MediWound Provides Corporate Update and Financial Outlook Ahead of the J.P. Morgan Healthcare Conference

Rhea-AI Summary

MediWound (Nasdaq: MDWD) provided a corporate update ahead of the J.P. Morgan Healthcare Conference outlining clinical and operational progress and updated financial outlooks. Key points: EscharEx VALUE Phase III enrollment targets 216 patients across ~40 U.S./EU sites with an interim assessment and enrollment completion expected by year-end 2026; Phase II in diabetic foot ulcers planned for H2 2026 and an investigator-initiated pressure‑ulcer study planned for mid‑2026. The expanded NexoBrid facility is fully operational with a sixfold capacity increase; regulatory approvals are targeted in 2026. Fiscal highlights: 2025 revenue $17M, cash $54M, no debt, and updated revenue guidance of $24–26M (2026), $32–35M (2027), and $50–55M (2028).

Positive

• Updated revenue guidance to $24–26M in 2026
• Three‑year revenue pathway to $50–55M in 2028
• Expanded NexoBrid capacity increased sixfold
• Cash balance of $54M with no debt
• EscharEx VALUE Phase III targeting 216 patients across ~40 sites

Negative

• Fourth‑quarter revenue recognition was delayed due to a U.S. government shutdown
• NexoBrid market availability remains contingent on regulatory approvals expected in 2026
• Guidance assumes continued support from BARDA and DoD, creating dependency on government programs

News Market Reaction – MDWD

-7.86%

7 alerts

-7.86% News Effect

-2.2% Trough in 14 min

-$19M Valuation Impact

$223M Market Cap

1.2x Rel. Volume

On the day this news was published, MDWD declined 7.86%, reflecting a notable negative market reaction. Argus tracked a trough of -2.2% from its starting point during tracking. Our momentum scanner triggered 7 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $19M from the company's valuation, bringing the market cap to $223M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

2025 Revenue: $17 million 2026 Guidance: $24–26 million 2027 Guidance: $32–35 million +5 more

8 metrics

2025 Revenue $17 million Full year 2025 revenue

2026 Guidance $24–26 million Updated 2026 revenue guidance

2027 Guidance $32–35 million Updated 2027 revenue guidance

2028 Guidance $50–55 million Updated 2028 revenue outlook

Cash position $54 million Cash, cash equivalents and deposits as of Dec 31, 2025

VALUE trial size 216 patients EscharEx VALUE Phase III trial in venous leg ulcers

Trial sites ≈40 sites U.S. and Europe sites for VALUE Phase III VLU study

Capacity increase Sixfold NexoBrid manufacturing capacity after facility expansion

Market Reality Check

Price: $18.15 Vol: Volume 70,566 is slightly...

normal vol

$18.15 Last Close

Volume Volume 70,566 is slightly below 20-day average of 78,661 (relative volume 0.9). normal

Technical Shares trade slightly above the 200-day MA of 18.48, at a price of 18.7.

Peers on Argus

MDWD fell 3.11% while peers were mixed: HRTX rose 8.59%, NTHI was flat, and TLSA...

MDWD fell 3.11% while peers were mixed: HRTX rose 8.59%, NTHI was flat, and TLSA, TNYA, TRDA declined between 0.57% and 5.65%. The blend of gains and losses suggests stock-specific factors rather than a broad sector move.

Historical Context

5 past events · Latest: Dec 10 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 10	Clinical data update	Positive	+3.8%	Peer-reviewed data showed strong NexoBrid efficacy in traumatic tattoo prevention.
Nov 20	Earnings & update	Neutral	-5.6%	Q3 2025 revenue growth and facility progress alongside equity raise and ongoing losses.
Nov 05	Earnings announcement	Neutral	+1.4%	Scheduled date and call details for upcoming Q3 2025 financial results release.
Nov 03	Manufacturing milestone	Positive	-0.1%	Completion of expanded GMP facility to enable sixfold NexoBrid capacity pending reviews.
Sep 29	Equity offering	Negative	+0.5%	$30M registered direct offering of ordinary shares to institutional investors.

Pattern Detected

Recent news often shows divergence: positive clinical or operational updates and even a dilutive offering did not consistently translate into sustained gains, with several events seeing flat or negative reactions.

Recent Company History

Over the past few months, MediWound reported multiple milestones. On Sep 29–30, 2025, it announced and registered a $30M direct offering, followed by commissioning of an expanded NexoBrid facility on Nov 3, 2025 aiming for a sixfold capacity increase. Q3 2025 results on Nov 20, 2025 highlighted $5.4M revenue and equity financing to bolster cash. Clinical data for NexoBrid in traumatic tattoos on Dec 10, 2025 were positive. Today’s multi‑year revenue outlook and pipeline update build directly on that manufacturing and clinical groundwork.

Market Pulse Summary

The stock moved -7.9% in the session following this news. A negative reaction despite clearer revenu...

Analysis

The stock moved -7.9% in the session following this news. A negative reaction despite clearer revenue visibility would fit past divergence patterns, where operational or financial milestones did not always produce lasting gains. The update details $17M in 2025 revenue, a $54M cash position, and rising guidance up to $50–55M for 2028, plus expanded NexoBrid capacity. Pressure could have reflected skepticism on long timelines to 2026–2028 milestones or sensitivity to prior equity issuance, rather than the absence of stated growth plans.

Key Terms

phase iii, phase ii, investigator-initiated trial, venous leg ulcers, +4 more

8 terms

phase iii medical

"Enrollment continues in the VALUE global Phase III study of EscharEx in VLUs"

A Phase III trial is the late-stage clinical study that tests whether a medical treatment works and is safe in a large group of patients, often comparing it to standard care. Think of it as a final dress rehearsal or full-scale road test before regulators decide on approval; positive or negative results strongly influence a drug maker’s chance to sell the treatment, future revenue, and investment risk.

phase ii medical

"plans to initiate a Phase II study of EscharEx in DFUs in the second half of 2026"

Phase II is the mid-stage clinical trial where a potential drug or medical treatment is tested in a larger group of patients to see if it works and to help determine the best dose and common side effects. For investors, Phase II results matter because they give the first meaningful evidence about effectiveness and safety—like a road test that shows whether a product has real promise before a much bigger, costly final trial and potential regulatory approval.

investigator-initiated trial medical

"A prospective, single-arm investigator-initiated trial (IIT) to evaluate the safety and efficacy"

A clinical study led and managed by an independent researcher or physician rather than the company that makes the drug or device; the investigator designs the protocol, runs the study at their site(s), and often controls the data even if the company supplies the product or funding. For investors, these trials can produce important third‑party validation or new uses for a product — like an independent test drive revealing strengths or limits — and their outcomes can change a product’s commercial and regulatory prospects.

venous leg ulcers medical

"Phase III trial in venous leg ulcers (VLUs) expected by year-end 2026"

A venous leg ulcer is an open sore on the lower leg that develops when veins fail to return blood effectively, causing long-term swelling and skin breakdown—think of it as a persistent pothole where poor drainage keeps making the surface worse. Investors track these wounds because they create sustained demand for treatments, dressings, devices and home-care services, affect healthcare spending and reimbursement patterns, and can drive sales and regulatory interest in new therapies.

diabetic foot ulcers medical

"plans to initiate a Phase II study of EscharEx in DFUs in the second half of 2026"

A diabetic foot ulcer is an open sore or wound on the foot that occurs when high blood sugar and nerve damage prevent normal healing, much like a small pothole that keeps widening because the road can’t be properly repaired. It matters to investors because these wounds drive demand for treatments, medical devices, wound-care drugs and hospital services, and they carry risks of infection and amputation that can shape healthcare costs, reimbursement decisions and clinical trial opportunities.

pressure ulcers medical

"trial (IIT) to evaluate the safety and efficacy of EscharEx in PUs is planned"

Pressure ulcers are areas of skin and underlying tissue damage that develop when constant pressure or friction cuts off blood flow, like a bruise that gets worse when a spot is pressed for too long. Investors track them because they signal care quality, drive treatment and legal costs, affect hospital and nursing-home ratings, and influence reimbursement and regulatory scrutiny—factors that can change a health provider’s revenue and reputation.

u.s. food and drug administration regulatory

"regulatory feedback on trial design and development strategy from both the U.S. Food and Drug Administration (FDA)"

The U.S. Food and Drug Administration is the federal agency that evaluates and enforces safety, effectiveness and labeling standards for medicines, medical devices, vaccines, food and related products before they reach consumers. For investors it matters because FDA approvals, warnings or recalls determine whether a product can be sold, how quickly it reaches the market and how costly compliance will be—changes that directly affect a company’s revenue, costs and stock value.

european medicines agency regulatory

"regulatory feedback on trial design and development strategy from both the ... European Medicines Agency (EMA)"

The European Medicines Agency is the central drug regulator that evaluates and authorizes medicines for use across the European Union and related countries, similar to a referee or safety inspector who checks that a medicine is safe and effective before it can be sold. Its decisions matter to investors because approvals, rejections, or safety warnings directly affect a drug maker’s ability to sell products, generate revenue, and face legal or reputational risks, which in turn influence stock value.

AI-generated analysis. Not financial advice.

MediWound Provides Corporate Update and Financial Outlook Ahead of the J.P. Morgan Healthcare Conference

Interim assessment and enrollment completion for the EscharEx^® VALUE Phase III trial in venous leg ulcers (VLUs) expected by year-end 2026; expansion to diabetic foot ulcers (DFUs) and pressure ulcers (PUs) anticipated in 2026

Expanded NexoBrid^® manufacturing facility fully operational; regulatory approvals targeted for 2026

$17 million in 2025 revenue; financial guidance updated to $24–26 million (2026), $32–35 million (2027), and $50–55 million (2028); $54 million cash position

YAVNE, Israel, January 12, 2026 -- MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for tissue repair, today provided a corporate and financial update ahead of its participation in the J.P. Morgan Healthcare Conference.

“As we enter 2026, we are encouraged by the momentum we’ve built as we continue to execute on our growth strategy, with meaningful progress across both our clinical pipeline and operational platform,” said Ofer Gonen, Chief Executive Officer of MediWound. “Over the past year, we advanced our Phase III VALUE trial toward key milestones, positioned the EscharEx^® program for expansion into additional chronic wound indications, strengthened our balance sheet, and completed the expansion of our NexoBrid^® manufacturing facility, which is now fully operational. While U.S. government shutdown–related delays impacted revenue recognition in our fourth quarter results, and certain activities are still pending, we believe these effects are timing-related, and that we now have the key elements in place to continue executing our strategy, as reflected in our revised three-year revenue guidance.”

Corporate Updates, Recent Developments, and Upcoming Milestones

EscharEx^®

• Enrollment continues in the VALUE global Phase III study of EscharEx in VLUs, targeting 216 patients across approximately 40 sites in the U.S. and Europe, the majority of which are active and recruiting. The pre-specified interim sample-size assessment and enrollment completion are expected by year-end 2026.
• Following constructive and aligned regulatory feedback on trial design and development strategy from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), the Company plans to initiate a Phase II study of EscharEx in DFUs in the second half of 2026.
• A prospective, single-arm investigator-initiated trial (IIT) to evaluate the safety and efficacy of EscharEx in PUs is planned to initiate in mid-2026.
• The EscharEx program is supported by collaborations with leading global wound care companies, including Coloplast, Convatec, Essity, Mölnlycke, Solventum, and MiMedx, reflecting strong industry validation of the program.

NexoBrid^®

• The expanded NexoBrid manufacturing facility is now fully operational, increasing production capacity sixfold to support growing global demand; market availability remains subject to completion of regulatory reviews and approvals, which are expected in 2026.
• Following the resolution of the recent U.S. government shutdown, MediWound currently believes that discussions between Vericel and the Biomedical Advanced Research and Development Authority (BARDA) regarding a potential multi-year program may progress toward completion during the first quarter of 2026. If completed and signed, the program would include stockpiling, development of a room-temperature-stable formulation of NexoBrid, and evaluation of an enzymatic debridement product for trauma, blast-injury, and friction-burn indications.

Financial

• Revenue for the full year 2025 totaled $17 million.
• Cash, cash equivalents, and deposits as of December 31, 2025 totaled $54 million, with no debt.
• Updated revenue guidance projects $24–26 million in 2026, $32–35 million in 2027, and $50–55 million in 2028. All guidance periods assume continued support from BARDA and the U.S. Department of Defense. The 2028 outlook also assumes a potential initial contribution related to EscharEx, subject to regulatory approval.
  
  

About MediWound

MediWound Ltd. (Nasdaq: MDWD) is a global biotechnology company pioneering enzymatic, non-surgical therapies 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, European Union, Japan, and additional international markets. MediWound’s late-stage pipeline product, EscharEx^®, is an investigational therapy for the debridement of chronic wounds, with 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).

Preliminary and Unaudited Nature of Reported Results

Our revenue expectations for full year ended 2025, as well as our estimates concerning cash, restricted cash and investments 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, 2025. Accordingly, you should not place undue reliance on this preliminary estimate.

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, including EscharEx^® and 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 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; 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; 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 current global macroeconomic climate 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, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 19, 2025 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 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.

MediWound Contacts:
Hani Luxenburg         Chief Financial Officer MediWound Ltd. ir@mediwound.com		Daniel Ferry Managing Director LifeSci Advisors, LLC daniel@lifesciadvisors.com

FAQ

What revenue guidance did MediWound (MDWD) provide for 2026–2028?

MediWound updated revenue guidance to $24–26M for 2026, $32–35M for 2027, and $50–55M for 2028.

How much cash did MediWound report as of December 31, 2025 (MDWD)?

MediWound reported $54 million in cash, cash equivalents, and deposits and noted no debt.

What is the timing for the EscharEx VALUE Phase III interim assessment for MDWD?

The pre‑specified interim sample‑size assessment and enrollment completion for EscharEx VALUE are expected by year‑end 2026.

When does MediWound plan to start EscharEx studies in diabetic foot ulcers and pressure ulcers (MDWD)?

A Phase II study in diabetic foot ulcers is planned for second half of 2026 and an investigator‑initiated pressure‑ulcer trial is planned to initiate in mid‑2026.

What changed for NexoBrid manufacturing and availability for MDWD?

The expanded NexoBrid manufacturing facility is now fully operational with a sixfold capacity increase; market availability remains subject to regulatory reviews expected in 2026.

How did the U.S. government shutdown affect MediWound's results (MDWD)?

The company said U.S. government shutdown–related delays impacted revenue recognition in the fourth quarter, which it characterized as timing‑related.