 (ClinicalTrials.gov NCT06667141).43

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

344 filings to the SEC since October 2021: 4 annual reports, 12 quarterly reports, 43 major events, 205 insider forms, 28 large holders, 1 private raises, 51 other. The latest 20:

  1. Oct 7, 20264 EDGAR
  2. Sep 2, 20264 EDGAR
  3. Sep 2, 20263 EDGAR
  4. Aug 27, 20264 EDGAR
  5. Aug 25, 2026144 EDGAR
  6. Aug 20, 20264 EDGAR
  7. Aug 20, 20264 EDGAR
  8. Aug 20, 20264 EDGAR
  9. Aug 20, 20264 EDGAR
  10. Aug 20, 20264 EDGAR
  11. Aug 13, 2026SCHEDULE 13G/A EDGAR
  12. Aug 12, 2026S-8 EDGAR
  13. Aug 12, 20268-K EDGAR
  14. Aug 12, 202610-Q EDGAR
  15. Aug 6, 20264 EDGAR
  16. Jul 23, 20264 EDGAR
  17. Jun 22, 20264 EDGAR
  18. Jun 22, 20264 EDGAR
  19. Jun 22, 20264 EDGAR
  20. Jun 22, 20264 EDGAR

The 344 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

24 open-market trades by officers, directors and large owners since October 2021: 6 buys and 18 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 25, 2026Blume-Jensen PeterPresident and CEOSale14,036$2.21$31.0KForm 4
Aug 18, 2026Peterson KatharineChief Accounting OfficerSale101$2.01$203Form 4
Aug 18, 2026Miller MaryChief Legal OfficerSale185$2.01$372Form 4
Aug 18, 2026Gamelin ErickChief Development OfficerSale400$2.01$804Form 4
Aug 18, 2026Devroe EricChief Operating OfficerSale604$2.01$1.2KForm 4
Aug 18, 2026Masson KristinaEVP - Business OperationsSale1,713$2.01$3.4KForm 4
Aug 4, 2026Levy Adam D.Chief Financial OfficerSale1,142$1.57$1.8KForm 4
Jul 21, 2026Miller MaryChief Legal OfficerSale573$1.76$1.0KForm 4
Jan 14, 2026Blume-Jensen PeterPresident and CEOBuy49,000$1.68$82.3KForm 4
Jan 14, 2026Levy Adam D.Chief Financial OfficerBuy8,832$1.70$15.0KForm 4
Jan 13, 2026Devroe EricChief Operating OfficerBuy10,000$1.72$17.2KForm 4
May 1, 2025PERCEPTIVE ADVISORS LLC10% ownerSale298,886$1.34$400.5KForm 4
Apr 30, 2025PERCEPTIVE ADVISORS LLC10% ownerSale437,881$1.41$617.4KForm 4
Apr 29, 2025PERCEPTIVE ADVISORS LLC10% ownerSale250,000$1.41$352.5KForm 4
Apr 28, 2025PERCEPTIVE ADVISORS LLC10% ownerSale215,283$1.56$335.8KForm 4
Apr 25, 2025PERCEPTIVE ADVISORS LLC10% ownerSale1,054,669$1.95$2.1MForm 4
Apr 11, 2024PERCEPTIVE LIFE SCIENCES MASTER FUND LTD10% ownerBuy2,353,000$8.50$20.0MForm 4
Jun 26, 2023Smolokowski Wiaczeslaw10% ownerSale16$12.93$207Form 4
Jun 15, 2023Nikolaou Anastasis10% ownerSale2,056$12.14$25.0KForm 4
Jun 14, 2023Chione Ltd10% ownerSale893$12.13$10.8KForm 4

All 24 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
2025Peter Blume-JensenM.D., Ph.D.$709.9K$2.7M51
2025Kristina MassonPh.D, M.B.A.$594.5K$1.4M51
2025Eric DevroePh.D.$528.7K$1.4M51
2024Chief Executive OfficerPresident and Director$655.1K$2.0M51
2024Executive Vice PresidentBusiness Operations, Director$565.5K$1.2M51
2024Chief Operating Officer$510.5K$1.1M51

Funding

Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.

Money received by year$100.0M 2021–2021
Money received by yearMoney received by year, 2021–2021: $100.0M in all. Private raises (Form D) $100.0M.$0$25M$50M$75M$100M2021 · Private raises (Form D): $100.0M2021
Figures by year
YearPrivate raises (Form D)Total
2021$100.0M$100.0M

Private raises

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

  1. Nov 9, 2021Raised $100 million in a private offering of equity26 Form D: 13 investors so far Form D

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 46. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Ra Capital Management, L.P.12,229,396$21.8M0.2%+3,888,888
Sands Capital Alternatives, LLC2,289,271$4.1M0.7%+166,666
Vanguard Capital Management LLC952,008$1.7M0.0%+229,973
Wellington Management Group Llp888,130$1.6M0.0%No change
Renaissance Technologies LLC758,863$1.4M0.0%+423
Two Sigma Investments, LP641,498$1.1M0.0%+252,103
Marshall Wace, Llp531,856$946.7K0.0%−28,580
Bridgeway Capital Management, LLC378,900$674.4K0.0%+220,000
Geode Capital Management, LLC265,241$472.3K0.0%+28,850
BlackRock, Inc.239,112$425.6K0.0%+30,173
Vanguard Fiduciary Trust Co184,128$327.7K0.0%+76,599
XTX Topco Ltd178,239$317.3K0.0%+111,357
Jane Street Group, LLC74,648$132.9K0.0%−165,043
Northern Trust Corp67,202$119.6K0.0%+18,300
State Street Corp67,145$119.5K0.0%No change
UBS Group AG43,850$78.1K0.0%+9,216
Citadel Advisors LLC41,276$73.5K0.0%New
Dimensional Fund Advisors LP29,332$52.2K0.0%+10,968
Spark Investment Management LLC28,300$50.4K0.1%New
Prelude Capital Management, LLC24,015$42.7K0.0%No change
Bank Of America Corp /de/16,407$29.2K0.0%−106
Verdad Advisers, LP15,054$26.8K0.0%New
Goldman Sachs Group Inc14,920$26.6K0.0%+178
Squarepoint Ops LLC13,309$23.7K0.0%−14,163
AAF Wealth Management, LLC10,678$19.0K0.0%No change

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

SEC filer profile

How Acrivon 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 EDGARAcrivon Therapeutics, Inc.1
  • CIK0001781174
  • Employer ID (EIN)82-51255324
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address480 Arsenal Way, Suite 100, Watertown, MA 024721
  • Phone617-207-89791
  • Shares outstanding42,853,362 as of Aug 7, 202610
  • Public float$20.4M as of Jun 30, 20254
  • AuditorPricewaterhouseCoopers LLP, Boston, Massachusetts PCAOB ID 238; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceFeb 12, 20211
  • Filings345 in all: 4 (183), 8-K (43), 3 (21), 10-Q (12), SC 13G/A (10), S-8 (8), SCHEDULE 13G/A (7), CORRESP (5)1
    All 35 form types

    DEFA14A (5), SC 13G (5), 10-K (4), ARS (4), DEF 14A (4), UPLOAD (4), EFFECT (3), 144 (2), D (2), S-1/A (2), S-3 (2), SC 13D/A (2), SCHEDULE 13D/A (2), SEC STAFF LETTER (2), 3/A (1), 424B4 (1), 8-A12B (1), CERT (1), DEFR14A (1), DRS (1), DRS/A (1), DRSLTR (1), FWP (1), S-1 (1), S-1MEF (1), SC 13D (1), SCHEDULE 13G (1)

  • Latest filingsAnnual report (10-K) Mar 19, 2026
    Quarterly report (10-Q) Aug 12, 2026
    Proxy statement (DEF 14A) Apr 30, 2026
    Latest 8-K (8-K) Aug 12, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.001 per shareACRVNasdaq Global Market

From the cover page of the 10-K filed Mar 19, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Acrivon Therapeutics, Inc. names in Item 1A of its 10-K filed Mar 19, 2026: 72 risks under these headings, as written.4

  • Risks Related to Our Financial Position and Capital Needs
  • We have incurred significant losses since our inception. We expect to incur losses over the next several years and may never achieve or maintain profitability.
  • We have a limited operating history and no history of commercializing products, which may make it difficult for an investor to evaluate the success of our business to date and to assess our future viability.
  • We will need additional funding to meet our financial obligations and to pursue our business objectives. If we are unable to raise capital when needed, we could be forced to curtail our planned longer-term operations and the pursuit of our growth strategy.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or drug candidates.
  • Risks Related to the Design and Development of Our Drug Candidates
  • Our business substantially depends upon the successful clinical development of drug candidates using our AP3 platform and OncoSignature companion diagnostics. If we are unable to obtain regulatory approval for, and successfully commercialize, drugs developed through the application of our AP3 platform and OncoSignature tests, our business may be materially harmed.
  • The regulatory approval processes of the FDA and comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our drug candidates, on a timely basis or at all, our business will be substantially harmed.
  • We are highly dependent on the success of ACR-368 and/or ACR-2316, as these are our first drug candidates being developed for clinical development and regulatory approval. We may never obtain approval for ACR-368, ACR-2316 or any other drug candidate.
  • Depending on our clinical trial results, we may seek NDA approval for ACR-368 in the United States under the FDA’s accelerated approval pathway, but this pathway may not lead to faster development, regulatory review, or approval process and does not increase the likelihood that ACR-368 will receiving marketing approval.
  • Early clinical trials for ACR-2316 may not predict the success of later clinical trials. Furthermore, the results of clinical trials for ACR-2316 may not satisfy the requirements of the FDA or comparable foreign regulatory authorities.
  • We may incur additional costs or experience delays in completing, or ultimately be unable to complete the development and/or commercialization of ACR-368, ACR-2316, or our other future drug candidates identified through the application of our AP3 platform and OncoSignature companion diagnostics.
The other 62 risks
  • The successful clinical development of some of our drug candidates may depend in part on the co-approval of an OncoSignature test as a companion diagnostic test. If we or our companion diagnostic collaborator are unable to obtain regulatory approval for our OncoSignature companion diagnostic tests for such drug candidates, we may not obtain regulatory approval and realize the commercial potential of certain drug candidates.
  • 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.
  • If we experience delays or difficulties in enrolling patients in our ongoing or planned clinical trials, our receipt of necessary regulatory approval could be delayed or prevented.
  • Unexpected adverse side effects or other safety risks associated with ACR-368, ACR-2316, or our other future drug candidates could delay or preclude approval, cause us to suspend or discontinue clinical trials or abandon further development, limit the commercial profile of an approved product or result in significant negative consequences following marketing approval, if any.
  • Preliminary, interim and topline data from our clinical trials that we announce or publish from time to time may change as more patient data becomes available and is subject to audit and verification procedures that could result in material changes in the final data.
  • We may in the future seek to engage in business co-development pharma partnerships leveraging our AP3 platform for patient responder identification or uncovering of resistance mechanisms to drug candidates or in strategic transactions to acquire or in-license additional products, drug candidates or technologies. If we are unable to realize the benefits from such transactions, it may adversely affect our ability to develop and commercialize an expanded pipeline of drug candidates, negatively impact our cash position, increase our expenses and present significant distractions to our management.
  • We may expend our limited resources to pursue a particular drug candidate or indication and fail to capitalize on drug candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • Our clinical development is focused on the development of precision oncology medicines utilizing our proprietary precision medicine platform, which is based on a novel scientific approach and may never lead to marketable products.
  • Increasing demand for compassionate use of our drug candidates could negatively affect our reputation and harm our business.
  • Risks Related to Government Regulation
  • Our relationships with customers, healthcare providers, including physicians, and third-party payors are subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, health information privacy and security laws and other healthcare laws and regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
  • Even if we obtain FDA approval of any of our drug candidates in the United States, we may never obtain approval for or commercialize any of them in any other jurisdiction, which would limit our ability to realize their full market potential.
  • Even if we receive regulatory approval of our current or future drug candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense, and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our drug candidates.
  • Enacted and future healthcare legislation may increase the difficulty and cost for us to progress our clinical programs and obtain marketing approval of and commercialize our drug candidates and may affect the prices we may set.
  • If we or our third-party manufacturers and suppliers 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.
  • Disruptions at the FDA, the SEC and other government agencies could hinder their ability to perform normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • If we obtain approval to commercialize any products outside of the United States, a variety of risks associated with international operations could adversely affect our business.
  • We may develop our current and future drug candidates in combination with other therapies, and safety or supply issues with combination-use products may delay or prevent development and approval of our drug candidates.
  • We may not be able to obtain or maintain orphan drug designation or exclusivity for our drug candidates.
  • A Fast Track designation by the FDA, even if granted for our lead drug candidate, or any of our future drug candidates, may not lead to a faster development or regulatory review or approval process and does not increase the likelihood that our drug candidates will receive marketing approval.
  • A Breakthrough Therapy or Breakthrough Device designation by the FDA, even if granted for any of our current or future drug candidates or companion diagnostics, may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our drug candidates will receive marketing approval.
  • The biopharmaceutical industry is subject to extensive regulatory obligations and policies that may be subject to change, including due to judicial challenges, election cycles, and resulting regulatory updates and changes in policy priorities.
  • Our business activities have been, and may in the future be, challenged under U.S. federal or state and foreign healthcare laws, which may subject us to civil or criminal proceedings, investigations, or penalties.
  • Risks Related to Our Reliance on Third Parties
  • We rely, and expect to continue to rely, on third parties, including independent clinical investigators, contracted laboratories and CROs, to conduct our preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our drug candidates and our business could be substantially harmed.
  • We rely on third parties to supply and manufacture our drug candidates, and we expect to continue to rely on third parties to manufacture our products, if approved. The development of such drug candidates and the commercialization of any products, if approved, could be stopped, delayed or made less profitable if any such third party fails to provide us with sufficient quantities of drug candidates or products or fails to do so at acceptable quality levels or prices or fails to maintain or achieve satisfactory regulatory compliance.
  • Our current and future partnerships will be important to our business. If we are unable to enter into new partnerships, or if these partnerships are not successful, our business could be adversely affected.
  • Risks Related to Commercialization of Our Drug Candidates
  • Even if any of our current or drug candidates receive marketing approval, they may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
  • If the market opportunities for our drug candidates are smaller than we estimate or if any approval that we obtain is based on a narrower definition of the patient population, then our revenue potential and ability to achieve profitability will be adversely affected.
  • We currently have no marketing and sales organization and may have to invest significant resources to develop these capabilities. If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our products, we may not be able to generate revenue.
  • The precision oncology space is competitive, which may result in others discovering, developing or commercializing products before or more successfully than we do.
  • Even if we are able to commercialize any drug candidates, the products may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, which would harm our business.
  • The market opportunities for any current or future drug candidate we develop, if and when approved, may be limited to those patients who are ineligible for established therapies or for whom prior therapies have failed, and may be small.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.
  • Risks Related to Employee Matters and Our Operations
  • Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
  • We expect to expand our clinical 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.
  • Our employees, independent contractors, consultants, collaborators, principal investigators, CROs, suppliers and vendors may be improperly classified and may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.
  • Our business and operations would suffer in the event of system failures, cyberattacks or a deficiency in our or our CROs’, manufacturers’, contractors’, consultants’ or collaborators’ cybersecurity.
  • Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
  • We are subject to a variety of privacy and data security laws, rules, regulations, policies, industry standards and contractual obligations, and our failure to comply with them could harm our business.
  • The development and use of artificial intelligence, or AI, presents risks and challenges that can impact our business, including by posing security risks to our confidential information, proprietary information, and personal data, and could give rise to legal and/or regulatory actions, damage our reputation or otherwise materially harm our business.
  • Risks Related to Intellectual Property
  • Our success depends in part on our ability to obtain intellectual property rights for our proprietary technologies and drug candidates, as well as 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 rely in part on trade secrets to protect our technology, and our failure to obtain or maintain trade secret protection could harm our business.
  • Patent terms may be inadequate to protect our competitive position on our drug candidates for an adequate amount of time.
  • 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.
  • We may be subject to claims challenging the inventorship or ownership of our future patents and other intellectual property.
  • We may become involved in lawsuits to protect or enforce our patents or other intellectual property rights, which could be expensive, time consuming and unsuccessful.
  • Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a negative impact on the success of our business.
  • We may need to license intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.
  • We depend on intellectual property licensed from a third party and termination of this license could result in the loss of significant rights, which would harm our business.
  • We may be subject to claims asserting 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.
  • Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our future drug candidates.
  • We may not be able to protect our intellectual property rights throughout the world, which could negatively impact our business.
  • Reliance on third parties requires us to share our proprietary information, which increases the possibility that such information will be misappropriated or disclosed.
  • Trademarks we own, license or may obtain may be infringed or successfully challenged, resulting in harm to our business.
  • If we are unable to protect the confidentiality of our proprietary information, our business and competitive position would be harmed.
  • If we do not obtain patent term extension for patents covering our drug candidates, our business may be materially harmed, and in any case, the terms of our patents may not be sufficient to effectively protect our drug candidates and business.
  • Risks Related to Ownership of our Common Stock and our Status as a Public Company
  • An active trading market for our common stock may not continue to be developed or sustained.
  • The trading price of the shares of our common stock may be volatile, and purchasers of our common stock could incur substantial losses.
  • A significant portion of our total outstanding shares are restricted from immediate resale but may be sold into the market in the near future. This could cause the market price of our common stock to drop significantly, even if our business is doing well.
  • If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume could decline.
  • Concentration of ownership of our common stock among our existing executive officers, directors and principal stockholders may prevent new investors from influencing significant corporate decisions.
  • We are an “emerging growth company” and a “smaller reporting company” and, as a result of the reduced disclosure and governance requirements applicable to emerging growth companies and smaller reporting companies, our common stock may be less attractive to investors.
  • We have broad discretion in the use of our cash, cash equivalents and investments and may invest or spend the cash, cash equivalents and investments in ways with which you do not agree and in ways that may not yield a return.

Legal proceedings

From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. We are not currently subject to any material legal proceedings.

The opening of Item 3, Legal Proceedings.4

Sources

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

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