Appendix 4C – Quarterly Cash Flow Report for the First Quarter of Fiscal 22

Strong points:

  • New details of the phase 2 clinical trial of ATH34 are published.
  • Data from bioMUSE presented at the International Congress of Parkinson’s Society and Movement Disorders.
  • The expanded intellectual property portfolio positions future opportunities.
  • Cash balance at September 30, 2021 of AU $ 41.3 million.
  • Quarterly operating cash outflow of $ 4.9 million as expected and in line with clinical trial activity.

Melbourne, Australia, October 29, 2021 / PRNewswire / – Alterity Therapeutics Limited (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to the development of disease-modifying treatments for neurodegenerative diseases, publishes its Schedule 4C Quarterly Cash Flow Report and an update on the company’s activities for the quarter ending September 30, 2021 (T1 FY22).

The Company’s cash position at September 30, 2021 of $ 41.3 million understand AU $ 17.2 million proceeds from the issuance of shares through the authorized ATM facility (“At market”) at July 2021 issued in accordance with ASX 7.1 and 7.1A listing rules.

Operating cash outflows were AU $ 4.9 million, which was in line with company expectations and in large part due to the preparation of the Phase 2 clinical trial of Alterity’s leading drug candidate, ATH434 in multisystem atrophy (MSA) and natural history of bioMUSE (Biomarkers of Progression in Multiple Systems Atrophy).

In accordance with ASX Enrollment Rule 4.7C, payments made to related parties and their associates included in section 6.1 of Schedule 4C include directors’ fees, consulting fees, remuneration and retirement pension at commercial rates.

Operational activities

During the quarter, the company advanced the ATH434 Phase 2 development program. In September, data from the bioMUSE natural history study was presented at the International Congress of the Parkinson’s Society and Movement Disorders, indicating that the advanced MRI methods used in the study, called quantitative susceptibility mapping (QSM), demonstrated a pathological accumulation of iron in several areas of the brain in patients with early-onset ASM. Study investigators, led by Dr. Daniel Claassen, associate professor of neurology at Vanderbilt University Medical Center, concluded that advanced MRI methods for measuring iron may improve patient selection in disease-modifying therapy clinical trials and have the potential to serve as a biomarker to assess treatment-induced changes.

More recently, and after the reporting period, Alterity announced that bioMUSE has achieved its initial recruitment target and will be expanded to a total of 20 patients with ASM. The study has proven invaluable in generating data to inform and reduce the risks of the Phase 2 trial design, and it will continue to provide longitudinal biomarkers and clinical data to characterize disease progression in a patient population that reflects those who will be recruited in the phase 2 study.

Alterity also announced the extension of the ATH434 clinical development program. The planned Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study of ATH434 in patients with early-stage AMS. The study will explore the effect of ATH434 treatment on imaging and protein biomarkers such as -synuclein aggregation and excess iron, which are important contributors to MSA pathology. Several other biomarkers and clinical parameters will allow a complete evaluation of the efficacy of ATH434 as well as the characterization of its safety and pharmacokinetics. Based on consultations with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and clinical experts in MSA, Alterity has determined that patients will receive treatment for 12 months. The longer treatment duration will provide a better opportunity to detect changes in biomarkers and clinical parameters in order to optimize the design of a definitive phase 3 study.

During the period, significant progress was made on two important new patents that place Alterity in a dominant position in its iron chaperone technology. These new molecules are designed to redistribute the excess iron involved in many neurodegenerative diseases. In July, we announced that the United States Patent and Trademark Office (USPTO) granted U.S. Patent No. 10/941,143 relating to claims to a group of 150 new compounds that act as iron chaperones. This was followed, in August, by a second Composition of Matter patent (No. 17 / 239,375) which was cleared by the USPTO, ensuring the exclusivity of a new group of iron chaperones and covering more than 80 new compounds.

TO FINISH

Authorization & additional information

This ad has been authorized by David stamler, CEO of Alterity Therapeutics Limited.

About Alterity Therapeutics Limited

Alterity Therapeutics is a clinical-stage biotechnology company dedicated to creating an alternative future for people living with neurodegenerative diseases. The Company’s main asset, ATH434, has the potential to treat various forms of parkinsonian disorders. Alterity also has an extensive drug discovery platform generating patentable chemicals to intervene in disease processes. The Company is based in Melbourne, Australia, and San Francisco, California, UNITED STATES. For more information, please visit the Company’s website at www.alteritytherapeutics.com.

Forward-looking statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The Company has attempted to identify such forward-looking statements by using such words. that “expects”, “intends”, “hopes”, “anticipates”, “believes”, “could”, “could”, “evidence” and “estimates” and other expressions similar, but these words are not the exclusive means of identifying such statements.

Significant factors that could cause actual results to differ materially from those indicated in these forward-looking statements are described in the sections headed “Risk Factors” in the Company’s filings with the SEC, including its annual report on most recent on Form 20-F as well as as reports on Form 6-K, including, but not limited to: but not limited to: ATH434, and any other statements which are not facts historical. These statements involve risks and uncertainties, including, but not limited to, risks and uncertainties relating to difficulties or delays in the financing, development, testing, regulatory approval, production and marketing of the products. drug components of the Company, including, but not limited to ATH434, uncertainties relating to the impact of the novel coronavirus (COVID-19) pandemic on the business, operations and employees of the Company, the the company’s ability to secure additional future sources of funding, unexpected adverse side effects or inadequate therapeutic efficacy of drug compounds, including, but not limited to ATH434, which could slow or prevent the development in the product market, the uncertainty of patent protection of the Company’s intellectual property or trade secrets, including, but not limited to, ownership intellectual property relating to ATH434.

Any forward-looking statements we make in this press release are based solely on information currently available to us and speak only as of the date on which they are made. We assume no obligation to publicly update any forward-looking statements, written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

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SOURCE Alterity Therapeutics Limited

Company codes: Australia: ATH, NASDAQ-NMS: ATHE


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