Latest news with #DanielO'Connell
Irish Independent
5 days ago
- General
- Irish Independent
Re-enactment of Daniel O'Connell's famous speech to take place in Cork town this Friday
2025 marks the 250th anniversary of the birth of Irish political leader who was one of Ireland's foremost politicians in the late 18th and early 19th centuries. The Kerry native has often been hailed in his time as The Liberator. O'Connell a qualified barrister was the acknowledged political leader of Ireland's Roman Catholic majority in the first half of the 19th century. Born near Cahersiveen on August 6, 1775, O'Connell was instrumental in the Catholic Emancipation Act that granted political and civil rights to Catholics in Ireland. He was also a leading abolitionist who sought to ban the international slave trade in the early 1800s. Two of Ireland's major cities – Limerick and Dublin – have their main streets named in honour of O'Connell. He staged one of his famous Monster Meetings in Mallow on June 11, 1843 which attracted a reported crowd of 250,000 people from all over north Cork and further afield at the Repeal of the Act of Union meeting. 40 bands also marched in the parade. The heights and fields were crowded with spectators. As a person, O'Connell was extraordinary. Deeply popular with the public, rather than being a 'populist', he could explain the essence of complex arguments to audiences of thousands. O'Connell's constitutional approach was carried on by Thomas Davis and by Charles Stewart Parnell. ADVERTISEMENT Friday's re-enactment in Mallow town will attempt to recreate the events of that famous day in Mallow history. A number of monster repeal meetings were held at various locations throughout Ireland and preparations for the great Mallow Repeal Meeting commenced in October 1842. During a powerful oration Mr O'Connell told the captivated audience that there was one thing which gave him pleasure, and that was the length of time he enjoyed the confidence of the people. He was counsel for Ireland – the people were his clients - he had none other. He also told the spectators that he had given up the profession in which he was successful; and now for the remainder of his life he was resolved to devote himself to the advocacy of the Irish people and old Ireland. The speech by Daniel O'Connell in Mallow became known as the Mallow Defiance. The famous sculptor John Hogan carved an 18 feet marble statue of O'Connell which is located in the City Hall in Dublin. Famous orator Daniel O'Connell made his first ever speech in 1800 in City Hall, then called the Royal Exchange, and his statue shows him as an orator, raising his right hand to make a point. In November 1841, O'Connell became Lord Mayor of Dublin, another reason for having his statue in City Hall, where council meetings are still held.
Irish Independent
7 days ago
- General
- Irish Independent
Wexford student highly commended for Oireachtas essay competition submission
The competition is open to students in the senior cycle, TY, fith and sixth, and encourages young people to explore politics in an original and though-provoking way. It was devised by Independent NUI Senator Rónán Mullen with the support of the Ceann Comhairle's Office and the Oireachtas Education Unit. Hundreds of students across the country submitted essays in Irish and English on the theme 'Parliamentary Politics Liberates' / 'An tSaoirse agus an Pholaitíocht Pharlaiminteach' – in reverence of the 250th Anniversary of the birth of 'The Liberator', Daniel O'Connell. Presenting the prizes, Deputy Ó Fearghaíl said that greater engagement by young people with the political system was 'vital for the health of our democracy and for our ability to overcome the many challenges we face at home and abroad.' 'We are delighted with the growing support for Aiste an Oireachtas – with a significant increase this year in the number of entries received,' says Senator Mullen, the Competition Convenor.' 'Since Aiste an Oireachtas began in 2022, we have had registrations and entries from almost half the secondary schools on the island of Ireland (47 per cent). 'It is clear that schools recognise the importance of getting students to think about our democracy and the need to work it for the common good.'
Yahoo
14-05-2025
- Business
- Yahoo
Q1 2025 Acumen Pharmaceuticals Inc Earnings Call
Alex Braun; Head of Investor Relations; Acumen Pharmaceuticals Inc Daniel O'Connell; Chief Executive Officer, Director; Acumen Pharmaceuticals Inc W. Matthew Zuga; Chief Financial Officer, Chief Business Officer; Acumen Pharmaceuticals Inc James Doherty; President, Chief Development Officer; Acumen Pharmaceuticals Inc Eric Siemers; Chief Medical Officer; Acumen Pharmaceuticals Inc Sarah Medeiros; Analyst; Cantor Fitzgerald Tom Shrader; Analyst; BTIG Ting Liu; Analyst; UBS Operator Good day and thank you for standing by. Welcome to the Acumen Pharmaceuticals Q1 2025 conference call and webcast. At this time, all participants are in a listen-only mode. Please be advised that today's conference is being recorded. (Operator Instructions) I would not like to hand the conference over to your speaker today, Alex Braun, Head of Investor Relations. Alex Braun Thanks, Josh. Good morning, and welcome to the Acumen conference call to discuss our business update and financial results for the quarter ended March 31, 2025. With me today are Dan O'Connell, our CEO; and Matt Zuga, our CFO and Chief Business Officer. Dan and Matt has some prepared remarks, and then we'll open the call for questions. Joining for the Q&A session, we also have Dr. Jim Doherty, our President and Chief Development Officer; and Dr. Eric Siemers, our Chief Medical Officer. Before we begin, we encourage listeners to go to the Investors section of the Acumen website to find our press release issued this morning that we'll discuss today. Please note that during today's conference call, we may make forward-looking statements within the meaning of the federal securities laws, including statements concerning our financial outlook and expected business plans. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Please see slide 2 of our corporate presentation, our press release issued this morning, and our most recent annual and quarterly reports filed with the SEC for important risk factors that could cause our actual results to differ materially from those expressed or implied in the forward-looking statements. We undertake no obligation to update or revise the information provided on this call or in the accompanying presentation as a result of new information or future results or developments. So with that, I'll turn the call over to Dan. Daniel O'Connell Great. Thanks, Alex. Good morning, everyone, and thanks for joining us today. As we noted in our year-end call in late March, Acumen continues to build momentum towards our goal of establishing sabirnetug as a next-generation treatment option for patients with mild cognitive impairment or mild dementia, known as early Alzheimer's disease or early AD. In the first quarter, we completed enrollment of our 542 participant Phase 2 study, ALTITUDE-AD, which is designed to evaluate the clinical efficacy and safety of sabirnetug in patients with early AD. We completed enrollment of ALTITUDE in roughly 10 months, much faster than expected. We attribute the rapid pace of enrollment to the interest in sabirnetug therapeutic potential as supported by an extensive non-clinical data set and positive Phase 1 results, innovative participant screening methods used in the trial and strong execution by our team and clinical partners. We expect top line results for ALTITUDE-AD in late 2026 inclusive of the key efficacy and safety measures. In April, we presented at two major Alzheimer's medical conferences, AD/PD and AAN. Consistent with the rapidly growing focus on the utility of fluid biomarkers in AD, our presentations highlighted an innovative use of a plasma phosphorylated 217 screening procedure in ALTITUDE-AD. Our study, combined with multiple recent clinical investigations support the use of plasma pTau217 as a sensitive indicator of the presence of amyloid pathology. Our objective for the pTau217 screen was to reduce the number of negative PET scans, thereby streamlining the screening process. In our INTERCEPT Phase 1 study, only 40% of individuals screened for participation in the study tested positive on amyloid PET. In comparison by screening for a specific threshold of pTau217 in ALTITUDE prior to a PET scan, 81% of screened individuals that met or exceeded the threshold tested positive on amyloid PET, a significant improvement. The use of the pTau217 screening assay improved enrollment efficiency, decreased patient burden and reduced screening costs in ALTITUDE. We believe this approach contributed to our very rapid enrollment rate and serves as a clear example of how we consistently implement innovative approaches to AD drug development based on insights and emerging data from the field. Building off the INTERCEPT manuscript and biomarker changes that published in Q1 in the Journal for the Prevention of Alzheimer's disease, at AD/PD and AAN, we also presented posters detailing other innovations our team has made to deepen the conversation around sabirnetug's therapeutic potential. These innovations include insights into the early effects of sabirnetug on synaptic biomarkers in AD, methods to develop a-beta oligomer selective assays and a non-clinical model to test more precisely the interactions between sabirnetug and a-beta oligomers that better replicates the human brain environment. Methods posters like these are important as they align with our view that a-beta oligomers are the most toxic form of amyloid in the Alzheimer's brain, and help us advancements to such assays and tools can help inform oligomer preference of selected drugs like sabirnetug. As communicated on our year-end call, during the first quarter, we also completed a Phase 1 study investigating a subcutaneous administration of sabirnetug, comparing subcutaneous and intravenous administrations of sabirnetug in healthy volunteers. Importantly, results from the study showed that sabirnetug was well tolerated with systemic exposure supporting the continued development of this route of administration. Our next steps for the development of sabirnetug for subcutaneous administration involve ongoing formulation and drug delivery assessments. We are confident in sabirnetug an innovative and differentiated potential treatment for people with Alzheimer's disease. Our team is driven each day by the opportunity to make a difference in the fight against this devastating disease. We continue to actually establish sabirnetug therapeutic potential and are excited to be on track to share the Phase 2 results late next year. And with that, I'll turn the call over for Matt for the financials. W. Matthew Zuga Thank you, Dan. As a reminder, our quarter 2025 financial results are available in the press release we issued this morning and in our 10-Q we will file later today. As of March 31, we had $197.9 million in cash and marketable securities on our balance sheet, which is expected to support our current clinical and operational activities into early 2027. R&D expenses were $25.3 million in the first quarter. The increase over the prior year was primarily due to the increased spending to support the ALTITUDE-AD trial, which completed enrollment in March 2025. G&A expenses were $5.1 million in the quarter, roughly flat to the same period in the prior year. This led to a loss from operations of $30.4 million and a net loss of $28.8 million in the quarter. We are off to a strong start without the two AD, and we look forward to sharing top line results, which are expected in late 2026. We remain dedicated to delivering a potential next-generation treatment option for the benefit of patients, caregivers and shareholders. And with that, we can open the call for Q&A. Operator? Operator (Operator Instructions) Paul Matteis, Stifel. Hi, this is Matthew for Paul. Thanks for taking our question and congrats on the progress. So a quick question on the subcu. Once the formulation and drug delivery assessments are complete, how or when are you thinking about incorporating that into your future development plans? Thank you. Daniel O'Connell Thanks, Matthew. And then we've got Jim and Eric on the call, I'm going to direct that one to Jim initially to provide comments. James Doherty Thanks Dan, and hi Matthew. Yeah, so your question is as we get to next stages in our understanding of the subcu development, how do we integrate it into the program. And I think there's a couple of options that we have in front of us. And the team is working very hard on establishing what's going to be the most efficient pathway. And I think basically the major options would include incorporating an arm of subcu administration into an ongoing Phase 3 study for IV sabirnetug that's planned based on outcomes from the ALTITUDE-AD IV study or alternatively doing a standalone study looking at the effects of subcu sabirnetug to be able to compare to the program. So those are the two major pathways. And at this time, the team is still evaluating what's going to be the most efficient path forward. Ultimately, that's our goal, is to be able to most rapidly and effectively evaluate both opportunities for patients. Thank you. Operator Pete Stavropoulos, Cantor Fitzgerald. Sarah Medeiros Hi, this is Sarah Medeiros for Pete. We have a couple of questions. The first question being, can you just remind us the powering assumptions for ALTITUDE and if there is an interim and futility look built into the study? Daniel O'Connell Sure. Eric, do you want to quickly hit on that? Eric Siemers Sure. So we do not have an interim analysis in the study. Initially, there was some discussion about that possibility, but we've made the decision not to do an interim analysis. There's really no need to do that. And in terms of the powering, we haven't disclosed any specific numbers, but I can just tell you that the powering is very appropriate for a Phase 2 study. It's 542 people. So it's not a small Phase 2. It's actually a fairly good sized Phase 2 study. But the powering is appropriate for a Phase 2 study. Sarah Medeiros Great. And just a quick follow-up. There's been a lot of progress in the Alzheimer's space, many of which show that changes in biomarkers start to appear far in advance of symptoms as well as some of the underlying pathologies like various calce pieces. How do these updates inform your approach and assumptions about the disease in clinical studies. And understanding that the data is in late 2026, what do you expect to show at the top line? Eric Siemers Well, thanks. That's a great question because the field has just made a lot of advances recently, especially in terms of these blood-based plasma biomarkers, which five years ago, probably people wouldn't have thought that was possible, but we're starting to see that now. But what we did in our development plan for sabirnetug is even in our Phase 1 study, we did that in patients, and we had a number of different biomarkers in the study. And interestingly, even in the MAD cohorts, those cohorts, where they still only got three administrations of the drug, we saw changes in these biomarkers that people are now looking at pretty commonly. So whether it's -- and not everything was statistically significant because it's a little Phase 1 study, but directionally, it was very consistent. So we had normalization of the a-beta 42 of over 40 ratio, which correlates with the amount of amyloid plaque. We had decreases in different pTau species. We had directional changes in a biomarker of GFAP, which is an astrocyte marker. So we had all these different things, even in our own Phase 1 study with just three administrations of drug go the right direction essentially. So the field is really moving rapidly. At this point, I think it's safe to say that there's not a broadly accepted surrogate biomarker for Alzheimer's disease. So you still need clinical outcomes to have approval, it is our general expectation. And by the way, our Phase 2 study, the primary outcome is the clinical measures, the scale called the hydrous. But these biomarkers really give you really a good indication of central pharmacology, and I think we've talked about this before, but we were just very pleased to see that even in a Phase 1 study that we had evidence of central pharmacology of sabirnetug in patients with Alzheimer's disease. So it's really nice for somebody like myself who's been in the field for quite a while to see these really rapid advances, many of which are based on these biomarkers that people are now better understanding, and we now have the technology, the tools to measure them better. James Doherty And maybe just to amplify a little bit on what Eric's saying. As you can hear, we think a lot about biomarkers and including biomarkers in our trials. As do most of the field at this point. So as Eric was saying, there's been a tremendous amount of advancement in the last few years, building off a long history of trying to address these issues. And I think you can see that progress is being made in understanding how to stage Alzheimer's patients as they move through this progressive disorder. And also different types of biomarkers may inform mechanism of action kind of question. So we've put some emphasis on synaptic biomarkers that could be measures of underlying synaptic health and activity. So we do think that by the time we're looking at readout from ALTITUDE-AD, there's going to be a lot of value in biomarkers as context to add to the primary endpoint, which, as Eric rightly points out on the cognitive endpoints. But there's a richness to the data that these biomarkers are bringing. And so for us, we think it's going to be an important part of the story. And in addition to the markers that we're currently measuring, we're also careful to do plasma sampling to allow us to do additional work as the field continues to learn. Great. Thank you. Operator Tom Shrader, BTIG. Tom Shrader Good morning. Thanks for taking the questions. It's fairly related to the last questioner. But it seems like the commercial antibodies are getting some traction and two companies are working very hard. Are you finding that, that poses any risk to your trial as your dropout rate about where you thought it would be given you had a placebo arm and then I have a mechanistic follow-up. Eric Siemers Yeah. Daniel O'Connell Good question. Go ahead, Eric. Eric Siemers Sure. Well, okay. Yeah, so no, it's a great question and it's something that we've thought about quite a bit is because there now our two FDA-approved drugs at least in the United States, could that be a risk to our study. And so far, that's just not been the case. And as you know, the launch of both of those drugs with lecanemab being a little sooner -- having a little more history to it now, has been relatively slow. A lot of that, we think, is due to just infrastructure not being present and it will continue to be built. But the bottom line is for our ALTITUDE study again, as Dan mentioned previously, the enrollment rate was much higher than we had actually projected. So we enrolled 542 people in 10 months, which is pretty substantial. But then in terms of discontinuation rates, this is an ongoing blinded trial, and we finished enrolling a relatively short period of time ago. But so far, the discontinuation rate looks quite good. So we're not seeing problems with these marketed drugs. One of the things to keep in mind is that we do have an open-label extension at the end of the study. So people who get randomized into ALTITUDE, so it's a three arm study, one arm is placebo. So chances are two out of three that you're not on placebo. And then when you get to the open-label extension, 100% of people will be on drug. So we think that's one of the study design aspects that's really made this an attractive study for people. And so far, the study is progressing very nicely. Tom Shrader Okay, and then for plasma tau217, and you guys are all over this this marker. Is this the best guess for a useful treatment biomarker? Or is that not likely to be the case? And do you have a sense of where we sit today, what's likely to be the best treatment biomarker? Do you think your synaptic markers that are kind of novel have a better chance. But where do we stand on a treatment biomarker? We understand staging biomarkers are quite advanced. James Doherty Yeah, Tom, this is Jim. Happy to take that one. As I was saying, we do definitely think that these plasma-based biomarkers are going to be continuing to evolve. And I think as you just said, staging is one clear use, and I think that's coming along. I think markers of activity or efficacy, I think everyone is asking that question. I think at this point, we don't yet know. Certainly, pTau217 is going to be critical in whatever plays out. I think my guess and our guess is that we're likely to see a series of markers that are used to both understand where patients are in their Alzheimer's journey, but also to be used to assess ongoing cognitive level. I don't think we're likely to see a single marker giving a clear progressive marker of cognitive activity, and you're likely to see multiple markers giving you a sense as patients continue. And I think beyond that, we'll just have to wait and see. But that would be my guess is that we'll see a number of different markers correlating with the progression of disease. And that's part of what's happening right now is there are a lot of studies ongoing trying to work out which markers at which time are correlating with function. So stay tuned. Eric Siemers Yeah, the interesting thing about that question is that these biomarkers be used either for diagnostic purposes or to assess (inaudible) testing biomarker can be used to do both. And so it gets a little confusing in terms of what's the purpose of your biomarker, but you can use them either way, either as a diagnostic or as evidence of drug effect. Tom Shrader Okay, great, thank you. Operator Ting Liu, UBS. Ting Liu Good morning and thank you for taking our question. I have a follow-up question on biomarker maybe focusing on the synaptic biomarkers given there are increasing interest in the field how oligomer target therapy may differentiate in promoting synaptic recoveries which are not much evidenced in the targeted therapies yet. However, we've seen some recent data from Roche, and they have shown trontinemab also meaningfully reduced synaptic biomarker like New York running. So can I ask what are you selling over the Roche's data. Also maybe if you could talk about the overall -- about your updated thoughts on how competitive -- on the competitive position of sabirnetug versus trontinimab? Thank you. Daniel O'Connell Thanks, Ting, and I think Eric, that kind of follows along the preview you gave of the INTERCEPT results, which were in a short duration study but meaningfully moving both some of the a-beta tau but also the synaptic markers. I think even the -- one of the presynaptic markers achieving significance across each of the higher dose cohorts. So I think for a short duration study such as INTERCEPT, we're encouraged to think that ALTITUDE-AD is certainly positioned to read out in potentially a more impactful and broader way. And we'll just we'll have to see, I think we're now positioned to read out the study next year. So excited about that prospect. Eric Siemers Yeah, right. I mean INTERCEPT may not have been the very first study to measure these synaptic biomarkers, but it was certainly one of the first. And as you go out with trontinemab now, for example, it's something that the field is looking at it broadly. So we are pleased that we were one of the first studies to show effects on synaptic biomarkers. And obviously, we'll look at those in our ALTITUDE study in addition. Ting Liu Thank you all. Those are really helpful. Operator Thank you. I would now like to turn the call back over to Alex Braun for any closing remarks. Alex Braun Great. Thanks, Josh, and thanks, everyone, for taking the time and for joining us today. We are available at the company any time for additional questions. And with that, I hope you all have a great day. Operator Thank you. This concludes the conference. Thank you for your participation. You may now disconnect. 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Irish Independent
09-05-2025
- Entertainment
- Irish Independent
Ancestral Kerry home of Daniel O'Connell to feature on new TV series
Legacy is a new four part documentary series for RTÉ featuring 15 of Ireland's National Historic Properties with each episode having a specific theme: Centres of Power, Writers and Collectors, Memory and Commemoration, and The Art of the Portrait. The first episode features four properties, each one a centre of power, and this includes Derrynane house - ancestral home of lawyer, politician and statesman, Daniel O'Connell, known worldwide as The Great Liberator, and whom some called the unofficial King of Ireland. Daniel O'Connell worked on his campaigns for Catholic Emancipation and for Irish freedom from British rule at Derrynane and held court there like an old Gaelic Chieftain. His greatest triumph was achieving Catholic Emancipation in 1829, giving Catholics the right to sit in Parliament. After O'Connell's death, the house remained the O'Connell family home until, in 1948, the Derrynane Trust was founded, preserving the house as a museum and memorial to Daniel O'Connell. In 1964, the house was transferred to the Commissioners of Public Works, and following restoration work completed in 1967, the house was officially opened by President Eamon De Valera. This year will mark the 250th anniversary of the birth of Daniel O'Connell so it is fitting tribute to the man and his seat of power in Kerry to be part of the series. Writer and director of Legacy David Hare, who wrote and directed Great Lighthouses of Ireland, explains the background to the documentary. 'The traditional way to approach this subject would be chronologically or geographically, but instead we've done so thematically. The thematic approach enabled us to include very different and seemingly unrelated buildings and sites from very different eras, and weave them together so that the connections between them become clear.' The first episode also features Dublin Castle, Oldbridge House, located beside the River Boyne, and Pearse Museum in St Enda's Park in Rathfarnham. From their power bases in Derrynane and Rathfarnham, using very different methods and separated by almost a century, Daniel O'Connell and Patrick Pearse fought back against British rule. Legacy will air on RTE one on Sunday May 11 at 6.30pm.
RTÉ News
02-05-2025
- Politics
- RTÉ News
Students honoured as part of Oireachtas essay competition
Students from 10 different counties have been honoured for their interest in and understanding of the political system, as part of the annual Oireachtas essay competition. The students - from Cork, Donegal, Dublin, Galway, Kilkenny, Louth and Mayo - were commended for their engagement in the "health of our democracy" at a ceremony in Leinster House today. Now in its third year, the annual Oireachtas Essay Competition was established to help encourage young people to become more engaged in politics and more aware of the political system. Among the winners were: National winner (English language) - Patrick Galvin, Abbey Community College, Abbeylands, Co Kilkenny Buaiteoir náisiúnta (Gaeilge) - Eimear Nic Dhonnchadha, Scoil Chuimsitheach Chiaráin, An Cheathrú Rua, Contae na Gaillimhe Dublin winner - Iseult McGovern, Rathdown School, Upper Glenageary Road Glenageary, Co Dublin Leinster winner - Chukwudike Kpaduwa, Dundalk Grammar School, The Crescent, Townparks, Dundalk, Co Louth Connacht winner - Marissa Illiana Divilley, St Joseph's Secondary School Castlebar, Convent of Mercy, Castlebar, Co Mayo Ulster winner - Jamie Anderson, St Catherine's Vocational School, Donegal Road, Corporation, Killybegs, Co Donegal Munster winner - Saoirse O'Connor Buckley, Colaiste Muire Realt na Mara, Crosshaven, Co Cork A further 12 students, from counties Dublin, Wexford, Mayo, Galway, Antrim, Cork, and Kerry will also be given "highly commended" awards in their schools in the coming weeks. The Oireachtas Essay Competition was devised by Independent Senator Ronan Mullen, along with the support of the Dáil ceann comhairle's office and the Oireachtas education unit. Senior cycle students and AS/A Level students across the island of Ireland were invited to submit essays in Irish or English and to compete for a prize fund of €6,000. Hundreds of students registered for this year's competition, which invited essays on the theme: 'Parliamentary Politics Liberates' / 'An tSaoirse agus an Pholaitíocht Pharlaiminteach' - reflecting the 250th Anniversary of the birth of The Liberator, Daniel O'Connell'. Winners were chosen by an expert panel of judges which included DCU Professor of Politics Gary Murphy and journalist, writer and academic Alan Titley MRIA. Prof Patrick Geoghegan of Trinity College Dublin, who authored a two-part biography of Daniel O'Connell, also provided expert views to the competition. The event was attended by CJ Fallon chief executive Brian Gilsenan and PTSB chief executive Eamonn Crowley, the latter of whom's company sponsors the competition. Presenting the prizes, the competition founding patron and Fianna Fáil TD Seán Ó Fearghaíl said that greater engagement by young people with the political system was "vital for the health of our democracy and for our ability to overcome the many challenges we face at home and abroad".
