Financial Data and Key Metrics Changes - Full year 2025 sales revenues increased by 4% to $37.1 million, representing record core product sales [5][15] - Gross margins reached 71% for the full year and improved to 74% in Q4 2025, driven by manufacturing efficiencies [7][17] - Operating loss for 2025 improved by 10% to $14.7 million compared to $16.5 million in 2024 [16] - Adjusted net loss for 2025 was $14.2 million or $0.23 per share, compared to an adjusted net loss of $12.7 million or $0.23 per share in 2024 [19] Business Line Data and Key Metrics Changes - Direct sales outside of Germany increased by 13% to $8.6 million, while distributor sales grew by 11.4% to $16.5 million, together accounting for approximately 68% of total revenue [6][15] - Sales in Germany declined by 10% to $11.8 million, reflecting the near-term impact of restructuring efforts [6][15] Market Data and Key Metrics Changes - The company has delivered over 300,000 treatments globally across 70 countries, indicating a broad and growing clinical footprint [4] - Clinical evidence continues to drive adoption, with over 75% of surveyed physicians adopting blood purification, with CytoSorb being one of the most commonly used modalities [10] Company Strategy and Development Direction - The company is focused on driving sales growth outside of Germany while repositioning the German market for long-term success [5] - Key priorities include advancing DrugSorb-ATR through the FDA regulatory process and achieving cash flow break-even by the second half of 2026 [22][23] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about early signs of improvement in the German market and expects gradual and sustained improvement throughout 2026 [8][31] - The company aims to create meaningful long-term value through consistent revenue growth and a strong focus on clinical evidence [23] Other Important Information - The PuriFi pump is a strategic initiative aimed at expanding access and utilization, with over 100 units placed globally [8] - The company is working on a streamlined and targeted resubmission for DrugSorb-ATR following a previous denial, with no safety concerns raised by the FDA [12][48] Q&A Session Summary Question: FDA regulatory process and timelines - Management is in interactive discussions with the FDA to ensure alignment before submission, aiming to streamline the process [27][29] Question: Confidence in reaching consensus with the FDA - Management believes they are on a defined regulatory path and is working to ensure no surprises during the submission process [28][29] Question: Early signs of improvement in the German market - Management noted a leadership change and a proactive approach to market development, leading to increased engagement and pipeline activity [31] Question: Status of the restructuring in Germany - Management believes they are in the later innings of restructuring, with expectations for incremental improvement over time [38] Question: Future gross margin expectations - Management aims to maintain gross margins above 71% and is optimistic about potential improvements with increased volumes [40] Question: PuriFi pump revenue model - The PuriFi pump is seen as an investment strategy, similar to a printer cartridge model, with expectations for future disposable revenue growth [41][42] Question: Pathway to operating break-even - Management is implementing cost reduction initiatives and expects to achieve cash flow break-even in the second half of 2026 [46][47] Question: De-risking steps for DrugSorb-ATR resubmission - Management is ensuring alignment with the FDA to avoid surprises and is taking a cautious approach to the resubmission process [48][49]

Financial Data and Key Metrics Changes - The fourth quarter net loss was $51 million or $0.97 per share, compared to a net loss of $36.7 million or $0.85 per share for the fourth quarter of 2024 [25] - The full year net loss was $177 million or $3.79 per share, compared to $111.8 million or $2.83 per share for the same period in 2024 [25] - Non-GAAP adjusted net loss for the fourth quarter was $38.4 million or $0.73 per share, compared to $32.3 million or $0.75 per share for the fourth quarter of 2024 [26] - Non-GAAP adjusted net loss for the full year was $150.8 million or $3.22 per share, compared to $101.9 million or $2.58 per share for 2024 [26] - Cash, cash equivalents, and short-term investments were $441.5 million at the end of fiscal year 2025, expected to finance operations through 2027 [30] Business Line Data and Key Metrics Changes - Research and development expenses for the fourth quarter were $37.6 million, up from $33.5 million for the prior year period [27] - R&D expenses for the full year were $145 million, compared to $104.2 million for the prior year [27] - General and administrative expenses for the fourth quarter were $11.6 million, compared to $3 million for the prior year period [28] - G&A expenses for the full year were $27.2 million, compared to $9.1 million for the prior year [28] Market Data and Key Metrics Changes - The total addressable market for gedatolisib in the second-line setting is estimated to be more than $5 billion, with potential peak revenue of up to $2.5 billion annually [18] Company Strategy and Development Direction - The company is preparing for the potential approval and commercialization of gedatolisib, with a PDUFA goal date of July 17, 2026 [5] - The company aims to establish gedatolisib as a new standard of care therapy for patients with HR-positive, HER2-negative advanced breast cancer [5] - The company is engaging with payers and strategic accounts to ensure access to gedatolisib for oncologists and their patients [16][17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the FDA's review of the NDA based on unprecedented efficacy data from the phase III VIKTORIA-1 clinical trial [6] - The company believes that the positive results from the PIK3CA wild-type cohort will position gedatolisib favorably in the market [14] - Management highlighted the importance of the safety profile of gedatolisib, which does not induce clinically relevant hypoglycemia [11][70] Other Important Information - The company has completed enrollment of the PIK3CA mutant cohort of the phase III VIKTORIA-1 trial and expects to announce results in the second quarter [7] - The company is also evaluating gedatolisib in combination with darolutamide for men with metastatic castration-resistant prostate cancer [15] Q&A Session Summary Question: Status update on the mutant data - Management could not comment on the database lock status [33] Question: Details on the disclosure of mutant data - Management indicated that top-line data will be provided in a press release, with details at a medical conference [34] Question: Feedback from physicians on launch segments - Management stated that the sales force will reach out generally to doctors to help them understand the benefits of gedatolisib [43] Question: Will physicians use it off-label for mutants? - Management confirmed that there have been no discussions with doctors about off-label use [44] Question: Details on the top-line release of median data - Management confirmed that the release will include a statement regarding the achievement of statistical significance [48] Question: Key gating factor for frontline endocrine-sensitive trial - The key gating factor is completing the safety run-in [58] Question: Challenges in getting patients for infusions - Management believes that efficacy is the most important factor for physicians and does not expect significant patient pushback on IV administration [61] Question: Commercial advantages of having a label across metastatic breast cancer subtypes - Management aims to simplify decision-making for physicians by providing a biomarker-agnostic alternative [66] Question: Learnings from the launch of inavolisib - Management noted that gedatolisib does not induce significant glycemic disruption, allowing broader patient treatment [70] Question: European commercial strategy for gedatolisib - Management plans to submit a supplemental NDA after initial approval and explore partnerships for launching in Europe [78]

Financial Data and Key Metrics Changes - The fourth quarter net loss was $51 million or $0.97 per share, compared to a net loss of $36.7 million or $0.85 per share for the fourth quarter of 2024 [25] - The full year net loss was $177 million or $3.79 per share, compared to $111.8 million or $2.83 per share for the same period in 2024 [25] - Non-GAAP adjusted net loss for the fourth quarter was $38.4 million or $0.73 per share, compared to $32.3 million or $0.75 per share for the fourth quarter of 2024 [26] - Non-GAAP adjusted net loss for the full year was $150.8 million or $3.22 per share, compared to $101.9 million or $2.58 per share for 2024 [26] - Cash, cash equivalents, and short-term investments were $441.5 million at the end of fiscal year 2025, expected to finance operations through 2027 [30] Business Line Data and Key Metrics Changes - Research and development (R&D) expenses for the fourth quarter were $37.6 million, up from $33.5 million for the prior year [27] - R&D expenses for the full year were $145 million, compared to $104.2 million for the prior year [27] - General and administrative (G&A) expenses for the fourth quarter were $11.6 million, compared to $3 million for the prior year [28] - G&A expenses for the full year were $27.2 million, compared to $9.1 million for the prior year [28] Market Data and Key Metrics Changes - The total addressable market for gedatolisib in the second-line setting is estimated to be more than $5 billion, with potential peak revenue of up to $2.5 billion annually [18] Company Strategy and Development Direction - The company is preparing for the potential approval and commercialization of gedatolisib, aiming to establish it as a new standard of care for HR-positive, HER2-negative advanced breast cancer [5][19] - The company has engaged extensively with payers and strategic accounts to ensure access to gedatolisib upon approval [16][90] - The company plans to conduct a supplemental NDA submission for the mutant cohort following initial approval for gedatolisib [76] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the FDA's review of the NDA for gedatolisib, citing unprecedented efficacy data from clinical trials [6][17] - The company believes that gedatolisib's unique mechanism of action and safety profile position it well in the market [19][92] - Management highlighted the importance of efficacy as the primary factor influencing physician and patient decisions regarding treatment [62] Other Important Information - The company completed enrollment of the PIK3CA mutant cohort of the phase III VIKTORIA-1 trial and expects to announce results in the second quarter of 2026 [7] - Safety results from clinical trials indicated that gedatolisib was generally well-tolerated, with low rates of treatment-related adverse events [10][11] Q&A Session Summary Question: Status update on the mutant data - Management could not comment on the database lock status for the mutant data [33] Question: Details on the disclosure of mutant data - Management indicated that top-line data will be provided in a press release, with further details at a medical conference [34] Question: Feedback from physicians on treatment segments - Management stated that the sales force will reach out to doctors generally to explain how gedatolisib offers improvements over current alternatives [43] Question: Will physicians use gedatolisib off-label for mutants? - Management confirmed that there have been no discussions with doctors regarding off-label use [44] Question: Details on the top-line release of median data - Management stated that the release will include a statement regarding the achievement of statistical significance [48] Question: Key gating factor for frontline endocrine-sensitive trial - The key gating factor is completing the safety run-in for the trial [58] Question: Challenges in getting patients for infusions - Management believes that efficacy will be the most important factor for physicians and patients, and they do not expect significant pushback on IV administration [61] Question: Commercial advantages of having a label across metastatic breast cancer subtypes - Management aims to simplify decision-making for physicians by providing a biomarker-agnostic alternative [66] Question: Learnings from the launch of inavolisib - Management noted that gedatolisib does not induce significant glycemic disruption, allowing broader patient eligibility [70] Question: European commercial strategy for gedatolisib - Management plans to explore partnerships for launching gedatolisib in Europe while proceeding with regulatory activities [78]

Financial Data and Key Metrics Changes - Full year revenue grew approximately 10% to $56.7 million, with fourth quarter revenue at $15.6 million, up 27% year-over-year, all organic growth [4][22] - Full year adjusted EBITDA reached $2.9 million, up over 200% from $900,000 in 2024, indicating strong operating leverage [5][24] - Fourth quarter adjusted EBITDA was $1.7 million compared to a loss of $500,000 in Q4 of 2024, demonstrating significant profitability improvement [5][25] Business Line Data and Key Metrics Changes - The company has focused on organic growth without major acquisitions in the past year, leading to improved profitability and cash flow [3][4] - The partnership with DealMaker is expected to unlock new revenue opportunities through capital raising for consumer products, leveraging existing marketing capabilities [9][10] Market Data and Key Metrics Changes - The online capital raising market is growing rapidly, particularly for celebrity and influencer-led brands, which are among the highest performing categories [11][12] - The company is targeting consumer products and lifestyle brands primarily at growth and expansion stages, expanding its addressable market [10][12] Company Strategy and Development Direction - The strategic partnership with DealMaker is seen as a significant growth catalyst, allowing the company to scale its capital raising capabilities [9][10] - The launch of Dolphin Intelligence, focused on AI-driven marketing strategies, aims to enhance service offerings and improve operational efficiency [13][15] Management's Comments on Operating Environment and Future Outlook - Management expects continued revenue growth in 2026, driven by organic growth and contributions from new services [17][18] - The company anticipates adjusted EBITDA margin expansion, with a goal of achieving higher margins as revenue grows [18][47] Other Important Information - The company has significant federal and state net operating loss carryforwards of approximately $127 million, which will shield cash payments for taxes as EBITDA grows [6][7] - Expected annualized lease savings of approximately $1 million beginning at the end of 2026 will flow directly to the bottom line [19][20] Q&A Session Summary Question: Can you elaborate on the revenue opportunities from the DealMaker partnership? - The partnership allows the company to scale opportunities in launching consumer products and raising capital for clients, with marketing fees expected during fundraising [26][27] Question: What is the expected length of deals and typical investors? - The company anticipates a typical deal length of 6-8 weeks for pre-production and 4 months for the fundraising process, with average investment sizes around $1,000-$2,000 [32][33] Question: When do you expect to add additional ventures? - The company plans to vet promising deals by the end of April and hopes to be in the market with the first venture by summer [35][36] Question: How do you expect Dolphin Intelligence to contribute to growth? - The new division is expected to provide services to existing clients and attract new business, enhancing the company's competitive edge [40][41] Question: What is the timeline for the Youngblood film's streaming rights? - The company expects higher revenue from streaming sales compared to box office performance, with a better indication of results by the next earnings call [42][43] Question: Is double-digit organic growth sustainable? - Management believes in the potential for continued organic growth and margin expansion, aiming for higher profitability as revenue increases [46][47]

Financial Data and Key Metrics Changes - Q4 revenue reached $178 million, representing a 35% year-over-year growth, while Gross Booking Value (GBV) reached $2.3 billion, up 42% year-over-year [13][14] - Non-GAAP operating margin was breakeven, showing a significant improvement of 1,100 basis points compared to the previous year [14] - The company turned free cash flow positive for the first time, a year ahead of schedule [6][14] Business Line Data and Key Metrics Changes - The company signed net new GBV that was over 50% more compared to Q4 of the previous year, indicating strong growth momentum [6] - The Reed & Mackay brand was retired for new sales, resulting in a $36.2 million non-cash amortization charge, but this strategic move is expected to enhance the integration of services [14][30] Market Data and Key Metrics Changes - The company reported a net revenue retention rate of 107% for FY 2026, with the core Navan platform achieving a retention rate of 110% [32] - The unmanaged travel market, targeted by the new Navan Edge platform, is estimated at $57 billion, indicating a significant growth opportunity [10][59] Company Strategy and Development Direction - The company aims to focus on high growth and scaling across all channels and offerings in FY 2027, with continued investment in AI and product innovation [11] - The integration of Reed & Mackay into the Navan platform is expected to improve unit economics and enhance sales capabilities [30][31] Management's Comments on Operating Environment and Future Outlook - Management noted minimal impact from geopolitical tensions on bookings, with a strong outlook for corporate travel [24][45] - The company anticipates revenue growth between $866 million and $874 million for FY 2027, representing a 24% growth at the midpoint [15] Other Important Information - The company has a strong balance sheet with $741 million in cash and short-term investments against $125 million in debt [15] - The company is leveraging AI to enhance customer experience and operational efficiency, with a focus on automating travel management processes [9][21] Q&A Session Summary Question: Can you provide insights on the bookings momentum and sustainability? - Management highlighted a 42% GBV growth in Q4 and clarified that the 50% growth mentioned refers to new signed GBV, indicating strong future revenue potential [19] Question: What impact has geopolitical conflict had on bookings? - Management reported minimal impact from geopolitical tensions, with a strong resilience in business travel observed [24] Question: What benefits are expected from the Reed & Mackay transition? - The integration is expected to enhance customer experience and improve unit economics, with higher gross margins anticipated from the AI-driven platform [30][31] Question: How does the company view the guidance for FY 2027? - Management expressed confidence in achieving a 24% revenue growth, driven by strong momentum and customer acquisition [15][46] Question: What is the impact of being a public company on RFPs? - Being public has increased transparency and confidence among potential clients, leading to a rise in RFPs from larger companies [85]

Financial Data and Key Metrics Changes - Total revenues for 2025 were $61.9 million, a 10% increase from $56.1 million in 2024, driven by the successful launch of EMROSI [17] - Gross margins improved to 66.2% in 2025 from 62.8% in 2024, reflecting a favorable product mix and lower inventory costs [17] - The company reported a GAAP net loss of $11.4 million, or $0.47 per share, compared to a loss of $14.7 million, or $0.72 per share in 2024 [18] - Adjusted EBITDA was positive at $2.9 million for 2025, up from $800,000 in 2024, indicating progress towards sustainable profitability [18] Business Line Data and Key Metrics Changes - EMROSI achieved $14.7 million in net sales during the three quarters it was available in 2025, with approximately 53,000 prescriptions written [5][7] - The total prescription volume for EMROSI grew nearly 50% sequentially in Q4 compared to Q3 [8] - The company ended 2025 with approximately 3,500 unique prescribers for EMROSI, surpassing its initial goal of 3,200 [9] Market Data and Key Metrics Changes - Approximately 100 million commercial covered lives have access to EMROSI, with contracts in place with two of the top three group purchasing organizations in the U.S. [10] - The company anticipates contracting with the third major GPO by late Q1 or early Q2 of 2026 [10] Company Strategy and Development Direction - The company aims to improve profitability and expand the commercial footprint of EMROSI while launching one or two additional dermatology products in 2026 [19][25] - Focus on building positive physician and patient experiences with EMROSI to drive prescription demand and improve reimbursement rates [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued sales growth and profitability, expecting to remain adjusted EBITDA positive in 2026 [7] - The company anticipates improved reimbursement rates and reduced reliance on co-pay bridging programs as coverage expands [11] - Management highlighted the importance of clinical data and publications in supporting EMROSI's market adoption and reimbursement evaluations [12][14] Other Important Information - The company ended 2025 with a cash position of approximately $24 million, up from $20.3 million at the end of 2024 [18] - Working capital at year-end was $29.4 million, an increase of $16.4 million from the previous year [19] Q&A Session Summary Question: Insights on EMROSI prescriptions trends for Q1 - Management noted that Q1 typically sees a slowdown due to insurance deductible resets and severe weather but expects Q1 prescriptions to surpass Q4 numbers [28][29] Question: Expectations for sequential growth in Q2 - Management indicated that momentum is building and expects Q2 to be stronger than Q1, with a run rate of over 126,000 prescriptions annually [30][46] Question: Clarification on revenue per script and gross-to-net expectations - Management explained that Q4's lower revenue per script was due to reimbursement mix and expects improvements in gross-to-net as reimbursement progresses [32][35][58] Question: Commentary on accounts receivable increase in Q4 - Management confirmed that most of the accounts receivable has been collected and attributed the increase to timing [66] Question: Future gross margins outlook as EMROSI gains coverage - Management expressed optimism for improved margins as EMROSI and other high-margin products become a larger part of the revenue mix [67]

Financial Data and Key Metrics Changes - Total revenues for 2025 were $61.9 million, a 10% increase from $56.1 million in 2024, driven by the successful launch of EMROSI [17] - Gross margins improved to 66.2% in 2025 from 62.8% in 2024, reflecting a favorable product mix and lower inventory costs [17] - GAAP net loss narrowed to $11.4 million ($0.47 per share) in 2025 from a loss of $14.7 million ($0.72 per share) in 2024 [18] - Adjusted EBITDA was positive at $2.9 million for 2025, compared to $800,000 in 2024, indicating progress towards sustainable profitability [18] Business Line Data and Key Metrics Changes - EMROSI achieved $14.7 million in net sales during its first three quarters on the market, with approximately 53,000 prescriptions written [5][7] - The total prescription volume for EMROSI grew nearly 50% sequentially in Q4 compared to Q3 [8] - The company ended 2025 with approximately 3,500 unique prescribers for EMROSI, surpassing its initial goal of 3,200 [9] Market Data and Key Metrics Changes - Approximately 100 million commercial covered lives have access to EMROSI, with contracts in place with two of the top three group purchasing organizations in the U.S. [10] - The company anticipates contracting with the third major GPO by late Q1 or early Q2 of 2026 [10] Company Strategy and Development Direction - The company plans to launch one or two additional dermatology products in 2026 to augment its revenue growth [15][25] - Focus on improving profitability through disciplined expense management and margin expansion as EMROSI's commercial footprint grows [19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued sales growth and expects to remain adjusted EBITDA positive in 2026 [7] - The company anticipates improved reimbursement rates and reduced reliance on co-pay bridging programs as coverage expands [11] - Management highlighted the importance of EMROSI's clinical efficacy and safety profile in driving demand and patient refill behavior [12] Other Important Information - The company ended 2025 with a cash position of approximately $24 million, up from $20.3 million at the end of 2024 [18] - Working capital at year-end was $29.4 million, an increase of $16.4 million from the previous year [19] Q&A Session Summary Question: Trends in EMROSI prescriptions for Q1 - Management noted that Q1 typically sees a slowdown due to insurance deductible resets and severe weather but expects Q1 prescriptions to surpass Q4 numbers [28][29] Question: Expectations for Q2 prescriptions - Management anticipates strong momentum in Q2, with expectations for prescription growth to continue [30] Question: Gross-to-net revenue predictions - Management indicated that gross-to-net figures are expected to improve as reimbursement progresses and the mix of reimbursed prescriptions changes [34][35] Question: Inventory movement and accounts receivable - Management confirmed that the increase in accounts receivable was due to timing and that most cash has been collected [66] Question: Future product launches - Management described upcoming product launches as incremental additions to the portfolio, aimed at supporting the base business [70]

Financial Data and Key Metrics Changes - For the year ended December 31, 2025, total revenue was $9.7 million, a significant increase of $5.8 million or 149% compared to $3.8 million in 2024, primarily driven by the launch of PAPZIMEOS [12][13] - Net product revenue for Q4 2025 was $3.4 million, with expectations for Q1 2026 revenues to exceed $18 million based on early commercial activity [4][14] - The net loss attributable to common shareholders was $429.6 million or $1.37 per share, which included non-cash items totaling $318.5 million [16][17] Business Line Data and Key Metrics Changes - The launch of PAPZIMEOS has transitioned the company from an R&D focus to a revenue-generating commercial biotech entity, marking a pivotal milestone [3] - The number of patients in the Precigen patient support hub increased from over 200 in mid-January to well over 300, indicating strong demand for PAPZIMEOS [9][10] Market Data and Key Metrics Changes - Payer coverage for PAPZIMEOS expanded from approximately 170 million lives in early January to about 215 million, covering nearly 90% of insured lives in the U.S. [10] - The publication of an expert consensus paper in January positioned PAPZIMEOS as the first choice for adult patients with RRP, reflecting strong support from the medical community [11] Company Strategy and Development Direction - The company is actively pursuing geographic expansion, including a marketing authorization application to the EMA for PAPZIMEOS, with positive feedback from European thought leaders [18][19] - Plans to initiate a clinical trial for PAPZIMEOS in pediatric RRP patients are underway, with hopes to start in Q4 2026 [18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong uptake of PAPZIMEOS, with expectations for continued revenue growth and institutional activation [12][14] - The assignment of a permanent J-code from April 1 is anticipated to streamline the reimbursement process and enhance patient access to PAPZIMEOS [28][34] Other Important Information - Research and development expenses decreased by 22.1% due to strategic prioritization, while selling, general, and administrative expenses increased by 69.8% due to PAPZIMEOS commercial activities [15] - The company ended the year with $100.4 million in cash equivalents and investments, which is expected to fund operations through cash flow breakeven by the end of 2026 [17] Q&A Session Summary Question: Can you help us think about the flow of patients from the hub to receiving reimbursed drug? - Management indicated that there is significant conversion of patients from the hub, and they aim for the majority of patients to receive treatment [24][26] Question: Are patients starting to get their second dose in the treatment regimen? - Management confirmed that patients are progressing through their treatment regimens, including those who started last year [27] Question: How is the J-code helping in terms of adding more patients? - The J-code simplifies the workflow and billing process, increasing certainty and speed for patient processing [34] Question: Can you clarify on the $18 million revenue guidance? - The $18 million guidance refers only to PAPZIMEOS product revenue, excluding other revenue sources [45] Question: What differentiates community sites that become repeat prescribers? - Management noted that community interest in PAPZIMEOS has been strong, and they have implemented logistics solutions to facilitate uptake [54][55] Question: What is the current channel mix of U.S. payers? - The payer mix is approximately 60%-65% commercial, with the remainder from Medicare and Medicaid [57]

Financial Data and Key Metrics Changes - SeaStar Medical reported net revenue of over $1 million from QUELIMMUNE sales in 2025, a significant increase from $135,000 in 2024, reflecting the first full year of product sales [22][24] - The gross profit margin for QUELIMMUNE sales was above 90% for both the fourth quarter and the full year [22][24] - Operating expenses decreased to $3.4 million in Q4 2025 from $4.8 million in Q4 2024, and for the full year, they were reduced to $13.4 million from $18 million [23][24] - The net loss for Q4 2025 was approximately $2.9 million, compared to a net loss of $4.4 million in Q4 2024 [24] Business Line Data and Key Metrics Changes - QUELIMMUNE net revenue in Q4 2025 was $315,000, compared to $67,000 in Q4 2024, with first quarter 2026 revenue already exceeding this figure [20][22] - The company added 13 new customers from top-rated children's hospitals, bringing the total customer base to 16 [3][4] - The SCD therapy is currently in the NEUTRALIZE-AKI pivotal trial, with 181 of the 339 patients enrolled [4][14] Market Data and Key Metrics Changes - The pediatric AKI market is estimated to be around $100 million, with SeaStar targeting the top 50 children's hospitals in the U.S. [12] - The company plans to add 15 new top-ranked children's medical centers in 2026, aiming for $2 million in product revenue from QUELIMMUNE sales [7][12] Company Strategy and Development Direction - SeaStar Medical aims to advance the SCD therapy for adult AKI, with a market opportunity 50 times that of the pediatric AKI market [5][8] - The company is focused on expanding QUELIMMUNE adoption and evaluating broader applicability of SCD therapy in new indications [7][8] - The company has received Breakthrough Device Designation from the FDA for SCD therapy, which may expedite the approval process [4][8] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, highlighting strong momentum in the pediatric market and plans for further expansion [6][25] - The company is committed to maintaining good cost controls and improving its balance sheet, having added approximately $24 million in capital during 2025 [4][24] - Management emphasized the importance of QUELIMMUNE in saving lives and its potential to improve outcomes in critically ill pediatric patients [17][46] Other Important Information - The company has no long-term debt and approximately $12 million in cash as of December 31, 2025, compared to $1.8 million at the end of 2024 [24] - The SAVE registry, which tracks the commercial use of QUELIMMUNE therapy, has completed enrollment of 50 patients, with positive early results reported [16][17] Q&A Session Summary Question: Confidence in QUELIMMUNE adoption in additional centers - Management expressed confidence in adding 15 new pediatric centers, having already added six in Q1 2026, and highlighted the importance of the SAVE registry in facilitating quicker site activation [28][29] Question: Manufacturing capacity for SCD - Management assured that the supply chain for SCD is robust, with contract manufacturer Fresenius Medical capable of meeting demand for both pediatric and adult indications [30] Question: Timeline for CRS study and next steps - Management did not provide specific timelines for the CRS study but indicated that a successful study could lead to a humanitarian device exemption for commercialization [32] Question: Spending outlook for 2026 - Management expects spending to align more with 2025 levels, supported by a capable team to execute the commercial and clinical plans [34][35] Question: Insights from NEUTRALIZE-AKI trial - Management indicated that while specific clinical insights from the 181 enrolled patients cannot be shared yet, there is enthusiasm about the trial's progress and the addition of new clinical sites [40][42] Question: Pediatric AKI outcomes and sales strategy - Management highlighted the positive outcomes from the SAVE trial and confirmed that no additional sales representatives will be added, focusing instead on enhancing clinical representation within existing hospitals [48][49]

Financial Data and Key Metrics Changes - Q4 revenues were $42.3 million, an increase of $4.6 million or 12% from $37.7 million in the same period last year [16] - Full year revenue was $150.5 million, an increase of $8 million or 6% from $142.6 million reported last year [16] - Adjusted EBITDA for Q4 was approximately $460,000, compared to $631,000 for the same period last year [22] - Free cash flow for Q4 was $335,000, compared to $593,000 in the same period last year [23] - Net loss for Q4 was $849,000, or a loss of $0.09 per share, compared to a net loss of $356,000 and a loss of $0.04 per share for the same period last year [24] Business Line Data and Key Metrics Changes - Carrier services revenue for Q4 was $26.8 million, an increase of $2.2 million compared to the same period last year [17] - Managed services fees for Q4 were $10.5 million, an increase of $1.1 million from the same period last year [18] - Reselling and other services in Q4 was $3.9 million, a $1.2 million increase from last year [19] - Gross profit for Q4 was $5.8 million or 14% of revenues, compared to $4.8 million or 13% of revenues in the same period last year [19] Market Data and Key Metrics Changes - Approximately $80 million in contract ceiling remains under the CWMS 2.0 contract [5] - The company expects to see an update from DHS by mid-second quarter regarding CWMS 3.0 award announcement or another extension [5] Company Strategy and Development Direction - The company is focused on CWMS 3.0, which carries a $3 billion contract ceiling over 10 years, providing significant revenue visibility [29] - The company aims to improve its margin profile through SaaS and DaaS pipeline initiatives [30] - The company is transitioning select existing clients towards an as-a-service model to enhance revenue visibility and predictability [9] Management's Comments on Operating Environment and Future Outlook - Management remains confident in their competitive positioning despite delays in CWMS 3.0 award due to federal government headwinds [3] - The company is optimistic about landing several opportunities in their pipeline throughout 2026 [10] - Management emphasized the importance of maintaining a strong cash position to weather potential government shutdowns [49] Other Important Information - The company has plans to file a prospectus to establish an at-the-market offering program for financial flexibility [27] - The company ended the year with $9.8 million in unrestricted cash and has additional liquidity options available [26] Q&A Session Summary Question: Clarification on DaaS transition and warehouse in Columbus - The company is converting existing IT as-a-service customers to a device as-a-service model to enhance revenue predictability and profitability [34][36] Question: Update on Spiral 4 contract with the Navy - The company has captured eight new task orders under the Spiral 4 contract, with a total contract value of approximately $30 million [40] Question: Cash balance and potential uses - The company is maintaining a strong cash position to ensure resilience during government shutdowns and is open to potential acquisitions [49][54]