Key figures from the report:

(The numbers in parenthesis refer to the corresponding quarter of last year)

AlzeCure obtained the rights to ACD440, a TRPV1 antagonist originally developed by Astra Zeneca as an oral systemic drug, in 2020. AlzeCure has repurposed it as a gel for topical use. TRPV1 is an established and validated target for pain, as demonstrated by David Julius's Nobel Prize in Medicine in 2021 for his discovery of TRPV1. The VR1 receptor, also known as TRPV1 (transient receptor potential vanilloid 1) is an ion channel present on sensory nerves. An ion channel is a passage in the cell membrane that controls the electrical charge in the cell. TRPV1 was discovered in the late 1990s when it was identified based on its response to capsaicin, the active ingredient in chili peppers. As well as capsaicin, a low pH is considered to have an activating action on TRPV1. The signalling pathway is otherwise principally associated with being a heat sensor. This is also logical in consideration of the burning sensation from eating chili peppers.

In February 2022, it was reported that AlzeCure had received a supportive response from the FDA regarding its pre-IND application for the phase IIa trial. The trial (n=14) is a crossover trial, conducted in a double-blind, randomized, placebo-controlled manner. Patients with peripheral neuropathic pain displaying symptoms such as allodynia or hyperalgesia to cold, heat, brush, and/or pinprick stimulation were selected to participate. The patients received either ACD440 Gel or placebo treatment twice daily for seven days, applied topically to the area of pain in random order. Following this, there was a two-week washout period, after which the patients will receive the alternate treatment. In this way, the patients were used both as a control and treatment population. The study's primary endpoint measure stimulated evoked pain, assessed through sub-items 8-10 on the Neuropathic Pain Symptom Inventory (NPSI). Secondary endpoints include overall symptom intensity measured by the full NPSI scale, pain intensity evaluated by the Numerical Rating Scale (NRS), and Patient Global Impression of Change (PGIC). Safety and tolerability will be carefully monitored and deemed crucial.

The first patient was included in June 2022, and the company reported in March 2023 that it had treated the last patient, indicating that top-line data could be presented by early summer.

We reiterate our base case of SEK13 per share, using a WACC based on our Redeye rating at 14.5% and an expected capital injection of SEK60m in early 2024/late 2023. Our bull- and bear case remains at SEK1.5 and SEK23, respectively.