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Health & Biotech
It’s the quarterly season again as the ASX market announcements page becomes increasingly flooded with update lodgements.
To save you the trouble of trudging through it all, we’ve wrapped up highlights from some of the reports in the ASX health sector that caught our eye.
Imricor is focused on the development and manufacture of MRI-compatible devices for performing cardiac ablations and reported several milestones during Q2 CY24.
In June IMR announced it had started its pivotal trial called VISABL-AFL for atrial flutter at the Cardiovascular Institute of South Paris (ICPS) to support potential US FDA approval in 2025.
The company says its interventional cardiac magnetic resonance (iCMR) equipment was installed at Lausanne University Hospital (CHUV) with Swiss Medic approval granted, and first procedures expected in August to further support FDA trial data.
In the US Johns Hopkins IRB approved use of IMR’s NorthStar 3D mapping system during the quarter in VISABL-AFL.
IMR’s NorthStar 3D Mapping System is the only MRI compatible 3D mapping system of the heart globally and an important part of its portfolio with collaborations underway with Siemens, Philipps and GE Healthcare to integrate with their respective MRI platforms.
Amsterdam UMC has also restarted iCMR-guided atrial flutter ablations. The VISABL-VT trial received ethics approval at Amsterdam UMC and preparation work is complete.
The first patient is due to be treated following scheduled hospital staff summer vacation leave.
IMR says first patients have also been successfully treated at Dubrava University Hospital in Croatia.
The company reported its first new customer in Hungary with Semmelweis University Hospital as it continues its global expansion.
IMR says Q2 CY24 consumable revenue of ~US$127k was up 375% on Q1 as procedure volumes increased following reactivations and new customer wins.
Total revenue of ~US$311k for the quarter was up 221% on Q1 CY24. Operating cash outflows in Q2 were well contained at US$3.3m and in line with Q1 guidance.
At June 30, 2024, IMR maintained a cash balance of US$1.5m. After quarter end in July IMR successfully raised $35m via a two-tranche placement.
The first tranche settled on July 26 and resulted in gross proceeds of ~US$16.8m, bringing IMR’s pro forma cash balance to US$18.3m.
BB1 says it achieved several key milestones during the quarter as it remains committed to its mission of revolutionising autism and ADHD diagnosis using its smartphone and tablet-based diagnostic platform.
In the June quarter BB1 initiated regulatory assessment ahead of its US registration study and subsequent 510k FDA submission.
During the first half of 2024, BB1 successfully completed a 280-patient study in autism and says results are now submitted for publication in a high-impact scientific journal.
The multi-centre study involved 280 children aged between 3-12 years, comprising 97 neurotypical children and 183 children with ASD.
During the quarter BB1 also initiated an autism clinical study in partnership with US based Turning Pointe Autism Foundation.
The company also initiated a new study in children between 5-16 years to validate the platform’s diagnostic accuracy for ADHD.
Beyond autism and ADHD, BB1 partnered with Erasmus University Medical Centre in Europe to evaluate its AI-powered test for early accurate diagnosis of front temporal dementia and Alzheimer’s.
The company also kicked off a clinical study with Bates College in the US to validate the smartphone-based platform for assessment of Functional Neurological Disorder.
BB1 also rolled out major software updates for Blinklab diagnostic application ahead of US clinical studies.
As at 30 June 2024, BB1 had a cash balance of $6.017m.
PAR submitted key documents to the US FDA in April 2024 for review and agreement on its Phase 3 trial in osteoarthritis (OA) using the optimal dose of lead drug injectable pentosan polysulfate sodium (iPPS).
The company says it has been in regular contact with the regulatory agency representative overseeing the review, using the benefits provided by the fast-track designation for iPPS and expects an “imminent response”.
The biotech also submitted a provisional determination application with Australia TGA at the end of June.
The determination application included outcome information from the PARA_OA_008 phase 2 clinical trial and a manuscript providing a comparison of iPPS clinical data with other available treatments for OA.
Following conclusion of PAR’s successful multi-centre Phase 2 clinical trial, which randomised 13 mucopolysaccharidosis Type VI (MPS VI) participants to iPPS or placebo, all 13 participants have elected to continue or start for the placebo group ongoing iPPS treatment under the supervision of the treating physician.
PAR reported in the March quarter that the multi-centre randomised trial conducted in Brazil successfully met the primary endpoint of safety and tolerability of iPPS and achieved positive results in several of the secondary outcomes.
During the quarter key executives also attended the Bio International Conference in San Diego in June, who engaged with global industry leaders, researchers, and potential partners.
Cash outflow for the June 2024 quarter was $8.35m, coming in under the guided $10m spend.
The company’s cash balance as at June 30, 2024 was $17.8m, down from $26.2m.
PAR says major spending areas for the quarter included significant regulatory costs associated with key submissions to the US FDA and Australian TGA.
Additionally, expenses were incurred to support the ongoing special access program for MPS VI participants from the Phase 2 clinical trial in Brazil, who all opted to continue the iPPS treatment.
PAR forecasts cash outflow for the September 2024 quarter to be under $7m with the target aligning with its strategic financial management practices, ensuring resource allocation towards critical costs related to the osteoarthritis Phase 3 trial and operational efficiency.
This manufacturer and distributor of cannabis-based medicines and recreational cannabis products reported $7.8m in receipts from customers for the last quarter, reaching a record $34.5m for FY24 as it progresses to EBITDA positive in FY25.
The company says net cash used in operating activities decreased by 61% during FY24, down from $6.9m in FY23 to $2.7m.
AGH says its recently completed organisational review is on track to deliver $4m in annualised savings for the company with the board providing FY25 guidance in the range of $50-$60m and positive EBITDA of between $4m and $7m.
The company says its wholly owned subsidiary Peak Processing Solutions (Peak) achieved $4.9m in cash receipts from customers for the quarter, up 16.7% from the previous quarter.
After quarter end Peak formalised a joint venture with Nasdaq-listed Flora Growth Corporation to enter the expanding US cannabis beverages market.
AGH’s global cannabis-based medicines business Althea achieved $2.9m in cash receipts from customers for the quarter, which while slightly below projections, was anticipated due to its strategic transition to two new suppliers.
The company says Althea successfully negotiated enhanced supply conditions with its new suppliers, securing better cost pricing boosting gross profit margins, more favourable payment terms to improve cash flow along with a commitment to high-quality, reliable product supply moving forward.
The company says Althea’s continuous supply of medicines is expected to return to normal in Q1 FY25.
In April, Althea announced it had secured a deal to distribute its medicinal cannabis products through Symbion’s network of over 3,850 pharmacies and 1,350 hospitals in Australia, enhancing accessibility and streamlining distribution.
The company has also launched a new range of medicinal cannabis dried flower products, Atmos by Althea, in collaboration with Rocket Factory.
After quarter end in July AGH successfully completed a $2m placement, bolstering its cash on hand position.
At Stockhead, we tell it like it is. While BlinkLab, Paradigm Biopharmaceuticals, Imricor Medical Systems and Althea Group are Stockhead advertisers, the companies did not sponsor this article.
Health & Biotech
Health & Biotech
Health & Biotech
