CUE on Nasdaq

Cue Biopharma, Inc.

In its 2026 annual report the company says: “We are a clinical-stage biopharmaceutical company developing a novel class of injectable therapeutics engineered to selectively engage and modulate disease-specific T cells for the treatment of autoimmune and inflammatory diseases.”5 It is headquartered in Cambridge, United States.2 Its shares trade on Nasdaq under the symbol CUE.2

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Last updated Oct 21, 2026.

Overview

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  • TickerCUE on Nasdaq2
  • IndustryPharmaceutical Preparations2
  • HeadquartersCambridge, United States2
  • Incorporated inDE3
  • Business address100 Chestnut Street, Suite 300, Somerville, Ma 021433
  • Filer categoryNon-accelerated filer, Smaller reporting company3
  • Legal formCorporation2
  • LEI549300PBW78KZA33WC972
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressC/O National Registered Agents, Inc., 19904 Dover, United States2
  • Registered withDivision of Corporations, Department of State, 56107502

We are a clinical-stage biopharmaceutical company developing a novel class of injectable therapeutics engineered to selectively engage and modulate disease-specific T cells for the treatment of autoimmune and inflammatory diseases. Unlike conventional approaches that broadly activate the immune system, our Immuno-STAT® platform is designed to selectively modulate disease-relevant T cells, enhancing efficacy while minimizing off-target effects. We believe our Immuno-STAT platform holds the promise of producing drug product candidates with the potential of establishing new standards of care in the treatment of autoimmune and inflammatory diseases. Our programs include, but are not limited to, drug product candidates designed to:5 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

-96.7%Operating margin6
-96.9%Net margin6
195.7%Revenue growth, 20256
-100.6%Return on equity6
-$21.9MFree cash flow6

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development98¢$37.7M
  • Interest0¢$100.0K
  • Income tax1¢$500.0K

Out of $27.5M in revenue.6 The company lost money this year.

Financial statements

Revenue78910116$27.5M in 2025+694% since 2019
0$10.0M$20.0M$30.0M2019: $3.5M$3.5M20192020: $3.2M$3.2M2020−9%2021: $14.9M$14.9M2021+374%2022: $1.2M$1.2M2022−92%2023: $5.5M$5.5M2023+341%2024: $9.3M$9.3M2024+69%2025: $27.5M$27.5M2025+196%
Operating income78910116-$26.6M in 2025−28% since 2019
-$60.0M-$40.0M-$20.0M02019: -$36.8M-$36.8M20192020: -$45.0M-$45.0M2020+23%2021: -$43.7M-$43.7M2021−3%2022: -$53.2M-$53.2M2022+22%2023: -$52.1M-$52.1M2023−2%2024: -$41.5M-$41.5M2024−20%2025: -$26.6M-$26.6M2025−36%
Net income78910116-$26.6M in 2025−28% since 2019
-$60.0M-$40.0M-$20.0M02019: -$36.7M-$36.7M20192020: -$44.8M-$44.8M2020+22%2021: -$44.2M-$44.2M2021−1%2022: -$53.0M-$53.0M2022+20%2023: -$50.7M-$50.7M2023−4%2024: -$40.7M-$40.7M2024−20%2025: -$26.6M-$26.6M2025−35%

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

Period ending2025-12-312024-12-31
Collaboration revenue$27.5M$9.3M
General and administrative$16.2M$14.6M
Research and development$37.7M$36.3M
Loss (gain) on fixed asset disposal$31.0K-$93.0K
Total operating expenses$54.0M$50.8M
Loss from operations-$26.6M-$41.5M
Interest income$807.0K$1.6M
Interest expense-$357.0K-$796.0K
Total other income, net$450.0K$826.0K
Loss before provision for income taxes-$26.1M-$40.7M
Provision for income taxes-$500.0K$0
Net loss-$26.6M-$40.7M
Net loss per common share - basic-$0.28-$0.72
Net loss per common share - diluted-$0.28-$0.72
Weighted average common shares outstanding, basic94.7M shares56.3M shares
Weighted average common shares outstanding, diluted94.7M shares56.3M shares

Compare Cue Biopharma, Inc. with another company

Corporate structure

Cue Biopharma, 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 Cue Biopharma, Inc.

  • Mark E. Strome Filed SCHEDULE 13G/A on Cue Biopharma, Inc., latest Oct 8, 2026 (2 filings since May 16, 2025)
  • Shao-Lee Lin Filed SCHEDULE 13D on Cue Biopharma, Inc., latest Aug 21, 2026
  • DRIEHAUS CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G on Cue Biopharma, Inc., latest Aug 14, 2026
  • Bleichroeder LP Filed SCHEDULE 13G/A on Cue Biopharma, Inc., latest Mar 21, 2025 (3 filings since Mar 11, 2024)
  • Slate Path Capital LP Filed SCHEDULE 13G/A on Cue Biopharma, Inc., latest Feb 14, 2025 (3 filings since Nov 18, 2022)
  • BlackRock Filed SC 13G on Cue Biopharma, Inc., latest Feb 7, 2024 (4 filings since Feb 3, 2022)
  • State Street Corporation Filed SC 13G/A on Cue Biopharma, Inc., latest Feb 3, 2023 (2 filings since Feb 10, 2022)
  • Nantahala Capital Management, LLC Filed SC 13G/A on Cue Biopharma, Inc., latest Dec 2, 2022 (2 filings since Feb 14, 2022)
  • Corriente Advisors, LLC Filed SC 13G/A on Cue Biopharma, Inc., latest Feb 14, 2022
  • Cue Biopharma, Inc. Cambridge, Massachusetts, United States
    • Cue Biopharma Securities Corp. Subsidiary · Massachusetts, United States

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); 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 Cue Biopharma, 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$3.9M6 Dec 31, 2025$4.2M6 Dec 31, 2024−6.0%
Accumulated depreciation$3.7M6 Dec 31, 2025$3.7M6 Dec 31, 2024−0.5%
Property and equipment, net$241.0K6 Dec 31, 2025$471.0K6 Dec 31, 2024−48.8%
Operating-lease assets (leased space)$4.1M6 Dec 31, 2025$4.4M6 Dec 31, 2024−6.8%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$27.1M6 Dec 31, 2025$22.5M6 Dec 31, 2024+20.8%
Debt securities available for sale$011 Dec 31, 2024$011 Dec 31, 2023

Properties, in its own words

Our principal office is located in Boston, Massachusetts. In March 2022, we entered into a License Agreement pursuant to which we relocated our corporate headquarters from Cambridge, Massachusetts to Boston, Massachusetts. We currently lease approximately 13,000 square feet of office and laboratory space under a lease that expires in April 2028. We use this space as our principal executive offices and for general office, research and development, and laboratory uses. We also lease additional laboratory space consisting of one procedure and two holding rooms under a lease that expires in July 2026. We believe that our facilities are sufficient to meet our current needs and that suitable additional space will be available as and when needed.

Item 2 of the 10-K filed Mar 16, 2026.5

Leadership

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

Board members and other officers (32)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive OfficerDominic Borie named Jul 22, 202650
  • Executive OfficerDaniel Baker named May 14, 202651
  • DirectorJill M. Broadfoot named May 14, 202651

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Cue Biopharma Securities Corp. Massachusetts4

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

Former names

  • Imagen Biopharma, Inc.Jun 19, 2015 to Jun 19, 20153

Timeline

  1. Sep 21, 20268-K Regulation FD disclosure; Other events52
  2. Aug 14, 20268-K Results of operations53
  3. Aug 3, 20268-K Executive or director change54
  4. Jul 10, 20268-K Entered a material agreement; Unregistered sale of shares; Executive or director change55
  5. Jun 3, 20268-K Executive or director change; Shareholder vote56
  6. Jun 2, 20268-K Executive or director change; Other events57
  7. May 14, 20268-K Financial statements and exhibits58
  8. May 7, 2026New chief executive Shao-Lee Lin becomes CEO14
  9. May 1, 20268-K Entered a material agreement; Unregistered sale of shares; Executive or director change59
  10. Apr 22, 20268-K Change to shareholders' rights; Bylaws or fiscal year changed60
  11. Apr 13, 20268-K Shareholder vote61
  12. Apr 7, 20268-K Other events62
  13. Mar 27, 20268-K Executive or director change63
  14. Oct 2, 2025New chief executive Usman Azam becomes CEO15
  15. Dec 27, 2017New chief executive Daniel R. Passeri becomes CEO16

Calendar

Coming up

  1. Nov 11, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($2.10) a share, on Nov 12, 2025.64

When it reported results

  1. Aug 14, 2026Reported quarterly or annual results53
  2. Mar 16, 2026Reported quarterly or annual results65
  3. Nov 12, 2025Reported quarterly or annual results66
  4. Aug 12, 2025Reported quarterly or annual results67
  5. May 12, 2025Reported quarterly or annual results68
  6. Apr 15, 2025Reported quarterly or annual results69
  7. Mar 31, 2025Reported quarterly or annual results70
  8. Nov 14, 2024Reported quarterly or annual results71

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

Filings

296 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 50 major events, 133 insider forms, 19 large holders, 3 private raises, 71 other. The latest 20:

  1. Oct 14, 20264 EDGAR
  2. Oct 14, 20264 EDGAR
  3. Oct 14, 20264 EDGAR
  4. Oct 13, 2026144 EDGAR
  5. Oct 13, 2026144 EDGAR
  6. Oct 8, 2026SCHEDULE 13G/A EDGAR
  7. Sep 21, 20268-K EDGAR
  8. Aug 28, 20264/A EDGAR
  9. Aug 28, 20264/A EDGAR
  10. Aug 21, 2026SCHEDULE 13D EDGAR
  11. Aug 20, 2026EFFECT EDGAR
  12. Aug 18, 2026CORRESP EDGAR
  13. Aug 17, 20264 EDGAR
  14. Aug 17, 20264 EDGAR
  15. Aug 17, 2026UPLOAD EDGAR
  16. Aug 14, 20264 EDGAR
  17. Aug 14, 2026144 EDGAR
  18. Aug 14, 202610-Q EDGAR
  19. Aug 14, 20268-K EDGAR
  20. Aug 14, 2026SCHEDULE 13G EDGAR

The 296 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

18 open-market trades by officers, directors and large owners since October 2021: 8 buys and 10 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 13, 2026Meluzio Michael VincentVP, Prin. Accounting OfficerSale5,628$30.09$169.3KForm 4
Aug 13, 2026Lin Shao-LeeChief Executive OfficerSale18,258$28.62$522.6KForm 4
Aug 13, 2026Ray SumitaChief Legal Compliance OfficerSale8,829$30.09$265.6KForm 4
Aug 12, 2026Lin Shao-LeeChief Executive OfficerSale40,000$27.10$1.1MForm 4
Dec 30, 2025Sarraf PashaDirectorBuy323,857$0.31$99.7KForm 4
Dec 16, 2024PASSERI DANIEL RCHIEF EXECUTIVE OFFICERBuy30,000$1.03$30.9KForm 4
Aug 25, 2023Suri AnishPRESIDENT AND CSOBuy4,000$2.76$11.0KForm 4
Aug 14, 2023PASSERI DANIEL RCHIEF EXECUTIVE OFFICERBuy3,000$2.86$8.6KForm 4
Mar 23, 2023Kiener Peter ADirectorSale9,325$3.28$30.6KForm 4
May 27, 2022Morich FrankDirectorBuy28,000$3.75$105.0KForm 4
May 24, 2022Fletcher Aaron G.L.DirectorBuy55,000$3.34$183.7KForm 4
May 23, 2022Fletcher Aaron G.L.DirectorBuy150,000$3.52$528.0KForm 4
Mar 31, 2022Fletcher Aaron G.L.DirectorBuy735,000$4.76$3.5MForm 4
Nov 16, 2021Kiener Peter ADirectorSale1,361$18.02$24.5KForm 4
Nov 15, 2021Kiener Peter ADirectorSale18,815$17.92$337.2KForm 4
Nov 15, 2021Suri AnishPRESIDENT AND CSOSale8,000$18.05$144.4KForm 4
Nov 11, 2021Suri AnishPRESIDENT AND CSOSale20,000$15.07$301.4KForm 4
Oct 1, 2021Millar Kerri-AnnCHIEF FINANCIAL OFFICERSale1,251$14.21$17.8KForm 4

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.

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$110.0M 2022–2026
Money received by yearMoney received by year, 2022–2026: $110.0M in all. Private raises (Form D) $110.0M.$0$20M$40M$60M$80M2022 · Private raises (Form D): $30.0M20222023202420252026 · Private raises (Form D): $80.0M2026
Figures by year
YearPrivate raises (Form D)Total
2026$80.0M$80.0M
2022$30.0M$30.0M

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. Jul 13, 2026Raised $50 million in a private offering of equity50 Form D: 4 investors so far Form D
  2. May 4, 2026Raised $30 million in a private offering of securities51 Form D: 118 investors so far Form D
  3. Nov 16, 2022Raised $30 million in a private offering of equity81 Form D: 64 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 49. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Bleichroeder LP370,682$11.7M2.1%New
Driehaus Capital Management LLC292,144$9.2M0.1%New
Vanguard Capital Management LLC161,700$5.1M0.0%New
Ikarian Capital, LLC104,364$3.3M0.5%New
Tetragon Partners GP Ltd93,819$3.0M0.5%New
Stempoint Capital LP66,995$2.1M0.4%New
BlackRock, Inc.57,807$1.8M0.0%New
ADAR1 Capital Management, LLC55,193$1.7M0.1%New
Lion Point Capital, LP52,928$1.7M8.0%New
Squadron Capital Management LLC50,000$1.6M0.5%New
Diadema Partners LP48,369$1.5M0.6%New
Geode Capital Management, LLC47,824$1.5M0.0%New
Boothbay Fund Management, LLC31,459$992.8K0.0%New
UBS Group AG26,700$842.7K0.0%New
Citadel Advisors LLC25,633$809.0K0.0%New
Vanguard Fiduciary Trust Co24,476$772.5K0.0%New
Texas Capital Bank Wealth Management Services Inc22,881$722.1K0.0%New
Renaissance Technologies LLC14,689$463.6K0.0%New
Persistent Asset Partners Ltd12,332$389.2K0.1%New
Robertson Stephens Wealth Management, LLC11,133$351.4K0.0%New
Susquehanna International Group, Llp11,003$347.3K0.0%New
Seven Fleet Capital Management LP10,702$337.8K0.1%New
Northern Trust Corp9,122$287.9K0.0%New
Advisory Research Inc8,573$270.6K0.0%New
Stifel Financial Corp8,218$259.4K0.0%New

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

SEC filer profile

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

  • Name on EDGARCue Biopharma, Inc.1
  • CIK0001645460
  • Employer ID (EIN)47-33245775
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company5
  • Incorporated inDelaware5
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address100 Chestnut Street, Suite 300, Somerville, MA 021431
  • Phone617-949-26801
  • Shares outstanding7,264,414 as of Aug 12, 202613
  • Public float$52.0M as of Jun 30, 20255
  • AuditorRSM US LLP, Boston, Massachusetts PCAOB ID 49; no auditor attestation of internal control over financial reporting5
  • On EDGAR sinceJun 19, 20151
  • Filings552 in all: 4 (214), 8-K (82), 3 (36), 10-Q (26), CORRESP (15), UPLOAD (15), SC 13G (13), 424B5 (12)1
    All 45 form types

    DEFA14A (12), DEF 14A (11), S-8 (11), 10-K (9), EFFECT (9), SC 13G/A (9), S-3 (7), 4/A (6), D (6), PRE 14A (6), S-1/A (6), 144 (5), SCHEDULE 13G/A (5), 10-K/A (4), ARS (4), 424B3 (3), 5 (2), 8-K/A (2), CT ORDER (2), POS AM (2), S-1 (2), 10-Q/A (1), 3/A (1), 424B1 (1), 424B7 (1), 8-A12B (1), CERT (1), D/A (1), FWP (1), POSASR (1), S-1MEF (1), S-3/A (1), S-3ASR (1), SC 13D (1), SC 13D/A (1), SCHEDULE 13D (1), SCHEDULE 13G (1)

  • Latest filingsAnnual report (10-K) Mar 16, 2026
    Quarterly report (10-Q) Aug 14, 2026
    Proxy statement (DEF 14A) May 21, 2026
    Latest 8-K (8-K) Sep 21, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.001 per shareCUENasdaq

From the cover page of the 10-K filed Mar 16, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks Cue Biopharma, Inc. names in Item 1A of its 10-K filed Mar 16, 2026: 63 risks under these headings, as written.5

  • Risks Related to Our Business
  • Our recurring losses from operations raise substantial doubt regarding our ability to continue as a going concern.
  • We are a clinical-stage biopharmaceutical company, have no history of generating commercial revenue, have a history of operating losses and may never achieve or maintain profitability.
  • We currently do not have, and may never develop, any FDA-approved or commercialized products.
  • We are substantially dependent on the success of our drug product candidates, and significant additional research and development and clinical testing will be required before we can potentially seek regulatory approval for or commercialize any of our drug product candidates.
  • We have limited experience in conducting clinical trials and no history of commercializing biologic products, which may make it difficult to evaluate the prospects for our future viability.
  • Our current or any future clinical trials or those of our collaborators may reveal significant adverse events, toxicities or other side effects not seen in our preclinical studies and may result in a safety profile that could inhibit or prevent regulatory approval or market acceptance of any of our drug product candidates.
  • Success in preclinical studies or early clinical trials may not be indicative of results obtained in later trials.
  • We plan to continue to seek collaborations or strategic alliances. However, we may not be able to establish such relationships, and relationships we have established may not provide the expected benefits.
  • Our collaboration agreements with each of LG Chem and BI contain exclusivity provisions that restrict our research and development activities.
  • We may not be successful in our efforts to identify additional drug product candidates. Due to our limited resources and access to capital, we must prioritize the development of certain drug product candidates; these decisions may prove to be wrong and may adversely affect our business.
  • We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively. Our competitors may be able to develop other compounds or drugs that are able to achieve similar or better results than our drug product candidates.
The other 52 risks
  • If we lose key management personnel, or if we fail to recruit additional highly skilled personnel, our ability to identify and develop new or next generation drug product candidates will be impaired, could result in loss of markets or market share and could make us less competitive.
  • Our internal computer systems, or those used by third-party CROs, manufacturers or other contractors or consultants, may fail or suffer security breaches.
  • Changes in and uncertainty surrounding U.S. and international trade policies may adversely impact our business and operating results.
  • Changes in tax laws or in their implementation or interpretation could adversely affect our business and financial condition.
  • War, terrorism, other acts of violence, or natural or manmade disasters may affect the markets in which we operate, our patients and resources required in our research and development activities.
  • Risks Related to Our Reliance on Third Parties
  • We rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to successfully complete development of, obtain regulatory approval for, or commercialize our drug product candidates and our business could be substantially harmed.
  • We rely completely on third parties to manufacture our preclinical and clinical drug supplies for our drug product candidates.
  • We rely on certain sole or limited sources of supply for our drug product candidates and disruptions in the chain of supply have in the past, and may in the future, cause delays in developing, obtaining approval for, and commercializing our drug product candidates.
  • Risks Related to Intellectual Property and Other Legal Matters
  • If we or our licensor(s) are unable to protect our or its intellectual property, then our financial condition, results of operations and the value of our technology and potential products could be adversely affected.
  • If we are unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and potential products could be adversely affected.
  • If we fail to comply with our obligations in the agreements under which we license development or commercialization rights to products or technology from third parties, we could lose license rights that are important to our business.
  • If we are unable to patent and protect the intellectual property used in our potential products, others may be able to copy our innovations, which may impair our ability to compete effectively in our markets.
  • Litigation or third-party claims of intellectual property infringement or challenges to the validity of our anticipated patents would require us to use resources to protect our technology and may prevent or delay our development, regulatory approval or commercialization of our drug product candidates.
  • Patent terms may be inadequate to protect our competitive position on our drug product candidates for an adequate amount of time.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our drug product candidates.
  • Risks Related to Government Regulation
  • 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 from obtaining approvals for the commercialization of any of our drug product candidates. If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize, or will be delayed in commercializing, our drug product candidates, and our ability to generate revenue will be materially impaired.
  • We are subject to regulation in respect of our research and federal funding.
  • Failure to obtain marketing approval in foreign jurisdictions would prevent any of our drug product candidates from being marketed in such jurisdictions, which, in turn, would materially impair our ability to generate revenue.
  • We may seek orphan drug designation for one or more of our drug product candidates, but even if such designation is granted, we may be unable to maintain any benefits associated with orphan drug designation, including market exclusivity that prevents the FDA or the EMA from approving other competing products.
  • If approved, our drug product candidates that are licensed and regulated as biologics may face competition from biosimilars approved through an abbreviated regulatory pathway.
  • We may seek fast track designation or breakthrough therapy and priority review programs for our drug product candidates. Even if our drug product candidates receive one or more of these designations, the product candidate may not be subject to a faster review process nor does any such designation assure approval of our drug product candidates.
  • We may seek approval from the FDA or comparable foreign regulatory authorities to use accelerated development pathways for our drug product candidates. If we are not able to use such pathways, we may be required to conduct additional clinical trials beyond those that are contemplated, which would increase the expense of obtaining, and delay the receipt of, necessary marketing approvals, if we receive them at all. In addition, even if an accelerated approval pathway is available to us, it may not lead to expedited approval of our drug product candidates, or approval at all.
  • We may in the future conduct clinical trials for certain of our drug product candidates at sites outside the United States. The FDA may not accept data from trials conducted in such locations and the conduct of trials outside the United States could subject us to additional delays and expense.
  • To obtain the necessary approval of our potential products, as a precondition, we will need to conduct various preclinical and clinical tests, all of which will be costly and time consuming, and may not provide results that will allow us to seek regulatory approval.
  • Even if we, or any collaborators we may have, obtain marketing approvals for any of our drug product candidates, the terms of approvals and ongoing regulation of our products could require the substantial expenditure of resources and may limit how we, or they, manufacture and market our products, which could materially impair our ability to generate revenue.
  • If we receive regulatory approval for any product candidate, we will be subject to ongoing obligations and continuing regulatory review, which may result in significant additional expense. Our drug product candidates, if approved, could be subject to restrictions or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our drug product candidates, when and if approved.
  • Any regulatory approval to market our products will be limited by indication. If we fail to comply or are found to be in violation of FDA regulations restricting the promotion of our products for unapproved uses, we could be subject to criminal penalties, substantial fines or other sanctions and damage awards.
  • Disruptions at the FDA and other government agencies from funding cuts, personnel losses, regulatory reform, government shutdowns and other developments could hinder our ability to obtain guidance from the FDA regarding our clinical development program, progress development efficiently, and secure approval of our product candidates in a timely manner, which would negatively impact our business.
  • 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 criminal sanctions, civil penalties, contractual damages, reputational harm, and diminished profits and future earnings.
  • If commercial third-party payors or government payors fail to provide coverage or adequate reimbursement, our revenue and prospects for profitability would be harmed.
  • Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our drug product candidates and affect the prices we may obtain for any products that are approved in the United States or foreign jurisdictions.
  • The prices of prescription pharmaceuticals in the United States and foreign jurisdictions are subject to considerable legislative and executive actions and could impact the prices we obtain for our products, if approved.
  • Compliance with the HIPAA security, privacy and breach notification regulations may increase our costs.
  • Compliance with global privacy and data security requirements could result in additional costs and liabilities to us or inhibit our ability to collect and process data globally, and the failure to comply with such requirements could subject us to significant fines and penalties, which may have a material adverse effect on our business, financial condition or results of operations.
  • We are subject to stringent federal and state privacy laws, information security laws, regulations, policies, and contractual obligations and failure to comply with such requirements could subject us to significant fines and penalties, which may have a material adverse effect on our business, financial condition or results of operations.
  • Our employees, principal investigators, consultants, and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.
  • Laws and regulations governing any international operations we may have in the future may preclude us from developing, manufacturing and selling certain drug product candidates outside of the United States and require us to develop and implement costly compliance programs.
  • If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
  • Risks Related to Our Financial Results, Our Need for Financing and Owning Our Common Stock
  • We anticipate future losses and negative cash flow, and it is uncertain if or when we will become profitable.
  • We will need substantial additional financing to support our growth and ongoing operations. Additional capital may be difficult to obtain, restrict our operations, require us to relinquish rights to our technologies or drug product candidates, encumber our assets and result in ongoing debt service cost, or result in additional dilution to our stockholders.
  • We are a “smaller reporting company,” and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors.
  • Our stock price can be volatile and fluctuate significantly, and our stockholders may have difficulty selling their shares and/or suffer substantial losses.
  • If we fail to regain compliance with the continued listing requirements of Nasdaq, our common stock may be delisted and the price and liquidity of our common stock and our ability to access the capital markets could be negatively impacted.
  • We may be subject to securities litigation, which is expensive and could divert management attention.
  • If securities or industry analysts do not publish research reports about our business, or if they issue an adverse opinion about our business, the price of our securities and trading volume could decline.
  • We have not paid dividends in the past and have no immediate plans to pay dividends.
  • Our ability to use net operating loss carryforwards and research and development tax credits to reduce future tax payments may be limited or restricted.
  • We incur significant costs as a result of being a public company and our management is required to devote substantial time to meet compliance obligations.
  • Our charter documents and Delaware law may inhibit a takeover that stockholders consider favorable.
  • Our Certificate of Incorporation provides, subject to certain exceptions, that the Court of Chancery of the State of Delaware will be the sole and exclusive forum for certain stockholder litigation matters, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, employees or stockholders.
  • If we are unable to implement and maintain effective internal control over financial reporting, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our securities may decrease.
  • If a significant number of our total outstanding shares are sold into the market, the market price of our common stock could drop significantly, even if our business is performing well.

Legal proceedings

We are not currently a party to any pending legal proceedings that we believe will have a material adverse effect on our business or financial conditions. We may, however, be subject to various claims and legal actions arising in the ordinary course of business from time to time.

The opening of Item 3, Legal Proceedings.5

Sources

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