Developing Breakthrough
Non-Surgical Therapies;
Improving Patient Lives
August 2022 I Nasdaq: MDWD
Cautionary Note Regarding Forward-Looking Statements
MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions. Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, expected data timing, objectives anticipated timelines, expectations and commercial potential of our products and product candidates. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; the approval of regulatory submission by the European Medicines Agency or by any other regulatory authority, our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; risks related to our contracts with BARDA; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the COVID-19 pandemic. For example, we are unable to predict how the pandemic will affect the overall healthcare infrastructure, including the ability to recruit patients, the ability to conduct the studies in medical sites and the pace with which governmental agencies, such as the FDA, will review and approve regulatory submissions. Additional government-imposed quarantines and requirements to "shelter at home" or other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future. 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, 2021, filed with the Securities and Exchange Commission ("SEC") on March 17, 2022, Quarterly Reports on Form 6-K 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
Trademarks included herein are the property of the owners thereof and are used for reference purposes only. Such use should not be construed as an endorsement of the products or services of the Company. Certain data in this presentation, including the market research data contained on slides 4, 22, 23, 24 and 26, was obtained from various external sources, and neither the Company nor its affiliates, advisers or representatives has verified such data with independent sources. Accordingly, neither the Company nor any of its affiliates, advisers or representatives makes any representations as to the accuracy or completeness of that data or to update such data after the date of this presentation. Such data involves risks and uncertainties and is subject to change based on various factors.
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 International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board. None of the consolidated financial statements incorporated by reference into this presentation were prepared in accordance with generally accepted accounting principles in the United States.
The information contained herein does not constitute a prospectus or other offering document, nor does it constitute or form part of any invitation or offer to sell, or any solicitation of any invitation or offer to purchase or subscribe for, any securities of MediWound or any other entity, nor shall the information or any part of it or the fact of its distribution form the basis of, or be relied on in connection with, any action, contract, commitment or relating thereto or to the securities of MediWound.
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Committed to innovation; developing breakthrough therapies, dedicated
to improving patient care
Innovative Biotherapeutic Company
Next generation non-surgical solutions for tissue repair and regeneration
Proprietary enzymatic technology platform
Clinically and commercially validated bioactive therapies;
100+ peer reviewed publications, 13 successful clinical studies, MA in 41 countries
Diversified and differentiated portfolio
Targeting unmet medical needs; multi-billion$ addressable markets
Supported by strategic collaborations
BARDA, Vericel (US) and Kaken (Japan)
cGMP certified sterile manufacturing facility
Proven management team with vast pharmaceutical experience and extensive capabilities
3
Portfolio of Advanced Therapies
EscharEx® | ||||||
Next-gen enzymatic therapy for wound care** | ||||||
Indication: Debridement of chronic/hard-to-heal wounds | ||||||
Classification: Biological drug candidate | ||||||
Target users: Outpatient setting | ||||||
NexoBrid® | ||||||
Development status: Phase II studies completed | ||||||
Disruptive therapy for burn care | ||||||
TAM* (U.S.): >$2 billion | ||||||
Indication: Eschar removal of deep partial and full | ||||||
thickness burns | ||||||
Classification: Orphan biological drug | ||||||
Target users: Hospitalized patients | Commercial | Pipeline | ||||
MW005 | ||||||
Substantial U.S. government support | ||||||
Biotherapy for non-melanoma skin cancers** | ||||||
Development status: EU and international market | ||||||
approvals in hand; registration-stage in U.S. | Indication: Treatment of non-melanoma actinic skin | |||||
TAM* (U.S.): >$200 million | cancers | |||||
Classification: Biological drug candidate | ||||||
Target users: Outpatient setting | ||||||
Development status: Phase I/II study underway | ||||||
Bromelain-based mixture | ||||||
of enzymes extracted | TAM* (U.S.): >$1 billion | |||||
from the pineapple stem | ||||||
*TAM - targeted addressable market; source: Oliver Wyman market research | 4 |
**Investigational Drug; not approved in any jurisdiction | |
Roadmap and Catalysts
2023
EscharEx® | |||||
Pharmacology | Meeting with | Scientific | Phase III | ||
Phase II | |||||
results | Phase II readout | FDA | Advise (EMA) |
NexoBrid® | ||||
Pediatric label | Marketing | BLA | Pediatric label | |
BLA | ||||
resubmission | extension submission | approval in | approval | extension |
acceptance | (EMA) | Japan | submission (FDA) |
MW005 | POC series studies | Phase I/II initial data | Phase I/II results | Phase II |
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MediWound Ltd. published this content on 09 August 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 09 August 2022 11:45:04 UTC.