AlzeCure publishes its Year-end report for 2021

“The year 2021 held many successes for AlzeCure, and the fourth quarter was no exception. During the quarter, we started a MAD phase I study, which is AlzeCure’s third clinical study with ACD856, the lead drug candidate in the NeuroRestore platform that targets Alzheimer’s disease. We also submitted an application for a “pre-IND meeting” with the U.S. Food and Drug Administration (FDA) prior to a Phase II trial with the Painless project ACD440. In addition, favorable preclinical results were obtained for a new series of molecules for Alzstatin. In other words, the organization continued to deliver and make progress within our projects throughout 2021, and we look forward with great confidence to 2022. In light of these advances and ongoing value-creating activities, the Board of Directors has decided to propose a capital raise during the first quarter of 2022, which will further strengthen AlzeCure.”

Martin Jönsson, CEO

Financial information for October – December, 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 -22,619 thousand (-17,720).
• Earnings per share, basic, totaled SEK -0.60 (-0.47).
• Total assets at the end of the period amounted to SEK 45,647 thousand (117,827).
• Cash and cash equivalents at the end of the period totaled SEK 41,741 thousand (112,434).

Financial information for January – December, 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 -77,781 thousand (-71,366).
• Earnings per share, basic, totaled SEK -2.06 (-1.89).
• Total assets at the end of the period amounted to SEK 45,647 thousand (117,827).
• Cash and cash equivalents at the end of the period totaled SEK 41,741 thousand (112,434).

Significant events during the period January – December, 2021

• In April, Associate Professor Märta Segerdahl Storck, MD/PhD, took up the position of Chief Medical Officer (CMO). Dr. Segerdahl is responsible for the company’s clinical development activities. She is also part of AlzeCure’s management group.
• In April, positive and significant efficacy data were obtained slightly ahead of plan from the company’s Phase Ib clinical trial with the drug candidate ACD440 for neuropathic pain. The drug candidate 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 in May. Eva further strengthens the company with her broad international regulatory and commercial experience.
• In July, a new article about ACD856 was published in the periodical “Cells,” presenting the findings and describing the preclinical development of the compounds in the NeuroRestore platform. (Identification of Novel Positive Allosteric Modulators of Neurotrophin Receptors for the Treatment of Cognitive Dysfunction, Cells 2021 Jul23;10(8):1871.)
• New data supporting ACD856 for treatment of Alzheimer’s disease were presented at the Alzheimer’s Association International Conference (AAIC) 2021, which was held July 26-30 in Denver, Colorado, in the US.
• In August, the company received approval from the Medical Products Agency to be able to give additional doses of ACD856 in the Phase I clinical trial (single ascending dose, SAD). The approval is based on the good tolerability of the drug candidate, which enables higher doses to be tested.
• In August, the company received approval from the regulatory authorities in Sweden to initiate a Phase I clinical trial (multiple ascending dose, MAD) for the drug candidate ACD856, with a focus on Alzheimer’s disease.
• In October, the first study participant in the company’s Phase I clinical trial (MAD) received a dose of the drug candidate ACD856.
• The company presented the potential of the NeuroRestore project for treatment of depression at the European College of Neuropsychopharmacology (ECNP) 2021 conference, held October 2–5 in Lisbon, Portugal.

Significant events after the end of the period

• The company has received indicative answers from the FDA that support the continued development program for ACD440, as well as the preparatory work for the upcoming clinical phase II study.
• The Board of Directors decided to perform a preferential rights issue. The Rights Issue is subject to approval at an Extraordinary General Meeting on March 1, 2022.

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