Trinity Delta Equity Research & Stock Reports

In an oral presentation at SITC, new results from Cohort A of the Phase II NSCLC trial with BerGenBio’s selective AXL inhibitor bemcentinib and pembrolizumab confirms the potential of the combination. 90% of the 44 evaluable patients in the cohort had PD-L1 low/negative tumours, and yet the objective response rate (ORR) was 25%; <10% would have been expected with pembrolizumab monotherapy. In those patients, who were AXL+ using a new composite score, the ORR was 33% compared to 7% in those classed as AXL-. Cohort A is in immuno-oncology (IO) naïve patients, and there are also two other cohorts in IO-refractory patients ongoing, the results of which will determine the design of the randomised Phase II study planned to start in 2020. We maintain our valuation of BerGenBio at NOK3.21bn (NOK53.13/share).

 View

Bonesupport’s commercially focused strategy has delivered a second successive quarter of record sales, with net revenue of SEK 39.1m achieved in Q319. It was the first full quarter of exclusive US sales (with first sales under major US GPO contracts), and there was a solid performance in Europe/RoW despite lower scheduled surgery rates in osteomyelitis over the summer. Ongoing commercial efforts in the US should benefit from the Healthtrust GPO win, while near-term publication of full CERTiFy trauma data for CERAMENT BVF should have global impact. Management remains on track to deliver 40%+ revenue growth from 2020 onwards, and we maintain our Bonesupport valuation of SEK37/share, or SEK 1.92bn.

 View

Mereo Biopharma Group

▪ The Phase II ASTEROID trial with setrusumab in osteogenesis imperfecta (OI) disappointingly missed the primary endpoint of an improvement in trabecular volumetric bone mineral density (Tr vBMD) of the radius (wrist) measured by HR-pQCT, but did hit various secondary endpoints. ▪ There was unexpected heterogeneity in patient’s trabecular bone baseline values in their wrists (high and low), which contributed to the primary endpoint being missed. ▪ There were, however, significant increases in total vBMD (measured using HR-pQCT) of the radius in both the medium and high dose arms; mean increase in vBMD were 4.11% (p=0.004) with high dose, 4.5% (p=0.028) with medium dose, and 0.58% (p=0.97) with low dose.

 View

MaxCyte

MaxCyte has completed the first two dose cohorts and initiated the third cohort of Phase I trial of MCY-M11, the first CARMA therapy in clinical development. No dose-limiting toxicities, infusion-related adverse events, on-target or off-target toxicities, or other safety concerns have been observed.

 View

NEXSTIM OYJ

▪ The offer period for the 15.6m warrants issued by Nexstim during the April capital raise has opened and will run through until 4 November, with a subscription price for each share of €0.115 or SEK1.24. ▪ The subscription price was based on the higher of a 25% discount to prevailing price (which was c €0.14) or €0.115. ▪ Subscription commitments for c €0.5m (4.1m warrants) have been made by Kaikarhenni Oy, Ossi Haapaniemi, Kalksten Properties Koy, and Capricorn Health-Tech Fund, together with members of the Board of Directors and management of Nexstim. ▪ The warrant offering is fully underwritten, guaranteeing that Nexstim will raise €1.79m (gross) from the warrant offering. There is an agreement with a limited number of existing shareholders and external investors, who will purchase any of the 15.6m shares allocated to the warrant offering that have not being bought, i.e. up to 11.5m shares after the subscription commitments. ▪ The capital raise will, subject to the approval of an EGM, be supplemented by a directed share issue at €0.115/share of up to 9.8m new shares to the group of investors underwriting the warrant offering. This could result in an additional €1.12m being raised, before expenses.

 View

NEXSTIM OYJ

Nexstim’s Q319 trading update confirms growth in both the number of customers and recurring revenues, with rapid expansion of the installed base of NBT (navigated brain therapy) systems and high system utilisation rates.

 View