Latest news with #Syntara
News.com.au
13 hours ago
- Business
- News.com.au
Health Check: Biotechs rush to short-term funding fix
Advances on research and development tax incentives are proving a popular source of ancillary financing Audeara shares surge up to 36% on China deal Bell Potter halves its Syntara valuation With traditional equity fundraising conditions remaining patchy – albeit far from impossible – biotechs are flocking to short-term cash injections by way of research and development (R&D) cash advances. Specialist lenders advance the funds with the security of the borrower receiving the federal Research & Development Tax Incentive (RDTI). The RDTI compensates innovators with a 43.5% cash offset for every eligible dollar spent. The company repays the loans when it pockets this payment, which can be some months after the financial year in question. New lenders have sprung up to avail of the market opportunity, which applies not just to biotechs. Today, psychedelic drug developer Tryptamine Therapeutics (ASX:TYP) said it raised $2.6 million, by way of an R&D advance with Rockford Equity Pty Ltd. The funds will support the company's trial TRP-8803. This program uses intravenously infused psilocin to treat the difficult binge eating disorder. The company can elect to drawdown on the facility in $500,000 tranches, accruing interest of 16% per annum on the outstanding balance. The loan is secured by the company's expected R&D refund for the 2025-26 year. As of June 30, Tryptamine had cash of $3.03 million. Joining the rush Last month, Neurizon Therapeutics (ASX:NUZ) took out a $1.5 million advance with Radium Capital and Zelira Therapeutics (ASX:ZLD) availed of $650,000 from RH Capital Finance. In June, Chimeric Therapeutics (ASX:CHM) secured $2.5 million from Endpoints Capital. Other companies using R&D advances include AdAlta (ASX:1AD), Recce Pharmaceuticals (ASX:RCE), Adherium (ASX:ADR) and Noxopharm (ASX:NOX). The facilities don't preclude other fundraisings. Recce recently raised $15.8 million of equity and took out a $30 million non-R&D loan with Avenue Capital Group of the US. The funds will support Recce's Indonesian and local phase III trials of its synthetic antibiotic candidate. These studies are to treat diabetic foot and acute bacterial skin and skin structure infections. Investors all ears as Audeara pushes into China Audeara (ASX:AUA) has signed a deal to sell its hearing aid-style devices in mainland China, which has 1.3 million people and (roughly) double the number of ears. Audeara has developed headphones that adjust the volume and other levels to the wearer's individual profile, with the help of algo-based technology. Over the past two years, Audeara has tweaked its business model from selling its headphones in its own right, to providing the tech to big-ticket international customers. True to this strategy, the Middle Kingdom push is by way of a licensing agreement with a subsidiary of Taiwan's Eastech Holding Limited. The parties signed a letter of intent last September. The tie-up involves Audeara licensing its tech and provide engineering services to support the development of "advanced hearing devices". These gizmos will be sold under a third-party brand and distributed via a 'leading Chinese e-commerce hearing aid provider with national reach'. Audeara says China presents is a 'significant market opportunity', with about 426 million people affected by hearing loss. This figure is expected to reach 561 million by 2034 – 40% of the population. Whatever the case investors sure heard the news, with Audeara shares vaulting up to 35% this morning. Syntara is half the company it used to be Following Syntara's (ASX:SNT) FDA setback over the conduct of its proposed myelofibrosis trial, broker Bell Potter has halved its valuation of the company. This is nice symmetry, give Syntara shares yesterday halved on the grim tidings. The FDA has advised the company to carry out a placebo-controlled phase IIb trial, rather than skip to a pivotal phase II-III style effort. The agency wanted extra safety and efficacy data for Syntara's drug candidate amsulostat, which is intended to be used alongside the standard of care ruxolitinib. Bell Potter notes the extra trial means clinical development could take four to five years, compared with around three years for the original intended path. 'The upshot is amsulostat is now a phase IIb ready asset rather than phase III-ready,' the firm says. 'This does not at all diminish our view that the data reported to date from the phase IIa trial is highly compelling and strongly supportive of future development in myelofibrosis.' The firm values the stock at six cents compared with 12 cents previously and today's opening price of 2.8 cents. Syntara has other trials in myelodysplastic syndrome, skin scarring and a Parkinson's disease related disorder, but the market has focused on the myelofibrosis program. Other indications should be child's play for Mesoblast Broker Canaccord sees a big opportunity for stem-cell developer Mesoblast (ASX:MSB) to branch into other childhood immune-related diseases. In December the FDA approved Mesoblast's maiden product, Ryoncil for steroid-resistant peadiatric graft-versus-host disease. Mesoblast isn't currently running any other pediatric trials. But Canaccord says the company's mesenchymal stromal cells have a 'strong mechanistic rationale' in areas of high unmet need. This is especially the case when there are safety concerns. 'These include paediatric Crohn's disease, systemic juvenile idiopathic arthritis, or multisystem inflammatory syndrome in children, where standard of care immunosuppressants are often inadequate or carry significant toxicity risks.' About 56,000 US children have Crohn's disease and up to 20,000 of have failed standard therapies. The firm sees a Ryoncil opportunity of 7000-10,000 of these patients - a circa US$3 billion opportunity. Mesoblast launched Ryoncil in April and reported gross June quarter revenues of US$13.2 million. So far the company has signed up 20 transplant centres, with ten patients prescribed the therapy. 'Mesoblast has achieved 220 million covered US lives (commercial and government payers), with limited pushback," Canaccord says. The firm assumes peak sales at $206 million a year. This is based on a 50% market share at around US$1.4 million per patient. The firm values the stock at $2.97 a share a modest increment on the current $2.30 (ish). This estimate does not factor in the potential childhood indications. Mesoblast is working on an FDA approval application for adult heart disease variant. It also has an advanced lower back pain program.
News.com.au
2 days ago
- Business
- News.com.au
Health Check: Syntara shares plunge on FDA ‘do more trial homework' edict
Syntara shares tumble almost 50% after the FDA 'suggests' another trial Avita Medical looks to raise capital after a disappointing quarter EBR Systems is on track for limited US launch of its novel heart pacing device Shares in cancer drug developer Syntara (ASX:SNT) this morning lost almost half their value, after unfavourable advice from the US Food & Drug Administration (FDA). The agency has advised the company to do a placebo-controlled phase II trial, before proceeding with a proposed pivotal study for myelofibrosis. As any drug developer would attest, it's always a good idea to take the agency's counsel on board. The FDA wants a placebo-controlled trial to glean "additional safety and efficacy data'. Syntara says the trial should focus on improvements in symptoms and spleen volume reductions, 'in order to optimise the design and efficiency of a subsequent pivotal phase III trial'. Agency takes "conservative" approach CEO Gary Phillips today told investors the company only heard the news on Saturday and was still digesting the implications. 'The FDA has taken a more conservative approach to get the drug to approval,' he says. 'It's not the fast track we were looking for, but nonetheless their guidance is extremely helpful.' In effect, the company can't leapfrog to a planned phase II/III trial, enrolling up to 300 patients at a cost of around US$80 million. The company now is likely to carry out a 90-patient phase 2b study, probably with 60 on active treatment and 30 on placebo. Phillips estimates the cost 'in order of US$25 million', but the study would mean a subsequent phase III trial potentially could be smaller and cheaper. The FDA's stance does blow out the company's time lines, given the phase II effort would take 12 to 18 months to recruit. Ironically, the more circuitous path means lower short-term cash requirements: the company's $15 million should last into 2027, rather than mid 2026 as envisaged. 'The FDA has given us a different clinical path, but everything else around this asset remains the same,' Mr Phillips says. Promising early results The FDA mulled the interim data from Syntara's ongoing phase 1c/2 trial, which tests Syntara's amsulostat (SNT-5505) in combination with the standard-of-care ruxolitinib. Results to date from the open-label study suggest amsulostat 'may deliver deep and long-lasting benefit of patients who are sub optimally controlled by ruxolitinib alone'. Syntara values the myelofibrosis market at US$1 billion a year. Meanwhile, the company expects to release further results from the current open-label trial before the end of September. Reimbursement 'confusion' crimps Avita's sales Friday's poorer-than-expected June quarter result from Avita Medical (ASX:AVH) shows the burns and wounds care pioneer is lagging its revenue and earnings targets, with US reimbursement delays delaying sales from upgraded products. Avita has commercialised Recell for thermal burn wounds and full-thickness skin defects. Unlike other treatments, Recell harnesses the patient's own skin in a spray-on format. In May 2024 the FDA approved Recell Go, which has enhanced features for clinicians. The agency in December then approved Recell Go Mini, for smaller wounds of up to 480 square centimetres. Missing expectations In short, the US rollout has been slower than expected, partly because of reimbursement delays. Bell Potter suggests this resulted from confusion over administration of these payments, which saw physicians not getting paid. There's no Hell like a doctor not being remunerated and they reverted to alternative therapies including skin grafts. Avita posted June quarter revenue of US$18.2 million 20% higher year-on-year but flat on the March quarter tally. The numbers were around 16% below market expectations. June half revenue gained 35% to US$36.5 million. The company lost US$9.9 million in the quarter, compared with a US$15.39 deficit a year ago. Management has trimmed calendar 2025 guidance to US$76-81 million, from the previously guided US$100-106 million. The tally is 19-27% higher year on year. Balance sheet concerns As of June 30, Avita had cash and equivalents of US$15.7 million. It also has a US$40 million debt facility, from specialist lender Orbimed Advisors. The company has won a series of waivers its debt covenants, relating to minimum quarterly and annual revenue. But Avita must continue to maintain a minimum US$10 million of cash. In a 'going concern' note to the accounts, management says that 'absent any mitigating action, the company probably won't be able to comply with a minimum cash balance covenant within the next 12 months. 'The company is actively evaluating strategies to obtain the required additional funding for future operations. This includes an equity raising.' Broker Morgans says 'despite a significant shortfall in sales, Avita successfully rolled through cost-base reductions as planned, decreasing the net loss with more to come in ." Nonetheless, "another missed guidance target is unlikely to reassure investors, and it is now evident that additional capital will be necessary to support the company to profitability.' Rating the stock a 'speculative buy', Morgans forecasts a calendar 2025 loss of US$36.5 million, improving to a US$18.1 million deficit in 2026. Avita then cracks a US$5.6 million profit in 2027. Morgans assumes a US$50 million equity raising. Bell Potter believes the administrative 'confusion' resulted in a 20% drop in demand for Recell over the half – a 'material circa $5 million in lost revenues over the top 10 accounts alone'. The firm says Medicaid patients account for 70-75% of Recell volumes, 'hence it is critical that the matter is resolved without further delay'. Avita shares have tumbled close to 20% since Thursday's close and have lost about two-third of their value since the start of the year. EBR Systems readies US rollout Following a pilot stage, EBR Systems (ASX:EBR) is on track to roll out its novel heart device in the US market in the December quarter. In April the FDA approved WISE, the world's first and only leadless pacing system for heart failure. Addressing a Canaccord Genuity conference in Boston, EBR CEO John McCutcheon said the company would focus on 'strategic' hospitals. Crucially, in October EBR won reimbursement for both inpatient and outpatient settings, at up to US$63,300 per procedure. EBR cites an 'initial addressable market' in the US of US$3.6 billion. In early June EBR announced its first commercial implants, at St David's Medical Centre in Texas and the Cleveland Clinic.
News.com.au
23-06-2025
- Business
- News.com.au
Health Check: It's ‘nothing personal' as major US biotech fund calls time on Syntara
San Francisco's BVF Partners has exited all its ASX investments because they are too small for the fund's mandate Alcidion shares soar 15% on earnings upgrade Optiscan enters 'win-win' supplier collab Syntara (ASX:SNT) CEO Gary Phillips says the exit of a long-term US backer should not be seen as a judgment on the company's late-stage myelofibrosis drug program. In a block trade the San Francisco BVF Partners has disposed of its $5 million, 6%, Syntara stake. The shares were taken up by some of Syntara's existing institutional holders. BVF's exit last week sent Syntara shares down by 25%, despite the company's previous Friday's positive update on its phase II myelofibrosis trial update. Phillips says the trial news created a 'liquidity event' which BVF availed of. But it was not a case of BVF (as in Biotech Value Fund) spurning Syntara's drug program. Rather, the fund grew to the extent where it can't justify a minimum investment below US$30-50 million. 'They always liked our science,' Phillips says. 'They have visited our labs and were always encouraged, but they just got bigger and bigger.' With US$9 billion of assets, BVF has called time on all its ASX investments. In May BVF divested its $3 million in Actinogen Medical (ASX:ACW), also via a block trade. The fund had also invested in Opthea (ASX:OPT), but got off before the eye drug developer's' trials went pear shaped. BVF also invested in immune-oncology drug developer Viralytics, famously taken over by Merck for an eyebrow-raising $500 million in 2018. Syntara's blood cancer program looks the goods Syntara's 'liquidly event' stemmed from further data from its phase II myelofibrosis trial, evaluating its drug candidate SNT-5505 in combo with the standard-of-care drug ruxolitinib. The patients had been treated with ruxolitinib, so had symptoms such as enlarged spleen size and blood counts 'indicative of high disease burden'. The results showed eight of 11 evaluable patients (73%) achieved a reduction of more than 50% at 24 weeks, as measured by a standard gauge called TSS50. Four out of nine patients (44%) had a spleen volume reduction of 25% at week 24 or beyond. The ongoing trial enrolled 16 patients with intermediate or high-risk myelofibrosis, for 52 weeks of treatment. However, five dropped out by the 24-week mark. This is a 'withdrawal rate consistent with that seen in other myelofibrosis studies of patients with similar disease severity." Eight patients reaching 38 weeks showed and average 56% reduction in symptoms, while five reaching 52 weeks exhibited a 63% decline. Syntara intends to chat with the FDA in the September quarter about the design of a pivotal phase 2c/3 study. Too much of a good thing for Immutep? With four trial updates on separate programs in less than two months, immunology drug play Immutep (ASX:IMM) must also feel underappreciated. Immutep stock has fallen around 10% in this period and trades at close to five-year lows, despite the upbeat clinical vibes. Too much activity from the multi-tentacled Immutep confusing investors, perhaps? Today, Immutep said a phase I autoimmune study showed 'significant T-cell suppression', thus highlighting potential efficacy of its candidate IMP-761. Initial data from placebo-controlled, double-blinded effort also showed good safety at the highest dosing level to date. By stimulating the LAG-3 (lymphocyte-activation gene-3) agonist antibody, IMP-761 promises to treat conditions including rheumatoid arthritis, Type 1 diabetes and multiple sclerosis. Since May 5 Immutep also has updated investors on its head and neck cancer, lung cancer and soft tissue sarcoma trials. Miya My! Alcidion has upgraded earnings Hospital patient management software supplier Alcidion (ASX:ALC) has upped its full-year earnings outlook, with strong take-up of its flagship Miya prompting clients to adopt its broader wares. 'Over the past few months this has resulted in several customers of varying size seeking extensions or module upgrades," CEO Kate Quirke says. "This has contributed to our improved financial position." Having guided to earnings before interest, tax depreciation and amortisation of $3 million, the company now expects the number to exceed $4.5 million (for the year to June 30 2025). The company earlier guided to revenue of at least $40 million. Alcidion provides to more than 400 hospitals and 87 healthcare organisations in the UK, here and New Zealand. In the UK, the most capacious market, the beloved National Health Service (NHS) is being merged with Department of Health and Social Care. This poses both threat to – and opportunities for – Alcidion, given it sells to NHS organisations. In April, Quirke said the push for more NHS productivity with fewer staff was likely to mean greater demand for Alcidion's digital platforms. 'I see the opportunity increasing,' she said. 'But we are waiting to see what the ten-year plan indicates in terms of where the priority areas are.' PYC gets FDA OK PYC Therapeutics (ASX:PYC) has provided evidence that the FDA continues to function, with the agency approving the company's proposed trial design at a preliminary (Type B) meeting. The company currently is undergoing a phase 1-2 trial of its drug candidate VP-001, to treat the blinding eye disease retinitis pigmentosa type 11 (RP11). With positive data to date, PYC wants to progress to a phase2/3 study pitched at FDA approval. The FDA says PYC can use similar endpoints and says trial design features (such as use of a sham arm and inclusion exclusion criteria) are OK as well. The company will use this guidance to finalise its proposed registrational study design. Tryptamine study aims to put binge eating disorder to BED Meanwhile, Tryptamine Therapeutics (ASX:TYP) has won ethics approval for the world's first trial, to test intravenously infused psilocin for binge eating disorder (BED). BED is the most common eating disorder in the US and second most common here. BED results in multiple other conditions including depression, anxiety, PTSD (post-traumatic stress disorder) and compulsive behaviours. A collaboration with Swinburne University, the local trial will enrol 12 patients and administer them with with Tryptamine's drug candite TRP-8803. They will be given two doses 14 days apart and also undergo psychotherapy. The trial has started recruiting, with first dosing expected in the September quarter. Investors can expect top-line results before the year is out. The good OIL on a 'win-win' collab Optiscan (ASX:OIL) has entered a five-year collaboration agreement with the US based Long Grove Pharmaceuticals, which provides a contrast agent for Optiscan's fluorescence-based endomicroscopic imaging systems. The idea of the collab is to use Long Grove's fluorescein drug, AK-FLUOR, with Optiscan's imaging technology in clinical studies. This potentially will identify new applications for the drug and expedite regulatory submissions. On the Optiscan side of things, the data should support the company' efforts to win FDA approval for its Invue device. Invue enables surgeons to gain real-time pathology insights and make on-the-spot decisions. Optiscan CEO Dr Camile Farah dubs the agreement a 'clear-cut win-win for both companies' development strategies'.
Yahoo
19-04-2025
- Business
- Yahoo
We Think Syntara (ASX:SNT) Needs To Drive Business Growth Carefully
There's no doubt that money can be made by owning shares of unprofitable businesses. By way of example, Syntara (ASX:SNT) has seen its share price rise 240% over the last year, delighting many 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. Given its strong share price performance, we think it's worthwhile for Syntara shareholders to consider whether its cash burn is concerning. 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. Let's start with an examination of the business' cash, relative to its cash burn. We've discovered 4 warning signs about Syntara. View them for free. A company's cash runway is calculated by dividing its cash hoard by its cash burn. As at December 2024, Syntara had cash of AU$18m and such minimal debt that we can ignore it for the purposes of this analysis. In the last year, its cash burn was AU$14m. That means it had a cash runway of around 16 months as of December 2024. That's not too bad, but it's fair to say the end of the cash runway is in sight, unless cash burn reduces drastically. Depicted below, you can see how its cash holdings have changed over time. See our latest analysis for Syntara Although Syntara reported revenue of AU$8.2m last year, it didn't actually have any revenue from operations. To us, that makes it a pre-revenue company, so we'll look to its cash burn trajectory as an assessment of its cash burn situation. With the cash burn rate up 22% in the last year, it seems that the company is ratcheting up investment in the business over time. However, the company's true cash runway will therefore be shorter than suggested above, if spending continues to increase. Clearly, however, the crucial factor is whether the company will grow its business going forward. So you might want to take a peek at how much the company is expected to grow in the next few years. While Syntara 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. Generally speaking, a listed business can raise new cash through issuing shares or taking on debt. One of the main advantages held by publicly listed companies is that they can sell shares to investors to raise cash and fund growth. We can compare a company's cash burn to its market capitalisation to get a sense for how many new shares a company would have to issue to fund one year's operations. Syntara has a market capitalisation of AU$83m and burnt through AU$14m last year, which is 16% of the company's market value. As a result, we'd venture that the company could raise more cash for growth without much trouble, albeit at the cost of some dilution. On this analysis of Syntara's cash burn, we think its cash burn relative to its market cap was reassuring, while its increasing cash burn has us a bit worried. Even though we don't think it has a problem with its cash burn, the analysis we've done in this article does suggest that shareholders should give some careful thought to the potential cost of raising more money in the future. On another note, we conducted an in-depth investigation of the company, and identified 4 warning signs for Syntara (2 are potentially serious!) that you should be aware of before investing here. If you would prefer to check out another company with better fundamentals, then do not miss this free list of interesting companies, that have HIGH return on equity and low debt or this list of stocks which are all forecast to grow. 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
