CytoSorbents Reports Second Quarter 2025 Financial Results and Provides Business Update
CytoSorbents (NASDAQ: CTSO) reported Q2 2025 financial results showing revenue growth of 9% to $9.6 million compared to Q2 2024, primarily driven by 22% growth in Germany. The company achieved a net income of $1.9 million ($0.03 per share) versus a net loss in Q2 2024, while maintaining a gross margin of 70.9%.
Key developments include an FDA appeal hearing for DrugSorb鈩�-ATR, with a final regulatory decision expected in 2025, and continued work with Health Canada following their Notice of Refusal. The company's cash position stands at $11.7 million as of June 30, 2025. Management expects to approach breakeven operations by the end of 2025 through improved execution and cost control measures.
The company announced an upcoming World Sepsis Day Global Webinar on September 10, 2025, highlighting CytoSorb's role in treating sepsis and septic shock, supported by recent positive clinical studies and meta-analyses showing significant mortality reduction.
CytoSorbents (NASDAQ: CTSO) ha comunicato i risultati finanziari del secondo trimestre 2025, registrando una crescita dei ricavi del 9% a 9,6 milioni di dollari rispetto al secondo trimestre 2024, trainata principalmente da una crescita del 22% in Germania. L'azienda ha raggiunto un utile netto di 1,9 milioni di dollari (0,03 dollari per azione) rispetto a una perdita netta nel secondo trimestre 2024, mantenendo un margine lordo del 70,9%.
Tra gli sviluppi principali si segnala un'udienza di appello presso la FDA per DrugSorb鈩�-ATR, con una decisione regolatoria finale attesa nel 2025, e la prosecuzione delle attivit脿 con Health Canada a seguito di un avviso di rifiuto. La posizione di cassa dell'azienda ammonta a 11,7 milioni di dollari al 30 giugno 2025. Il management prevede di raggiungere il pareggio operativo entro la fine del 2025 grazie a una migliore esecuzione e a misure di controllo dei costi.
脠 stato inoltre annunciato un webinar globale in occasione della Giornata Mondiale della Sepsi il 10 settembre 2025, che metter脿 in evidenza il ruolo di CytoSorb nel trattamento della sepsi e dello shock settico, supportato da recenti studi clinici positivi e meta-analisi che mostrano una significativa riduzione della mortalit脿.
CytoSorbents (NASDAQ: CTSO) inform贸 los resultados financieros del segundo trimestre de 2025, mostrando un crecimiento de ingresos del 9% hasta 9,6 millones de d贸lares en comparaci贸n con el segundo trimestre de 2024, impulsado principalmente por un crecimiento del 22% en Alemania. La compa帽铆a logr贸 un ingreso neto de 1,9 millones de d贸lares (0,03 d贸lares por acci贸n) frente a una p茅rdida neta en el segundo trimestre de 2024, manteniendo un margen bruto del 70,9%.
Los desarrollos clave incluyen una audiencia de apelaci贸n ante la FDA para DrugSorb鈩�-ATR, con una decisi贸n regulatoria final esperada en 2025, y el trabajo continuo con Health Canada tras su Aviso de Rechazo. La posici贸n de efectivo de la empresa es de 11,7 millones de d贸lares al 30 de junio de 2025. La direcci贸n espera alcanzar operaciones en equilibrio para finales de 2025 mediante una mejor ejecuci贸n y medidas de control de costos.
La compa帽铆a anunci贸 un pr贸ximo seminario web global por el D铆a Mundial de la Sepsis el 10 de septiembre de 2025, destacando el papel de CytoSorb en el tratamiento de la sepsis y el shock s茅ptico, respaldado por recientes estudios cl铆nicos positivos y metaan谩lisis que muestran una reducci贸n significativa de la mortalidad.
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欤检殧 臧滊皽 靷暛鞙茧電� DrugSorb鈩�-ATR鞐� 雽�頃� FDA 頃唽 鞁Μ臧� 鞛堨溂氅�, 斓滌 攴滌牅 瓴办爼鞚� 2025雲勳棎 鞓堨儊霅╇媹雼�. 霕愴暅 Health Canada鞚� 瓯半秬 韱奠 鞚错泟 瓿勳啀 順戨牓 欷戩瀰雼堧嫟. 2025雲� 6鞗� 30鞚� 旮办 須岇偓鞚� 順勱笀 氤挫湢鞎§潃 1170毵� 雼煬鞛呺媹雼�. 瓴届榿歆勳潃 鞁ろ枆霠� 頄レ儊瓿� 牍勳毄 韱奠牅 臁办箻毳� 韱淀暣 2025雲� 毵愱箤歆� 靻愳澋攵勱赴鞝� 雼劚鞚� 旮半寑頃橁碃 鞛堨姷雼堧嫟.
須岇偓電� 2025雲� 9鞗� 10鞚� 靹戈硠 韺槇歃濎潣 雮� 旮�搿滊矊 鞗箘雮橂ゼ 臧滌禍頃� 鞓堨爼鞚措┌, 斓滉芳 旮嶌爼鞝侅澑 鞛勳儊 鞐瓣惮鞕� 氅旐儉攵勳劃鞐愳劀 鞛呾霅� 靷毳� 鞙犾潣氙� 臧愳唽毳� 氚旐儠鞙茧 CytoSorb鞚� 韺槇歃� 氚� 韺槇靹� 靽柬伂 旃橂 鞐暊鞚� 臧曥“頃� 瓴冹瀰雼堧嫟.
CytoSorbents (NASDAQ : CTSO) a publi茅 ses r茅sultats financiers du deuxi猫me trimestre 2025, affichant une croissance du chiffre d'affaires de 9 % 脿 9,6 millions de dollars par rapport au deuxi猫me trimestre 2024, principalement port茅e par une croissance de 22 % en Allemagne. La soci茅t茅 a enregistr茅 un b茅n茅fice net de 1,9 million de dollars (0,03 dollar par action) contre une perte nette au deuxi猫me trimestre 2024, tout en maintenant une marge brute de 70,9 %.
Les d茅veloppements cl茅s incluent une audience d'appel aupr猫s de la FDA concernant DrugSorb鈩�-ATR, avec une d茅cision r茅glementaire finale attendue en 2025, ainsi que la poursuite des 茅changes avec Sant茅 Canada suite 脿 leur avis de refus. La tr茅sorerie de la soci茅t茅 s'茅l猫ve 脿 11,7 millions de dollars au 30 juin 2025. La direction pr茅voit d'atteindre le seuil de rentabilit茅 d'ici la fin 2025 gr芒ce 脿 une meilleure ex茅cution et 脿 des mesures de contr么le des co没ts.
La soci茅t茅 a annonc茅 un prochain webinaire mondial 脿 l'occasion de la Journ茅e mondiale de la septic茅mie le 10 septembre 2025, mettant en lumi猫re le r么le de CytoSorb dans le traitement de la septic茅mie et du choc septique, soutenu par des 茅tudes cliniques r茅centes positives et des m茅ta-analyses montrant une r茅duction significative de la mortalit茅.
CytoSorbents (NASDAQ: CTSO) meldete die Finanzergebnisse f眉r das zweite Quartal 2025 mit einem Umsatzwachstum von 9 % auf 9,6 Millionen US-Dollar im Vergleich zum zweiten Quartal 2024, haupts盲chlich getrieben durch ein 22 % Wachstum in Deutschland. Das Unternehmen erzielte einen Nettoertrag von 1,9 Millionen US-Dollar (0,03 US-Dollar pro Aktie) im Gegensatz zu einem Nettoverlust im zweiten Quartal 2024 und hielt eine Bruttomarge von 70,9 % aufrecht.
Wesentliche Entwicklungen umfassen eine Berufungsverhandlung bei der FDA f眉r DrugSorb鈩�-ATR, mit einer endg眉ltigen beh枚rdlichen Entscheidung, die f眉r 2025 erwartet wird, sowie die Fortsetzung der Zusammenarbeit mit Health Canada nach deren Ablehnungsbescheid. Die Barposition des Unternehmens betr盲gt zum 30. Juni 2025 11,7 Millionen US-Dollar. Das Management erwartet, bis Ende 2025 durch verbesserte Umsetzung und Kosteneinsparungen die Gewinnschwelle zu erreichen.
Das Unternehmen k眉ndigte ein bevorstehendes globales Webinar zum Welt-Sepsis-Tag am 10. September 2025 an, das die Rolle von CytoSorb bei der Behandlung von Sepsis und septischem Schock hervorhebt, unterst眉tzt durch k眉rzlich positive klinische Studien und Metaanalysen, die eine signifikante Mortalit盲tsreduktion zeigen.
- Revenue increased 9% year-over-year to $9.6 million
- Strong 22% sales growth in Germany both year-over-year and sequentially
- Achieved net income of $1.9 million ($0.03 per share) vs previous year loss
- Maintained healthy gross margin of 70.9%
- Recent meta-analysis showed statistically significant reduction in mortality with CytoSorb
- Received $1.7 million from sale of tax credits through NJEDA program
- Operating loss of $3.6 million persists
- Cash position decreased to $11.7 million from $13.1 million in previous quarter
- Adjusted EBITDA loss widened to $2.6 million from $2.2 million in Q2 2024
- FDA and Health Canada regulatory challenges continue for DrugSorb-ATR approval
- Gross margin declined from 73.5% in Q2 2024
Insights
CytoSorbents posts mixed Q2 results with 9% revenue growth but widening adjusted net loss amid progress on regulatory pathways for DrugSorb-ATR.
CytoSorbents' Q2 2025 results present a mixed financial picture with both encouraging and concerning elements. The company achieved
The company's cash position has declined to
On the regulatory front, CytoSorbents is in active discussions with both FDA and Health Canada regarding marketing authorization for DrugSorb-ATR. The company conducted an in-person appeal hearing with the FDA in July, with a decision expected by August's end. The Health Canada process appears to be contingent on FDA outcomes. These regulatory pathways represent critical catalysts that could significantly impact the company's commercial outlook.
The company is also emphasizing its CytoSorb therapy for sepsis and septic shock treatment, highlighted by three recent peer-reviewed publications showing positive outcomes. This focus on sepsis represents a strategic shift toward a large market opportunity where the company believes its technology provides unique advantages by complementing antibiotic therapy with broad-spectrum blood purification.
While revenue growth is positive, the expanding losses and declining margins suggest challenges in achieving sustainable profitability without significant regulatory breakthroughs or market expansion. Investors should closely monitor the FDA decision expected this month as it represents a pivotal near-term catalyst.
Second Quarter 2025 Financial Results
- Revenue was
$9.6 million 9% , or4% on a constant currency basis, compared to$8.8 million 22% year-over-year and sequential sales growth inGermany . - Gross margin was
70.9% compared to73.5% in Q2 2024. - Operating loss was
$3.6 million - Net income was
$1.9 million $0.03 $4.3 million $0.08 - Adjusted net loss was
$3.7 million $0.06 $0.05 $2.8 million $0.05 - Adjusted EBITDA loss was
$2.6 million $2.2 million - Total cash, cash equivalents, and restricted cash of
$11.7 million $13.1 million $1.7 million
"Our performance in the second quarter was led by strong
DrugSorb鈩�-ATR Updates
- In July, the Company conducted an in-person appeal hearing with the
U.S. FDA for supervisory review (administrative appeal) under 21 CFR 10.75 for its De Novo Request for DrugSorb鈩�-ATR. The appeal hearing included FDA senior leadership and review team, Company management, our FDA regulatory counsel, and our external cardiac surgery experts. The Company continues to believe that remaining deficiencies in its DeNovo application can be effectively resolved through this supervisory review process which is expected to be completed by the end of August 2025, and that a final regulatory decision can be achieved in 2025. - The Company continues to work with Health Canada after receipt of their Notice of Refusal in June. As part of Health Canada's prescribed reconsideration process, and after discussions with Health Canada, the Company has filed a Level 1 "Request for Reconsideration" and with agreement from the Medical Devices Directorate Bureau Director, will pursue the review following the completion of the Company's review with the
U.S. FDA. - In May 2025, Prof. Matthias Thielmann, STAR Registry investigator, received the "Best Oral Presentation Award" at the for his presentation entitled, "Early CABG with Intraoperative Hemoadsorption in Patients on Ticagrelor: AG真人官方 World Data from the International Safe and Timely Antithrombotic Removal (STAR) Registry" - underscoring the importance of our technology and these findings in the international community.
- In May 2025, , highlighting the intraoperative use of our technology to significantly and safely reduce the severity of bleeding in urgent coronary artery bypass grafting (CABG) patients on the blood thinner, ticagrelor (Brilinta庐, AstraZeneca) who had not completed the recommended drug washout period, reinforcing the clinical value of our therapy.
"Following our recent meeting with the FDA, we remain committed to working collaboratively with the agency to secure marketing authorization for DrugSorb-ATR, an FDA Breakthrough Designated Device," said Dr.听Chan.听 "Meanwhile adoption of our blood thinner removal application continues to grow with an increasing number of heart centers around the world incorporating our technology as part of their standard care to reduce bleeding complications in patients on blood thinners undergoing cardiac surgery.听 We remain confident in the strength of our DrugSorb-ATR market authorization requests with both FDA and Health Canada and believe that the remaining issues can be expeditiously and successfully addressed."
Turning the Tide in Sepsis and Septic Shock with CytoSorb
Dr. Chan stated, "On September 10, 2025, we invite you to participate in our 听that is intended to spotlight the vital and evolving role of CytoSorb庐 in the treatment of sepsis and septic shock 鈥� among the deadliest challenges in critical care medicine today 鈥� and a major global growth opportunity for us. 听This special presentation, which will feature听physician-user guests discussing CytoSorb therapy best practices and its impact in the fight against sepsis, along with our , commemorates 听补苍诲 听in September."
Date:听听Wednesday, September 10, 2025
Time:听 11:00 AM EDT
Webinar registration required:听
"CytoSorbents has worked closely with clinicians and scientists for more than a decade to advance the treatment of sepsis and septic shock by complementing traditional antibiotics with the broad-spectrum, blood purification capability of CytoSorb庐.听 While antibiotics fight the infection, CytoSorb broadly targets the other key drivers of septic shock, including severe inflammation driven by cytokine storm and bacterial toxins, circulatory collapse, capillary leak, fluid overload, and organ failure.听 We believe this dual approach, when combined with standard of care therapy, represents a paradigm shift in how to treat septic shock - emphasizing early, intensive, and sufficiently long CytoSorb treatment, much like the principles guiding effective antibiotic therapy."
"This philosophy of treating the "Right Patient at the Right Time with the Right Dose" was highlighted in recent published, peer-reviewed septic shock studies, including:
- ., from the well-respected Charit茅 Berlin Hospital in
Germany , showing a statistically significant reduction of mortality with CytoSorb, in the Journal of Clinical Medicine (2025) - A emphasizing high survival with early and intensive CytoSorb treatment, in the Journal of Intensive Care Medicine (2025), and
- The positive clinical outcomes from the first 150 patients (
58% had septic shock) enrolled in the international, prospective COSMOS (CytOSorb treatMent Of critically ill patientS) critical care registry, reported by Ferrer et al. in the Journal of Intensive Medicine (2025)
Backed by these and other robust peer-reviewed clinical and scientific data, CytoSorb is being used by physicians around the world to help turn the tide for patients with sepsis and septic shock by sequentially achieving the following key treatment goals:
1)听听听听听 Break the vicious cycle of uncontrolled inflammation
2)听听听听听 Reverse shock and restore oxygenated blood flow
3)听听听听听 Promote the repair of leaky blood vessels
4)听听听听听 Actively remove excessive fluid and reduce fluid overload in organs
5)听听听听听 Prevent or treat multiple organ failure
Our 听on September 10, 2025 is intended to highlight the leadership role that CytoSorbents and its many collaborators have been playing to advance a new era in sepsis management.听 We also invite you to follow our new septic shock blog series where we delve into greater detail on these points, found .听 Meanwhile, watch videos from healthcare providers from around the world who detail their first-hand experiences with CytoSorb in the treatment of septic shock and other critical illnesses in our "Voices Around the World" segment, found ."
Second Quarter 2025 Earnings Conference Call
CytoSorbents' management will host a live conference call, presentation webcast, and a question-and-answer session with the following information:
Date: Thursday August 7, 2025
Time:听4:30 PM EDT
North American toll-free:听1-800-836-8184
International toll:听1-646-357-8785
Live webcast link:听听
It is recommended that participants dial in approximately 10 minutes prior to the start of the call.
An archived recording of the conference call will be available under the Investor Relations section of the Company's website at
About Non-GAAP Financial Measures
To supplement our condensed consolidated financial statements, we use the non-GAAP financial measures of EBITDA, which measures earnings before interest, income taxes, depreciation and amortization, and Adjusted EBITDA which further excludes non-cash stock compensation expense, and gain or loss of foreign exchange translation. We also use the non-GAAP financial measures of Adjusted Net Income or Loss and Adjusted Net Income or Loss Per Common Share which excludes non-cash stock compensation expense and gain or loss of foreign exchange translation from Net Loss and Net Loss Per Common Share, respectively. These non-GAAP measures are not based on any comprehensive set of accounting rules or principles and should not be considered a substitute for, or superior to, financial measures calculated in accordance with GAAP and may be different from non-GAAP measures used by other companies. In addition, these non-GAAP measures should be read in conjunction with our financial statements prepared in accordance with GAAP. The reconciliations of the non-GAAP measures to the most directly comparable financial measures calculated and presented in accordance with GAAP should be carefully evaluated. We use these non-GAAP financial measures for financial and operational decision-making and as a means to evaluate period-to-period comparisons. We believe that these non-GAAP financial measures provide meaningful supplemental information regarding our performance and that both management and investors benefit from referring to these non-GAAP financial measures in assessing our performance and when planning, forecasting, and analyzing future periods. We believe these non-GAAP financial measures are useful to investors because (1) they allow for greater transparency with respect to key metrics used by management in its financial and operational decision-making and (2) they are used by investors and the analyst community to help them analyze the performance of our business, the Company's cash available for operations, and the Company's ability to meet future capital expenditure and working capital requirements.听 For a reconciliation of non-GAAP financial measures to the most comparable GAAP measure, see the reconciliation included in the financial tables.听 All non-GAAP adjustments are presented pre-tax.
About CytoSorbents Corporation (NASDAQ: CTSO)
听is a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery through blood purification. CytoSorbents' proprietary blood purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Cartridges filled with these beads can be used with standard blood pumps already in the hospital (e.g. dialysis, continuous renal replacement therapy or CRRT, extracorporeal membrane oxygenation or ECMO, and heart-lung machines), where blood is repeatedly recirculated outside the body, through our cartridges where toxic substances are removed, and then back into the body. CytoSorbents' technologies are used in a number of broad applications. Specifically, two important applications are 1) the removal of blood thinners during and after cardiothoracic surgery to reduce the risk of severe bleeding, and 2) the removal of inflammatory agents and toxins in common critical illnesses that can lead to massive inflammation, organ failure and patient death. The breadth of these critical illnesses includes, for example, sepsis, burn injury, trauma, lung injury, liver failure, cytokine release syndrome, and pancreatitis as well as the removal of liver toxins that accumulate in acute liver dysfunction or failure, and the removal of myoglobin in severe rhabdomyolysis that can otherwise lead to renal failure. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments.
CytoSorbents' lead product,听, is approved in the听European Union听补苍诲 distributed in over 70 countries worldwide, with nearly 300,000 devices used cumulatively to date.听 CytoSorb was originally launched in the听European Union听under CE mark as the first cytokine adsorber.听 Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for听听补苍诲听听removal in cardiothoracic surgery procedures. CytoSorb has also received听听in听the United States听for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure.听 CytoSorb is not yet approved or cleared in听the听United States.
In the
In听November 2024, the Company received its MDSAP听certification and submitted its Medical Device License (MDL) application to听Health Canada.听 On June 26, 2025, Health Canada issued a Notice of Refusal of the Company's Medical Device License application, identifying remaining deficiencies that must be addressed before the application may be granted and the device authorized for commercialization.听 As part of Health Canada's prescribed reconsideration process, and after discussions with Health Canada, the Company has filed a Level 1 "Request for Reconsideration" and with agreement from the Medical Devices Directorate Bureau Director, will pursue the review following the completion of the Company's review with the
DrugSorb-ATR is not yet granted or approved in
The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued听U.S.听补苍诲 international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY庐, CytoSorb-XL鈩�, HemoDefend-RBC鈩�, HemoDefend-BGA鈩�, VetResQ庐, K+ontrol鈩�, DrugSorb鈩�, ContrastSorb, and others. For more information, please visit the Company's website at听 听or follow us on听听补苍诲听.听
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, representations and contentions, and the outcome of our regulatory submissions, and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, our restructuring of our direct sales team and strategy in
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Peter J. Mariani, Chief Financial Officer
305 College Road East
[email protected]听
Investor Relations Contact:
Aman Patel, CFA & Adanna G. Alexander, PhD
ICR Healthcare
[email protected]听
听
CYTOSORBENTS CORPORATION CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share data) | ||||||
June听30,听 | December听31,听 | |||||
2025 | 2024 | |||||
(unaudited) | ||||||
ASSETS | ||||||
Current Assets: | ||||||
Cash and cash equivalents | $ | 10,204 | $ | 3,280 | ||
Restricted cash, current | 鈥� | 5,000 | ||||
Grants and accounts receivable, net of allowances of | 7,743 | 7,320 | ||||
Inventories | 3,710 | 2,733 | ||||
Prepaid expenses and other current assets | 1,330 | 3,271 | ||||
Total current assets | 22,987 | 21,604 | ||||
Property and equipment - net | 8,466 | 9,002 | ||||
Restricted cash | 1,522 | 1,484 | ||||
Right-of-use asset | 11,223 | 11,511 | ||||
Other assets | 3,792 | 3,771 | ||||
Total assets | $ | 47,990 | $ | 47,372 | ||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||
Current Liabilities: | ||||||
Accounts payable | $ | 3,394 | $ | 3,340 | ||
Accrued expenses and other current liabilities | 5,953 | 6,032 | ||||
Lease liability 鈥� current portion | 495 | 453 | ||||
Total current liabilities | 9,842 | 9,825 | ||||
Lease liability, net of current portion | 12,185 | 12,444 | ||||
Long-term debt | 14,377 | 13,996 | ||||
Total liabilities | 36,404 | 36,265 | ||||
Commitments and Contingencies | ||||||
Stockholders' equity | ||||||
Preferred Stock, par value | 鈥� | 鈥� | ||||
Common Stock, par value | 63 | 55 | ||||
Additional paid-in capital | 319,023 | 310,809 | ||||
Accumulated other comprehensive income (loss) | (3,960) | 4,252 | ||||
Accumulated deficit | (303,540) | (304,009) | ||||
Total stockholders' equity | 11,586 | 11,107 | ||||
Total liabilities and stockholders' equity | $ | 47,990 | $ | 47,372 | ||
See accompanying notes to condensed consolidated financial statements
听
CYTOSORBENTS CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED) (in thousands, except share and per share data) | ||||||||||||
Three Months Ended June听30,听 | Six Months Ended June听30,听 | |||||||||||
2025 | 2024 | 2025 | 2024 | |||||||||
Revenue | $ | 9,617 | $ | 8,842 | $ | 18,344 | $ | 17,831 | ||||
Cost of goods sold | 2,803 | $ | 2,339 | 5,323 | 4,455 | |||||||
Gross profit | 6,814 | 6,503 | 13,021 | 13,376 | ||||||||
Operating expenses | ||||||||||||
Research and development, net of grant income | 1,262 | 1,519 | 2,924 | 3,766 | ||||||||
Selling, general and administrative | 9,167 | 8,554 | 17,599 | 17,837 | ||||||||
Total operating expenses | 10,429 | 10,073 | 20,523 | 21,603 | ||||||||
Loss from operations | (3,615) | (3,570) | (7,502) | (8,227) | ||||||||
Other income (expense) | ||||||||||||
Interest expense, net | (616) | (180) | (1,221) | (187) | ||||||||
Gain (loss) on foreign currency transactions | 6,178 | (544) | 9,192 | (1,970) | ||||||||
Total other income (expense), net | 5,562 | (724) | 7,971 | (2,157) | ||||||||
Net income (loss) attributable to common stockholders | $ | 1,947 | $ | (4,294) | $ | 469 | $ | (10,384) | ||||
Basic net income (loss) per common share | $ | 0.03 | $ | (0.08) | $ | 0.01 | $ | (0.19) | ||||
Diluted net income (loss) per common share | $ | 0.03 | $ | (0.08) | $ | 0.01 | $ | (0.19) | ||||
Weighted Average Shares of Common Stock Outstanding | ||||||||||||
Basic | 62,608,598 | 54,306,041 | 61,675,447 | 54,284,416 | ||||||||
Diluted | 67,166,377 | 54,306,041 | 66,255,298 | 54,284,416 | ||||||||
Other comprehensive income (loss): | ||||||||||||
Foreign currency translation adjustment, net of tax | (5,476) | 421 | (8,212) | 1,644 | ||||||||
Comprehensive loss | $ | (3,529) | $ | (3,873) | $ | (7,743) | $ | (8,740) | ||||
See accompanying notes to condensed consolidated financial statements.
听
CYTOSORBENTS CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (UNAUDITED) (in thousands, except share data) | |||||||||||||||||
Accumulated | |||||||||||||||||
Additional | Other | ||||||||||||||||
Common听Stock | Paid-In | Comprehensive | Accumulated | Stockholders' | |||||||||||||
Shares | Par听value | Capital | Income (Loss) | Deficit | Equity | ||||||||||||
Balance as of March听31,听2025 (unaudited) | 62,529,466 | $ | 63 | $ | 318,452 | $ | 1,516 | $ | (305,487) | $ | 14,544 | ||||||
Stock-based compensation | 80,910 | 鈥� | 571 | 鈥� | 鈥� | 571 | |||||||||||
Foreign translation adjustment | 鈥� | 鈥� | 鈥� | (5,476) | 鈥� | (5,476) | |||||||||||
Net income | 鈥� | 鈥� | 鈥� | 鈥� | 1,947 | 1,947 | |||||||||||
Balance at June听30,听2025 (unaudited) | 62,610,376 | $ | 63 | $ | 319,023 | $ | (3,960) | $ | (303,540) | $ | 11,586 | ||||||
Balance at December听31,听2024 | 54,830,146 | $ | 55 | $ | 310,809 | $ | 4,252 | $ | (304,009) | $ | 11,107 | ||||||
Stock-based compensation | 113,231 | 1 | 1,390 | 鈥� | 鈥� | 1,391 | |||||||||||
Issuance of common stock and warrants from rights offerings, net of fees incurred | 6,249,791 | 6 | 5,386 | 鈥� | 鈥� | 5,392 | |||||||||||
Issuance of common stock from exercise of warrants | 1,417,208 | 1 | 1,438 | 鈥� | 鈥� | 1,439 | |||||||||||
Foreign translation adjustment | 鈥� | 鈥� | 鈥� | (8,212) | 鈥� | (8,212) | |||||||||||
Net income | 鈥� | 鈥� | 鈥� | 鈥� | 469 | 469 | |||||||||||
Balance as of June听30,听2025 (unaudited) | 62,610,376 | $ | 63 | $ | 319,023 | $ | (3,960) | $ | (303,540) | $ | 11,586 | ||||||
Accumulated | |||||||||||||||||
Additional | Other | ||||||||||||||||
Common听Stock | Paid-In | Comprehensive | Accumulated | Stockholders' | |||||||||||||
Shares | Par听value | Capital | Income | Deficit | Equity | ||||||||||||
Balance as of March听31,听2024 (unaudited) | 54,293,555 | $ | 54 | $ | 307,200 | $ | 1,752 | $ | (289,380) | $ | 19,626 | ||||||
Stock-based compensation | 鈥� | 鈥� | 989 | 鈥� | 鈥� | 989 | |||||||||||
Warrants issued in connection with long-term debt | 鈥� | 鈥� | 691 | 鈥� | 鈥� | 691 | |||||||||||
Foreign translation adjustment | 鈥� | 鈥� | 鈥� | 421 | 鈥� | 421 | |||||||||||
Issuance of restricted stock options | 12,860 | 鈥� | (6) | 鈥� | 鈥� | (6) | |||||||||||
Net loss | 鈥� | 鈥� | 鈥� | 鈥� | (4,294) | (4,294) | |||||||||||
Balance at June听30,听2024 (unaudited) | 54,306,415 | $ | 54 | $ | 308,874 | $ | 2,173 | $ | (293,674) | $ | 17,427 | ||||||
Balance at December听31,听2023 | 54,240,265 | $ | 54 | $ | 306,187 | $ | 529 | $ | (283,290) | $ | 23,480 | ||||||
Stock-based compensation | 鈥� | 鈥� | 1,949 | 鈥� | 鈥� | 1,949 | |||||||||||
Warrants issued in connection with long-term debt | 鈥� | 鈥� | 691 | 鈥� | 鈥� | 691 | |||||||||||
Foreign translation adjustment | 鈥� | 鈥� | 鈥� | 1,644 | 鈥� | 1,644 | |||||||||||
Issuance of common stock offerings, net of fees | 53,290 | 鈥� | 53 | 鈥� | 鈥� | 53 | |||||||||||
Issuance of restricted stock units | 12,860 | 鈥� | (6) | 鈥� | 鈥� | (6) | |||||||||||
Net loss | 鈥� | 鈥� | 鈥� | 鈥� | (10,384) | (10,384) | |||||||||||
Balance as of June听30,听2024 (unaudited) | 54,306,415 | $ | 54 | $ | 308,874 | $ | 2,173 | $ | (293,674) | $ | 17,427 | ||||||
See accompanying notes to condensed consolidated financial statements
听
CYTOSORBENTS CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) (in thousands) | ||||||
Six | Six | |||||
Months Ended | Months Ended | |||||
June听30,听 | June听30,听 | |||||
2025 | 2024 | |||||
Cash flows from operating activities | ||||||
Net income (loss) attributable to common stockholders | $ | 469 | $ | (10,384) | ||
Adjustments to reconcile net income (loss) attributable to common stockholders to net cash used in operating activities: | ||||||
Accrued final fee | 鈥� | 111 | ||||
Amortization of debt discount | 381 | 鈥� | ||||
Depreciation and amortization | 773 | 798 | ||||
Amortization of right-of-use asset | 72 | 92 | ||||
Write-off of patent cost | 鈥� | 250 | ||||
Write-off of inventory | 253 | 鈥� | ||||
Bad debt expense | 9 | 29 | ||||
Stock-based compensation | 1,391 | 1,949 | ||||
Foreign currency transaction (gains) losses | (9,192) | 1,970 | ||||
Changes in operating assets and liabilities | ||||||
Grants and accounts receivable | 257 | (1,952) | ||||
Inventories | (925) | (1,030) | ||||
Prepaid expenses and other current assets | 1,897 | 574 | ||||
Other assets | 鈥� | 1 | ||||
Accounts payable and accrued expenses | (360) | (2,032) | ||||
Net cash used in operating activities | (4,975) | (9,624) | ||||
Cash flows from investing activities | ||||||
Purchases of property and equipment | (39) | (63) | ||||
Payments for patent costs | (140) | (183) | ||||
Net cash used in investing activities | (179) | (246) | ||||
Cash flows from financing activities | ||||||
Proceeds from long-term debt | 鈥� | 15,000 | ||||
Repayment of long-term debt | 鈥� | (5,000) | ||||
Payment of final fee | 鈥� | (150) | ||||
Payment of loan costs | 鈥� | (640) | ||||
Equity contributions - net of fees incurred | 鈥� | 53 | ||||
Proceeds from exercise of common stock warrants | 1,439 | 鈥� | ||||
Proceeds from rights offering, net of fees incurred | 5,392 | 鈥� | ||||
Net cash provided by financing activities | 6,831 | 9,263 | ||||
Effect of exchange rates on cash | 285 | (64) | ||||
Net change in cash, cash equivalents, and restricted cash | 1,962 | (671) | ||||
Cash, cash equivalents, and restricted cash at beginning of year | 9,764 | 15,615 | ||||
Cash, cash equivalents, and restricted cash 鈥� end of period | $ | 11,726 | $ | 14,944 | ||
Supplemental disclosure of cash flow information | ||||||
Cash paid for interest | $ | 1,018 | $ | 538 | ||
Supplemental disclosure of non-cash financing activities | ||||||
Warrants issued in connection with long-term debt | $ | 556 | $ | 691 | ||
See accompanying notes to condensed consolidated financial statements.
听
Reconciliation of GAAP Financial Measures to Non-GAAP Financial Measures 听 | ||||||||||||
Three Months Ended | Six Months Ended | |||||||||||
June听30,听 | June听30,听 | |||||||||||
2025 | 2024 | 2025 | 2024 | |||||||||
(amounts, in thousands) | ||||||||||||
Net income (loss) attributable to common stockholders | $ | 1,947 | $ | (4,294) | $ | 469 | $ | (10,384) | ||||
Depreciation and amortization expense | $ | 404 | $ | 401 | $ | 773 | $ | 798 | ||||
Income tax expense (benefit) | $ | - | $ | - | $ | - | $ | - | ||||
Interest expense (income) | $ | 616 | $ | 180 | $ | 1,221 | $ | 187 | ||||
EBITDA 鈥� non-GAAP measure | $ | 2,967 | $ | (3,713) | $ | 2,463 | $ | (9,399) | ||||
Non-cash stock-based compensation expense | $ | 571 | $ | 989 | $ | 1,391 | $ | 1,949 | ||||
(Gain)/Loss on foreign currency transactions | (6,178) | 544 | (9,192) | 1,970 | ||||||||
Adjusted EBITDA 鈥� non-GAAP measure | $ | (2,640) | (2,180) | $ | (5,338) | $ | (5,480) | |||||
Net income (loss) attributable to common stockholders | $ | 1,947 | $ | (4,294) | $ | 469 | $ | (10,384) | ||||
Non-cash stock-based compensation expense | 571 | 989 | 1,391 | 1,949 | ||||||||
(Gain)/Loss on foreign currency transactions | $ | (6,178) | $ | 544 | $ | (9,192) | $ | 1,970 | ||||
Adjusted net income (loss) 鈥� non-GAAP measure | $ | (3,660) | $ | (2,761) | $ | (7,332) | $ | (6,465) | ||||
Weighted average common shares outstanding | ||||||||||||
Basic | 62,608,598 | 54,306,041 | 61,675,447 | 54,284,416 | ||||||||
Diluted | 67,166,377 | 54,306,041 | 66,255,298 | 54,284,416 | ||||||||
Basic net income (loss) per common share | $ | 0.03 | $ | (0.08) | $ | 0.01 | $ | (0.19) | ||||
Diluted net income (loss) per common share | $ | 0.03 | $ | (0.08) | $ | 0.01 | $ | (0.19) | ||||
Non-cash stock-based compensation expense - basic | $ | 0.01 | $ | 0.02 | $ | 0.02 | $ | 0.04 | ||||
Non-cash stock-based compensation expense - diluted | $ | 0.01 | $ | 0.02 | $ | 0.02 | $ | 0.04 | ||||
(Gain)/Loss on foreign currency transactions - basic | $ | (0.10) | $ | 0.01 | $ | (0.15) | $ | 0.04 | ||||
(Gain)/Loss on foreign currency transactions - diluted | $ | (0.09) | $ | 0.01 | $ | (0.14) | $ | 0.04 | ||||
Adjusted net income (loss) per common share 鈥� basic 鈥� non-GAAP measure | $ | (0.06) | $ | (0.05) | $ | (0.12) | $ | (0.12) | ||||
Adjusted net income (loss) per common share 鈥� diluted 鈥� non-GAAP measure | $ | (0.05) | $ | (0.05) | $ | (0.11) | $ | (0.12) | ||||
听
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