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Currency in USD
Last close As at 25/03/2023
USD1.90
▲ −0.06 (−3.06%)
Market capitalisation
USD124m
Research: Healthcare
The Therapeutic Goods Administration (TGA), the Australian regulatory authority, has announced it will permit psychiatrists to prescribe (off-label) therapeutics containing psilocybin (for treatment-resistant depression, TRD) and MDMA (for post-traumatic stress disorder, PTSD), which we deem to be a landmark decision (effective 1 July). We view this as a step toward softening the stigma attached to the use of psychedelic drugs, which is critical for broader provider/patient acceptance. There is growing clinical evidence of the utility and efficacy of these drugs to treat mental illness, an unmet space characterized by high relapse rates and therapeutic resistance. Incannex Healthcare’s program for generalized anxiety disorders (GAD) is currently in an ongoing Phase II study (Psi-GAD). We note that the FDA has already granted the ‘breakthrough therapy’ designation to two ongoing psilocybin clinical programs in the United States and real-world patient data from Australia may further support regulatory decision-making.
Incannex Healthcare |
On the road to mainstream acceptance |
Regulatory update |
Pharma & biotech |
9 February 2023 |
Share price performance
Business description
Analysts
Incannex Healthcare is a research client of Edison Investment Research Limited |
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The Therapeutic Goods Administration (TGA), the Australian regulatory authority, has announced it will permit psychiatrists to prescribe (off-label) therapeutics containing psilocybin (for treatment-resistant depression, TRD) and MDMA (for post-traumatic stress disorder, PTSD), which we deem to be a landmark decision (effective 1 July). We view this as a step toward softening the stigma attached to the use of psychedelic drugs, which is critical for broader provider/patient acceptance. There is growing clinical evidence of the utility and efficacy of these drugs to treat mental illness, an unmet space characterized by high relapse rates and therapeutic resistance. Incannex Healthcare's program for generalized anxiety disorders (GAD) is currently in an ongoing Phase II study (Psi-GAD). We note that the FDA has already granted the ‘breakthrough therapy’ designation to two ongoing psilocybin clinical programs in the United States and real-world patient data from Australia may further support regulatory decision-making.
Year end |
Revenue (A$m) |
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 |
0.0 |
(20.6) |
(1.35) |
0.0 |
N/A |
N/A |
06/24e |
0.0 |
(33.4) |
(2.12) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalized, excluding amortization of acquired intangibles, exceptional items and share-based payments.
Psychedelics such as psilocybin and MDMA work by stimulating the formation of new neural pathways (brain neuroplasticity) and downregulating the serotonergic 5-HT2A receptors in the brain, which become overactive in patients with depression and other mental health conditions.
Following the TGA’s decision, Australia has become the first country to officially recognize MDMA and psilocybin as potentially clinically efficacious medicines. Under the ruling, psilocybin and MDMA will now transition from being slotted as Schedule 9 drugs (prohibited for patient use) to Schedule 8 or controlled drugs (for PTSD and TRD, respectively), allowing them to be prescribed under certain strict pre-conditions by qualified psychiatrists. Given there are currently no ‘approved’ products containing these psychedelics, usage is likely to be off label for now and limited to the most extreme cases. Lack of reimbursement at present is also likely to restrict usage, although we believe data from these first users would be crucial to inform broader clinical development and regulatory decision-making.
This decision supports the overall development of psilocybin, including Incannex’s program for GAD, in an ongoing Phase II study (Psi-GAD). The study is a triple-blind, active-placebo controlled trial aiming to recruit a total of 72 patients. Patient recruitment began in Q1 CY22 and, as per latest available information, 45 patients have been enrolled, of whom 29 have completed the 10-week treatment protocol. Data from the study will be used to support an investigational new drug application with the FDA. It is estimated that c 6.8 million US adults suffer from GAD (c 3% of the population), with c 50% of the treated cases not responding to first-line treatment, highlighting the significant unmet need in the space.
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Research: TMT
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