Latest news with #Dimerix
News.com.au
11 hours ago
- Business
- News.com.au
Closing Bell: ASX arrests slide to fall just 0.2pc as utilities sector leads recovery
ASX pulls back from 0.55pc slide to dip 0.21pc Utilities leads recovery, up 0.74pc ASX All Ord Gold index climbs 0.62pc ASX pulls out of tailspin to make up ground While the ASX closed lower today, down 0.21%, it was looking a lot worse around lunchtime, when the bourse was 0.55% in the red. The market managed to put the breaks on its slide, with the utilities (+0.74%) sector in particular providing support, followed by industrials, health care and info tech. Standouts in those sectors included Dimerix (ASX:DXB) up 9.8%, ZIP Co (ASX:ZIP) adding 5.9%, Droneshields (ASX:DRO) up 5.6% and Fluence Corporation (ASX:FLC) jumping 13.8%. The ASX All Ord Gold index (+0.62%) also put in some work, alongside the Small Ords (+0.19%). The ASX lost 0.49% over the last five trading days, now sitting 1.55% off its 52-week high. ASX SMALL CAP LEADERS Today's best performing small cap stocks: Security Name Last % Change Volume Market Cap PV1 Provaris Energy Ltd 0.015 50% 3831208 $6,980,013 E79 E79Goldmineslimited 0.028 40% 2009033 $3,168,253 MOH Moho Resources 0.004 33% 5000 $2,236,242 RNX Renegade Exploration 0.004 33% 521227 $3,865,090 HAW Hawthorn Resources 0.068 28% 634353 $17,755,827 BMO Bastion Minerals 0.002 27% 22379119 $1,419,960 NSB Neuroscientific 0.078 26% 991242 $8,965,502 ALM Alma Metals Ltd 0.005 25% 807408 $6,345,381 AUK Aumake Limited 0.0025 25% 176755 $6,046,718 CUL Cullen Resources 0.005 25% 183700 $2,773,607 FIN FIN Resources Ltd 0.005 25% 100000 $2,779,554 GGE Grand Gulf Energy 0.0025 25% 1458526 $5,640,850 JAV Javelin Minerals Ltd 0.0025 25% 651325 $12,252,298 MEM Memphasys Ltd 0.005 25% 1004099 $7,934,392 HCL Highcom Ltd 0.295 23% 641196 $24,643,841 HAR Harangaresources 0.065 20% 4915026 $11,585,428 MCA Murray Cod Aust Ltd 1.045 20% 124393 $92,023,850 AJL AJ Lucas Group 0.006 20% 356600 $6,878,648 TON Triton Min Ltd 0.006 20% 2099975 $7,841,944 HIQ Hitiq Limited 0.02 18% 3191499 $6,885,382 BAS Bass Oil Ltd 0.027 17% 2429874 $7,345,899 AHN Athena Resources 0.007 17% 6103136 $13,595,742 BGE Bridgesaaslimited 0.014 17% 61111 $2,398,310 NAE New Age Exploration 0.0035 17% 50877 $8,117,734 PGY Pilot Energy Ltd 0.007 17% 4218242 $12,951,960 Making news… Hydrogen compression and shipping solution company Provaris Energy (ASX:PV1) has teamed up with global shipping leader 'K' LINE. K LINE, otherwise known as Kawasaki Kisen Kaisha, will provide technical, commercial and operation support, offering its extensive global shipping expertise as PV1 develops its hydrogen transport and storage model. PV1's main focus is the proprietary H2Neo Carrier and H2Leo Barge, which offer a combination of offshore compression, storage and shipping solutions for hydrogen gas transportation. Bastion Minerals (ASX:BMO) has tapped John Ribbons as company secretary, effective immediately. The appointment follows the resignation of Justin Clyne, who exits on good terms with the board and will make himself available during the transition. Ribbons will fill dual roles, as he already holds the position of chief financial officer for BMO as well. ASX SMALL CAP LAGGARDS Today's worst performing small cap stocks: Security Name Last % Change Volume Market Cap RPG Raptis Group Limited 0.044 -73% 2637660 $56,109,577 CT1 Constellation Tech 0.001 -50% 1542725 $2,949,467 BCB Bowen Coal Limited 0.18 -49% 2933425 $37,715,145 BEL Bentley Capital Ltd 0.008 -33% 7852 $913,535 ENT Enterprise Metals 0.002 -33% 2756 $3,543,952 FTC Fintech Chain Ltd 0.002 -33% 530785 $1,952,309 PKO Peako Limited 0.002 -33% 2925298 $4,463,226 RLC Reedy Lagoon Corp. 0.001 -33% 135000 $1,165,060 SHP South Harz Potash 0.002 -33% 310000 $3,308,186 ADD Adavale Resource Ltd 0.0015 -25% 186313 $4,574,558 AFA ASF Group Limited 0.003 -25% 79842 $3,169,590 ASR Asra Minerals Ltd 0.0015 -25% 577297 $7,983,396 EEL Enrg Elements Ltd 0.0015 -25% 16582818 $6,507,557 VFX Visionflex Group Ltd 0.0015 -25% 199999 $6,735,721 HPC Thehydration 0.01 -23% 4074374 $4,982,912 WEC White Energy Company 0.035 -20% 212 $13,711,276 EXT Excite Technology 0.008 -20% 2685646 $20,726,419 MTB Mount Burgess Mining 0.004 -20% 409514 $1,758,513 OEL Otto Energy Limited 0.004 -20% 3458960 $23,975,049 SKK Stakk Limited 0.004 -20% 5016 $10,375,398 VRC Volt Resources Ltd 0.004 -20% 1463043 $23,423,890 ODY Odyssey Gold Ltd 0.019 -17% 5122049 $20,674,036 GUL Gullewa Limited 0.068 -17% 420322 $17,877,818 HMG Hamelingoldlimited 0.069 -17% 66142 $16,340,625 AMS Atomos 0.005 -17% 1700232 $7,290,111 In the news... Bowen Coking Coal (ASX:BCB) has signalled it's considering placing the Burton Mine Complex operation into a temporary pause if an effort to transition the project to an owner-operator model is unsuccessful. The company is exploring a range of options to fund the transition plan and provide immediate liquidity, but the most recent Resources and Energy Quarterly forecasts falling demand for met coal as low emissions steel production gains pace. Atomos (ASX:AMS) has launched a new employee incentive plan, with over half of the company's roll to be offered defined annual bonuses linked to share price performance. AMS says the incentives are a way to recognise the contributions of staff who worked tirelessly on minimal salaries over the last few years, and aligns employee interests with those of shareholders. IN CASE YOU MISSED IT Pure Hydrogen Corporation (ASX:PH2) has completed the handover of a Taurus hydrogen fuel cell prime mover to Barwon Water, Victoria's largest regional urban water corporation. Legacy Minerals (ASX:LGM) has wrapped up its first drilling campaign at the Thomson project, intersecting wide zones of quartz-sulphide mineralisation. Cyclone Metals' (ASX:CLE) power study has highlighted potential to power the Iron Bear project entirely with renewable energy. TRADING HALTS AIC Mines (ASX:A1M) – cap raise betr Entertainment (ASX:BBT) – off-market takeover offer for PointsBet GBM Resources (ASX:GBZ) – cap raise and board changes Great Boulder Resources (ASX:GBR) – cap raise New Murchison Gold (ASX:NMG) – Crown Prince project approvals update Victory Metals (ASX:VTM) – strategic alliance and funding facility Zenith Minerals (ASX:ZNC) – resource update for Dulcie Far North gold project LAST ORDERS Hillgrove Resources (ASX:HGO) is ahead of schedule on development efforts at the Nugent underground, hitting the orebody at the Kanmantoo copper mine earlier than expected. It's the first development ore produced at the Nugent underground operation, marking an important milestone toward formal ore production.
News.com.au
06-06-2025
- Business
- News.com.au
Scott Power: ASX health stocks dip but it was a good news week for EMVision
ASX health stocks dipped 0.82% over the past five days while the broader market has risen 1.26% EMVision appoints Ramsay Health Care CEO to board and expands sites of pivotal trial First Japan site opens for Dimerix's phase III clinical trial of DMX-200 in rare kidney disease Healthcare and life sciences expert Scott Power, who has been a senior analyst with Morgans Financial for 27 years, gives his take on the ASX healthcare sector for the week and his 'Powerplay' stock pick. Power said that, while healthcare markets were down this week, broader markets remained elevated with things starting to look more positive at the halfway mark of a thus-far volatile 2025. US President Donald Trump's trade and health policies have been impacting the sector throughout the year. At about lunchtime on Friday the S&P/ASX 200 Health Care index was down 0.82% for the past five days, while the benchmark ASX 200 rose 1.26% for the same period. "The broader market is up this week and May was a reasonably good month," he said. "We are coming up to June 30 and the end of financial year so there will be some tax-loss selling coming through across various portfolios. "June tends to be a weaker month as investors look to clean up their portfolio, while July seasonally tends to be a stronger month and there is potentially some good value out there across the smaller names which really haven't done too much for the last couple of years." Ramsay CEO joins EMVision board, trial expands EMVision Medical Devices (ASX:EMV) has had two major announcements this week including the appointment of Ramsay Health Care (ASX:RHC) CEO Carmel Monaghan as non-executive director and broadening of a pivotal trial for its emu bedside brain scanner, which is designed to rapidly diagnose stroke. Monaghan has worked across hospital, corporate and global positions at Ramsay for almost three decades. "She is highly regarded and will bring a lot of credibility and contacts into the business," Power said. He said EMvision was also making good progress with the activation of its third US site, Mount Sinai Hospital in New York, scheduled for this month. Activation of its second Australian site, Liverpool Hospital in Sydney, has also been in progress this week. Five world-leading hospitals in stroke care are now taking part in EMVision's pivotal trial with a sixth set to be activated shortly. The pivotal (validation) trial is designed to support US Food and Drug Administration (FDA) de novo (new device) clearance of the emu point-of-care brain scanner device. "The expectation is that they will get approval sometime in 2026," Power said. Power's Powerplay: Big year for Dimerix Dimerix (ASX:DXB) is Power's stock of the week after announcing it had opened the first trial site in Japan for its ACTION3 phase III drug candidate DMX-200 to treat focal segmental glomerulosclerosis (FSGS) kidney disease. Opening of Japan's first clinical trial site for ACTION3 triggers the first development milestone payment of ¥400 million (~A$4.3m) to Dimerix from FUSO Pharmaceutical Industries Ltd, its exclusive licensee of DMX-200 for FSGS in Japan. FUSO is one of four regional licensing deals executed for DMX-200, which collectively provide up to ~$1.4bn in total upfront payments and potential milestone payments, plus royalties on net sales. FSGS is a serious kidney disease that causes progressive scarring, leading to permanent damage and, ultimately, end-stage kidney failure – often requiring dialysis or a transplant. It affects adults and children and no treatments are currently approved specifically for the condition anywhere in the world, affecting overall prognosis. As a result, DMX-200 has received orphan drug designation in both the US and Europe, along with the UK's equivalent designation under the Innovative Licensing and Access Pathway (ILAP). Dimerix last year reported positive interim results from the ACTION3 trial, showing DMX-200 was performing better than placebo in reducing proteinuria with no safety concerns to date. Full enrolment in the ACTION3 study is expected by the end of 2025 with a further blinded interim analysis planned. "It's going to be a big year for Dimerix," Power said. Mayne Pharma takeover deal far from over Adelaide-headquartered pharmaceutical company Mayne Pharma (ASX:MYX) is continuing to do battle with its US-based suitor Cosette Pharmaceuticals after announcing on Wednesday it had received a notice "purporting to terminate" the $7.40 per share offer worth more than $600 million. The withdrawal comes after Cossette asserted that a "material adverse change" had occurred, and consequently freeing Cosette from its obligations under the scheme implementation deed (SID). The announcement sent the stock lower and came hours after Mayne put out another one telling the market it had not received a notice of termination, which sent its shares higher. On Thursday Mayne put out another announcement saying the scheme meeting would go ahead on June 18, as scheduled with the stock rising more than 7%. "Mayne Pharma directors continue to unanimously recommend that vote in favour of the scheme resolution at the scheme meeting, in the absence of a superior proposal," said chairman Frank Condella. However, the company needs a court decision to affirm its view that the "material adverse change" were not, in fact, material. "There is a fair bit more water to flow under the bridge with this one and it just looks very messy at the moment," Power said. ReNerve enters partnership to expand product range Biotech company ReNerve (ASX:RNV) this week announced it had entered a strategic partnership with US-based Berkeley Biologics LLC to develop and commercialise two new complementary tissue-based product ranges. The first range addresses the need for human dermal tissued, deeper layers of the skin often sourced from donors. The second product range will provide amniotic tissue products, which are known for their regenerative and healing properties. The products are set to be produced at Berkeley Biologics' California facility and launch before the end of CY25. ReNerve said the new products represent a natural extension of its existing sales activities, leveraging the same sales network and continuing to target the same surgeon and hospital customer base. The company said surgeons could incorporate additional tissue grafts when treating nerve injuries, enabling them to address both the damaged nerve and any associated trauma. "It is a strong indication that they're trying to build their sales momentum by expanding the product offering to the surgeons," Power said. "Sales are expected to grow over subsequent quarters." The views, information, or opinions expressed in the interview in th is article are solely those of the interviewee and do not represent the views of Stockhead. Stockhead has not provided, endorsed or otherwise assumed responsibility for any financial product advice contained in this article.
News.com.au
03-06-2025
- Business
- News.com.au
Health Check: Don't dis-May! ASX biotechs record strong year-on-year share gains
Medadvisor and Dimerix lead the valuation gains in a choppy month Emvision and Paradigm open more pivotal trial sites Capital raisings click over MedAdvisor (ASX:MDR) is the ASX hero biotech of an otherwise subdued May, stacking on more than 52% in market capitalisation for the month. The medication compliance group said it had found a probable buyer for its Australian operations, thus spurring the rally. This supersized effort eclipsed Dimerix's (ASX:DXB) 24% surge, on the back of its May 1 news of a US distribution deal for its putative kidney disease drug. The numbers are based on Biotech Daily's top 40 index, which records the performance of the biggest stocks. The newsletter also recorded the Big Four – CSL (ASX:CSL), ResMed (ASX:RMD), ProMedicus (ASX:PME) and Cochlear (ASX:COH) – separately. Overall, the top 40 eased 2.6%, with Avita Medical (ASX:AVH) leading the decliners with a 40% tumble and Imugene (ASX:IMU) shedding 37%. shares lost 6%, translating to $555 million of lost value. Don't dis-May But don't dis-May too much: the sector's still up 9.7% year on year, just eclipsing the overall market's 9.5% increment. The Big Four gained 2.6%, thanks to Pro Medicus's 21% rebound from subdued levels. Investors had to go beyond the top 40 for the best return: pot and psychedelic drug play Incannex Healthcare (ASX:IHL) climbed 300 per cent, albeit having plunged 80% in April. We're doing better than our American friends, with the Nasdaq Biotechnology Index shedding 4.2% for the month. The index is also down 7% over the past 12 months. On trial In trial news, EMvision Medical Devices (ASX:EMV) is poised to activate its third US site in its pivotal trial of its bedside stroke detection device, Emu. The site is at The Mount Sinai Hospital in New York, a recognised leader in stroke research and treatment. The company is activating its second Australian site this week, at Sydney's Liverpool Hospital (a large stroke referral centre). These activations will bring the total of sites activated in the pivotal (validation) trial to five. These include Houston's UTHealth and Memorial Hermann-Texas Medical Centre, Mayo Clinic in Jacksonville and the Royal Melbourne Hospital. The study aims for US Food & Drug Administration (FDA) clearance for Emu, under the new device route. Knees up Paradigm Biopharmaceuticals (ASX:PAR) has activated the first of 11 proposed sites, for the local leg of its phase III knee osteoarthritis trial. Melbourne's Sportsmed Biologic is the first site, with the treatment overseen by prominent sports physician Dr Philip Bloom. The other sites are in 'various stages of start-up and activation'. Meanwhile, 48 sites are in advanced preparation stages. The study is pitched at FDA approval for Paradigm's repurposed drug candidate, to treat the common and debilitating condition. Capital-raising corner While finding a dime in the sector remains difficult, companies are managing decent smaller raisings. Shrugging off its US reimbursement setback, Pacific Edge (ASX:PEB) today upsized its NZ$15 million placement to NZ$16 million, with the board accepting oversubscriptions. A NZ$5 million share purchase plan (SPP) is yet to come. The offer is priced at NZ10 cents a share, a healthy 20% premium to the 20-day weighted average price. The raising is partly to grow sales channels for its non-invasive bladder cancer assay Cxbladder, independent of US Medicare reimbursement. Pacific Edge's Medicare coverage ceased in April, after a code pertaining to genetic oncology testing was excised. Not surpisingly, the company wants to re-gain this funding via legal and other means of suasion. Also today, Recce Pharmaceuticals (ASX:RCE) said it had placed a $7.4 million shortfall from its recent entitlement offer. This takes total proceeds from its capital raising to $15.8 million. The funds will support the synthetic anti-infective outfit's phase III trials, in Indonesia and locally. The Indonesian study treats diabetic foot infections, while the local effort is for acute bacterial skin and skin structure infections. Meanwhile heart device play Cardiex (ASX:CDX) has raised $2.4 million in an insto placement at 4 cents a share, with a $4.1 million rights issue opening on Friday. And OncoSil Medical (ASX:OSL) has raised $6.7 million in a placement and hopes an SPP will reap another $2 million. The price is one-third of a cent, a circa 20% discount. The funds will support the Oncosil's eponymous pancreatic cancer targeted radiation device. Thirty geographies have approved the tool, including Europe and the UK. Best of British biotech Data analytics house Global Data reports that venture financing for UK biopharmaceutical companies doubled in the March quarter, to US$1.1 billion. This is the highest quarterly total since 2021. This foreign investment surge also highlights danger for the Brit 'Growing dependence on US capital and policy-driven cost pressures signal an urgent need to strengthen domestic investment for sustainable growth.'
News.com.au
22-05-2025
- Business
- News.com.au
Health Check: ‘Forgotten' drug maker AFT Pharma aims high with revenue
AFT Pharmaceuticals boosts revenue, but profits still lag Telix Pharmaceuticals chair and CEO reflect on a prosperous 2024 – and promise more riches to come Dimerix's pivotal trail passes another safety check The bourse's 'forgotten' drug maker, Kiwi-based AFT Pharmaceuticals (ASX:AFP) is confident of reaching its 'aspirational' target of $NZ300 million ($270 million) of revenue within the next two years. This comes after the company posted a record turnover of $NZ208 million for the year to March, up 6%. 'AFT is well positioned to achieve this target,' said CEO and co-founder Dr Hartley Atkinson. 'While the global trading environment is looking more difficult, we are confident that we can continue to overcome these challenges by focusing on what we do best.' 'What we do best' is identifying unmet needs and then in-licensing or developing medicines to commercialisation. Often these are drugs for conditions overlooked by big pharma. AFT reported operating profit came in at NZ$17.6 million, as per guidance but down 27% year on year. Net profit declined 23% to NZ$12 million. The company said its performance was crimped by some significant 'one off' events flagged in the first half. These included destocking by customers and the prolonged doctors' strike in South Korea. Bulging medicine cabinet AFT's products cover everything from pain, eyecare, dermatology, gut disorders, medicated vitamins and hospital injectables. The company's best sellers are Maxigesic – a paracetamol and ibuprofen combination – and Hylo eye drops. Atkinson says AFT has 'significantly advanced' its push into multiple geographies and expanding its research and development pipeline. 'These efforts have come at the cost of short-term earnings growth, but we are convinced they will deliver growth in long term shareholder value.' During the year AFT launched Maxigesic tablets in the US, having already introduced the intravenous version. AFT also launchd proprietary antiseptic cream in mainland China, the world's second biggest pharma market behind the US. Atkinson cites a pipeline of injectable drugs with a potential market value of over US$400 million. 'I am confident … AFT has reached an inflexion point and can further extend its decades long record for growth and value creation,' Atkinson says. That said, some investors would like earnings to grow at a faster clip. Telix says 2024 was big, 2025 will be bigger Eight years ago, Telix Pharmaceuticals (ASX:TLX) was merely a gleam in the eye of co-founder Dr Chris Behrenbruch, who convinced former Macquarie Banker Kevin McCann to chair the fledgling business. At yesterday's AGM, the board revelled in the progress of Telix, which recorded revenue of $800 million in calendar 2024. This was on the back of the company's flagship prostate cancer imaging agent, Illuccix. 'Last year I stood at this same lectern and said that 2024 would be the biggest year yet for Telix, and that proved to be the case,' Behrenbruch told the gathered faithful. 'I make a similar prediction again for 2025, as we continue to execute on our strategy and continue the momentum we've built.' The US aside, regulators in the UK, several European countries and Brazil have also approved Illucix. 'The Telix brand now stretches as far as the tropical heat of Rio de Janeiro to the wintry climes of Scandinavia,' said McCann, whose literary flourish can be excused given he retired at the meeting. While most of Telix's revenue derives from Illucix, the company has also commercialised Gozellix (also for prostate cancer imaging) and a lesser-known offering called Scintimun (for imaging bone infections). The company awaits an FDA decision on approving its kidney cancer imaging agent on or before August 27. Telix's holy grail is to develop therapeutic – as opposed to imaging – products. 'We have one of the deepest therapeutic radiopharmaceutical pipelines in the industry,' Behrenbruch said. 'We are poised to have three assets in pivotal trials by the end of this year, comprised of our lead prostate, kidney and brain cancer therapy candidates.' Re-doing the homework Not everything has gone Telix's way, with the FDA last month knocking back the company's US marketing approval application for its brain cancer imaging agent, Pixclara. The FDA issued complete response letter, which demands that an applicant do more homework. Behrenruch said the company met with the FDA to glean what is required. 'At this stage, we believe resubmission in 2025 is achievable,' he said. Behrenbruch adds Telix has focused on developing its supply of isotopes, which need to be manufactured close to the patient. 'As most investors understand by now, there is no 'magic isotope store in the sky' and no 'man with a van' that turns up with a product,' he said. 'Radiopharma is a logistically and supply-chain intensive field of medicine. "The network of capabilities that we have built – and bought – is critical for the reliable delivery of just-in-time manufactured products like ours.' Manufacturing in the US – where most of Telix's patients currently reside – has a flow-on benefit of 'managing the risk of tariffs and other trade barriers affecting the supply and cost of our products.' As of the end of March, Telix had cash of $710 million. Given the company has set a minimum cash buffer of US$100m ($156 million), that implies plenty more firepower for acquisitions or shareholder returns. Dimerix trial passes safety audit – again Long-running and expansive trials are all about the little moments along the way – and Dimerix (ASX:DXB) has chalked up another one with its pivotal phase III kidney disease study. In its sixth review of the trial, the US-based Independent Data Monitoring Committee (IDMC) recommends the trial, dubbed Action3, continue unchanged. 'The IDMC has again noted no safety concerns to date, consistent with their prior reviews and the existing and emerging strong safety profile of (the drug candidate) DMX-200,' the company says. The IDMC will take another peek in the December quarter. DMX-200 tackles the rare kidney disease focal segmental glomerulosclerosis, for which there is no effective treatment. Meanwhile, Blinklab (ASX:BB1) has secured its first clinical site for its pivotal trial of its autism detection algorithm, pitched at FDA approval. The company has enrolled 100 patients in the initial stage, with an additional 750 to 900 participants undergoing testing thereafter. The first site is the Arizona based Southwest Autism Research & Resource Center. Blinklab expects to be able to file an FDA submission in the March quarter of next year, using the 510(k) route.
News.com.au
12-05-2025
- Business
- News.com.au
Dr Boreham's Crucible: The wheels keep turning for Dimerix and its kidney drug candidate
As a former bus driver, Dimerix (ASX:DXB) CEO Dr Nina Webster knows that the drug development journey is just as important as the destination when it comes to delivering value to shareholders. The therapeutic trip can be painfully long, especially when investors are in the back street screaming: 'are we there yet'? The developer of a drug for a rare kidney disease, Dimerix is out of the depot and down the road. But with the results of its phase III trial not due for some years, the company needs to navigate a few more twists and turns. At least it's keeping the kids in the back – er, shareholders – entertained with some scenic road stops and ice cream along the way. Last week, Dimerix shares rocketed after the company announced its fourth – and largest – geographic partnership, with the Nasdaq-listed rare diseases house Amicus Therapeutics. The deal delivers US$30 million ($48 million) upfront to Dimerix, with the potential for up to US$520 million of success-based payments. That's a lot of Choc Wedges. Dimerix CEO Dr Nina Webster dubs the deal as 'likely to be one of the biggest in the history of Australian biotech'. Who are we to argue? 'We are absolutely thrilled to be partnering with Amicus,' she adds. The four deals have delivered $66.5 million in upfront cash, with $1.4 billion of potential milestones – payable mainly when the company reaches its destination of US Food and Drug Administration (FDA) approval (see 'finances and performance'). But what's the point of the journey? Dimerix is developing its lead compound, DMX-200, for the rare and regressive kidney disease focal segmental glomerulo-sclerosis (FSGS). FSGS attacks the kidney's filtering units – glomeruli – causing irreversible scarring and permanent kidney damage. Kidney failure typically happens within five years of diagnosis, with 60 % of patients receiving a transplant experiencing recurring FSGS. With no other disease-specific treatment available, the FDA has accorded the condition orphan drug designation. This confers benefits such as marketing exclusivity, higher prices and other regulatory leg-ups. Currently, FSGS is treated with blood pressure medications known as angiotensin receptor blockers. A bit of history Dimerix was founded in 2004 by Dr James Williams and former Macquarie Group adviser Liddy McCall, based on technology developed at the University of Western Australia. Dimerix Bioscience was acquired in July 2015 by the ASX-listed Sun Biomedical, which was developing saliva-based drug tests. The company changed its name to Dimerix Limited in November 2015. Patent lawyer and scientist Kathy Harrison was appointed inaugural CEO in August 2017, having been the company's sole employee when she joined in 2014. A year later she was replaced by Webster. Also, a patent lawyer – as well as a former bus driver – Webster held senior positions at drug companies including Wyeth Pharmaceuticals (now Pfizer), Acrux and Immuron. Amic-able deal Webster says the US$2.2 billion Amicus is an ideal partner because it already has two rare disease medicines and considerable commercial and regulatory experience. 'Collectively this puts us in a far stronger position to bring our exciting drug candidate to patients with limited treatment options.' Here's the nitty-gritty: Amicus pays an upfront US$30 million ($A48 million) to Dimerix, with the potential for up to US$520 million of success-based payments. These milestones consist of US$410 million of sales milestones, US$75 million on regulatory approval and US$35 million on first sales. Dimerix is also entitled to tiered royalties on sales, in the 'low tens to low twenties' percentage range. 'The royalties we have achieved are very good for a deal of this structure and fit very much with the industry standard,' Webster says. Amicus becomes responsible for the FDA approval process and selling the drug, while Dimerix bears the ongoing phase III trial costs. Webster says the Amicus deal had been negotiated in earnest since last November, in a competitive tender process. Past – and future – deals Unveiled in October 2023, Dimerix signed the European, Canadian, Australia and New Zealand rights to the London-based Advanz Pharma. This deal delivered $10.8 million upfront and potential milestones of $219 million. In May last year, the company struck a deal for Iraq and the Gulf Countries with the World Health Organisation. In January this year, Dimerix then signed on the dotted line with Japanese company Fuso, which delivered another $7.2 million upfront and $100 million of potential milestones. Investor attention now turns to likely follow-on deals in the major territories still up for grabs. These include China, Latin America and South Korea. Webster cites 'significant interest' from potential partners, but 'deals get done when they get done'. Action stations Dimerix's centrepiece is its ongoing phase III trial, dubbed Action 3, which combines DMX-200 with the standard-of care blood pressure drugs. The trial aims for 286 patients across multiple sites, with 185 already randomized and dosed. The study is blinded and placebo-controlled, with the patients medicated for two years, at 70 sites in 11 countries. The primary endpoint is the reduction in the amount of protein seeping from blood in the urine – proteinuria – a telltale sign of kidney disease. This is a similar endpoint to the company's phase II trial. In 2020, the company reported the phase II showed a circa 17% proteinuria reduction relative to placebo, on top of a 15 to 20% benefit from the standard-of-care drug (as measured by published data). In a March 2024 interim phase III analysis of the first 72 patients, the company reported DMX-200 performing better than placebo in reducing proteinuria. Because the trial was blinded, this finding stemmed from statistical modelling. 'This suggests DMX-200 may achieve a statistically significant and clinically meaningful result at the end of the study,' Webster says. 'The results are very encouraging, especially for FSGS patients who currently have very limited treatment options.' The company adds that 42 patients have completed the two-year treatment and rolled on to the open-label extension trial. What's next? Dimerix expects Action 3 enrolment to complete by the end of 2025. Then there's a two-year wait for all of them to finish the treatment and then a few months of analysis before a final read-out. Equating progress to a Melbourne-to-Sydney slog up the Hume Highway, we're at Gundagai. But there are diversions along the Action 3 highway far more interesting than the dog on the tucker box. Sometime before the end of calendar 2025, Dimerix should produce a second interim analysis, which could pave the way for an FDA accelerated approval application. This means that while the company would have to complete the trial, it would be able to sell the drug before then. Last week, the FDA told the company it would accept proteinuria as a so-called 'surrogate endpoint' for the trial. The alternative is to wait for the incidence of kidney end failure, which could take years. The company can use the proportion of patients either achieving a defined proteinuria reduction relative to placebo, or the percentage change in proteinuria from baseline. In any event, the company has been keeping data on both proteinuria trends and estimated glomerular filtration rate (EGFR), which measures the loss of kidney function more directly. 'Proteinuria is far easier to measure because it has far fewer variabilities, so you will get better statistical powering with it,' Webster says. Meanwhile, Dimerix is liaising with a third-party working group called Parasol, which will advise on an 'appropriate endpoint for accelerated approval in FSGS'. This work should take three to six months. Because the next analysis is also blinded, the company needs to discuss the parameters for unblinding with the FDA. Finances and performance At the end of March, Dimerix had cash of $17.5 million and this week banked the $48 million Amicus upfront payment. The company expects the $4.1 million from the Fuso agreement to lob this quarter. So, let's say Dimerix has a smidge under $70 million of cash. There are more riches on the way, with options worth up to $6.2 million due to expire in June 2025. These options are exercisable at 15.3 cents, so there's a handy 360% gain on the table. Any investor who forgets to convert will be kicking themselves. Webster says Dimerix has spent around $60 million on the Action 3 trial to date. But having broken the back of the recruitment stage – the most expensive stanza – outgoings should moderate. Webster says the company is well-funded to pursue its development pipeline and other potential opportunities (see below). On potential drug pricing, there's no directly comparable FSGS therapy. Webster says rare disease drugs in the US typically sell for US$120,000 to US$500,000 per patient per year. Over the last 12 months Dimerix shares have traded between 31 cents in late December last year and 76 cents last Friday. The shares could be picked up for a mere six cents in late 2023. Interestingly, in September 2020 the stock traded at around 74 cents – not far off-peak levels – well before the four company-transforming partnerships. Other diseases? While the US deal involves all DMX-200 indications, the company is free to ponder other therapies. Dimerix has another pre-clinical drug candidate called DMX-700, which targets major lung ailments including chronic obstructive pulmonary disease (COPD). DMX700 works by blocking the interleukin-8 (IL-8) receptor, which is expressed at elevated levels in sick patients. This in turn causes lung tissue damage. Cystic fibrosis also has been mentioned in dispatches. The company has mulled diabetic kidney disease (DKD) in the past. The DKD market has heavy competition and would require much bigger trials, while the advent of anti-obesity GLP-1 drugs may ameliorate the incidence of the disease. Dr Boreham's diagnosis The spectre of eye drug developer Opthea's recent two-phase III trial results cast a dark shadow over the sector. In road trip terms, Opthea followed Siri (the FDA's guidance) to the word but still ended up a dead-end. So why should Dimerix holders be reassured? Apart from the company's positive interim data readout, Webster says the four global partners all underwent extensive due diligence. 'Dimerix has good validation of the asset, both technically and commercially,' she says. 'We have already demonstrated a strong safety profile and have collected encouraging efficacy data, across both the phase II trial and the first unblinded clinical analysis of the phase III trial.' FSGS is a worthwhile journey for the company to make, with the potential market estimated at US$6 billion a year by 2032, across eight key geographies (including US$2 billion in the US). That said, Dimerix is wise in organising some 'side trips' by way of its secondary programs as the risks with DMX-200 – which combines two compounds – always will remain. As Opthea has attested, driving miles and miles only to find a flea-ridden BnB is no one's idea of fun. At a glance ASX code: DXB Share price: 61 cents Shares on issue: 563,520,000 Market cap: $343.75 million Chief executive officer: Dr Nina Webster Financials (March 2025 quarter): customer receipts $3.5 million, cash outflows $4.3 million, cash of circa $70 million (after $52.1 million payments from Amicus and Fuso) Identifiable major holders: Peter Meurs 13.6%, Precision Opportunities Fund 1.8%, Bavaria Bay Pty Ltd (Perth high net worth individuals) 1.3% Dr Boreham is not a qualified medical practitioner and does not possess a doctorate of any sort. Being old fashioned, his guiding star is Melways, not Siri and Gen Y-ers will need to Google this reference.
