SeaStar Medical Q2 2025 Earnings Call Transcript

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August 13, 2025

Key Takeaways

  • Positive Sentiment: Company saw Quellimmune net revenue grow nearly 370% year-to-date with a 15% sequential increase in Q2, reflecting strong early commercial traction.
  • Positive Sentiment: Early real-world data from the SAVE registry reported 75% survival in 20 critically ill pediatric patients treated with Quellimmune and no device-related safety events.
  • Positive Sentiment: The adult neutralized AKI pivotal trial has enrolled 125 of 200 patients, with a DSMB interim analysis of 100 patients’ 90-day follow-up expected in Q3 2025.
  • Positive Sentiment: SeaStar strengthened its balance sheet by raising $12.4 million in Q2 and $8.6 million subsequently, ending the quarter with $6.3 million cash and zero debt while cutting operating expenses to $2.1 million and narrowing net loss to $2 million.
AI Generated. May Contain Errors.
Earnings Conference Call
SeaStar Medical Q2 2025
00:00 / 00:00

There are 3 speakers on the call.

Operator

Thank you for standing by. My name is Tina, and I will be your conference operator today. At this time, I would like to welcome everyone to the SeaStar Medical Second Quarter Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. Due to the speakers' remarks, there will be a question and answer session.

Operator

To ask a question, simply press star followed by the number one on your telephone keypad. To withdraw your question, press star one again. It is now my pleasure to turn the call over to Jackie Cosmos. You may begin. Thank you, Tina.

Operator

Good afternoon, and thank you for joining the c SeaStar Medical second quarter twenty twenty five financial results conference call. I'm Jackie Cosman with Wheelhouse Life Science Advisors. Joining me from SeaStar Medical today are Eric Schlarf, chief executive officer David Green, chief financial officer doctor Kevin Chung, chief medical officer and Tim Baruchak, senior vice president of commercial and business operations. I would like to remind listeners that comments made during this call by management will include forward looking statements within the meaning of federal securities laws. These forward looking statements involve risks and uncertainties that could cause actual results to materially differ from any anticipated results.

Operator

For a list and description of these risks and uncertainties, please review SeaStar Medical's filings with the Securities and Exchange Commission. Furthermore, the comments of this conference call contain information that is accurate only as of the date of the live broadcast, 08/13/2025. KeyStar Medical undertakes no obligation to revise or update any statements to reflect events or circumstances as required by law. And now I'll turn the call over to Eric.

Speaker 1

Eric? Thank you, Jackie. Thank you, Jackie, and thank you for joining us today. Since the beginning of the second quarter, we've made great progress on several fronts. We enrolled a 125 patients in total, 12 in the month of July into the neutralized AKI trial, reported three new Quellimmune customers from top rated U.

Speaker 1

S. Based children's hospitals, announced positive survival results from the first 20 pediatric patients treated in a commercial setting with Quellimmune from the SAVE surveillance registry and raised additional capital to shore up our balance sheet. With respect to our Quellimmune product launch, we predicted that sales would be lumpy in the first year, and that rings true of the first half of the year. The first quarter net revenue jumped up fourfold from the fourth quarter, and we saw a 15% increase in net revenue in the second quarter. So overall, we saw nearly a 370% increase in revenue in the 2025 compared to the first six months of launch.

Speaker 1

As such, we are pleased with our progress on the Quellimmune launch and plan to continue to focus our efforts on new customer adoptions, which should translate to an upward trend in sequential quarter sales. Now let me say a few words about the SAVE surveillance registry. We are especially pleased with the early data from the registry that continues to show life saving benefits from the Quellamine therapy, confirming that seventy five percent survival data is decisive in our view and clearly demonstrates that the Quell immune therapy is benefiting patients in the real world setting. As Tim will explain, we are already sharing these early results with existing and potential customers in hopes of expanding the use of Quellamine in these critically ill pediatric patients with acute kidney injury or AKI. Before I turn the call over to Tim, I'd like to emphasize one last point.

Speaker 1

That is we experience great reward when we hear that Quellimmune has helped another critically ill pediatric patient who, in many cases, have little hope of survival. With each of these cases, we realize that we may be able to do this again and again with adult patients who suffer the same disruptive hyper inflammation that shuts down organs and takes lives. The numerous stories that we have heard about the use of Quellamine is why we, at CCAR Medical, are so eager to bring the c SCD therapy to a much broader market than we serve today. And we believe we are well on our way. We look forward to reporting our upcoming milestone and progress in our neutralized AKI pivotal trial.

Speaker 1

And with that as an overview, I will turn the call over to Tim to discuss our commercial achievements and market opportunities. Thanks, Eric, and thanks, everyone, for joining us today on the SeaStar Medical call. I'm pleased to report that we've made good progress on our primary goal of new Qualimmune site adoptions. We secured three new customers since the start of the second quarter and continue to see strong enthusiasm for the Qualimmune therapy by existing customers. Specifically, the addition of Texas Children's Hospital to the Qualimmune family is indicative of the belief in the clinical results that can be achieved and the conviction around this product, and it's notable that the premier pediatric hospitals across the country are adopting Qualimmune therapy.

Speaker 1

Qualimmune net revenue for the second quarter increased 15% sequentially. And as Eric indicated, we still anticipate that sales will be lumpy until more pediatric hospitals are activated and we can gain a further understanding of the cadence of patient presentation within these hospitals. We have already started discussing the recent early stage surveillance registry with our pipeline of customers. These data and the more extensive data from the registry that we hope to present at a prominent pediatric nephrology meeting later this year will provide detailed real world data to further support the use of the Qualimmune therapy. Now turning to our next potential product offering, the SCD therapy for adult patients with AKI requiring CRRT.

Speaker 1

We have begun our pre commercialization efforts to support the potential launch of the adult SCD, assuming positive clinical trial results and FDA approval. We estimate that the total U. S. Market opportunity is approximately 50 times the size of the pediatric population or about two hundred thousand patients annually that face organ failure and potentially loss of life with no FDA approved treatment options beyond the current standard of care, which is CRRT and antibiotics. At our current projected revenue per patient, this translates to a total addressable market greater than $4,000,000,000 annually in The U.

Speaker 1

S. With even a modest market penetration, we could deliver significant revenue for SeaStar Medical. For this near term potential market, we are also modeling a more favorable time to adoption than Qualimmune and Pediatrics, and that's based on factors such as increased clinical need due to the size of the population, the potential lack of post market registry requirements and our ability to leverage pediatric customer experiences with Qualimmune. And looking beyond the adult AKI indication, we have received FDA breakthrough device designation for five additional indications. We believe the market for our adult indications in The U.

Speaker 1

S. Alone is hundreds of thousands of patients that currently have no approved therapies to address conditions where disruptive hyperinflammation creates critical care issues, organ failure and death. This is why we are so excited about the future prospects for SeaStar Medical and the STD therapy. And with that, I'll turn the presentation over to our Chief Medical Officer, Doctor. Kevin Chung.

Speaker 1

Kevin? Thanks, Tim, and thank you, everyone, for joining us today. I am pleased to report steady progress in our neutralized AKI pivotal trial. As of today, we've enrolled 125 of our target 200 patients. That's 31 additional patients since the start of Q2, reflecting meaningful progress despite across the board low census during the summer months.

Speaker 1

For those newer to our story, NEUTLAGE HKI is a randomized controlled trial evaluating whether up to ten, twenty four hour treatments with our STD therapy can improve ninety day survival or renal recovery in patients with AKI requiring CRRT compared to CRRT alone. Our primary endpoint is a composite of mortality or dialysis dependency at ninety days, and the trial is powered for 200 patients. We also reached a key milestone in May. The tenth patient was enrolled or 100 patients was enrolled, triggering our prespecified interim analysis. And in early August, the 100 patients reached the ninety day follow-up.

Speaker 1

This analysis is being conducted independently by our data safety monitoring board or GSMB, which will review pool data to assess outcomes between treatment and control arms. Their recommendation will guide the next phase of the trial. We expect the DSMB to deliver its recommendation in Q3 twenty twenty five. Possible recommendations include continuing the trial to 200 patients as planned, re estimating the total number of patients needed, stopping early for overwhelming efficacy or stopping for futility. While we are prepared for all outcomes, our current assumptions support continuation as planned towards full enrollment of 200 patients.

Speaker 1

To maintain scientific and regulatory integrity, only the DSMB's recommendation, not the underlying outcomes data, will be shared publicly. Now regarding the pace of trial enrollment, we can ensure all of you that our sites are extremely motivated and are continuously screening patients daily. When we find eligible patients, our sites are able to successfully consent and enroll a large proportion. In fact, more than eighty percent of eligible patients are successfully consented and randomized into our trial. This reflects highly on the site investigators and the incredibly professional research staff who are tactfully approaching family members during our patients' most desperate hour.

Speaker 1

We must reemphasize that we are focused on enrolling the right type of patient. Our protocol includes strict criteria to exclude those who may not have any modifiable disease, as in patients unlikely to benefit from any intervention. This careful selection of the right patients is essential to demonstrating therapeutic effect and avoiding the pitfalls that have undermined many prior API and sepsis trials. One of those enrichment criteria is c reactive protein or CRP level of 3.5 milligrams per deciliter. Patients who do not have a CRP greater than 3.5 are excluded.

Speaker 1

Why? Because this is a very sensitive marker of inflammation, and those patients who do not have a CRP greater than 3.5 do not have significant inflammation and are unlikely to benefit from our therapeutic device. Therefore, we are selecting these patients out. In past interventional sepsis or AKI trials directed at inflammation, many of these types of patients were included and have failed as a result. Still, in an effort to optimize our rate of enrollment, we selectively added key sites.

Speaker 1

We have also shut down sites that have not performed to optimize efficiencies across the study while minimizing costs. We are not done adding sites. By the end of Q3, we aim to add at least three to four more strategically selected sites. Finally, in several of our already activated sites, we are working to expand screening into additional ICUs within the same site. This move will help us increase our enrollment pace, and we will do this without having to absorb any additional start up costs.

Speaker 1

Based on current projections, we believe we still have a decent chance of reaching full enrollment by the end of the year. Following enrollment completion and final data loss, we will move swiftly to analyze the results and share them with the global medical community. Should we meet our primary endpoint, we plan to file our premarket approval or PMA application with the FDA. Our breakthrough device designation for adult AKI requiring CRT will support expedited regulatory review. In parallel, I'm proud to share top line data from our SAVE surveillance registry recently announced in a July press release.

Speaker 1

Among the first 20 critically ill pediatric patients treated with FELIIMUN under our real world registry, we observed a seventy five percent survival rate at twenty eight days with no device related safety events. These children work extremely ill, most receiving therapy as a last resort. And yet, three quarters survived the immediate life threatening phase, strongly suggesting the possibility for more than a fifty percent reduction in mortality compared to historical benchmarks. As an ICU physician, these better than expected outcomes reinforce our conviction that Qualimmune is giving these extremely sick children children a fighting chance. These encouraging results have given our clinical team at CCAR a major adrenaline boost for both the pediatric rollout as well as the adult trial.

Speaker 1

Our collective goal remains the same as it has always been. This is our true norm, to accelerate pediatric clinical adoption, to save as many sick children as possible, and when the time comes, to do the same for the adult population. While neutralized AKI is our immediate focus, our broader strategy remains to expand the use of FCD therapy across a range of hyper inflammatory conditions. We believe this platform has potential to redefine treatment paradigms beyond AKI, pediatrics and adults alike. With that, I'll hand it over to our CFO, David Green.

Speaker 2

Thank you, Kevin, and thank you all for joining us today. I'll describe our second quarter financial results and conclude with some of our expectations for the remainder of 2025. First, for some housekeeping, please note that our Form 10 Q will be filed with the SEC in the next twenty four hours. You can find it at seastarmedical.com or at sec.gov. And before I turn to our financial results for the second quarter, let me also say that since the beginning of the second quarter, we have achieved a number of key milestones for the company.

Speaker 2

We've positioned the company to build on the first three quarters of commercial revenue for Quellimmune and pushed forward the adult neutralized AKI pivotal trial. We've made good progress in our priorities as reported in our press release today. To highlight three of these accomplishments, first, we've advanced our neutralized AKI pivotal trial for adults, adding 31 new patients through today, bringing total enrollment to 125 of the 200 patient total targeted to complete the trial. Second, we've increased Quellimmune adoption, adding three new customers since the beginning of the second quarter. And third, we raised $12,400,000 of new equity capital through a public offering and two registered direct offerings, each priced at the market.

Speaker 2

With that, I'll turn to our second quarter twenty twenty five financial results. We recorded our highest quarterly revenue to date, achieving a 15% increase in sequential quarter revenue through sales of Quellimmune therapy. Revenue for the 2025 was $338,000 compared to approximately $293,000 in the 2025 and $0 in the year ago second quarter. Year to date revenue was $631,000 We attribute q two revenue growth to existing customers expanding their usage of Qualimmune and the addition of new hospital customers purchasing Qualimmune therapy. Moving to gross profit, the Q2 financial statements reflect a gross profit margin of approximately 92%.

Speaker 2

As I indicated last quarter, Q2 was a transition quarter where we began to recognize COGS. This is consistent with GAAP and due to sales of QUELIMUNE units that had been previously recognized as research and development expense. As we build and then sell new inventory as a commercial enterprise, we will record additional cost of goods sold matching sales from inventory. Operating expenses declined to approximately $2,100,000 in the 2025 compared to $4,700,000 in 2024. The decline was primarily due to a reduction in personnel costs and clinical trial expenses as most of our new clinical trial set activations occurred in 2024, which carry upfront initiation expenses.

Speaker 2

We also experienced a decline in preclinical research, audit fees and professional services expenditures. And finally, our net loss for the 2025 declined to $2,000,000 compared to a loss of $3,200,000 in 2024. We ended the quarter with $6,300,000 of cash and no debt. Also of note, subsequent to June 30, and therefore, not reflected in the Q2 balance sheet, we raised $8,600,000 through two registered direct offerings and the warrant exercise. Looking forward, we will focus our resources on our top three objectives.

Speaker 2

Number one, completing the neutralized AKI pivotal trial for adults. Number two, preparing to file a PMA following the completion of the adult AKI pivotal trial. And number three, new customer acquisition for Qualivune. In wrapping up, as we drive our strategic objectives forward, we expect momentum to continue as we bring our life saving therapy to more patients and clinicians and as more investors become aware of the significant market opportunity developing for our STD therapy. And with that, I'll hand the call back to Eric.

Speaker 2

Eric?

Speaker 1

Thanks, Dave. Our goal today for our second quarter financial results conference call was to provide you with a summary of our progress as well as a clear picture of why we believe the future opportunities for CTAR Medical are significant. We are passionate about our ability to provide a life saving therapy to critically ill patients who today have no alternative treatment for calming the cytokine storm caused by an overreactive immune system. We have a number of upcoming milestones. And as we complete the neutralized AKI pivotal trial enrollment, we look forward to reporting the results.

Speaker 1

Provided the data are supportive, we plan to file a PMA in 2026. If approved, we believe we have a significant opportunity to capture a sizable portion of the adult AKI market. In short, we believe we are continuing to create strong value for our investors and stakeholders, and we'll be looking to close what we see as a substantial gap in our current market cap and the outlook that we have for the company. With that, I'll ask the operator to open the call for questions. Operator?

Operator

Thank you. I will now turn the call back over to Jackie Cosmet for closing remarks. Thank you, Tina, and thank you all for joining us today for the SeaStar Medical second quarter financial results conference call. If you have questions, please contact us at ir@seastarmed.com or visit our website to see our latest news, product, pipeline and company information. Thank you all and goodbye.

Operator

Thank you again for joining us today. This does conclude today's presentation. You may now disconnect.

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