Latest news with #PhaseScientific
News.com.au
2 days ago
- Business
- News.com.au
Health Check: On Lamington Day, biotechs serve up their chocolate-dipped quarterly morsels
Today's news is all sweet on trial progress, revenue and cash Amplia to raise capital after runaway share performance Tryptamine starts binge eating 'magic mushie' trial Today is National Lamington Day and biotechs are serving up a solid sponge-like base of news encased in chocolate and coconut – occasionally interspersed with a jam layer. Hold the cream and pink jelly though – it just doesn't work. Like so many drug discoveries, the lamington had serendipitous origins. The story goes that one of Queensland governor Lord Lamington's maids was serving up a yellow sponge, but accidentally dunked it into molten chocolate. Lord Lammo recommended the squares to be rolled into coconut shavings for ease of eating – and the rest is history. As is this non-sequitur. Now onto the biotech news. Lumos glows after last week's mega deal Point-of-care diagnostics house Lumos Diagnostics (ASX:LDX) reports revenue of $12.4 million for the year to June 30, up 12%. June quarter revenue declined 26% to $2.6 million, owing to the end of the US flu season. Lumos reported cash outflows of US$1.7 million for the quarter, taking June 30 cash to US$2 million. Investor interest has focused on last week's mega US distribution deal with Phase Scientific, which could deliver Lumos up to US$317 million ( $487 million) over six years. This pertains to the company's bacterial-versus-viral rapid lateral flow test, Febridx. Lumos has also signed a term sheet for a $5 million loan facility, proffered by shareholders Tenmile Ventures (Andrew Forrest) and Ryder Capital. At its discretion, Lumos can draw down the facility over the next 12 months. Cleo eyes FDA approval for ovarian cancer assay Still on diagnostics, Cleo Diagnostics (ASX:COV) says it aims to submit a US Food & Drug Administration (FDA) marketing approval application for its ovarian cancer assay next year. The company is on track to complete a supportive US trial in the December quarter. Thanks to government grants and tax incentives, Cleo reported cash inflows of $38,000, taking end of quarter cash to $6.46 million. Turning to drug development, genetic disease specialist PYC Therapeutics (ASX:PYC) reports cash outflows of $17.6 million. At quarter's end the company still had cash of $153 million. The company has dosed the first patient in a combined phase 1a/2b trial for polycystic kidney disease. PYC has achieved 'alignment' with the FDA on the structure of a registrational trial for its lead program, the blinding eye disease retinitis pigmentosa type 11. The company believes the regulator will require only a phase II trial. Tryptamine BEDS down eating disorder trial Psychedelic medicines house Tryptamine Therapeutics (ASX:TYP) has started recruiting patients for a world-first binge eating disorder (BED) study. In the open-label trial, 12 patients will be administered intravenously infused psilocybin, combined with psychotherapy. Melbourne's Swinburne University is undertaking the study, with first dosing this quarter and top line results due by the end of the year. BED is the most common eating disorder in the US and second most prevalent in Australia here. The condition can result in depression, anxiety, post-traumatic stress disorder and compulsive behaviour. Amplia passes the hat Meanwhile Amplia (ASX:ATX) shares this morning entered trading halt, ahead of a share placement and share purchase plan. Amplia thus continues the rich tradition of companies leveraging clinical trial results, in this case its stunning data for hard-to-treat pancreatic disease. Amplia has reported 17 'partial response' rates in it Accent trial, in 17 out of 55 advanced disease patients. A confirmed partial response is tumour shrinkage of more than 30%, sustained for two or more months with no new cancerous lesions detected. Amplia is testing AMP-945 (narmafotinib). AMP-945 appears to inhibit the protein FAK, which is overexpressed in pancreatic cancers. Amplia shares have surged 376% in the past 12 months, but investors still value the company at a modest $110 million. As of the end of March, Amplia had cash of $10.8 million. 'Perplexed' Imugene laments soft-as-a-sponge share price Imugene (ASX:IMU) chairman Paul Hopper hopes the company's lamington-soft share price will 'do an Amplia' (our words) and reflect the company's progress with its multiple cancer trials. The company last Monday announced its phase 1b study for an aggressive blood cancer had resulted in two additional 'complete responses' (that is, the tumours disappeared). Imugene is trialing Azer-cel, its allogeneic Car-T drug made from healthy donor T-cells rather than the patient's. Naturally, Imugene announced a $22.5 million and share purchase plan for up to $15 million. On reinstatement, the shares lost 4.5 cents, or 10%, taking the loss over the past year to around 80%. This allows for a one for 34 share consolidation. 'We are very disappointed with the share price performance,' Hopper says. 'We are perplexed why we had such a lukewarm reception to the earlier data at the start of year.' Cashed up for pivotal trial But with the share raising in train, Imugene investors should no longer fear that such a dilutionary event is around the corner. Post raising Imugene should have cash of $64 million, with management costing a 60-80 patient pivotal trial at $30-40 million. If approved, Azer-cel would be the first commercial allogenic Car-T treatment, enabling mass produced, off-the-shelf therapies. 'We are in active discussions with partners on the strategy for developing the drug and getting it approved,' Hopper says. Shares settle in orbit after last week's Meso-blast off Mesoblast (ASX:MSB) shares have taken a breather after Friday's 35% surge on the back of initial US sales of its first US-approved stem cell product. The company reported unaudited June quarter revenue of US$13.2 million ($20.3 million) for Ryoncil, its treatment for childhood graft-versus-host disease. The FDA approved Ryoncil in December last year. Mesoblast founder and CEO Prof Silviu Itescu points to higher sales in the current quarter, given US Centres for Medicare and Medicaid Services coverage became effective on July 1. The company has signed up more than 25 transplant centres and hopes to enlist all 45 priority centres by October. Bell Potter analyst John Hester says the sales were in line with the firm's expectations. 'The figure is inclusive of sales to the distributor, nevertheless it represents a reasonable proxy for hospital demand.' The firm values Mesoblast at $3.50 a share, implying 55% of upside.
News.com.au
7 days ago
- Business
- News.com.au
Health Check: Lumos shares 150pc brighter after company-making US diagnostics deal
Lumos Diagnostics says its US distribution deal is worth up to $487 million Impedimed's US device sales are on a roll Noxopharm treats its first lupus trial patient In one of the 'largest distribution deals of its type' by an ASX-listed point-of-care diagnostics company, minnow Lumos Diagnostics (ASX:LDX) has inked a US compact worth up to US$317 million ($487 million) over six years. The agreement is with the Hong Kong-based Phase Scientific and relates to Lumos's lateral-flow assay, Febridx. With a finger prick blood sample, Febridx enables clinicians to differentiate between bacterial and non-bacterial acute respiratory infections in around 10 minutes. Lumos expects to sell Febridx under a mechanism called the CLIA (Clinical Laboratory Improvements Amendment ) waiver. The provision is for simple tests that have an insignificant risk of an erroneous result and can be used by less trained staff such as nurses and receptionists. Dissecting the deal As is always the case with such deals, the up-front amount is modest: US$2 million by way of a US$1 million exclusivity fee and a US$1 million pre-paid purchase order. Phase Scientific pays a further US$1.5 million from a further purchase order when Lumos lodges the CLIA waiver application. Investors should expect this within three months. There's then a further US$5 million pre-paid order if Lumos achieves the exemption. Between the second and sixth years, Phase's minimum order quantities gradually ramp up – and that's where the US$317 million comes into the picture. Put in context, Lumos was valued at a little over $20 million before this morning's 150% romp – handy pocket money for billionaire backers Andrew and Nicola Forrest, who hold 19.9% of LDX's stock. 'This agreement validates the value of the Febridx technology and provides a clear pathway to the US market, which we expect will accelerate rapidly,' says Lumos CEO Doug Ward. To support the requisite CLIA waiver application, Lumos is carrying out a supportive study which has enrolled 105 of the targeted 120 bacterial positive patients. Stretched US hospital funding is no impediment to Impedimed The US also is proving fertile ground for ImpediMed (ASX:IPD), with sales doubling in the June quarter. The maker of a lymphodema detection device called Sozo, Impedimed sold 44 units in the US in the quarter, compared with 22 in the March quarter. This included a nine-unit contract with Legacy Health, which has six hospitals and 70 primary care facilities across the east coast. Renewals during the quarter took total contract value (new and renewed contracts) to a record $6.3 million, 29% higher than the March stanza. 'Over the last year, Impedimed has seen a significant increase in leads and opportunities resulting from the initiatives implemented under the new leadership team,' the company says. Management expects a current level of sales in the current quarter, 'with improvement in subsequent quarters as the pipeline matures and additional internal initiatives take effect.' Lymphodema is swelling of the limbs, typically the arms and legs, usually caused by cancer treatments. Before Sozo came along, the condition was appraised with a tape measure. The sales uptick qualifies Impedimed for an additional US$5 million under a US$15 million debt facility, with specialist lender SWK Funding. Impedimed plans to release its quarterly numbers on July 31. Imugene targets $37.5 million equity raising Immuno-oncology play Imugene (ASX:IMU) has raised $22.5 million in an institutional placement and hopes for another $15 million by way of a share purchase plan. The whip 'round follows Monday's revelation of further strong clinical results from the company's phase 1b trial of its blood cancer therapy, Azer-cel. The funds will support a planned US pivotal trial. The company did the deal at 33 cents, a 22% discount to Monday's frozen price. Subscribers receive a free option on a three-for-four basis, exercisable at 43 cents after March next year. On exercise of those options, investors receive one-for-one piggyback oppies, exercisable at 86 cents. The raising takes Imugene's cash kitty to $64 million. Noxopharm hopes that HERACLES will slay lupus Noxopharm (ASX:NOX) has dosed the first patient in its first-in-human trial of its drug candidate for the painful autoimmune disease lupus. Dubbed HERACLES, the dose escalation study aims to evaluate the safety and tolerability profile of its candidate, SOF-SKN. Lupus affects about five million people globally – 90% of them women. The HERACLES trial targets cutaneous lupus erythematosus (CLE), the most common form. This is when body's immune system mistakenly attacks skin cells, causing inflammation and skin lesions and sores. SOF-SKN modulates inflammation at its source. 'The global lupus market is worth more than US$3 billion and is expected to grow significantly over the coming years,' Noxopharm CEO Dr Gisela Mautner says. SOF-SKN is an exponent of the company's core tech Sofra, acquired from the Hudson Institute of Medical Research. Noxopharm hopes to apply the core Sofra tech to rheumatoid arthritis, type 1 diabetes, inflammatory bowel disease and dementia (which also is immune related). HERACLES stands for 'harnessing endogenous regulation against CLE study'. Heracles was famed in Greek mythology for his immense strength, courage and ability to slay monsters. Along with a bucket of money, these are all prerequisites for drug development. August 1 D-day for Trump tariff drug slug? It's hard to distinguish Donald Trump's genuine intentions from his brain farts, but it looks like the global pharma sector should expect some movement on his threatened pharma tariff by August 1. Trump told reporters that along with a tariff on semiconductors, he should announce the drug impost 'probably at the end of the month'. 'We're going to start off with a low tariff and give the pharmaceutical companies a year or so to build, and then we're going to make it a very high tariff,' the Prez said. Drug makers can avoid the tariff – mooted to be up to 200% – by moving drug manufacturing to US shores. As reported, CSL is the most likely ASX drug stock in the firing line. But given the maker of plasma derived therapeutics draws on US blood donors and has some US manufacturing, the repercussions are as clear as Trump's Ukraine peace plan.
Forbes
23-05-2025
- Business
- Forbes
This Biotech Startup Raised $34 Million For Urine-Based Tests To Help Diagnose Cancer
Ricky Chiu, Phase Scientific's cofounder, chairman and CEO. With rising cancer rates necessitating new forms of diagnosis and treatment, Hong Kong-based biotech startup Phase Scientific International announced Tuesday it raised $34 million in a Series A funding round led by Asian asset management firm Value Partners Group. Under a private equity fund of Value Partners, which was cofounded by billionaire Cheah Cheng Hye, the Series A brought Phase Scientific's total funding raised to $57 million. The round included participation from 'new healthcare-focused investors and continued support from existing global backers,' according to the company. Phase Scientific declined to disclose its current valuation. The decade-old company's previous investors include the Gates Foundation, which provided a $100,000 grant in 2016, and the U.S. National Institutes of Health, which provided a total of around $1.1 million in funding between 2017 and 2018. 'We are delighted to become a partner of Phase Scientific as it rapidly grows and addresses critical unmet needs in early disease detection,' said Chuen Yan Leung, partner at Value Partners Group, in a statement about the funding round. 'Its innovative technology represents a paradigm shift, offering an unparalleled combination of clinical precision and patient-centric solutions that accelerates the development of early disease detection.' Phase Scientific's HPV urine test. Founded in 2015, Phase Scientific develops diagnostic products and services for cancer, infectious diseases and women's health conditions. Its range of 30 products, chiefly offered through at-home testing kit brand Indicaid, includes pregnancy tests, Covid-19 rapid antigen tests, and sexual health tests. To date, the company says it's distributed more than 100 million tests in over 30 countries, with Covid-19 tests comprising the majority of its business. The fresh capital will go towards research and development (R&D) and commercialization efforts for its urine-based diagnostics. Phase Scientific's proprietary sample preparation technology, called Phasify, can amplify biomarkers, or biological molecules, in urine to detect a range of medical conditions. By concentrating and purifying urine, Phasify is capable of capturing over ten times more target molecules than existing tests regarded as the 'gold standard' for urine samples, according to the company. Of particular interest to Phase Scientific is using urine to test for human papillomavirus (HPV), the cause of almost all cases of cervical cancer globally, per World Health Organization (WHO) statistics. In 2023, Phase Scientific unveiled what it described as the world's first urine-based HPV test, which it claimed could detect HPV with 98.1% accuracy. Priced at around HK$880 ($112), the test has received approval in the U.S. to screen for HPV, but not for cervical cancer itself. 'Everyone in our industry wants to crack urine to test for HPV, because it's such a huge market,' says Ricky Chiu, cofounder, chairman and CEO of Phase Scientific, in a video interview with Forbes. HPV infections account for an estimated 690,000 cases of cancer worldwide each year, according to the European Cancer Organization, citing statistics published in the Lancet Global Health journal – but many infections are easily preventable through vaccinations and screenings. Urine may offer a more convenient alternative to widely adopted clinical methods of testing for HPV. For women, these include cervical smears, commonly known as pap smears, in which healthcare practitioners vaginally insert a clamp-like tool called a speculum and then use a swab to extract cells from the cervix. There are no standardized tests for men, but options include penile swabs and anal swabs. A gynecologist holds up a speculum during an examination. 'A lot of testing is still being done through pap smears, which a lot of women find uncomfortable, unhygienic, and are embarrassed to kind of do,' says Maaike Steinebach, founder and CEO at Hong Kong-based women's health consultancy firm FemTech Future, in a phone interview. 'The fact that we now have a urine test that we can actually use to test in a very simple, non-invasive way, I think, is great to create more options.' To Chiu, one edge Phase Scientific has over potential competitors is its 'cross-border setup' that allows it to tap into global R&D and commercialization opportunities. With offices in California and across mainland China, the company was originally spun out of the bioengineering program of the University of California, Los Angeles, where Chiu received a PhD. The majority of its 180 employees are based in Hong Kong, a key market alongside the U.S., the company says. While Phase Scientific aims to initiate the 'world's largest clinical studies in urine HPV,' says Chiu, it also plans to eventually target 'more systemic' types of cancer. 'Lung cancer, breast cancer, these are the cancers that no one else is able to crack by using a urine test as an early cancer detection,' he adds. 'Of course, it would take a long time to go through our R&D, to demonstrate feasibility…so that would be our long-term vision.' Around one in five people will develop cancer in their lifetime, according to the WHO's International Agency for Research (IARC), which operates the Global Cancer Observatory (GLOBOCAN) database. In an announcement last February, the IARC reported an estimated 20 million new cancer cases and 9.7 million deaths in 2022. Asia had the highest burden of cancer that year, accounting for 49.2% of new cases and 56.1% of deaths, per GLOBOCAN figures. An aging population and increasing exposure to risk factors, such as air pollution, tobacco use, alcohol consumption, and obesity, have spurred a 'rapidly growing global cancer burden,' with an estimated 35 million new cancer cases predicted in 2050, a 77% increase from 2022, the IARC added. The increasing need to detect cancers early on, along with monitoring potential recurrence, has spurred scientific research into non-invasive cancer diagnostics. This field includes liquid biopsy, referring to techniques that process bodily fluids such as blood, urine, and saliva for different disease biomarkers. Aside from Phase Scientific, another rising liquid biopsy company is Singapore-based precision medicine developer Lucence, backed by billionaire Min-Liang Tan. Cofounded in 2016 by Tan's brother, Min-Han Tan, Lucence secured Medicare coverage for its cancer-detecting blood test in early 2023 and made the Forbes Asia 100 to Watch list that year.
Bloomberg
21-05-2025
- Business
- Bloomberg
Covid Cases Spike in Hong Kong, Singapore
Phase Scientific CEO & founder Ricky Chiu discusses the recent Covid-19 spikes in Hong Kong, Singapore and how that has affected the company's business with Bloomberg's Yvonne Man and David Ingles. (Source: Bloomberg)
Bloomberg
21-05-2025
- Business
- Bloomberg
Covid Testing Demand Surges as Cases Spike Across Asia
Demand for Covid tests is increasing in Hong Kong as cases surge in recent weeks, according to the top executive of diagnostic kit-maker Phase Scientific International Ltd. The Hong Kong-based company, which is a major provider of Covid testing kits in Asia Pacific, has seen business gain because of the Covid wave across Asia, Chief Executive Officer Ricky Chiu said in an interview with Bloomberg TV.
