Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
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Evgen Pharma raised £11m to fund/progress SFX-01 to key valuation inflection points that will provide a cash runway until at least mid-2023.
LifeArc’s selection of SFX-01 and funding of a 300- patient Phase II/III trial in Acute Respiratory Distress Syndrome (ARDS), including COVID-19 patients, is a significant endorsement of SFX-01’s potential value, with near-term interim safety and futility data analysis expected in Q2 2021.
Additionally, Evgen should have potentially three Phase II-ready programmes by
year-end 2021, a platform technology that can translate into further investigator led studies and a royalty stream from the application of Sulforadex as a delivery vehicle in non-pharma applications (up to $10.5m milestones plus royalties).
With this number of shots on goal, any one of which would be significant, we increase our SOTP rNPV-based target price to 29p with a bear/bull scenario of 15-52p.
Placing raised £11m by way of the issue of up to 137.5m shares at 8p, representing 50.0% of the enlarged equity.
Net funds will be used for
(i) additional preclinical studies,
(ii) a glioma clinical trial,
(iii) formulation and scale-up manufacturing for SFX-01 and
(iv) work to file an IND for SFX-01 in the US.
This will provide a cash runway to mid-2023 and through multiple valuation inflection points.
Novel molecule that has been shown to directly modulate at least three unrelated
mechanistic targets; Nrf2, STAT3 and more recently SHP2, resulting in Evgen targeting four diseases in cancer and inflammation, all with high unmet clinical needs.
Acute Respiratory Distress Syndrome (ARDS) +/- COVID-19
The trial design includes an assessment of safety and futility by a Data Safety and Monitoring Board ("DSMB") who will review unblinded data on the first 100 patients treated. In addition to the DSMB safety and futility assessment, Dundee University ("the Sponsor") has decided to review the top-level unblinded data in a preliminary assessment of possible efficacy.
This may lead to adjustments to the design of the trial for remaining patients, including in patient numbers, and possibly early termination for either safety, futility or alternatively, strong efficacy. It is expected that this initial data will be available during the second quarter of calendar 2021.
The Sponsor has also requested that the DSMB review data from the first 60 patients solely for safety and this process will be starting shortly. The outcome of this is expected to be available in early Q2 2021.
Pre-clinical data updates in H1 2021 should provide the clarity for Evgen’s positioning of SFX-01 in breast cancer (eg. CDK4/6 resistant tumours), glioma (brain cancer) and a third undisclosed oncology indication and the evidence to partners for monetisation events.
Not without risk, but multiple shots on goal provide investors substantial upside potential, given the number of opportunities that exist for monetising SFX-01 and Sulforade