Trinity Delta Equity Research & Stock Reports

BerGenBio is steadily accumulating compelling clinical data with bemcentinib in nonsmall cell lung cancer (NSCLC) with pembrolizumab and acute myeloid leukaemia (AML). Its competitive position is being enhanced just as the potential of targeting AXL is being increasingly validated. In NSCLC, bemcentinib appears to significantly boost the activity of pembrolizumab in tumours with normal or no PD-L1 expression. In AML, promising responses have been observed with bemcentinib monotherapy and in combination with low-dose cytarabine (LDAC). BerGenBio is planning to initiate randomised Phase II trials in NSCLC and AML in 2020, though the precise trial design will not be finalised until additional data from the ongoing trials has been analysed. We raise our valuation of BerGenBio to NOK3.31bn (NOK54.20/share).

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NEXSTIM OYJ

Nexstim leaves 2019 in a very different shape to how it entered the year, with its strategic focus firmly on fully exploiting the commercial potential of the SmartFocus NBT system in depression, by leveraging its unique navigation capabilities. The strengthened balance sheet means the company is better positioned to deliver on its new year’s resolutions for 2020 and build shareholder value. Priorities include continuing the growth momentum of NBT, particularly in the US; further building the clinical evidence base in depression and pain through increased usage; concluding the strategic licencing agreement with the leading US academic institution to expand the market opportunity; and securing funding through 2020-21. With commercial and financial progress made over 2019, we raise our valuation to €31.4m (€0.50/share).

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Mereo Biopharma Group

Mereo BioPharma is developing a portfolio of rare disease therapies that have been sourced from larger drug players. An appropriate selection of these will be retained for self-commercialisation. The longer-term goal is the creation of a self-sustaining speciality pharmaceutical company that addresses Orphan and rare diseases. In the near term these clinical assets are progressed to value-inflection points and then partners are sought. The partnering deals will likely be structured to provide funding for the continuing development operations, yet retaining a sizeable element of longerterm upside. The company has a cash runway extending to mid-2020. We have updated our rNPV model to 412p/share or $20.60/ADS (fully diluted).

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Futura Medical

Futura Medical has presented details of the pivotal Phase III study (FM57) results for its lead compound, MED2005. All doses achieved all primary endpoints against baseline (p<0.001) throughout the 12-week period, with secondary endpoints also being met. However, the placebo arm, consisting of the DermaSys formulation alone, achieved similarly impressive results. Dose-dependent variation in side-effects should allay fears that administration errors may be to blame. These data suggest that the DermaSys gel alone has a significant clinical effect across the three severities of ED (Erectile Dysfunction) examined. Clearly the data needs to be digested, but this would appear to open up new opportunities, especially in terms of regulatory pathways, patent life, and commercial potential. Until we have greater visibility, we suspend our valuation and forecasts; for context we valued Futura Medical at £127m (62p a share).

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Futura Medical

Futura Medical has reported the results of the pivotal Phase III study (FM57) for its lead compound, MED2005. Whilst all doses achieved all primary endpoints against baseline (p<0.001) at 12 weeks, there was no differentiation between any active arms and placebo. The placebo arm consisted of the DermaSys formulation and these results suggest that this proprietary gel has an effect comparable to the active arms at all three glyceryl trinitrate doses (0.2%, 0.4%, and 0.6%). This data is clinically relevant and suggests that DermaSys alone may be effective in treating Erectile Dysfunction (ED). Clearly the data needs to be digested before licensing discussions with possible partners continue. Equally, the commercial opportunity, especially the OTC potential, will need to be assessed. Until we have greater visibility, we suspend our valuation and forecasts; for context our model valued Futura Medical at £127m (62p a share).

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MaxCyte

MaxCyte has signed a development and commercialisation agreement for multiple therapies with KSQ Therapeutics (KSQ), the seventh such deal to be signed over the last 15 months, and the eighth since its IPO in March 2016.

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