STOCK TITAN

MediWound Awarded Additional $3.3 Million from U.S. Department of War to Advance Room-Temperature-Stable Formulation of NexoBrid®

New U.S. Department of War funding expands the NexoBrid room-temperature program to $21.8 million and supports work toward an IND submission.

(Neutral)
(Very Positive)
Tags

MediWound (MDWD) received an additional $3.3 million in non-dilutive funding from the U.S. Department of War to advance a room-temperature-stable formulation of NexoBrid for battlefield burn care.

This award increases the total development program budget to $21.8 million and is intended to support progress through submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration. MediWound plans to complete CMC development, establish in-house cGMP manufacturing capabilities, and produce clinical batches for the planned clinical program. The program is within MediWound’s existing North American license agreement with Vericel (VCEL), which holds exclusive commercial and development rights to NexoBrid in North America.

Loading...
Loading translation...

Positive

  • $3.3 million additional non-dilutive funding from U.S. Department of War
  • Total room-temperature NexoBrid program budget raised to $21.8 million
  • Funding intended to support development through IND submission to FDA
  • Program includes building in-house cGMP manufacturing and clinical batches

Negative

  • None.

Market Context

The -14.09% reaction on May 27 followed a related MediWound update involving government-backed NexoB...
Analysis

The -14.09% reaction on May 27 followed a related MediWound update involving government-backed NexoBrid support, providing precedent for this additional non-dilutive funding while showing the earlier announcement diverged from its positive development.

Key Figures

Additional funding: $3.3 million Total program budget: $21.8 million IND submission: IND application
Additional funding
$3.3 million
Non-dilutive Department of War award
Total program budget
$21.8 million
After supplemental award
IND submission
IND application
Planned development milestone for the room-temperature-stable formulation

Historical Context

2 past events · Latest: Aug 13
2 events
  1. Aug 13

    Q2 earnings report

    24h Move
    -2.7%

    Weaker revenue and operating results accompanied Vericel BARDA-related revenue expectations.

  2. May 27

    NexoBrid BARDA contract

    24h Move
    -14.1%

    Vericel received a BARDA contract supporting NexoBrid procurement and future revenue.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

non-dilutive funding, investigational new drug (ind), cmc, cgmp
4 terms
non-dilutive funding financial
"an additional $3.3 million in non-dilutive funding"
Non-dilutive funding is money a company raises that does not require issuing new shares or reducing existing owners’ percentage ownership, such as grants, certain loans, contract revenue, or licensing deals. It matters to investors because it lets a company finance growth or research without shrinking shareholder stakes or changing control, much like topping up a car’s gas tank instead of selling part of the car to pay for the trip.
investigational new drug (ind) regulatory
"through submission of an IND application to the U.S. Food and Drug Administration"
An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.
cmc technical
"Our focus is now on completing CMC development"
Chemistry, Manufacturing, and Controls (CMC) describes the technical documentation and processes that show how a drug or medical product is made, tested for consistent quality, and kept stable from batch to batch. Investors care because strong CMC means a product can be manufactured reliably at scale and meet regulatory standards—similar to proving a recipe can be cooked the same way in any kitchen before restaurants expand—affecting approval, production costs, and potential revenue.
cgmp regulatory
"establishing in-house cGMP manufacturing capabilities"
cGMP (current Good Manufacturing Practice) are government-enforced quality standards that manufacturers must follow to ensure drugs, medical devices, and related products are made consistently, safely, and meet specified quality tests. For investors, cGMP compliance is like a restaurant passing health inspections: it reduces the risk of product recalls, regulatory fines, or production stoppages that can hurt revenue and company value, and it supports market access and long-term trust.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google
Add on Google

MediWound Awarded Additional $3.3 Million from U.S. Department of War to Advance Room-Temperature-Stable Formulation of NexoBrid®

Award raises the total program budget to $21.8 million and supports development through Investigational New Drug (IND) submission for battlefield burn care

YAVNE, Israel, September 22, 2026MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for tissue repair, today announced that the U.S. Department of War (DoW) has awarded the Company an additional $3.3 million in non-dilutive funding to advance the development of a room-temperature-stable formulation of NexoBrid® as a non-surgical debridement solution for battlefield burn care.

The supplemental award raises the total program budget to $21.8 million. The program is intended to support development of the room-temperature-stable formulation through submission of an IND application to the U.S. Food and Drug Administration.

“A room-temperature-stable formulation of NexoBrid is designed to simplify storage and handling requirements and enable the use of non-surgical enzymatic debridement in battlefield and other austere settings, where access to surgical capabilities and cold-chain infrastructure may be limited,” said Ofer Gonen, Chief Executive Officer of MediWound. “This additional funding supports the next stage of development toward an IND submission. Our focus is now on completing CMC development, establishing in-house cGMP manufacturing capabilities, and producing clinical batches to support the clinical program.”

The room-temperature-stable NexoBrid development program is within the scope of MediWound’s existing North American license agreement with Vericel Corporation (Nasdaq: VCEL). Under the agreement, Vericel holds exclusive commercial and development rights to NexoBrid in North America.

About MediWound

MediWound Ltd. (Nasdaq: MDWD) is a global leader in next-generation enzymatic therapeutics for tissue repair. The company’s FDA-approved biologic, NexoBrid®, is indicated for the enzymatic removal of eschar in thermal burns and is marketed in the United States, the European Union, Japan, and additional international markets. MediWound’s late-stage development candidate, EscharEx®, is an investigational therapy for the debridement of chronic wounds, with the potential to become a new standard of care in wound management.

For more information, visit www.mediwound.com and follow us on LinkedIn and X (formerly Twitter).

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 the expectations reflected in such forward-looking statements are reasonable, 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, including NexoBrid®. 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 review and approval of regulatory submission by the FDA, 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; our contracts with governmental agencies, including risks associated with government-funded programs such as the potential for termination for convenience, modification, non-renewal, or reduction of government awards, and the risk that government funding may be affected by budget sequestration, changes in government priorities, or failure of Congress to appropriate funds; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products candidates; the interpretation and applicability of third-party publications or clinical data to our product candidates; our expectations regarding future growth, including our ability to develop new products; 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 global macroeconomic conditions on 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, 2025, filed with the Securities and Exchange Commission (“SEC”) on March 5, 2026, and 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 does not undertake, 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.


MediWound Contacts:
   
Hani Luxenburg
Chief Financial Officer
MediWound Ltd.
ir@mediwound.com

 Daniel Ferry
Managing Director
LifeSci Advisors, LLC
daniel@lifesciadvisors.com
 



FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What is the goal of the room-temperature-stable formulation of NexoBrid?

The room-temperature-stable formulation of NexoBrid is designed to simplify storage and handling and enable non-surgical enzymatic debridement in battlefield and other austere settings where access to surgical capabilities and cold-chain infrastructure may be limited.

How will MediWound use the new funding in the NexoBrid program?

MediWound intends to use the funding to complete CMC development, establish in-house cGMP manufacturing capabilities, and produce clinical batches to support the clinical program for the room-temperature-stable NexoBrid formulation.

What rights does Vericel (VCEL) have in relation to NexoBrid in North America?

Under MediWound’s existing North American license agreement, Vericel holds exclusive commercial and development rights to NexoBrid in North America, and the room-temperature-stable NexoBrid development program falls within the scope of this agreement.

What is NexoBrid currently approved for and where is it marketed?

NexoBrid is an FDA-approved biologic indicated for the enzymatic removal of eschar in thermal burns and is marketed in the United States, the European Union, Japan, and additional international markets.

Keep reading