Latest news with #WillKnox
News.com.au
07-07-2025
- Business
- News.com.au
Dr Boreham's Crucible: ASX newbie Tetratherix plays it slow and steady
By taking the 'less is more' approach to funding, the backers of the first ASX life sciences initial public offer (IPO) in seven months have been rewarded with a robust share price over the first few trading days. The developer of the world's first 'bio-stealth fluid matrix' wound management house, Tetratherix (ASX:TTX) listed on Monday after reducing the size of its raising from $35 million to $25 million. 'This IPO is not an endpoint or an exit strategy, rather a foundation upon which we will accelerate product development, expand our global clinical footprint and scale manufacturing and commercial operations,' CEO Will Knox declared. The company's Tetramatrix platform has nothing to do with stealth fighters or furtive FBI agents, but is the basis of novel tools for applications including tissue healing, bone regeneration and surgical spacing. 'Bio-stealth refers to the ability to quietly enter the body through minimally invasive means,' Knox says. 'It tricks the body, so it doesn't know it has been in there and done the things it needs to do before being reabsorbed. 'That's important because the product doesn't elicit any inflammatory or foreign body response.' 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,' he says. 'Our path to market is a lot faster and simpler because the data is interchangeable across the different applications.' 'Intelligent chemistry' The technology combines four liquid monomers in ready-to-use syringes. The 'intelligent chemistry' means it sets to a chewing-gum consistency at body temperature, causing minimal damage to other tissue. The material avoids the fibrotic response associated with healing. 'The ethos is to have something everyone can use, without changing clinical workflows,' says Dr Ali Fathi, the company's co- founder. 'Even a first-year school student can use it.' The material can be easily moulded to suit the application and is not rejected by the body. Eventually, the material breaks down into water and carbon dioxide. These qualities make it suitable for day surgeries, which are increasingly common. Tetratherix currently does not have an approved product. Pending expected US Food and Drug Administration approval, the company hopes to launch products for dental applications, bone regeneration and orthopaedic uses next year. This thesis was more than theory Academic theses tend to be derided as esoteric or theoretical - or both. That's not the case with University of Sydney researcher and chemical engineer Dr Fathi, whose thesis spawned the Tetra-tech. The topic? 'Injectable Hydrogels with Tunable Physico-chemical Characteristics and Cell-interactive Behaviour for Musculo-skeletal Tissue Regeneration'. Dr Fathi and Terence Abrams formed the company, then known as Trimph Holdings, in 2025. In 2018, a dental clinical study established the technology's street cred. The company adopted its current moniker in 2020 and carried out its first private fund-raising (series A round) for $2.5 million of preference shares. This was followed by two convertible note raisings, totalling $8.45 million. The company then converted to an unlisted public company structure. Knox has extensive experience on commercializing regenerative therapies including at Cochlear. The board includes John Kelly, co-founder of the ASX-listed Atomo Diagnostics. With an initial focus on dermal repair and orthopaedic bone regeneration, Tetratherix expanded into surgical spacing and tissue healing (preventing scars forming in surgery) The company also plans to commercialise a 'spacer' to protect surrounding tissue (such as the rectum) during prostate cancer radiation therapy. Tegenix … First off the commercialisation rank is the company's dental bone regeneration tool, Tegenix. Clinicians mix the material for a bone graft. The putty is then pressed into the bone defect, providing flexibility. 'It also means general dentists can carry out some of these more complex procedures,' Knox says. Tetratherix has carried out two clinical trials that show Tegenix supports natural bone healing. The company expects to bring Tegenix to market by July 2026, following expected FDA clearance. Identical in chemistry to Tegenix, fast follower Tegeneous is intended for orthopaedic uses, enabling minimally invasive treatment of trauma and spinal injuries. Tutelix … Under a joint venture with the local Koda Health, Tetratherix is developing Tutelix for prostate spacing. The material is injected through a long needle between the prostate and the rectum, which protects the latter from radiation during prostate procedures. 'We make cancer radiation therapy safer and simpler. It provides clinicians with optionality in that they can inject it at the pace they want,' Knox says. 'It's visible under a scan and ultrasound, enabling precision.' The joint venture has ethics approval for a human trial, expected to start within weeks. On the ophthalmic front, the Tetratherix 'eyes' a product called Optelex, to maintain the volume and shape of peepers during surgery. … and Tetraderm Tetraderm prevents scar formation after procedures such as caesarean sections and breast augmentation and reductions. The product forms a gel between layers of the dermal tissue, reducing 'dead space' and providing cushioning to prevent scar formation. Carried out on the Gold Coast, a trial has passed the first safety and efficacy hurdles. The company expects a pre-submission meeting with the FDA by the end of 2026. In the fast lane Knox says Tetratherix is taking the relatively easy FDA 510(k) path to market. 'We are not a drug, so don't need phase I to III style programs,' he says. 'The average time for an FDA response is 124 calendar days, rather than months or years.' The company's regulatory team sifted through 300 510(k) applications and discovered a 95% success rate. 'It is a much lower risk profile from a market access perspective.' Take your partners Management describes a dual revenue model, by which the technology is licenced to partners in a specific field. This approach means the company does not have to set up a large marketing team: 'an expensive and arduous process'. The partners have the right to self-fund expanded indications, with Tetratherix providing the material. For Tegenix, the company has an agreement with Henry Schein, the world's biggest dental supplier. Tetratherix has teamed up New York's Bio-Optix Inc to develop and commercialise a novel ophthalmic visco-elastic device (for cataract surgery). Knox describes the partnerships as distinct and long term. 'We try to avoid the difficult two-to-three-year distribution arrangement,' he says. 'Over many years I have found that doesn't provide enough long-term stability. 'Our partnerships are more a co-development agreement over 15 to 20 years.' Made in Australia US tariffs aside – and such imposts shouldn't overly affect the company – Tetratherix is intent at keeping its manufacturing and development on local shores. 'We are setting ourselves up to be an Australian leader in advanced material manufacturing in the biological and medical device space,' Knox says. The polymers are made at the company's facility at Alexandria, near Sydney Airport. About $10 million IPO proceeds are earmarked for a new plant around the corner, with 10 times the capacity. Knox says the products are made from widely available raw materials, using 'catalogue' equipment. 'The smarts are how you combine and cook those ingredients and how the parts of the process are put in place.' Finances and performance The IPO consisted of an institutional round and limited retail offering, raising $25 million at $2.88 a pop. The shares jumped 15% after listing on Monday and now are more than 50% to the good – a lusty showing indeed. Knox says the company could have raised the $35 million but wanted to avoid 'fast money' subscribers unlikely to stick around. The company now has cash on hand of circa $30 million. This funding provides a runway to mid-2027. It factors in two FDA approvals, one further submission and 'multiple clinical trial readouts'. Knox says the company has spent about $15 million in research and development over the last decade, with little extra spending required. Currently, US reimbursement depends on the product. With bone regeneration, the patient pays out of pocket in what's a low-cost, high-volume game. But prostate spacing has a well-defined US reimbursement model. Tetratherix expects milestone licensing payments, as well as on-going annuity-style revenue from licencing and manufacturing margins. The register includes Rod Drury, who founded small to middle sized enterprise (SME) 'software as a service' (SaaS) accounting pioneer Xero. Mr Drury says he was attracted to Tetratherix because the company applies 'SaaS platform thinking' to smart medical devices. Dr Boreham's diagnosis Knox says the IPO coincides with the company maturing from research and development stage to a commercially focused entity. The company cites a combined addressable market for bone regeneration, tissue spacing and tissue healing at US$6.8 billion and forecast to grow to US$9.5 billion by 2023. 'We have five very distinct products across three franchises, built on a platform opportunity,' Knox says. Still, wound-care newbies need to prove they have the superior – or cheaper – mousetrap. That often doesn't work. This week, the struggling ASX-listed Next Science said it would sell most of its assets to an Italian acquiror for US$50 million ($75.9 million). Knox says, typically, the company won't compete with ASX peers such as Aroa Biosurgery, Avita, Orthocell and Polynovo. 'Instead, we try to disrupt markets, such as in bone regeneration in dental and orthopaedic procedures. Tetratherix management is most excited about Tutelix and Tetraderm, given their potential to displace incumbent products from sector giants like Teleflex and Boston Scientific. First thing's first, though: Tetratherix needs to win the two initial FDA approvals and start to accrue that annuity revenue. But Knox says Wound mana will take it slowly, wooing the top opinion-leading clinicians before tackling the others. 'There is a very deliberate and strategic way of launching these products,' he says. 'Going too hard, too fast can be the death knell because if used in the wrong hands, the messaging is not controlled.' At a glance ASX Code: TTX Share price: $4.35 Shares on issue: 50,331,637 (8.7 million issued in IPO) Market cap: $218 million Chief executive officer: Will Knox (co-founder) Board: Emma Cleary (chair) Ali Fathi (co-founder), Knox, Gillian Shea, David Bottomley, Atlanta Daniel, John Kelly (Atomo), Maurizio Vecchione Financials (half year to December 31, 2024): revenue nil, R&D Tax Incentive $459,000, net loss after tax $2.63 million, cash of $31 million (post IPO) Major identifiable shareholders: Ali Fathi 28%, Radar Ventures (Atlanta Daniel and Rod Drury) 13.3%, David Bottomley and Ryder Capital 11.1%, Will Knox 6.7%. Abrams family 4.95%, Marsden Pty Ltd 4.95%, Aspirate Investments 4.16%
News.com.au
30-06-2025
- 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.
