Ian has over 25 years of international experience in management and transactions within the life sciences sector. In addition to his role at F2G, he is currently an Operating Partner of London-based Advent Life Sciences LLP. He has worked extensively in licensing, M&A and market development in the UK, Europe and the US and holds a BSc (Hons.) from University College London and an MBA from Boston University. Ian also holds Board positions at Consort Medical plc, Clinigen Group plc and Bioventix plc.
Biotech and Money recently caught up with CEO Ian Nicholson
- Biotech companies specialising in anti-fungals are uncommon
The relative lack of companies that specialise in fungal infectious diseases is compounded by how little interested has been shown in the research space in recent years due to the rise of anti-fungal resistance, in a pattern mirroring that of antibiotic research.
“We specialise in anti-fungals, which makes us something of a rarity. Although there are a number of antifungal companies, this area of research has in fact been somewhat forgotten for the last 10 or 20 years.”
- F2G’s orotomide anti-fungal agent bypasses anti-fungal resistance
F2G are currently developing orotomides; a class of anti-fungal chemicals that work via a novel mechanism, and are thus impervious to the modes of resistance encountered in many fungal infections.
“What sets us apart is our novel mechanism agent – orotomides – for the treatment of invasive aspergillosis. We believe we are the only company with a novel agent in clinical development for this indication, which is important because there hasn’t been any new class of drugs in this high mortality indication for over twenty years, despite a clear and significant unmet medical need for one.
Why is this? It’s based on two fundamental issues: one is the poor safety and tolerability of the existing agents – in many recent clinical studies between 10 and 30% of patients cannot tolerate any given initial therapy – and secondly there’s the fact there is growing resistance against the azole class, which is the standard route of care for this indication. In certain European countries this resistance rate is now over 25%.
This combination of poor tolerability and increasing resistance in mainstay therapy leads, we believe, to a significant unmet medical need; a need for new agents, such as ours, which can overcome resistance.”
- The growing awareness of an unmet medical need has piqued investor interest
A complex, long-term medical issue such as antimicrobial resistance is not necessarily the most attractive prospect for investors, who do after all wish for an exit at some point within their lifetime. A potential solution to such a problem, however, is an entirely different kettle of fish…
“There are a number of very sophisticated investors in the infectious disease space, and we have been able to garner interest from several. I think this is mostly due to the emergence of resistance: as major pharma has pulled back over the past few years, there’s now a growing awareness that there is a desperate medical need for new agents in both antimicrobials and antifungals. Investors are interested in novel agents with a new mechanism that can overcome cross resistance, as this is where they see commercial opportunity.”
- Development of F2G’s novel mechanism agent is well underway and looking very promising
“The interesting facet with anti-infective development – as opposed to oncology or autoimmune disease – is if you can show that the agent is active in preclinical models, then the agent will generally be effective in man as well. The main question then becomes one of safety and tolerability
– is the agent sufficiently tolerable for use as a drug? I can tell you that we’ve now tested in over 140 human subjects, and we have a very attractive safety profile.
We’ve developed orotomides as both an IV formulation, which has completed phase 1 studies for both single and multiple ascending dose regimes, and an oral regime, which is currently completing phase 1 studies with a view start phase 2 in September. We’re hoping to commence phase 3 studies for this agent around June/July 2017.”
5. This antifungal area is a multi-billion dollar market
F2G’s backers understand the importance of their work, and are investing to secure a piece of their future potential.
“Having achieved agreement with regulators on both sides of the Atlantic for an accelerated path to initial approval for the agent, we have since raised $60 million with a group of top tier investors, which will enable us to complete this phase 3 programme and file for registration.
The current total market size, for both invasive aspergillosis and rare mould indications, is in the single digit billions of dollars – somewhere in the region $3 to 4 billion in our estimation. Having done a lot of research with external consultancies and key opinion leaders, we predict that our drug has the potential to be somewhere between a $500 million and $1 billion agent. There’s a significant commercial opportunity here if we’re successful.”
- CEOs need a clear story if they hope to raise capital
When raising capital, CEOs need to be able to sum up their mission succinctly and poignantly, grabbing the investors’ interests and ensuring them of their expertise in the area.
“I think that having a good awareness of the medical need is critical when it comes to raising capital, along with a strong management team with deep experience in both the biotech sector in general, and the specific therapeutic area. I also think that a clear story and an ability to address not just the scientific/clinical opportunity but also the commercial opportunity, is key to closing significant funding.”
- Instead of seeking out M&A, F2G plan to wait until pharma comes to them
“I don’t think entering a licensing deal is on the horizon just yet. Companies of our sort tend to be bought, not sold, so once we generate sufficient data I suspect we will have interest from both major pharma and major biopharma.
For now, the company is funded to conduct the studies all the way through to registration, and we’re also funded to continue with our research programmes, which we see as being important value drivers for the organisation in the long term.”
- F2G have put a fantastic team in place
F2G have an impressive collection of talent in their management. Their crack team includes senior advisor John Rex, currently at AstraZeneca; chairman Richard Wright, former Head of Infectious Disease Discovery at BMS and Chief Scientific Officer of Vicuron; Tony Kennedy, ex-Head of Roche Global Project Management Group in Basel; Marcus Heap, formally of Novartis; and newly appointed CFO Ralf Schmidt, former CFO and Chief Operating Officer of Nabriva Therapeutics.
“Altogether it’s a significant amount of experience we have around the table!”
- Success is the speed at which this new agent can be brought to market
We asked Ian what success looks like to him, and what long term ambitions he has for F2G. Despite uncertainty of the exact route the company will take, his clear focus and passion for the science at hand is obvious from his response. Which route F2G takes will be based entirely upon how fast it can get their agents to the people who need them the most.
“This is an area of very high mortality, with a desperate need for new agents; even with current therapy, mortality rates are at 20% or above. For me, success would mean rapidly developing the drug and being able to bring it to the market so we can help patients who are in desperate medical need. Whether we do this on our own theme and go down the IPO route or do it with a partner is yet to be seen.”
Founded in 1998, Manchester-based F2G specialises in the development of new treatments for serious fungal infections. As the use of immunocompromising therapies for cancer treatment and organ transplants has increased, cases of fungal infections which typically affect patients with weakened immune systems, such as aspergillosis and scedosporiosis, are on the rise. F2G are well positioned to resolve this unmet medical need: as well as developing orotomides, their novel-mechanism antifungal compounds, F2G boast strong R&D and a successful recent fundraising of $60 million.