Actinogen Medical Bolsters Cash Reserves to Extend Runway for Alzheimer’s Trial

Actinogen Medical Ltd (ASX: ACW) is raising up to $8.9 million before costs at $0.025 per share.

Binding commitments have been received for $5 million, with a non-renounceable 1 for 15 entitlement offer to raise up to $3.9 million.

The raising includes 1 option for every 2 new shares with an exercise price of $0.05, with a three-year term to expiry.

Funds will be applied to progressing the XanaMIA trial in patients with mild-moderate Alzheimer’s disease beyond the interim results in the first 100 patients, which is expected in mid-2025.

Prior to this raising, Actinogen held $6.3 million in cash with no debt.

The company is also anticipating a higher R&D rebate this year in the December quarter, with the previous financial year providing a rebate of $4.8 million.

Funding runway

The raising secures funding beyond two important clinical trial milestones in the next 18 months.

Dr Steven Gourlay, chief executive officer and managing director, commented:

“Our near-term clinical milestone is the results for the XanaCIDD phase 2a trial in patients with cognitive impairment and depression due in early Q3 this year.

“Confirmatory cognitive results for the primary endpoint will read through to our other program in Alzheimer’s disease, plus to other dementias and schizophrenia, where cognitive impairment can be crippling.

“Xanamem’s ability to improve other symptoms of depression will also be explored by a number of secondary endpoints.”

Actinogen’s second clinical program will report interim results for the first 100 patients in the phase 2b trial of Alzheimer’s disease by mid-2025.

The extensive clinical data generated on safety and activity to date indicate that these trials have relatively high probabilities of success.

Gourlay added: “An effective and novel treatment mechanism in these diseases could revolutionize the lives of patients.”

Xanamem was developed in response to evidence that there is a strong association between chronically raised cortisol levels in the blood and in the brain, and the development of cognitive impairment in Alzheimer’s Disease.

Current clinical trials

The XanaCIDD Phase 2a cognition & depression trial is a double-blind, six-week proof-of-concept, placebo-controlled, parallel group design trial in 167 patients.

Participants are evenly randomised to receive Xanamem 10 mg once daily or placebo, in some cases in addition to their existing anti-depressant therapy, and effects on cognition and depression are assessed.

The XanaMIA Phase 2b Alzheimer’s disease trial is a double-blind, 36-week treatment, placebo-controlled, parallel group design trial in 220 patients with mild to moderate Alzheimer’s disease and progressive disease.

This was determined by a clinical criterion and confirmed by an elevated level of the pTau181 protein biomarker in blood.

Patients receive Xanamem 10 mg or placebo, once daily, and effects on cognition, function and progression of Alzheimer’s disease are assessed.

Therefore, Xanamem is being assessed in this trial for its potential effects as a both a cognitive enhancer and a disease course modifier.

 

 

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