Futura Medical
Guildford, United Kingdom

Futura Medical is a R&D-driven small pharma with a novel proprietary transdermal delivery system, DermaSys, and a lead programme, MED2005, in Phase III development for erectile dysfunction.

www.futuramedical.com

Investment Perspective

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).

Market information

SymbolPrimary exchanges
FUMAIM London

Research

Remarkable data from pivotal trial opens new possibilities
Update | 11 Dec 2019
Are these unprecedented results a major opportunity?
Update | 10 Dec 2019
Elegant and effective treatment for Erectile Dysfunction
Initiation | 25 Nov 2019

Recent News

Top line results from MED2005 Phase III study
10 Dec 2019
Publishes Fireside Chat with Prof Wayne Hellstrom
14 Nov 2019
MED2005 safety and efficacy data at SMSNA
28 Oct 2019
Final dosing of last patient in MED2005 Phase III study
21 Oct 2019
Scancell
Oxford, United Kingdom

Scancell is a clinical-stage immuno-oncology specialist that is developing two innovative and flexible therapeutic vaccine platforms. ImmunoBody and Moditope induce high avidity cytotoxic CD8 and CD4 responses, respectively, with the potential to treat various cancers.

www.scancell.co.uk

Investment Perspective

Scancell reported FY19 results in line with expectations. The cash balance at April 19 was £4.6m, with an initial inflow of £3.9m (gross) from Vulpes Life Sciences post-period. However, the main news is that SCIB1 is back in the clinic, with the Phase II trial in combination with the checkpoint inhibitor pembrolizumab (Keytruda) now underway in the UK. This 25-patient open-label study should produce its first data in H120. The delay in initiating the US study has been frustrating for both the medical community and investors. Other development programmes are progressing as expected and the management team continues to be strengthened. We continue to value the company, using a risk-adjusted NPV model, at £82.0m, or 17.6p a share.

Market information

SymbolPrimary exchanges
SCLPAIM London

Research

A sweet source of financing
Update | 04 Sep 2019
SCIB1 Phase II study starts in UK
Update | 21 Aug 2019
Ground prepared for an important period
Lighthouse | 01 Jul 2019

Recent News

Six posters at the CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference
26 Sep 2019
First collaboration agreement for its new platform technology, AvidiMab
04 Sep 2019
FY19 preliminary results
20 Aug 2019
SCIB1 study update
19 Aug 2019
Hutchison China MediTech
Hong Kong, China

Hutchison China MediTech (Chi-Med), a Hong Kong-based biopharmaceutical company, is on track to become a global leader in the discovery, development, and commercialisation of innovative, highly selective oral tyrosine kinase inhibitor therapies for oncology and immunological indications.

www.chi-med.com

Investment Perspective

Hutchison China MediTech (Chi-Med) H119 results highlight ongoing financial and operational progress. First China NDA filings for surufatinib and savolitinib are on track for H219 and H120 respectively, following in the footsteps of Elunate’s November 2018 launch. Global registration studies of surufatinib and fruquintinib will also initiate in H120. Investment into the maturing China Oncology and Global Innovation pipelines means future R&D spend will continue to grow, but Chi-Med is well-funded with flexibility surrounding future funding options. These are not limited to a future Hong Kong IPO, but include prospects of enhanced revenues from Elunate (post potential NRDL inclusion in Q4) and near-term China approvals/launches, plus possible non-dilutive finance from non-core asset divestment (eg OTC). Our valuation remains $38.55/ADS ($5.14bn) or £5.93/share (£3.95bn).

Market information

SymbolExchanges
HCMNASDAQ/AIM London

Research

Elunate (fruquintinib) secures China NRDL listing
Lighthouse | 29 Nov 2019
Acceptance of surufatintib China NDA in epNET
Lighthouse | 12 Nov 2019
ESMO 2019: surufatinib epNET PFS benefit confirmed
Update | 03 Oct 2019

Recent News

Elunate (fruquintinib) included in the China NRDL
28 Nov 2019
Surufatinib granted FDA Orphan Drug Designation for Pancreatic NET
25 Nov 2019
NDA acceptance in China for surufatinib in non-pancreatic NET
11 Nov 2019
Publication of Phase II data showing promising efficacy for Savolitinib in MET-amplified gastric cancers
17 Oct 2019
Mereo BioPharma
London, United Kingdom

Mereo BioPharma develops and commercialises innovative therapeutics addressing rare diseases. It also has specialty pharmaceutical products that it will partner. The assets are acquired or licensed in at clinical stages from large pharmaceutical companies. The portfolio consists of six compounds that are in clinical development.

www.mereobiopharma.com

Investment Perspective

Mereo BioPharma’s Phase II ASTEROID study with setrusumab in osteogenesis imperfecta (OI) failed to achieve its primary endpoint, but the overall data was compelling. The gold standard for measuring bone mineral density (BMD) and indirectly bone strength, DXA, was a secondary endpoint and this achieved clear positive outcomes. There were significant increases in BMD in various bones, which were materially greater than that seen with teriparatide or bisphosphonates. Consistent with the total BMD data, there was a trend of reduction in fractures (trial not powered for significance). Mereo is now advancing with its plans for the pivotal trial programme, subject to financing. It should also be remembered that there is currently no approved medication for OI. Our valuation is 506p/share or $25.59/ADS.

Market information

SymbolExchanges
MPH/MREOAIM London/NASDAQ

Research

Setrusumab ready to advance into pivotal studies
Update | 25 Nov 2019
Setrusumab set to advance
Lighthouse | 11 Nov 2019
Entering an important 12 month period
Update | 19 Sep 2019

Recent News

Phase 2b ASTEROID study data in adults with osteogenesis imperfecta
11 Nov 2019
FDA Fast Track Designation for Navicixizumab
07 Oct 2019
H119 interims and corporate update
17 Sep 2019
Setrusumab Phase IIb data to be presented at ASBMR 2019 meeting
04 Sep 2019
Nexstim
Helsinki, Finland

Nexstim is a targeted neuro-modulation company that has developed a proprietary navigated rTMS platform for use in diagnostics (NBS) and therapeutics (NBT). NBS is used in planning brain surgery while NBT is focused on depression and chronic pain. FDA approval for depression was given in 2017, and the focus is on commercial roll out in the US, Europe and Asia.

www.nexstim.com

Investment Perspective

Nexstim’s revenues grew by 13% to €1.2m on the back of sales of NBT systems increasing by 170% to €0.6m. The company has only been focused on this marketing NBT in major depressive disorder (MDD) since September 2019. Nexstim increased its installed base of NBT systems by eight to 18 during H119, and appears to be gaining momentum with repeat orders, and progress should be boosted by the White Paper from Island Psychiatry. Sales from NBS systems for pre-surgical mapping were slightly disappointing as sales were pushed back into H219, but careful cost control means that cash burn was as expected. The company had cash of €6.4m on 30 June, and continues to look to strengthen its balance sheet. We value Nexstim at €0.41/share diluted.

Market information

SymbolExchanges
NXTMH/NXTMSHelsinki/Stockholm

Research

Warrants to be topped up with share placement
Lighthouse | 22 Oct 2019
Q319 update shows therapy business momentum
Lighthouse | 16 Oct 2019
A possible new opportunity in severe depression
Update | 09 Oct 2019

Recent News

Four new NBS system orders in October-November
26 Nov 2019
15,687,350 shares subscribed in the directed share issue raising €1.8m gross
15 Nov 2019
Dr Leena Niemistö starts as new Chair of the Board
11 Nov 2019
Approximately 67.4% of offer warrants under Warrant Plan 2019 used for share subscription
06 Nov 2019
Bonesupport
Lund, Sweden

Bonesupport is an orthobiologics company focused on developing and commercialising a pipeline of unique injectable drug-eluting, bioceramic bone graft substitutes based on its proprietary CERAMENT technology.

www.bonesupport.com

Investment Perspective

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.

Market information

SymbolPrimary exchangeCurrency
BONEXOMX StockholmSEK

Research

A second consecutive quarter of record revenue
Update | 18 Nov 2019
All eyes on Q3 following a record Q2
Update | 31 Jul 2019
Building momentum
Update | 07 May 2019

Recent News

CERAMENT BVF CERTiFy study published in The Journal of Bone and Joint Surgery
09 Dec 2019
Appointment of General Manager and EVP Commercial Operations EUROW
12 Nov 2019
Q319 report
07 Nov 2019
Bonesupport presents health economic evidence
18 Sep 2019
MaxCyte
Gaithersburg, United States

MaxCyte has a patented flow electroporation platform, which can transfect a wide array of cells. It generates revenues from the sale and lease of equipment, disposables and licence fees; with an impressive client list. Additionally, a novel mRNA mediated CAR technology, known as CARMA, is being explored in various cancers, including solid tumours.

www.maxcyte.com

Investment Perspective

MaxCyte has signed another multi-product clinical and commercial licence agreement, this time with Vor Biopharma after signing a similar deal with Editas last month. This licence agreement will allow Vor Biopharma to use MaxCyte’s ExPERT flow electroporation instruments to develop and commercialise up to five oncology therapies. The lead therapy is VOR33, and uses engineered haemopoietic stem cells to allow acute myeloid lymphoma (AML) patients to be better treated. The strength of MaxCyte’s technology in enabling novel cell therapies to be developed is also highlighted by the initial data from Vertex/CRISPR Therapeutics with CTX001 in the treatment of beta-thalassaemia and sickle cell disease. We continue to value MaxCyte at £195m (341p/share), but there is now more upside potential.

Market information

SymbolPrimary exchange
MXCT/MXCSAIM London

Research

Commercial licence agreement with KSQ
Lighthouse | 04 Dec 2019
And yet another commercial licence agreement
Update | 21 Nov 2019
Third cohort in CARMA Phase I initiated
Lighthouse | 24 Oct 2019

Recent News

Development and commercial licence agreement with KSQ Therapeutics
04 Dec 2019
Clinical and commercial licence agreement with Vor Biopharma
21 Nov 2019
Phase I with lead CARMA therapy advances to third cohort
24 Oct 2019
Editas clinical and commercial license agreement
07 Oct 2019
Kind Consumer
London, United Kingdom

Kind Consumer has developed a novel nicotine delivery device that mimics the important aspects of cigarette smoking. Uniquely, the Voke device is registered as a medical product, yet it can still be sold easily (General Sales List). Management aims to market Voke directly in the UK, ahead of licensing out for other geographies.

www.kindconsumer.com

Investment Perspective

Kind Consumer is poised to introduce Voke, a novel nicotine delivery device, into the UK market. Voke closely mimics the key aspects of cigarette smoking, but without tobacco’s harmful effects. The notable recent shifts in consumer acceptance of such novel devices suggest market adoption will be positive. The development, regulatory, and production processes have now been completed. Management is seeking funds to execute its commercialisation plans. Our rDCF valuation, using modest assumptions for the UK only, yields a value of £154m.

Market information

SymbolPrimary exchangeCurrency
N/APrivateGBP

Research

No smoke but plenty of fire
Initiation | 11 Oct 2017

Recent News

Appointment of new CEO
01 Jan 2019
Further funding to support manufacturing facilities and commercial launch of Voke
15 Aug 2018
BAT and Kind Consumer announce new approach to commercialise Voke
05 Jan 2017
BerGenBio
Bergen, Norway

BerGenBio is a clinical-stage, biopharmaceutical company based in Bergen, Norway and Oxford, UK. It is developing innovative therapies for aggressive cancers by way of inhibiting the AXL signalling pathway. The lead oncology compound, bemcentinib, is in multiple Phase II trials.

www.bergenbio.com

Investment Perspective

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).

Market information

SymbolPrimary exchanges
BGBIOOslo

Research

ASH data continues to support AML potential
Lighthouse | 10 Dec 2019
Bemcentinib NSCLC data continues to impress
Update | 19 Nov 2019
Refining the route ahead
Lighthouse | 20 Aug 2019

Recent News

Q319 report
19 Nov 2019
Clinical data from Phase II combination trial of bemcentinib and LDAC trial in elderly AML to be presented at ASH 2019
07 Nov 2019
Bemcentinib meets primary endpoint in first cohort of Phase II NSCLC combination study with Keytruda
06 Nov 2019
FDA Fast Track designation for bemcentinib in elderly relapsed AML
22 Oct 2019