“During the third quarter, we received positive data from our Phase I SAD clinical trial with the drug candidate ACD856, which is part of the NeuroRestore platform and which we are developing with a focus on Alzheimer’s disease. We also received approval to test higher doses of the compound in the study, which is now underway, and after the end of the quarter we also started our Phase I MAD clinical trial with this compound. Regarding our ACD440 pain project, that belongs to the Painless platform and targets neuropathic pain, we have now submitted a request for a pre-IND meeting to the FDA for a planned Phase II study. We also focused on further developing new compounds in our preclinical pain project, TrkA-NAM, with the aim of choosing a drug candidate for the project in the second half of 2021. Thus we have once again closed the books on yet another positive and very active quarter at AlzeCure.”

Martin Jönsson, CEO

Financial information for July – September, 2021
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 -16,507 thousand (-21,455).
• Earnings per share, basic, totaled SEK -0.44 (-0.57).
• Total assets at the end of the period amounted to SEK 68,299 thousand (138,334).
• Cash and cash equivalents at the end of the period totaled SEK 62,672 thousand (132,976).

Financial information for January – September, 2021
Figures in parentheses refer to the corresponding period of the previous year.

• Net sales during the period amounted to SEK 0 thousand (0).
• The earnings for the period amounted to SEK –55,162 thousand (–53,646).
• Earnings per share before dilution amounted to SEK –1.46 (–1.42).
• Total assets amounted to SEK 68,299 thousand (138,334) at the end of the period.
• Cash and cash equivalents amounted to SEK 62,672 thousand (132,976) at the end of the period.

Significant events during the period January – September, 2021

• The company appointed Associate Professor Märta Segerdahl Storck, MD/PhD, to serve as Chief Medical Officer (CMO). Dr. Segerdahl took up the position on April 1 and is responsible for our clinical development activities. She is also part of AlzeCure’s management group.
• In April the company received, slightly ahead of plan, positive and significant efficacy data from the phase Ib clinical trial with the drug candidate ACD440 for neuropathic pain. It was also well tolerated as a topical treatment.
• Eva Lilienberg was elected to serve on AlzeCure’s Board of Directors at the Annual General Meeting on May 17. Eva further strengthens the company with her broad international regulatory and commercial experience.
• In July, a new publication on ACD856 was published in the journal Cells, describing the preclinical development of the substances within the NeuroRestore platform and results were presented. (Identification of Novel Positive Allosteric Modulators of Neurotrophin Receptors for the Treatment of Cognitive Dysfunction, Cells 2021 Jul23; 10 (8): 1871.)
• New data supporting targeting Trk receptors with ACD856 for treatment of Alzheimer’s disease presented at Alzheimer’s Association International Conference (AAIC) 2021 on July 26-30 in Denver USA.
• In August the company received approval from the Medical Products Agency to be able to give additional doses of ACD856 in the clinical phase I study (single ascending dose, SAD) with ACD856, as its good tolerability enables higher doses to be tested.
• In August the company received approval from the regulatory authorities in Sweden to begin the next clinical phase I study (multiple ascending dose, MAD) with the candidate drug ACD856 focused on Alzheimer’s disease.

Significant events after the end of the period

• In October the first participant in the clinical phase I study (MAD) with the drug candidate ACD856 was dosed.
• The company presented the potential of the NeuroRestore project in depression at the European College of Neuropsychophamacology (ECNP 2021 on October 2-5 in Lisbon.

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