Fresh from announcing a heavily oversubscribed fund-raise that should ensure it is well-funded until mid-2023, we speak to Evgen Pharma Chief Executive Officer Dr Huw Jones on the growth plans for the clinical stage drug development company.
With a focus on in its core core technology of Sulforadex®, Evgen’s lead product called SFX-01 is showing promise in stopping progress of a number of cancers.
Find out why Dr Huw Jones why believes this could be the start of an exciting era of development for the company and what he’d say to legendary investor Warren Buffett to convince him to invest!
Firstly, can you tell us a bit about Evgen and its valuation proposition?
Evgen is a clinical stage drug development company focussed on the development of sulforaphane-based compounds, a new class of pharmaceuticals which are synthesised in a proprietary, well-tolerated, stable formulation. Sulforaphane is a compound found in nature, particularly the green super foods. Our core technology is Sulforadex®, a method for synthesising and stabilising this compound and we also own novel proprietary analogues based on sulforaphane.
Sulforaphane has attracted enormous interest from scientists, and a considerable bank of data has been generated that shows the molecule has great potential in offering new treatments in some of the most serious diseases. To date though, progress towards new sulforaphane drugs has been limited because the molecule is unstable and without modification would not comply with the strict regulations around new drugs.
SFX-01 though is stable and is the only clinical grade formulation of sulforaphane, protected by an extensive patent family.
Through our work on SFX-01, we have delivered positive headline results in an open-label Phase II trial in 46 for patients with oestrogen-positive (ER+) metastatic breast cancer. Following on from these results and through our own research, we have determined that there are multiple possibilities and uses for SFX-01 including other cancers, acute respiratory disease including but not limited to COVID-19 and a number of non-pharmaceutical applications. Our trial on community acquired pneumonia including COVID patients began last year and we are hopeful that SFX-01 can make a difference to patients with respiratory distress syndrome.
The current climate is presenting challenge and opportunity – how has this applied to the business?
COVID-19 has affected us in the same way as everyone else in our sector although in fairness as a semi virtual company the effect has been fairly minimal. We have had to adjust to some new working patterns and travel restrictions, and this has caused us to make some adjustments in the running of the business. On the positive side, the pandemic has created an opportunity for us to further examine other indications for the use of SFX-01. Our expectations as a management team remain very positive, and we are confident we can fully exploit the opportunities that lie ahead of us.
Following the outbreak of COVID-19, SFX-01 was selected to be part of a randomised Phase II/III trial with the University of Dundee to investigate whether it could be used to reduce the severity, or prevent the onset of, Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19 and other community acquired pneumonia infections. The study is funded by LifeArc after a rigorous selection process that culminated in the choice of SFX-01 as the test treatment. Without going into too much scientific detail, SFX-01 upregulates the Nrf2 pathway which is part of the natural human defence against inflammatory and oxidative stress, such as the inflammation that occurs during a severe viral or bacterial infection. We are hopeful that activating the Nrf2 pathway with SFX-01 will help alleviate the respiratory distress that many patients suffer with community acquired pneumonia or COVID-19 infection.
We are not limited to COVID infections in our collaboration, any patient with pneumonia acquired out in the community, whether COVID-19 positive or not, can be admitted into the study. By 1 February 2021, we had recruited 89 patients to the trial. The Data Safety and Monitoring Board will review the unblinded data on the first 100 patients when this point is reached and at the time of writing, the study remains ongoing.
Also during the pandemic we’ve received compelling pre-clinical data in the most common of the malignant brain cancers, glioma and glioblastoma and we’ve identified with an academic collaborator a new target for SFX-01 that leads us into different areas in the oncology field.
Growth catalysts are crucial to business growth – what do you believe yours are?
As a company we have exclusive rights to the only technology (Sulforadex®) proven to stabilise sulforaphane (in its natural form, a very unstable molecule) in a composition that will satisfy regulatory and medicinal needs for a pharmaceutical and that can be used as a therapeutic. Sulforaphane shows a range of biological activities and health benefits in humans and has been found to have very promising anti-cancer properties, against a variety of cancers such as breast cancer, some rare blood cancers and other cancers that have few treatments and high death rates. In January 2021, we announced that our collaboration with a prominent European university has generated highly positive pre-clinical data for SFX-01 in pre-clinical models of glioma and glioblastoma, the most common form of brain tumour affecting around 5 per 100,000 people.
We have also recently announced strong preclinical data demonstrating that SFX-01 is an inhibitor of SHP2. SHP2 (Src homology-2 domain-containing protein tyrosine phosphatase-2) is a non-receptor protein tyrosine phosphatase that is associated with breast cancer, leukaemia, lung cancer, liver cancer, gastric cancer, laryngeal cancer, oral cancer and other cancer types.
Our constant task is to match the properties of SFX-01 and follow-on compounds with the major unmet needs in cancer and inflammatory diseases. Growth will come from our research showing clear ways forward in these diseases and then partnering with large organisations.
Our IP portfolio is strong, and we have had number of key patents granted.
What are the biggest headwinds you foresee to growth in the coming months?
Like everyone, we believe our biggest challenges lie in the ongoing pandemic and its effects on the business, although we are dealing with this well as outlined in the above questions. The rollout of the COVID-19 vaccines has been well executed, however it is worth noting that our most recent trial in ARDS will remain a condition in its own right long after we have beaten the pandemic and will continue to be a huge problem for patients.
Another big problem for companies of our size is restrictions in capital, however we have just announced a heavily oversubscribed placing to raise gross proceeds of up to £11 million. This is transformative for us, and the proceeds will be used to further the preclinical work for metastatic breast cancer (mBC), glioma/glioblastoma and a further cancer indication yet to be announced, as well as finalising a scaled-up manufacturing process for SFX-01 that could support in-market needs.
Imagine you find yourself in a lift with Warren Buffet, what would your elevator pitch to summarise why he should invest in your business?
We are a growing, clinical stage company with a strong pipeline and excellent data to back up our lead product. Thanks to our recent fundraise, we are well funded through to mid-2023. We have a unique and patented technology that stabilises sulforaphane and allows its use as a regulated medicine. Sulforaphane has immense therapeutic potential, but its inherent instability has to date prevented development for medical use. Our technology solves this problem
Our technology has been recently validated in an out-licensing deal with Juvenescence, a leading nutraceutical company, for non-pharmaceutical applications of our technology..
SFX-01 has shown its potential in stopping progression, and in some cases reducing the size, of tumours in patients with metastatic breast cancer. We have an ongoing late phase clinical trial in patients with ARDS, such as Covid-19 patients, and we have very interesting preclinical data for SFX-01 in other cancers.
Please note: this interview with Dr Huw Jones of Evgen Pharma is part of the ShareBuyers’ going for growth series. This series enables companies with strong growth potential to share their story with retail investors.