InflaRx Q1 2024 Financial Results and Business Update

InflaRx N.V., a biopharmaceutical firm based in Jena, Germany, announced its financial results for Q1 2024 and shared updates on its ongoing projects. The company, known for its innovative anti-inflammatory therapies targeting the complement system, is making significant strides in its clinical programs.

Prof. Niels C. Riedemann, the CEO and founder, highlighted the company's advancements, particularly with vilobelimab in treating pyoderma gangrenosum (PG). The pivotal Phase III trial for vilobelimab is progressing, with an interim analysis anticipated in 2025. PG, a chronic inflammatory skin condition, remains an area with no approved treatments, presenting a substantial market opportunity for InflaRx.

InflaRx is also focusing on INF904, an orally administered C5aR inhibitor, showing promising potential in its Phase I trial. The company plans to initiate Phase IIa trials for chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS) by the end of 2024, with data expected in 2025.

A key event for the company will be the virtual R&D session on June 5, 2024. This event will delve into the development of INF904 and its role in CSU and HS, featuring notable experts like Prof. Dr. Marcus Maurer, Christopher Sayed, MD, and Prof. Dr. Jörg Köhl. This session aims to shed light on the commercial potential and the broader therapeutic applications of INF904 in immuno-inflammation.

In addition, InflaRx will participate in the Capital One Securities Dermatology Panel on May 14, 2024, discussing new potential treatments for dermatological conditions such as psoriasis, urticaria, and alopecia.

The company is optimistic about the potential of INF904. Initial studies suggest that INF904 could offer a significant improvement in treating CSU and HS, two chronic inflammatory skin conditions with limited effective treatments. The Phase IIa "basket study" will begin by the end of 2024, assessing the safety and pharmacokinetics (PK) and pharmacodynamics (PD) of INF904.

Positive results from the Phase I trial for INF904 were announced earlier this year. The trial demonstrated that the drug is well tolerated without serious adverse events and showed promising PK and PD profiles, achieving over 90% blocking activity of C5a-induced neutrophil activation.

Enrollment for the pivotal Phase III trial of vilobelimab in PG is ongoing. This study involves two groups: one receiving vilobelimab plus low-dose corticosteroids and the other receiving a placebo. The primary goal is the complete closure of the target ulcer within 26 weeks of treatment initiation. An interim analysis will be conducted once around 30 patients are enrolled, with the total trial enrollment expected to take at least two years.

Financially, InflaRx reported revenues of €36 thousand for Q1 2024 from the sales of GOHIBIC (vilobelimab). The cost of sales primarily included inventory write-downs. Sales and marketing expenses were €1.5 million, primarily for personnel and distribution services. R&D expenses decreased by €7.4 million compared to Q1 2023 due to lower third-party costs related to GOHIBIC's commercial manufacturing process and EUA efforts.

General and administrative expenses remained steady at €3.6 million. Other income significantly dropped to €36 thousand from €7.7 million due to the end of a government grant period. The net financial result saw a positive shift, mainly from increased interest income and foreign exchange gains. The net loss for the quarter was €9.7 million, slightly lower than the €11.1 million loss in Q1 2023.

As of March 31, 2024, InflaRx had €85.8 million in total available funds, consisting of cash, cash equivalents, and marketable securities, expected to fund operations into 2026.

In summary, InflaRx is making notable progress in its clinical programs, particularly with vilobelimab and INF904. The company's strategic focus and strong financial position underscore its potential to advance in its targeted therapeutic areas.