Chimeric is heading to the well for much needed funding. Pic: Getty Images
Health & Biotech
Cancer cell therapy house Chimeric Therapeutics (ASX:CHM) is going to the well for a much-needed capital raising of at least $5 million to fund its multiple clinical programs.
Chimeric shares have been suspended since October 1, after the company failed to lodge its full-year accounts. As at June 30 the company had a mere $3 million in the bank having burnt just under $6 million during the quarter – numbers on which the auditors would not have looked too kindly.
The company had expected to complete the raising last Friday, with “any further updates announced in due course.”
Last Monday, Chimeric set the tone for the capital raising by reporting its first patient in the blood cancer arm of its phase 1b combination trial had a ‘complete response’ after 28 days. In other words: the tumour vanished.
Carried out at the UH Seidman Cancer Center in Ohio, the trial combined Chimeric’s so-called ‘natural killer’ cells with vactosertib, an agent that suppresses tumour growth in cells overexpressing a certain biomarker.
Three patients are currently enrolled in the phase 1b study with the goal to enrol 12 patients. Earlier, another patient in the phase 1a stanza also had a complete response, now sustained for 48 months.
Meanwhile, EBR Systems (ASX:EBR) has completed the retail leg of its unwritten rights offer, raising $3.06 million of the maximum targeted $4.2 million at 82c per share (chess depository interest).
In September the company raised $45.8 million in an institutional placement and insto leg of the rights offer.
EBR is developing the world’s only wireless cardiac pacing device for heart failure, with US Food & Drug Administration approval (FDA) expected in the March quarter of 2025.
Meanwhile, Respiri (ASX:RSH) is in a trading halt pending “finalisation of a strategic fund investment in the company.” Respiri’s mainstay device is the FDA-approved Wheezo, an app that enables phone-based breathing analysis.
With June-end cash of $763,000 after a full-year cash burn of $6.6 million on just under $500,000 of revenue, Respiri could also use a long drink.
Other biotechs to raise funds this month include Lumos Diagnostics (ASX:LDX) ($10 million), Actinogen Medical (ASX:ACW) ($11.1 million), Imagion Biosystems (ASX:IBX) ($3 million) and Island Pharmaceuticals (ASX:ILA) ($3.5 million).
Chimeric shares remain suspended at 1.4 cents, while EBR shares were unchanged at $1.07.
Radiopharmacy group Clarity Pharmaceuticals (ASX:CU6) will launch a phase III trial for diagnosing recurrent prostate cancer, having received positive feedback from the US Food & Drug Administration.
Dubbed Amplify, the trial will enrol about 220 patients with “rising or detectable” levels of prostate specific antigen, the biomarker that can indicate the disease.
The device being trialled is Clarity’s copper isotope-based 64Cu-SAR-bisPSMA Positron Emission Tomography (PET).
“As a pivotal trial, the final study results are intended to provide sufficient evidence to support an application to the FDA for approval of [the device] as a new diagnostic imaging agent in prostate cancer,” the company says.
Patient recruitment is expected to start in early 2025.
Clarity is regarded as a small, less advanced version of Telix Pharmaceuticals (ASX:TLX), which already has a cancer diagnostic on the market in the US, with a kidney cancer tool expected to be approved in the not-too-distant future.
Clarity shares gained 3% to $1.84.
Further data evaluation from LTR Pharma’s (ASX:LTP) recent clinical study shows that its nasally-delivered erectile dysfunction (ED) candidate Spontan stands up better – and faster – than oral vardenafil tablets (a.k.a. Viagra).
This morning’s disclosure fleshes out the trial results from June 7, which showed that five milligrams of nasal vardenafil hit the blood stream “significantly faster” when compared to 10mg of the oral vardenafil tablet.
A phosphodiesterase-5 (PDE5) inhibitor, vardenafil helps blood vessels to relax and increase blood flow to the penis.
The difference was 12 minutes versus 56 minutes for oral delivery, enabling “greater spontaneity and convenience” in the bedroom department.
On a “dose-normalised” basis, the nasal spray showed 111.8% better bioavailability despite the lower dosage. So in essence, it’s twice as effective in a fraction of the time.
The study enrolled 18 healthy adult males, who took both Spontan and oral tablets under a crossover design.
Efficacy was measured by levels of vardenafil in the blood over 25 hours, with safety and tolerance endpoints as well.
“These results are highly encouraging from a clinical perspective,” says LTR chief medical officer Geoffrey Strange.
“The rapid onset of action and pharmacokinetic profile of Spontan have the potential to address significant unmet needs in erectile dysfunction treatment.”
He says the positive data is supported by anecdotal evidence from patients who have taken the yet-to-be approved drug under the Therapeutics Goods Administration’s (TGA’s) special access scheme.
The trial results will support a marketing application to either the TGA or the FDA.
LTP shares were 4% lower at $1.85.
Pacific Smiles’ (ASX:PSQ) new CEO Gary Carroll will soon find out whether his former role was child’s play compared to presiding over a dental group in the midst of a prolonged takeover saga.
Carroll was CEO of the private childcare operator MindChamps Australia and for five years headed G8 Education (ASX:GEM), the country’s biggest for-profit preschool provider.
At Pacific Smiles, Carroll replaces Andrew Vidler, whose resignation was announced on 6 September 2024 with a six-month notice period.
But with Carroll clocking on today, Vidler will hang on for a two-week transition only.
Carroll’s main job will be to ensure the dentists don’t lose focus with the drill bit during the takeover stalemate, which has seen a $1.90-a-share offer from 19.9% holder Genesis Capital’s Beam Dental blocked by other large investors in MA Financial (13.4%) and Dr Alison Hughes (9.94%).
But all’s fair in love and takeover war, given Beam previously voted down a $2.05 a share cash scheme of arrangement from Crescent Capital in August.
Pacific Smiles shares were steady at $1.85.
At Stockhead, we tell it like it is. While EBR Systems, LTR Pharma, Lumos Diagnostics and Island Therapeutics are Stockhead advertisers, they did not sponsor this article.
Health & Biotech
Health & Biotech
Health & Biotech
