Latest news with #MultipleSystemAtrophy
Yahoo
22-05-2025
- Business
- Yahoo
Multiple System Atrophy (MSA or Shy-Drager Syndrome or Multi-System Degeneration) Global Clinical Trials Market Review 2025
Dublin, May 22, 2025 (GLOBE NEWSWIRE) -- The "Multiple System Atrophy (MSA or Shy-Drager Syndrome or Multi-System Degeneration) - Global Clinical Trials Review, 2025" clinical trials has been added to report provides top line data relating to the clinical trials on Multiple System Atrophy (MSA or Shy-Drager Syndrome or Multi-System Degeneration). Report includes an overview of trial numbers and their average enrollment in top countries conducted across the globe. The report offers coverage of disease clinical trials by region, country (G7 & E7), phase, trial status, end points status and sponsor also provides prominent drugs for in-progress trials (based on number of ongoing trials). The Clinical Trial Reports are generated using the proprietary database - Pharma - Clinical trials database. Clinical trials are collated from 80+ different clinical trial registries, conferences, journals, news etc across the globe. Clinical trials database undergoes periodic update by dynamic report enhances the decision making capabilities and helps to create an effective counter strategies to gain competitive The report provides a snapshot of the global clinical trials landscape Report provides top level data related to the clinical trials by Region, Country (G7 & E7), Trial Status, Trial Phase, Sponsor Type and End point status The report reviews top companies involved and enlists all trials (Trial title, Phase, and Status) pertaining to the company The report provides all the unaccomplished trials (Terminated, Suspended and Withdrawn) with reason for unaccomplishment The Report provides enrollment trends for the past five years Report provides latest news for the past three months Reasons to Buy Assists in formulating key business strategies with regards to investment Helps in identifying prominent locations for conducting clinical trials which saves time and cost Provides top level analysis of Global Clinical Trials Market which helps in identifying key business opportunities Supports understanding of trials count and enrollment trends by country in global therapeutics market Aids in interpreting the success rates of clinical trials by providing a comparative scenario of completed and uncompleted (terminated, suspended or withdrawn) trials Facilitates clinical trial assessment of the indication on a global, regional and country level Key Topics Covered: Report Guidance The analyst Clinical Trials Report Coverage Clinical Trials by Region Clinical Trials and Average Enrollment by Country Top Five Countries Contributing to Clinical Trials in Asia-Pacific Top Five Countries Contributing to Clinical Trials in Europe Top Countries Contributing to Clinical Trials in North America Top Countries Contributing to Clinical Trials in Middle East and Africa Top Countries Contributing to Clinical Trials in Central and South America Clinical Trials by G7 Countries: Proportion of Multiple System Atrophy (MSA or Shy-Drager Syndrome or Multi-System Degeneration) to Central Nervous System Clinical Trials Clinical Trials by Phase in G7 Countries Clinical Trials in G7 Countries by Trial Status Clinical Trials by E7 Countries: Proportion of Multiple System Atrophy (MSA or Shy-Drager Syndrome or Multi-System Degeneration) to Central Nervous System Clinical Trials Clinical Trials by Phase in E7 Countries Clinical Trials in E7 Countries by Trial Status Clinical Trials by Phase In Progress Trials by Phase Clinical Trials by Trial Status Clinical Trials by End Point Status Subjects Recruited Over a Period of Time Clinical Trials by Sponsor Type Prominent Sponsors Top Companies Participating in Multiple System Atrophy (MSA or Shy-Drager Syndrome or Multi-System Degeneration) Therapeutics Clinical Trials Prominent Drugs Clinical Trial Profile Snapshots Appendix Company Profiles Teva Pharmaceutical Industries Ltd The Lundbeck Foundation Alterity Therapeutics Ltd ICON Plc Pfizer Inc AstraZeneca Plc Corestemchemon Inc Modag GmbH Theravance Biopharma Inc Thermo Fisher Scientific Inc For more information about this clinical trials report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900
Associated Press
07-05-2025
- Business
- Associated Press
Alterity Therapeutics Announces Multiple Oral and Poster Presentations to be Featured at the International MSA Congress
MELBOURNE, Australia and SAN FRANCISCO, May 07, 2025 (GLOBE NEWSWIRE) -- 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 multiple oral and poster presentations related to Alterity's clinical programs in Multiple System Atrophy (MSA) will be featured at the 2025 International MSA Congress taking place May 9 - 11, 2025 in Boston, MA, USA. The Congress is presented by Mission MSA, a non-profit organization dedicated to improving the quality of life and building hope for people affected by MSA through support services, educational resources, research funding, and community engagement. David Stamler, M.D., Chief Executive Officer of Alterity, commented, 'We are excited to play a prominent role at the MSA Congress which brings together a noteworthy group of physicians and scientists as well as patients and care partners, all of whom are focused on advancing MSA research and care. Mission MSA is one of the primary patient education and advocacy organizations for the disease in the U.S., and we are also proud to support the event as a sponsor. We look forward to presenting our double-blind Phase 2 data for ATH434 as well as our bioMUSE natural history study with our colleagues at Vanderbilt University Medical Center. Our clinical advancements in MSA continue to generate significant interest throughout the community, bolstered by the recent Fast Track Designation for ATH434 that was granted by the US FDA.' Type: Oral Presentation Session: Opening Plenary: Toward Disease Modifying Therapies of MSA Title: ATH434 Slowed Disease Progression in a Phase 2 Study in Multiple System Atrophy Presenter: David Stamler, M.D., Chief Executive Officer of Alterity Date/Time: Friday, May 9, 2025 at 9:10 AM EDT (USA) Type: Oral Presentation Session: Biomarkers in MSA: Imaging Title: MSA Atrophy Index (MSAai): A Quantitative Imaging Marker for Diagnosis and Monitoring of Multiple System Atrophy Presenter: Amy Brown, M.D., M.S., Assistant Professor, Movement Disorders Division, Department of Neurology, Vanderbilt University Medical Center Date/Time: Saturday, May 10, 2025 at 2:55 PM EDT Type: Poster Session Title: ATH434 Slowed Disease Progression in a Phase 2 Study in Multiple System Atrophy Presenter: David Stamler, M.D., Chief Executive Officer of Alterity Date/Time: Saturday, May 10, 2025 at 12:00 PM EDT Poster: #85 Type: Poster Session Title: Cutaneous Phosphorylated Alpha-Synuclein Deposition Informs Autonomic Function in Individuals with Early-Stage Multiple System Atrophy Presenter: Leah Mann, PhD, Postdoctoral Research Fellow, Vanderbilt University Medical Center Date/Time: Saturday, May 10, 2025 at 12:00 PM EDT Poster: #86 About ATH434 Alterity's lead candidate, ATH434, is an oral agent designed to inhibit the aggregation of pathological proteins implicated in neurodegeneration. ATH434 has been shown preclinically to reduce α-synuclein pathology and preserve neuronal function by restoring normal iron balance in the brain in preclinical models. As an iron chaperone, it has excellent potential to treat Parkinson's disease as well as various Parkinsonian disorders such as Multiple System Atrophy (MSA). Phase 1 studies have demonstrated the agent is well tolerated and achieved brain levels comparable to efficacious levels in animal models of MSA. Positive results from the randomized, double-blind, placebo-controlled Phase 2 clinical trial in patients with MSA demonstrated robust clinical efficacy, target engagement on key biomarkers, and a favorable safety profile. A second Phase 2 open-label biomarker trial in patients with more advanced MSA is ongoing. ATH434 has been granted Fast Track Designation by the U.S. FDA, and Orphan Drug Designation by the U.S. FDA and the European Commission for the treatment of MSA. About ATH434-201 Phase 2 Clinical Trial The ATH434-201 Phase 2 clinical trial is a randomized, double-blind, placebo-controlled investigation of 12 months treatment with ATH434 in patients with MSA. The study evaluated the efficacy, safety and pharmacokinetics of ATH434 as well as the effect of ATH434 on neuroimaging and protein biomarkers. Wearable sensors were employed to evaluate motor activities outside of the clinic. The study enrolled 77 adults who were randomly assigned to receive ATH434 50 mg or 75 mg twice daily or matching placebo. The data showed that, compared to placebo, ATH434 produced clinically and statistically significant improvement on the modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I, a functional rating scale that assesses disability on activities of daily living affected in MSA. Additional efficacy assessments demonstrated improvement consistent with the positive UMSARS Part I findings including trends in improved motor performance on the Parkinson's Plus rating scale, the Clinical Global Impression of Severity Scale, and the Orthostatic Hypotension Symptom Assessment (a patient reported outcome). Wearable sensor data indicated that ATH434 also led to increased activity in an outpatient setting. Biomarkers were used to evaluate potential drug effect and target engagement relative to placebo. Both dose levels stabilized or reduced iron accumulation in MSA affected brain regions with trends in preservation of brain volume. ATH434 was well tolerated with similar adverse event rates compared to placebo and no serious adverse events attributed to ATH434. Additional information on the Phase 2 trial can be found by Identifier: NCT05109091 . About bioMUSE Biomarkers of progression in Multiple System Atrophy (bioMUSE) is a natural history study that aims to track the progression of individuals with MSA, a Parkinsonian disorder without approved therapy. The study is being conducted in collaboration with Vanderbilt University Medical Center in the U.S. under the direction of Daniel Claassen, M.D., M.S., Professor of Neurology and Principal Investigator. Natural history studies are important for characterizing disease progression in selected patient populations. The study has provided rich data for optimizing the design of Alterity's randomized ATH434-201 Phase 2 clinical trial and enrolled approximately 20 individuals with clinically probable or clinically established MSA. BioMUSE continues to provide vital information on early stage MSA patients, informs the selection of biomarkers suitable to evaluate target engagement and preliminary efficacy, and delivers clinical data to characterize disease progression in a patient population that mirrors those currently enrolling in the Phase 2 clinical trial. About Multiple System Atrophy Multiple System Atrophy (MSA) is a rare, neurodegenerative disease characterized 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 hallmark of MSA is the accumulation of the protein α-synuclein within glia, the support cells of the central nervous system, and neuron loss in multiple brain regions. MSA affects at least 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 1 Multiple System Atrophy | National Institute of Neurological Disorders and Stroke ( About Alterity Therapeutics Limited Alterity Therapeutics is a clinical stage biotechnology company dedicated to creating an alternate future for people living with neurodegenerative diseases. The Company is initially focused on developing disease modifying therapies in Parkinson's disease and related disorders. Alterity recently reported positive data for its lead asset, ATH434, in a Phase 2 clinical trial in participants with Multiple System Atrophy (MSA), a rare and rapidly progressive Parkinsonian disorder. ATH434 is also being evaluated in a Phase 2 clinical trial in advanced MSA. In addition, Alterity has a broad drug discovery platform generating patentable chemical compounds to treat the underlying pathology of neurological diseases. The Company is based in Melbourne, Australia, and San Francisco, California, USA. For further information please visit the Company's website at . Authorisation & Additional information This announcement was authorized by David Stamler, CEO of Alterity Therapeutics Limited. Investor and Media Contacts: Australia Millie Macdonald Head of Investor Relations and Business Development [email protected] +61 468 304 742 Ana Luiza Harrop [email protected] +61 452 510 255 U.S. Remy Bernarda [email protected] +1 (415) 203-6386 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 tried to identify such forward-looking statements by use 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 such statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are described in the sections titled 'Risk Factors' in the Company's filings with the SEC, including its most recent Annual Report on Form 20-F as well as reports on Form 6-K, including, but not limited to the following: statements relating to the Company's drug development program, including, but not limited to the initiation, progress and outcomes of clinical trials of the Company's drug development program, including, but not limited to, ATH434, and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to the difficulties or delays in financing, development, testing, regulatory approval, production and marketing of the Company's drug components, including, but not limited to, ATH434, the ability of the Company to procure additional future sources of financing, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug compounds, including, but not limited to, ATH434, that could slow or prevent products coming to market, the uncertainty of obtaining patent protection for the Company's intellectual property or trade secrets, 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 speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Yahoo
04-05-2025
- Yahoo
Cyclist completes 'dream' ride across the world
TV viewers may be glued to the new series of Race Across the World - but one adventurous cyclist has just completed his own remarkable ride across the globe. Nathan Hurley of Blackwood in Caerphilly county set off on his bicycle from Cardiff on 1 March - St David's Day - 2024. More than 14 months, 26 countries and 16,250 miles (26,000km) later, he has arrived in Sydney. The "exhausting" journey from south Wales to New South Wales is a "dream come true" for Nathan and has so far raised £4,000 for the Multiple System Atrophy (MSA) Trust. Easter walkers warned after record rise in call-outs Clifftop camping warning as adventurer goes viral Top tips for solo hiking and camping The self-confessed "urban dweller" admitted setting off with a tent, stove and a blow-up pillow was a daunting prospect. Nor was he a particularly good or keen cyclist having almost fallen off his just 50m (164ft) into the ride leaving his nervous parents looking on with their heads in their hands. "One of the challenging things is being on your own," he said from Sydney. "I've been racking up 60 to 80 miles and sometimes up to 10 hours on the saddle each day but it's taken a lot mentally as well as physically. "I'm not an outdoorsman and out of all of my friends I'm the guy who doesn't do adventure well. I always forget something. "I like my flat whites and eggs benedict so it's been a real struggle when I've been out there camping and cooking." The 35-year-old travelled through France, across the Alps and onto the ancient Silk Road from northern Italy to Turkey before crossing the Caucuses where he hit his first diplomatic hurdle. To avoid conflict and visa restrictions he took a short flight from Armenia to Kazakhstan where he continued to climb the Pamir mountain ranges to China, not only overcoming the challenges of altitude but suspicious local police as he crossed the Taklamakan and Gobi deserts. "I didn't mind the police following me, they made me feel like a VIP but they weren't very inconspicuous, they were the only car following 200m behind me at 12mph," he said. From there Nathan rode south through South-East Asia to Jakarta, Indonesia and then flew to Australia where he embarked on a 2,500-mile (4,000km) journey from Perth to Sydney. "Australia is famously wider than the moon and for weeks it really felt like that in the heat," he said. "It's home to wonderful people but it doesn't help that I'm terrified of snakes." While on the road Nathan has been invited to two weddings and shared countless meals with locals curious about the cycling Welshman. "Spending months speaking to strangers through a translation app can be exhausting [but] you wouldn't believe how many remote villagers know who Gareth Bale is." And he has decided he is not stopping there. Having taken redundancy from his job as a furniture design manager he now intends to cycle all the way home, ploughing on to New Zealand before flying to Alaska and then Africa with the aim of returning to Cardiff by Christmas. "I had every intention of coming home after Sydney but I've got a bit more time now and I've got the bug, which is a bit of a surprise." Nathan hopes that his journey can encourage others to take up cycle touring as a mode of travel and form of sustainable tourism. "I've learnt to love it. I just feel I'm on the journey now and I've got it into my head I'm halfway home. "And there's no point in cycling half way around the world, is there?" Multiple System Atrophy Trust
BBC News
04-05-2025
- Sport
- BBC News
Welsh cyclist completes 'dream' ride across the world for charity
TV viewers may be glued to the new series of Race Across the World - but one adventurous cyclist has just completed his own remarkable ride across the Hurley of Blackwood in Caerphilly county set off on his bicycle from Cardiff on 1 March - St David's Day - than 14 months, 26 countries and 16,250 miles (26,000km) later, he has arrived in "exhausting" journey from south Wales to New South Wales is a "dream come true" for Nathan and has so far raised £4,000 for the Multiple System Atrophy (MSA) Trust. The self-confessed "urban dweller" admitted setting off with a tent, stove and a blow-up pillow was a daunting prospect. Nor was he a particularly good or keen cyclist having almost fallen off his just 50m (164ft) into the ride leaving his nervous parents looking on with their heads in their hands."One of the challenging things is being on your own," he said from Sydney."I've been racking up 60 to 80 miles and sometimes up to 10 hours on the saddle each day but it's taken a lot mentally as well as physically."I'm not an outdoorsman and out of all of my friends I'm the guy who doesn't do adventure well. I always forget something."I like my flat whites and eggs benedict so it's been a real struggle when I've been out there camping and cooking." The 35-year-old travelled through France, across the Alps and onto the ancient Silk Road from northern Italy to Turkey before crossing the Caucuses where he hit his first diplomatic hurdle. To avoid conflict and visa restrictions he took a short flight from Armenia to Kazakhstan where he continued to climb the Pamir mountain ranges to China, not only overcoming the challenges of altitude but suspicious local police as he crossed the Taklamakan and Gobi deserts. "I didn't mind the police following me, they made me feel like a VIP but they weren't very inconspicuous, they were the only car following 200m behind me at 12mph," he there Nathan rode south through South-East Asia to Jakarta, Indonesia and then flew to Australia where he embarked on a 2,500-mile (4,000km) journey from Perth to Sydney."Australia is famously wider than the moon and for weeks it really felt like that in the heat," he said."It's home to wonderful people but it doesn't help that I'm terrified of snakes."While on the road Nathan has been invited to two weddings and shared countless meals with locals curious about the cycling Welshman. "Spending months speaking to strangers through a translation app can be exhausting [but] you wouldn't believe how many remote villagers know who Gareth Bale is." And he has decided he is not stopping there. Having taken redundancy from his job as a furniture design manager he now intends to cycle all the way home, ploughing on to New Zealand before flying to Alaska and then Africa with the aim of returning to Cardiff by Christmas."I had every intention of coming home after Sydney but I've got a bit more time now and I've got the bug, which is a bit of a surprise."Nathan hopes that his journey can encourage others to take up cycle touring as a mode of travel and form of sustainable tourism."I've learnt to love it. I just feel I'm on the journey now and I've got it into my head I'm halfway home."And there's no point in cycling half way around the world, is there?"
Associated Press
03-04-2025
- Business
- Associated Press
Alterity Therapeutics to Deliver an Oral Presentation of the Positive ATH434 Phase 2 Trial Results at the American Academy of Neurology Annual Meeting
MELBOURNE, Australia and SAN FRANCISCO, April 03, 2025 (GLOBE NEWSWIRE) -- 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 an oral presentation and a poster presentation related to Alterity's clinical programs in Multiple System Atrophy (MSA) will be delivered at the American Academy of Neurology (AAN) 2025 Annual Meeting taking place April 5 - 9, 2025 in San Diego, CA. David Stamler, M.D., Chief Executive Officer of Alterity, commented, 'We are excited to present the positive topline data along with new analyses from our ATH434-201 clinical trial via an oral presentation at AAN, one of the premier global neurology meetings. In addition, data will be presented on the use of wearable sensor technology to assess patient outcomes, an important component of evaluating novel treatments for individuals with MSA.' About ATH434 Alterity's lead candidate, ATH434, is an oral agent designed to inhibit the aggregation of pathological proteins implicated in neurodegeneration. ATH434 has been shown preclinically to reduce α-synuclein pathology and preserve neuronal function by restoring normal iron balance in the brain. As an iron chaperone, it has excellent potential to treat Parkinson's disease as well as various Parkinsonian disorders such as Multiple System Atrophy (MSA). ATH434 successfully completed Phase 1 studies demonstrating the agent is well tolerated and achieved brain levels comparable to efficacious levels in animal models of MSA. ATH434 recently announced positive results from the randomized, double-blind, placebo-controlled Phase 2 clinical trial in patients with early-stage MSA. A second Phase 2 open-label 2 Biomarker trial in patients with more advanced MSA is ongoing. ATH434 has been granted Orphan Drug Designation for the treatment of MSA by the U.S. FDA and the European Commission. About ATH434-201 Phase 2 Clinical Trial The ATH434-201 Phase 2 clinical trial is a randomized, double-blind, placebo-controlled investigation of 12 months treatment with ATH434 in patients with MSA. The study evaluated the efficacy, safety and pharmacokinetics of ATH434 as well as the effect of ATH434 on neuroimaging and protein biomarkers. Wearable sensors were employed to evaluate motor activities outside of the clinic. The study enrolled 77 adults who were randomly assigned to receive ATH434 50 mg or 75 mg twice daily or matching placebo. The topline data showed that ATH434 produced clinically and statistically significant improvement on the modified UMSARS Part I, a functional rating scale that assesses disability on activities of daily living affected in MSA. In addition to the robust efficacy demonstrated on the UMSARS Part I, trends in improved motor performance were observed on the Parkinson's Plus rating scale and overall benefit was shown on the Clinical Global Impression of Severity at the 50 mg dose. Wearable sensor data indicated that both dose levels of ATH434 led to increased activity in an outpatient setting as compared to placebo. Biomarkers were used to evaluate potential drug effect and target engagement. Both dose levels reduced iron accumulation in MSA affected brain regions and trends in preservation of brain volume were observed relative to placebo. Additional information on the Phase 2 trial can be found by Identifier: NCT05109091. About Multiple System Atrophy Multiple System Atrophy (MSA) is a rare, neurodegenerative disease characterized 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 hallmark of MSA is the accumulation of the protein α-synuclein within glia, the support cells of the central nervous system, and neuron loss in multiple brain regions. MSA affects at least 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 About Alterity Therapeutics Limited Alterity Therapeutics is a clinical stage biotechnology company dedicated to creating an alternate future for people living with neurodegenerative diseases. The Company is initially focused on developing disease modifying therapies in Parkinson's disease and related disorders. Alterity recently reported positive data for its lead asset, ATH434, in a Phase 2 clinical trial in participants with Multiple System Atrophy (MSA), a rare and rapidly progressive Parkinsonian disorder. ATH434 is also being evaluated in a Phase 2 clinical trial in advanced MSA. In addition, Alterity has a broad drug discovery platform generating patentable chemical compounds to treat the underlying pathology of neurological diseases. The Company is based in Melbourne, Australia, and San Francisco, California, USA. For further information please visit the Company's website at Authorisation & Additional information This announcement was authorized by David Stamler, CEO of Alterity Therapeutics Limited. Investor and Media Contacts: Australia Ana Luiza Harrop +61 452 510 255 U.S. Remy Bernarda +1 (415) 203-6386 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 tried to identify such forward-looking statements by use 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 such statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are described in the sections titled 'Risk Factors' in the Company's filings with the SEC, including its most recent Annual Report on Form 20-F as well as reports on Form 6-K, including, but not limited to the following: statements relating to the Company's drug development program, including, but not limited to the initiation, progress and outcomes of clinical trials of the Company's drug development program, including, but not limited to, ATH434, and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to the difficulties or delays in financing, development, testing, regulatory approval, production and marketing of the Company's drug components, including, but not limited to, ATH434, the ability of the Company to procure additional future sources of financing, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug compounds, including, but not limited to, ATH434, that could slow or prevent products coming to market, the uncertainty of obtaining patent protection for the Company's intellectual property or trade secrets, the uncertainty of successfully enforcing the Company's patent rights and the uncertainty of the Company freedom to operate.
