Alterity Therapeutics Limited Q2 FY2021 earnings call

David Stamler's Highlights

• Progress with ATH434: First indication for MSA, Phase I results successful, preparatory work for Phase II underway, launched natural history study bioMUSE in early MSA with Vanderbilt University, new animal data for ATH434 presented at conferences, cardiac safety data showed no cardiac liability.
• Patent allowance: U.S. Patent and Trademark Office allowed a new composition of matter patent covering over 150 novel pharmaceutical compositions.
• PBT2 license: Granted license by UniQuest to combat antimicrobial resistance, PBT2 could reverse antibiotic resistance in superbugs.
• Michael J. Fox Foundation grant: Awarded nearly $500,000 to evaluate ATH434 in primate model for Parkinson's disease.

Kathryn Andrews' Highlights

• As a development stage company, no revenue to report. Operating loss $8.6 million, net operating cash outflow $7.3 million, cash position $35 million as at December 31, with $35 million capital raising fully subscribed.

Alterity Therapeutics is a development stage biopharmaceutical company with no revenue to report. For the period, the operating loss was $8.6 million and the net operating cash outflow was $7.3 million. Cash position as at December 31 was $35 million, buoyed by a $35 million capital raising during the year. The R&D tax incentive rebate eligibility for the last financial year is currently under assessment.

Forward-Looking Statements

• Preparatory work for ATH434 Phase II trial ongoing, expecting European regulatory advice in the near future.
• Plan to progress novel compounds from the new patent, evaluating and optimizing them pharmacologically.
• Evaluate PBT2 program for antimicrobial resistance, may seek nondilutive funding for this program.

Risks Identified

• Eligibility for R&D tax incentive rebate for the last financial year is under assessment.
• PBT2 had a partial clinical hold by the U.S. FDA for Alzheimer's, which will need to be addressed when determining future clinical trials for PBT2.

Q: How is the preparation for ATH434 Phase II trial going?

A: Things are going quite well. Received FDA feedback in the first half of last year, awaiting European regulatory advice, and completing preparatory work for clinical trials including site and country selection.

Q: Are you expecting further peer-reviewed and published research on ATH434?

A: Yes, expect to publish data on recent animal work and mechanism of action of ATH434 later this year.

Q: Are you planning to do mitochondrian-level studies?

A: Yes, looking at establishing cellular models to assess mitochondrial function as part of interrogating the mechanism of ATH434.

Q: Have you confirmed any participation in scientific congresses?

A: Yes, will present at the 7th international MSA conference (virtual in Japan) with new safety data, and has upcoming presentations at the American Academy of Neurology and movement disorder conference later this fall.

Q: Any general interest in Alterity's technology with big pharma?

A: Yes, ongoing discussions with several large pharma companies interested in their novel research.

Q: Estimates of market value for PBT2 in treating antibiotic-resistant infections?

A: Significant potential but no market value determined yet; will seek nondilutive funding if beginning a development program in this area.

Q: Effect of PBT2 partial clinical hold by FDA on future trials?

A: Will take FDA feedback into account when determining the clinical plan for PBT2, and will address the partial clinical hold to overcome nonclinical findings.

Q: Plans to progress new compounds under new patent?

A: Ongoing effort from discovery chemists and Head of Biology to evaluate, optimize, and test novel compounds from the new patent, with progression to nonclinical models as milestones are met.