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ABEO on Nasdaq

ABEONA THERAPEUTICS INC.

ABEONA THERAPEUTICS INC. is an American pharmaceutical preparations company based in Dallas, active since 1989.2

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Last updated Oct 21, 2026.

Overview

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  • TickerABEO on Nasdaq2
  • IndustryPharmaceutical Preparations2
  • HeadquartersDallas, United States2
  • Incorporated inDE3
  • Business address6555 Carnegie Ave, 4Th Floor, Cleveland, Oh 441033
  • Filer categoryNon-accelerated filer, Smaller reporting company3
  • Legal formCorporation2
  • LEI54930002Z8PIJRCB45762
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressC/O THE CORPORATION TRUST COMPANY, 19801 Wilmington, United States2
  • Registered withDivision of Corporations, Department of State, 22001722

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ZEVASKYN ® and Advancing and Commercializing our Cell and Gene Therapy Programs.4 From its latest annual report

Financials

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

Key numbers, fiscal 2025

-1536.9%Operating margin5
1223.1%Net margin5
44.7%Return on equity5
0.05×Debt to equity5
-$84.3MFree cash flow5

What sells

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

Products and services

License brought in 58% of the revenue ABEONA THERAPEUTICS INC. broke down this way in fiscal 2025.

  1. License$3.4M558%
  2. Product$2.4M542%
Products and services by year
Products and services2025
License$3.4M
Product$2.4M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue1¢$1.5M
  • Research and development16¢$26.8M
  • Selling, general and admin39¢$65.0M
  • Interest2¢$3.7M
  • Income tax0¢$100.0K
  • Profit42¢$71.2M

Out of $5.8M in revenue.5

Financial statements

Revenue67895$5.8M in 2025−42% since 2020
0$2.5M$5.0M$7.5M$10.0M2020: $10.0M$10.0M20202021: $3.0M$3.0M2021−70%2022: $1.4M$1.4M2022−53%2023: $3.5M$3.5M2023+148%2025: $5.8M$5.8M2025+66%
Operating income1067895-$89.4M in 2025+16% since 2019
-$100.0M-$75.0M-$50.0M-$25.0M02019: -$77.1M-$77.1M20192020: -$81.4M-$81.4M2020+6%2021: -$89.8M-$89.8M2021+10%2022: -$50.9M-$50.9M2022−43%2023: -$47.1M-$47.1M2023−7%2024: -$64.2M-$64.2M2024+36%2025: -$89.4M-$89.4M2025+39%
Net income1067895$71.2M in 2025
-$100.0M-$50.0M0$50.0M$100.0M2019: -$76.3M-$76.3M20192020: -$84.2M-$84.2M2020+10%2021: -$84.9M-$84.9M2021+1%2022: -$39.7M-$39.7M2022−53%2023: -$54.2M-$54.2M2023+37%2024: -$63.7M-$63.7M2024+18%2025: $71.2M$71.2M2025

Every line of the income statement as filed: the last 2 fiscal years, latest first.5

Period ending2025-12-312024-12-31
Total revenues$5.8M
Cost of sales$1.5M
Royalties$1.9M
Research and development$26.8M$34.4M
Selling, general and administrative$65.0M$29.9M
Total costs and expenses$95.3M$64.2M
Loss from operations-$89.4M-$64.2M
Interest income$5.6M$4.2M
Interest expense-$3.7M-$4.2M
Change in fair value of warrant and derivative liabilities$6.1M-$755.0K
Gain from sale of priority review voucher, net$152.4M
Other income, net$410.0K$1.2M
Income (loss) before income taxes$71.3M-$63.7M
Income tax (benefit) expense$100.0K
Net income (loss)$71.2M-$63.7M
Basic income (loss) per common share$1.34-$1.55
Dilutive income (loss) per common share$1.01-$1.55
Basic53.0M shares41.0M shares
Dilutive66.1M shares41.0M shares
Change in unrealized gains related to available-for-sale debt securities$130.0K$74.0K
Comprehensive income (loss)$71.3M-$63.7M

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Corporate structure

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

Major holders of ABEONA THERAPEUTICS INC.

  • ABEONA THERAPEUTICS INC. Dallas, Texas, United States

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What ABEONA 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$27.1M5 Dec 31, 2025$19.4M5 Dec 31, 2024+39.8%
Accumulated depreciation$17.2M5 Dec 31, 2025$15.0M5 Dec 31, 2024+14.9%
Property and equipment, net$9.9M5 Dec 31, 2025$4.4M5 Dec 31, 2024+124.0%
Operating-lease assets (leased space)$4.0M5 Dec 31, 2025$3.6M5 Dec 31, 2024+11.5%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$78.4M5 Dec 31, 2025$23.4M5 Dec 31, 2024+235.8%
Marketable securities, current$113.0M5 Dec 31, 2025$74.4M5 Dec 31, 2024+51.9%
Debt securities available for sale$113.0M5 Dec 31, 2025$74.4M5 Dec 31, 2024+51.9%

Inventory

ItemLatestA year beforeChange
Inventory, total$5.5M5 Dec 31, 2025$013 Dec 31, 2013
Raw materials$5.5M5 Dec 31, 2025

Properties, in its own words

Our corporate headquarters are located in Cleveland, Ohio, where we currently lease approximately 73,100 square feet of manufacturing, laboratory and office space. Those leases expire in December 2030. We leased 10,400 square feet of office space located in New York, New York. That lease expired in September 2025.

We believe that our facilities are sufficient to meet our current needs and that suitable space will be available as and when needed for potential future expansion.

Item 2 of the 10-K filed Mar 17, 2026.4

Leadership

Who has led ABEONA THERAPEUTICS INC., and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Stephen R. Seiler2007
  2. B. Davis Jeffrey2008–2014
  3. Carsten Thiel2018
  4. Joao Siffert Md.2019–2020
  5. Michael Amoroso2021
  6. Vishwas Seshadri2021–now

Chair

  1. Steven H. Rouhandeh2015–2020
  2. Brian Jg Pereira2020

President

  1. Stephen R. Seiler2007

Chief financial officer

  1. Christine Berni Silverstein2019–2020
  2. Joseph Walter Vazzano2022–now

Chief operating officer

  1. B. Davis Jeffrey2015–2017
  2. Michael Amoroso2020–2021
2010201520202025
Board members and other officers (29)

Former names

  • PLASMATECH BIOPHARMACEUTICALS INCSep 22, 2014 to Jun 4, 20153
  • ACCESS PHARMACEUTICALS INCApr 1, 1996 to Aug 14, 20143
  • CHEMEX PHARMACEUTICALS INCNov 14, 1995 to Feb 5, 19963

Timeline

  1. Sep 15, 20268-K Regulation FD disclosure51
  2. Aug 13, 20268-K Results of operations52
  3. Jun 12, 20268-K Executive or director change53
  4. Jun 12, 20268-K Shareholder vote54
  5. Jun 10, 20268-K Regulation FD disclosure55
  6. Jun 4, 20268-K Other events56
  7. May 13, 20268-K Results of operations57
  8. Apr 7, 20268-K Executive or director change; Regulation FD disclosure58
  9. Mar 20, 20268-K Bylaws or fiscal year changed59
  10. Mar 17, 20268-K Results of operations60
  11. Mar 9, 20268-K Other events61
  12. Nov 12, 20258-K Results of operations62
  13. Oct 18, 2021New chief executive Vishwas Seshadri becomes CEO15
  14. Mar 23, 2021New chief executive Michael Amoroso becomes CEO14
  15. Apr 11, 2019New chief executive Joao Siffert Md. becomes CEO16
  16. Apr 2, 2018New chief executive Carsten Thiel becomes CEO17
  17. Jan 8, 2008New chief executive B. Davis Jeffrey becomes CEO18
  18. Jan 8, 2007New chief executive Stephen R. Seiler becomes CEO19
  19. Jun 22, 1989Founded ABEONA THERAPEUTICS INC. is founded2

Calendar

Coming up

  1. Nov 11, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.10) a share, on Nov 12, 2025.63

When it reported results

  1. Aug 13, 2026Reported quarterly or annual results52
  2. May 13, 2026Reported quarterly or annual results57
  3. Mar 17, 2026Reported quarterly or annual results60
  4. Nov 12, 2025Reported quarterly or annual results62
  5. Aug 14, 2025Reported quarterly or annual results64
  6. Jul 2, 2025Reported quarterly or annual results65
  7. May 15, 2025Reported quarterly or annual results66
  8. Mar 20, 2025Reported quarterly or annual results67

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

Filings

422 filings to the SEC since October 2021: 6 annual reports, 15 quarterly reports, 66 major events, 192 insider forms, 44 large holders, 99 other. The latest 20:

  1. Sep 29, 2026144 EDGAR
  2. Sep 29, 2026144 EDGAR
  3. Sep 29, 2026144 EDGAR
  4. Sep 29, 2026144 EDGAR
  5. Sep 29, 20264 EDGAR
  6. Sep 29, 20264 EDGAR
  7. Sep 29, 20264 EDGAR
  8. Sep 29, 20264 EDGAR
  9. Sep 15, 20268-K EDGAR
  10. Sep 1, 2026144 EDGAR
  11. Sep 1, 20264 EDGAR
  12. Aug 14, 2026SCHEDULE 13G/A EDGAR
  13. Aug 13, 202610-Q EDGAR
  14. Aug 13, 20268-K EDGAR
  15. Jul 22, 20264 EDGAR
  16. Jul 10, 2026424B3 EDGAR
  17. Jul 9, 2026144 EDGAR
  18. Jul 9, 2026144 EDGAR
  19. Jul 9, 2026144 EDGAR
  20. Jul 9, 2026144 EDGAR

The 422 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

95 open-market trades by officers, directors and large owners since October 2021: 12 buys and 83 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 29, 2026Seshadri VishwasChief Executive OfficerSale19,608$5.16$101.2KForm 4
Sep 29, 2026Vazzano Joseph WalterChief Financial OfficerSale9,191$5.16$47.4KForm 4
Sep 29, 2026O'Malley Brendan M.SVP, Chief Legal OfficerSale6,727$5.16$34.7KForm 4
Sep 29, 2026Vasanthavada MadhavChief Commercial OfficerSale4,902$5.16$25.3KForm 4
Sep 1, 2026Alvino MarkDirectorSale15,000$5.86$87.9KForm 4
Jul 21, 2026Vazzano Joseph WalterChief Financial OfficerSale1,478$6.53$9.7KForm 4
Jul 9, 2026Vazzano Joseph WalterChief Financial OfficerSale24,880$6.96$173.2KForm 4
Jul 9, 2026Seshadri VishwasChief Executive OfficerSale67,971$6.96$473.1KForm 4
Jul 9, 2026O'Malley Brendan M.SVP, Chief Legal OfficerSale12,050$6.96$83.9KForm 4
Jul 9, 2026Vasanthavada MadhavChief Commercial OfficerSale12,606$6.96$87.7KForm 4
Jun 30, 2026Alland LeilaDirectorSale11,000$5.92$65.1KForm 4
Jun 15, 2026Silverstein Christine BerniDirectorSale18,160$5.71$103.7KForm 4
Jun 9, 2026Vazzano Joseph WalterChief Financial OfficerSale39,067$5.36$209.4KForm 4
Jun 9, 2026Vasanthavada MadhavChief Commercial OfficerSale5,450$5.30$28.9KForm 4
Jun 9, 2026Seshadri VishwasChief Executive OfficerSale31,916$5.30$169.2KForm 4
Jun 9, 2026O'Malley Brendan M.SVP, Chief Legal OfficerSale6,305$5.30$33.4KForm 4
Jun 8, 2026Vazzano Joseph WalterChief Financial OfficerSale10,271$5.43$55.8KForm 4
Jun 8, 2026Vasanthavada MadhavChief Commercial OfficerSale4,170$5.43$22.6KForm 4
Jun 8, 2026Seshadri VishwasChief Executive OfficerSale24,428$5.43$132.6KForm 4
Jun 8, 2026O'Malley Brendan M.SVP, Chief Legal OfficerSale4,826$5.43$26.2KForm 4

All 95 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
2025Vishwas SeshadriPresident and Chief Executive Officer$662.0K$4.0M85
2025Joseph VazzanoChief Financial Officer42$475.9K$1.7M85
2025Brendan O’MalleyChief Legal Officer$456.4K$1.4M85
2024Vishwas SeshadriPresident and Chief Executive Officer$615.4K$3.5M85
2024Joseph VazzanoChief Financial Officer42$456.9K$1.6M85
2024Brendan O’MalleyChief Legal Officer$438.2K$1.3M85

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Nantahala Capital Management, LLC10,272,980$63.5M1.9%+5,259,928
BlackRock, Inc.3,352,474$20.7M0.0%+156,944
Cable Car Capital, LP3,007,329$18.6M0.4%No change
AIGH Capital Management LLC2,987,000$18.5M1.7%−113,000
Vanguard Capital Management LLC2,211,433$13.7M0.0%+46,582
OneDigital Investment Advisors LLC1,653,024$10.2M0.1%New
AWM Investment Company, Inc.1,486,130$9.2M0.8%+683,000
Geode Capital Management, LLC1,261,090$7.8M0.0%+51,293
Kennedy Capital Management LLC1,240,071$7.7M0.1%−23,440
Goldman Sachs Group Inc1,224,806$7.6M0.0%+94,187
State Street Corp1,040,228$6.4M0.0%+82,900
Propel Bio Management, LLC983,070$6.1M3.2%−346,829
Nan Fung Trinity (hk) Ltd956,770$5.9M0.6%No change
Diametric Capital, LP755,021$4.7M0.5%+143,501
J. Goldman & Co LP678,173$4.2M0.1%+37,643
Silverarc Capital Management, LLC610,407$3.8M0.4%−38,535
Rubric Capital Management LP608,771$3.8M0.0%New
Stonepine Capital Management, LLC557,284$3.4M2.6%−189,303
Northern Trust Corp552,630$3.4M0.0%+116,657
Citigroup Inc548,300$3.4M0.0%+25,855
National Bank Of Canada /fi/500,000$3.1M0.0%No change
Montanova Capital, LLC500,000$3.1M0.1%−2,176,000
Knoll Capital Management, LLC485,515$3.0M1.7%No change
Panagora Asset Management Inc409,075$2.5M0.0%+209,930
Bank Of America Corp /de/372,406$2.3M0.0%−21,868

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

SEC filer profile

How ABEONA 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 EDGARABEONA THERAPEUTICS INC.1
  • CIK0000318306
  • Employer ID (EIN)83-02215174
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; 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 address6555 Carnegie Ave, 4Th Floor, Cleveland, OH 441031
  • Phone646-813-47011
  • Shares outstanding57,184,017 as of Aug 10, 202612
  • Public float$273.3M as of Jun 30, 20254
  • AuditorDeloitte & Touche LLP, Morristown, New Jersey PCAOB ID 34; it also attests to the company’s internal control over financial reporting4
  • On EDGAR sinceAug 15, 19951
  • Filings1,313 in all: 4 (349), 8-K (264), 10-Q (91), 144 (57), SC 13G/A (54), CORRESP (44), 3 (36), DEF 14A (33)1
    All 64 form types

    10-K (30), SC 13G (29), UPLOAD (27), S-1/A (20), SC 13D/A (20), 424B5 (19), EFFECT (19), S-8 (18), 8-K/A (12), SCHEDULE 13G/A (12), 10-Q/A (11), PRE 14A (11), S-3 (11), S-3/A (10), 4/A (8), POS AM (8), S-1 (8), SC 13D (8), ARS (7), NT 10-Q (7), SCHEDULE 13G (7), 424B1 (6), AW (5), 10-K/A (4), 425 (4), CT ORDER (4), D (4), DEFA14A (4), REGDEX (4), SB-2 (4), 424B3 (3), DEFS14A (3), S-4 (3), S-4/A (3), SB-2/A (3), 10QSB (2), 424B4 (2), 8-A12B (2), DEFR14A (2), NT 10-K (2), PRE 14C (2), RW (2), SEC STAFF LETTER (2), 10KSB (1), 25-NSE (1), 8-A12G (1), CERTNAS (1), DEF 14C (1), NO ACT (1), NTN 10Q (1), PRER14A (1), PRES14A (1), PX14A6G (1), REGDEX/A (1), S-3DPOS (1), S-3MEF (1)

  • Latest filingsAnnual report (10-K) Mar 17, 2026
    Quarterly report (10-Q) Aug 13, 2026
    Proxy statement (DEF 14A) Apr 27, 2026
    Latest 8-K (8-K) Sep 15, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.01 par valueABEONasdaq

From the cover page of the 10-K filed Mar 17, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks ABEONA THERAPEUTICS INC. names in Item 1A of its 10-K filed Mar 17, 2026: 59 risks under these headings, as written.4

  • Risks Related to the Commercialization of ZEVASKYN® and our Ability to Generate Revenue
  • We are in the early stages of commercializing ZEVASKYN® and our limited operating history as a commercial-stage company makes it difficult to predict the long-term success of our business.
  • Our financial performance depends on the commercial success of ZEVASKYN® and we have limited experience as a commercial-stage company. As such, we may not be able to successfully commercialize ZEVASKYN® and the revenue that we generate from its sales, if any, may be limited.
  • The commercial success of ZEVASKYN® will depend upon the extent of market acceptance by physicians, patients, payors, and other stakeholders.
  • Our revenues currently depend on sales of ZEVASKYN®, which increases our exposure to risks associated with a single product.
  • We may encounter challenges with engaging or coordinating with qualified treatment centers needed for the ongoing commercialization of ZEVASKYN®.
  • The manufacturing, testing and delivery of ZEVASKYN® present significant challenges for us, and we may not be able to produce ZEVASKYN® at the quality, quantities, or timing needed to support commercialization.
  • We rely on third-party suppliers for our manufacturing of ZEVASKYN®, and supply interruptions could disrupt commercialization.
  • Post-marketing requirements and ongoing regulatory obligations could restrict or delay commercialization.
  • Our commercialization efforts may expose us to increased risk of product liability and other litigation.
  • Our commercial success depends in part on our ability to protect and enforce our intellectual property rights relating to ZEVASKYN®.
  • Our products and product candidates may face competition sooner than anticipated.
The other 48 risks
  • Risks related to manufacturing
  • We could experience production problems in our manufacturing facilities that result in delays in our development or commercialization programs or otherwise adversely affect our business.
  • If we or any of our vendors, contract laboratories or suppliers are found to be out of compliance with cGMP or other regulations, we may experience delays or disruptions in manufacturing while we implement corrective actions or work with these third parties to remedy the violation or while we work to identify suitable replacement vendors, contract laboratories or suppliers.
  • We and our third-party suppliers, laboratories, and manufacturers may be unable to comply with our specifications, cGMP requirements and with other FDA, state, and foreign regulatory requirements.
  • If any inspection or audit by regulatory authorities identifies a failure to comply with applicable regulations, or if a violation of product specifications or applicable regulations occurs independent of such an inspection or audit, the relevant regulatory authority may require remedial measures that may be costly or time-consuming to implement and that may include the temporary or permanent suspension of a clinical trial or commercial sales or the temporary or permanent closure of a manufacturing facility.
  • If we, our collaborators, or any third-party manufacturers we engage fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business.
  • We may be unable to successfully develop, market, or commercialize our products or our product candidates without establishing new relationships and maintaining current relationships and our ability to successfully commercialize, and market our product candidates could be limited if a number of these existing relationships are terminated.
  • We are subject to extensive governmental regulation, which increases our cost of doing business and may affect our ability to commercialize any new products that we may develop.
  • We may incur substantial product liability expenses due to the use or misuse of our products for which we may be unable to obtain insurance coverage.
  • Intense competition may limit our ability to successfully develop and market commercial products.
  • Healthcare reform measures could hinder or prevent our product candidates’ commercial success.
  • We may be subject, directly or indirectly, to federal, state, and foreign healthcare laws and regulations, including fraud and abuse laws, false claims laws and health information privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
  • We are subject to extensive laws and regulations related to data privacy, and our failure to comply with these laws and regulations could harm our business.
  • Trends toward managed health care, health technology assessment, and downward price pressures on medical products and services may limit our ability to profitably sell any drugs that we may develop.
  • Changes in and uncertainty surrounding U.S. trade policy could have a material adverse impact on our business, financial condition, cash flow, and results of operations.
  • Risks related to the discovery and development of our product candidates
  • Our cell and gene therapy product candidates are based on proprietary methodologies, which makes it difficult to predict the time and cost of product candidate development and subsequently obtaining regulatory approval. Only a few gene therapy products have been approved in the U.S. and the EU.
  • Our ability to successfully develop and commercialize our product candidates will substantially depend upon the availability of reimbursement funds for the costs of the resulting drugs and related treatments.
  • Our drug candidates are subject to the risks of failure inherent in the development of pharmaceutical products based on new technologies, and our failure to develop safe and commercially viable drugs would severely limit our ability to become profitable or to achieve significant revenues.
  • Adverse public perception of gene therapy products may negatively affect demand for, or regulatory approval of, our product candidates.
  • The market may not accept any pharmaceutical products that we develop, thereby materially impairing our ability to generate revenue from such products.
  • Regulatory requirements governing cell and gene therapy products have evolved and may continue to change in the future.
  • We may encounter substantial delays in our clinical studies, such as clinical holds, or we may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities.
  • We may find it difficult to enroll patients in our clinical studies, which could delay or prevent clinical studies of our product candidates.
  • Our products or product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval or commercialization.
  • Even if we complete the necessary preclinical and clinical studies, we cannot predict when or if we will obtain regulatory approval to commercialize a product candidate or the approval may be for a narrower indication than we expect.
  • We have received and may apply for additional designations intended to facilitate or encourage product candidate development. We may not receive any such designations or be able to maintain them. Moreover, any such designations may not lead to faster development or regulatory review or approval and it does not increase the likelihood that our product candidates will receive marketing approval.
  • There is no guarantee that we will be able to obtain or maintain orphan drug designation for our product candidates or receive or maintain any corresponding benefits, including periods of exclusivity.
  • Even if we obtain regulatory approval for a product candidate, our products will remain subject to regulatory scrutiny.
  • Disruptions at FDA and other government agencies, such as those that may be caused by funding shortages, could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved, or commercialized in a timely manner or at all, which could negatively impact our business.
  • Risks related to our reliance on third-parties
  • We expect to rely on third parties to conduct some or all aspects of our viral vector production, drug product manufacturing, research and preclinical, and clinical testing, and these third parties may not perform satisfactorily.
  • Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
  • Risks related to our intellectual property
  • Our rights to develop and commercialize our product candidates are subject to, in part, the terms and conditions of licenses granted to us by others.
  • If we are unable to obtain and maintain patent protection for our products, product candidates, or technology, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully commercialize our products and technology may be adversely affected.
  • Our intellectual property licenses with third parties may be subject to disagreements over contract interpretation, which could narrow the scope of our rights to the relevant intellectual property or technology or increase our financial or other obligations to our licensors.
  • We may not be successful in obtaining necessary rights to our product candidates through acquisitions and in-licenses.
  • Issued patents covering our product candidates could be found invalid or unenforceable if challenged in court. We may not be able to protect our trade secrets in court.
  • Third-parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could 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.
  • If we do not obtain patent term extension and data exclusivity for our product candidates, our business may be harmed.
  • Risks related to our financial condition and capital requirements
  • We have experienced a history of losses; we expect to incur future losses and we may be unable to obtain necessary additional capital to fund operations in the future.
  • We do not have significant operating revenue and may never achieve profitability.
  • If the estimates we make, or the assumptions on which we rely, in preparing our consolidated financial statements are incorrect, our actual results may vary from those reflected in our projections and accruals.
  • We may need to raise additional capital to operate our business, and our failure to obtain funding when needed or on terms that are favorable to us may force us to delay, reduce or eliminate our development programs or commercialization efforts.
  • Failure to achieve and maintain effective internal controls could have a material adverse effect on our business.
  • Our ability to use our net operating loss carryforwards to offset future taxable income and taxes may be subject to certain limitations.
  • General Risk Factors
  • The market price of our common stock may be volatile and adversely affected by several factors.
  • Raising additional funds by issuing securities or through licensing or lending arrangements or through our at-the-market sale agreement would cause dilution to our existing stockholders, restrict our operations, or require us to relinquish proprietary rights.
  • Actual or potential sales of our common stock by our employees, including our executive officers, pursuant to pre-arranged stock trading plans could cause our stock price to fall or prevent it from increasing for numerous reasons, and actual or potential sales by such persons could be viewed negatively by other investors.
  • Significant disruptions of information technology (“IT”) systems, breaches of data security, or unauthorized disclosures of personal information (including sensitive personal information) could adversely affect our business and could subject us to liability or reputational damage.

Legal proceedings

We are not currently subject to any material pending legal proceedings.

The opening of Item 3, Legal Proceedings.4

Sources

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