Health Check: On Lamington Day, biotechs serve up their chocolate-dipped quarterly morsels
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.
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.
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