ASX Quarterly Health Wrap: Bioxyne revenue up 77%, Radiopharm lists on Nasdaq
Health & Biotech
Health & Biotech
Quarterly season is nearing its end, triggering a rush from small caps to hit the month-end reporting deadline.
Here, we wrap up report highlights from three standout stocks in the ASX health sector.
Bioxyne said it achieved a record Q2 FY25 trading with several major contracts, a growing customer base and expanding product range.
The company said the standout in the group continued to be its wholly-owned subsidiary Breathe Life Science (BLS) Australia, following granting of its Good Manufacturing Practice (GMP) licence to manufacture medical cannabis products.
Bioxyne said BLS was also granted Australia’s first licence to manufacture Psilocybin and MDMA by the Therapeutic Goods Administration in February 2024.
The company’s expansion of its BLS manufacturing capacities for pastilles products will come online by mid-February 2025. Bioxyne said the expansion would triple current manufacturing output for pastilles and immediately increase the capacity of other product lines to meet growing demand.
BLS is projecting revenue growth in individual product categories in the next two quarters of between 30% to 50%.
Bioxyne said the group expects to shortly receive ARTG Listing approval for the export of its Dr Watson Pharmaceutical products to the UK. The company is also completing a business case for establishing a proposed GMP manufacturing facility in Europe to meet local demand.
Bioxyne ended Q2 FY25 with $2.7 million in hand and will release its H2 FY25 results on February 28.
It’s been a big quarter for the nuclear medicine play, often seen as a ‘mini me’ version of the all-conquering Telix Pharmaceuticals (ASX:TLX).
The company became dual-listed in the US with Radiopharm Theranostics American Depository Shares (RADX) hitting the Nasdaq on November 27.
In December, Radiopharm received ethics approval in Australia to initiate a Phase 1 trial of Lu-RAD202 for HER2-positive metastatic solid tumours, including breast and gastric cancers.
The company presented positive data on 68Ga–RAD202 at the 2024 European Association of Nuclear Medicine (EANM) Annual Meeting during October.
Radiopharm received ethics approval during the quarter from the Australian Human Research Ethics Committee (HREC) to expand the scope of its ongoing Phase 1 trial of the radiotherapeutic 177Lu-RAD204. It also completed preclinical studies for RAD 402, with human trials planned for H2 2025.
The company partnered with AtomVie to develop and manufacture 177Lu- BetaBart, a radiopharmaceutical targeting B7-H3, an immune checkpoint molecule over expressed in several solid tumours.
In October, the company announced a partnership with BAMF Health to manufacture and dose its proprietary radiotracer, 18F-RAD 101, for a Phase 2b imaging trial targeting brain metastases.
Radiopharm also inked a strategic co-development partnership with Nasdaq-listed Lantheus to advance clinical development of innovative radiopharmaceuticals in Australia. Post quarter Lantheus became the largest shareholder in Radiopharm following an $8m placement.
Finally, the company appointed Noel Donnelly as non-executive director, who has 25 years of leadership experience in finance, strategy, and operations within the biopharmaceutical and biotechnology industries.
Worth reading Dr Boreham’s Crucible: Radiopharm hopes to turn up the sweet sound of success
The clinical-stage biotech said it had achieved several key milestones during the quarter including the Safety Review Council (SRC) determining its novel IV-infused psilocin formulation TRP-8803 was safe and well-tolerated in human volunteers.
The company reported in November its Phase 1b study of TRP-8803 met all key objectives for safety and optimal dosage rates, enabling advancement to Phase 2 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 2 trials.
In further clinical development progress Tryptamine reported in December positive interim analysis for its phase 2a clinical study of oral psilocybin formula TRP-8802 in patients with irritable bowel syndrome (IBS).
During the quarter Tryptamine completed a placement to new and existing sophisticated and institutional investors to raise $6m, which was corner-stoned by the Merchant Biotech Fund and seasoned biotech investor Dr Daniel Tillett.
It was also supported by existing major shareholders Dr Bill Garner, Mr Herwig Janssen and Mr Ludwig Criel, as well as CEO Jason Carroll and director Chris Ntoumenopoulos, subject to shareholder approval at an upcoming general meeting.
Tryptamine finished the quarter with $2.8m cash with $3.25m binding commitments and ~$1.1m ATO R&D tax refund expected this quarter.
LTR Pharma said it “achieved significant R&D, commercial and market access milestones” in the clinical and commercial development of its novel intranasal formulation of vardenafil for erectile dysfunction SPONTAN.
In October the company announced completion of its data evaluation phase for the SPONTAN pivotal clinical study, showing 470% faster absorption than oral vardenafil of 12 minutes versus 56 minutes.
During the quarter LTR Pharma entered into a strategic joint venture with Restorative Sexual Health for a new online healthcare platform, providing comprehensive men’s health services through telehealth consultations.
The company also inked a key access agreement with with men’s health pharmacy clinic network Men’s Health Downunder, enabling SPONTAN availability through an established pharmacy network under the Therapeutic Good’s Administration’s Special Access Scheme.
In December, LTR Pharma completed a $25m capital raise with strong support from institutional and sophisticated investors, including key healthcare focused funds.
The company said it was now in the strongest cash position to date with a balance of $34.1m as at December 31 2024 and financially positioned well to progress US commercial preparations including FDA regulatory pathway activities.
Island Pharmaceuticals CEO Dr David Foster said Q2 FY25 was a pivotal quarter for the antiviral drug development company, marked by significant progress in its ISLA-101 Phase 2a/b PROTECT clinical trial of ISLA-101 in dengue fever.
“We’re very pleased to have completed the dosing of subjects in the Phase 2a prophylactic arm and to have recorded positive safety and anti-dengue activity.
“These achievements demonstrate the potential of ISLA-101 to address the major unmet need for effective treatments against dengue fever.
Foster said with its recent A$3.5 million placement the company was well-funded to drive its clinical programs forward and explore new opportunities for growth.
During the quarter ILA strengthened its team with the appointment of Phillip Lynch as executive chairman, which the company said brought extensive consumer healthcare and biotech experience and expertise to the board.
Island closed the quarter with a cash position of $3.99m.
At Stockhead, we tell it like it is. While Bioxyne, Tryptmanine Therapeutics, LTR Pharma and Island Pharmaceuticals are Stockhead advertisers, they did not sponsor this article.