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Health & Biotech
The biotech sector is powering out of its two-year funk, with a slew of announcements likely to drive improved investor sentiment into the New Year.
A feature of the revival is that many of the plodding tortoises are catching up with the outperforming hares – sometimes on the back of the most modest of news.
Today, stem cell developer Cynata Therapeutics (ASX:CYP) said the results of a 30-patient phase I trial for diabetic foot ulcers showed safety and tolerability. What’s more, the trial saw an average 83.6% decrease in the wound area of the treated group after 24 months, compared with a 47.8% reduction for the control group.
Diabetic foot ulcers are the topic du jour, with Recce Pharmaceuticals (ASX:) shares entering trading halt, ahead of approval of its phase III to test its anti-infective treatment on the disease.
The trial is slated to take place in Indonesia – where the incidence of diabetes is high – and support US approval, with a commercial launch expected in 2026.
Shares in knee osteoarthritis-buster Paradigm Biopharmaceuticals (ASX:PAR) have entered trading halt, ahead of a much-anticipated capital raising to support its intended pivotal phase III trial aimed at US registrations.
We gather the raising is for $10-15 million and up to $20 million if the appetite is there. The issue price is 40 cents a share – a steep 31% discount on yesterday’s close – but there are attached loyalty options.
Naturally, companies are not wasting the opportunity and capital raisings are a daily occurrence.
Today, generic drug developer Acrux (ASX:ACR) said it had completed a $2.65 million share placement, with a $2 million share purchase plan to follow.
Following sales numbers above the company’s guidance, brain monitoring stalwart Compumedics (ASX:CMP) has raised $1.15 million in a placement.
Shares in stem cell giant Mesoblast (ASX:MSB) have entered trading halt ahead of a mystery announcement. The company also this morning said its treatment for a kids’ heart disease, Revascor, had won Regenerative Medicines Advanced Therapy status from the US Food & Drug Administration.
Revascor already has orphan drug and rare peadiatric disease status – but sadly no approval as yet.
On Biotech Daily’s reckoning, the top 40 biotech stocks gained 7% in November, taking the 12-month gain to 59% compared with 19% for the ASX200 index.
This excludes the Big Three – CSL (ASX:CSL) , ResMed (ASX:RMD) and Compumedics (ASX:CMP) – now expanded to the Big Four with the addition of ProMedicus (ASX:PME).
In some cases, investors don’t need too many excuses to buy.
A few weeks back, no-one wanted to know about the sub $10 million market cap Invion (ASX:IVX), which is developing cancer therapies based on photodynamic light therapy.
On Tuesday the stock popped on modest news that the first patient in a skin cancer trial had been dosed – and investors have been happy to extend this week’s share gain to a rollicking 270% on momentum alone.
In contrast, Micro-X (ASX:MX1) shares are up 77% this week on the company-making news of a US grant of up to US$16.4 million – and a definite US$8.2 million – to develop a lightweight, portable full-body computed tomography scanner.
Inflammatory diseases specialist Syntara (ASX:SNT) (formerly Pharmaxis) joined the party with a 23% share surge this week, a gain that yesterday attracted an ASX ‘speeding’ query.
In its response, the company said the reason couldn’t be its interim myelofibrosis trial results expected later this month, because the data is shrouded in confidentiality.
In other words: ‘dunno’.
Wellnex Life (ASX:WNX) has joined the winner’s circle after today’s powerful trading update that shows that Australians have not lost their taste for supplemental and non-prescription medicines amid the cost-of-living crunch.
After a slow start to this financial year, Wellnex reports sales of $8.92 million in July to November, up 66% year on year. If anything, momentum is improving with sales of $3.16 million for the month of November, up 320%.
Wellnex last year acquired the popular brand Pain Away, for relief of joint and muscle pain, for $22 million in cash.
The company’s offerings include iron gummies, whitening toothpaste and the sleep-inducing Nighty Night, a “traditionally used ayurvedic medicine”.
(With ancient Indian roots, ayurvedic medicines are based on ancient writings that rely on a natural and holistic approach to physical and mental health.)
Nighty Night users then can reverse the effect with the caffeine-bearing pick-me-up, Wakey Wakey.
Wellnex shares this morning gained 14% to 79.5 cents.
Checking in again on Inoviq (ASX:IIQ), which says it has successfully completed specificity testing of its blood-based breast cancer assay, neuCA15-3.
The company doesn’t do itself any favours with its messy releases – we suggest some Stockhead-style dot points at the top – but the gist is the immunoassay does a great job detecting the biomarker CA15-3 which is produced by cancer cells.
The test was able to detect breast cancers of all stages with an 81% sensitivity (accuracy).
Just as importantly, the assay was 93% effective in specificity – that is – ruling out the disease which might make it handy as a screening tool.
“The aim is to demonstrate that our [underlying] SubB2M technology can be used as a detection reagent to enhance the performance of multiple existing cancer biomarker tests,” chairman David Williams says.
The test initially will be developed as a lab-developed offering – an easier route to market than full approval – for the US market.
On Tuesday, Inoviq posted ‘outstanding’ ovarian cancer detection results pertaining to its exosome-based Exo-oc blood test.
Exo-oc accurately identified early stages of ovarian cancer – which is notoriously hard to pick up – with a sensitivity of more than 90% and specificity of 96%.
Inoviq shares spiked 12% on Tuesday and bounced another 10% to 55 cents today.
Yep, (almost) everything is on a roll.
At Stockhead, we tell it as it is. While Recce and Paradigm are Stockhead advertisers, they did not sponsor this article.
Health & Biotech
Health & Biotech
Health & Biotech
