Form 8-K

8-K — Protalix BioTherapeutics, Inc.

Accession: 0001104659-26-064850

Filed: 2026-05-21

Period: 2026-05-21

CIK: 0001006281

SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — plx-20260521x8k.htm (Primary)

EX-99.1 (plx-20260521xex99d1.htm)

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8-K

8-K (Primary)

Filename: plx-20260521x8k.htm · Sequence: 1

Protalix BioTherapeutics, Inc._May 21, 2026

0001006281false00010062812026-05-212026-05-21

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of Report (Date of Earliest Event Reported): May 21, 2026

Protalix BioTherapeutics, Inc.

(Exact name of registrant as specified in its charter)

Delaware

001-33357

65-0643773

(State or other jurisdiction

of incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

2 University Plaza

Suite 100

Hackensack, NJ

07601

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code 201-696-9345

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common stock, $0.001 par value

PLX

NYSE American

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ◻

Item 7.01

Regulation FD Disclosure

On May 21, 2026, Protalix BioTherapeutics, Inc., a Delaware corporation, posted a corporate presentation to its website. A copy of the corporate presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

In accordance with General Instruction B.2 of Form 8-K, the information in this Item 7.01 to this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 9.01Financial Statements and Exhibits

Exhibit No.

Description

99.1

May 2026 Corporate Presentation

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: May 21, 2026

PROTALIX BIOTHERAPEUTICS, INC.

By:

/s/ Dror Bashan

Name:

Dror Bashan

Title:

President and

Chief Executive Officer

EX-99.1

Filename: plx-20260521xex99d1.htm · Sequence: 2

Exhibit 99.1

PROTALIX BIOTHERAPEUTICS

C O R P O R A T E P R E S E N T A T I O N

J u n e 2024

PROTALIX BIOTHERAPEUTICS

Pioneering solutions to transform the treatment of rare diseases

C O R P O R A T E P R E S E N T A T I O N

M a y 2026

Forward-Looking Statements

This presentation contains forward-looking statements that involve risks and uncertainties within the meaning of Section 27A of the

Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Exchange Act. Forward-looking statements are neither

historical facts nor assurances of future performance. Instead, they are based on management’s current expectations or plans, and

projections for future operating and financial performance, based on assumptions currently believed to be valid. Forward-looking statements

can be identified by the use of words such as “anticipate,” “believe,” “estimate,” “expect,” “can,” “continue,” “could,” “intend,” “may,” “plan,”

“potential,” “predict,” “project,” “should,” “will,” “would” and other words or phrases of similar import, as they relate to Protalix, its

subsidiary, or its management, are intended to identify forward-looking statements, although not all forward-looking statements contain these

identifying words. The forward-looking statements in this presentation include, among other things, statements regarding our cash runway and

the commercialization of our products. Forward-looking statements are subject to many risks and uncertainties that could cause our actual

results to differ materially from any future results expressed or implied by the forward-looking statements, including, but not limited to, risks

related to the commercialization of Elfabrio®; that Elfabrio’s revenue, expenses, and costs may not be as expected; Elfabrio’s market

acceptance, competition, reimbursement, and regulatory actions, including as a result of the boxed warning contained in the U.S. Food and

Drug Administration, or FDA, approval received for the product; risks related to the regulatory approval and commercial success of our other

product and product candidates, if approved; risks related to our expectations with respect to the potential commercial value of our

products and product candidates; failure or delay in the commencement or completion of our preclinical studies and clinical trials, which may

be caused by several factors, including: slower than expected rates of patient recruitment; unforeseen safety issues; determination of dosing

issues; lack of effectiveness during clinical trials; inability to satisfactorily demonstrate non-inferiority to approved therapies; inability or

unwillingness of medical investigators and institutional review boards to follow our clinical protocols; inability to monitor patients adequately

during or after treatment; and/or lack of sufficient funding to finance our clinical trials; delays in the approval or potential rejection of any

applications we file with the FDA, European Medicines Agency or other health regulatory authorities for our product candidates, and other

risks relating to the review process; our ability to manage our relationship with our collaborators, distributors, or partners, including, but not

limited to, Pfizer Inc., and Chiesi Global Rare Diseases; and other factors described in our filings with the U.S. Securities and Exchange

Commission. In addition, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and

uncertainties. Given these uncertainties, investors should not place undue reliance on these forward-looking statements. Except as required

by law, Protalix undertakes no obligation to update or revise the information contained in this presentation whether as a result of new

information, future events, or circumstances or otherwise.

This presentation also contains estimates and

other data made by independent parties

and Protalix relating to market size and growth and

other data related to the industry in

which Protalix operates. This data involves a

number of assumptions and limitations, and you

are cautioned not to give undue weight to such

estimates. Neither Protalix nor any other person

makes any representation as to the accuracy or

completeness of such data. In light of the

foregoing, you are urged not to rely on any forward-looking statement or third-party data in reaching

any conclusion or making any investment decision

about any securities of the Company. The

appropriateness of a particular investment or

strategy will depend on an investor’s individual

circumstances and objectives. We recommend

that investors independently evaluate specific

investments and strategies.

Third-Party Information

Experienced leadership team

ORI KALID, PH.D.

VP of R&D

Dr. Kalid brings >20 years of leadership experience in

pharmaceutical R&D. Previously he was co-founder and

CEO of Silverskate Bio, as well as co-founder and CEO

of Pi Therapeutics. He also served at Hotaru Innovation

Partners, PREDIX/EPIX Pharmaceuticals and

Karyopharm Therapeutics.

Dror Bashan

President and CEO

Mr. Bashan has over 20 years of experience in the

pharmaceutical industry with roles ranging from business

development, marketing, sales and finance, providing him

with both cross regional and cross discipline experience and

a deep knowledge of the global pharmaceutical and health

industries.

SHOSHI TESSLER, PH.D.

VP, Clinical Dev & Regulatory Affairs

Dr. Tessler has >20yrs experience in the pharma,

leading innovative drug development projects, from

discovery to market. Previously, she served as VP, R&D of

Biosight and of Enzymotec. (currently part of International

Flavors & Fragrances Inc.) and as a Project Champion at

Innovative R&D, Teva.

YARON NAOS

Chief Operating Officer

Mr. Naos has been with Protalix for >20 years. He has a

wealth of hands-on experience and knowledge in the field

of pharmaceutical development. Previously, he was R&D

Product Manager at Dexxon Pharmaceutical Co., one of

Israel's largest pharmaceutical companies, where he was

responsible for technology transfer from R&D to

production

GILAD MAMLOK

SVP & CFO

Mr. Mamlok brings 30 yrs experience in healthcare/

technology companies. His has extensive experience in

capital markets transactions, mergers and acquisitions and

BD. Previously, he served as the CFO of TytoCare and CFO

of Sol-Gel Technologies. Earlier, he served in other medical

device and technology companies, including Given Imaging

for 10 years (acquired by Covidien) and Nice.

Fernando Sallés, PH.D., CLP

Chief Business Officer

Dr. Salles has spent >25 years in senior strategic/BD

roles. Most recently as CBO at Kallyope. Previously at

IMAB, Teva, Merck, Schering-Plough and Organon.

Notable transactions: Acquired phase 2b ready asset,

novel obesity target to Novo Nordisk, BioCentury/Bay Helix

deal of the year award for IMab - AbbVie >$2B

Accomplished Board of Directors

AMOS BAR SHALEV

Director

POL F. BOUDES, M.D.

Director

GWEN A. MELINCOFF

Director

AHARON SCHWARTZ,

PH.D.

Director

ELIOT FORSTER, PH.D.

Chairman

DROR BASHAN

President & CEO, Director

SHMUEL “MULI” BEN

ZVI, PH.D.

Director

Christian Else

Director

BATM logo

Regulatory milestone payment of $25 million received from Chiesi

EC and MHRA approve E4W dosing for Elfabrio® for adults with Fabry disease1

Now the only ERT in the EU and UK offering an every-4-weeks (E4W) option, reducing treatment burden from standard bi-weekly regimens

E4W dosing clinically validated

BRIGHT study

• E4W maintained clinical and renal

outcomes in stable patients

Long-term extension data

• Confirmed durable response and

• Comparable safety profile

PopPK + exposure-response analysis

• Support for E4W regimen

Quality-of-life

improvement for

Fabry patients

in the EU

Infusions per year Elfabrio®

50% reduction

in infusion days

E4W

E2W

1: European Commission (EC) approved a novel 2mg/kg every-4-weeks (E4W) dosing regimen for Elfabrio in adults with Fabry disease who are stable on an enzyme replacement therapy (ERT) (March 2026);

MHRA (UK) approved the same E4W dosing regimen (May 2026); FDA-approved dosing regimen for Elfabrio in the United States remains 1mg/kg every 2 weeks; EU=European Union; UK=United Kingdom.

Protalix delivers innovations from concept to market

Proven execution of delivering protein products for rare diseases with a pipeline for the future

1: Elfabrio has been approved for marketing in the United States, the European Union, and additional markets. Chiesi Global Rare Diseases, a business unit of the Chiesi Group, is our global partner

2: Elelyso is approved in 23 markets. Pfizer Inc. is our global partner, with the exception of Brazil where we partner with Fundação Oswaldo Cruz (“Fiocruz”), an arm of the Brazilian Ministry of Health

Partnered commercial products

Enzyme replacement therapies (ERTs)1,2

Pipeline for the future

• 3-year goal: 5-7 programs

spanning discovery to clinic

• Rare disease discovery and development

with a focus on renal indications

PRX-115 best-in-class potential

for uncontrolled gout

• Uncontrolled gout has high unmet need

• Potentially differentiated based on

Phase 1 data: less frequent dosing, less

immunogenicity

• Phase 2 PRX-115 trial actively enrolling

(NCT05745727)

ProCellEx® Proprietary Discovery Platform

Protein therapeutics: Plant cell-based protein expression

Chemical modifications: PEGylation, others

Drug delivery: Exploring new modalities

Commercial Manufacturing

ProCellEx® Manufacturing

Revenue generating Next phase of the company

Indication

Discovery

and Preclinical

Phase 1 Phase 2 Phase 3

Marketing

Application

Status

Fabry Disease

Approved in the US,

European Union, and in

additional other markets

Gaucher

Disease

Approved in the US and

other markets

PEGylated Uricase (PRX-115)

Uncontrolled

Gout

Phase 2 PRX-115 trial

actively enrolling

Long Acting (LA) DNase I

(PRX-119)

NETs-Related

Diseases*

Research programs** Rare Renal

Diseases

Partnership

Two commercial products and a growing pipeline for the future

Developing recombinant proteins for rare diseases with unmet medical needs

* Neutrophil extracellular traps (NETs)

**Includes internal programs and a collaboration and option agreement with Secarna Pharmaceuticals

Development portfolio for the next phase of the company

Commercial portfolio

Well-capitalized to advance Protalix to the next phase

$33.8M in revenue, which includes the $25M milestone (Q1 2026)

$51.1M (as of: March 31, 2026); no debt no warrants

~80.5M shares of common stock outstanding (May 1, 2026)

PRX-115 recombinant PEGylated uricase product candidate. Best-in-class potential.

Phase 2 PRX-115 trial actively enrolling.

REVENUES

CASH & CASH RUNWAY

and OUTSTANDING SHARES

DEVELOPMENT PORTFOLIO

DRIVES FUTURE GROWTH

Financial strength to support ongoing operations and pipeline

Key upcoming milestones and catalysts

Business development activities in rare renal diseases

3 revenue streams and projected consistent growth in the medium-term

Significant milestone payments expected in mid- and long-term

Continued internal R&D pipeline growth

Elfabrio®

Topline results

from Ph2 trial

2H 2027

PRX-115

Expanding

geographic

approvals

1H 2026 Ongoing

2 mg/kg IV

every four weeks

(EU & UK)

Phase 2 PRX-115 trial

actively enrolling

Ongoing Q1 2026

Increasing market share

in current geographies

(organic growth)

Phase 2

Actively enrolling

PRX-115 in development for

uncontrolled gout

Gout and uncontrolled gout

• Metabolic disorder characterized by elevated blood urate that causes recurrent inflammatory arthritis and joint damage

• Rheumatologists report that ~25% of their patients have above target urate blood levels which can lead to uncontrolled gout*

• Uncontrolled gout is a severe disease with high morbidity and high pain with low quality of life

Current uricase therapy for uncontrolled gout

Krystexxa® (pegloticase) with/without methotrexate (MTX)

• Net sales of Krystexxa reached $1.3B (2025)

NASP (nano encapsulated sirolimus plus pegadricase)

PDUFA Date – June 2026

Significant unmet needs and challenges

• Infusion logistics and burden

• Immunogenicity and loss of efficacy

• Safety concerns

• Clinical inertia and physician familiarity

• Costs and insurance coverage

Uncontrolled gout: limited options and disadvantages with current therapy

An unsatisfied market

*Internal research

11.3M1 5M2 1.2M2 0.3M3 0.18M3 6-8K4

The US Gout Market

1. Global Data – Aug 2025; 2. ACR Open Rheumatology Vol. 2 March 2020; 3. proprietary PRX Mkt Research 75 Rheums; 4. Internal estimates proprietary calculation ** Urate transporter 1 inhibitor; none

currently available in the US

† Neither the xanthine oxidase inhibitors nor the URAT1s should be co-administered with uricases

Treatments

The market is poised to expand significantly

as newer therapies and competitors enter

and further expand disease awareness and

reduce clinical inertia

A differentiated best-in-class uricase like

PRX-115 is poised to increase the market

further and capture significant market share

Sales of Krystexxa are $1.3B (2025),

yet less than 5% who qualify for uricase

are currently treated

Gout

patients

Uncontrolled

gout

Referred to

rheumatologists

Seek treatment

at PCP

Qualify

for uricase Krystexxa®

allopurinol, febuxostat†

URAT1s**,†

Uricase

PRX-115 Phase 1 single ascending dose study: encouraging data supports Phase 2

Recombinant PEGylated uricase enzyme produced via ProCellEx®

Study Scheme

Primary Endpoint: Safety and tolerability

Secondary Endpoints: PK, PD (uric acid levels)

Subjects with elevated uric acid

N = 8 per cohort (6 PRX-115 + 2 placebo in each cohort)

Dose escalation meeting by blinded Safety Monitoring Committee

(SMC) following completion of each cohort

For subject safety, each cohort/dose level started at least 7 days

from the dosing of the previous cohort

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Cohort 5

Cohort 6

Cohort 7

Cohort 8

PRX-115 best in class potential for uncontrolled gout

Addresses an important unmet medical need

Phase 2 RELEASE study

• Actively enrolling (NCT07280156)

• Trial in uncontrolled gout patients

• Fixed 36 mg dose across extended

dosing intervals with and without

methotrexate (MTX)

• Top-line results anticipated in 2H 2027

PRX-115 Phase 1 outcome

• Favorable tolerability profile

• Ability to reduce uric acid levels rapidly and maintain below 6.0 mg/dL

for greater than 8 weeks

Targeted Phase 2 differentiation(s)

• IV infusion every 4 weeks without

requirement for co-administration of the

immunomodulator MTX

• Improved dosing interval

• IV infusion every 6 or 8 weeks in the

presence of MTX

• Favorable safety and immunogenicity

profile

PRX-115 Phase 2 double blind placebo-controlled study design: actively enrolling

MTX = Methotrexate

Patient Population: uncontrolled gout

Primary Endpoint: proportion of patients who achieve

a reduction in serum uric acid (sUA) to <6.0 mg/dL

for at least 80% of the time during Month 6

Secondary Endpoints: additional uric acid

parameters, safety, and immunogenicity

Exploratory Endpoints: tophi, flares, swollen & tender

joints, quality of life (QoL), pharmacokinetics (PK)

PRX-115 IV Dosing Regimens and Treatment Arms

Arm A* every 4 weeks w/o MTX N=30

Arm B every 4 weeks + MTX N=30

Arm C every 6 weeks + MTX N=30

Arm D* every 8 weeks + MTX N=30

Arm E Placebo N=30

* Key differentiators no MTX (A); 8-wk dosing interval (D)

Fixed Dose at Various Dosing Intervals

Commercial products

Reliably partnered and delivering revenue

Rare autosomal recessive disorder (~1/40,000 WW) with

systemic visceral and skeletal disease-causing disability

and organ dysfunction

Rare X-linked disorder (~1/40,000-60,000 males WW) with

progressive renal, cardiac, and neurological burden

Fabry disease

Two commercial products sustaining future growth

Enzyme replacement therapies (ERTs) continue to be the gold standard treatment for lysosomal storage diseases

17 1 GlobalData extracted (forecast) March 2026

Approved in 23 markets

Worldwide (ex-Brazil) license with Pfizer

Brazil collaboration with Fundação Oswaldo Cruz

• Market share in Brazil: ~25%

• Sales ~$11M in Brazil (FY2025)

Gaucher disease

Approved in US, EU plus additional markets

Commercial Potential

• Fabry Market: ~$2.2B1

(2025) expected to reach ~$3.2B (2031)

• Elfabrio® poised to capture significant global market share

(15% to 20%)

• Protalix royalties per year from Chiesi

(15% to 35% ex-US, 15% to 40% US)

• Significant milestone payments potential in mid- and long-term

Commercialization

Partners

Commercialization

Partner

Fabry disease competitive landscape

~$2.2B market (2025) expected to reach over ~$3.2B (2031), CAGR of 6.4%1

Product Name Fabrazyme® Replagal® Galafold® Elfabrio®

Parent Company

Mechanism ERT ERT Pharmacological chaperone

ERT

longer half-life (pegylated)

Approved for

Adults & pediatric patients 2+ years

(US). Adults, children and adolescents

aged 8+ years (EU)

Adults, children and adolescents aged

7+ years (EU only)

Accelerated approval in adults (US).

Adults and adolescents 12+ years

(EU)

Adults (US, EU and others).

Global pediatric study ongoing

Dosing 1 mg/kg every 2 weeks 0.2 mg/kg every 2 weeks 123 mg every other day

1 mg/kg every 2 weeks

2 mg/kg every 4 weeks (EU & UK)

Administration

mode Intravenous infusions Intravenous infusions Oral Intravenous infusions

Approval Date Full approval in 2021; accelerated

approval in 2003 (US); 2001 (EU) Not approved in US; 2001 (EU) 2018 (US); 2016 (EU) 2023 (US and EU)

Elfabrio is poised to capture meaningful global market share (15% to 20%)

1 Source global data extracted Aug 2025

Commitment and execution from global partnership with Chiesi

Committed Global Partner 1

• International research-focused biopharmaceutical group with sales of €3.6B in 2025 (reflecting 8% growth year-on-year)

• Air (respiratory) - €1.9B, Rare - €906M (22.3% growth), Care (Specialty) - €904M

• The Rare Diseases unit now accounts for approximately 25% of total Group sales, contributing 50% of overall growth in 2025.

• Annual R&D investment of €885M in 2025

• Experience with data generation/ongoing post-marketing studies to support further uptake

Chiesi Farmaceutici S.p.A.

• Experienced sales team

• Strategic focus on rare diseases

• Specific expertise in Fabry disease

• Ideally suited to bring Elfabrio to patients with Fabry disease

1 – update based on 2025 Annual Report

Growth strategy

Next phase of the company

Research strategy - leveraging internal strengths to fuel the company's next phase

Proven ability to drive discovery, development, and registration of new drugs

Internal development Protein therapeutics

Plant cell-based expression

Chemical modification

PEGylation, other

Drug delivery

Exploring new modalities

Business development

• Innovative platform

in-licensing

• China dedicated scouting

activity

• Opportunistic in-licensing

• Commercial partnership

establishment

Rare renal disease focus

• ADPKD, Alport, FSGS, others

• Modality agnostic: nucleic acids, peptides, small molecules, etc.

3-year goal

5-7 programs spanning

discovery to clinic

ProCellEx® platform

Leveraging existing platforms

Expand Applications

Protalix delivers innovation from concept to the market

* (as of May 1, 2026)

Revenues

USD 33.8M for Q1 2026

Cash and Shares Outstanding

USD 51.1M (March 31, 2026)

80.5M shares of common stock*

Debt

No Debt / Warrants

Growing pipeline for the company's next phase

• PRX-115 best-in-class potential for uncontrolled gout

• Collaboration and Option Agreement with Secarna

• Internal research focus – Rare Renal Diseases (includes collaboration with Secarna)

Three revenue streams

Two commercial products

PROTALIX BIOTHERAPEUTICS

C O R P O R A T E P R E S E N T A T I O N

J u n e 2024

PROTALIX BIOTHERAPEUTICS

Pioneering solutions to transform the treatment of rare diseases

C O R P O R A T E P R E S E N T A T I O N

M a y 2026

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v3.26.1

Document and Entity Information

May 21, 2026

Document and Entity Information [Abstract]

Document Type

8-K

Document Period End Date

May 21, 2026

Entity File Number

001-33357

Entity Registrant Name

Protalix BioTherapeutics, Inc.

Entity Incorporation, State or Country Code

Entity Tax Identification Number

65-0643773

Entity Address, Address Line One

2 University Plaza

Entity Address, Adress Line Two

Suite 100

Entity Address, State or Province

Entity Address, City or Town

Hackensack

Entity Address, Postal Zip Code

07601

City Area Code

201

Local Phone Number

696-9345

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false

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false

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false

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Common stock, $0.001 par value

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PLX

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NYSEAMER

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0001006281

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