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Herald Sun
21-07-2025
- Business
- Herald Sun
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. READ: Why $487 million US distribution deal is a 'watershed moment' for skyrocketing biotech Lumos 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. At Stockhead, we tell it as it is. While Lumos and Tryptamine are Stockhead advertisers, the companies did not sponsor this article. Originally published as Health Check: On Lamington Day, biotechs serve up their chocolate-dipped quarterly morsels
The Australian
12-05-2025
- Business
- The Australian
Tryptamine appoints global pharma leader as chair
Global pharmaceutical leader Herwig Janssen appointed Tryptamine non-executive chairman Janssen held senior leadership roles with multinational pharmaceutical company Johnson & Johnson Chris Ntoumenopoulos will transition to role of executive director Special Report: Psychedelic drug developer Tryptamine Therapeutics has appointed a global pharmaceutical leader as its new chairman and made targeted board changes to strengthen leadership ahead of the next phase in its clinical development and commercialisation strategy. Tryptamine Therapeutics (ASX:TYP) has appointed Herwig Janssen as non-executive chairman effective today and he brings experience in senior roles at multinational pharmaceutical conglomerate Johnson & Johnson (J&J) for more than 40 years. Most recently, Janssen was vice president for licensing & acquisitions (emerging markets) at J&J Innovative Medicine (formerly Janssen Pharmaceuticals), a subsidiary of J&J for nearly three decades. Tryptamine said Janssen brought significant pharmaceutical sector experience to Tryptamine, having led led business development activities for J&J across global emerging markets with a demonstrated track record in licensing, technology transfers and M&A. As a member of the Janssen family, he has a long association with J&J in connection with the strategic acquisition of Janssen Pharmaceuticals. Tryptamine said Janssen's ability had been recognised through the James E Burke Award, which is J&J's highest internal honour and is awarded for outstanding leadership and integrity, while delivering exceptional business impact. Additional board changes Mark Davies will step down from the chairman role while Chris Ntoumenopoulos will transition to the role of executive director from non-executive director, a position he has held since May 2024. Ntoumenopoulos intends to increase his operational and market engagement involvement as Tryptamine embarks on the next phase of the comprehensive clinical development pathway for its lead drug candidate, TRP-8803, following the successful completion of phase I trials. He has a strong track record in the biotech sector and has advised on multiple transactions as managing director of boutique corporate advisory firm Twenty1 Corporate. His previous directorships include Race Oncology (ASX: RAC) and ResApp Health, which was acquired by Pfizer in 2022 for almost $200 million. He currently serves as the chairman of NeuroScientific Biopharmaceuticals (ASX:NSB) and holds other directorships in the ASX biotech sector. Advancing clinical pathway for TRP-8803 Tryptamine reported in November its Phase 1b study of its IV-infused psilocin treatment TRP-8803 met all key objectives for safety and optimal dosage rates, enabling advancement to phase II clinical trials in specific clinical indications. The phase 1b study was extended to an obese patient population who were safely administered TRP-8803. Tryptamine said safe dosing of TRP-8803 in obese patients provided valuable, cost-effective human pharmacokinetic data to support dose selection for future phase II trials. Plans are underway to undertake a trial of TRP-8803 in binge eating disorder (BED). The company completed a phase 2a study, in collaboration with the University of Florida, to assess the application of its oral psilocybin formula TRP-8802 to treat BED. Strong initial results from the BED trial included an average reduction in binge eating episodes of more than 80% in patients compared with baseline, along with reductions in anxiety and depression and a durability of effect up to 60 days. Joining board at 'important juncture' Janssen said he was excited to be joining the Tryptamine board at an 'important juncture', with the company having already established itself as a pioneer in the field of precision psychedelic therapies. 'My decision to join as chairman was informed in part by my belief in the potential of these treatments to achieve improved health outcomes and through its clinical program to-date, Tryptamine has demonstrated its commitment to designing and executing a comprehensive trial framework in accordance with best-in-class quality control standards,' he said. 'As we advance to the next phase of trials, I look forward to leveraging my experience in international healthcare markets to help guide the strategic direction of the business and, in the process, advancing the field of psychedelic-assisted medicine with our world-first research and clinical development program.' CEO Jason Carroll said the addition of Herwig as chairman was a significant appointment. 'With decades of experience as a senior global healthcare executive, we look forward to benefiting from his insights to help guide the company's commercialisation strategy at board level,' Carroll said. He said along with the transition of Ntoumenopoulos to executive director role, the changes were consistent with Tryptamine's strategy to continually strengthen its board and management with best-in-class candidates skilled to oversee advancement of its clinical development pathway. 'In turn, the company is now ultimately positioned at an important juncture, with the pending commencement of world-first clinical trials for the use of our lead drug candidate TRP-8803 to treat binge eating disorder.' 'I'd also like to take this opportunity to thank Mark Davies for his significant contribution as chairman,' he said. Having overseen a strategic acquisition, a $6m funding round and the successful completion of phase I trials, Mark hands over the reins with the company in a strong position to achieve our commercial objectives.' This article was developed in collaboration with Tryptamine Therapeutics, a Stockhead advertiser at the time of publishing. This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
News.com.au
06-05-2025
- Health
- News.com.au
Biocurious: With psychedelic therapies gaining cred, Tryptamine offers patients and investors the trip of a lifetime
Tryptamine is focused on using psilocybin to treat difficult mental health and neurological conditions In league with Swinburne University, the company will launch a groundbreaking binge eating disorder trial using intravenous delivery With government and regulatory attitudes rapidly evolving, the company says the first FDA-approved psychedelic treatment is nigh The CEO of local psychedelic drug developer Tryptamine Therapeutics (ASX:TYP), CEO Jason Carroll isn't afraid to make the big call. His bold prediction? The US Food & Drug Administration (FDA) will approve a mind-altering agent for a broad mental health indication by the end of next year, after decades of psychedelics being in the drug-development wilderness. Carroll says several drug developers are close to amassing enough clinical data to front the agency. The Nasdaq-listed Compass Pathways is in phase III trial stage for using psilocybin – a.k.a. 'magic mushrooms' – for treatment-resistant depression (TRD). A read-out is due later this year. 'Compass will have the data buttoned down and I think they will present a good proposal to the FDA,' he says. 'They will produce the data the world wants to see on psilocybin and its efficacy.' Most drug developers don't exactly wish their rivals the best of success, but Carroll says what's good for Compass benefits the whole nascent sector. 'It will help the market to understand there is a viable pathway to approval.' Turn on, tune in and don't drop out In the early 1970s Richard Nixon's war on drugs halted medical research on psychedelics, which had amassed plenty of – er – real-world evidence in the 1960s. Trippy hippies aside, hundreds of formal LSD trials had been carried out since the 1940s. As the protest-era Bob Dylan crooned, the times they are a-changin'. In 2019 the FDA granted psilocybin 'breakthrough' status, enabling potentially fast-track registration. In a February 2023 surprise, the Australian Therapeutic Goods Administration said it would allow authorised psychiatrists to prescribe psilocybin and MDMA (a.k.a. molly or ecstasy). This was to treat TRD and post-traumatic stress disorder (PTSD) respectively. Now, new US health secretary Robert F Kennedy Junior keenly supports advancing psychedelic therapies. Carroll says while the laws are changing, 'the challenge is to bring pharmaceutical rigour to the category'. In effect, the sector needs to transcend the reputation of the microdosing worried well at $1000 a night at Californian wellness retreats, as portrayed by Nicole Kidman's character in Nine Perfect Strangers. 'The world needs to see efficacy data, not just trendy buzzwords,' he says. Make room for the 'shroom Tryptamine's drug of choice – so to speak – is a synthetic version of psilocybin, the active ingredient in magic mushrooms. Psilocybin currently is being researched in no fewer than 25 indications. Tryptamine is targeting three overlooked disorders: binge eating disorder (BED), fibromyalgia and irritable bowel syndrome (IBS). IBS affects about 6-8% of the population, BED 2-3% and fibromyalgia 3-5%. 'These are significant conditions, and they are less discussed from a neurological viewpoint,' Carroll says. Tryptamine has completed phase II studies for BED and fibromyalgia, while an IBS study is ongoing. These trials have used an oral version of the drug, TRP-8802. In a world first, the company is poised to carry out a BED trial using an intravenous (IV) infused version, TRP-8803. TRP-8803 uses the psilocybin metabolite psilocin. IV takes the direct route Carroll says IV delivery is better controlled, with a faster effect because the agent goes directly from bloodstream to brain. While oral delivery is more convenient, IV infusions ensure the products are taken in the right dosage under the right supervision. 'The results are known quickly, whereas with oral delivery it takes one or three hours for an effect,' he says. IV delivery offers practical and commercial benefits, because an oral patient might have to be in the supervised clinic for up to 10 hours. 'If you can treat four or five patients in a day instead of one, it makes a significant difference.' IV delivery also avoids the big variabilities in the level of patient-by-patient responses, which are hit or miss. The BED trial follows an IV safety study in Adelaide last year, enrolling 14 healthy volunteers. Let's put binge eating to BED BED is the most common eating disorder in the US and second most prevalent in Australia. Patients may suffer depression, anxiety, PTSD and compulsive behaviours. Carried out at the University of Florida, the phase 2a TRP-8802 trial showed a mean reduction of more than 80% in binge eating, as well as a 60% reduction in anxiety and 45% decline in depression. This was after a single dose, over three to four months. Tryptamine last month inked a clinical trial research deal with Swinburne University, by which the house of learning carries out the world's first BED trial using the IV-based TRP-8803. Starting in the June quarter, the study entails two six-person cohorts being dosed two weeks apart (accompanied by psychotherapy). Each cohort will receive two doses, either high or mid-range. The trial assesses the safety, feasibility and efficacy of TRP-8803. The company expects top-line results from the open-label study in the December quarter. Fibromyalgia and IBS Suffered by about one million Australians and 10 million Americans, fibromyalgia stems from the brain and manifests itself as pain throughout the body. Doctors often dismiss the condition as 'all in the head' and they are right – but not in the dismissive manner intended. The company's five-patient study was done at the University of Michigan, which specialises in chronic pain. Reported in August last year, the results showed not only reduced pain, but improved sleep and cognitive functions. Meanwhile the trial of the 'neuro-gastric' condition IBS was done at the esteemed Massachusetts General Hospital. Interim results last December showed a 75% pain reduction in the first four of up to 10 patients, as well as a 'meaningful decrease' in anxiety. Tryptamine expects final results by mid 2025. Cashed up and ready to dose Courtesy of a $6 million placement last year, Tryptamine held cash of $4.58 million as of the end of March, with a further R&D tax refund of $900,000 to $1 million to come. Carroll says this will fully fund the study. The placement was backed by luminaries including Dr Daniel Tillett, a medical entrepreneur and the force behind cancer drug developer Race Oncology. Tillett has become a Tryptamine non-executive director. Carroll says Tryptamine is happy to stick with psilocybin, rather than dabble in MDMA, LSD or the ultra-trendy horse tranquilliser ketamine. 'Psilocybin is the gold-standard psychedelic,' he says. 'It's the safest because it's non-addictive with a high dosage needed to make you ill.' Ultimately, psychedelics are not so much about blocking the pain, but re-wiring how the brain works. 'People with depression have a certain way of thinking about themselves and if you break that cycle, they will be much more comfortable with their condition.'
