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Currency in USD
Last close As at 07/06/2023
USD1.96
▲ 0.03 (1.29%)
Market capitalisation
USD124m
Research: Healthcare
Incannex has released its Q323 cash flow report, providing key operational highlights. Clinical developments during the quarter included a positive interim review of its Phase II Psi-GAD trial (assessing psilocybin for generalized anxiety disorder (GAD)), initiation of the Phase II trial of IHL-675A (for treatment of rheumatoid arthritis (RA)), and continued progression of the BA/BE study for its lead asset IHL-42X (for obstructive sleep apnea). In a new development, Incannex announced the commercial launch of psychedelic-assisted psychotherapy clinics for treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD), with plans to scale across Australia. Though we have low visibility on the prospects of the clinics currently, if they materialize, they may support the company’s cash inflows in the medium term. With a cash balance of A$37.1m at end-March 2023 and at the current quarterly burn rate (A$4.3m), management has guided that operations are funded into CY25.
Incannex Healthcare |
A clinically active quarter |
Quarterly update |
Pharma and biotech |
2 May 2023 |
Share price performance
Business description
Analysts
Incannex Healthcare is a research client of Edison Investment Research Limited |
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Incannex has released its Q323 cash flow report, providing key operational highlights. Clinical developments during the quarter included a positive interim review of its Phase II Psi-GAD trial (assessing psilocybin for generalized anxiety disorder (GAD)), initiation of the Phase II trial of IHL-675A (for treatment of rheumatoid arthritis (RA)), and continued progression of the BA/BE study for its lead asset IHL-42X (for obstructive sleep apnea). In a new development, Incannex announced the commercial launch of psychedelic-assisted psychotherapy clinics for treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD), with plans to scale across Australia. Though we have low visibility on the prospects of the clinics currently, if they materialize, they may support the company’s cash inflows in the medium term. With a cash balance of A$37.1m at end-March 2023 and at the current quarterly burn rate (A$4.3m), management has guided that operations are funded into CY25.
Year |
Revenue |
PBT* |
EPS* |
DPS |
P/E |
Yield |
06/21 |
2.0 |
(8.2) |
(0.83) |
0.0 |
N/A |
N/A |
06/22 |
0.8 |
(14.9) |
(1.25) |
0.0 |
N/A |
N/A |
06/23e |
0.1 |
(20.7) |
(1.43) |
0.0 |
N/A |
N/A |
06/24e |
0.1 |
(33.4) |
(2.10) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalized, excluding amortization of acquired intangibles, exceptional items and share-based payments.
Q323 was marked by clinical progress across Incannex’s clinical pipeline. During the quarter, the company reported a positive interim blinded review (of the first 29 patients enrolled) of its ongoing Australian Phase II Psi-GAD study, projecting a high probability that the trial will show a statistically significant benefit. A review by an independent Data Safety Monitoring Board (of the first 37 patients enrolled) identified no safety concerns and has recommended no changes to the study design. To date, the study has enrolled 55 out of 72 participants.
Following favorable safety data from the Phase I study of IHL-675, Incannex initiated a blinded, placebo-controlled Phase II study in February 2023 for the management of RA. The trial intends to recruit up to 120 patients across sites in Australia and New Zealand, investigating the safety and effect of IHL-675A on pain and function, with trial participants being assessed over a 24-week period. As Incannex is currently preparing for a pre-IND meeting with the FDA, the results of the study, if favorable, could form a key component of the data package.
For its lead asset, IHL-42X, Incannex has been progressing with patient dosing for the BA/BE study (initiated November 2022), which is a prerequisite to pursue the FDA’s 505(b)(2) new drug application regulatory pathway and forms a critical part of management’s expedited clinical development strategy. Incannex now targets the IND application for Q2 CY23, a slight delay from the previous target of Q1 CY23.
In a new development, Incannex announced its plans to commercialize its psychedelic-assisted psychotherapy business (Psychedelic Clinics, 84.5% owned by subsidiary Psychennex). In collaboration with Clarion Clinics Group, this will focus on using psilocybin for TRD and MDMA for PTSD. The first clinic is set to open in Melbourne in September 2023, and if successful, the company plans to expand to larger clinics across Australia.
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Research: TMT
1Spatial’s full year results confirm the solid progress made over the course of the year with revenue growing 11%, recurring revenues growing 21% and EBITDA margins expanding from 15.5% to 16.7%. With momentum continuing into this year, and a healthy order book and pipeline, the company looks well set for 2024. Progress in its key strategic growth pillars – traffic management, US expansion and smart partnerships – looks promising and could accelerate scalable high-margin recurring revenue growth. Investment in key sales hires suppresses our profitability estimates for FY24, but we expect this to start delivering returns in the form of faster growth and margin expansion from FY25.
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