AlzeCure Publishes its Interim Report for January – June 2022

STOCKHOLM, SE / ACCESSWIRE / August 25, 2022 / AlzeCure Pharma (STO:ALZCUR) (FRA:AC6)

AlzeCure Pharma AB (publ) (FN STO: ALZCUR) today announced that its interim report for the period January - June 2022 is now available on the company's website: www.alzecurepharma.com/en/section/investors/financial-reports/

"The second quarter of 2022 was yet another active and successful period for AlzeCure, with the commencement of the first Phase IIa clinical trial in the company's history and in a field with a very high unmet medical need, neuropathic pain. In addition, we concluded our Phase I MAD study with NeuroRestore ACD856 for Alzheimer's and other cognitive disorders, according to plan. The study showed positive safety and tolerability data, which support continued development. We also generated new preclinical data in the TrkA-NAM pain project, where we showed that the compounds have not only analgesic but also anti-inflammatory effects. Based on this AlzeCure is progressing well and according to plan."

Martin Jönsson, CEO

Financial information for April - June, 2022
Figures in parentheses refer to the corresponding period of the previous year.

  • Net sales during the period totaled SEK 0 thousand (0).
  • Earnings for the period totaled SEK -21,548 thousand (-15,693).
  • Earnings per share, basic, totaled SEK -0.43 (-0.42).
  • Total assets at the end of the period amounted to SEK 55,303 thousand (82,030).
  • Cash and cash equivalents at the end of the period totaled SEK 51,673 thousand (77,915).

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

  • Net sales during the period totaled SEK 0 thousand (0).
  • Earnings for the period totaled SEK -34,194 thousand (-38,655).
  • Earnings per share, basic, totaled SEK -0.77 (-1.02).
  • Total assets at the end of the period amounted to SEK 55,303 thousand (82,030).
  • Cash and cash equivalents at the end of the period totaled SEK 51,673 thousand (77,915).

Significant events during the period January - March, 2022

  • The company receives a guiding response from the FDA that supports 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.
  • In March, the company received new indicative data from the ongoing clinical phase I MAD study with ACD856 showing that the substance reaches the brain, the target organ for the substance which is developed as a treatment for Alzheimer's disease.

Significant events during the period April - June, 2022

  • 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 substance AC-0027136 on mitochondrial function, which is particularly interesting since impaired mitochondrial function is common in neurodegenerative conditions such as Alzheimer's disease.
  • In April, the company also presented new data on a new potent small-molecule gamma-secretase modulator (GSM from the Alzstatin research platform. The presentation contained preclinical data from studies that show that the substance, AC-0027875, effectively crosses the blood-brain barrier and reaches this 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 leads 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. The data were presented at the Alzheimer's Conference AAIC in July.

Significant events after the end of the period

  • No significant events have occurred after the end of the period.

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

For more information, please contact

Martin Jönsson, CEO
Tel: +46 707 86 94 43
martin.jonsson@alzecurepharma.com

About AlzeCure Pharma AB (publ)

AlzeCure® is a Swedish pharmaceutical company that develops new innovative small molecule drug therapies for the treatment of severe diseases and conditions that affect the central nervous system, such as Alzheimer's disease and pain - indications for which currently available treatment is very limited. The company is listed on Nasdaq First North Premier Growth Market and is developing several parallel drug candidates based on three research platforms: NeuroRestore®, Alzstatin® and Painless.

NeuroRestore consists of two symptomatic drug candidates where the unique mechanism of action allows for multiple indications, including Alzheimer's disease, as well as cognitive disorders associated with traumatic brain injury, sleep apnea and Parkinson's disease. The Alzstatin platform focuses on developing disease-modifying and preventive drug candidates for early treatment of Alzheimer's disease and comprises two drug candidates. Painless is the company's research platform in the field of pain and contains two projects: ACD440, which is a drug candidate in the clinical development phase for the treatment of neuropathic pain, and TrkA-NAM, which targets other types of severe pain in conditions such as osteoarthritis. AlzeCure aims to pursue its own projects through preclinical research and development through an early clinical phase and is continually working on business development to find suitable solutions for license agreements with other pharmaceutical companies.

FNCA Sweden AB is the company's Certified Adviser. For more information, please visit www.alzecurepharma.se

Attachments

Alzecure Q2 2022 ENG Final

SOURCE: AlzeCure Pharma


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