“The fourth quarter was once again extremely active and eventful for AlzeCure, including the presentation of new favorable results for NeuroRestore ACD856 and new promising preclinical data in the Alzstatin Alzheimer’s project. During the quarter, we also completed a rights issue oversubscribed by over 134% that raised approximately SEK 42.5 million before issue expenses. This without offering a guarantee commitment, which is a clear sign of strength for the company.”

Martin Jönsson, CEO

Financial information for October – December, 2022
Figures in parentheses refer to the corresponding period of the previous year.

• Net sales during the period totaled SEK 0 thousand (0).
• Loss for the period totaled SEK -10,948 thousand (-22,619).
• Earnings per share, basic, totaled SEK -0.22 (-0.60).
• Cash flow from operating activities totaled SEK -51,194 thousand (-20,931).
• Total assets at the end of the period amounted to SEK 70,836 thousand (45,647).
• Cash and cash equivalents at the end of the period totaled SEK 25,577 thousand (41,741).

Financial information for January – December, 2022
Figures in parentheses refer to the corresponding period of the previous year.

• Net sales during the period totaled SEK 0 thousand (0).
• Loss for the period totaled SEK -56,239 thousand (-77,781).
• Earnings per share, basic, totaled SEK -1.18 (-2.06).
• Cash flow from operating activities totaled SEK -99,911 thousand (-70,639).
• Total assets at the end of the period amounted to SEK 70,836 thousand (45,647).
• Cash and cash equivalents at the end of the period totaled SEK 25,577 thousand (41,741).

Significant events during the period October – December, 2022

• The company publishes new data at the ISMND Conference demonstrating that NeuroRestore ACD856 improves mitochondrial function and increases BDNF levels in neurons.
• The company has an abstract accepted by the CTAD Alzheimer conference on positive clinical EEG findings with NeuroRestore ACD856.
• The company publishes new data at the CTAD Alzheimer conference showing the potential disease-modifying and plasticity effects of NeuroRestore ACD856.
• The Board of Directors resolves to carry out a rights issue of SEK 31.7 million, secured to approximately 82.6 percent, with an over-allotment option of up to SEK 15 million, and announces an extraordinary general meeting on November 29, 2022 to approve the resolution.
• New data on Alzstatin, intended for preventive treatment of Alzheimer’s shows greatly reduced levels of harmful amyloid beta 42 (Aβ42), which are presented at the CTAD conference.
• The company has a late breaking-abstract on new data for the Alzstatin Alzheimer’s project accepted at the AD/PD 2023 Alzheimer’s and Parkinson’s conference.
• The new share issue was completed on December 20 and raised SEK 42.6 million before issue expenses for the company. In all, 134.3 percent was subscribed with and without exercising subscription rights. Issue expenses totaled SEK 3.0 million.

Significant events during the period January – September, 2022

• The company received a guiding response from the FDA supporting the continued clinical development program for ACD440, and preparations for the upcoming Phase II clinical trial.
• The Board of Directors approved a rights issue, subject to the approval of the Extraordinary General Meeting on March 1, 2022.
• The new share issue was completed on March 22 and raised SEK 48.5 million before issue expenses for the company. Issue expenses totaled SEK 7.2 million.
• In March, the company received new indicative data from the ongoing clinical phase I MAD study with ACD856 (NeuroRestore) showing that the substance reaches the brain, the target organ for the substance which is developed as a treatment for Alzheimer’s disease.
• A directed set-off issue was carried out in April in connection with ACD440 entering phase II and Acturum Life investing in the company. The set-off issue is the result of a previously agreed milestone payment, which will be made in the form of 845,070 shares instead of a cash payment.
• In April, the company presented results from the Phase I Single-Ascending-Dose-clinical study, which show that ACD856 has a good safety and tolerability profile in humans, as well as suitable pharmacokinetic properties, both of which support further clinical development of the substance. In addition, new preclinical data were also presented, demonstrating a dose-dependent positive effect of the NeuroRestore compound on mitochondrial function, which is particularly interesting since impaired mitochondrial function is common in conditions such as Alzheimer’s disease.
• In April, the company also presented new data concerning a new potent small-molecule gamma-secretase modulator (GSM), part of the Alzstatin research platform. The presentation contains preclinical data from studies that show that the substance, AC-0027875, effectively crosses the blood-brain barrier and reaches the target organ, i.e. the brain, in high concentrations – which is essential for a good pharmacological effect. Furthermore, data show that the potent effect of the substance on γ-secretase led to a reduction in the amount of harmful amyloid beta 42 (Aβ42) by more than 50 percent.
• In May, the company received approval to start a Phase II clinical trial with the non-opioid substance ACD440 for the treatment of neuropathic pain.
• In June, the first patient was included in the aforementioned study, the company’s Phase II clinical trial in neuropathic pain patients with the non-opioid ACD440.
• The Phase I clinical trial Multiple-Ascending-Dose for AlzeCure’s Alzheimer’s project NeuroRestore ACD856 ended in June. The data show that ACD856, the primary drug candidate in the company’s NeuroRestore platform, has good tolerability and safety. Furthermore, the results demonstrate that the substance has suitable pharmacokinetic properties with rapid uptake into the body, as well as relevant and dose-dependent exposure in the CNS.
• In August, the company presented new clinical data concerning NeuroRestore ACD856 at the Alzheimer’s Association International Conference (AAIC).
• An overview article on AlzeCure’s NeuroRestore platform as a novel Alzheimer’s therapy was published in August in Drug Discovery Today.
• The company also had an abstract accepted on potential neuroprotective effects of NeuroRestore ACD856 in August.
• In September, the company communicated that a patent was approved for ACD856 in the US.
• On September 16, the company presented new data from the Phase I clinical trial (multiple ascending dose, MAD) in the NeuroRestore project, which show that ACD856 has a pharmacodynamic effect on EEG activity in healthy volunteers. The new EEG results show that ACD856 not only crosses the blood-brain barrier, but also has a demonstrated effect on EEG activity in the brain.
• In September, AlzeCure presented new data on the anti-inflammatory effects of the TrkA-NAM pain project at IASP 2022.

Significant events after the end of the period

• In January, the company chose a drug candidate (DC) and initiated the preclinical development phase with the company’s preventive and disease-modifying drug candidate Alzstatin ACD680.
• In January, the last patient was included in the ongoing Phase II clinical trial with the leading non-opioid drug candidate in the Painless platform, ACD440, which is being developed to treat peripheral neuropathic pain.

The full report is attached as PDF and is available on the company’s website: www.alzecurepharma.com/en/section/investors/financial-reports/