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Currency in USD
Last close As at 02/06/2023
USD5.48
▲ −0.13 (−2.32%)
Market capitalisation
USD391m
SIGA Technologies has shared an update on the progress of three clinical trials assessing TPOXX for treating monkeypox. Recently, three randomized, placebo-controlled trials were launched in the US, UK and Democratic Republic of Congo (DRC) to assess the safety and efficacy of TPOXX in treating patients with monkeypox. The US and UK trials are both aiming to enroll more than 500 participants, while the DRC is targeting over 450. Positive trial results should boost TPOXX order momentum in the US and other nations, as management plans to file with US regulators for a regulatory review of a TPOXX expanded indication for treating monkeypox. We maintain our valuation of $19.80 per share.
SIGA Technologies |
TPOXX trials launched in treating monkeypox |
Update on clinical trials |
Pharma and biotech |
14 October 2022 |
Share price performance
Business description
Analysts
SIGA Technologies is a research client of Edison Investment Research Limited |
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SIGA Technologies has shared an update on the progress of three clinical trials assessing TPOXX for treating monkeypox. Recently, three randomized, placebo-controlled trials were launched in the US, UK and Democratic Republic of Congo (DRC) to assess the safety and efficacy of TPOXX in treating patients with monkeypox. The US and UK trials are both aiming to enroll more than 500 participants, while the DRC is targeting over 450. Positive trial results should boost TPOXX order momentum in the US and other nations, as management plans to file with US regulators for a regulatory review of a TPOXX expanded indication for treating monkeypox. We maintain our valuation of $19.80 per share.
Year end |
Revenue (US$m) |
EBITDA* (US$m) |
PBT* (US$m) |
EPS* (US$) |
P/E (x) |
Net cash (US$m) |
12/20 |
125.0 |
88.6 |
81.5 |
0.81 |
11.1 |
117.9 |
12/21 |
133.7 |
89.7 |
89.1 |
0.91 |
9.9 |
103.1 |
12/22e |
125.0 |
63.5 |
63.0 |
0.66 |
13.6 |
71.8 |
12/23e |
128.1 |
65.6 |
65.1 |
0.72 |
12.5 |
94.2 |
Note: *EBITDA, PBT and EPS (diluted) are normalized, excluding amortization of acquired intangibles, exceptional items and share-based payments.
The US-based trial (Study of Tecovirimat for Human Monkeypox Virus; A5418) is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Trial participants will be adults, including women who are pregnant or breastfeeding, and children. There will also be an open arm that will include children, pregnant/breastfeeding individuals and those who are immunocompromised or have severe monkeypox.
The UK trial, PLATINUM, was commissioned and funded by the National Institute for Health Care and Research and is being led by Oxford University. PLATINUM participants will include adults and children weighing >13kg. The DRC trial, PALM 007, is also sponsored by NIAID and the Institut National de Recherche Biomédicale. Trial participants will include children weighing >3kg and women who are pregnant or breastfeeding.
With about 72,000 global cases and 27,000 in the US, monkeypox remains a growing concern for governments and health agencies. Amid rising cases in the US, monkeypox was declared a public health emergency on 4 August and antivirals remain the first line in easing monkeypox symptoms. SIGA’s antiviral product TPOXX is the leading therapeutic, originally designed to treat smallpox. In the US, TPOXX was approved by the FDA for smallpox and is now available to treat monkeypox through the Centers for Disease Control and Prevention’s expanded access investigational new drug protocol. Currently, it is the only allowed therapy for all orthopoxvirus pathogens, including monkeypox, approved in both the UK (July 2022) and the EU (January 2022).
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Research: Healthcare
Incannex has announced encouraging safety data from the Australian Phase I trial for its anti-inflammatory drug IHL-675A, having successfully completed patient dosing. The study found that IHL-675A cannabinoid combination therapy (cannabidiol (CBD) and hydroxychloroquine (HCQ)) was well tolerated in healthy volunteers with no serious adverse events reported. Following these positive results, Incannex will continue to progress the development of IHL-675A and is now gearing towards the initiation of a Phase II study, initially focusing on rheumatoid arthritis patients. HCQ (Plaquenil) has already received FDA approval for the treatment of rheumatoid arthritis as a monotherapy, so we view management’s decision to prioritise development in this indication as a sensible clinical strategy. Additionally, global sales of rheumatoid arthritis drugs reached c US$30bn (source: EvaluatePharma) in 2021, highlighting the potential opportunity in this target market. We value Incannex at US$714.7m or US$11.74 per ADR.
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