Alterity Therapeutics(US:ATHE)2023-08-30 16:00Drug Development and Clinical Trials - Alterity's lead drug candidate, ATH434, is designed to block the accumulation of α-synuclein and has shown preclinical efficacy in reducing α-synuclein pathology and improving motor function[128]. - ATH434 has successfully completed Phase 1 clinical studies and is currently in two Phase 2 clinical trials for Multiple System Atrophy (MSA), with regulatory approvals in New Zealand, Italy, and the UK[147]. - In March 2023, Alterity announced a new Composition of Matter patent covering more than 100 novel compounds, with at least one showing efficacy in an animal model of dementia[140]. - The ongoing Phase 2 trial ATH434-201 aims to enroll approximately 60 patients with early-stage MSA, assessing treatment effects on imaging and protein biomarkers[177]. - ATH434 demonstrated neuroprotective effects in a genetic model of Parkinson's disease, preventing loss of smell in younger mice and motor impairment in older mice[186]. - In a study published in January 2022, ATH434 reduced toxic forms of α-synuclein and improved motor performance in a murine model of Multiple System Atrophy (MSA)[188]. - PBT2 demonstrated safety and tolerability in Phase 1 and Phase 2 trials, with 95% of participants completing the 52-week treatment period[158][159]. - The Phase 2 trial "Reach2HD" for Huntington disease demonstrated PBT2 as safe and well tolerated, achieving its primary objective[165]. - PBT2 has shown efficacy in preclinical studies for Huntington disease, leading to the recommendation for clinical trials[164]. - In the IMAGINE trial, PBT2 did not meet its primary endpoint for reducing beta-amyloid plaques, but showed a trend towards preserving hippocampal brain volume[159]. Research and Intellectual Property - The company has a diversified library of over 1000 validated compounds and continues to strengthen its intellectual property portfolio with new patents, including a US patent covering more than 80 novel compounds[140][138]. - The technology developed by Alterity is based on the interrelationship of metals and proteins, targeting neurodegenerative diseases such as Alzheimer's and Parkinson's[135]. - Alterity's research efforts have historically focused on neurological diseases, with a current emphasis on Parkinson's disease and related disorders, aiming to address underlying pathologies[133]. - The patent portfolio includes over 150 imidazo[l,5-a]pyridine compounds, with a patent granted in the US on July 1, 2021, with no prior art cited against the application[197]. - A European Patent for a related compound was granted on August 23, 2023, patent number 3938364[197]. - The company has filed a provisional application for an additional 80 novel compounds for treating neurodegenerative diseases, with a US patent granted on October 26, 2021[198]. Financial Performance and Funding - The company incurred an operating loss of A$13,806,515 for the year ended June 30, 2023, compared to A$12,847,061 in 2022, representing an increase of 7.4%[215]. - Research and development expenses decreased to A$13,198,583 for the year ended June 30, 2023, down A$1,547,193 or 10.5% from A$14,745,776 in 2022[222]. - General and administrative expenses decreased to A$5,056,571 for the year ended June 30, 2023, a reduction of A$457,345 or 8.3% from A$5,513,915 in 2022[222]. - Interest income increased significantly to A$16,436 for the year ended June 30, 2023, up A$13,932 or 556.4% from A$2,504 in 2022, due to higher cash balances and interest rates[220]. - The company recognized A$3,914,230 for the R&D Tax Incentive refundable cash offset for the year ended June 30, 2023, compared to A$4,669,405 in 2022[221]. - As of June 30, 2023, the company had A$15,773,783 in cash and cash equivalents, a decrease from A$34,806,799 as of June 30, 2022[232]. - The accumulated deficit totaled A$195,130,889 as of June 30, 2023[232]. - The company plans to raise new equity funding within six months of the financial year end to support its research and development programs[215]. - The company recorded A$3.9 million in other income related to the research and development tax incentive scheme for the financial year ended June 30, 2023[237]. - Operating losses were A$13.8 million and A$12.8 million for the years ended June 30, 2023 and 2022, respectively, with an operating cash outflow of A$20 million in 2023[238]. Corporate Structure and Governance - The company has two wholly-owned subsidiaries, Alterity Therapeutics Inc. and Alterity Therapeutics UK Limited, incorporated in the US and the UK respectively[206]. - The company has established valuable research collaborations with institutes in Australia and the U.S. to investigate various therapeutic indications[243]. - The company has established a Remuneration Committee comprised solely of independent directors to oversee executive compensation[307]. - The Audit Committee currently consists of two members, Messrs. Marks and Meltzer, both of whom meet the independence requirements[306]. - The company maintains a directors' and officers' liability insurance policy to cover certain liabilities incurred by its officers[313]. - The company has a staggered election process for its Board of Directors, requiring one-third of directors to retire and seek re-election at each annual general meeting[300]. Employee and Director Compensation - Total remuneration for directors in 2023 amounted to A$523,300, with Mr. Geoffrey Kempler receiving A$313,300, the highest among directors[276]. - Dr. David Stamler, a key management personnel, received total compensation of A$1,649,998, including a performance bonus of A$194,570[276]. - The aggregate amount available for non-executive directors' remuneration is A$1,250,000 per annum, as approved by shareholders[269]. - Total remuneration for directors and key management personnel amounted to A$2,690,011 for the fiscal year ended June 30, 2022[278]. - Long-term incentives (LTI) were provided in the form of share-based payments, while short-term incentives (STI) were provided as cash bonuses[282][281]. - The performance income for executives is based on a set monetary value or a portion of base salary, with no fixed proportion between incentive and non-incentive remuneration[279]. - As of June 30, 2023, the company had 11 employees, with 8 in research and development and 3 in management and administration[314]. - The total beneficial ownership of all directors and executive officers as a group is 86,999,032 ordinary shares, representing 2.65% of total ownership[317]. Market Position and Competition - There are currently no approved drugs for MSA, positioning ATH434 as a potential first-in-class treatment if approved[204]. - Competitors in the MSA treatment space include H. Lundbeck A/S and Takeda, both of which are developing drugs currently in Phase 2 studies[204]. - The pharmaceutical industry is highly competitive, with many competitors having greater resources and experience in clinical trials and regulatory approvals[203]. Shareholder Information - As of August 28, 2023, the total number of ordinary shares and unlisted options outstanding is 3,284,635,277, comprising 2,439,897,618 ordinary shares and 844,737,659 unlisted options[2]. - The company is authorized to issue up to an aggregate of 240,000,000 ordinary shares or ADSs under the Stock Option Plans, following shareholder approvals[321]. - The 2004 ASX Plan allows for the issuance of ordinary shares or options to purchase ordinary shares, promoting the interests of employees, directors, and consultants[322]. - The 2018 ADS Plan is designed for non-Australian based employees and allows for the issuance of incentive stock options and non-qualified stock options[325]. - The maximum fair market value of ADSs for incentive stock options exercisable in a calendar year is capped at U.S.$100,000[325]. - The vesting schedule for options under the 2004 ASX Plan typically spans four years, with 25% vesting at the end of each year[324].