Alterity Therapeutics Announces Regulatory Authorization to Proceed with ATH434 Phase 2 Clinical Trial in Italy

MELBOURNE,Australia andSAN FRANCISCO,June 23,2022 -- Alterity Therapeutics (ASX: ATH,NASDAQ: ATHE) ("Alterity" or "the Company"),a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases,today announced that the Italian Medicines Agency,or Agenzia Italiana del Farmaco(AIFA),has authorized Alterity to conduct its Phase 2 clinical trial of ATH434 in Multiple System Atrophy (MSA),a rare and highly debilitating Parkinsonian disorder.

"Approval by the Italian authorities provides another endorsement of the approach we are taking with our Phase 2 clinical trial," said David Stamler,M.D.,Chief Executive Officer,Alterity. "MSA is a devastating disease,and we want to reach patients in several regions of the globe to offer ATH434 as a potential treatment for their condition. With our trial now open for enrolment in New Zealand and regulatory authorizations in the UK and Italy,we are focused on opening study sites in these regions and expanding access to other countries throughout the year."

The Phase 2 clinical trial is a randomized,double-blind,placebo-controlled investigation of ATH434 in patients with early-stage MSA. The study will explore the effect of ATH434 treatment on imaging and protein biomarkers,such as aggregating α-synuclein and excess iron,which are important contributors to MSA pathology. Clinical and biomarker endpoints,including use of wearable sensors,will permit comprehensive assessment of ATH434 efficacy along with characterization of safety and pharmacokinetics. The use of wearable sensors will allow evaluation of motor parameters that are important in patients with MSA. The study is expected to enroll approximately 60 adult patients to receive one of two doses of ATH434 or placebo. Patients will receive treatment for 12 months which will provide an opportunity to detect changes in efficacy endpoints to optimize design of a definitive Phase 3 study. Additional information on the Phase 2 trial can be found by ClinicalTrials.gov Identifier: NCT05109091.

About ATH434

Alterity's lead candidate,ATH434,is the first of a new generation of small molecules designed to inhibit the aggregation of pathological proteins implicated in neurodegeneration. ATH434 has been shown preclinically to reduce α-synuclein pathology and preserve nerve cells by restoring normal iron balance in the brain. In this way,it has excellent potential to treat Parkinson's disease as well as various forms of atypical Parkinsonism such as Multiple System Atrophy (MSA). ATH434 has successfully completed a Phase 1 clinical trial demonstrating the agent is well tolerated,orally bioavailable,and achieved brain levels comparable to efficacious levels in animal models of MSA,with the objective of restoring function in patients with MSA and other Parkinsonian disorders.

ATH434 has been granted Orphan designation for the treatment of MSA by the U.S. FDA and the European Commission.

About Multiple System Atrophy

Multiple System Atrophy (MSA) is a rare,neurodegenerative diseasecharacterized by failure of the autonomic nervous system and impaired movement. The symptoms reflect the progressive loss of function and death of different types of nerve cells in the brain and spinal cord. It is a rapidly progressive disease and causes profound disability. MSA is a Parkinsonian disorder characterized by a variable combination of slowed movement and/or rigidity,autonomic instability that affects involuntary functions such as blood pressure maintenance and bladder control,and impaired balance and/or coordination that predisposes to falls. A pathological hallmarkof MSA is theaccumulation of the protein α-synuclein within glia,the support cells of the central nervous system,and neuron loss in multiple brain regions. MSA affects approximately 15,000 individuals in the U.S.,and while some of the symptoms of MSA can be treated with medications,currently there are no drugs that are able to slow disease progression and there is no cure.1

1National Institute of Health: Neurological Disorders and Stroke,Multiple System Atrophy Fact Sheet

About Alterity Therapeutics Limited

Alterity Therapeutics is a clinical stage biotechnology company dedicated to creating an alternate future for people livingwith neurodegenerative diseases. The Company's lead asset,has the potential to treat various Parkinsonian disorders. Alterity also has a broad drug discovery platform generating patentable chemical compounds to intercede in disease processes. The Company is based in Melbourne,Australia,and San Francisco,California,USA. For further information please visit the Company's web site at www.alteritytherapeutics.com.

Authorisation & Additional information

This announcement was authorized by David Stamler,CEO of Alterity Therapeutics Limited.

Forward Looking Statements

This press release contains "forward-looking statements" within the meaning of section 27A of the Securities Act of 1933 and section21EoftheSecuritiesExchange Actof1934.TheCompany hastriedtoidentifysuchforward-lookingstatementsbyuse of such words as "expects," "intends," "hopes," "anticipates," "believes," "could," "may," "evidences" and "estimates," and other similar expressions,but these words are not the exclusive means of identifying suchstatements.

Importantfactors thatcouldcause actualresultstodiffermateriallyfromthoseindicated bysuchforward-lookingstatements aredescribedinthesections titled"RiskFactors" intheCompany'sfilingswiththeSEC,includingitsmostrecent AnnualReport onForm20-FaswellasreportsonForm6-K,including,butnotlimited tothefollowing:statementsrelating totheCompany's drug development program,but not limited to the initiation,progress and outcomes of clinical trials of the Company'sdrugdevelopmentprogram,butnotlimitedto,andanyotherstatementsthatarenothistorical facts.Suchstatementsinvolverisksanduncertainties,thoserisksanduncertaintiesrelatingtothe difficultiesordelaysinfinancing,development,testing,regulatoryapproval,productionandmarketingoftheCompany's drug components,butnotlimited to,uncertainties relating to the impact of the novel coronavirus (COVID-19)pandemic onthecompany'sbusiness,operationsandemployees,theability oftheCompanytoprocure additionalfuturesources offinancing,unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug compounds,but not limitedto,thatcouldslowor prevent productscomingtomarket,the uncertaintyof obtaining patent protectionfortheCompany's intellectualproperty ortradesecrets,the uncertainty of successfully enforcing the Company's patent rights and the uncertainty of the Company freedom to operate.

Any forward-looking statement made by us in this press release is based only on information currently available to us and speaksonlyasofthedateonwhichitismade.Weundertakenoobligationtopubliclyupdate anyforward-lookingstatement,whetherwrittenororal,thatmaybemadefromtimetotime,whetherasaresult ofnewinformation,futuredevelopmentsor otherwise.

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