Actinogen Medical — Taking steps to mitigate funding headwinds

Actinogen Medical (ASX: ACW)

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Research: Healthcare

Actinogen Medical — Taking steps to mitigate funding headwinds

Actinogen is refining the design of its XanaMIA Phase IIb study of lead candidate Xanamem in patients with cognitive impairment (CI) associated with mild-to-moderate Alzheimer’s disease (AD). The study will forego the 5mg dose group and will concentrate on the 10mg dose, which has already shown effectiveness in the subgroup analysis of XanADu as reported in Q422. The XanaMIA Phase IIb study will continue to assess c 110 AD patients in the 10mg dose cohort, as well as a placebo arm, and will concentrate on Australian test sites for the first 100 enrolled patients. These measures are expected to significantly reduce study costs, as Actinogen expects c A$30m in cost savings between now and June 2025 compared to its initial plan. Given that US sites may not begin recruitment for another c 12–18 months, we are pushing back our projection for study completion until CY26 (from H2 CY25 previously) and our timeline for potential Xanamem commercialisation in AD to CY29 (from CY28 previously). In September, Actinogen completed a A$10m rights offering and we now expect the company to be funded into Q424 (Q2 CY24). We determine a new risk-adjusted net present value (rNPV) of A$528m, versus A$645m previously.

Written by

Pooya Hemami

Analyst - Healthcare

Actinogen Medical

Healthcare

Actinogen Medical

Taking steps to mitigate funding headwinds

Study and funding update

Pharma and biotech

25 October 2023

Price

A$0.03

Market cap

A$54m

A$0.63/US$

Estimated net cash (A$m) at 30 September 2023

13.1

Shares in issue

2,214m

Free float

90%

Code

ACW

Primary exchange

ASX

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(11.1)

(53.7)

(84.9)

Rel (local)

(8.3)

(50.6)

(85.0)

52-week high/low

A$0.13

A$0.02

Business description

Actinogen Medical is an ASX-listed Australian biotech developing its lead asset Xanamem, a specific and selective 11β-HSD1 inhibitor designed to treat cognitive impairment (CI) that occurs in chronic neurodegenerative and neuropsychiatric diseases. Currently, Actinogen is targeting CI in two indications: the early stages of Alzheimer’s disease and major depressive disorder.

Next events

Start enrolment for XanaMIA Part IIb study in biomarker-confirmed early AD

Q4 CY23

Results for Phase II XanaCIDD study in cognitive impairment associated with major depressive disorder

H1 CY24

Analyst

Pooya Hemami OD MBA CFA

+1 646 653 7026

Zoe Karamanoli

+44 (0)20 3077 5700

Actinogen Medical is a research client of Edison Investment Research Limited

Actinogen is refining the design of its XanaMIA Phase IIb study of lead candidate Xanamem in patients with cognitive impairment (CI) associated with mild-to-moderate Alzheimer’s disease (AD). The study will forego the 5mg dose group and will concentrate on the 10mg dose, which has already shown effectiveness in the subgroup analysis of XanADu as reported in Q422. The XanaMIA Phase IIb study will continue to assess c 110 AD patients in the 10mg dose cohort, as well as a placebo arm, and will concentrate on Australian test sites for the first 100 enrolled patients. These measures are expected to significantly reduce study costs, as Actinogen expects c A$30m in cost savings between now and June 2025 compared to its initial plan. Given that US sites may not begin recruitment for another c 12–18 months, we are pushing back our projection for study completion until CY26 (from H2 CY25 previously) and our timeline for potential Xanamem commercialisation in AD to CY29 (from CY28 previously). In September, Actinogen completed a A$10m rights offering and we now expect the company to be funded into Q424 (Q2 CY24). We determine a new risk-adjusted net present value (rNPV) of A$528m, versus A$645m previously.

Year
end

Revenue
(A$m)

PBT*
(A$m)

EPS*
(A$)

DPS
(A$)

P/E
(x)

Yield
(%)

06/22

3.6

(7.9)

(0.005)

0.0

N/A

N/A

06/23

4.9

(9.0)

(0.005)

0.0

N/A

N/A

06/24e

3.9

(23.8)

(0.012)

0.0

N/A

N/A

06/25e

4.8

(60.6)

(0.027)

0.0

N/A

N/A

Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments. EPS are fully diluted.

XanaMIA Phase IIb interim data expected in H1 CY25

The XanaMIA Phase IIb trial aims to assess Xanamem versus a placebo in patients with an elevated level of phosphorylated Tau-181 (pTau-181) protein in their blood. The updated design maintains the same endpoints and 36-week treatment duration, but eliminates the 5mg dose arm, and includes only the 10mg dose arm or a placebo, with 220 patients (vs 330 as per the initial design). Recruitment should start by end-CY23 and will concentrate on Australian sites for the initial c 100 patients to reduce costs. Initial efficacy and safety results will be analysed when these patients reach 24 weeks of treatment. These results are expected in H1 CY25 and could serve as a significant catalyst if data are positive.

Valuation: Revised to reflect CY29 AD launch timeline

The recent close of the A$10m rights offering, leading to the issuance of 400m shares at A$0.025 per share, extends the company’s cash runway into Q424 (Q2 CY24). We believe Actinogen is seeking non-dilutive funding arrangements, which may reduce future funding needs. We adjusted our model to reflect lower near-term R&D expenditure forecasts, our new assumed AD commercialisation timelines (CY29 vs CY28 previously) and revised forex assumptions and we rolled forward our estimates. We now obtain a total rNPV valuation of A$528m (vs A$645m previously), or A$0.24 per share (vs A$0.36 previously). The pushback in the launch timeline is largely responsible for the decrease in total rNPV, with the estimated value per share further reduced by the issuance of 400m shares due to the Q3 CY23 rights offering.

XanaMIA Phase IIb study to focus on the higher dose

Actinogen is refining the design of its XanaMIA Phase IIb study of lead candidate Xanamem in patients with CI associated with mild-to-moderate AD. The adjustments are intended to help reduce study costs before the attainment of interim data and, therefore, reduce the need for significantly dilutive additional financing ahead of this key milestone and potential value-driver.

Xanamem is an inhibitor of enzyme 11β-Hydroxysteroid dehydrogenase type 1 (11β-HSD1) designed to penetrate the brain. Much scientific literature suggests that excessive cortisol is associated with CI in patients with various chronic conditions, including age-related CI and AD. As the naturally present enzyme 11β-HSD1 normally converts cortisone to cortisol inside cells, Xanamem is designed to reduce excessive cortisol production in the brain.

The initial XanaMIA Phase IIb study design involved the recruitment of c 330 patients across three once-daily dose arms: 10mg, 5mg and a placebo. This design had received investigational new drug (IND) clearance by the US FDA and this plan involved the inclusion of US study sites. Under the revised plan, the study will forego the lower 5mg dose group and concentrate on the 10mg dose, which has already shown effectiveness in the subgroup analysis of the XanADu study, as reported in Q4 CY22 and described further below. The XanaMIA Phase IIb study will now recruit c 220 patients in total, but it will continue to assess c 110 AD patients in the 10mg dose cohort, as well as in the placebo arm, and will concentrate on Australian test sites for the first 100 enrolled patients. Altogether, these measures are expected to significantly reduce study costs, as the company expects c A$30m in cost savings between now and June 2025 compared to its initial plan. The new study design maintains the same endpoints (including a cognitive composite of several tests as the primary endpoint) and the same 36-week treatment length.

Interim XanaMIA study expected to report in H1 CY25

Actinogen plans to provide interim efficacy data in H1 CY25 (vs prior guidance of late CY24 or early CY25), which should correspond to results from 24 weeks of treatment in the first c 100 patients (ie from the Australian study sites). The interim data could be a meaningful value driver for the company and potentially lead to a material re-rating in the share price (ahead of a subsequent need for further financing), if data from this study can demonstrate, on a prospectively defined basis, trends towards a significant improvement in the chosen primary and/or secondary AD efficacy measures versus placebo.

The Phase IIb study now aims to assess Xanamem 10mg once daily versus placebo by recruiting patients with an elevated level of pTau-181 protein in their blood. Actinogen reported biomarker data in Q4 CY22 using blood samples from a subset of patients in the prior 185-patient XanADu study in AD patients showing clinical activity and a relatively large effect size at 12 weeks using the FDA-recognised Clinical Dementia Rating Sum of Boxes (CDR-SB) in biomarker-positive AD patients (as determined through patients who had elevated pTau). The 34 patients (16 on Xanamem 10mg daily, 18 on placebo) with pTau levels at or above 6.74pg/ml showed a 0.6 mean difference (effect size) in CDR-SB (representing a 60% relative reduction in disease progression versus placebo) at 12 weeks between the placebo and treatment arms. As mentioned above, the primary endpoint of the XanaMIA Phase IIb study will be the change in a cognitive composite of several tests and the CDR-SB functional score will be a secondary endpoint.

XanaCIDD study on schedule to report data in H1 CY24

In late CY22, Actinogen initiated the XanaCIDD Phase II study in patients with major depressive disorder (MDD) and CI, despite standard-of-care anti-depression therapy. Patients are administered Xanamem at a daily dose of 10mg or a placebo in addition to their existing anti-depression treatment. The study assesses cognitive improvement using the Cogstate Cognitive Test Battery and evaluates depression changes through the Montgomery-Asberg Depression Rating Scale. Actinogen expects to report study results in H1 CY24. Positive results from the trial could lead the company to advance Xanamem into pivotal studies for patients with CI and/or depression. Positive data could also lead to a re-rating in the share price and facilitate future fund-raising activities for CI and/or AD programmes.

To this end, the company now suggests that the timing of the expansion of the XanaMIA Phase IIb study (to sites outside Australia) will occur when new positive data are received in the XanaCIDD study (by mid-CY24), and/or following the interim analysis for XanaMIA Phase IIb (as discussed above). Hence, we interpret this as Actinogen waiting for a positive value inflection point before committing to expanding the study to sites outside of Australia and, most particularly, to the US, given that US site study costs are likely to be significantly higher than in Australia. We also note that net R&D costs for Australian sites are dampened by the Australian government R&D tax incentives for up to 43.5% of study costs.

Pushing back AD launch timelines given new XanaMIA Plan

Given the phased approach for XanaMIA Phase IIb (with initial recruitment to focus only on Australian study sites), our base case now assumes that US study site recruitment will not likely occur for another c 12–18 months. Further, the removal of the 5mg arm (the dose-ranging portion of XanaMIA Phase IIb) may add additional regulatory complexity, given that the approved US IND had been based on the inclusion of a 5mg dose arm. Given that Actinogen will accumulate safety data from the Australian study sites on the 10mg arm as the XanaMIA Phase IIb study is ongoing, we believe it is very likely that the company will be able to satisfy any potential FDA concerns on the removal of the 5mg arm, before it intends to proceed with US study site enrolment. We estimate that if regulators require a 5mg dose-ranging arm, this could now be part of a forthcoming Phase III pivotal study programme.

Nonetheless, given that US sites may not begin recruitment for another c 12–18 months, we are pushing back our base case projection for XanaMIA Phase IIb study completion until CY26 (from H2 CY25 previously), and our timeline for potential Xanamem commercialisation in AD into CY29 (from CY28 previously). However, we note that the company retains significant optionality on XanaMIA Phase IIb study progress. In particular, should circumstances arise (such as the attainment of material non-dilutive funding or partnership arrangements) that permit the company to open global sites sooner, it could accelerate progression of the study compared to our new base case forecasts.

Alzheimer’s disease competitive landscape

The AD market presents an attractive opportunity, given its size (accounting for c 6070% of the 55 million individuals with dementia worldwide) and high unmet need. Even with the first proper disease-modifying treatments emerging (such as anti-amyloid beta monoclonal antibodies like Leqembi), we believe there remains tremendous potential for alternative AD treatment approaches (such as the 11β-HSD1 inhibition approach used by Xanamem resulting in lower brain cortisol), particularly those that can be taken orally (such as Xanamem), given better convenience and ease-of-use compared to the intravenous (IV) approach required by the anti-amyloid beta drugs. AD pathophysiology is complex and there are many potential mechanisms involved with disease progression. Exhibit 1, compiled by Cummings et al, illustrates the diverse mechanisms of actions sought for therapeutic agents in clinical development for AD, including, among others, neurogenesis, synaptic plasticity, inflammation, tau, amyloid and neurotransmitters/receptors.

Exhibit 1: Mechanisms of action of all agents in all phases of clinical trials for AD

Source: Cummings et al. Alzheimer's disease drug development pipeline: 2023, Translational research and clinical interventions, May 2023. https://doi.org/10.1002/trc2.12385

In Exhibit 2, we provide a selected list of small-molecule drugs investigated for AD and currently listed on ClinicalTrials.gov with ongoing Phase II and Phase III studies, along with relevant upcoming catalysts. We believe that small-molecule therapeutics are more likely to be potential competitors to Xanamem, if approved, given the significant differences in mode of administration (eg IV or injection for biologics vs potentially oral for small-molecule), cost of manufacturing and sought mechanisms of action, compared to biological drugs (such as the anti-amyloid monoclonal antibodies).

Exhibit 2: Small molecules in development for the treatment of AD

Company

Drug

Stage

Mechanism of action

Stage of AD patients

Next catalyst

BioVie Pharma

NE3107

Phase III

Beta androstenetriol with anti-inflammatory and insulin-signalling effects via ERK1 and 2

Mild-to-moderate AD

Topline data on efficacy in
Nov/Dec 2023

Anavex Life Sciences

Blarcamesine

Phase IIb/III

Activates the upstream sigma-1 receptor, involved in restoring neural cell homeostasis and promoting neuroplasticity

Early Alzheimer's; MMSE: 20–28

Additional preliminary results of surrogate biomarker and regulatory discussions for path forward Q423

T3D Therapeutics

T3D-959

Phase II

Dual nuclear receptor agonist of PPAR delta/gamma; regulates glucose and lipid metabolism

Mild-to-moderate AD; MMSE: 14–26

CTAD late breaker data 24–27 October 2023

Cognition Therapeutics

Elayta (CT1812)

Phase II

Sigma-2 receptor antagonist; binds to sigma2/ Progesterone receptor membrane component 1 receptor and regulates Amyloidβ (Aβ) oligomermediated synaptic toxicity

Mild-to-moderate AD; MMSE: 18–26

Full Phase II data from SEQUEL study Q423

Athira Pharma

Fosgonimeton

Phase II/III

Activates signalling via the Hepatocyte growth factor/MET receptor system; aims to promote survival of neurons, enhances hippocampal synaptic plasticity

Mild-to-moderate AD

End of Phase II meeting with the FDA complete; Phase II/III trial continues enrolment; topline data expected H224

Cassava Sciences

Simufilam

Phase III

Filamin A protein inhibitor, stabilises the interaction of 42-amino acid β amyloid and the α7 nicotinic acetylcholine receptor to decrease tau phosphorylation and improve synaptic function

Mild-to-moderate AD; MMSE: ≥ 16 and ≤ 27

Second Phase III study to complete enrolment in Q423; Phase III data in H224 and H225

TauRx Therapeutics

TRx0237

Phase III

Tau-aggregation inhibitor

Mild-to-moderate AD; MMSE: 16–27

Regulatory filling and additional 24month follow-up data expected in Q423/2024

Alzheon

ALZ-801

Phase III

Prodrug of homotaurine that inhibits aggregation of Aβ into toxic forms, antioligomer agent for APOE4/4 homozygotes

Early AD and APOE4/4; MMSE 20–30

APPOLOE4 Phase III is fully enrolled; topline data due Q324

Eli Lilly

LY3372689

Phase II

O-GlcNAcase inhibitor, reduces tau from forming toxic aggregates

Early Alzheimer's; MMSE: 22–30

Recruitment complete and data readout expected in H224

Vivoryon Therapeutics

Varoglutamstat

Phase II

Inhibitor of glutaminyl cyclase to reduce pyroglutamate Aβ

Mild CI and dementia due to AD; MMSE: >20

Phase IIb VIVIAD data readout due Q124

Annovis Bio

Buntanetap

Phase II/III

Selective inhibitor of amyloid precursor protein to reduce amyloid; also reduces synthesis of tau and alpha-synuclein proteins

Mild-to-moderate AD; MMSE: 14–24

Data from 320 patient trial in Q124

Sage Therapeutics

SAGE-718

Phase II

Enhances synaptic function through NmethylD-aspartate receptor blockade

Mild CI and dementia due to AD; MoCA: 15–25

Data from 150 patients in Q125

Medesis Pharma

NanoLithium (NP03)

Phase II

Ion with effects on amyloid, oxidation and inflammation

Mild-to-severe AD; MMSE: 10–26

Data from 68 patient study in H124

NewAmsterdam Pharma

Obicetrapib

Phase II

Cholesteryl ester transfer protein inhibitor

Mild-to-moderate AD and APOE4/4; MMSE: >20

Full data from proof-of-concept study in upcoming scientific conferences

Source: Edison Investment Research, Evaluate and various sources. Note: MMSE, mini mental state examination; MoCA, Montreal Cognitive Assessment.

Financials

Actinogen’s FY23 results (ending 30 June 2023) showed a normalised operating loss of A$9.2m (up from A$7.9m in FY22), with net R&D costs of A$8.9m (vs A$8.2m in FY22). The increase in R&D costs was largely due to the initiation of the XanaCIDD study in late CY22, as well as activities required for the preparation for the XanaMIA Phase IIb study, including final development of the tablet Xanamem formulation to be used as part of the study (and intended for use in subsequent Xanamem trials and potential commercialisation, as discussed in a prior note). Due to favourable year-on-year working capital dynamics, including those relating to the timing of Australian government R&D tax rebates and grants, Actinogen had a lower net operating cash burn rate of A$8.7m in FY23 (vs A$9.5m in FY22). The company’s quarterly cash burn rate in Q124 (ending 30 September) was A$4.9m.

Given the changes to the XanaMIA Phase IIb study, which we estimate will significantly curtail R&D expenses for the initial c 100 patients recruited (as these will now only involve lower-cost Australian sites vs the global site rollout including US sites previously assumed), we have reduced our FY24 and medium-term R&D cost expectations. We now project FY24 R&D costs and net operating cash burn of A$22.2m and A$23.7m, respectively, versus our prior assumptions of A$36.4m and A$37.2m, respectively. We expect costs to rise substantially in FY25 as we model US study site expansion for XanaMIA Phase IIb as well as the initiation of a larger, potentially pivotal, global study for Xanamem in patients with CI associated with MDD. We project an FY25 net operating cash burn rate of A$60.4m, driven by A$55.6m in projected R&D expenses.

With the funding from the rights offering now complete and the changes in our near-term R&D expenses, we now model Actinogen to be funded into Q424 (Q2 CY24) versus Q1 CY24 previously. We continue to model that the company will raise an additional A$20m before end-FY24, given our expectations of increases in R&D expenses as the Phase IIb portion of the XanaMIA study ramps up.

As stated previously, given that we now expect XanaMIA Phase IIb results in CY26, we have pushed back our projected launch timeline for Xanamem in patients with AD to CY29 (from CY28, previously) although we continue to assume commercialisation of the drug for patients with MDD in CY28. Our base-case projection assumes that Actinogen will independently fund all studies needed for regulatory approval in these indications. Given the push back in our assumed commercialisation timeline in AD and the decrease in the US dollar versus the Australian dollar since our prior note (A$0.63/US$ vs A$0.66/US$ previously), we have increased our total projected future funding need to recurring operating profitability to A$495m (vs A$445m previously). Reasons for the increase include higher R&D costs (in Australian dollar terms) through FY29, given that the development programme is expected to have a significant contribution from US-based sites, as well as the resulting anticipated need for the company to cover selling general and administrative, and operating costs over a longer period without operating revenues from Xanamem in the AD indication.

Valuation

Our valuation continues to be based on a rNPV analysis, which includes A$13.1m in net cash at the end of September 2023. We apply a discount rate of 12.5% and include Xanamem in the two lead indications. We continue to use a probability of success of 10% for Xanamem to reach the market in the AD indication and 12.5% in the MDD indication. We have adjusted our model for our revised expenditure forecasts, our new assumed AD commercialisation timelines (CY29 vs CY28 previously) and revised forex assumptions, and have rolled forward our estimates. We now obtain a total rNPV valuation of A$528m (vs A$645m previously), or A$0.24 per share (vs A$0.36 previously). The pushback in the commercialisation timeline in AD is largely responsible for the decrease in total rNPV, with the estimated value per share further reduced by the issuance of 400m shares as a result of the Q3 CY23 shareholder rights offering.

Exhibit 3: Actinogen rNPV Valuation

Product

Market

Launch

Sales in 2034 (A$m)

NPV
(A$m)

Probability of success

rNPV
(A$m)

rNPV/basic share (A$)

Xanamem in CI related to AD

US

CY29

3,660

3,230.3

10.0%

261.7

0.12

Xanamem in CI-related to AD

EU5 and Australia

CY29

1,732

1,586.9

10.0%

158.7

0.07

Xanamem in CI related to MDD

US

CY28

1,193

926.2

12.5%

77.5

0.04

Xanamem in CI related to MDD

EU5 and Australia

CY28

696

577.4

12.5%

72.2

0.03

Corporate costs

(55.4)

100%

(55.4)

(0.03)

Estimated net cash at 30 September 2023

13.1

13.1

0.01

Total equity value

6,278.5

527.8

0.24

Source: Edison Investment Research

As stated earlier, we forecast A$495m in additional financing will be required before FY29 to fund the development of both the CI-MDD and AD programmes, after which, provided it receives regulatory approval, Actinogen should be able to generate sufficient operating revenues to reach recurring profitability. Our model assumes all financing will be raised through illustrative debt, as per usual Edison methodology. If our projected funding need of A$495m is raised through equity issuances at the prevailing market price of c A$0.02, our effective value per share would decrease to A$0.038.

The amount of fund-raising estimated to be necessary for Actinogen to independently bring Xanamem to commercialisation in these indications is larger than the company’s current market capitalisation. Although we note that the funding intervals may be staggered over the next several years, which may alleviate potential challenges associated with raising funds in excess of a company’s market capitalisation. We also believe Actinogen will seek non-dilutive funding arrangements and/or partnership arrangements (actions towards the latter would likely particularly increase after the XanaMIA Phase IIb portion is completed), which may reduce the overall funding need, but such scenarios are not included in our forecasts.

Considering that AD pivotal trials are reported to cost more per patient than studies in nearly any other therapeutic area, we believe Actinogen will likely explore partnerships or non-dilutive funding strategies if the XanaCIDD data (expected in H1 CY24) or interim XanaMIA Phase IIb data (expected in H1 CY25) are positive.

Exhibit 4: Financial summary

A$’000s

2020

2021

2022

2023

2024e

2025e

Year end 30 June

IFRS

IFRS

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

3,516

1,984

3,640

4,888

3,871

4,833

Cost of Sales

0

0

0

0

0

0

Gross Profit

3,516

1,984

3,640

4,888

3,871

4,833

Sales, General & Administrative

(2,962)

(3,111)

(4,558)

(6,568)

(5,757)

(6,045)

Net Research & Development

(5,537)

(2,406)

(8,215)

(8,900)

(22,222)

(55,556)

EBITDA

 

 

(4,983)

(3,533)

(9,133)

(10,580)

(24,108)

(56,767)

Amortisation of intangible assets

(314)

(313)

(313)

(235)

(235)

(235)

Depreciation & other

(99)

(74)

(88)

(171)

(83)

(219)

Normalised Operating Profit (ex. amort, SBC, except.)

(4,888)

(3,318)

(7,933)

(9,234)

(24,191)

(56,986)

Operating profit before exceptionals

(5,396)

(3,920)

(9,533)

(10,985)

(24,426)

(57,220)

Exceptionals including asset impairment

0

0

0

0

0

0

Other

(194)

(289)

(1,288)

(1,517)

0

0

Reported Operating Profit

(5,590)

(4,209)

(10,821)

(12,502)

(24,426)

(57,220)

Net Finance income (costs)

65

5

36

233

342

(3,584)

Profit Before Tax (norm)

 

 

(4,822)

(3,313)

(7,897)

(9,001)

(23,849)

(60,570)

Profit Before Tax (FRS 3)

 

 

(5,331)

(3,915)

(9,497)

(10,752)

(24,084)

(60,805)

Tax

0

0

0

0

0

0

Profit After Tax and minority interests (norm)

(4,822)

(3,313)

(7,897)

(9,001)

(23,849)

(60,570)

Profit After Tax and minority interests (FRS 3)

(5,331)

(3,915)

(9,497)

(10,752)

(24,084)

(60,805)

Average Basic Number of Shares Outstanding (m)

1,118.0

1,405.2

1,717.1

1,806.0

2,015.3

2,214.3

EPS - normalised (A$)

 

 

(0.004)

(0.002)

(0.005)

(0.005)

(0.012)

(0.027)

EPS - normalised and fully diluted (A$)

 

(0.004)

(0.002)

(0.005)

(0.005)

(0.012)

(0.027)

EPS - (IFRS) (A$)

 

 

(0.005)

(0.003)

(0.006)

(0.006)

(0.012)

(0.027)

Dividend per share (A$)

0.0

0.0

0.0

0.0

0.0

0.0

BALANCE SHEET

Fixed Assets

 

 

3,772

3,287

2,889

2,520

2,809

2,995

Intangible Assets

3,346

3,033

2,720

2,408

2,732

2,997

Tangible Assets

19

17

13

113

77

(3)

Investments in long-term financial assets

408

237

156

0

0

0

Current Assets

 

 

8,164

15,091

20,417

12,688

17,974

6,984

Short-term investments

0

0

0

0

0

0

Cash

5,040

13,457

16,370

8,460

13,746

2,756

Other

3,123

1,634

4,047

4,228

4,228

4,228

Current Liabilities

 

 

(744)

(755)

(1,480)

(1,802)

(1,911)

(1,911)

Creditors

(744)

(755)

(1,480)

(1,802)

(1,911)

(1,911)

Short term borrowings

0

0

0

0

0

0

Long Term Liabilities

 

 

(304)

(165)

(87)

0

(20,000)

(70,000)

Long term borrowings

0

0

0

0

(20,000)

(70,000)

Other long-term liabilities

(304)

(165)

(87)

0

0

0

Net Assets

 

 

10,889

17,458

21,740

13,407

(1,127)

(61,932)

CASH FLOW STATEMENT

 

 

 

 

 

 

 

 

Operating Income

(5,590)

(4,209)

(10,821)

(12,502)

(24,426)

(57,220)

Movements in working capital

(3,591)

(1,513)

(3,143)

132

109

0

Net interest and financing income (expense)

65

5

36

233

342

(3,584)

Depreciation & other

99

74

88

171

83

219

Taxes and other adjustments

6,161

3,920

4,323

3,268

235

235

Net Cash Flows from Operations

 

(2,856)

(1,724)

(9,517)

(8,698)

(23,657)

(60,351)

Capex

(23)

(6)

(3)

(37)

(606)

(639)

Acquisitions/disposals

0

0

0

0

0

0

Interest received & other investing activities

0

0

0

(0)

0

0

Net Cash flows from Investing activities

 

(23)

(6)

(3)

(37)

(606)

(639)

Net proceeds from share issuances

0

10,195

12,491

903

9,547

0

Net movements in long-term debt

0

0

0

0

20,000

50,000

Dividends

0

0

0

0

0

0

Other financing activities

282

(84)

(71)

(78)

0

0

Net Cash flows from financing activities

282

10,111

12,420

825

29,547

50,000

Effects of FX on Cash & equivalents

0

0

49

0

2

0

Net Increase (Decrease) in Cash & equivalents

(2,596)

8,381

2,949

(7,910)

5,286

(10,990)

Cash & equivalents at beginning of period

7,637

5,040

13,422

16,370

8,460

13,746

Cash & equivalents at end of period

5,040

13,422

16,370

8,460

13,746

2,756

Closing net debt/(cash)

 

 

(5,448)

(13,694)

(16,527)

(8,460)

6,254

67,244

Lease debt

390

236

165

87

87

87

Closing net debt/(cash) inclusive of IFRS16 lease debt

(5,058)

(13,458)

(16,361)

(8,373)

6,341

67,331

Free cash flow

(2,878)

(1,730)

(9,520)

(8,735)

(24,263)

(60,990)

Source: Edison Investment Research, company reports


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Accuracy of content: All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations.

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Copyright: Copyright 2023 Edison Investment Research Limited (Edison).

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New Zealand

The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (i.e. without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision.

United Kingdom

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This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person.

United States

Edison relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

General disclaimer and copyright

This report has been commissioned by Actinogen Medical and prepared and issued by Edison, in consideration of a fee payable by Actinogen Medical. Edison Investment Research standard fees are £60,000 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

No personalised advice: The information that we provide should not be construed in any manner whatsoever as, personalised advice. Also, the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The securities described in the report may not be eligible for sale in all jurisdictions or to certain categories of investors.

Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report, subject to Edison's policies on personal dealing and conflicts of interest.

Copyright: Copyright 2023 Edison Investment Research Limited (Edison).

Australia

Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Crown Wealth Group Pty Ltd who holds an Australian Financial Services Licence (Number: 494274). This research is issued in Australia by Edison AU and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation and needs. If our advice relates to the acquisition, or possible acquisition, of a particular financial product you should read any relevant Product Disclosure Statement or like instrument.

New Zealand

The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (i.e. without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision.

United Kingdom

This document is prepared and provided by Edison for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person.

United States

Edison relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

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In the wake of the release of Edison’s updated long-term gold price assumptions (Shades of the 1970s), we have amended our forecasts for Endeavour, prior to the release of its Q323 results on 9 November. On a like-for-like basis, this has resulted in a 13.7% increase in our absolute valuation of the company to US$33.52/share. On a headline basis, it compares with a valuation of US$36.73/share prior to the sales of Boungou and Wahgnion, a decline of only 8.7%. Following the sale of the two mines, Endeavour updated its FY23 guidance from 1,325–1,425koz (including Wahgnion and Boungou) to 1,060–1,135koz, while its AISC guidance has improved to US$895–950/oz (cf US$940–995/oz). As previously indicated, performance is expected to be weighted towards H223, predominantly Q423, driven largely by Hounde, Sabodala-Massawa and Mana as focus is shifted towards production from development. In the meantime, Endeavour has continued with its shareholder returns programme, declaring a US$100m (US$0.40/share) interim dividend for H123 and repurchasing US$20m worth of shares in Q323.

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