Latest news with #NeurenPharmaceuticals
News.com.au
7 days ago
- Business
- News.com.au
Biocurious: Inspired by Neuren, Nyrada aims to change the treatment landscape for brain and heart disorders
Nyrada is focused on a particular ion pathway to tackle disorders including stroke and traumatic brain injury Preclinical work has shown a significant reduction in secondary brain injury and cardiac damage CEO James Bonnar spent 15 years at Neuren Pharmaceuticals in the company's formative stage Nyrada (ASX:NYR) CEO James Bonnar is too modest to admit it, but he played a key role in developing and commercialising Neuren Pharmaceuticals' (ASX:NEU) neurological drug Daybue. Bonnar was one of the then New Zealand-based Neuren's first employees and spent a decade at the company, which now bears a $1.7 billion market cap. Bonnar seeks to channel Neuren's virtues as Nyrada pursues small molecule treatments for both brain and heart protection. Before Neuren, Bonnar was with Protemix, which worked on a drug for diabetes-related cardiomyopathy. 'This is not my first rodeo." Nyrada's indications of interest include traumatic brain injury (TBI), which Neuren pursued before switching development to the childhood disorder Rett syndrome. 'You learn a lot of lessons along the way, competing in both successful and unsuccessful programs,' Bonnar says. Have a nice TRPC Nyrada's lead drug was called NYR-BI03, but last week the company bestowed the 'proper' name of Xolatryp to reflect the drug's 'advancing development'. The science is based on bodily transient receptor potential canonical (TRPC) ion channels (often pronounced 'tripsy'). These conduits regulate calcium influx into cells. 'Following ischemia or injury, these ion channels are activated and let in calcium into the cell,' Bonnar says. 'That calcium builds up to the extent where they're toxic.' As with Neuren, Nyrada had a spare clinical program in its back pocket. The Delaware-incorporated Nyrada listed in 2020, having spun off from immunology play Noxopharm (ASX:NOX). Nyrada initially focused on oral inhibitors which failed preclinical toxicology studies. 'Fortunately, we had a promising secondary program, which is now the lead program," Bonnar says. Xolatryp blocks TRPC channels to protect key cells in vital organs when under stress. In the case of brain neurons, that could be after ischaemia (a blood clot) and reperfusion (the sudden flow of blood returning to an organ or tissue). Ischemic-reperfusion injury is also a key cause of tissue damage following the restoration of blood flow to the heart post-injury. It's a knock-out! Using a 'knock out' mice model, pioneering work at the University of NSW (Uni NSW) showed the rodents were protected from stroke. The 'knock out' doesn't refer to concussing the critters with a mallet, but genetically modifying and cross breeding them so they no longer express the TRPC channels. 'This confirmed that completely knocking out the channel is safe and for all intents and purposes these mice lived a normal life,' Bonnar says. Over the last 12 months, Nyrada has focused on expanding efficacy data that builds on this 'knock out' mouse work. 'We went through a few iterations of molecules that showed promise, but they weren't target specific,' Bonnar says. Let's get clinical Preclinical work suggests Xolatryp is delivering significant reduction in secondary brain injury and cardiac damage For cardiac reperfusion, rat models showed an 86% reduction in injury (there are no other approved treatments). With ischemic strokes, a mouse study showed 42% protection. The company also ran a neuroprotection study with the Walter Reed Army Institute Research and Uni NSW, deploying a TBI model. Based on follow-up magnetic resonance imaging, this showed a 'statistically significant' neuroprotective benefit. Now for a human study As they say, everything works in mice … or rats. Nyrada's attention now has turned to a phase I healthy volunteer study to appraise dosing safety. The randomised, double blinded effort involves three-hour infusions, compared with 20 hours for the first preclinical study. The study consists of three eight-patient cohorts, six on the active drug and two on the placebo in each group. Bonnar says the trial will guide the company on what indication to pursue in a phase II study. 'In each one, there is first-in-class potential with large markets and unmet need.' The company is hoping to complete the study in September. Later, the company also would like to run a TBI study in the US, given the large addressable population. 'You would struggle to do that in Australia,' Bonnar says. Tackling a barren treatment landscape Bonnar describes Xolatryp as a 'Swiss Army knife' drug candidate, in that it could have broad uses. He says the current TBI treatments only alleviate the symptoms, rather than the condition. 'It's a similar situation with ischaemic stroke, but not quite so bad.' While clot-busting drugs work effectively, they need to be administered in a narrow time window (the 60 minutes after a stroke is called the Golden Hour). Given that, they only apply to 10-15% of patients. As for cardio protection, existing drugs can reduce the ticker's workload after a heart attack, but none of them protects the heart tissue. Can Nyrada 'do a Neuren?' Despite Xolatryp's snazzy name, Nyrada faces many years and development dollars before it 'does a Neuren'. Of course, most drug developers tripsy-up before reaching the end game. Bonnar dubs TRPC as a 'hot' research area reflected in Nyrada's share price: up 68% over the last month and 160% over the last year, ascribing a $38 million market cap. 'Big Pharma is looking at cardio protection in particular and we think our novel molecule … should attract interest,' Bonnar says. At the end of March Nyrada had $4.7 million of cash, enough to fund the phase I study. 'We are pretty lean; we work as a virtual company with a low head count.' Bonnar notes Boehringer Ingelheim has developed a TRPC inhibitors for renal fibrosis, while elsewhere work is afoot to develop one for the chronic condition of cardiac hypertrophy. 'But as far as I'm aware, we are the first company to be looking at a TRPC channel blocker in the clinic in our chosen indications.'
Yahoo
21-05-2025
- Business
- Yahoo
Is There An Opportunity With Neuren Pharmaceuticals Limited's (ASX:NEU) 31% Undervaluation?
Using the 2 Stage Free Cash Flow to Equity, Neuren Pharmaceuticals fair value estimate is AU$18.71 Neuren Pharmaceuticals' AU$12.82 share price signals that it might be 31% undervalued The AU$25.27 analyst price target for NEU is 35% more than our estimate of fair value Today we'll do a simple run through of a valuation method used to estimate the attractiveness of Neuren Pharmaceuticals Limited (ASX:NEU) as an investment opportunity by taking the expected future cash flows and discounting them to their present value. One way to achieve this is by employing the Discounted Cash Flow (DCF) model. Believe it or not, it's not too difficult to follow, as you'll see from our example! We would caution that there are many ways of valuing a company and, like the DCF, each technique has advantages and disadvantages in certain scenarios. For those who are keen learners of equity analysis, the Simply Wall St analysis model here may be something of interest to you. Trump has pledged to "unleash" American oil and gas and these 15 US stocks have developments that are poised to benefit. We're using the 2-stage growth model, which simply means we take in account two stages of company's growth. In the initial period the company may have a higher growth rate and the second stage is usually assumed to have a stable growth rate. In the first stage we need to estimate the cash flows to the business over the next ten years. Where possible we use analyst estimates, but when these aren't available we extrapolate the previous free cash flow (FCF) from the last estimate or reported value. We assume companies with shrinking free cash flow will slow their rate of shrinkage, and that companies with growing free cash flow will see their growth rate slow, over this period. We do this to reflect that growth tends to slow more in the early years than it does in later years. A DCF is all about the idea that a dollar in the future is less valuable than a dollar today, so we discount the value of these future cash flows to their estimated value in today's dollars: 2025 2026 2027 2028 2029 2030 2031 2032 2033 2034 Levered FCF (A$, Millions) AU$89.0m AU$22.9m AU$53.8m AU$65.2m AU$75.4m AU$84.4m AU$92.0m AU$98.6m AU$104.4m AU$109.5m Growth Rate Estimate Source Analyst x2 Analyst x2 Analyst x2 Est @ 21.26% Est @ 15.70% Est @ 11.81% Est @ 9.09% Est @ 7.19% Est @ 5.85% Est @ 4.92% Present Value (A$, Millions) Discounted @ 6.2% AU$83.8 AU$20.3 AU$44.9 AU$51.2 AU$55.8 AU$58.8 AU$60.4 AU$60.9 AU$60.7 AU$60.0 ("Est" = FCF growth rate estimated by Simply Wall St)Present Value of 10-year Cash Flow (PVCF) = AU$557m The second stage is also known as Terminal Value, this is the business's cash flow after the first stage. The Gordon Growth formula is used to calculate Terminal Value at a future annual growth rate equal to the 5-year average of the 10-year government bond yield of 2.7%. We discount the terminal cash flows to today's value at a cost of equity of 6.2%. Terminal Value (TV)= FCF2034 × (1 + g) ÷ (r – g) = AU$110m× (1 + 2.7%) ÷ (6.2%– 2.7%) = AU$3.2b Present Value of Terminal Value (PVTV)= TV / (1 + r)10= AU$3.2b÷ ( 1 + 6.2%)10= AU$1.8b The total value is the sum of cash flows for the next ten years plus the discounted terminal value, which results in the Total Equity Value, which in this case is AU$2.3b. The last step is to then divide the equity value by the number of shares outstanding. Compared to the current share price of AU$12.8, the company appears quite undervalued at a 31% discount to where the stock price trades currently. Remember though, that this is just an approximate valuation, and like any complex formula - garbage in, garbage out. We would point out that the most important inputs to a discounted cash flow are the discount rate and of course the actual cash flows. You don't have to agree with these inputs, I recommend redoing the calculations yourself and playing with them. The DCF also does not consider the possible cyclicality of an industry, or a company's future capital requirements, so it does not give a full picture of a company's potential performance. Given that we are looking at Neuren Pharmaceuticals as potential shareholders, the cost of equity is used as the discount rate, rather than the cost of capital (or weighted average cost of capital, WACC) which accounts for debt. In this calculation we've used 6.2%, which is based on a levered beta of 0.800. Beta is a measure of a stock's volatility, compared to the market as a whole. We get our beta from the industry average beta of globally comparable companies, with an imposed limit between 0.8 and 2.0, which is a reasonable range for a stable business. See our latest analysis for Neuren Pharmaceuticals Strength Currently debt free. Weakness Earnings declined over the past year. Opportunity Annual earnings are forecast to grow for the next 3 years. Good value based on P/E ratio and estimated fair value. Threat Annual earnings are forecast to grow slower than the Australian market. Although the valuation of a company is important, it shouldn't be the only metric you look at when researching a company. DCF models are not the be-all and end-all of investment valuation. Preferably you'd apply different cases and assumptions and see how they would impact the company's valuation. If a company grows at a different rate, or if its cost of equity or risk free rate changes sharply, the output can look very different. Why is the intrinsic value higher than the current share price? For Neuren Pharmaceuticals, we've compiled three essential aspects you should explore: Financial Health: Does NEU have a healthy balance sheet? Take a look at our free balance sheet analysis with six simple checks on key factors like leverage and risk. Future Earnings: How does NEU's growth rate compare to its peers and the wider market? Dig deeper into the analyst consensus number for the upcoming years by interacting with our free analyst growth expectation chart. Other High Quality Alternatives: Do you like a good all-rounder? Explore our interactive list of high quality stocks to get an idea of what else is out there you may be missing! PS. Simply Wall St updates its DCF calculation for every Australian stock every day, so if you want to find the intrinsic value of any other stock just search here. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
News.com.au
08-05-2025
- Health
- News.com.au
Health Check: Neuren says more patients are staying the course as US Daybue sales lift
Neuren says the number of patients discontinuing its Rett syndrome drug has fallen by two-thirds over the last year LTR Pharma launches a secondary program for swallowing disorders Telix targets throat – and other - cancers Neuren Pharmaceuticals' (ASX:NEU) global marketing partner Acadia has reported strong March quarter sales of the duo's treatment Daybue in the US, for the rare neurological disorder Rett syndrome. More heartening is a drop-off in patient discontinuation rates – a sensitive topic given the drug's known side effects (diarrhoea, vomiting, possible weight loss). A rare genetic disorder evident mainly in girls, Rett syndrome affects brain development, resulting in slower development and often a shorter lifespan. The Nasdaq-listed Acadia disclosed net sales for the quarter of US$84.6 million ($130 million), 11% higher than a year previously. Sales were 15% lower than the December quarter, owing to seasonal variations and a small cut in the per-bottle price, as determined by the US Medicare system. Acadia has the US rights to Daybue, on which Neuren generates royalty income. Neuren pocketed royalties of $13.5 million, up 17%. Acadia has stuck with its calendar 2025 sales guidance of US$380-405 million, implying $62-67 million of royalty income for Neuren. Acadia says a record 954 patients received Daybue, with discontinuations down 35% on the December quarter and 66% year on year. Put another way, more than 50% of patients have continued the therapy at 12 months, while 65% of 'active patients' have been on the drug for 12 months or longer. Neuren says there's still plenty of untapped potential, given two-thirds of the 5500 to 5800 diagnosed Rett patients are yet to try the drug. Meanwhile, Neuren expects European approval in the March 2026 quarter, with pending distribution agreements to sell in certain Latin America, Middle East and Asia Pacific geographies. Neuren was due to present at Macquarie's corporate jamboree today. The developer of a nasally delivered spray treatment for erectile dysfunction, LTR Pharma (ASX:LTP) has also turned its mind to a secondary program. LTR has signed a development agreement to develop Oroflow, a spray for oesophageal motility disorders (OMD) – a group of conditions that cause impaired swallowing (dysphagia). The compact is with Strategic Drug Solutions of the US. As well as not being able to down solids and liquids, OMD patients suffer regurgitation, chest pain and sometimes weight loss. Substandard current treatments include dilation, surgery, or Botox injections. Oroflow aims to deliver relief in 10 minutes. 'There is a clear need for effective, non-invasive treatment options that can provide rapid relief for patients with swallowing difficulties,' executive chairman Lee Rodne says. The company values the OMD market globally at US$4.49 billion, with the US accounting for US$1.94 billion. The condition affects about 10.8 in every 100,000 people, but for unexplained reasons the incidence is higher in Australia (16.9). We blame all the flies. Telix's side program could be FAP-ulous Nuclear medicine house Telix Pharmaceuticals (ASX:TLX) also reports promising results from an acquired secondary program – with a throaty theme as well. The program pertains to the fibroblast activation protein – FAP – as expressed by several cancers. As reported in the American Thyroid Association's official journal, unsurprisingly monikered Thyroid, FAP showed 'encouraging efficacy' against aggressive thyroid cancer in a 73-patient study. The heavily pre-treated patients showed median progression-free survival of 29 months, which meant their tumours didn't get bigger. Overall survival was 32 months, with a 'manageable' safety profile. Telix last year acquired the FAP program, dubbed TLX-400, from its inventors at Germany's Johannes-Gutenberg University. The terms were €10 million ($17.6 million) cash and €132 million of milestones if the program progresses as either a diagnostic tool or a therapy. Telix chief medical Dr David Cade says the results compare positively to the current treatment – tyrosine kinase inhibitor drugs – which can have nasty side effects. The company is eyeing multiple solid tumour types, including bladder cancer. Telix has two approved prostate cancer diagnostics on market and is angling for US Food & Drug Administration (FDA) consent for a kidney cancer diagnostic. A Roxsta moment for Memphasys Last week we mentioned Memphasys (ASX:MEM) and its successful trial of its sperm separation device for assisted reproduction purposes, Felix. There's another leg to the Memphasys tale: its Roxsta device that measures antioxidant levels in human and animal biological samples. Memphasys today said various pilot studies had shown Roxsta's ability to perform mass testing in various contexts, including oxidative stress in cattle and antioxidant levels in professional footballers. In the case of the latter, the technology 'demonstrated the capacity to process 96 samples in less than an hour, delivering highly accurate data in a fraction of the time compared to traditional methods.' Currently, commercially available methods can take up to 16 hours to deliver a single result, while Roxsta can do in around three minutes. 'To date, much of the focus has been on smaller-scale assessments of Roxsta, ensuring the results are accurate and the device is capable of being deployed in a commercial setting,' CEO Dr David Ali says. Memphasys shares gained 40% – or two-tenths of a cent – this morning. Robot says 'yes' on the best drug combos Why carry out expensive drug trials if a robot can do the job instead? We're being a tad facetious, but minnow Algorae Pharmaceuticals (ASX:1AI) highlights the potential for artificial intelligence to short-cut the initial stages of drug development. Algorae has partnered with the Victorian Centre for Functional Genomics, an arm of Melbourne's Peter MacCallum Cancer Centre, to validate AI-predicted drug interactions in oncology. Alogorae has developed AlgoraeOS, a machine learning tool to identify the best drug combinations. The study will focus on 24 AI-generated drug candidates, which are tested for synergies across four cancer cell lines (glioblastoma, pancreatic, breast and prostate). The company expects to release preclinical data within six months.
AU Financial Review
23-04-2025
- Business
- AU Financial Review
This $1.3b biotech is still run out of a spare bedroom in Melbourne
Jon Pilcher's spare bedroom in Melbourne's southern suburbs is the unlikely engine room of a $1.3 billion global biotech. The chief executive of Neuren Pharmaceuticals has overseen two capital raisings and the rapid growth of the company, which has developed the world's first approved drug to treat Rett syndrome, a neurological disorder disrupting signalling between brain cells mainly in young girls.
Yahoo
04-03-2025
- Business
- Yahoo
Neuren Pharmaceuticals Full Year 2024 Earnings: Beats Expectations
Revenue: AU$216.8m (down 6.5% from FY 2023). Net income: AU$142.0m (down 9.6% from FY 2023). Profit margin: 66% (down from 68% in FY 2023). EPS: AU$1.11 (down from AU$1.24 in FY 2023). All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue exceeded analyst estimates by 13%. Earnings per share (EPS) also surpassed analyst estimates by 21%. In the last 12 months, the only revenue segment was Commercial Products contributing AU$213.2m. The most substantial expense, totaling AU$37.1m were related to Non-Operating costs. This indicates that a significant portion of the company's costs is related to non-core activities. Explore how NEU's revenue and expenses shape its earnings. Looking ahead, revenue is expected to decline by 11% p.a. on average during the next 3 years, while revenues in the Pharmaceuticals industry in Australia are expected to grow by 44%. Performance of the Australian Pharmaceuticals industry. The company's shares are down 7.9% from a week ago. It is worth noting though that we have found 1 warning sign for Neuren Pharmaceuticals that you need to take into consideration. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Sign in to access your portfolio
