|
Date: November 20, 2025
|
MEDIWOUND LTD.
By: /s/ Hani Luxenburg
Name: Hani Luxenburg
Title: Chief Financial Officer
|
| Exhibit | Description |
| 99.1 |
|
|
• |
Enrollment continues to advance in VALUE, a global Phase III study of EscharEx in venous leg ulcers (VLUs), targeting 216 patients across approximately 40 sites in the U.S. and Europe, the majority of which are already active. The
co-primary endpoints are the incidence of complete debridement and the facilitation of wound closure. A pre-specified interim sample-size assessment is planned after 65% of patients complete treatment.
|
|
|
• |
Following constructive FDA feedback aligning on trial design and development strategy, the Company expects to initiate its clinical trial in diabetic foot ulcers (DFU) in the second half of 2026.
|
|
|
• |
An updated market access and pricing assessment conducted by an independent global consulting firm estimated a peak sales opportunity of approximately $831 million for EscharEx. The estimate reflects updated clinical data and modeled
health-economic considerations.
|
|
|
• |
U.S. adoption continues to expand, with Vericel reporting NexoBrid’s highest quarterly revenue since launch, up 38% year-over-year and 26% sequentially. Vericel reported broad utilization across more than 60 burn centers and plans to
pursue a permanent CPT code, which would become effective in 2027.
|
|
|
• |
Commissioning of the expanded NexoBrid manufacturing facility has been completed. The facility is expected to reach full operational readiness by year-end 2025, increasing production capacity sixfold to
|
|
|
• |
support growing global demand. Market availability remains subject to the completion of regulatory reviews.
|
|
|
• |
The Therapeutic Goods Administration (TGA) approved NexoBrid for use in Australia for both adult and pediatric burn patients, expanding approved markets to 45 countries worldwide.
|
|
|
• |
Raised $30 million in equity financing from healthcare-focused investors, providing capital to advance the Company’s development programs and commercialization initiatives.
|
|
|
• |
Revenue for the third quarter of 2025 was $5.4 million, compared to $4.4 million for the same period in 2024. The increase was primarily driven by higher development service revenue, reflecting additional contracts with the U.S. Department
of Defense (DoD).
|
|
|
• |
Gross profit was $0.9 million, or 16.5% of total revenue, compared to $0.7 million, or 15.5% of total revenue, in the prior-year period.
|
|
|
• |
Research and development expenses were $3.5 million, compared to $2.5 million in the same period of 2024, driven by increased investment in the EscharEx VALUE Phase III trial and related clinical activities.
|
|
|
• |
Selling, general and administrative expenses were $4.0 million, compared to $3.2 million in the same period of 2024, primarily due to increased marketing authorization holder expenses.
|
|
|
• |
Operating loss was $6.5 million, compared to $5.1 million for the same period in 2024.
|
|
|
• |
Net loss was $2.7 million, or $0.24 per share, compared to a net loss of $10.3 million, or $0.98 per share, in the third quarter of 2024. The reduction in net loss was primarily driven by non-cash financial income from the revaluation of
warrants in the third quarter of 2025, compared to non-cash financial expenses from the revaluation of warrants in the same quarter last year.
|
|
|
• |
Non-GAAP Adjusted EBITDA loss was $5.4 million, compared to a loss of $3.7 million in the prior-year quarter.
|
|
|
• |
Revenue for the first nine months of 2025 was $15.1 million, compared to $14.4 million in the same period of 2024.
|
|
|
• |
Gross profit was $3.0 million, or 19.7% of total revenue, compared to $1.7 million, or 12.0% of total revenue, in the first nine months of 2024. The margin improvement primarily reflects a more favorable revenue mix.
|
|
|
• |
Research and development expenses were $9.8 million, compared to $5.9 million for the same period in 2024.
|
|
|
• |
Selling, general and administrative expenses were $10.6 million, compared to $9.1 million in the first nine months of 2024.
|
|
|
• |
Operating loss was $17.5 million, compared to $13.3 million for the same period in 2024.
|
|
|
• |
Net loss was $16.7 million, or $1.53 per share, compared to $26.3 million, or $2.72 per share, in the first nine months of 2024. The reduction in net loss was primarily driven by non-cash financial income from the revaluation of warrants
in 2025, compared to non-cash financial expenses from the revaluation of warrants in the same period of 2024.
|
|
|
• |
Non-GAAP Adjusted EBITDA loss was $13.9 million, compared to a loss of $9.9 million in the same period of 2024.
|
|
MediWound Contacts:
|
|
|
Hani Luxenburg
Chief Financial Officer
MediWound Ltd.
ir@mediwound.com
|
Daniel Ferry
Managing Director
LifeSci Advisors, LLC
daniel@lifesciadvisors.com
|
|
September 30,
|
December 31,
|
|||||||||||
|
2025
|
2024
|
2024
|
||||||||||
|
CURRENT ASSTS:
|
||||||||||||
|
Cash and cash equivalents and short-term deposits
|
59,090
|
45,562
|
43,161
|
|||||||||
|
Trade and other receivable
|
6,038
|
5,304
|
6,310
|
|||||||||
|
Inventories
|
4,405
|
3,022
|
2,692
|
|||||||||
|
Total current assets
|
69,533
|
53,888
|
52,163
|
|||||||||
|
NON-CURRENT ASSETS:
|
||||||||||||
|
Other receivables and long-term restricted bank deposits
|
465
|
484
|
439
|
|||||||||
|
Property, plant and equipment
|
16,715
|
13,453
|
14,132
|
|||||||||
|
Right of use assets
|
7,660
|
6,793
|
6,663
|
|||||||||
|
Intangible assets
|
50
|
116
|
99
|
|||||||||
|
Total non-current assets
|
24,890
|
20,846
|
21,333
|
|||||||||
|
Total assets
|
94,423
|
74,734
|
73,496
|
|||||||||
|
CURRENT LIABILITIES:
|
||||||||||||
|
Current maturities of long-term liabilities
|
1,057
|
726
|
612
|
|||||||||
|
Warrants
|
12,979
|
19,056
|
17,092
|
|||||||||
|
Trade payables and accrued expenses
|
8,510
|
3,131
|
5,281
|
|||||||||
|
Other payables
|
3,708
|
2,664
|
3,556
|
|||||||||
|
Total current liabilities
|
26,254
|
25,577
|
26,541
|
|||||||||
|
NON- CURRENT LIABILITIES:
|
||||||||||||
|
Grants received in advance
|
758
|
-
|
736
|
|||||||||
|
Liabilities in respect of IIA grants
|
8,528
|
8,046
|
8,149
|
|||||||||
|
Lease liabilities
|
8,271
|
6,460
|
6,513
|
|||||||||
|
Severance pay liability, net
|
456
|
416
|
404
|
|||||||||
|
Total non-current liabilities
|
18,013
|
14,922
|
15,802
|
|||||||||
|
Total liabilities
|
44,267
|
40,499
|
42,343
|
|||||||||
|
Shareholders' equity*
|
50,156
|
34,235
|
31,153
|
|||||||||
|
Total liabilities and equity
|
94,423
|
74,734
|
73,496
|
|||||||||
|
Nine months ended
|
Three months ended
|
Year ended
|
||||||||||||||||||
|
September 30,
|
September 30,
|
December 31,
|
||||||||||||||||||
|
2025
|
2024
|
2025
|
2024
|
2024
|
||||||||||||||||
|
Total revenues
|
15,092
|
14,382
|
5,429
|
4,355
|
20,222
|
|||||||||||||||
|
Cost of revenues
|
12,116
|
12,651
|
4,533
|
3,678
|
17,588
|
|||||||||||||||
|
Gross profit
|
2,976
|
1,731
|
896
|
677
|
2,634
|
|||||||||||||||
|
Research and development
|
9,842
|
5,892
|
3,465
|
2,524
|
8,878
|
|||||||||||||||
|
Selling and marketing
|
4,385
|
3,466
|
1,636
|
1,063
|
4,936
|
|||||||||||||||
|
General and administrative
|
6,211
|
5,672
|
2,320
|
2,171
|
8,202
|
|||||||||||||||
|
Other expenses
|
4
|
-
|
-
|
-
|
18
|
|||||||||||||||
|
Operating loss
|
(17,466
|
)
|
(13,299
|
)
|
(6,525
|
)
|
(5,081
|
)
|
(19,400
|
)
|
||||||||||
|
Financing income (expenses), net
|
866
|
(12,974
|
)
|
3,926
|
(5,180
|
)
|
(10,763
|
)
|
||||||||||||
|
Taxes on income
|
(96
|
)
|
(43
|
)
|
(53
|
)
|
(21
|
)
|
(61
|
)
|
||||||||||
|
Net loss
|
(16,696
|
)
|
(26,316
|
)
|
(2,652
|
)
|
(10,282
|
)
|
(30,224
|
)
|
||||||||||
|
Foreign currency translation adjustments
|
(19
|
)
|
3
|
(9
|
)
|
(7
|
)
|
7
|
||||||||||||
|
Total comprehensive loss
|
(16,715
|
)
|
(26,313
|
)
|
(2,661
|
)
|
(10,289
|
)
|
(30,217
|
)
|
||||||||||
|
Basic and diluted net loss per share
|
(1.53
|
)
|
(2.72
|
)
|
(0.24
|
)
|
(0.98
|
)
|
(3.03
|
)
|
||||||||||
|
Number of shares used in calculating basic and diluted loss per share
|
10,886,487
|
9,679,599
|
11,022,459
|
10,511,288
|
9,959,723
|
|||||||||||||||
|
Nine months ended
|
Three months ended
|
Year Ended
|
||||||||||||||||||
|
September 30,
|
September 30,
|
December 31,
|
||||||||||||||||||
|
2025
|
2024
|
2025
|
2024
|
2024
|
||||||||||||||||
|
Cash flows from operating activities:
|
||||||||||||||||||||
|
Net loss
|
(16,696
|
)
|
(26,316
|
)
|
(2,652
|
)
|
(10,282
|
)
|
(30,224
|
)
|
||||||||||
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||||||||||||||
|
Adjustments to profit and loss items:
|
||||||||||||||||||||
|
Depreciation and amortization
|
1,170
|
1,086
|
418
|
361
|
1,483
|
|||||||||||||||
|
Share-based compensation
|
2,446
|
2,316
|
740
|
1,046
|
3,138
|
|||||||||||||||
|
Revaluation of warrants accounted at fair value
|
(1,838
|
)
|
12,668
|
(4,215
|
)
|
4,661
|
10,704
|
|||||||||||||
|
Revaluation of liabilities in respect of IIA grants
|
704
|
711
|
258
|
241
|
752
|
|||||||||||||||
|
Revaluation of liabilities in respect of TEVA
|
-
|
770
|
-
|
564
|
770
|
|||||||||||||||
|
Financing expenses and exchange differences of lease liability
|
1,286
|
238
|
343
|
221
|
487
|
|||||||||||||||
|
Increase (decrease) in severance pay liability, net
|
52
|
(46
|
)
|
(23
|
)
|
(94
|
)
|
(30
|
)
|
|||||||||||
|
Other expenses
|
4
|
-
|
-
|
-
|
18
|
|||||||||||||||
|
Financial income, net
|
(1,341
|
)
|
(1,486
|
)
|
(399
|
)
|
(568
|
)
|
(2,039
|
)
|
||||||||||
|
Unrealized foreign currency loss (gain)
|
(34
|
)
|
74
|
(13
|
)
|
(4
|
)
|
47
|
||||||||||||
|
2,449
|
16,331
|
(2,891
|
)
|
6,428
|
15,330
|
|||||||||||||||
|
Changes in asset and liability items:
|
||||||||||||||||||||
|
Decrease (increase) in trade receivables
|
458
|
285
|
675
|
(468
|
)
|
(1,141
|
)
|
|||||||||||||
|
Decrease (increase) in inventories
|
(1,713
|
)
|
(161
|
)
|
(562
|
)
|
184
|
187
|
||||||||||||
|
Decrease (increase) in other receivables
|
(239
|
)
|
(283
|
)
|
102
|
291
|
120
|
|||||||||||||
|
Increase (decrease) in trade payables and accrued expenses
|
2,409
|
(1,948
|
)
|
1,718
|
(48
|
)
|
406
|
|||||||||||||
|
Increase in grants received in advance
|
-
|
-
|
-
|
-
|
1,181
|
|||||||||||||||
|
Increase in other payables
|
227
|
105
|
371
|
139
|
517
|
|||||||||||||||
|
1,142
|
(2,002
|
)
|
2,304
|
98
|
1,270
|
|||||||||||||||
|
Net cash used in operating activities
|
(13,105
|
)
|
(11,987
|
)
|
(3,239
|
)
|
(3,756
|
)
|
(13,624
|
)
|
||||||||||
|
Nine months ended
|
Three months ended
|
Year Ended
|
||||||||||||||||||
|
September 30,
|
September 30,
|
December 31,
|
||||||||||||||||||
|
2025
|
2024
|
2025
|
2024
|
2024
|
||||||||||||||||
|
Cash flows from investing activities:
|
||||||||||||||||||||
|
Purchase of property and equipment
|
(3,053
|
)
|
(5,467
|
)
|
(1,045
|
)
|
(1,192
|
)
|
(6,273
|
)
|
||||||||||
|
Interest received
|
1,409
|
1,588
|
824
|
461
|
2,252
|
|||||||||||||||
|
Proceeds from (investment in) short-term bank deposits, net
|
7,585
|
(9,346
|
)
|
4,600
|
(13,555
|
)
|
(4,376
|
)
|
||||||||||||
|
Net cash provided by (used in) investing activities
|
5,941
|
(13,225
|
)
|
4,379
|
(14,286
|
)
|
(8,397
|
)
|
||||||||||||
|
Cash flows from financing activities:
|
||||||||||||||||||||
|
Repayment of leases liabilities
|
(867
|
)
|
(686
|
)
|
(330
|
)
|
(228
|
)
|
(928
|
)
|
||||||||||
|
Proceeds from exercise of warrants and share options
|
3,624
|
1,210
|
2,786
|
600
|
1,210
|
|||||||||||||||
|
Proceeds from issuance of shares, net
|
28,169
|
22,436
|
28,169
|
22,436
|
22,165
|
|||||||||||||||
|
Repayment of IIA grants
|
(214
|
)
|
(219
|
)
|
(100
|
)
|
(99
|
)
|
(219
|
)
|
||||||||||
|
Repayment of liabilities in respect of TEVA
|
-
|
(2,834
|
)
|
-
|
(2,000
|
)
|
(2,834
|
)
|
||||||||||||
|
Net cash provided by financing activities
|
30,712
|
19,907
|
30,525
|
20,709
|
19,394
|
|||||||||||||||
|
Exchange rate differences on cash and cash equivalent balances
|
34
|
(86
|
)
|
13
|
18
|
(84
|
)
|
|||||||||||||
|
Increase (decrease) in cash and cash equivalents
|
23,582
|
(5,391
|
)
|
31,678
|
2,685
|
(2,711
|
)
|
|||||||||||||
|
Balance of cash and cash equivalents at the beginning of the period
|
9,155
|
11,866
|
1,059
|
3,790
|
11,866
|
|||||||||||||||
|
Balance of cash and cash equivalents at the end of the period
|
32,737
|
6,475
|
32,737
|
6,475
|
9,155
|
|||||||||||||||
|
Nine months ended
|
Three months ended
|
Year Ended
|
||||||||||||||||||
|
September 30,
|
September 30,
|
December 31,
|
||||||||||||||||||
|
2025
|
2024
|
2025
|
2024
|
2024
|
||||||||||||||||
|
Net loss
|
(16,696
|
)
|
(26,316
|
)
|
(2,652
|
)
|
(10,282
|
)
|
(30,224
|
)
|
||||||||||
|
Adjustments:
|
||||||||||||||||||||
|
Financial income (expenses), net
|
866
|
(12,974
|
)
|
3,926
|
(5,180
|
)
|
(10,763
|
)
|
||||||||||||
|
Other expenses
|
(4
|
)
|
-
|
-
|
-
|
(18
|
)
|
|||||||||||||
|
Taxes on income
|
(96
|
)
|
(43
|
)
|
(53
|
)
|
(21
|
)
|
(61
|
)
|
||||||||||
|
Depreciation and amortization
|
(1,170
|
)
|
(1,086
|
)
|
(418
|
)
|
(361
|
)
|
(1,483
|
)
|
||||||||||
|
Share-based compensation expenses
|
(2,446
|
)
|
(2,316
|
)
|
(740
|
)
|
(1,046
|
)
|
(3,138
|
)
|
||||||||||
|
Total adjustments
|
(2,850
|
)
|
(16,419
|
)
|
2,715
|
(6,608
|
)
|
(15,463
|
)
|
|||||||||||
|
Adjusted EBITDA
|
(13,846
|
)
|
(9,897
|
)
|
(5,367
|
)
|
(3,674
|
)
|
(14,761
|
)
|
||||||||||