X4 Pharmaceuticals, Inc.

meaningful levels. Finally, we'll be also looking for continued tolerability and safety of Mavericks IV as seen in all of our other clinical programs to date. In June, we also announced the initiation of our Global Pivotal Phase III clinical trial, branded the FORWARD Study, evaluating the efficacy, safety, and tolerability of oral once daily Mavericks IV with and without stable doses of GCSF in people with congenital acquired primary autoimmune or idiopathic CN who are experiencing recurrent and or serious infections. The 52-week forward trial is a randomized, double-blinded, placebo-controlled, multicenter study aiming to enroll 150 participants. The clinical operations team is in full swing, opening up sites, and we are on track to fully enroll the trial in mid-2025. We believe that the interim Phase II CN data presented to date strongly support our decision to initiate the Phase III trial as well as its design. Importantly, we believe that the interim results de-risk the Phase III trial, given that the ANC increases seen in CN patients to date mirror those in our successfully completed IV-WIM Phase III trial. where similar levels of ANC increases led to clinical benefit by reducing the frequency, duration, and severity of infections. As we focus our efforts on the forward CN trial, we are also looking to maximize the global opportunity in WHIM syndrome. We expect an MAA submission to the European Medicines Agency for Mavericks IV and WHIM syndrome by early 2025, while we also explore additional potential opportunities and geographies where we may be able to efficiently leverage our U.S. FDA approval. With that, I'll now turn it over to our CFO, Adam Mostafa, to review the second quarter financials. Adam?

Thanks, Paula, and thanks to all of you for being on the call with us today. As we had previously discussed, upon FDA approval of Zolt Remedy, we were awarded a Priority Review Voucher, or PRV, based on Maverick X4's rare pediatric disease designation. We monetized this PRV very shortly after receipt, and in May, we recognized a gain on the sale to a third party for $105 million in cash. So, as of the end of the second quarter, X4 had $169.5 million in cash, cash equivalents, restricted cash, and short-term marketable securities. We believe these funds are sufficient to support our company operations into late 2025. I want to note that this projected runway does not include potential future ZorMD revenue. For the three months ended June 30th, we reported revenues of $0.6 million and cost of revenue of $0.3 million related to the sale of ZorMD. This cost of revenue includes approximately $0.2 million of license costs including sales-based royalties and operational milestones capitalized as an intangible asset and amortized over the life of the underlying intellectual property. We would like to note that there was a small amount of inventory stocking at our specialty pharmacy during the quarter, and this is reflected in the sales number. Research and development expenses were $20.9 million for the second quarter, compared to $15.6 million for the comparable period in 2023. R&D expenses for the second quarter of 2024 included $1.2 million of non-cash expense. Selling, general, and administrative expenses were $13.3 million for the second quarter of 2024. This compares to $10.2 million for the comparable period in 2023. SG&A expenses for the second quarter also included $1.2 million of non-cash expense. Finally, we reported net income of $90.8 million for the second quarter of 2024 compared to a net loss of $55.7 million for the comparable period in 2023. Note that net income in the current period included the sale of the PRV for $105 million, as well as a non-cash gain of $20.2 million related to the fair value remeasurement of the company's Class C warrants liability I'll now turn it back to Paula for some concluding remarks.

As you can see, all of these accomplishments mark a significant step forward for X4, now a fully integrated biopharmaceutical company. As we continue to explore additional uses for and maximize the global potential of Maverick's score for patients, we look forward to reporting on our sales, regulatory, and clinical progress over the coming 6 to 12 months. We'll now open up the call for your questions. Operator?