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Currency in AUD
Last close As at 09/06/2023
AUD0.05
— 0.00 (0.00%)
Market capitalisation
AUD87m
Research: Healthcare
Actinogen announced that the first patient was randomised and treated in its XanaCIDD Phase II study in major depressive disorder (MDD) assessing the effects of lead candidate Xanamem on cognitive performance and depression. The study aims to enrol about 160 patients who have persistent depressive symptoms and cognitive impairment (CI) despite taking standard-of-care (SoC) anti-depression therapy. Having demonstrated the ability to improve cognition in two trials (XanaHES and the Phase Ib portion of XanaMIA) in healthy adults, Actinogen is confident that Xanamem can exert similar cognitive improvement effects in MDD patients; this study will also explore whether the drug can have effects on depression as well. Results are expected in late 2023 or early 2024.
Actinogen Medical |
XanaCIDD study in MDD now underway |
Clinical study update |
Pharma and biotech |
9 December 2022 |
Share price performance
Business description
Analysts
Actinogen Medical is a research client of Edison Investment Research Limited |
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Actinogen announced that the first patient was randomised and treated in its XanaCIDD Phase II study in major depressive disorder (MDD) assessing the effects of lead candidate Xanamem on cognitive performance and depression. The study aims to enrol about 160 patients who have persistent depressive symptoms and cognitive impairment (CI) despite taking standard-of-care (SoC) anti-depression therapy. Having demonstrated the ability to improve cognition in two trials (XanaHES and the Phase Ib portion of XanaMIA) in healthy adults, Actinogen is confident that Xanamem can exert similar cognitive improvement effects in MDD patients; this study will also explore whether the drug can have effects on depression as well. Results are expected in late 2023 or early 2024.
Year end |
Revenue (A$m) |
PBT** (A$m) |
EPS** |
DPS |
P/E |
Yield |
06/21 |
2.0 |
(3.3) |
(0.002) |
0.0 |
N/A |
N/A |
06/22 |
3.6 |
(7.9) |
(0.005) |
0.0 |
N/A |
N/A |
06/23e |
3.6 |
(8.7) |
(0.005) |
0.0 |
N/A |
N/A |
06/24e |
3.3 |
(38.7) |
(0.022) |
0.0 |
N/A |
N/A |
Note: *Revenues include tax rebates and financial interest (local GAAP). **PBT and EPS are normalised, excluding amortisation of acquired intangibles and exceptional items.
The XanaCIDD Phase II Depression study is a six-week proof-of-concept, placebo-controlled, parallel group design trial aiming to enrol c 160 patients with persistent MDD and CI despite taking SoC anti-depressant therapy. Xanamem 10mg daily or placebo will be added to patients’ existing anti-depressant therapy and effects on cognition (using the Cogstate Cognitive Test Battery) and depression (using the Montgomery Asberg Depression Rating Scale) will be evaluated.
MDD is a common disorder, with a c 5% prevalence globally. CI is a feature in most MDD patients and commonly persists even when depression symptoms subside. Elevated cortisol levels have been associated with depression and modification of brain cell cortisol levels has been proposed as a strategy to treat both depression and its associated CI. As Xanamem targets excess brain cortisol, and given the benefits shown in healthy adults in XanaHES and the Phase Ib portion of XanaMIA, we believe it is plausible for cognitive benefits to be shown in patients with persistent MDD. If the XanaCIDD study is successful in showing CI improvement, the company may then move to advance it into pivotal studies. Given that no US-approved antidepressant has a CI label, we believe there is a significant opportunity for Xanamem in this market if it can demonstrate an improvement in CI in this population.
Actinogen reported a gross cash position of A$13.0m at 30 September (excluding a A$4.2m R&D tax rebate received on 20 October 2022), and a Q123 operating cash burn rate of A$3.4m. We continue to model the company will raise A$20m in FY23 and A$40m in FY24. As a reminder the Phase IIb portion of the XanaMIA study is expected to start enrolment in H1 CY23 and is designed to demonstrate the safety and efficacy of Xanamem in a population of patients with mild cognitive impairment and mild Alzheimer’s disease (AD) who at baseline will have been confirmed as biomarker-positive for AD (as determined through elevated blood pTau).
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Research: TMT
Vantiva’s deleveraging exercise and partial spin-off of Technicolor Creative Studios (TCS) have put it on a more stable financial footing from both an income and balance sheet perspective. Its two divisions, Connected Home and Supply Chain Services (SCS), have leadership positions in their respective markets, with blue-chip client rosters. Adjacent diversification opportunities are being developed and should underpin medium-term prospects. Vantiva’s Q322 revenue growth was 27% at constant currency, as robust demand for Connected Home’s broadband equipment coincided with improving componentry supply. Management has confirmed FY22 guidance and reasserted its confidence in meeting FY23 expectations, and we now publish forecasts for Vantiva on a standalone basis.
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