6-K - MDWD - Equibles

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 May 2023

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): __

INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K

On May 31, 2023, MediWound Ltd. (the “Company”) made available a corporate presentation on its website. A copy of the presentation is attached hereto as Exhibit 99.1. The fact that the presentation is being made available and furnished herewith is not an admission as to the materiality of any information contained in the presentation. The information contained in the presentation is being provided as of May 31, 2023 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.

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.

	MEDIWOUND LTD.
Date: May 31, 2023	By:	/s/ Hani Luxenburg
	Name:	Hani<br> Luxenburg
	Title:	Chief Financial Officer

EXHIBIT INDEX

The following exhibit is filed as part of this Form 6-K:

Exhibit	Description
99.1	Corporate presentation dated May 2023

Exhibit 99.1

        ![](exhibit_99-1slide1.jpg)

May 2023 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 part with federal funding from U.S. Biomedical Advanced Research and Development Authority (BARDA), Administration for Strategic Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), under ongoing USG Contract numbers HHSO100201500035C and HHSO100201800023C. Contract number HHSO100201500035C provides funding and technical support for the pivotal U.S. Phase 3 clinical study (DETECT) and 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 randomized, controlled pivotal clinical trial for use in pediatric population, 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.

3 Company Highlights Diversified portfolio Global strategic partnerships cGMP certified sterile manufacturing facility Solid balance sheet & strong investor base NexoBrid® - 2022 revenues: $26.5M EscharEx® - $2B* opportunity Validated enzymatic technology platform FDA/EMA/PMDA approvals 14 successful clinical trials 120+peer reviewed publications Provides capacity to scale revenue growth BARDA, Vericel, DoD (US), Kaken (JP), BSV (IN) Cash of ~$57M *TAM - targeted addressable market; Source: Oliver Wyman market research

4 Leadership Team Nachum (Homi) Shamir Chairman of the Board Ofer Gonen Chief Executive Officer Dr. Ety Klinger Chief R&D Officer Tzvi Palash Chief Operating Officer Hani Luxenburg Chief Financial Officer Dr. Robert J. Snyder Chief Medical Officer Barry Wolfenson EVP Strategy & Corp Dev.

5 Clinically and Commercially Validated Protein-Based Therapies Pineapple stem harvest Protein extraction Purification, enrichment, stabilization Complex mixture of proteolytic enzymes Images modified from Labster theory and bioinfo Healthy skin Damaged skin Selective enzymes quickly target only non-viable tissue Viable tissues preserved; healing begins Proprietary IP protected manufacturing process

6 Multibillion Dollar Portfolio Indication: Eschar removal of deep partial and full thickness burns Classification: Orphan biological drug Target users: Hospitalized patients Substantial U.S. government support Development status: FDA/EU/JP approved NexoBrid® Disruptive therapy for burn care Indication: Debridement of chronic / hard-to-heal wounds Classification: Biological drug - optimized for outpatient setting Development status: Phase III ready EscharEx® Next-gen enzymatic therapy for wound care** Indication: Treatment of non-melanoma skin cancers Classification: Biological drug - optimized for outpatient setting Development status: Phase I/II MW005 Biotherapy for non-melanoma skin cancers** Pipeline Commercial *TAM - targeted addressable market; Source: Oliver Wyman market research **Investigational drug TAM* (U.S.): >$2B >$300M TAM* (U.S.): >$1B TAM* (U.S.): Pipeline

Burn eschar removal in adults Pediatric indication for burns Expanded access protocol Sulfur mustard injuries Battlefield treatment Debridement of VLUs Debridement of VLU/DFU/post-op Pharmacology study VLU/DFU BCC (topical) Tissue disorders (injectable) 7 Pipeline Development Phase I Phase II Phase III Registration Market MW005 MW003 Approved Study completed On-going DoD funded P2 Study completed P2 Study completed P1/2 On-going P1 ready P3 ready – initiation in H2/2023 BARDA funded

8 Upcoming Milestones 2023 Phase I/II results MW005 Phase I/II data 2024 NexoBrid® US commercial launch FDA approval FDA pediatric label extension submission Marketing approval in JP/IN EU pediatric label extension approval Meetings with FDA EscharEx® CHMP scientific advice Phase III initiation Phase II results JP/IN commercial launch 2022 FDA feedback on Phase III protocol

Financial Highlights 9 * Cash, cash equivalents and short-term bank deposits $57M in cash* as of December 31, 2022 Cash runway - through profitability High quality investor base BALANCE SHEET 2022 revenues of ~$26.5M NexoBrid is profitable 2023 Product revenues >30% growth 2023 Product gross margin >50%; scale-up drives further increase REVENUES Global expansion via strategic collaborations (Vericel, Kaken, BSV, GAG) Up to $216M support by BARDA EU direct sales force; focus on EU-5 (CAGR >20%) COMMERCIALIZATION MDWD ANALYSTS: Josh Jennings, MD, Cowen Francois Brisebois, Oppenheimer Jason McCarthy, Ph.D, Maxim Swayampakula Ramakanth, PhD, HCW David Bouchey, Aegis

Early, effective and selective non-surgical eschar removal for severe burns Approved in the U.S., EU, JP, IN; 12,000 patients treated globally to date Validated & commercialized

11 Clear Unmet Need for Early, Effective and Selective Non-Surgical Eschar Removal in Severe Burns Eschar removal is the 1st critical step in burn care Loss of healthy tissue & blood Current practice* is traumatic & non-selective 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 *current non-surgical eschar removal has limited efficacy, and requires multiple dressing changes

12 Indicated for eschar removal of deep-partial & full-thickness thermal burns A sterile mixture of proteolytic enzymes Effectively removes eschar within 4 hours without harming viable tissue or blood loss Allows for early visual assessment of the wound 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 III Studies Demonstrate Superiority Incidence of complete eschar removal P<0.0001 Time to complete eschar removal 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 SOC® NexoBrid® SOC NexoBrid® Gel Vehicle [N=175] [N=175] [N=175] [N=175] Consistent with EU Phase III study & pediatrics Phase III study No safety issues after 24 month follow-up Non-inferiority in time to complete wound closure & scarring NexoBrid® SOC 815ml 14ml

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

Modalities by Efficacy and Convenience Modalities by Wound Type (U.S.)* Efficacy Trained Specialist Untrained HCP/ Nurses Ultrasonic Hydrosurgery Biological Sharp Enzymatic Autolytic 29% 29% Legend 15 Approaches in Chronic Wound Debridement are abundant but sub-optimal *Source: OW Primary Research (6/2022) | VLU – Venus Leg Ulcers | DFU – Diabetic Foot Ulcer Surgical

16 Targeting debridement of chronic and hard-to-heal wounds Investigational drug containing a sterile mixture of proteolytic enzymes Debrides chronic wounds in 4-6 daily applications Next-Generation Enzymatic Debridement - Wound Bed Preparation within Days Inline 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 ®

17 Average # of applications Time to complete debridement EscharEx - 9 days vs. NSSOC - 59 days P<0.001 P = 0.016 # of Days EscharEx NSSOC % of subjects Incidence of complete debridement EscharEx vs. Non-Surgical SOC Incidence of complete debridement P <0.001 No safety issues | Consistent with two additional phase II studies Current enzymatic treatment has limited efficacy and is slow acting EscharEx® Phase II Studies - High Efficacy vs. SOC Primary Endpoint P = 0.004 EscharEx® Gel Vehicle EscharEx® NSSOC EscharEx® NSSOC N = 46 N = 43 N = 46 N = 30 N = 29 N = 21

18 *Source: OW Primary Research (6/2022) 29% 55% Market potential growth EscharEx® anticipated to draw share from all other debridement modalities 2.1M patients VLU: 1.0M | DFU: 1.1M 400K patients 1.3M patients VLU: 560K DFU: 770K 2022 Epidemiology Estimate TAM - $2B 30% expected market share 70% eligible debridement EscharEx® U.S. Market Opportunity* Cost of treatment: 1,500-1,800$

19 EscharEx® Phase III Study in VLU Patients STUDY OBJECTIVES To assess safety and efficacy of EscharEx compared to Gel Vehicle in VLUs A global (USA, EU, Israel), randomized, double blind, adaptive design study in patients with VLUs Two arms: EscharEx vs. Gel Vehicle, 1:1 ratio Sample size: 244 VLU patients, Interim assessment after 160 patients Treatment: up to 8 applications of 24 hours each Overall duration: up to 25 weeks STUDY DESIGN Co-primary*: Secondary: ENDPOINTS Safety: Time to complete debridement Incidence of complete granulation tissue Wound area reduction Incidence of complete debridementTime to wound closure Safety & tolerability | Change in pain | Immunogenicity Incidence of wound closure (*) Co-primary endpoints are supported by Phase II data: Incidence of complete debridement: 63% vs. 30% (p=0.004) Time to wound bed prepared for closure: 11 days vs. 85 days (p=0.002)

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.

21 Novel Biotherapy for Non-Melanoma Skin Cancer MW005 Before After The Market 4.3M annual cases of Basal Cell Carcinomas diagnosed in the US Surgery is the SOC; topical products have high AEs & recurrence rates The Product Investigational drug containing a sterile mixture of proteolytic enzymes Easy to use, high potency, 5-7 topical applications US Phase I/II study, demonstrated efficacy, safety and tolerability MW005

$26.5M revenues mainly from non-products NexoBrid® FDA approved Robust EscharEx® Phase II results $42M in cash 22 Investment Highlights 2022 2023 2024-5 2026-7 $27.5M financing EscharEx® Phase III initiation Scale-up manufacturing facility NexoBrid® Product revenue growth >30% MW005 Phase I/II results $30-40M Revenues from products Additional revenues (BARDA, DoD) Gross Margin >60% EscharEx® approval Cashflow positive >$100M Revenues with contribution from EscharEx®