“Edison’s accessible and high-quality research gives us the opportunity to communicate an independent perspective of Tyman to a wide variety of potential stakeholders.”
Currency in USD
Last close As at 30/03/2023
USD2.09
▲ 0.05 (2.56%)
Market capitalisation
USD124m
Research: Healthcare
Incannex has announced the completion of a pre-investigational new drug (IND) meeting with the US FDA for its proprietary inhaled drug product IHL-216A for the treatment of concussion and traumatic brain injury (TBI), following submission of the data package in August 2022. According to the company, the FDA has provided detailed feedback and guidance on the most efficient clinical trial development plan to effect successful commercialisation, in particular related to the complexities and specific requirements of developing an inhaled drug. As the next step, Incannex is preparing a follow-up request seeking additional information on the FDA’s recommendations. We see the current development as a positive step towards clinical development for IHL-216A. Our valuation remains unchanged at US$714.7m or US$11.74 per ADR, but we note the upside potential on successful clinical transition.
Incannex Healthcare |
Constructive pre-IND FDA meeting for IHL-216A |
Regulatory update |
Pharma and biotech |
12 October 2022 |
Share price performance
Business description
Analysts
Incannex Healthcare is a research client of Edison Investment Research Limited |
||||||||||||||||||||||||||||||||||||||
Incannex has announced the completion of a pre-investigational new drug (IND) meeting with the US FDA for its proprietary inhaled drug product IHL-216A for the treatment of concussion and traumatic brain injury (TBI), following submission of the data package in August 2022. According to the company, the FDA has provided detailed feedback and guidance on the most efficient clinical trial development plan to effect successful commercialisation, in particular related to the complexities and specific requirements of developing an inhaled drug. As the next step, Incannex is preparing a follow-up request seeking additional information on the FDA’s recommendations. We see the current development as a positive step towards clinical development for IHL-216A. Our valuation remains unchanged at US$714.7m or US$11.74 per ADR, but we note the upside potential on successful clinical transition.
Year end |
Revenue (A$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) |
(1.38) |
0.0 |
N/A |
N/A |
06/24e |
0.0 |
(33.4) |
(2.24) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalized, excluding amortization of acquired intangibles, exceptional items and share-based payments.
IHL-216A is a combination of cannabidiol (CBD) and the anaesthetic agent isoflurane (ISO) designed to be administered soon after head trauma to reduce secondary brain injuries and related neurological deficits. The combination has been shown to deliver superior neuroprotective capabilities compared to CBD alone in animal models of concussion and brain trauma. IHL-216A has been assessed in two separate animal models representing both mild and severe TBI. In a 2020 animal study, it outperformed CBD alone by 53% for cornu ammonis (CA) 1 and 60% for CA2 parts of the brain, demonstrating less neuronal damage relative to CBD alone. In a 2022 study, the combination treatment demonstrated reduced neuroinflammation and better spatial memory restoration than CBD or ISO.
Globally, it is estimated that approximately 27–69 million people are diagnosed with TBI annually and Energias Market Research estimates that the global TBI treatment market will reach US$156.8bn by 2024 (CAGR of 4.8% between 2018 and 2024). Notably, there are currently no pharmaceutical drugs approved for the treatment of TBI, highlighting the sizable market potential for any approved treatments.
In August, Incannex submitted a pre-IND meeting package to the FDA, which included details of the formulation, an overview of the clinical development plan and queries related to filing an IND application. The FDA has confirmed FDA505(b)2 as the relevant regulatory pathway for IHL-216A and provided guidance on the necessary data requirements for IND submission. The 505(b)2 pathway will allow Incannex to leverage pre-existing data for marketed compounds and may expedite future clinical development. Incannex will now seek additional information on the FDA’s recommendations, which will be followed by the IND submission, with the target of commencing clinical trials in CY23.
|
|
Antisense Therapeutics is an Australian biotechnology company developing antisense oligonucleotide (ASO) therapies for the treatment of rare diseases. Its lead asset, ATL1102, is being investigated as a targeted anti-inflammatory therapy to treat Duchenne muscular dystrophy (DMD). In a positive strategic pivot, trial design was amended to a smaller Phase IIb study (n=42 vs 108) that should provide a nearer-term catalyst, if positive readouts are achieved. As a result of the reduced trial costs, the company’s cash runway is anticipated to be extended (net cash at end-June 2022 of A$19.2m) into Q4 CY23. Management envisages a need to raise funds in the mid-single digit (A$m) region, which it anticipates will fund operations to trial readouts in Q124.
Get access to the very latest content matched to your personal investment style.
