We need treatments not just vaccines….
Hello again everybody. Sadly, despite all the vaccine optimism over the past couple of months, Covid infections continue to rise, blighting our lives and impacting economic prospects. Yes, we now have Covid vaccines and therefore some hope that an end to the pandemic is in sight. However, the reality is dawning about the slow and difficult logistics of rolling out the vaccine…
In 2020, my investments in Covid testing companies were very profitable. I didn’t feel I could forecast with accuracy who would win the Covid vaccine race but what I did know with more certainty was that governments around the world would test their populations for Covid and anyway, tests were far quicker and easier to develop! These testing stocks fell sharply in the initial euphoria surrounding the first vaccine launch in November but have since strongly rebounded on the renewed rise of Covid infections and the general feeling that Covid is here to stay for now, despite newly launched vaccines.
A Dearth of Effective COVID-19 Treatments
More was spent on vaccine development last year than in all the past 30 years, with stunningly fast results (thanks in part to new technology and AI). However, it amazes me that we still haven’t developed a really effective Covid treatment. This is despite the huge global focus and the sheer cash that has been thrown at the COVID problem. Really the only existing Covid drugs we have, such as Remdesivir and Dexamethasone, only show marginal effectiveness in reducing the severity of the disease among critically ill patients. After all, if we could cut the rate at which the virus becomes life-threatening with effective treatment, this would go a long way towards helping our hospitals and the World as a whole get back to normal.
Experts have warned that more must be done to develop effective treatments for Covid-19, amid mounting concern that the push for a vaccine has led to a global “deficit of high quality” medicines for the disease. Experts from Wellcome Trust and Unitaid agree that “what we really need are drugs for all stages of the disease.”
Dr Nick Cammack, head of the Wellcome Trust’s Covid-19 Therapeutic Accelerator project into promising therapies, said the World needed “drugs that will stop people having to go to the hospital in the first place, drugs that will, if you’re in the hospital, get you out quickly, or at the very least prevent you from progressing to critical care and intensive care units." He added that there needs to be more “global funding and the engagement of large and small companies” in this space, highlighting that £1.5bn has been pumped into the race for a vaccine, while only £232m has been invested in the research and development of treatments.
“What we do need are other options,” Dr Cammack said. “The pipeline today is bare. We’ve estimated that to provide treatments around the world, it will probably need $7bn (£5.4bn) - a huge number, I know, but compared with a probable $7 trillion (£5.4trn) economic hit, it’s minuscule,” Dr Cammack added.
Janet Ginnard, director of strategy at Unitaid, a global initiative that focuses on pandemics, said that medicines for treating Covid-19 would still be needed "even when we have a vaccine. Treatments and vaccines are complementary. We need both tools,” she said.
In the UK, NHS chiefs have acknowledged that, with the mass delivery of a vaccine still some way off, there is a need to “see better and more effective treatments for the virus as the pandemic continues and changes shape”.
Dr Layla McCay, director at the NHS Confederation, said: “As case numbers rise, and especially those requiring hospital care, new, specific treatments will be important to help to keep people out of the hospital and to treat the virus at different stages.”
Within this context, we can clearly see that there is a huge untapped demand for a more effective Covid treatment. Today I’d like to tell you about a company called Synairgen who I believe has very exciting prospects thanks to their novel Covid treatment. This smaller (£300 market cap) UK business seems to be one of only a handful of investable companies worldwide with a treatment that has been shown in trials to be protective against Covid complications. It has been a stock I have held for most of 2020 but interestingly, Razvan pointed out recently that it was amongst the top five stocks searched for on a popular share platform so I thought it might be of interest to some of you.
What I like about this situation is that their drug - Interferon B - is a long-established drug, therefore has a proven safety profile. Synairgen’s COVID innovation is mainly focused on the delivery of the drug in a new novel way (inhaled into the lungs). From an investment and risk standpoint, using existing drugs in new ways – technically known as repurposing drugs - is an attractive and quicker route to market as there already exists so much patient data, familiarity, and manufacturing capability.
I caution that Synairgen is a loss-making biotech company and therefore a higher risk binary type proposition, but the series of stunning trial results over the past six months means there is now more than an even chance of the company successfully bringing a treatment to market.
Synairgen is engaged in the drug discovery and development of therapies for respiratory diseases, particularly in the areas, including severe asthma, chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF). More recently, they have conducted trials showing promising efficacy of their novel therapies for COVID-19 patients.
Synairgen, a respiratory drug development company, is a specialist in lung disease using Interferon, which is a long-established drug in this space. Interferon beta (IFN-β) is a cytokine protein involved in the body’s antiviral responses as part of the innate immune system. Coronaviruses, such as SARS-CoV-2, are thought to have mechanisms to suppress IFN-β production to evade the body’s immune system and a deficiency in IFN-β production by the lung may explain why certain patients develop severe lung diseases during infection.
Recent Newsflow: Reassuring Trial data, Timeline hastened by expedited FDA approval path
We have had a series of positive and increasingly reassuring trial results over the second half of 2020, all of which is supportive of Synairgen’s drug (SNG001) becoming a novel treatment for COVID-19.
July 2020: Synairgen announced Phase II trial results of SNG001 in COVID-19 hospitalised patients. The double-blind placebo-controlled trial recruited 101 patients from 9 specialist hospital sites in the UK. Patients treated with SNG001 had a 79% reduction in the odds of developing severe disease (e.g. requiring ventilation or resulting in death) during the treatment period, compared to patients who received placebo. Patients who received SNG001 were more than twice as likely to recover over the course of the treatment period compared to those receiving placebo.
September 2020: A fuller disclosure and analysis of the Phase II trial of inhaled interferon (SNG001) in hospitalised COVID-19 patients confirms the earlier optimism.
October 2020: A very encouraging peer review of Synairgen’s trial data in the Lancet, further confirming the company’s promising results.
December 2020: Synairgen announces positive data from an interim analysis of SNG001 trial in COPD patients. SNG001 was well tolerated in this older population with a significant comorbidity (COPD) and showed a strong interferon driven antiviral biomarker response. This positive data is obviously supportive of the SNG001 COVID-19 programme. Importantly, the company also announced that this further data was received favourably by the FDA who have now granted the drug ‘expedited approval status’.
Key Implications from the Trial Results
- The fast-track designation by the US Food and Drug Administration (FDA) for the company’s Covid19 is hugely significant: not only does Fast Track FDA designation mean smaller/shorter/less costly trials needed before approval, but it also means a higher likelihood of drug approval.
- By removing the lower dose arm of the trial, “thereby reducing the number of patients required to complete the placebo-controlled trial from 900 patients to 610” and changing primary endpoints to ‘time to hospital discharge’ and ‘time to recovery’, Synairgen gets to complete its phase 3 trials more cheaply and quickly.
- Company can initiate its smaller phase III trial in the US and dosing is at the same time expected to start imminently in the UK.
- The data is being used to demonstrate efficacy and safety of the drug in patients with co-morbidities, a significant at-risk group in terms of Covid.
- Outside of Covid treatment, the data published shows promising results for COPD. That in itself is hugely important as it’s an enormous addressable market.
Synairgen reported interim results in which the adjusted net loss was £3.9m with period-end cash of £10.9m. The adjusted net loss of £3.9m was up from £1.7m and driven by a 165% (£2.8m) rise in R&D expenses relating to the start of its COVID-19 activities (Phase II clinical trials and manufacturing scale-up) and ongoing Phase II study in COPD. Net cash at 30 June was £10.9m.
In terms of the balance sheet, Synairgen is in good shape, having subsequently raised £80m to fund a Phase III trial for SNG001 in COVID-19 disease, which will be run globally by Parexel, one of the top 20 CRO’s worldwide, with results expected in Q2 2021. Part of the funds are also being spent on scaling up manufacturing ready for launch.
Prospect of Near-Term Revenues from MAP
While we await trial results and FDA approval, there are prospects of near-term revenues from the company’s Managed Access Program (MAP). Managed Access Programs allow doctors and patients access to investigational drugs outside of the clinical trial setting and prior to regulatory approval. Launched with larger partner Clinigen, Synairgen’s MAP seeks to provide SNG001 to hospitalised COVID-19 patients in the UK and Europe and is a significant step towards first commercial revenues before regulatory approval.
Manufacturing scale-up and partnerships in place
Synairgen is already working on putting in place a much larger manufacturing capability. They are partnering with Florida-based Akron Biotechnology to access a second-source supplier for SNG001, in order to be able to fully meet expected clinical and commercial demand for the drug. Together with its current manufacturing partner, Rentschler Biopharma, the aim is to scale production of SNG001 from the current few thousand to c.100,000 treatments per month in early 2021. Benchmarking against existing treatments implies potential best-case revenues of c.$300m per month at that level!
In addition, a device manufacturing partnership with Aerogen (Ireland) is in place to provide its Aerogen Solo and Aerogen Ultra aerosol delivery systems, to deliver SNG001 directly into patients’ lungs. This is a global business with the capacity to supply the necessary volume of devices with operations in the US, China, India and Germany.
Despite the drip-feed of excellent news over the past six months, the share price was absolutely decimated on the new vaccine approval in November, the thinking being that we apparently no longer needed any treatments for Covid, thanks to the vaccine. This has given us as investors an excellent buying opportunity (despite the subsequent partial share price rebound).
2021 forecasts are slowly being introduced to reflect the costs of the Phase III clinical trial, manufacturing scale-up activities as well as potential revenues. Despite these costs and the dilution from the recent placing, a sum of the parts analysis gives a target price (420p) far in excess of current levels, with the probability of SNG001 being commercialised for COVID-19 now seen as rising from 50% to 70% by market analysts. With plans to scale manufacturing to c.100,000 treatment courses per month in 2021, Synairgen is clear in its ambitions. Based on pricing points for Rebif and Avonex and Gilead’s Remdesivir, future supplies suggest significant potential revenues in 2021, giving significant upside to analyst forecasts.
- Synairgen is a higher risk investment in that it is loss-making and has yet to commercialise its lead product
- There can be no guarantee that Synairgen achieves the necessary approvals to commercialise SNG001
- There may be further delays in the trial recruitment process so that the commercialised treatment arrives too late to address the pandemic
- Other better competing treatments may be launched
- The phase 3 trials may show new adverse reactions or lack of effectiveness
- Risk of Manufacturing and logistical difficulties
- Company may need to fundraise if its COVID-19 treatment doesn’t become revenue generating in the expected timeframe
In conclusion, Synairgen is a higher risk investment given its early stage and loss-making nature, but one with significant upside. With full trial data and peer review having now been released, and an expedited FDA approval path now in place, we can be more confident of a commercial product launch. In addition, with product safety seemingly a non-issue and infections on the up all over the World, effective therapy is needed more than ever and, better still, if it can be used both at the hospital and at home before hospitalisation. Even if Synairgen misses the boat on Covid, it is worth remembering that their original disease focus (COPD) is a very large and attractive market to address.
Disclaimer: This information does not constitute any form of advice or recommendation by Pynk One Ltd. and is not intended to be relied upon by users in making (or refraining from making) any investment decisions. Appropriate independent advice should be obtained before making any such decision. When investing, your capital is at risk and you may recover less than the initial investment.