SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
______________________
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16 of the
Securities Exchange Act of 1934
For the month of January 2024
Commission File Number: 001-36349
MediWound Ltd.
(Translation of registrant’s name into English)
42 Hayarkon Street
Yavne, 8122745 Israel
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒
Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): __
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): __
CONTENTS
On January 8, 2024, MediWound Ltd. (the “Company”) made a presentation at the J.P. Morgan 42nd Annual Healthcare
Conference, highlighting its commercial product, its clinical products as well as certain estimates and projections as to expected future financial results and information. Materials used in conjunction with the presentation are available on the
Company’s website at www.mediwound.com and are furnished as Exhibit 99.1 to this Report of Foreign Private Issuer on Form 6-K (this “Form 6-K”). The contents of the foregoing website are not a part of this Form 6-K.
The information contained in the presentation is provided as of January 8, 2024, and the Company does not undertake any
obligation to update the presentation in the future or to update forward-looking statements to reflect subsequent actual results. The furnishing of the materials related to the presentation is not an admission as to the materiality of any information
contained in those materials.
The content of this report on Form 6-K (including the information contained in Exhibit 99.1), is hereby incorporated by
reference into the Company’s Registration Statements on Form S-8 filed with the SEC on April 28, 2014, March 24, 2016, March 19, 2018, March 25, 2019, February 25, 2020, May 15, 2021 August 9, 2022 and August 15, 2023 (Registration Nos. No.
333-195517, 333-210375, 333-223767, 333-230487, 333-236635, 333-255784, 333-266697 and 333-273997, respectively) and on Form F-3 filed with the SEC on May 25, 2022 and March 31, 2023 (Registration Nos. 333-265203 and 333-268297, respectively).
SIGNATURE
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, thereunto duly authorized.
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MEDIWOUND LTD.
By: /s/ Hani Luxenburg
Name: Hani Luxenburg
Title: Chief Financial Officer
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EXHIBIT INDEX
The following exhibit is filed as part of this Form 6-K:
4
Exhibit 99.1
January 2024 I Nasdaq: MDWD Next-Generation Enzymatic Therapeuticsfor
Non-Surgical Tissue Repair
2 Cautionary Note Regarding Forward-Looking Statements This presentation
contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws, including but not limited to the statements related to the commercial potential of our products and product
candidates, the anticipated development progress of our products and product candidates, and our expected cash runaway. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,”
“continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are not historical facts, and are based upon management’s current
expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations,
beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Important factors that could cause such differences include, but are not limited to
the uncertain, lengthy and expensive nature of the product development process; market acceptance of our products and product candidates; the timing and conduct of our studies of our product candidates; our ability to obtain marketing
approval of our products and product candidates in the U.S. or other markets; our expectations regarding future growth, including our ability to develop new products; risks related to our contracts with BARDA; our ability to maintain adequate
protection of our intellectual property; competition risks; and the need for additional financing. These and other significant factors are discussed in greater detail in MediWound’s annual report on Form 20-F for the year ended December 31,
2022, filed with the Securities and Exchange Commission (“SEC”) on March 16, 2023, and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound’s current views as of the date hereof and MediWound
undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by
law Certain studies and data presented herein have been conducted for us by other entities as indicated where relevant. Intellectual property, including patents, copyrights or trade secret displayed in this presentation, whether registered
or unregistered, are the intellectual property rights of MediWound. MediWound's name and logo and other MediWound product names, slogans and logos referenced in this presentation are trademarks of MediWound Ltd. and/or its subsidiaries,
registered in the U.S.A., EU member states and Israel. NexoBrid development has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and
Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, under contract HHSO100201500035C.
This contract provided funding and technical support for the pivotal U.S. Phase 3 clinical study (DETECT), the randomized, controlled pivotal clinical trial for use in the pediatric population (CIDS), the marketing approval registration
process for NexoBrid as well as its procurement and availability under the expanded access treatment protocol (NEXT) in the U.S. Additional projects for evaluation of NexoBrid funded under the BARDA contract include establishment of a
pre-emergency use data package and development of the health economic model to evaluate the cost savings impact to enable market adoption in the United States. We maintain our books and records in U.S. dollars and report under IFRS. Our
revenue expectations for the fourth quarter and full-year ended 2023, as well as our estimates concerning cash as of December 31,2023 are preliminary, unaudited and are subject to change based on the completion of ongoing internal control,
review, and audit procedures. As a result, these amounts may differ materially from the amounts that will be reflected in the Company’s consolidated financial statements for the year ended December 31, 2023. Accordingly, you should not place
undue reliance on this preliminary estimate.
3 Company Highlights Global strategic collaborations Solid balance
sheet & strong investor base Validated enzymatic technology platform Diversified portfolio NexoBrid® - Eschar removal for burns EscharEx® - Debridement of wounds MW005 - Biotherapy for skin cancer 14 successful clinical
trials 120+peer reviewed publications Key approvals: FDA/EMA/JPN cGMP certified sterile manufacturing facility Scale up program to provide6X capacity by 2025 Supports growing global demand Vericel, Kaken, 3M, Mölnlycke, MIMEDX, BARDA,
DoD, PolyMedics, BSV Cash of $41M2 Runway through profitability 1 Oliver Wyman (OW) primary research 2 As of December 31, 2023 Significant commercial growth potential NexoBrid® - 2023 revenues of $19M;Launched in US by VericelEscharEx®
- Targets a $2B US market1 Challenging $360M+ dominant product
4 Core Platform Enzymatic Technology Pineapple stem
harvest Protein extraction Purification, enrichment, stabilization Complex mixture of proteolytic enzymes Images modified from Labster theory and bioinfo Healthy skin Non-viable tissue is rapidly and effectively removed to obviate
surgery Viable tissues preserved; healing begins Proprietary IP protected manufacturing process Complex mixture of enzymes Damaged skin Core biotherapeutic enzymatic platform technology
5 Multi-billion Dollar Portfolio Indication: Eschar removal of deep partial
and full thickness burns Classification: Orphan biological drug Target users: Hospitalized patients Development status: FDA/EU/JP approved NexoBrid® Disruptive therapy for burn care Indication: Debridement of chronic/ hard-to-heal
wounds Classification: Biological drug Target users: Optimized for all settings Development status: Phase 3 initiation 2H 2024 EscharEx® Next-gen enzymatic therapy for wound care1 Indication: Treatment of non-melanoma skin cancers
Classification: Biological drug Target users: Optimized for outpatient setting Development status: Phase 1/2 MW005 Biotherapy for non-melanoma skin cancers1 TAM2 (U.S.): >$2B >$300M TAM3 (U.S.): >$1B TAM
(U.S.): Pipeline Commercialized Pipeline 1 Investigational drug 2 ~90% of eligible patients require eschar removal; Assumes NexoBrid average price of ~$9,000 per patient 3 TAM - targeted addressable market; Oliver Wyman market
research
6 Pipeline Debridement of VLU Debridement of DFU Debridement of post
traumatic wounds P2 studies completed P2 study completed P3 initiation in 2H 2024 EscharEx® BCC (topical) MW005 P1/2 completed BCC & Tissue disorders (injectable) MW003 P1 ready Development Phase 1 Phase 2 Phase
3 Registration Market Indication Burn eschar removal in adults Burn eschar removal in pediatrics Battlefield burn treatment Approved EMA/JPN approved; submitted to FDA DoD funded BCC=basal cell carcinoma; DFU=diabetic foot ulcers;
DoD=U.S. Department of Defense; VLU=venous leg ulcers
2024 2023 7 Value Creating Milestones Phase 1/2 positive results FDA
approval Phase 2 positive results Protocols submissions Strategic research collaborations US pediatric label extension submission EU pediatric label extension approval US commercial launch StrategicBusiness Development Scale up
facility completion Capacityincrease US pediatric label extension approval Phase 3initiation EscharEx® MW005 NexoBrid® Type CMilitary use Head-to-head data EscharEx® vs. SANTYL®
Financial Highlights 8 2023 revenues of $19MNexoBrid is profitable 2024
product revenuesexpected >40% growth Scale-up will increasegross margin >65% REVENUES MDWD SHAREHOLDERS2 MDWD ANALYSTS: Josh Jennings, MD - Cowen Francois Brisebois - Oppenheimer Jason McCarthy, PhD - Maxim Swayampakula
Ramakanth, PhD - HCW David Bouchey - Aegis 1 Cash, cash equivalents and short-term bank deposits as of December 31, 2023 2 As of September 30, 2023 3 Including the Company’s founder, directors, executive officers, and members of
advisory board $41M in cash1 Cash runway through profitability BALANCE SHEET CBI Point72 Insight IBF Institutional biotech investors Insiders3 Other 30% 16% 9% 6% 6% 28% 5% Avg. Price Target - $28.00
9 NexoBrid® Growth Supported by Manufacturing Facility Scale Up Planning and
Initiation 2023 2024 2025 Construction FDA/EMA Submissions 6X Capacity Increase Full manufacturing capacity in 2025 NexoBrid forecast revenues ($M) Global demand exceeds current manufacturing capacity 3-fold 1 Includes binding order
received from Vericel for the full year of 2024 (CAGR=39%)
Early, effective and selective non-surgical eschar removal for severe
burns Approved in the U.S., EU, JP, IN; 14,000 patients treated globally to date Validated & commercialized (10% concentration)
11 Emerging SOC for Effective & Selective Eschar Removal that Preserves
Viable Tissue Eschar removal is the first critical step in burn care Loss of healthy tissue & blood Surgery is traumatic & non-selective1,2 Prevents local infection and sepsis Eschar Requires surgical team, operating
room Challenging in delicate areas Avoids further deterioration and scarring Enables initiation of wound healing Allows visual assessment of wound bed 1 Edmondson et al., 2018; Burns 2 Gurfinkel et al., 2010; Can J Plast Surg
12 Indicated for eschar removal of deep partial-thickness and/or
full-thickness thermal burns Effectively removes eschar within 4 hours without harming viable tissue or blood loss Allows for early visual assessment of the wound Commercially available in US (Vericel), Japan (Kaken), India (BSV) and
Europe Before After Disruptive Bioactive Therapy for Burn Care Significantly reduces need for surgery & improves patient outcomes Easy-to-use, topical application at patient’s bedside
13 NexoBrid® - Phase 3 Studies Demonstrate Superiority1 Consistent results in
pediatric Phase 3 study, EU Phase 3 study and post marketing data2 Safe and well tolerated Improved scarring and comparable wound closure Incidence of complete eschar removal P<0.0001 Time to complete eschar removal(days)
P<0.0001 NexoBrid N=75 SOC N=75 1.0 0.5 0.0 0 10 20 30 40 Incidence of surgical eschar removal P <0.0001 Blood loss P<0.0001 NexoBrid® SOC NexoBrid® SOC NexoBrid® Gel
Vehicle [N=175] [N=175] [N=175] [N=175] NexoBrid® SOC 815ml 1 Shoham et al. 2023; Journal of Burn care & Research 2 Shoham et al. 2023; IWJ
14 NexoBrid® - Market & Commercialization 1 Hirche et al., 2020; Burns 2
2017 National Burn Repository 3 ~90% of eligible patients require eschar removal 4 Shoham et al., 2023; IWJ Commercialization strategy 2M Annual burns 160K Hospitalized patients Estimated burn patients in key markets2 8% hospitalized
patients Cost of treatment varies by country International markets Global expansion via strategic collaborations: Japan, India, UAE, Australia, Asia-pacific North America Commercial collaboration Up to $200M BARDA & DoD
Contracts Europe Direct sales in 6 key markets Distribution in 7 territories Commercial collaboration (PMI) Included in consensus guidelines1 14,000 patients treated globally supporting the benefits of NexoBrid as an Emerging
SOC4 $425MTAM3
Next-Generation Enzymatic Debridement for Wound Care Superior to SOC - Sets a
new bar for efficacy De-risked: Based on a validated technology Targets $2B market opportunity (5% concentration)
Modalities by Efficacy and Convenience Modalities by Wound Type
(U.S.)1 Efficacy Trained Specialist Untrained HCP/ Nurses Ultrasonic Hydrosurgery Biological Sharp Current Enzymatic Autolytic 29% 29% Legend 16 Chronic Wound Debridement Approaches are Abundant but Sub-Optimal 1 OW Primary
Research Surgical Unmet medical need
17 Targeted for rapid debridement and granulation tissue formation in chronic
& hard-to-heal wounds Investigational drug containing a sterile mixture of proteolytic enzymes Debrides chronic wounds in 4-8 daily applications Promotes granulation tissue, and reduction of biofilm & bacterial load
Next-Generation Enzymatic Debridement - Wound Bed Preparation1 within Days In-line with current treatment workflows and reimbursement landscape Easy to use, daily topical application for outpatient setting Extended IP
protection *Investigational Drug, not approved in any jurisdiction *Investigational Drug, not approved in any jurisdiction VLU Before After Before After DFU ® 1 Wound bed preparation (WBP) = complete debridement + complete
granulation
18 EscharEx® is Well-Positioned to Become Market Leader Data from a
head-to-head study anticipated in 1H 2024 1 OW Primary Research 2 Lantis JC and Gordon I., 2017; Wounds 3 Patry et al., 2017 4 Snyder et al., 2023; Wounds 5 SOC in the Phase 2 trial included SANTYL® 6 Based on the data to date 7 SANTYL® PI
EscharEx® Investigational drug - Phase 3 in 2H 2024 Mixture of enzymes; Multiple targets of action Debridement, promotion of granulation, reduction of biofilm & bacteria4,6 1-2 weeks, daily; Monotherapy Controlled Phase 2
trials; Significant superiority over hydrogel & SOC5 Demonstrated to be safe and well-tolerated6 Approved in the 1960s; $360M+ annual revenues (2022) Existing reimbursement code1 Collagenase; Single target of action Debridement7
4-8+ weeks, daily; Typically coupled with sharp debridement2 “There is a lack of RCTs with adequate methodological quality”3 Demonstrated to be safe and well-tolerated SANTYL®
19 No safety issues; Efficacy consistent with previous Phase 2
studies EscharEx® Phase 2 Study – Endpoints Significantly Met Primary Endpoint Incidence of complete debridement EscharEx: 63% vs NSSOC: 13% EscharEx® Gel Vehicle n = 46 n = 43 P = 0.004 P = 0.001 Time to complete debridement:
EscharEx: 9 days vs NSSOC: 59 days Secondary Endpoint P = 0.004 % Patients NSSOC P = 0.002 Gel Vehicle EscharEx NSSOC n = 30
20 EscharEx® Phase 2 Study – Rapid Wound Bed Preparation Time to
WBP Subjects reaching WBP are 4.1X more likely to achieve wound closure (p = 0.0004) Significant correlation -WBP vs. time to wound closure. HR of 11.96 (p < 0.0001) Faster wound bed preparation Increased probability of wound
closure EscharEx® Gel Vehicle NSSOC P = 0.0108 n = 23 n= 11 n = 3 EscharEx Gel Vehicle NSSOC Incidence of WBP P = 0.002 Survival probability Days from start of treatment EscharEx 11 days vs. Gel Vehicle 85 days Incidence of
WBP EscharEx 50% vs. Gel Vehicle 25%
21 Beyond traditional debridement: reduction in wound size, biofilm and
bacterial burden EscharEx® Phase 2 Pharmacology Results: Fast, Safe, Effective1 64% 35% 100% Bioburden reduced by end of treatment Wound size reduced by end of two-week follow-up Biofilm substantially reduced for all patients
positive for biofilm at baseline 70% Complete debridement achieved within 8 applications (avg 3.9 applications) 1 Snyder et al., 2023; Wounds Journal
22 EscharEx® Phase 3 Study in VLU Patients STUDY OBJECTIVES To assess safety
and efficacy of EscharEx compared to placebo in VLUs A global (USA, EU, ROW)1, randomized, double blind, adaptive design study in patients with VLUs Two arms: EscharEx vs. placebo, 1:1 ratio Sample size: 216 VLU patients Treatment: up to
8 applications of 24 hours each Total course: 12 weeks Post Treatment Follow-Up: 3 months (to monitor wound recurrence) Pre-defined interim assessment: after 67% of patients completed the initial 12-week period STUDY
DESIGN Co-primary: Secondary: ENDPOINTS Safety: Incidence of 100% granulation tissue Time to complete debridement Time to complete wound closure Change in wound area Incidence of complete debridementIncidence of complete wound
closure Safety & tolerability | ECG | Change in pain | Wound infection rates | Immunogenicity 1 R&D collaborations with 3M, Mölnlycke and MIMEDX
23 1 OW Primary Research 29% 55% Market potential growth EscharEx®
anticipated to draw market share from all other debridement modalities 2.1M patients VLU: 1.0M | DFU: 1.1M 400K patients 1.3M patients VLU: 560K DFU: 770K Epidemiology Estimate TAM - $2B 30% expected market share 55-70% eligible
debridement EscharEx® U.S. Market Opportunity1 Cost of treatment: $1,600-$2,000 Post EscharEx launch Enzymatic Only Sharp + Enzymatic Non-sharp Combo (with Enzymatic)
24 1 OW Primary Research An Established Market With Strong Pricing
Capability1 Site of care: Hospital-based outpatient department Wound care clinics Skilled nursing facilities Home care Key clinicians: Vascular specialists Plastic surgeons Podiatrists Primary care physicians Current enzymatic
debridement average cost of treatment estimated at $1,600-$2,000 Pricing to reflect cost saving Existing reimbursement codes for enzymatic debridement Hospital Outpatient Prospective Payment System (OPPS) code 97602: TARGET
AUDIENCE REIMBURSEMENT CODE PRICING “Removal of devitalized tissue from wound(s), non-selective debridement, without anesthesia (e.g., wet-to-moist dressings, enzymatic abrasion), including topical applications(s), wound assessment, and
instruction(s) for ongoing care, per session.”
Novel biotherapy for Non-Melanoma Skin Cancer MW005 Effective and safe
topical application BCC is the most frequently diagnosed skin cancer in the U.S. (5% concentration)
26 Novel Biotherapy forNon-Melanoma Skin Cancer MW005 Before After The
Market 4.3M of BCC cases diagnosed in the US annually Surgery is the SOC; topical products have high AEs & recurrence rates SOC requires a 6-weeks treatment MW005 Investigational drug containing a sterile mixture of proteolytic
enzymes Easy to use, high potency, 5-7 topical applications US Phase 1/2 study, demonstrated efficacy, safety and tolerability MW005
MW005 27 MW005 is safe and well-tolerated; complete clinical clearance of
target lesions within 2 weeks (vs. 6+ weeks for standard BCC topicals) 1 Rosenberg et al 2021; The Open Dermatology Journal 15-39 Study Subject Applications Clinical Assessment No Recurrence Period Phase 1/2 (POC)1 N = 7 4
superficial 2 nodular 1 morpheaform 5-6 7/7 cleared (100%) >36 months Phase 1/2 (U.S.) N = 15 5 superficial 10 nodular 7 11/15 cleared (73%) NA Phase 2 (IIT) N = 1 1 nodular 7 1/1 cleared (100%) > 6 months Phase 1/2
Studies
28 Leadership Team Nachum (Homi) Shamir Chairman Ofer Gonen CEO Dr. Ety
Klinger Chief R&D Officer Dr. Shmulik Hess COO & CCO Hani Luxenburg CFO Dr. Robert J. Snyder CMO Barry Wolfenson EVP Strategy & Corp Dev.
NexoBrid® FDA approved 29 2023 2024 2025 2026-7 Interim assessment of
EscharEx® Phase 3 Strategic Timeline EscharEx® Phase 2 results EscharEx® Phase 3 initiation 6X facility scale up $27.5M financing NexoBrid® >$24M revenues BARDA/DoD collaborations EscharEx® approval >$100M revenues
with contribution from EscharEx® Cashflow positive MW005 Phase 2 results Strategic research collaborations >$30Mrevenues Head-to-head dataEscharEx® vs. SANTYL® Additional data from EscharEx® studies
