PLX on NYSE

Protalix Biotherapeutics Inc

Logo: http://www.protalix.com/index.asp, Non-free logo, via Wikipedia6

Israeli pharmaceutical company

Protalix BioTherapeutics is an Israeli pharmaceutical company that manufactures a plant-based enzyme, taliglucerase alfa, which has received U.S. Food and Drug Administration approval for the treatment of Gaucher disease.3 It was founded by Joseph Chaaltiel.1 It is headquartered in Karmiel.1 Its shares trade on NYSE under the symbol PLX.1 Wikipedia text CC BY-SA 4.0

$2.71 up 0.10 (4.02%)Price as of Oct 15, 2026 at 17:33 UTC

Last updated Oct 20, 2026.

Overview

1993Founded1

Compare with Invivyd, Inc., Champions Oncology or FENNEC PHARMACEUTICALS INC., or pick any stock.

  • TickerPLX on NYSE1
  • Industrybiotechnology1
  • HeadquartersKarmiel1
  • Founded inUnited States1
  • Websitewww.protalix.com
  • Legal formlimited company1
  • Listed onNYSE American (PLX), Tel Aviv Stock Exchange (PLX)1
  • Incorporated inDE7
  • Business address2 University Plaza, Suite 100, Hackensack, Nj 076017
  • Filer categoryNon-accelerated filer, Smaller reporting company7
  • LEI549300SDVB3GP4XDFM604
  • StatusActive4
  • LEI statusLapsed (not renewed)4
  • Registered addressC/O Vcorp Services, LLC, 19805 Wilmington, United States4

Protalix BioTherapeutics is an Israeli pharmaceutical company that manufactures a plant-based enzyme, taliglucerase alfa, which has received U.S. Food and Drug Administration approval for the treatment of Gaucher disease.3

Financials

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

Key numbers, fiscal 2025

-10.4%Operating margin9
-12.5%Net margin9
-1.2%Revenue growth, 20259
-13.7%Return on equity9
-$13.6MFree cash flow9

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue46¢$27.0M
  • Research and development33¢$19.6M
  • Selling, general and admin20¢$11.7M
  • Income tax2¢$996.0K

Out of $52.7M in revenue.9 The company lost money this year.

Financial statements

Revenue101112139$52.7M in 2025−4% since 2019
0$20.0M$40.0M$60.0M$80.0M2019: $54.7M$54.7M20192020: $62.9M$62.9M2020+15%2021: $38.4M$38.4M2021−39%2022: $47.6M$47.6M2022+24%2023: $65.5M$65.5M2023+37%2024: $53.4M$53.4M2024−18%2025: $52.7M$52.7M2025−1%
Operating income101112139-$5.5M in 2025−49% since 2019
-$30.0M-$20.0M-$10.0M0$10.0M$20.0M2019: -$10.7M-$10.7M20192020: $2.7M$2.7M20202021: -$20.5M-$20.5M20212022: -$13.0M-$13.0M2022−36%2023: $10.5M$10.5M20232024: $3.9M$3.9M2024−63%2025: -$5.5M-$5.5M2025
Net income101112139-$6.6M in 2025−64% since 2019
-$30.0M-$20.0M-$10.0M0$10.0M2019: -$18.3M-$18.3M20192020: -$6.5M-$6.5M2020−64%2021: -$27.6M-$27.6M2021+323%2022: -$14.9M-$14.9M2022−46%2023: $8.3M$8.3M20232024: $2.9M$2.9M2024−65%2025: -$6.6M-$6.6M2025
Fiscal year2019202020212022202320242025
Revenue$54.7M10$62.9M11$38.4M12$47.6M13$65.5M9$53.4M9$52.7M9
Cost of revenue$10.9M10$10.9M11$16.3M12$19.6M13$23.0M9$24.3M9$27.0M9
Gross profit
Research and development$44.6M10$38.2M11$29.7M12$29.3M13$17.1M9$13.0M9$19.6M9
Selling, general and admin$9.9M10$11.1M11$12.7M12$11.7M13$15.0M9$12.2M9$11.7M9
Operating income-$10.7M10$2.7M11-$20.5M12-$13.0M13$10.5M9$3.9M9-$5.5M9
Interest
Income before tax-$27.6M12-$14.4M13$8.6M9$4.2M9-$5.6M9
Income tax$530.0K13$254.0K9$1.2M9$996.0K9
Net income-$18.3M10-$6.5M11-$27.6M12-$14.9M13$8.3M9$2.9M9-$6.6M9
Earnings per share-$1.2310-$0.2211-$0.6212-$0.3113$0.129$0.049-$0.089
Earnings per share (diluted)-$1.2310-$0.2211-$0.6212-$0.3113$0.099$0.049-$0.089
Shares (weighted, basic)44.1M shares1248.5M shares1367.5M shares972.5M shares978.5M shares9
Shares (weighted, diluted)44.1M shares1248.5M shares1382.4M shares981.1M shares978.5M shares9

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Corporate structure

Protalix Biotherapeutics 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 Protalix Biotherapeutics Inc

  • Alapkezelo Zrt. Hold Filed SCHEDULE 13G on Protalix Biotherapeutics Inc, latest Oct 15, 2026
  • BlackRock Filed SCHEDULE 13G on Protalix Biotherapeutics Inc, latest Jul 29, 2026
  • MAK Capital Fund LP Filed SCHEDULE 13G/A on Protalix Biotherapeutics Inc, latest Mar 30, 2026 (2 filings since Mar 4, 2026)
  • WHITEBOX ADVISORS LLC Filed SC 13G/A on Protalix Biotherapeutics Inc, latest Oct 25, 2024 (2 filings since Jun 9, 2022)
  • Marius Nacht Filed SC 13G/A on Protalix Biotherapeutics Inc, latest Jan 2, 2024 (3 filings since Jan 31, 2022)
  • HIGHBRIDGE CAPITAL MANAGEMENT LLC Filed SC 13G/A on Protalix Biotherapeutics Inc, latest Feb 14, 2022 (2 filings since Feb 11, 2022)
  • Protalix Biotherapeutics Inc Karmiel, Israel

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 Protalix Biotherapeutics 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$41.9M9 Dec 31, 2025$40.3M9 Dec 31, 2024+4.0%
Accumulated depreciation$37.0M9 Dec 31, 2025$35.7M9 Dec 31, 2024+3.7%
Property and equipment, net$4.9M9 Dec 31, 2025$4.6M9 Dec 31, 2024+6.3%
Operating-lease assets (leased space)$7.7M9 Dec 31, 2025$5.4M9 Dec 31, 2024+41.8%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$14.7M9 Dec 31, 2025$19.8M9 Dec 31, 2024−25.7%

Inventory

ItemLatestA year beforeChange
Inventory, total$25.7M9 Dec 31, 2025$21.2M9 Dec 31, 2024+21.1%
Raw materials$6.0M9 Dec 31, 2025$4.5M9 Dec 31, 2024+31.5%
Work in process$9.4M9 Dec 31, 2025$11.2M9 Dec 31, 2024−16.6%
Finished goods$10.4M9 Dec 31, 2025$5.4M9 Dec 31, 2024+90.4%

Properties, in its own words

Our headquarters, including a manufacturing facility, executive offices and other facilities, are located in Carmiel, Israel. We also maintain a U.S. corporate office in Hackensack, New Jersey. Our facilities in Israel currently contain approximately 1,466 sq/m of manufacturing space and 316 sq/m for a pilot plant, 1,057 sq/m for offsite warehouse space and approximately 4,400 sq/m of laboratories, front warehouse and office space, and are leased at a rate of approximately $90,000 per month. In addition, we are entitled to use an additional 1,347 sq/m in the same facility, which we may utilize in connection with any future expansion of our manufacturing facilities. Our facilities are equipped with the requisite laboratory services required to conduct our business, and we believe that the existing facilities are adequate to meet our needs for the foreseeable future. Our original lease for the facility was in effect until 2016 and included three options to extend the leases for additional five-year periods. The leases have been amended to provide that the third option period for all leases will end on December 31, 2031, and will be associated with a uniform rent increase equal to 7.5%. Thereafter, each lease will extend automatically, on an individual basis, for up to four additional five-year periods unless we provide the lessor with six months’ advance notice that we do not intend that any individual option extension become effective. Each option to renew a lease in each of the four option periods shall include a rent increase equal to 5% of the rent payable for the applicable previous option period.

Item 2 of the 10-K filed Mar 18, 2026.17

The story

Founded by Joseph Chaaltiel in 1993, in United States.1

Protalix BioTherapeutics was established in 1993. It was founded by Yoseph Shaaltiel, who received his Ph.D. in Plant Biochemistry from the Weizmann Institute in Israel and served in the Biology Department of the Israel Defense Forces' Biological and Chemical Center. One of the earliest and largest investors in the company was Phillip Frost. Protalix has two Nobel Prize winners (Chemistry) in its Scientific Advisory Board, Roger Kornberg Ph.D and Prof. MD. Aaron Ciechanover.

In its early days Protalix operated out of a warehouse in the town of Qiryat Shemona in northern Israel. On July 19, 2005, Protalix Biotherapeutics announced the closing of a $5.3 million private placement of its series C preferred stock. Protalix entered into a partnership agreement with Teva Pharmaceutical Industries in 2006 for the development of two proteins and in 2009 signed a collaboration agreement with Pfizer for the development and commercialization of its taliglucerase alfa treatment. Also in 2009, Protalix reported that Frost & Sullivan presented the company with its 2009 European Orphan Diseases

Market Product Innovation of the Year Award. In 2011 Protalix announced that the U.S. Food and Drug Administration had approved the company's manufacturing facility in Karmiel.

Protalix initially became a public company through a reverse merger process with Orthodontix, a company which was at the time traded "over the counter" on the NASDAQ. This merger was completed on December 31, 2006, and is notable as one of the largest reverse mergers executed, valuing the joint entity at almost $1 billion. It subsequently applied for a listing on the AMEX, and sold 10 million shares in a public offering.

From Wikipedia’s article on Protalix BioTherapeutics, shared under CC BY-SA 4.0.8

Leadership

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

Board members and other officers (29)

Products and brands

  • taliglucerase alfa

Listed on Wikidata.1

Protalix has been using cultured plant cells to manufacture biopharmaceuticals. As of 2017, Protalix has one FDA approved product sold by Pfizer in the U.S. and currently developing four products:

Taliglucerase alfa (Elelyso) – a recombinant glucocerebrosidase enzyme produced from transgenic carrot cell cultures. Known also as Elelyso, taliglucerase won approval from the U.S. Food and Drug Administration in May 2012 as an orphan drug for the treatment of Type 1 Gaucher's disease. Protalix has licensed global development and commercialization rights for Elelyso to Pfizer, except for Brazil, where Protalix retains full rights. Brazil has the third largest number of Gaucher patients identified worldwide, after the U.S. and Israel. The Brazilian National Health Surveillance Agency, known as ANVISA, granted regulatory approval for Elelyso (Uplyso) to treat adults with Gaucher disease in March 2013, and extended that approval to children in December 2016.

Alidornase alfa (PRX-110) – proprietary plant cell-expressed recombinant form of human deoxyribonuclease I (DNase I), that Protalix has designed, through chemical modification, to be resistant to inhibition by actin. DNase I is part of current Cystic Fibrosis therapy, intended to reduce sputum viscosity that accumulates in the lungs of Cystic Fibrosis patients, which exposes patients to recurrent infections and compromises lung function. AIR DNase (alidornase alfa), developed to make mucus in the lungs of cystic fibrosis patients less sticky, showed remarkably good results in 2017.

Pegunigalsidase alfa (PRX-102) – plant cell culture expressed and a chemically modified version of the recombinant alpha-Galactosidase-A protein. Protein sub-units are covalently bound via chemical cross-linking using PEG chains, resulting in a more active and stable molecule than the current available versions. Protalix is currently conducting Phase 3 clinical trial for PRX-102 for the treatment of Fabry Disease following a successful meeting with U.S. Food and Drug Administration. Protalix announced positive results from its clinical trial for PRX-102. Pegunigalsidase alfa is being developed to replace Fabrazyme and interim data shows potential superiority in efficacy.

Read the full text

OPRX-106 – plant cell-expressed recombinant human tumor necrosis factor receptor II fused to an IgG1 Fc domain (TNFRII-Fc), in development for oral administration. If successful, OPRX-106 will be the first ever oral enzyme treatment as currently there are no other oral enzyme treatments available.

PRX-105 – a recombinant human Acetylcholinesterase, produced from genetically modified cell line of tobacco cells (Nicotiana tabacum), which can be used as a counter-measure against nerve agents attack. PRX-105 completed exploratory Phase I clinical trials.

From Wikipedia’s article on Protalix BioTherapeutics, shared under CC BY-SA 4.0.8

Former names

  • ORTHODONTIX INCApr 22, 1998 to Feb 22, 20077
  • EMBASSY ACQUISITION CORPAug 13, 1996 to Mar 31, 19987

Timeline

  1. Aug 12, 20268-K Results of operations52
  2. Jun 25, 20268-K Shareholder vote53
  3. May 21, 20268-K Regulation FD disclosure54
  4. May 13, 20268-K Results of operations55
  5. Mar 18, 20268-K Results of operations56
  6. Mar 9, 20268-K Other events57
  7. Feb 11, 20268-K Regulation FD disclosure58
  8. Jan 30, 20268-K Other events59
  9. Jan 5, 20268-K Regulation FD disclosure60
  10. Nov 13, 20258-K Results of operations61
  11. Nov 3, 20258-K Other events62
  12. Oct 17, 20258-K Regulation FD disclosure; Other events63
  13. Jul 2, 2019New chief executive Dror Bashan becomes CEO18
  14. Nov 3, 2014New chief executive Moshe Manor becomes CEO19
  15. Jan 5, 2007New chief executive David Aviezer becomes CEO20
  16. 1993Founded Founded in United States1

Calendar

Coming up

  1. Nov 12, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported $0.03 a share, on Nov 13, 2025.64

When it reported results

  1. Aug 12, 2026Reported quarterly or annual results52
  2. May 13, 2026Reported quarterly or annual results55
  3. Mar 18, 2026Reported quarterly or annual results56
  4. Nov 13, 2025Reported quarterly or annual results61
  5. Aug 14, 2025Reported quarterly or annual results65
  6. May 9, 2025Reported quarterly or annual results66
  7. Mar 17, 2025Reported quarterly or annual results67
  8. Nov 14, 2024Reported quarterly or annual results68

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

Filings

184 filings to the SEC since October 2021: 6 annual reports, 15 quarterly reports, 60 major events, 56 insider forms, 11 large holders, 36 other. The latest 20:

  1. Oct 15, 2026SCHEDULE 13G EDGAR
  2. Sep 9, 20264 EDGAR
  3. Sep 4, 20264 EDGAR
  4. Sep 4, 20264 EDGAR
  5. Sep 4, 20264 EDGAR
  6. Sep 4, 20264 EDGAR
  7. Sep 4, 20264 EDGAR
  8. Sep 4, 20264 EDGAR
  9. Sep 4, 20264 EDGAR
  10. Sep 4, 20264 EDGAR
  11. Aug 12, 2026S-8 EDGAR
  12. Aug 12, 202610-Q EDGAR
  13. Aug 12, 20268-K EDGAR
  14. Jul 29, 2026SCHEDULE 13G EDGAR
  15. Jun 25, 20268-K EDGAR
  16. May 21, 20268-K EDGAR
  17. May 13, 202610-Q EDGAR
  18. May 13, 20268-K EDGAR
  19. Apr 30, 2026ARS EDGAR
  20. Apr 30, 2026DEF 14A EDGAR

The 184 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

6 open-market trades by officers, directors and large owners since October 2021: 5 buys and 1 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Dec 19, 2025Bashan DrorPRESIDENT AND CEOBuy56,000$1.81$101.4KForm 4
Nov 18, 2025Bar-Shalev AmosDirectorSale168$1.87$314Form 4
Jun 10, 2025Schwartz AharonDirectorBuy129,000$1.60$206.4KForm 4
Oct 19, 2023Bashan DrorPRESIDENT AND CEOBuy64,516$1.40$90.5KForm 4
Jan 3, 2023Schwartz AharonDirectorBuy110,000$1.42$156.2KForm 4
Apr 11, 2022Bashan DrorPRESIDENT AND CEOBuy68,000$1.50$102.0KForm 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.

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
2025Dror Bashan59$401.8K$1.2M75
2025Eyal Rubin$240.6K$832.5K75
2025Yaron Naos62$232.8K$575.8K75
2025Gilad Mamlok57$133.9K$405.2K75
2024President and Chief Executive Officer$374.1K$1.5M75
2024Senior VicePresident and Chief Financial Officer$287.4K$859.5K75
2024Senior Vice PresidentChief Operating Officer$215.5K$640.0K75

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
BlackRock, Inc.4,046,650$9.4M0.0%+429,688
Renaissance Technologies LLC1,096,000$2.6M0.0%−128,800
State Street Corp983,582$2.3M0.0%+10,767
Geode Capital Management, LLC979,995$2.3M0.0%+114,697
Northern Trust Corp922,340$2.1M0.0%+36,892
Vanguard Portfolio Management LLC510,639$1.2M0.0%+78,154
Stratos Wealth Partners, LTD.500,000$1.2M0.0%No change
Dimensional Fund Advisors LP493,424$1.1M0.0%+196,581
Goldman Sachs Group Inc475,922$1.1M0.0%+224,577
Marshall Wace, Llp452,757$1.1M0.0%New
Citadel Advisors LLC334,227$778.7K0.0%New
Strs Ohio296,100$689.9K0.0%New
Bank of New York Mellon Corp232,992$542.9K0.0%+13,685
Main Street Financial Solutions, LLC214,100$498.9K0.0%No change
Bridgeway Capital Management, LLC189,100$440.6K0.0%No change
Hillsdale Investment Management Inc.185,711$432.7K0.0%New
Charles Schwab Investment Management Inc180,381$420.3K0.0%+21,070
Millennium Management LLC171,535$399.7K0.0%New
Aqr Capital Management LLC167,826$391.0K0.0%+137,333
Lazard Asset Management LLC165,561$385.8K0.0%+78,944
UBS Group AG138,646$323.0K0.0%−126,889
Jpmorgan Chase & Co132,991$312.5K0.0%+101,306
Nuveen, LLC90,188$210.1K0.0%No change
Deutsche Bank Ag\77,537$180.7K0.0%+2,552
Vanguard Fiduciary Trust Co70,277$163.7K0.0%+6,926

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

SEC filer profile

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

  • Name on EDGARProtalix BioTherapeutics, Inc.2
  • CIK0001006281
  • Employer ID (EIN)65-064377317
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company17
  • Incorporated inDelaware17
  • Fiscal year endsDecember 312
  • Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address2 University Plaza, Suite 100, Hackensack, NJ 076012
  • Phone201-696-93452
  • Shares outstanding80,571,642 as of Aug 1, 202615
  • Public float$113.1M as of Jun 30, 202517
  • AuditorKesselman & Kesselman C.P.A.s, Tel Aviv, Israel PCAOB ID 1309; no auditor attestation of internal control over financial reporting17
  • On EDGAR sinceAug 13, 19962
  • Filings972 in all: 8-K (334), 4 (178), 10-Q (67), SC 13G/A (46), 3 (39), SC 13G (27), DEF 14A (26), 10QSB (25)2
    All 44 form types

    10-K (24), CORRESP (24), UPLOAD (22), DEFA14A (16), 424B5 (15), PRE 14A (11), ARS (10), CT ORDER (10), EFFECT (9), S-8 (9), 10-Q/A (8), 8-K/A (8), S-3 (7), SC 13D (6), SC 13D/A (6), 10KSB40 (5), 10-K/A (4), 4/A (4), S-3/A (4), 424B3 (3), NT 10-K (3), SCHEDULE 13G (3), 3/A (2), DEF 14C (2), NT 10-Q (2), POS AM (2), PREM14C (2), 10KSB (1), 10KSB/A (1), 10QSB/A (1), 8-A12B (1), CERTAMX (1), S-3MEF (1), S-4 (1), SC 14F1 (1), SCHEDULE 13G/A (1)

  • Latest filingsAnnual report (10-K) Mar 18, 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, $0.001 par valuePLXNYSE American

From the cover page of the 10-K filed Mar 18, 2026 (Section 12(b) of the Exchange Act).17

Risk factors and legal proceedings

The risks Protalix Biotherapeutics Inc names in Item 1A of its 10-K filed Mar 18, 2026: 73 risks under these headings, as written.17

  • Risks Related to the Commercialization and Continued Approval of our Products
  • ●We currently depend heavily on the generation of revenues from the sales of Elfabrio and Elelyso.
  • ●Any current products or future product candidates may cause serious adverse events or undesirable side effects.
  • ●There may be safety issues regarding our products that were not known at the time of approval are discovered.
  • ●Physicians, patients, third party payors and others in the medical community might not accept and use our current or future products.
  • ●Coverage and reimbursement may not be available for our current or future products in all territories.
  • Risks Related to Our Business
  • ●We have a limited commercial operating history.
  • ●We may fail to supply drug substance to Chiesi or Pfizer.
  • ●We may be unable to enhance our portfolio of product candidates.
  • ●We or our providers may experience manufacturing problems.
  • ●Reliance on third parties for final processing of our products and product candidates exposes us to a number of risks.
The other 63 risks
  • ●Developments by competitors may render our products or technologies obsolete or non-competitive.
  • ●If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud.
  • ●Our internal computer systems, or those used by our third-party contractors or consultants, may fail or suffer security breaches and expose our company to liabilities.
  • ●We may face product liability claims.
  • ●Our ability to utilize net operating loss carryforwards may be limited.
  • Risks Related to Clinical Trials and Regulatory Matters
  • ●We may not obtain the necessary U.S., EMA, or other worldwide regulatory approvals to commercialize our drug candidates in a timely manner, if at all.
  • ●We may experience delays in obtaining regulatory approvals with respect to any drug candidate.
  • ●Preclinical and clinical trials are very expensive, time-consuming and difficult to design and implement and may result in unforeseen costs.
  • ●If the results of our clinical trials do not support our claims relating to a drug candidate, or if serious side effects are identified, the completion of development of such drug candidate may be significantly delayed or we may be forced to abandon development altogether.
  • ●We may find it difficult to enroll patients in our clinical trials or patients may discontinue their participation in our clinical trials.
  • ●Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.
  • ●Dependence upon third-party service providers in connection with our clinical trials expose us to risks.
  • Risks Related to our Financial Condition and Capital Requirements
  • ●We may need to raise additional capital to operate our business, which may not be available on favorable terms, or at all.
  • Risks Related to Intellectual Property Matters
  • ●We may fail to adequately protect or enforce our intellectual property rights or secure rights to third party patents, and the terms of certain of our patents are limited or have expired.
  • Risks Relating to our Operations in Israel
  • ●Our results may be adversely affected by military, political and economic conditions in Israel.
  • ●The Israeli government grants we have received for certain research and development expenditures restrict our ability to manufacture products and transfer technologies outside of Israel and require us to satisfy specified conditions.
  • Risks Related to Investing in our Common Stock
  • ●The market price of our common stock may fluctuate significantly; future sales of our common stock could reduce our stock price.
  • ●Compliance with changing regulation of corporate governance and public disclosure may result in additional expenses or divert management’s attention.
  • ●Delaware law and our organizational documents contain certain anti-takeover provisions.
  • ●Our Amended and Restated Bylaws provide for limits on our stockholders’ ability to obtain a favorable judicial forum.
  • We currently depend heavily on the generation of revenues from the sales of Elfabrio and Elelyso. Any failure to successfully commercialize Elfabrio will have a material adverse effect on our business, results of operations, and financial condition.
  • Any current products or future product candidates may cause serious adverse events, or SAEs, undesirable side effects or have other properties that could halt their clinical development, prevent, delay, or cause the withdrawal of their regulatory approval, limit their commercial potential, or result in material negative consequences.
  • If safety issues regarding our products that were not known at the time of approval are discovered, or if we or the applicable marketing authorization holder fails to comply with continuing U.S. and applicable foreign regulations, commercialization efforts for our products could be adversely affected and the products could lose their approval or their sales could be suspended.
  • If physicians, patients, third party payors and others in the medical community do not accept and use Elfabrio, Elelyso or any other future products, our ability to generate revenue from product sales will be materially impaired.
  • If the market opportunities for Elfabrio, Elelyso or any other future products are smaller than we believe they are, our revenues may be adversely affected and our business may suffer.
  • Coverage and reimbursement may not be available for Elfabrio, Elelyso, or any other future products in all territories, which could diminish sales of our products or adversely affect the profitably of such sales.
  • We and our collaborating partners may be subject, directly or indirectly, to federal and state healthcare fraud and abuse and false claims laws and regulations. If we or our collaborating partners are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
  • We have a limited commercial operating history which may limit the ability of investors to make an informed investment decision.
  • Any failure by us to supply drug substance to Chiesi or Pfizer may have a material adverse effect on our business, results of operations, and financial condition.
  • Our strategy, in certain cases, is to enter into collaboration agreements with third parties to develop product candidates. Failure to enter into such agreements, or non-compliance by us or our collaborators with such agreements, may have a material adverse effect on our business, results of operations, and financial condition.
  • Fiocruz is not complying, and we expect they will continue to not comply, with the terms and conditions of the Brazil Agreement.
  • We have limited experience in selling, marketing or distributing products and limited internal capability to do so.
  • If we are unable to enhance our portfolio of product candidates, our business may be adversely affected.
  • The manufacture of our products is an exacting and complex process, and any manufacturing problems encountered by us or certain of our providers may have a material adverse effect on our business, results of operations, and financial condition.
  • We rely on third parties for final processing of Elfabrio, Elelyso, and our other product candidates, which exposes us to a number of risks that may delay development, regulatory approval, and commercialization of Elfabrio, Elelyso, or our other product candidates or result in higher product costs.
  • Developments by competitors may render our products or technologies obsolete or non-competitive which would have a material adverse effect on our business, results of operations, and financial condition.
  • If we in-license drug candidates, we may delay or otherwise adversely affect the development of our existing drug candidates, which may negatively impact our business, results of operations and financial condition.
  • If we acquire companies, products, or technologies, we may face integration risks and costs associated with those acquisitions that could potentially negatively impact our business, results of operations and financial condition.
  • We depend upon key employees and consultants in a competitive market for skilled personnel. If we are unable to attract and retain key personnel, it could adversely affect our ability to develop and market our products.
  • Under current U.S. and Israeli laws, we may not be able to enforce employees’ covenants not to compete and therefore may be unable to prevent our competitors from benefiting from the expertise of some of our former employees.
  • If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, stockholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our common stock.
  • Our internal computer systems, or those used by our third-party contractors or consultants, may fail or suffer security breaches, resulting in liability and harm to our reputation, which could negatively affect our business, results of operation and financial condition. We may face liability if we breach our obligations related to the protection, security, nondisclosure of confidential information or disclosure of sensitive data or fail or are perceived to fail to comply with applicable data protection laws and regulations, or consumer protection laws, regulations and standards.
  • We could be subject to securities class action litigation.
  • In the past, securities class action litigation has often been brought against a company following a decline in the market price of its securities. This risk is especially relevant for us because biotechnology companies have experienced significant stock price volatility in recent years. Any such litigation, could result in substantial costs and divert management’s attention and resources, which could have a material adverse effect on our business, results of operations, and financial condition.
  • If product liability claims are brought against us, it may result in reduced demand for our products and product candidates or damages that exceed our insurance coverage.
  • Our ability to utilize net operating loss carryforwards may be limited.
  • Our corporate structure may create U.S. federal income tax inefficiencies.
  • We are a holding company with no operations of our own.
  • Outbreaks of contagious disease or similar public health threats could materially and adversely affect our business, results of operations and financial condition.
  • Our operating costs and business operations could be adversely affected by climate-related events and increasing regulatory requirements and security.
  • and goals related to climate action could adversely affect our reputation with suppliers and customers, financial performance, or the ability to recruit and retain talent.
  • We may not obtain the necessary U.S., EMA or other worldwide regulatory approvals to commercialize our drug candidates in a timely manner, if at all, which would have a material adverse effect on our business, results of operations, and financial condition.
  • We are subject to extensive governmental regulation including the requirements of the FDA and other comparable regulatory authorities before our drug candidates may be marketed.
  • Delays in obtaining regulatory approvals with respect to any drug candidate may materially and adversely affect our prospects, business, results of operations and financial condition.
  • Preclinical and clinical trials are very expensive, time-consuming, and difficult to design and implement and may result in unforeseen costs, which may have a material adverse effect on our business, results of operations, and financial condition.
  • If the results of our clinical trials do not support our claims relating to a drug candidate, or if serious side effects are identified, the completion of development of such drug candidate may be significantly delayed or we may be forced to abandon development altogether, which will significantly impair our ability to generate product revenues.
  • Interim, top-line or preliminary data from clinical trials that we announce or publish may change as more patient data becomes available and are subject to audit and verification procedures that could result in material changes in the final data.
  • We may find it difficult to enroll patients in our clinical trials, or patients may discontinue their participation in our clinical trials, which could cause significant delays in the completion of such trials or may negatively impact the results of these studies and extend the timeline for completion of our development programs or cause us to abandon one or more clinical trials.
  • Our clinical trials depend upon third-party service providers and, accordingly, the results of our clinical trials and such research activities are subject to delays and other risks which are, to a certain extent, beyond our control, which could impair our clinical development programs and our competitive position.
  • We have limited experience in regulatory affairs compared to our larger competitors, and some of our drug candidates may be based on new technologies. These factors may affect our ability or the time we require to obtain necessary regulatory approvals.
  • Uncertainty surrounding and future changes to healthcare law in the United States and other United States Government related mandates may adversely affect our business.
  • In the coming years, additional changes could be made to U.S. governmental healthcare programs and U.S. healthcare laws that could significantly impact the success of our products. We cannot predict what other legislation relating to our
  • business or to the health care industry may be enacted, or what effect such legislation or other regulatory actions may have on our business, prospects, operating results, and financial condition.

Legal proceedings

We are not involved in any material legal proceedings.

The opening of Item 3, Legal Proceedings.17

Sources

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