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Appendix 4C – Q3 FY25 Quarterly Cash Flow Report
Globenewswire· 2025-04-30 11:35
Core Viewpoint - Alterity Therapeutics reported significant progress in its clinical trials for ATH434, a treatment for Multiple System Atrophy (MSA), highlighting its potential to change the treatment landscape for this condition [3][8]. Financial Summary - As of March 31, 2025, Alterity's cash position was A$17.96 million, with operating cash outflows of A$0.73 million for the quarter [4]. - The company raised approximately A$15.0 million during the period and an additional A$27.1 million after the quarter ended [11]. Clinical Trial Updates - The ATH434-201 Phase 2 trial demonstrated a 48% relative treatment effect at the 50 mg dose and a 30% effect at the 75 mg dose, indicating significant efficacy in reducing disease severity compared to placebo [7]. - The ATH434-202 open-label trial in advanced MSA was completed, with topline data expected to be reported mid-year 2025 [10]. Operational Activities - The ATH434-201 trial involved 77 participants and utilized wearable sensors to assess outpatient activity levels, showing clinically meaningful improvements in various metrics [6][9]. - The company plans to engage with regulatory authorities to advance ATH434's development for MSA [3]. Corporate Activities - Alterity received a refund of A$1.65 million from the Australian Taxation Office under the Research and Development Tax Incentive Scheme for eligible activities conducted in the financial year ending June 30, 2020 [11].
Immunic Announces Vidofludimus Calcium Reduced Risk of Disability Worsening by 30% in Primary Progressive Multiple Sclerosis Patients from Phase 2 CALLIPER Trial
Prnewswire· 2025-04-30 11:30
Core Insights - Immunic, Inc. announced positive results from its phase 2 CALLIPER trial for vidofludimus calcium (IMU-838) in patients with progressive multiple sclerosis (PMS), showing a 20% reduction in the relative risk of 24-week confirmed disability worsening (24wCDW) events compared to placebo [1][2][8] Clinical Efficacy - In the overall PMS patient population (n=467), vidofludimus calcium reduced the relative risk of 24wCDW events by 20% compared to placebo, with a 30% reduction observed in the primary progressive multiple sclerosis (PPMS) subgroup (n=152) [2][8] - The drug also demonstrated a 15% reduction in the non-active secondary progressive multiple sclerosis (naSPMS) subgroup (n=268) [2] - A consistent reduction in disability worsening was noted in patients without gadolinium-enhancing lesions at baseline, with a 29% reduction in 24wCDW events compared to placebo [4][8] MRI Endpoints - Vidofludimus calcium reduced the annualized rate of thalamic brain volume loss by 20% compared to placebo, indicating a significant neuroprotective effect [5][16] - The total volume of new or enlarging T2 lesions showed a mean percent change of -0.22% for vidofludimus calcium versus +2.97% for placebo at month 24, highlighting the drug's efficacy in reducing lesion formation [6] Safety and Tolerability - The CALLIPER trial confirmed a favorable safety and tolerability profile for vidofludimus calcium, with treatment-emergent adverse events occurring in 69.4% of treated patients compared to 68.5% in the placebo group [9] - Serious adverse events were rare, observed in 8.1% of vidofludimus calcium-treated patients versus 6.5% in the placebo group, with no new safety signals identified [9] Future Directions - The company plans to advance vidofludimus calcium to a phase 3 registration study based on the positive results from the CALLIPER trial, particularly focusing on its potential as a neuroprotective treatment option for PMS [8][11] - Ongoing analysis of the full CALLIPER data set will be presented at upcoming scientific meetings, with the phase 3 clinical trial program for relapsing multiple sclerosis expected to be completed in 2026 [11][17]
涨超1.1%,创业板50ETF华夏(159367)费率在可比基金中最低
Sou Hu Cai Jing· 2025-04-30 02:13
Group 1 - The ChiNext 50 Index (399673) has shown a 0.92% increase as of April 30, 2025, with notable gains from constituent stocks such as Runhe Software (300339) up 4.55% and Softcom Power (301236) up 3.48% [3] - The ChiNext 50 ETF (159367) has increased by 1.12%, with a latest price of 0.9 yuan, and has seen a cumulative increase of 0.56% over the past week [3] - The liquidity of the ChiNext 50 ETF is reflected in a turnover rate of 0.13% and a transaction volume of 51,000 yuan, with an average daily transaction of 7.24 million yuan over the past year [3] Group 2 - The ChiNext 50 Index selects the top 50 stocks from the top 100 by market capitalization and liquidity on the ChiNext board, representing large-cap companies with strong growth potential across various sectors including power equipment, non-bank finance, and pharmaceuticals [4] - The ChiNext 50 ETF has two core advantages: a 20% price fluctuation limit providing greater trading flexibility compared to traditional broad-based indices, and the lowest management fee of 0.15% and custody fee of 0.05% among similar products [4] - As of March 31, 2025, the top ten weighted stocks in the ChiNext 50 Index account for 64.18% of the index, with Ningde Times (300750) holding the highest weight at 24.47% [4][6]
Growth Is Priced Out Of Novo Nordisk
Seeking Alpha· 2025-04-29 18:29
Group 1 - Recent developments have been unfavorable for Novo Nordisk A/S, particularly as competitor Eli Lilly has gained a significant advantage in the obesity and adjacent markets [2] - The Growth Stock Forum focuses on identifying attractive risk/reward situations in growth stocks, particularly in the biotech sector, and maintains a model portfolio of 15-20 stocks [2] Group 2 - The article emphasizes the importance of tracking portfolio and watchlist stocks closely to identify potential investment opportunities [2] - The Growth Stock Forum also provides a top picks list of up to 10 stocks expected to perform well in the current calendar year, along with trading ideas for short-term and medium-term moves [2]
ImmunityBio Q1 Earnings Preview: I Fear A Selloff, But Am Long-Term Bullish
Seeking Alpha· 2025-04-29 16:50
Group 1 - The article discusses the investment opportunities in ImmunityBio, Inc. (NASDAQ: IBRX), highlighting previous coverage and ratings issued by the author, including a "Hold" rating since April last year [1] - The Haggerston BioHealth marketplace channel offers exclusive stock tips focused on Pharma, Biotech, and Healthcare, providing access to financial models and research [1] - The investing group is designed for both novice and experienced biotech investors, offering insights on catalysts, product sales forecasts, and integrated financial statements [1] Group 2 - The author, Edmund Ingham, has over 5 years of experience in covering biotech, healthcare, and pharma, with detailed reports on over 1,000 companies [1]
FibroBiologics Presents at the ThymUS 2025 Meeting
GlobeNewswire News Room· 2025-04-29 13:15
Core Insights - FibroBiologics, Inc. is a clinical-stage biotechnology company focused on developing therapeutics for chronic diseases using fibroblasts and fibroblast-derived materials, holding over 240 patents [1][5] - The company presented research on a scalable artificial thymus organoid at the ThymUS 2025 Meeting, which aims to recover the functionality of the thymus [2][3] Company Overview - Founded in 2001, FibroBiologics is based in Houston and is engaged in developing a pipeline of treatments for various chronic diseases, including multiple sclerosis, cancer, and wound healing [5] - The company emphasizes the unique immunomodulatory properties of fibroblasts, which are believed to enhance the functionality and durability of therapeutic organoids [3][5] Research and Development - The presented abstract details a method for developing transplantable and scalable thymus organoids that can generate functional T cells, indicating significant progress in the field [2][3] - The research highlights the potential of organoids to transform the study and treatment of chronic diseases, showcasing the innovative approaches being explored by the company [3]
CytoDyn Leadership Team To Attend ESMO Breast Cancer Meeting in Munich, Germany
Globenewswire· 2025-04-29 12:30
This news release contains forward-looking statements relating to, among other things, product development, market position, future operating and financial performance, and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations ...
INOVIO to Report First Quarter 2025 Financial Results on May 13, 2025
Prnewswire· 2025-04-29 12:05
Core Points - INOVIO, a biotechnology company, focuses on developing and commercializing DNA medicines for HPV-associated diseases, cancers, and infectious diseases [1][3] - The company will release its first quarter 2025 financial results on May 13, 2025, after market close [1] - A live conference call and webcast will follow the financial results release at 4:30 p.m. ET, including a Q&A session with analysts [1][2] Company Overview - INOVIO's technology is designed to optimize the design and delivery of DNA medicines that enable the body to produce its own disease-fighting tools [3] - The company aims to protect and treat individuals from HPV-related diseases and other infectious diseases through its innovative approach [3]
BioAtla to Announce First Quarter 2025 Financial Results and Provide Business Highlights on May 6, 2025
Globenewswire· 2025-04-29 12:00
Core Viewpoint - BioAtla, Inc. is set to host a conference call on May 6, 2025, to discuss its Q1 2025 financial results and business highlights [1][2]. Company Overview - BioAtla is a global clinical-stage biotechnology company focused on developing Conditionally Active Biologic (CAB) antibody therapeutics for solid tumors [3]. - The company operates in San Diego, California, and Beijing, China, through a partnership with BioDuro-Sundia for preclinical development services [3]. - BioAtla utilizes its proprietary CAB platform technology to create novel monoclonal and bispecific antibodies, aiming for selective targeting, greater efficacy, lower toxicity, and cost-efficient manufacturing compared to traditional antibodies [3]. - The company holds extensive patent coverage with over 780 active patent matters, including more than 500 issued patents, covering methods of making, screening, and manufacturing CAB product candidates [3]. Product Development - BioAtla's first dual CAB bispecific T-cell engager antibody, BA3182, is in Phase 1 development, targeting EpCAM, which is commonly expressed in adenocarcinomas [3]. - The company has two first-in-class CAB programs in Phase 2 clinical testing: mecbotamab vedotin (CAB-AXL-ADC) and ozuriftamab vedotin (CAB-ROR2-ADC) [3]. - The Phase 2 CAB-CTLA-4 antibody, evalstotug, is designed to reduce systemic toxicity and enable safer combination therapies with checkpoint inhibitors like anti-PD-1 antibody [3].
Pasithea Therapeutics Announces Completion of Enrollment and Initial Dosing of Patients in Cohort 6 from its Phase 1 Trial of PAS-004 in Advanced Cancer Patients
Globenewswire· 2025-04-29 11:02
Core Insights - Pasithea Therapeutics Corp. has completed enrollment and initial dosing of three subjects in Cohort 6 with 30 mg capsules of PAS-004, a next-generation macrocyclic MEK inhibitor for treating neurofibromatosis type 1 (NF1) and other MAPK pathway driven cancers [1][2] Group 1: Clinical Trial Progress - The ongoing Phase 1 clinical trial is a multi-center, open-label, dose escalation 3+3 study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of PAS-004 in patients with MAPK pathway driven advanced solid tumors with documented RAS, NF1, or RAF mutations, or patients who have failed BRAF/MEK inhibition [3] - The company expects to complete enrollment of all patients in the trial by the end of 2025, having recruited and commenced dosing of the initial three subjects more rapidly than anticipated [2] Group 2: Company Overview - Pasithea Therapeutics is a clinical-stage biotechnology company focused on the discovery, research, and development of innovative treatments for central nervous system (CNS) disorders, RASopathies, and MAPK pathway driven tumors [4]