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Currency in AUD
Last close As at 25/03/2023
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Market capitalisation
AUD132m
Research: Healthcare
Actinogen’s recent quarterly update confirmed that the company remains on track to start US recruitment in H1 CY23 for its six-month, placebo-controlled Phase IIb portion of the XanaMIA study. The study is designed to assess the safety and efficacy of Xanamem in a population of patients with mild cognitive impairment (CI) and mild Alzheimer’s disease (AD), who at baseline will have been confirmed as biomarker-positive for AD (as determined through elevated blood phosphorylated Tau, or pTau). The company also started enrolment in Q4 CY22 for its XanaCIDD Phase IIa study assessing Xanamem in patients with CI relating to persistent depression despite ongoing treatment with standard-of-care medications. We expect the next material clinical data milestone for the company will be the XanaCIDD results, due in late CY23 or early CY24.
Actinogen Medical |
On track to start Phase IIb XanaMIA study |
Quarterly update |
Pharma and biotech |
6 February 2023 |
Share price performance
Business description
Analysts
Actinogen Medical is a research client of Edison Investment Research Limited |
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Actinogen’s recent quarterly update confirmed that the company remains on track to start US recruitment in H1 CY23 for its six-month, placebo-controlled Phase IIb portion of the XanaMIA study. The study is designed to assess the safety and efficacy of Xanamem in a population of patients with mild cognitive impairment (CI) and mild Alzheimer’s disease (AD), who at baseline will have been confirmed as biomarker-positive for AD (as determined through elevated blood phosphorylated Tau, or pTau). The company also started enrolment in Q4 CY22 for its XanaCIDD Phase IIa study assessing Xanamem in patients with CI relating to persistent depression despite ongoing treatment with standard-of-care medications. We expect the next material clinical data milestone for the company will be the XanaCIDD results, due in late CY23 or early CY24.
Year end |
Revenue* |
PBT** |
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.
We remain encouraged by the positive biomarker data whereby a subset of XanADu study patients with elevated pTau taking Xanamem demonstrated clinical activity and a relatively large effect size at 12 weeks using the FDA-recognised Clinical Dementia Rating – Sum of Boxes scale. The objective of the Phase IIb portion of XanaMIA is to confirm whether Xanamem can reproduce a similar treatment effect in a prospective study aiming to enrol 330 patients with elevated pTau. Top-line results, which we anticipate in late CY24 or in H1 CY25, could, if positive, introduce the possibility of material out-licensing or value realisation opportunities. The AD market remains substantial, in our view, and the recent FDA approval of Leqembi may raise investor awareness of the sector.
The company recently appointed Dr Dana Hilt as its chief medical officer (CMO). Dr Hilt is based in the US and has over 25 years of drug development experience, largely focused on treatments targeting central nervous system diseases, notably including AD. We view the appointment of a US-based CMO as supportive of the company’s planned entrance in H1 CY23 into US clinical AD drug development and US study sites through the XanaMIA Phase IIb study.
Actinogen reported a H123 operating cash burn rate of A$2.8m, which was dampened by the company’s receipt in October 2022 of an A$4.2m R&D tax rebate, leading the company to finish CY22 with a cash balance of A$14.5m. After adjusting for the R&D tax rebate, the company’s H123 operating cash outflows are trending mildly above our current forecast for A$8.4m in net FY23 operating cash outflow. Our model assumes that Actinogen will raise A$60m to fund its development programmes before the end of FY24, as we expect R&D expenditure rates to rise materially once the XanaCIDD and XanaMIA Phase IIb studies ramp up. Development partnerships, if formed, may fulfil part of the funding need.
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Research: Real Estate
Picton Property Income’s (PCTN’s) Q323 report shows asset management and leasing activity continuing to grow rental income. This provided a partial offset to strong market-wide pressure on property valuations in response to higher interest rates, while moderate gearing mitigated the impact on NAV. Although the NAV total return was a negative 11.7%, PCTN appears to have delivered strong outperformance relative to MSCI indices and those immediate peers that have so far reported.
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