speaker
Tawanda
Conference Operator

Hello, and welcome to the C-STAR Medical First Quarter 2026 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After this speaker's presentation, there will be a question-and-answer session. To ask the question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. I would now like to hand the conference over to Jackie Cosmo. You may begin.

speaker
Jackie Kosman
Wheelhouse Life Science Advisors

Thank you, Tawanda. Good afternoon, and thank you for joining the Seastar Medical First Quarter 2026 Financial Results Conference Call. I'm Jackie Kosman with Wheelhouse Life Science Advisors. Joining me from Seastar Medical today are Eric Schlarf, Chief Executive Officer, Dr. Kevin Shang, Chief Medical Officer, Kim Baracek, Senior Vice President of Commercial and Business Operations, and Mike Messinger, Chief Financial Officer. 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 and could cause actual results to differ materially from any anticipated results. For a list and description of these risks and uncertainties, please review CSTAR Medical's filings with the Securities and Exchange Commission. Furthermore, the content of the conference call contains information that is accurate only as of the date of the live broadcast, May 13, 2026. Eastar Medical undertakes no obligation to revise or update any statements to reflect events or circumstances except as required by law. And now, I'd like to turn the call over to Eric. Eric?

speaker
Eric Schlarf
Chief Executive Officer

Thank you. Thank you, Jackie, and thank you all for joining us today. We are making good progress towards achieving our 2026 goals and also maintaining a disciplined use of our financial resources. The increase in our Quell Immune customer base has helped propel our first quarter Quell Immune net revenue with a nearly 70% increase from the first quarter of 2025 with seven new hospitals adopting the Quell Immune therapy in the first quarter of 2026. Our goal this year is 15 new customers, and we are well on our way to achieving that. With our growing presence and the continued adoption of Quell Immune in the pediatric AKI market, we believe we are on track to meet our net revenue goal of approximately $2 million over the year. More importantly, we are setting the stage for our next and potentially far larger market opportunity in the adult AKI market. To that end, we continue to enroll patients in the neutralized AKI pivotal trial, with 198 patients enrolled of our planned total 339 patients. Last year, we determined that we would add new clinical sites to expand our enrollment efforts to reach completion of enrollment around the end of 2026. Kevin and his team are working diligently to make this happen, and it's been extremely rewarding to see the highest caliber medical institutions participate in our trial, with UCLA as an example of one of the latest hospitals to join in, and more on the way. In addition, we continue to work closely with the FDA on several fronts. First, we are discussing the elements of a modular PMA submission for the adult AKI indication, which we believe Second, we are working with the FDA to obtain agreement on a rapid approval pathways for our STD therapy. The STD therapy is a potential life-saving therapy for indications where there are no treatments today, and we believe patients with hyperinflammation should have more immediate access to therapies that could reduce or avoid severe organ damage and potential loss of life. Finally, and before I turn the call over to Tim, we have maintained a strong financial discipline. Mike will share our efforts on this front shortly. And now, I will turn the call over to Tim to discuss not only our commercial achievements, but how we are building a strong presence in the pediatric AKI community.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

-

-