RNAC on Nasdaq

Selecta Biosciences (United States)

Selecta Biosciences (United States) is an American pharmaceutical preparations company based in Watertown.1 It was founded in 2008.1 Its shares trade on Nasdaq under the symbol RNAC.1

Price unavailable

Last updated Oct 21, 2026.

Overview

Jan 1, 2008Founded1

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  • TickerRNAC on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersWatertown1
  • Websitewww.selectabio.com
  • Incorporated inDE4
  • Business address7495 New Horizon Way, Frederick, Md 217034
  • Filer categoryNon-accelerated filer, Smaller reporting company4
  • Legal formCorporation3
  • LEI529900NMN0LACZOL7C433
  • StatusActive3
  • LEI statusLapsed (not renewed)3
  • Registered addressc/o The Corporation Trust Company, Corporation Trust Center 1209 Orange St, 19801 Wilmington, United States3
  • Registered withDivision of Corporations, Department of State, 44703213

The Company (formerly known as Selecta Biosciences, Inc., or Selecta) was incorporated in Delaware on December 10, 2007, and is headquartered in Frederick, Maryland. On November 13, 2023, the Company and the Delaware corporation which, immediately prior to the Merger (as defined below), was known as Cartesian Therapeutics, Inc., or Old Cartesian, entered into an Agreement and Plan of Merger, or the Merger Agreement, by and among the Company, Sakura Merger Sub I, Inc., a Delaware corporation and a wholly owned subsidiary of the Company, or First Merger Sub, Sakura Merger Sub II, LLC, a Delaware limited liability company and wholly owned subsidiary of the Company, or Second Merger Sub, and Old Cartesian. Pursuant to the Merger Agreement, and simultaneously with execution thereof, (i) First Merger Sub merged with and into Old Cartesian, pursuant to which Old Cartesian was the surviving corp…6 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

-35851.2%Operating margin7
-32575.5%Net margin7
-99.0%Revenue growth, 20257
-$79.4MFree cash flow7

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development86¢$58.0M
  • Income tax14¢$9.2M

Out of $400.0K in revenue.7 The company lost money this year.

Financial statements

Revenue8910117$400.0K in 2025−94% since 2019
0$50.0M$100.0M$150.0M2019: $6.7M$6.7M20192020: $16.6M$16.6M2020+149%2021: $85.1M$85.1M2021+413%2022: $110.8M$110.8M2022+30%2023: $26.0M$26.0M2023−77%2024: $38.3M$38.3M2024+47%2025: $400.0K$400.0K2025−99%
Operating income8910117-$143.4M in 2025+173% since 2019
-$150.0M-$100.0M-$50.0M0$50.0M2019: -$52.5M-$52.5M20192020: -$56.8M-$56.8M2020+8%2021: -$4.6M-$4.6M2021−92%2022: $14.5M$14.5M20222023: -$86.4M-$86.4M20232024: -$43.9M-$43.9M2024−49%2025: -$143.4M-$143.4M2025+227%
Net income8910117-$130.3M in 2025+135% since 2019
-$300.0M-$200.0M-$100.0M0$100.0M2019: -$55.4M-$55.4M20192020: -$68.9M-$68.9M2020+24%2021: -$25.7M-$25.7M2021−63%2022: $35.4M$35.4M20222023: -$219.7M-$219.7M20232024: -$77.4M-$77.4M2024−65%2025: -$130.3M-$130.3M2025+68%

Every line of the income statement as filed: the last 2 fiscal years, latest first.7

Period ending2025-12-312024-12-31
Collaboration and license$400.0K$38.3M
Grant$2.4M$638.0K
Total revenues$2.8M$38.9M
Research and development$58.0M$45.1M
General and administrative$31.5M$30.1M
Impairment of indefinite-lived intangible and long-lived assets$56.7M$7.6M
Total operating expenses$146.2M$82.8M
Operating loss-$143.4M-$43.9M
Interest income$6.6M$7.4M
Gain on change in fair value of warrant liabilities$3.7M$2.6M
Loss on change in fair value of contingent value right liability-$4.4M-$36.9M
Loss on change in fair value of forward contract liabilities$0-$6.9M
Other (expense) income, net-$2.0M$606.0K
Total other income (expense), net$3.9M-$33.2M
Loss before income taxes-$139.5M-$77.1M
Income tax benefit (expense)$9.2M-$287.0K
Net loss-$130.3M-$77.4M
Foreign currency translation adjustment$45.0K-$21.0K
Total comprehensive loss-$130.3M-$77.4M
Basic (in dollars per share)-$5.02-$4.48
Diluted (in dollars per share)-$5.02-$4.49
Basic (in shares)26.0M shares17.3M shares
Diluted (in shares)26.0M shares17.4M shares

Compare Selecta Biosciences (United States) with another company

Corporate structure

Selecta Biosciences (United States) sits at the top of its group. 3 entities, 2 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Selecta Biosciences (United States)

  • Barclays Filed SCHEDULE 13G on Selecta Biosciences (United States), latest Aug 13, 2026
  • JPMorgan Chase Filed SCHEDULE 13G/A on Selecta Biosciences (United States), latest Jul 22, 2026 (2 filings since Apr 25, 2025)
  • FMR LLC Filed SCHEDULE 13G/A on Selecta Biosciences (United States), latest May 6, 2026 (8 filings since Feb 9, 2024)
  • Murat Kalayoglu Filed SCHEDULE 13D/A on Selecta Biosciences (United States), latest Apr 2, 2026 (4 filings since Nov 22, 2023)
  • Squarepoint Ops LLC Filed SCHEDULE 13G on Selecta Biosciences (United States), latest Mar 13, 2026
  • Timothy A. Springer Filed SCHEDULE 13D/A on Selecta Biosciences (United States), latest Jan 15, 2025 (12 filings since Dec 15, 2021)
  • Artal International S.C.A. Filed SC 13G/A on Selecta Biosciences (United States), latest Jul 12, 2024 (3 filings since Jun 12, 2023)
  • Michael Singer Filed SC 13D/A on Selecta Biosciences (United States), latest Apr 10, 2024 (2 filings since Nov 22, 2023)
  • MANGROVE PARTNERS IM, LLC Filed SC 13G/A on Selecta Biosciences (United States), latest Feb 14, 2024 (4 filings since May 24, 2022)
  • BlackRock Filed SC 13G on Selecta Biosciences (United States), latest May 9, 2022 (2 filings since Feb 3, 2022)
  • BIOTECHNOLOGY VALUE FUND L P Filed SC 13G/A on Selecta Biosciences (United States), latest Feb 14, 2022
  • Selecta Biosciences (United States) Watertown, Massachusetts, United States
    • Cartesian Bio, LLC Subsidiary · Delaware, United States
    • Selecta (RUS) LLC Subsidiary · Russia

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 Selecta Biosciences (United States) 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$16.9M7 Dec 31, 2025$12.3M7 Dec 31, 2024+37.9%
Accumulated depreciation$4.7M7 Dec 31, 2025$2.4M7 Dec 31, 2024+100.8%
Property and equipment, net$12.2M7 Dec 31, 2025$9.9M7 Dec 31, 2024+22.9%
Operating-lease assets (leased space)$5.6M7 Dec 31, 2025$5.5M7 Dec 31, 2024+1.2%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$125.1M7 Dec 31, 2025$212.6M7 Dec 31, 2024−41.1%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$48.2M7 Dec 31, 2025$48.2M7 Dec 31, 20240%
Indefinite-lived intangibles (excluding goodwill)$93.9M7 Dec 31, 2025$150.6M7 Dec 31, 2024−37.6%

Properties, in its own words

Our corporate headquarters are currently located at 7495 New Horizon Way, Frederick, Maryland and consists of over 35,000 total square feet of integrated manufacturing and office space under a lease that expires in June 2031. Additionally, we lease approximately 7,909 total square feet of office, laboratory, and manufacturing space in Gaithersburg, Maryland under a lease that expires in January 2027 and 32,294 total square feet of office and laboratory space in Watertown, Massachusetts under a lease that expires in May 2028.

Item 2 of the 10-K filed Mar 9, 2026.6

Leadership

Who has led Selecta Biosciences (United States), and when. Pick a name to see everywhere that person has worked.

Board members and other officers (34)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • DirectorMichael C. Singer named Dec 4, 2023 to Jul 17, 202455
  • DirectorNishan C. de Silva named Dec 4, 2023 to Jul 17, 202455

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Cartesian Bio, LLC Delaware5
  • Selecta (RUS) LLC Russia5

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

Former names

  • SELECTA BIOSCIENCES INCJan 5, 2009 to Nov 13, 20234

Timeline

  1. Sep 29, 20268-K Regulation FD disclosure; Other events56
  2. Aug 6, 20268-K Results of operations57
  3. Jun 17, 20268-K Shareholder vote58
  4. Jun 9, 20268-K Regulation FD disclosure59
  5. May 26, 20268-K Entered a material agreement; New debt or obligation; Unregistered sale of shares60
  6. Apr 30, 20268-K Results of operations61
  7. Mar 30, 20268-K Executive or director change62
  8. Mar 9, 20268-K Results of operations63
  9. Jan 9, 20268-K Regulation FD disclosure64
  10. Dec 18, 20258-K Executive or director change; Code of ethics changed; Regulation FD disclosure65
  11. Nov 13, 20258-K Regulation FD disclosure; Other events66
  12. Nov 6, 20258-K Results of operations67
  13. Dec 3, 2018New chief executive Carsten Brunn becomes CEO15
  14. Jun 21, 2016New chief executive Werner Cautreels becomes CEO16
  15. Jan 1, 2008Founded Founded1

Calendar

Coming up

  1. Nov 5, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($1.38) a share, on Nov 6, 2025.68

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results57
  2. Apr 30, 2026Reported quarterly or annual results61
  3. Mar 9, 2026Reported quarterly or annual results63
  4. Nov 6, 2025Reported quarterly or annual results67
  5. Aug 7, 2025Reported quarterly or annual results69
  6. May 8, 2025Reported quarterly or annual results70
  7. Mar 13, 2025Reported quarterly or annual results71
  8. Nov 7, 2024Reported quarterly or annual results72

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

Filings

418 filings to the SEC since October 2021: 6 annual reports, 15 quarterly reports, 84 major events, 187 insider forms, 40 large holders, 3 private raises, 83 other. The latest 20:

  1. Sep 29, 20268-K EDGAR
  2. Aug 13, 2026SCHEDULE 13G EDGAR
  3. Aug 6, 202610-Q EDGAR
  4. Aug 6, 20268-K EDGAR
  5. Jul 22, 2026SCHEDULE 13G/A EDGAR
  6. Jun 17, 20268-K EDGAR
  7. Jun 9, 2026144 EDGAR
  8. Jun 9, 20268-K EDGAR
  9. Jun 2, 2026144 EDGAR
  10. May 26, 20268-K EDGAR
  11. May 6, 2026SCHEDULE 13G/A EDGAR
  12. Apr 30, 2026S-8 EDGAR
  13. Apr 30, 202610-Q EDGAR
  14. Apr 30, 20268-K EDGAR
  15. Apr 28, 2026DEF 14A EDGAR
  16. Apr 28, 2026DEFA14A EDGAR
  17. Apr 6, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  18. Apr 6, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  19. Apr 2, 2026SCHEDULE 13D/A EDGAR
  20. Mar 30, 20268-K EDGAR

The 418 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

97 open-market trades by officers, directors and large owners since October 2021: 43 buys and 54 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jan 6, 2026Brunn CarstenPresident and CEOSale23,766$6.82$162.1KForm 4
Jan 6, 2026Miljkovic MilosChief Medical OfficerSale3,573$6.82$24.4KForm 4
Jan 6, 2026Davis BlaineChief Financial OfficerSale10,591$6.82$72.2KForm 4
Dec 4, 2025BARABE TIMOTHY CDirectorBuy30,000$6.86$205.8KForm 4
Apr 11, 2025SPRINGER TIMOTHY ADirectorBuy42,750$10.77$460.4KForm 4
Apr 10, 2025SPRINGER TIMOTHY ADirectorBuy57,170$10.46$598.3KForm 4
Apr 9, 2025SPRINGER TIMOTHY ADirectorBuy49,155$9.43$463.6KForm 4
Mar 20, 2025SPRINGER TIMOTHY ADirectorBuy54,889$15.59$855.7KForm 4
Mar 19, 2025SPRINGER TIMOTHY ADirectorBuy20,234$14.97$302.9KForm 4
Mar 18, 2025SPRINGER TIMOTHY ADirectorBuy14,740$14.42$212.6KForm 4
Jan 14, 2025SPRINGER TIMOTHY ADirectorBuy4,022$18.00$72.4KForm 4
Jan 13, 2025SPRINGER TIMOTHY ADirectorBuy16,945$17.35$294.0KForm 4
Jan 6, 2025Kurtoglu MetinChief Technology OfficerSale2,458$16.83$41.4KForm 4
Jan 6, 2025Miljkovic MilosChief Medical OfficerSale948$16.83$16.0KForm 4
Jan 6, 2025Jewell Christopher MChief Scientific OfficerSale1,286$16.83$21.6KForm 4
Jan 6, 2025English EmilyChief Operations OfficerSale906$16.83$15.2KForm 4
Jan 6, 2025Brunn CarstenPresident and CEOSale8,708$16.83$146.6KForm 4
Jan 6, 2025Davis BlaineChief Financial OfficerSale4,028$16.83$67.8KForm 4
Jan 3, 2025Kurtoglu MetinChief Technology OfficerSale2,417$16.72$40.4KForm 4
Jan 3, 2025Miljkovic MilosChief Medical OfficerSale932$16.72$15.6KForm 4

All 97 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
2025Carsten BrunnPh.D.$674.0K$4.3M84
2025Metin KurtogluM.D., Ph.D.$163.5K$2.5M84
2025Christopher JewellPh.D.$390.7K$2.0M84
2025Blaine Davis52$475.9K$1.9M84
2025Milos MiljkovicM.D.42$439.0K$1.7M84
2024President and Chief Executive Officer$642.7K$7.3M84
2024Chief Financial Officer$462.0K$4.0M84
2024Former Chief Technology Officer$431.5K$2.7M84
2024Former Chief Scientific Officer$411.9K$1.7M84
2024Chief Medical Officer$392.3K$1.3M84

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$190.3M 2023–2024
Money received by yearMoney received by year, 2023–2024: $190.3M in all. Private raises (Form D) $190.3M.$0$50M$100M$150M2023 · Private raises (Form D): $60.2M20232024 · Private raises (Form D): $130.0M2024
Figures by year
YearPrivate raises (Form D)Total
2024$130.0M$130.0M
2023$60.2M$60.2M

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 2, 2024Raised $130 million in a private offering of equity55 Form D: 22 investors so far Form D
  2. Nov 13, 2023Raised $60.2 million in a private offering of securities85 Form D: 2 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 94. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Squarepoint Ops LLC2,254,619$23.5M0.0%+16,133
BlackRock, Inc.819,239$8.5M0.0%+220,131
683 Capital Management, LLC650,000$6.8M0.7%+320,000
Vanguard Capital Management LLC555,823$5.8M0.0%+148,226
Fmr LLC368,429$3.8M0.0%−431,314
Geode Capital Management, LLC356,525$3.7M0.0%+92,831
Aqr Capital Management LLC356,456$3.7M0.0%+272,436
Millennium Management LLC309,887$3.2M0.0%+25,570
Two Sigma Investments, LP296,293$3.1M0.0%+128,980
State Street Corp249,212$2.6M0.0%+48,875
Marshall Wace, Llp232,919$2.4M0.0%−18,196
UBS Group AG208,647$2.2M0.0%+71,807
Jupiter Topco LLC200,905$2.1M0.0%New
Privium Fund Management B.V.151,675$1.6M0.3%−27,439
Northern Trust Corp105,698$1.1M0.0%+13,706
ADAR1 Capital Management, LLC98,877$1.0M0.0%New
Vanguard Fiduciary Trust Co91,854$957.1K0.0%+21,558
Vanguard Portfolio Management LLC87,317$909.8K0.0%+26,734
Diadema Partners LP87,057$907.1K0.3%New
Bank Of America Corp /de/84,624$881.8K0.0%New
Walleye Capital LLC81,828$852.6K0.0%New
Goldman Sachs Group Inc80,572$839.6K0.0%+49,645
Jump Financial, LLC66,800$696.1K0.0%New
Bnp Paribas Financial Markets63,977$666.6K0.0%+54,027
Nuveen, LLC63,454$661.2K0.0%+26,003

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

SEC filer profile

How Selecta Biosciences (United States) is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARCartesian Therapeutics, Inc.2
  • CIK0001453687
  • Employer ID (EIN)26-16221106
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company6
  • Incorporated inDelaware6
  • Fiscal year endsDecember 312
  • Industry code (SIC)2834 Pharmaceutical Preparations2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address7495 New Horizon Way, Frederick, MD 217032
  • Phone301-348-86982
  • Shares outstanding30,255,352 as of Jul 31, 202613
  • Public float$108.7M as of Jun 30, 20256
  • AuditorErnst & Young LLP, Boston, Massachusetts PCAOB ID 42; no auditor attestation of internal control over financial reporting6
  • On EDGAR sinceJan 5, 20092
  • Filings874 in all: 4 (356), 8-K (172), 3 (50), 10-Q (31), SC 13D/A (29), CORRESP (19), SC 13G (19), 144 (17)2
    All 46 form types

    SC 13G/A (16), D (15), DEF 14A (13), DEFA14A (13), EFFECT (12), S-8 (12), UPLOAD (12), 10-K (10), CT ORDER (9), S-3 (8), SC 13D (5), SCHEDULE 13G/A (5), 4/A (4), 424B5 (4), DRS/A (4), PRE 14A (4), S-1/A (4), 424B7 (3), 8-K/A (3), SCHEDULE 13D/A (3), SCHEDULE 13G (3), POS AM (2), S-1 (2), 10-K/A (1), 424B3 (1), 424B4 (1), 8-A12B (1), 8-A12G (1), CERTNAS (1), D/A (1), DEFR14A (1), DRS (1), DRSLTR (1), FWP (1), NT 10-Q (1), REGDEX (1), S-1MEF (1), S-3/A (1)

  • Latest filingsAnnual report (10-K) Mar 9, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Apr 28, 2026
    Latest 8-K (8-K) Sep 29, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.0001 par value per shareRNACThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Mar 9, 2026 (Section 12(b) of the Exchange Act).6

Risk factors and legal proceedings

The risks Selecta Biosciences (United States) names in Item 1A of its 10-K filed Mar 9, 2026: 45 risks under these headings, as written.6

  • Risks Related to the Development of our Product Candidates
  • We develop our mRNA-based product candidates by leveraging our proprietary technology and our manufacturing platform, which is an unproven approach to the treatment of autoimmune disease. We may not be successful in our efforts to build a pipeline of product candidates and develop marketable drugs.
  • Clinical drug development is inherently risky and involves a lengthy and expensive process which is subject to a number of factors, many of which are outside of our control. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
  • If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.
  • We may conduct clinical trials for product candidates at sites outside the United States, and the FDA may not accept data from trials conducted in such locations or the complexity of regulatory burdens may otherwise adversely impact us.
  • We may not be able to qualify for or obtain various designations from regulators that would have the potential to expedite the review process of one or more of our product candidates and even if we do receive one or more such designations there is no guarantee that they will ultimately expedite the process, or aid in our obtaining marketing approval or provide market exclusivity.
  • Interim, top-line and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any.
  • Inadequate funding for the FDA and other government agencies and/or potentially shifting priorities under the new presidential administration could hinder the FDA’s and/or those other government agencies’ ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner, or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • Risks Related to our Financial Position and Need for Additional Capital
  • We are a development-stage company, and we expect to incur losses for the foreseeable future and may never achieve or maintain profitability.
  • We will need substantial additional funding in order to complete development of our product candidates and commercialize our products, if approved. If we are unable to raise capital when needed and on terms favorable to us, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.
The other 35 risks
  • Our ability to use our net operating loss and research and development tax credit carryforwards to offset future taxable income may be subject to certain limitations.
  • We have recorded a material amount of goodwill and indefinite-lived intangible assets in connection with the Merger. We have, and may in the future, record impairment charges, which would adversely impact our financial position and results of operations.
  • We have incurred substantial expenses related to the integration of Old Cartesian.
  • Risks Related to Manufacturing and our Dependence on Third-Parties
  • We expect to continue to grow our manufacturing capabilities and resources and we must incur significant costs to develop this expertise and/or rely on third-parties to manufacture our products.
  • We rely, and expect to continue to rely, on third-parties to conduct our clinical trials, and those third-parties may not perform satisfactorily, including by failing to meet deadlines for the completion of such trials.
  • Risks Related to Commercialization of our Product Candidates and Legal Compliance Matters
  • Even if any of our product candidates receives marketing approval, it 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.
  • We currently have no sales organization. If we are unable to establish effective sales, marketing and distribution capabilities, or enter into agreements with third-parties with such capabilities, we may not be successful in commercializing our product candidates if and when they are approved.
  • We face substantial competition, including from biosimilars, which may result in others discovering, developing or commercializing competing products before or more successfully than we do.
  • We expect the product candidates we develop will be regulated as biological products, or biologics, and therefore they may be subject to competition sooner than anticipated.
  • Even if we are able to commercialize any of our product candidates, the products may become subject to unfavorable pricing regulations or third-party coverage or reimbursement policies, any of which would have a material adverse effect on our business.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and limit commercialization of any products that we may develop.
  • Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and affect the prices we may obtain.
  • Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.
  • We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic and international markets. We can face criminal liability and other serious consequences for violations, which can have a material adverse effect on our business.
  • If we or third-parties we rely upon 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.
  • Risks Related to our Intellectual Property
  • If we or our licensors are unable to adequately protect our proprietary technology, or obtain and maintain issued patents that are sufficient to protect our product candidates, others could compete against us more directly, which would negatively impact our business.
  • If we are unable to protect the confidentiality of our trade secrets and know-how, our business and competitive position would be harmed.
  • Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
  • 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 material adverse effect on the success of our business.
  • We may become involved in lawsuits to protect or enforce our patents or other intellectual property, and our issued patents covering our product candidates could be found invalid or unenforceable or could be interpreted narrowly if challenged in court.
  • The lives of our patents may not be sufficient to effectively protect our products and business.
  • Obtaining and maintaining our patent protection depends on 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 noncompliance with these requirements.
  • We may not be successful in obtaining or maintaining necessary rights to our product candidates through acquisitions and in-licenses.
  • We may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
  • We will not seek to protect our intellectual property rights in all jurisdictions throughout the world, and we may not be able to adequately enforce our intellectual property rights even in the jurisdictions where we seek protection.
  • If we do not obtain additional protection under the Hatch-Waxman Act and similar foreign legislation extending the terms of our patents for our product candidates, our business may be harmed.
  • Risks Related to our Operations
  • Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
  • We have incurred increased costs as a result of operating as a public company, and our management will be required to devote substantial time to compliance initiatives and corporate governance practices.
  • A variety of risks associated with winding down operations of our subsidiary in Russia or expanding operations internationally could adversely affect our business.
  • Our business and operations, including our development programs, could be materially disrupted in the event of system failures, security breaches, violations of data protection laws or data loss or damage by us or third-parties on which we rely, including our CROs or other contractors or consultants.
  • Acquisitions or joint ventures could disrupt our business, cause dilution to our stockholders and otherwise harm our business.
  • Risks Related to our Common Stock
  • The market price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for purchasers of our common stock.
  • Our executive officers, directors, and principal stockholders, if they choose to act together, will continue to have the ability to control or significantly influence all matters submitted to stockholders for approval.
  • Anti-takeover provisions in our charter documents and under Delaware law and the terms of some of our contracts could make an acquisition of us more difficult and may prevent attempts by our stockholders to replace or remove our management.
  • We have been in the past and may in the future be subject to stockholder litigation.

Sources

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