Negative Points

• Revenue for the quarter ended June 30, 2026, was flat at $1.8 million, showing no growth compared to the prior quarter.

• The company reported a net loss of $7.9 million for the quarter, with losses per share improving only due to a higher share count.

• Cash position remains tight at $15.2 million as of June 30, 2026, excluding the recent financing, indicating ongoing cash burn.

• The FDA approval for the Gen II LungFit PH system is still pending, with no exact timeline, and potential approval is likely pushed to Q4 2026, creating uncertainty.

• The company's 2026 revenue guidance excludes any contribution from the Gen II system, highlighting reliance on existing products for near-term growth.

• Other expenses increased significantly to $1.5 million from $500,000 year-over-year, impacting overall financial performance.

• The company is in a cash burn position, and the recent financing will be used to absorb operational burn, limiting flexibility for other investments.

• International expansion is still in early stages, with revenue recognition from these markets not yet materializing significantly.

Q & A Highlights

Q: Can you provide more detail on what the capital from the recent financing will be used for and where you expect to see the biggest investment over the next several quarters? A: Daniel Moorhead (CFO) stated that the capital will primarily be used for operations, specifically for building pilot devices for the Gen II system in the near term. Upon FDA clearance, the company will scale up device production to gain commercial steam for 2027 and beyond. The funds will also help absorb the company's cash burn during this period.

Q: Are things starting to pick up on the contracting side, and do you think hospitals may be more willing to spend remaining budgets heading into year-end? A: Robert Goodman (CEO) confirmed a significant pickup in contracting activity. The commercial pipeline has doubled over the last five to six months, with numerous new opportunities emerging. While sales cycles remain long, the increased pace of activity is a positive indicator for future growth.

Q: Any update on the supplement PMA applications and interactions with the FDA? A: Robert Goodman (CEO) reported significant progress with the PMA supplement. The company has submitted the necessary paperwork, and the FDA is currently reviewing it. They are in the audit phase, with pilot builds being finalized. Communication with the FDA has been excellent, with quick response times, and the company is confident in the process.

Q: At this point, is everything pretty much done except waiting for the FDA's decision? A: Robert Goodman (CEO) clarified that the process is less about a final decision and more about completing the audit phase. The FDA will schedule audits as they review the paperwork. The company is ready for some audits and is finalizing its pilot builds. They have submitted nearly everything required, with only minor back-and-forth clarifications, and are on track.

Q: Given we are in the third quarter, should we expect the potential FDA decision likely in the fourth quarter? A: Robert Goodman (CEO) noted that unlike pharmaceuticals, there is no PDUFA date for medical devices. While the company remains on track for a second-half 2026 approval, he acknowledged that with Q3 already underway, a decision is likely to fall in Q4, depending on the FDA's processing timeline.

Q: Given the $8 million revenue guidance for calendar 2026, what gives you confidence that the second half will have greater revenue growth than the first half? A: Robert Goodman (CEO) explained that with approximately $3.7 million in H1 revenue, the company needs around $4.3 million in H2 to hit its target. Confidence is driven by a strong pipeline, early wins in the current quarter, and a pickup in international sales, which provide immediate revenue recognition. The subscription model also allows for full revenue recognition upon closing deals, rather than spreading it out.

Q: Can you elaborate on the progress of the international distribution expansion and its impact on revenue? A: Robert Goodman (CEO) highlighted that the company has partnerships covering more than 40 countries. With the strengthened financial position from the recent equity raise, they are better equipped to support partners in bringing LungFit PH to market internationally. This expansion is expected to contribute to revenue growth, with international sales providing immediate revenue recognition.

Q: What are the key priorities for the company as it prepares for the commercial launch of the second-generation LungFit PH system? A: Robert Goodman (CEO) stated that the priorities are focused on expanding market access, deepening relationships with hospitals and health systems, growing the commercial pipeline, and executing with financial discipline. These efforts are designed to drive broader adoption of LungFit PH and create a stronger platform for long-term growth.

For the complete transcript of the earnings call, please refer to the full earnings call transcript .