
| • |
Third quarter 2025 revenue of $9.5 million, up 10% year-over-year
|
| • |
Amended credit agreement with Avenue Capital Group which strengthens our balance sheet with an additional $2.5 million of cash, and extends the interest
only-period through December 31, 2026, with an additional $2.5 million available and an additional extension of the interest-only period to June 30, 2027 with DrugSorb-ATR FDA marketing approval
|
| • |
Implemented Workforce and Cost Reduction Program to accelerate path to cash-flow breakeven to Q1 2026
|
| • |
Submitted DrugSorb™-ATR De Novo pre-submission package to FDA, with meeting expected in Q4 2025 or early Q1 2026, followed by planned submission of new De Novo
application in Q1 2026, and anticipated regulatory decision mid-2026
|
| • |
Revenue was $9.5 million, an increase of 10%, or 4% on a constant currency basis, compared to $8.6 million in Q3 2024. Growth was led by record performance in our distributor
territories and near-record performance in direct sales outside Germany.
|
| • |
Gross margin in Q3 2025 was 70% compared to 61% in Q3 2024. Last year’s gross margin was
affected by a planned production slow-down to rebalance inventory and a temporary manufacturing issue that was resolved during Q3 2024.
|
| • |
Operating loss improved to $2.9 million, compared to $4.8 million in Q3 2024 due to improved gross margins and lower operating expenses
|
| • |
Net loss was $3.2 million or $0.05 per share, compared to a net loss of $2.8 million or $0.05 per share in Q3
2024.
|
| • |
Adjusted net loss improved to $2.6 million or $0.04 per share, compared to an adjusted net loss of $4.5 million or $0.08 per share in Q3 2024.
|
| • |
Adjusted EBITDA loss improved to $2.0 million compared to a loss of $3.6 million in Q3 2024.
|
| • |
Total cash, cash equivalents, and restricted cash of $9.1 million on September 30, 2025, compared
to $11.7 million as of June 30, 2025, reflecting net operating cash burn in the quarter of $2.6 million.
|
| • |
Proforma cash, cash equivalents, and restricted cash was $11.6 million on September 30, 2025, as if the additional $2.5 million term loan capital made available
through the amended credit agreement with Avenue Capital Group were drawn on September 30, 2025. Total proforma debt drawn under the agreement as of September 30, 2025, is $17.5 million.
|
| • |
On September 10, 2025, in commemoration of Sepsis Awareness Month and World Sepsis Day, Dr. Chan
hosted a special webinar featuring the clinical insights of leading international critical care experts entitled “Turning the Tide on Sepsis and
Septic Shock: Real World Insights with CytoSorb”. This webinar highlighted CytoSorb’s broad mechanisms of action in helping to manage the
complex pathophysiology of sepsis and septic shock, with a focus on controlling deadly inflammation, stabilizing organ function, promoting a reversal of capillary leak, and enabling fluid removal. Recent exciting publications reinforce the
importance of early and intensive CytoSorb treatment in septic shock, particularly the retrospective study of 175 septic shock patients (Berlot, et
al. 2025), while the first meta-analysis of 744 patients with septic shock from Charité Berlin Hospital demonstrated that CytoSorb usage in these patients led to significant reductions in both in-hospital and 28-30-day mortality (Steindl, et al. 2025). Access the entire webinar here, or the white paper here.
|
| • |
At the European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting in October, Prof. Richard Whitlock (McMaster University) presented the first randomized controlled
trial data on the “Intraoperative Removal of Direct Oral Anticoagulants in Patients Undergoing Urgent Cardiothoracic Surgery” where intraoperative
use of DrugSorb™-ATR in cardiac surgery significantly reduced levels of direct oral anticoagulants (DOACs), such as Eliquis® (apixaban, Pfizer/Bristol Myers Squibb) and Xarelto® (rivaroxaban, Janssen/Bayer), compared to sham controls. This
supports the notion that our technology can be a “one-size fits all” countermeasure for different classes of blood thinners in cardiac surgery.
|
| • |
In a presentation titled, “Dual Antiplatelet Therapy (DAPT) and Urgent CABG in Acute Coronary
Syndrome (ACS): Impact of P2Y12 Inhibitor Choice & Intraoperative Hemoadsorption on Perioperative Bleeding: Comparative Real-World Analysis,” Professor Matthias Thielmann (Westerman Heart & Vascular Center) presented
compelling real-world data from a real-world study demonstrating that among heart attack patients undergoing urgent CABG, combining dual antiplatelet therapy (aspirin + ticagrelor) with intraoperative use of CytoSorb® reduces severe bleeding
complications compared with patients treated with aspirin + Plavix (clopidogrel) without CytoSorb.
|
| • |
|
September 30,
|
December 31,
|
|||||||
|
2025
|
2024
|
|||||||
|
(unaudited)
|
||||||||
|
$
|
7,536
|
$
|
3,280
|
|||||
|
—
|
5,000
|
|||||||
|
7,427
|
7,320
|
|||||||
|
4,002
|
2,733
|
|||||||
|
2,348
|
3,271
|
|||||||
|
21,313
|
21,604
|
|||||||
|
8,193
|
9,002
|
|||||||
|
1,522
|
1,484
|
|||||||
|
11,075
|
11,511
|
|||||||
|
3,647
|
3,771
|
|||||||
|
$
|
45,750
|
$
|
47,372
|
|||||
|
$
|
3,035
|
$
|
3,340
|
|||||
|
6,559
|
6,032
|
|||||||
|
518
|
453
|
|||||||
|
10,112
|
9,825
|
|||||||
|
12,051
|
12,444
|
|||||||
|
14,567
|
13,996
|
|||||||
|
36,730
|
36,265
|
|||||||
|
—
|
—
|
|||||||
|
63
|
55
|
|||||||
|
319,511
|
310,809
|
|||||||
|
(3,844
|
)
|
4,252
|
||||||
|
(306,710
|
)
|
(304,009
|
)
|
|||||
|
9,020
|
11,107
|
|||||||
|
$
|
45,750
|
$
|
47,372
|
|||||
|
Three Months Ended September 30,
|
Nine Months Ended September 30,
|
|||||||||||||||
|
2025
|
2024
|
2025
|
2024
|
|||||||||||||
|
(Unaudited)
|
(Unaudited)
|
(Unaudited)
|
(Unaudited)
|
|||||||||||||
|
$
|
9,485
|
$
|
8,613
|
$
|
27,829
|
$
|
26,444
|
|||||||||
|
2,819
|
3,357
|
8,142
|
7,812
|
|||||||||||||
|
6,666
|
5,256
|
19,687
|
18,632
|
|||||||||||||
|
918
|
1,826
|
3,842
|
5,592
|
|||||||||||||
|
8,610
|
8,260
|
26,209
|
26,097
|
|||||||||||||
|
9,528
|
10,086
|
30,051
|
31,689
|
|||||||||||||
|
(2,862
|
)
|
(4,830
|
)
|
(10,364
|
)
|
(13,057
|
)
|
|||||||||
|
(645
|
)
|
(588
|
)
|
(1,866
|
)
|
(775
|
)
|
|||||||||
|
(64
|
)
|
2,650
|
9,128
|
680
|
||||||||||||
|
(709
|
)
|
2,062
|
7,262
|
(95
|
)
|
|||||||||||
|
(3,571
|
)
|
(2,768
|
)
|
(3,102
|
)
|
(13,152
|
)
|
|||||||||
|
401
|
—
|
401
|
—
|
|||||||||||||
|
$
|
(3,170
|
)
|
$
|
(2,768
|
)
|
$
|
(2,701
|
)
|
$
|
(13,152
|
)
|
|||||
|
$
|
(0.05
|
)
|
$
|
(0.05
|
)
|
$
|
(0.04
|
)
|
$
|
(0.24
|
)
|
|||||
|
62,753,959
|
54,453,006
|
62,038,902
|
54,340,583
|
|||||||||||||
|
116
|
(2,330
|
)
|
(8,096
|
)
|
(686
|
)
|
||||||||||
|
$
|
(3,054
|
)
|
$
|
(5,098
|
)
|
$
|
(10,797
|
)
|
$
|
(13,838
|
)
|
|||||
|
Accumulated
|
||||||||||||||||||||||||
|
Additional
|
Other
|
|||||||||||||||||||||||
|
Common Stock
|
Paid-In
|
Comprehensive
|
Accumulated
|
Stockholders’
|
||||||||||||||||||||
|
Shares
|
Par Value
|
Capital
|
Income (Loss)
|
Deficit
|
Equity
|
|||||||||||||||||||
|
62,610,376
|
$
|
63
|
$
|
319,023
|
$
|
(3,960
|
)
|
$
|
(303,540
|
)
|
$
|
11,586
|
||||||||||||
|
183,929
|
—
|
488
|
—
|
—
|
488
|
|||||||||||||||||||
|
—
|
—
|
—
|
116
|
—
|
116
|
|||||||||||||||||||
|
—
|
—
|
—
|
—
|
(3,170
|
)
|
(3,170
|
)
|
|||||||||||||||||
|
62,794,305
|
$
|
63
|
$
|
319,511
|
$
|
(3,844
|
)
|
$
|
(306,710
|
)
|
$
|
9,020
|
||||||||||||
|
54,830,146
|
$
|
55
|
$
|
310,809
|
$
|
4,252
|
$
|
(304,009
|
)
|
$
|
11,107
|
|||||||||||||
|
297,160
|
1
|
1,878
|
—
|
—
|
1,879
|
|||||||||||||||||||
|
6,249,791
|
6
|
5,386
|
—
|
—
|
5,392
|
|||||||||||||||||||
|
1,417,208
|
1
|
1,438
|
—
|
—
|
1,439
|
|||||||||||||||||||
|
—
|
—
|
—
|
(8,096
|
)
|
—
|
(8,096
|
)
|
|||||||||||||||||
|
—
|
—
|
—
|
—
|
(2,701
|
)
|
(2,701
|
)
|
|||||||||||||||||
|
62,794,305
|
$
|
63
|
$
|
319,511
|
$
|
(3,844
|
)
|
$
|
(306,710
|
)
|
$
|
9,020
|
||||||||||||
|
Accumulated
|
||||||||||||||||||||||||
|
Additional
|
Other
|
|||||||||||||||||||||||
|
Common Stock
|
Paid-In
|
Comprehensive
|
Accumulated
|
Stockholders’
|
||||||||||||||||||||
|
Shares
|
Par Value
|
Capital
|
Income
|
Deficit
|
Equity
|
|||||||||||||||||||
|
54,306,415
|
$
|
54
|
$
|
308,874
|
$
|
2,173
|
$
|
(293,674
|
)
|
$
|
17,427
|
|||||||||||||
|
—
|
—
|
891
|
—
|
—
|
891
|
|||||||||||||||||||
|
—
|
—
|
—
|
(2,330
|
)
|
—
|
(2,330
|
)
|
|||||||||||||||||
|
—
|
—
|
(41
|
)
|
—
|
—
|
(41
|
)
|
|||||||||||||||||
|
194,198
|
—
|
204
|
—
|
—
|
204
|
|||||||||||||||||||
|
—
|
—
|
—
|
—
|
(2,768
|
)
|
(2,768
|
)
|
|||||||||||||||||
|
54,500,613
|
$
|
54
|
$
|
309,928
|
$
|
(157
|
)
|
$
|
(296,442
|
)
|
$
|
13,383
|
||||||||||||
|
54,240,265
|
$
|
54
|
$
|
306,187
|
$
|
529
|
$
|
(283,290
|
)
|
$
|
23,480
|
|||||||||||||
|
—
|
—
|
2,840
|
—
|
—
|
2,840
|
|||||||||||||||||||
|
—
|
—
|
—
|
(686
|
)
|
—
|
(686
|
)
|
|||||||||||||||||
|
53,290
|
—
|
12
|
—
|
—
|
12
|
|||||||||||||||||||
|
—
|
—
|
691
|
—
|
—
|
691
|
|||||||||||||||||||
|
207,058
|
—
|
198
|
—
|
—
|
198
|
|||||||||||||||||||
|
—
|
—
|
—
|
—
|
(13,152
|
)
|
(13,152
|
)
|
|||||||||||||||||
|
54,500,613
|
$
|
54
|
$
|
309,928
|
$
|
(157
|
)
|
$
|
(296,442
|
)
|
$
|
13,383
|
||||||||||||
|
Nine
|
Nine
|
|||||||
|
Months Ended
|
Months Ended
|
|||||||
|
September 30,
|
September 30,
|
|||||||
|
2025
|
2024
|
|||||||
|
$
|
(2,701
|
)
|
$
|
(13,152
|
)
|
|||
|
—
|
111
|
|||||||
|
571
|
132
|
|||||||
|
—
|
58
|
|||||||
|
1,137
|
1,181
|
|||||||
|
109
|
138
|
|||||||
|
176
|
313
|
|||||||
|
253
|
—
|
|||||||
|
17
|
107
|
|||||||
|
1,879
|
2,840
|
|||||||
|
(9,128
|
)
|
(680
|
)
|
|||||
|
560
|
(629
|
)
|
||||||
|
(1,247
|
)
|
153
|
||||||
|
989
|
505
|
|||||||
|
—
|
2
|
|||||||
|
(167
|
)
|
(3,166
|
)
|
|||||
|
(7,552
|
)
|
(12,087
|
)
|
|||||
|
(56
|
)
|
(215
|
)
|
|||||
|
(68
|
)
|
(330
|
)
|
|||||
|
(124
|
)
|
(545
|
)
|
|||||
|
—
|
15,000
|
|||||||
|
—
|
(5,000
|
)
|
||||||
|
—
|
(150
|
)
|
||||||
|
—
|
(698
|
)
|
||||||
|
—
|
12
|
|||||||
|
1,439
|
—
|
|||||||
|
5,392
|
—
|
|||||||
|
6,831
|
9,164
|
|||||||
|
139
|
21
|
|||||||
|
(706
|
)
|
(3,447
|
)
|
|||||
|
9,764
|
15,615
|
|||||||
|
$
|
9,058
|
$
|
12,168
|
|||||
|
$
|
1,535
|
$
|
772
|
|||||
|
$
|
—
|
$
|
691
|
|||||
|
Three Months Ended
|
Nine Months Ended
|
|||||||||||||||
|
September 30,
|
September 30,
|
|||||||||||||||
|
2025
|
2024
|
2025
|
2024
|
|||||||||||||
|
(amounts, in thousands)
|
||||||||||||||||
|
Net loss
|
$
|
(3,170
|
)
|
$
|
(2,768
|
)
|
$
|
(2,701
|
)
|
$
|
(13,152
|
)
|
||||
|
Depreciation and amortization expense
|
$
|
364
|
$
|
383
|
$
|
1,137
|
$
|
1,181
|
||||||||
|
Income tax benefit
|
$
|
(401
|
)
|
$
|
-
|
$
|
(401
|
)
|
$
|
-
|
||||||
|
Interest expense, net
|
$
|
645
|
$
|
588
|
$
|
1,866
|
$
|
775
|
||||||||
|
EBITDA – non-GAAP measure
|
$
|
(2,562
|
)
|
$
|
(1,797
|
)
|
$
|
(99
|
)
|
$
|
(11,196
|
)
|
||||
|
Non-cash stock-based compensation expense
|
$
|
488
|
$
|
891
|
$
|
1,879
|
$
|
2,840
|
||||||||
|
(Gain)/Loss on foreign currency transactions
|
64
|
(2,650
|
)
|
(9,128
|
)
|
(680
|
)
|
|||||||||
|
Adjusted EBITDA – non-GAAP measure
|
$
|
(2,010
|
)
|
(3,556
|
)
|
$
|
(7,348
|
)
|
$
|
(9,036
|
)
|
|||||
|
Net loss
|
$
|
(3,170
|
)
|
$
|
(2,768
|
)
|
$
|
(2,701
|
)
|
$
|
(13,152
|
)
|
||||
|
Non-cash stock-based compensation expense
|
488
|
891
|
1,879
|
2,840
|
||||||||||||
|
(Gain)/Loss on foreign currency transactions
|
$
|
64
|
$
|
(2,650
|
)
|
$
|
(9,128
|
)
|
$
|
(680
|
)
|
|||||
|
Adjusted net loss – non-GAAP measure
|
$
|
(2,618
|
)
|
$
|
(4,527
|
)
|
$
|
(9,950
|
)
|
$
|
(10,992
|
)
|
||||
|
Weighted average common shares outstanding
|
||||||||||||||||
|
Basic
|
62,753,959
|
54,453,006
|
62,038,902
|
54,340,583
|
||||||||||||
|
Diluted
|
62,753,959
|
54,453,006
|
62,038,902
|
54,340,583
|
||||||||||||
|
Basic net income (loss) per common share
|
$
|
(0.05
|
)
|
$
|
(0.05
|
)
|
$
|
(0.04
|
)
|
$
|
(0.24
|
)
|
||||
|
Diluted net income (loss) per common share
|
$
|
(0.05
|
)
|
$
|
(0.05
|
)
|
$
|
(0.04
|
)
|
$
|
(0.24
|
)
|
||||
|
Non-cash stock-based compensation expense - basic
|
$
|
0.01
|
$
|
0.02
|
$
|
0.03
|
$
|
0.05
|
||||||||
|
Non-cash stock-based compensation expense - diluted
|
$
|
0.01
|
$
|
0.02
|
$
|
0.03
|
$
|
0.05
|
||||||||
|
(Gain)/Loss on foreign currency transactions - basic
|
$
|
-
|
$
|
(0.05
|
)
|
$
|
(0.15
|
)
|
$
|
(0.01
|
)
|
|||||
|
(Gain)/Loss on foreign currency transactions - diluted
|
$
|
-
|
$
|
(0.05
|
)
|
$
|
(0.15
|
)
|
$
|
(0.01
|
)
|
|||||
|
Adjusted net income (loss) per common share – basic – non-GAAP measure
|
$
|
(0.04
|
)
|
$
|
(0.08
|
)
|
$
|
(0.16
|
)
|
$
|
(0.20
|
)
|
||||
|
Adjusted net income (loss) per common share – diluted – non-GAAP measure
|
$
|
(0.04
|
)
|
$
|
(0.08
|
)
|
$
|
(0.16
|
)
|
$
|
(0.20
|
)
|
||||