Latest news with #WillKnox
News.com.au
a day ago
- Business
- News.com.au
Health Check: Tetratherix breaks biotech IPO drought with 13pc gain on debut
Tetratherix's listed life starts on a solid note Dimerix pockets a $4.2 million milestone – with close to $1.4 billion to come Orthocell chalks up first commercial US procedure for its Remplir device Today's ASX debut of wound management house Tetratherix (TTX) has raised the hopes of other life-science plays that have eyed an IPO but have relegated the idea to the too-hard basket. Having downsized its offer from $35 million $25 million to banish the fast money, Tetratherix traded up to 13% above their $2.88 a share offer price. The company has developed an injected liquid polymer that hardens at body temperature and then biodegrades after the job is done. Yet to be approved, the platform-based tech targets novel applications including tissue healing, bone regeneration and surgical spacing (such as in prostate radiation therapy). CEO Will Knox dubs the platform as 'medical Lego', in that the products are built from the same polymer structure. 'That means you can use the same underlying biological performance and safety data in all regulatory applications. 'Our path to market is a lot faster and simpler because the data is interchangeable across the different applications.' Post raising, Tetratherix has cash of circa $30 million. This factors in two US Food & Drug Administration (FDA) approval applications, one further submission and 'multiple clinical trial readouts'. Tetratherix is the first life sciences IPO since late November 2024, when cryogenics play Vitrafy Life Sciences (ASX:VFY) and nerve repair house ReNerve (ASX:RNV) listed on the same day. Their shares are down 20% and 50% to date, respectively. Aptium is on IPO foot-ing The developer of an AI-powered tool for the podiatry market, the private Aptium is eyeing an IPO after a private whip-'round. Aptium's scanner provides real-time thermal and three and four dimensional analysis of motion and the shape of the foot. This enables 3D manufacturing of patient-specific insoles 'with precision-grade firmness and softness:. The tech also may detect diabetic foot ulcers early. Co-founded by biotech greybeards Dr Mel Bridges and Carl Stubbings, Aptium is seeking to tap $5 million in a private convertible note round. The company aspires to list within the next 18 months or so. Bridges has founded six companies, including ImpediMed (ASX:IPD) and the formerly ASX-listed Panbio. Stubbings was former CEO of Sienna Cancer Diagnostics, which merged with Bard1 to become Inoviq (ASX:IIQ). Aptium could test IPO appetite in more ways than one. That's because the company is 40% owned by Greg Creed, the former CEO of US giant Yum! Brands which owns KFC, Pizza Hut and Taco Bell. Dimerix pockets first milestone from Japanese partner Kidney drug developer Dimerix (ASX:DXB) has pocketed $4.2 million as its first milestone payment from Japan's Fuso, one of the company's four global partners. Signed in January this year, the Fuso compact could deliver up to $100 million of milestone payments. This is subject to progress on Dimerix's lead phase III program, for the kidney ailment focal segmental glomerulosclerosis. In October 2023 Dimerix inked distribution deals with the London-based Advanz Pharma (covering Europe, Canada, Australia and New Zealand). The company followed up in May last year by entering a Middle East licensing agreement with the Oman-based pharma group, Taiba. In its biggest deal, Dimerix last May signed up the Nasdaq-listed rare diseases house Amicus Therapeutics for the US honours. Collectively, the deals promise $1.4 billion of potential milestones, largely contingent on eventual FDA drug approval. The Amicus deal alone involves of US$520 million of success-based payments. The Fuso milestone became payable on opening of the first Japanese site for the Action 3 trial. Investors now expect likely follow-on deals in territories including China, Latin America and South Korea. LTR Pharma is full bottle on safety study Drug development is all about getting the small stuff right, such as whether the packaging is tickety-boo. In this vein, LTR Pharma (ASX:LTP) has affirmed that the bottle and pump components for its proposed nasal mist based erectile dysfunctional treatment meet accepted standards. LTR completed the so-called extractables study with co-development partner Aptar Pharma. The study confirmed that all detected compounds met International Council for Harmonisation safety thresholds – the standard adopted by the FDA and other agencies. A 'leachables' study is now underway, to support an FDA marketing submission. As the name suggests, the leachables study evaluates the potential migration of compounds from packaging into the liquid. This takes account of 'real-world' storage conditions, such as the back of the bedside drawer. The study will run for at least 24 months, after which the company can submit its FDA entreaty. Dubbed Spontan, LTR's treatment is based on the same active ingredient as current oral treatments but is much faster acting. LTR is also developing Oroflow, a spray treatment for a group of ailments that affect swallowing function. Orthocell hits the right nerve Nerve repair play Orthocell (ASX:OCC) reports the first use of its Remplir device in a US surgical procedure, to repair a foot injury. The FDA approved Remplir in April. The company says the first use is a crucial step in its US rollout, 'building surgical experience and knowledge of the product that will be key in driving product sales'. Remplir is a collagen 'wrap' that improves regeneration of damaged nerves and requires less stitching. The surgery took place at an unnamed Ohio hospital, sourced from Orthocell's network of 14 specialist distributors. These intermediaries have 'mature, direct-to-surgeon, hospital and other customer relationships' across 25 US states. Orthocell CEO Paul Anderson said the critical first step in the US rollout was 'getting Remplir into surgeons' hands for them to gain familiarity with its key features and benefits in clinical practice'. The company promises 'material' sales growth in the December half - which of course starts tomorrow – with the financial benefits reflected in the June half 2026 accounts. Orthocell estimates that surgeons carry out two million peripheral nerve repairs annually, equating to a US$3.5 billion market. This is across its approved markets of Australia/New Zealand, Singapore, the US, Europe/UK, Canada, Brazil, Japan, Hong Kong and Thailand.
News.com.au
17-06-2025
- Business
- News.com.au
Health Check: In shunning the IPO hot money, Tetraherix says ‘less is more'
Wound management house Tetraherix takes a haircut on its pending IPO, so the register has stayers rather than short-term players The FDA has approved CSL's next-gen treatment for hereditary angioedema Nothing fishy as zebrafish don The Big Freeze beanies Wound management house Tetraherix is on track to list on Monday week, June 30, having shaved its initial public offer to $25 million from the targeted $35 million. Tetraherix's EOFY special will be the first biotech IPO since nerve regeneration play ReNerve (ASX:RNV) listed in November last year and is a key bellwether of investor appetite for such offerings. 'We are all done,' says CEO Will Knox. 'The company had bids up to $35 but there was some fast money in there. 'We weren't confident of them being a long-term investor. So, to protect current shareholders and investors we reduced it a bit.' Tetraherix is based on a 'biostealth fluid matrix', which has applications in tissue healing, bone regeneration and surgical spacing. Supplied in ready-to-use syringes, the polymer is injected into the relevant anatomy and sets to a 'chewing-gum' consistency at body temperature. This means the material can be easily moulded to suit the application, and breaks down into water and carbon dioxide when the job is done. Pending expected US Food and Drug Administration (FDA) approval, the company hopes to bring its first products to market in the first half of 2026. These are for dental applications and bone regeneration and orthopaedic uses. In the pipeline The company also has tools in the pipeline for scar prevention during surgery and a prostate surgery 'spacer' to protect surrounding tissue during radiation therapy. Knox said the company had been 'very deliberate' about the timing of the IPO, given it has transitioned from a research-focused business to a fully-fledged commercial entity. Tetraherix has earmarked part of the funds to a new manufacturing facility in Sydney's Alexandria, with ten times the capacity of its current digs around the corner. 'We are setting ourselves up to be an Australian leader in advanced material manufacturing in the biological and medical device space,' Knox says. CSL wins key US drug approval Out-of-sorts CSL (ASX:CSL) has notched up a win, with the FDA approving its prophylactic hereditary angioedema treatment called Andembry (garadacimab). Affecting about one in 50,000 people, hereditary angioedema (HAE) is a rare genetic disorder. It results in unpredictable swelling on various parts of the body including the airway (which can be life threatening). CSL describes Andembry as the 'first and only treatment' providing sustained protection from the disorder. It works by inhibiting Factor XII (FXIIa), a key driver of HAE attacks. Administered via an autoinjector, Andembry is the only treatment to offer once-monthly dosing via a pre-filled pen. The treatment 'complements' CSL's Behring arm's existing portfolio of the (subcutaneous) Haegarda and the intravenous Berinert. Combined, these therapies chalked up US$374 million of sales in the first half. CSL shares have lost about 17% over the past year and investors were unmoved by the news in early trading today. A nice earner In an earlier note, broker Wilsons estimated Andembry could generate peak annual sales of US$600 million as well as post-tax earnings of US$400 million. Put another way, the firm believes the drug accounts for 7% of CSL's valuation and will add 180 basis points to Behring's gross profit margins. Wilsons says Andembry stacks up against rival product Takhzyro in terms of superior disease control, convenient dosing and 'pristine ' safety. 'Attack-free prophylaxis is a powerful influence on prescribing and the main reason we expect garadacimab to become the new standard of care.' Of course, Andembry could cannibalise Haegarda sales to a degree. Regulators already have approved Andembry in Europe, the UK, Japan, Switzerland, the United Arab Emirates and Australia. The company will launch Andembry in the US 'immediately', via third-party specialty pharmacies. CSL shares have been buffeted by the uncertainties over US tariffs and drug pricing, as well as softness in its Seqirus flu vaccine division. Neurizon taps the aquarium for drug inspiration Neurizon Therapeutics (ASX:NUZ) announcement this week pertaining to its pre-clinical study of Huntington's disease raises a crucial question: what is the relevance of a zebrafish? The answer is a zebrafish is a freshwater species popular in aquariums, because the piscatorial samples have traits conducive to human biological research. According to sometimes reliable sources – ok, Wikipedia – the zebrafish genome is well developed. It is also 'well-understood, easily observable and with testable developmental behaviours.' Coming back to Neurizon, the company said its lead drug candidate NUZ-001 (monepantel) lead to 'significant neuroprotective effects in a zebrafish model of Huntington's disease'. In essence, NUZ-001 might prevent early neuro-degenerative damage. Neurizon's key focus is on amyotrophic lateral sclerosis, ALS, a form of motor neurone disease. Former AFL footballer and coach Neale Daniher, the force behind the wildly popular Big Freeze campaign and charity FightMND, suffers ALS. In December last year, the company said a nine-patient study showed that after nine months, NUZ-001 reduced the risk of death by 78%. US researchers win a court reprieve In the latest medical news from Trumpland, a federal judge has deemed that some of the grant terminations foisted on the National Institutes of Health (NIH) were 'void and illegal'. The NIH is the world's biggest funder of medical research. The US District Court decision related to two suits filed over the termination of hundreds of grants, which rattled life science researchers. The presiding judge ruled the cuts were invalid because they discriminated against activities including women's health and LGBTQ+ health research. ASX biotechs are likely to be indirectly affected by the cuts – reportedly totalling US$3.8 billion – as their university and hospital partners are deprived of funds. Given the Trump administration doesn't take well to adverse judicial decisions, biotech watchers will wait and see whether the court order is merely a temporary reprieve.
