ASX Quarterly Wrap: Dimerix sees strong kidney drug trial recruitment, Prescient advances cancer therapy
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 the highlights from some of the (non-resources) reports that caught our eye.
During the June 2023 quarter, the company continued to recruit patients to its lead global program – the ACTION3 Phase 3 clinical study into the use of its DMX200 drug to treat focal segmental glomerulosclerosis (FSGS) kidney disease.
The study now has 133 patients recruited for the trial, which has two interim analysis points built in that are designed to capture evidence of proteinuria and kidney function, which will generate sufficient evidence to support accelerated marketing approval.
With randomisation of the first cohort of 72 patients now complete, the company has scheduled the final data collection to occur on 26 February 2024, with the Part 1 interim outcome expected to be announced on, or around, 15 March 2024.
Success in the first interim analysis outcome will allow Dimerix to announce a clinically significant and statistical meaningful improvement in proteinuria in patients on DMX-200 vs a placebo.
Meanwhile, the trial continues to recruit patients for Part 2 of the trial.
Dimerix also raised $8.7m during the quarter through a partially underwritten non-renounceable pro-rata entitlement offer, which raised $5.2m, and convertible notes for the remaining $3.5m.
It has the option to exercise a further optional tranche of convertible note funding of up to $8.5m by mutual agreement.
Prescient continued to advance its targeted cancer therapy PTX-100 through clinical development whilst advancing its CellPryme and OmniCAR cell therapy platforms during the June 2023 quarter.
Encouraging responses – including the total eradication of the cancer in two patients – from the PTX-100 Phase 1b trial in patients with relapsed and refractory T cell lymphomas led the company’s clinical and regulatory advisors to recommend enrolling more patients.
Additionally seven of the 10 evaluable patients have reported durable responses exceeding those typically seen using standard of care treatments.
In parallel with the Phase 1b trial, the company has initiated an additional manufacturing campaign of PTX-100 to support the planned Phase 2 study with the commensurate regulatory documentation required of a potential registration study.
Meanwhile, the company continues to make steady progress with developing its OmniCAR platform during the June quarter.
Current work is focused on methodically exploring variables such as the number of cells to administer, the doses of binders to administer and the dosing schedule, against a dynamic background of varying cell numbers that expand in vivo.
These demonstrate the control and flexibility features of the platform, and will be used prepare a robust pre-clinical data set to inform clinical studies.
Notably, the company also found that various “resting” periods – achieved through the temporary cessation of binder administration, which is made possible by OmniCAR’s ability to permit “pulsed” stimulation of OmniCAR-T cells – correspond with superior performance of T cell longevity and tumour killing.
This is in keeping with the hypothesis that T cells do not perform optimally when constantly stimulated and become prone to premature exhaustion.
Further optimisation was also made to CellPryme-M during the period, which improved the already impressive performance of this cell therapy manufacturing enhancement.
CellPryme-M is a non-disruptive additive added during cell manufacturing that doubles the effectiveness of CART cells tested to date by making them longer-lasting and potent.
Non-bank lender Wisr has delivered positive earnings before interest, taxes, depreciation, and amortisation (EBITDA) of $900,000 and operating cash flow of $2.6m in the June 2023 quarter after opting to moderate its loan origination volume to prioritise profitability.
This allowed the company to reduce its operating expenditure by 21% compared to the previous quarter even as revenues rose 39% on the previous corresponding quarter to $24.6m.
Wisr recorded $53m in loan originations during the quarter, taking its total loan originations up to $1.6bn while its loan book increased by 19% PCP to $931m.
Net interest margin (NIM), which measures the difference between interest paid and interest received, also expanded to a run rate of 5% on new business written.
Its cash balance increased from $21.8m in the March quarter to $23.1m.
“The business has continued to focus on NIM expansion through lifting front book yield in response to the higher cash rate,” chief financial officer Andrew Goodwin noted.
“Combined with a clear capital management strategy, Wisr is in a strong position to safeguard against the current macroeconomic climate and deliver a profitable company.
“When the conditions are deemed appropriate, the business has measures in place to pivot quickly and recommence scaling.”
At Stockhead we tell it like it is. While Dimerix, Prescient Therapeutics and Wisr are Stockhead advertiser, it did not sponsor this article.