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AlzeCure publishes its interim report for January - September 2022

AlzeCure Pharma

STOCKHOLM, SWEDEN / ACCESSWIRE / November 10, 2022 / AlzeCure Pharma (STO:ALZCUR)(FRA:AC6) AlzeCure Pharma AB (publ) (FN STO:ALZCUR) today announced that its interim report for the period January - September 2022 is now available on the company's website: www.alzecurepharma.com/en/section/investors/financial-reports/

"The third quarter of 2022 was yet another successful and active period for AlzeCure. We presented positive results from our Phase I study with ACD856, intended for treatment of Alzheimer's disease, with good safety and tolerability data as well as brain activity data, which support continued clinical development work. In addition, we presented new preclinical data in the TrkA-NAM pain project, where we showed that the compounds demonstrate not only analgesic, but also anti-inflammatory effects. Furthermore, our goal to deliver results in the summer of 2023 from our ongoing Phase IIa clinical trial with ACD440 in patients with neuropathic pain, remains."

Martin Jönsson, CEO

Financial information for July - September, 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 -11,097 thousand (-16,507).

  • Earnings per share, basic, totaled SEK -0.22 (-0.44).

  • Cash flow from operating activities totaled SEK -14,504 thousand (-15,243).

  • Total assets at the end of the period amounted to SEK 40,486 thousand (68,299).

  • Cash and cash equivalents at the end of the period totaled SEK 37,169 thousand (62,672).

Financial information for January - September, 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 -45,291 thousand (-55,162).

  • Earnings per share, basic, totaled SEK -0.97 (-1.46).

  • Cash flow from operating activities totaled SEK -48,717 thousand (-49,708).

  • Total assets at the end of the period amounted to SEK 40,486 thousand (68,299).

  • Cash and cash equivalents at the end of the period totaled SEK 37,169 thousand (62,672).

Significant events during the period July - September, 2022

  • 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 for NeuroRestore ACD856 has been approved 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 during the period January - June, 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.

  • 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 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), 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 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.

Significant events after the end of the period

  • The Board of Directors decided to perform a preferential rights issue of SEK 31.7 million, guaranteed to 82.6 percent, with a possible over-allotment of SEK 15 million. The Rights Issue is subject to an approval at an Extraordinary General Meeting on November 29, 2022.

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 projects. 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 arthritis. 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 Q3 2022 ENG Final

SOURCE: AlzeCure Pharma



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https://www.accesswire.com/724966/AlzeCure-publishes-its-interim-report-for-January--September-2022