Latest news with #LTRPharma
Daily Telegraph
3 days ago
- Business
- Daily Telegraph
LTR Pharma completes ED study milestone
Don't miss out on the headlines from Stockhead. Followed categories will be added to My News. LTR Pharma & co-development partner Aptar Pharma complete extractables study on SPONTAN All identified compounds below ICH safety thresholds for nasal spray-mist erectile dysfunction treatment Leachables study initiated to support FDA regulatory submission under real-world storage conditions Special Report: LTR Pharma has completed a key extractables study for its SPONTAN intranasal spray for erectile dysfunction and kicked off a leachables study as part of a regulatory development program. LTR Pharma (ASX:LTP) said the extractables study, conducted under the supervision of co-development partner Aptar Pharma, evaluated the bottle and pump components of SPONTAN's container closure system. The study confirmed that all detected compounds were below ICH safety thresholds – the internationally recognised standards adopted by the US Food and Drug Administration (FDA) and regulatory authorities worldwide for pharmaceutical impurities. LTR Pharma said the identified compounds would be monitored in the ongoing leachables study. FDA requires extractables and leachables (E&L) studies for all pharmaceutical products to ensure packaging materials do not compromise product safety or efficacy. For nasal spray products, these studies must meet specific regulatory thresholds due to direct tissue exposure. Leachables study now underway The leachables study has started under Aptar Pharma's management, evaluating the potential migration of the compounds from packaging into SPONTAN under real-world storage conditions. LTR Pharma said SPONTAN used industry-standard bottle and pump components as used in multiple FDA-approved nasal spray products. The study will run for at least 24 months to support shelf-life requirements. Consistent with FDA practice for nasal sprays, the company can submit its application once sufficient robust data is available, with study completion continuing post-approval as standard. E&L studies form part of LTR Pharma's comprehensive regulatory strategy following its FDA pre-IND meeting, where the FDA confirmed the proposed development pathway. The company said E&L data were required for the chemistry, manufacturing and controls (CMC) section of its planned new drug application (NDA). With extractables results meeting regulatory requirements, the company progresses to the leachables phase for comprehensive regulatory submission data. Watch: LTR's new appointment Progress on SPONTAN and new US-targeted ROXUS LTR Pharma continues to progress SPONTAN through established regulatory pathways while building commercial foundations through its Australian early access programs. It is also progressing its new ED nasal spray called ROXUS, which offers a fast-track pathway to serve patients through the US personalised healthcare sector. As with SPONTAN, ROXUS is based on the common active ingredient vardenafil. It will be delivered via the 503(a)-compounding pharmacy pathway, which exempts drugs from the usual approval, labelling and manufacturing requirements. "The completion of our extractables study and commencement of the leachables phase keep our regulatory program on schedule,' LTR Pharma executive chairman Lee Rodne said. 'Working with Aptar Pharma provides us with their established expertise in nasal spray device development and FDA submissions. 'These studies are necessary steps in our development pathway, and we look forward to progressing through each regulatory milestone." This article was developed in collaboration with LTR Pharma, a Stockhead advertiser at the time of publishing. This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions. Originally published as LTR Pharma completes study milestone for SPONTAN ED treatment
Herald Sun
21-05-2025
- Business
- Herald Sun
StockTake: LTR's new appointment rises to the occasion
Don't miss out on the headlines from Stockhead. Followed categories will be added to My News. LTR Pharma (ASX:LTP) appoints Associate Professor Darren Katz to its scientific advisory board to spearhead consultancy for Spontan, LTR's innovative nasal spray treatment for e rectile dysfunction. Katz is a prominent urologist and medical director of Men's Health Melbourne, and will advise on R&D along with clinical development activities for Spontan and Roxus, whilst engaging with key international opinion leaders to expanding LTR's prescriber networks. Watch the video to hear more. This video was developed in collaboration with LTR Pharma, a Stockhead advertiser at the time of publishing. This video does not constitute financial product advice. You should consider obtaining independent advice before making any financial. Originally published as StockTake: LTR's new appointment rises to the occasion Stockhead The appointment of industry trailblazer Ashok Parekh underscores the company's commitment to leveraging deep expertise as it advances its gold projects. Stockhead Waratah Minerals has mobilised a third drill rig to its Spur gold-copper project in NSW, fuelled by a recent placement.
News.com.au
08-05-2025
- Health
- News.com.au
Break it Down: LTR Pharma develops new nasal spray for OMD's
LTR Pharma has joined forces with Strategic Drug Solutions to developed a nasal spray to treat oesophageal motility disorders.
Yahoo
28-02-2025
- Business
- Yahoo
Here's Why We're Not Too Worried About LTR Pharma's (ASX:LTP) Cash Burn Situation
Just because a business does not make any money, does not mean that the stock will go down. Indeed, LTR Pharma (ASX:LTP) stock is up 107% in the last year, providing strong gains for shareholders. But while the successes are well known, investors should not ignore the very many unprofitable companies that simply burn through all their cash and collapse. So notwithstanding the buoyant share price, we think it's well worth asking whether LTR Pharma's cash burn is too risky. For the purposes of this article, cash burn is the annual rate at which an unprofitable company spends cash to fund its growth; its negative free cash flow. We'll start by comparing its cash burn with its cash reserves in order to calculate its cash runway. See our latest analysis for LTR Pharma A company's cash runway is calculated by dividing its cash hoard by its cash burn. In December 2024, LTR Pharma had AU$34m in cash, and was debt-free. Importantly, its cash burn was AU$5.3m over the trailing twelve months. That means it had a cash runway of about 6.4 years as of December 2024. While this is only one measure of its cash burn situation, it certainly gives us the impression that holders have nothing to worry about. The image below shows how its cash balance has been changing over the last few years. In our view, LTR Pharma doesn't yet produce significant amounts of operating revenue, since it reported just AU$451k in the last twelve months. As a result, we think it's a bit early to focus on the revenue growth, so we'll limit ourselves to looking at how the cash burn is changing over time. Over the last year its cash burn actually increased by a very significant 78%. Oftentimes, increased cash burn simply means a company is accelerating its business development, but one should always be mindful that this causes the cash runway to shrink. LTR Pharma makes us a little nervous due to its lack of substantial operating revenue. We prefer most of the stocks on this list of stocks that analysts expect to grow. While LTR Pharma does have a solid cash runway, its cash burn trajectory may have some shareholders thinking ahead to when the company may need to raise more cash. Issuing new shares, or taking on debt, are the most common ways for a listed company to raise more money for its business. One of the main advantages held by publicly listed companies is that they can sell shares to investors to raise cash and fund growth. By looking at a company's cash burn relative to its market capitalisation, we gain insight on how much shareholders would be diluted if the company needed to raise enough cash to cover another year's cash burn. Since it has a market capitalisation of AU$109m, LTR Pharma's AU$5.3m in cash burn equates to about 4.9% of its market value. That's a low proportion, so we figure the company would be able to raise more cash to fund growth, with a little dilution, or even to simply borrow some money. It may already be apparent to you that we're relatively comfortable with the way LTR Pharma is burning through its cash. For example, we think its cash runway suggests that the company is on a good path. Although its increasing cash burn does give us reason for pause, the other metrics we discussed in this article form a positive picture overall. Looking at all the measures in this article, together, we're not worried about its rate of cash burn; the company seems well on top of its medium-term spending needs. Separately, we looked at different risks affecting the company and spotted 4 warning signs for LTR Pharma (of which 2 make us uncomfortable!) you should know about. Of course LTR Pharma may not be the best stock to buy. So you may wish to see this free collection of companies boasting high return on equity, or this list of stocks with high insider ownership. 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
