This article first appeared on GuruFocus .
Release Date: August 12, 2026
For the complete transcript of the earnings call, please refer to the full earnings call transcript .
Positive Points
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Qualimmune net revenue grew 82% year-over-year in Q2 2026, with six-month revenue of $1.1 million, tracking toward the $2 million annual target.
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Customer base doubled to 20 of the top 50 U.S. children's hospitals, with a goal of 25 by year-end, and high repurchase rates from existing sites.
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CMS assigned ICD-10 PCS codes for SCD therapy, effective October 1, 2026, removing a billing barrier and simplifying future commercialization.
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Neutralize-AKI trial enrollment reached 223 of 339 patients, with plans to add more sites to accelerate enrollment, and PMA submission timeline remains on track for late 2027.
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Gross margins remain above 90%, and the company holds breakthrough device designations for multiple indications, supporting expedited regulatory review.
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Positive real-world outcomes, including a 70% survival rate in rescue-therapy patients and growing adoption at mature sites, validate the therapy's clinical value.
Negative Points
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Net loss widened to $3.7 million in Q2 2026, up from $2 million in Q2 2025, due to increased R&D and G&A expenses.
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Cash balance declined to $7 million at June 30, 2026, from $12 million at year-end 2025, raising potential funding concerns.
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Monthly enrollment in Neutralize-AKI averaged only 8-12 patients, slower than desired, with a risk of missing the year-end/Q1 2027 completion target.
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Operating expenses more than doubled to $4.4 million in Q2 2026, driven by higher clinical site costs, compensation, and legal fees.
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The company remains dependent on successful trial outcomes and FDA approval for adult AKI, which is a high-risk regulatory pathway.
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Pediatric market is ultra-rare, limiting near-term revenue potential, and adult market expansion is still several years away.
Q & A Highlights
Q: What is the current monthly enrollment rate for the Neutralize-AKI study, and are you seeing acceleration at newer high-volume sites? Can you quantify your confidence in hitting the 339-patient target by year-end or Q1 2027? A: Dr. Kevin Chung, Chief Medical Officer: Over the last few months, we've averaged around 8 to 12 patients per month. While that's slower than I'd like, our focus is on enrolling the right patientsthose with modifiable diseaseto optimize our chance for success. We are actively activating new sites, with four close to activation and eight more committed, which should bring us to 15 to 20 subjects per month. CEO Eric Schlorf added that the timeline remains on track for year-end or Q1 2027, with the PMA submission in late 2027 unchanged.
Q: Can you walk through the major activities between completing enrollment and the final PMA submission? A: Eric Schlorf, CEO: Once we lock the database, we'll release top-line results and analyze the data. The key is that we are using a modular PMA approach, submitting non-clinical sections (device description, sterilization, etc.) to the FDA ahead of time. This means after data lock, we only need to submit the clinical section, allowing the FDA to focus solely on that and expedite the review process.
Q: Can you quantify the revenue contribution from existing customers versus new hospitals added during the quarter? A: Tim Varacek, SVP of Commercial and Business Operations: The revenue growth was a combination of both new hospital systems and existing ones. We have a very high repurchase rate among existing sites, and new sites typically stock the product immediately upon onboarding to be ready to treat patients. It was a group effort across all customers.
Q: How do you ensure that the 20 pediatric hospitals using Qualimmune become meaningful, recurring customers rather than one-time users? A: Tim Varacek, SVP of Commercial and Business Operations: It's a multidisciplinary, ongoing effort. After a hospital formally adopts Qualimmune, we provide clinical support for the first patient and then maintain a continuous educational approach. Hospital systems have high staff turnover, so we constantly engage with new doctors, nurses, and advanced practice providers to keep Qualimmune top-of-mind. Dr. Kevin Chung added that mature sites (using the therapy for over a year) have shifted from using it as a rescue therapy to proactively scanning their ICUs for eligible patients, leading to even better outcomes.
Q: What work is being done behind the scenes on other indications for the SCD therapy, such as ARDS, hepatorenal syndrome, or cardiorenal syndrome? A: Eric Schlorf, CEO: We evaluate all other applications, but as a company, we must stay focused on Qualimmune for pediatric AKI and the Neutralize-AKI trial for adults. We have the NIH-funded Neutralize-CRS study and are in discussions with various parties, including non-dilutive and strategic business development opportunities, to advance other pipeline indications. Dr. Kevin Chung added that the Neutralize-AKI trial uses block randomization to ensure equal distribution of patients with ARDS and sepsis, allowing us to make specific statements about those subpopulations.
Q: What are the key milestones between completing enrollment and the final PMA submission? A: Eric Schlorf, CEO: We are in the process of submitting the modular PMA sections. The goal is to have all non-clinical sections (device, sterilization, technical details) already submitted and discussed with the FDA. After data lock, we'll present top-line results and submit the clinical section, which is the final module. This strategy allows the FDA to focus solely on the clinical data, potentially speeding up the approval process.
Q: Can you provide more detail on the difference between new and mature sites in terms of clinical adoption? A: Dr. Kevin Chung, Chief Medical Officer: New sites typically use Qualimmune as a rescue therapy due to natural skepticism, often after other experimental therapies have failed. Even in those cases, we see a remarkable 70% survival rate. However, mature sites that have been using the therapy for over a year have experienced an "aha moment" and are now proactively scanning their ICUs for patients who could benefit. They are starting therapy earlier, which is leading to even better outcomes. This shift was a key takeaway from our recent educational webinar.
Q: What is the status of the SAVE registry and the ICD-10 PCS codes? A: Tim Varacek, SVP of Commercial and Business Operations: We have completed the 50-patient SAVE registry required by the FDA, submitted the preliminary report, and are preparing the final report for FDA review. Results from the first 21 patients were published in the peer-reviewed journal Pediatric Nephrology. Additionally, CMS assigned ICD-10 PCS codes for our SCD therapy, which will be implemented on October 1st of this year. This removes a significant administrative barrier to adoption and will apply to all future potential indications.
Q: What were the key financial results for the second quarter of 2026? A: Mike Messenger, CFO: Net revenue for Q2 2026 was $615,000, an 82% increase from $338,000 in Q2 2025, accelerating from the 69% growth in Q1. Gross profit margin remained above 90%. Operating expenses were $4.4 million, up from $2.1 million, driven by increased R&D costs from additional clinical sites and higher G&A expenses. Net loss was approximately $3.7 million, or $0.91 per share, compared to a net loss of $2 million, or $1.77 per share, in Q2 2025. Cash on hand was approximately $7 million at June 30, 2026, down from $12 million at year-end 2025.
For the complete transcript of the earnings call, please refer to the full earnings call transcript .
