Research, Charts & Company Announcements
Research Tree provides access to ongoing research coverage, media content and regulatory news on Celyad. We currently have 18 research reports from 2 professional analysts.
Celyad has reported a complete morphological leukemia-free status (MFLS) response in acute myeloid leukemia (AML) in the NKR CAR T-cell THINK study. Spontaneous remission in refractory/relapsed AML is extremely rare, so this is a significant result. Importantly, the response was achieved with no toxic preconditioning. CYAD-01 has shown limited toxicities to date. The clinical strategy has been updated to focus on AML and colorectal cancer. Additionally, with the approvals of Yescarta (Gilead) at a price of $373k and Kymirah (Novartis) at $475k, we have increased our expected price for NRK CAR T-cell therapy to $200k, formerly $150k. The revised strategy and price assumption change moves the indicative value to $122 per ADR, formerly $61 per ADR.
Celyad has reported a complete morphological leukaemia-free status (MFLS) response in acute myeloid leukaemia (AML) in the NKR CAR T-cell THINK study. Given that spontaneous remission in refractory/relapsed AML is extremely rare, this is an important result for natural killer CAR T-cell therapy. Importantly, the complete remission was achieved with no toxic preconditioning. CYAD-01 has shown limited toxicities to date
The development of Celyad’s natural killer (NK) receptor-based CAR T-cell therapy (NKR-2/CYAD-01) has taken an important step with the initiation of the SHRINK trial, which moves NK CAR T-cell therapy towards the 90%+ of cancer patients who do not have CD19 or BCMA tumors. CYAD-01 is already being tested in THINK with five solid tumor types plus AML and MM. Promising THINK results have been reported at the lowest dose. Celyad has paid $25m in cash and shares to reduce the royalties payable on potential short-term deals and long-term sales. Our indicative value of Celyad has been revised to $616m or $61 per ADR.
The development of Celyad’s natural killer (NK) receptor-based CAR T-cell therapy (NKR-2/CYAD-01) has taken an important step with the initiation of the SHRINK trial, which moves NK CAR T-cell therapy towards the 90%+ of cancer patients who do not have CD19 or BCMA tumours. CYAD-01 is already being tested in THINK with five solid tumour types plus AML and MM. Promising THINK results have been reported at the lowest dose. Celyad has paid $25m in cash and shares to reduce the royalties payable on potential short-term deals and long-term sales. Our indicative value of Celyad has been revised to €524m or €51.6 per share.
Novartis has taken a non-exclusive licence to Celyad’s granted allogeneic US patent for $96m (an upfront fee, we assume $12m, and milestones) plus single-digit royalties. Novartis, a leading player in the haematological CAR T-cell cancer area, presumably aims to expand out of the limited autologous ALL indication where it has a filed BLA. The $96m deal sends a clear signal to other CAR T-cell companies to license quickly or risk being locked out of any allogeneic mass market until 2031. Celyad already has an allogeneic deal with ONO in Japan and Asia. Our indicative value has moved to €52.25 per share, formerly €45.
Celyad has provided an update on its trial plans and announced 2016 preliminary results. The THINK Phase Ib trial is a major expansion of CAR therapy with five solid tumours plus AML and MM being explored. The THINK dose escalation results are expected in Q417 with six-month efficacy results possible from H218. The colorectal, SHRINK trial starting in Q2 will explore combining NKR-2 therapy with chemotherapy. The Q3 LINK trial will explore direct delivery of NKR-2 cells to metastatic liver tumours. The move into solid tumours puts Celyad in a leading position. Our interim indicative value remains at €45 per share. Cash remains strong at €82.6m.
Celyad has enrolled the first patient the Phase Ib THINK study. The THINK Phase Ib trial is a major expansion of CAR therapy with five solid tumors plus AML and MM being explored. The first patient has colorectal cancer, a key move into solid tumors, and will be dosed at 3 x 108 autologous cells. In the previous Phase I study, one patient at the highest 3 x 107 dose showed unexpected signs of efficacy. The US allogenic CAR patent has been confirmed. Our interim indicative value remains at $50 per share.
Celyad has reported at the American Society of Haematology (ASH) conference that the last treated patient from the three patient 30m cell dose cohort had stable AML disease for 12 weeks after NRK-2 treatment. Laboratory tests also indicate that responses to therapy were seen. The single dose used is 100x lower than the expected NKR-2 effective dose assessed in animal studies. Some other patients at lower doses also showed prolonged survival with unanticipated responses to other treatments despite their aggressive disease. Overall safety was good and importantly no cases of cytokine release syndrome, neurotoxicity and autoimmunity were observed. The new THINK Phase Ib trial is a major expansion of CAR therapy with five solid tumours plus AML and MM being explored. Our interim indicative value remains at €45 per share.
Celyad has noted that the Phase I safety study on its NKR-2 CAR T-cell autologous therapy produced some “reports of clinical benefit”. The THINK Phase Ib trial has been approved in Belgium and awaits FDA clearance. This is a major expansion of CAR therapy with five solid tumours plus AML and MM being explored. As a result, we have raised the probability of success to 20% from 18.5%. There is a challenge to the granted 2009 US patent on allogeneic CAR T-cells. While the claim is being re-examined, the patent remains in force; other patents and patent applications provide protection. Edison’s interim indicative value has been rebased and increased to €45 per share, formerly €41 per share.
The Japanese pharmaceutical company ONO is jumping a therapeutic generation by licensing Celyad’s allogeneic preclinical NKR-T cancer cell therapy for Japan, Korea and Taiwan. Allogeneic NKR-T has the same action as the Phase I/II NKR-T autologous product; allogeneic versions could be mass produced and provided “off the shelf”. ONO paid €11.25m cash with €270.75m possible in milestones plus royalties. NKR-T is being tested in two haematological cancers with trials in solid tumours planned for early 2017. On an interim basis, until more data on NKR-T and C-Cure are available, the indicative value moves from €32 to €41 per share.
And then worst of all, you never get approval when you say you will. There is nothing that causes investor whiplash more than a sudden announcement of an unsuccessful clinical trial. Whether you are the onedrug wonder on AIM or the multi-drug portfolio NASDAQ darling, the market never takes too kindly to unsavoury news from the FDA on clinical results. But should investors lambast these two scenarios similarly based on poor trial results? The variables are endless but in this example the clear answer is no. Investors who invest in one-drug companies edging ever closer to FDA decision day do not have much cause for complaint as they are rolling the dice. But what of the company with many drug candidates in the clinic? Surely the usual knee-jerk reaction of a mass selloff is not rational when a company has a singular failure amongst a well-developed and advanced portfolio?
Companies: AZN BTG CYAD CIR ETX GSK GTCL GWP INDV SHP VER VRP
Celyad’s Phase III CHART-1 study in cardiac regeneration missed its primary endpoint, but a clinically defined subgroup with 60% of patients saw a positive outcome, p=0.015. Celyad management believes data are robust enough to discuss submitting a conditional marketing authorization to the EMA for European approval. Data on the CHART-1 composite endpoint will be presented on 28 August 2016. The US Chart-2 trial with a new endpoint and EDV focus will run if partnered. On the basis of limited data, the indicative value has been revised from $96.8 to $35.2 per share.
Celyad’s Phase III CHART-1 study in cardiac regeneration missed its primary endpoint, but a clinically defined subgroup with 60% of patients saw a positive outcome, p=0.015. Celyad management believes data are robust enough to discuss submitting a conditional marketing authorisation to the EMA for European approval. Data on the CHART-1 composite endpoint will be presented on 28 August 2016. The US Chart-2 trial with a new endpoint and EDV focus will run if partnered. On the basis of limited data, the indicative value has been revised from €88 to €32 per share.
Celyad can now move to the highest planned dose of 3x107 cells in the important NKR-2 Phase II CAR trial. If the next 30m cell dose is also safe (and the MTD) it will lead to two separate six patient open label studies in Acute Myeloid Leukemia and Multiple Myeloma. Further data is possible in late June. Efficacy indications in either of these could enable a series of solid tumor exploratory studies. The advantage of the NKR-T immuno-oncology approach is that it is easily transferred to multiple cancer types. FY15 accounts were as expected with year-end cash of $122m.
Celyad can now move to the highest planned dose of 3x107 cells in the important NKR-2 Phase II CAR trial. If the next 30m cell dose is also safe (and the MTD) it will lead to two separate six patient open label studies in Acute Myeloid Leukaemia and Multiple Myeloma. Further data is possible in late June. Efficacy indications in either of these could enable a series of solid tumour exploratory studies. The advantage of the NKR-T immuno-oncology approach is that it is easily transferred to multiple cancer types. FY15 accounts were as expected with year-end cash of €108m.
Research Tree provides access to ongoing research coverage, media content and regulatory news on Celyad. We currently have 18 research reports from 2 professional analysts.
The latest Office for National Statistics (ONS) survey, ‘Ownership of UK quoted shares: 2016’, shows that retail investors are more important than most company managements realise or most capital markets professionals admit. When it is also appreciated that the data shows that retail investors set the share price for most quoted companies, most days, it becomes clear that engaging with such an audience enhances a company’s standing, whilst ignoring them courts disaster.
Companies: OPM ABZA AVO AGY APH ARBB AVCT BUR CMH CLIG COS DNL EVG EHP INL MCL MUR NSF OBT ODX OXB PPH NIPT RE/ REDX SCLP SCE SIXH TRX TON VAL
A look back at our 2017 ideas In aggregate our analyst picks outperformed the FTSE All Share last year by 9% and the cumulative performance of our portfolio over 6 years would have given a total return of 300% (almost double the return on the FTSE All Share). In addition, many of our top-down themes played out very well such as our focus on secular growth in Tech, Life Sciences, Healthcare and Financials, an increase in M&A, our cautious stance on the Consumer and especially our bet on continued strength in the Industrials last year and solid growth in the global economy. What does 2018 have in store? We continue to play ongoing secular growth themes in Tech, Life Sciences, Healthcare and Financials. In addition, we tap into domestic areas of cyclical strength such as regional construction and house building, plus self-help initiatives and potential market share gains. We maintain a favourable view of Industrials given the global economic backdrop but think this could moderate during the year. Other changes of nuance include the potential for a better H2 in the Consumer sectors, which remain under pressure for now, and a better outlook in Media from a mini-quadrennial year in 2018.
Companies: AMO AVG CBP CVSG DNLM EKF FENR IOM SAA GLE PURI SFR PGIT PURI SFR SOG VRP
Today’s update confirms a financial performance for H1 in line with expectations. We continue to believe that the recent acquisition of Quantum Pharma added a number of growth opportunities, and that the Group’s mid-teens growth is sustainable over the medium term, backed up by strong cash generation, which again was ahead of expectations for the period. We reiterate our Buy recommendation and 1,225p target price.
Companies: Clinigen Group
The AIM Healthcare index has shown positive returns in all but three out of the past 11 years (2007, 2008 and 2011), growing at a CAGR of 7.6% over the period. This compares with a CAGR of -0.3% for the broader FT AIM All Share, +0.6% for the AIM 100 and +3.5% for its more senior FT All Share Health index. Sector growth and relative performance to the AIM All Share index has accelerated over the past five years; the sector having risen 19.19% CAGR since 1 Jan 2012. This compares with 6.8% growth in the AIM All Share and 6.1% in the FT All Share. This outperformance can be attributed to the increasing success amongst the Healthcare constituents which have progressed their business plans to a point where substantial value has been/is being created and where many companies have successfully scaled their businesses to sustain future growth. We highlight four companies that have different business models but exemplify the opportunities that are increasingly becoming evident within the sector.
Companies: ABZA AKR AGY APH AGL AVCT BVXP COG CTH IHC LID MTFB ODX OPTI NIPT PRM SDI STX SNG TSTL
In its healthcare conference, Shire slashed its 2020 sales forecast from $20bn (given two years back) to $17-18bn and also pushed out the strategic review of the neuroscience (ADHD) business to H2 18. Until the final decision on the review, it will be restructuring the group into two businesses – rare diseases (accounting for 70% of the group sales) and neuroscience. Post the review, Shire will decide whether to keep the businesses under one roof or go for other options such as a separate listing. It also announced a more specific debt target – a Net Debt to EBITDA (non-GAAP) ratio of below 2.5x by the end of 2018 vs 5x in 2016.
In our third edition of Trend spotting we stick with our suggestion at the end of March to up European exposure and we review the recent market moves and macro trends. We comment on the recent strong performance of our growth, quality and momentum styles which we expect to continue and we examine what happened to sectors around the last general election period in 2015, adding some new colour.
Companies: AUG GNS IQE NTG SDL SPH SDY TRI VEC XAR GHT BOY CRW EMIS VCT ECK GLE GHH DATA AVON CHH DPH HILS SDM ZYT MUR RPS LWB EKF SUN UDG SYNT CINE DOTD MPM FUM CLIN RENE ATQT SERV ERGO BCA BUR DRV SCS JUP FDP GBG GTLY HW/ EAH SFR PHD CXENSE KNOS NETD G4M GFIN ULS RHL RAT FEN LOOP MYSL FUTR
A further strong trading update for FY17 has prompted further double digit PBT/EPS upgrades this morning, adding to the strong forecast momentum experienced in recent months. The core Biodecon activities are benefitting from the improved commercial focus and this is now being seen strongly in the reported financials, which are beginning to look increasingly attractive in terms of growth, margins and cash generation. Net Cash reached £14.5m at the year end, increasing the scope for some kind of further returns to shareholders. We see intrinsic value of 300p+, with further upside scope on growth, forecast outperformance and possible cash returns.
Following Vectura’s recent trading and strategy update, we have updated forecasts principally to reflect lower expected R&D expenditure, partially offset in valuation terms by later expected VR315 approval and launch. We note that the stock has risen 29% since our upgrade to Buy on 10th November at 90.7p. Our revised target price of 120p (from 113p) leaves limited upside from current levels. We downgrade to Hold.
Companies: Vectura Group
ECO Animal Health has received its seventh Aivlosin® marketing authorisation of the year with the most recent being in the Philippines in chickens laying eggs for human consumptions in a water soluble formulation. The Philippines is the fourth most important egg producing country in South East Asia and seventeenth globally. ECO Animal Health continues its global roll out of Aivlosin® for commercial layers after it was first approved in a water soluble formulation for the treatment of layers in Europe in 2016. We re-iterate our positive stance and continue to expect Aivlosin® to generate strong growth in multiple geographies.
Companies: Eco Animal Health Group
BMK has updated on overall FY17 sales being c. £138m – in line with market expectations and equivalent to 26% growth over FY16.
CVS Group (CVSG LN) - Move to strengthen the Board CVS has moved to strengthen the Board by appointing Deborah Kemp as a Non-Executive Director from immediate effect. Deborah brings a wealth of experience of working in multi-site consumer facing businesses both from an operating, M&A and property development perspective – features which are all relevant to CVS going forward. Notably, her career has involved serving as CEO of Laurel Funerals from 2010-15, Chief Operating Officer at De Vere Hotels & Resorts from 2009-10 and a lengthy period at Punch Taverns plc culminating in being the MD of the leased business. Since 2015 she has been a director of Vennco Limited, a consultancy specialising in consumer businesses and in September 2017 became interim CEO of private equity backed Synseal Group. Overall, we view this as a positive appointment in light of CVS’s rapid growth in recent years and as it looks to move to the next phase of development. Following this appointment the Board of CVS now comprises two Executive Directors and two independent Non-Executives and a Non-Executive Chairman. We continue to be positive on CVS and see the recent share price weakness as a rare buying opportunity into a structural growth story. We anticipate LFL sales newsflow to improve in 2018 as it laps softer comps and self-help measures kick in. This is an important catalyst. Fundamentally the veterinary industry is attractive and CVS is very well positioned to capitalise on its leading market position and service/geographic diversity to double earnings over the next 5 years. We see a cal’18 P/E of 22x (ex further consolidation) as attractive and argue for fair value >1300p on a 12m view. Gresham Technologies (GHT LN) - Significant CTC win in the Nordics Gresham Technologies won a significant contract win with one of the largest financial services groups in the Nordic region. The bank will use Clareti Transaction Control (CTC) as part of a modernisation programme in its wholesale banking operations The contract has an initial value of approximately €2 million, around half of which is immediately recognisable (contributing in 2017), with the remainder to be recognised over the initial five-year term of the contract. This is another good win for CTC, following on from a number of significant wins in 2017, leaving us confident of its prospects. Summit Therapeutics (SUMM LN) - Discuva acquisition enhances infectious disease offering Summit has acquired Discuva and its research and development platform for the generation of differentiated antibiotic compounds for a total consideration of £10m in cash and shares. Summit will aim to generate a pipeline of new mechanism of action antibiotics to address serious infectious diseases and expand its pipeline in this area. The group’s infectious disease pipeline currently includes its flagship antibiotic candidate ridinilazole for the treatment of C. difficile infection (CDI). Summit is on track to commence two Phase III trials evaluating ridinilazole vs. vancomycin in H1 2018. We remain very excited about Summit’s potential and welcome this sensible bolt-on.
Companies: CVSG GHT SUMM
In January Glycotest announced that it had completed a 149-person Chinese retrospective study of its test for hepatocellular carcinoma (HCC). It demonstrated 93% sensitivity at 92% specificity, which is superior to the commonly used alpha-fetoprotein (AFP) test. Additionally, ProAxsis announced continued commercial progress with the CE mark of a ProteaseTag research kit for a new enzyme, plasmin, which may have utility in inflammatory conditions of the lung.
Deltex has announced the addition of a major new hospital account in the US. The hospital is a well-known and highly regarded university teaching facility ranked in the top ten hospitals in the US and is the flagship site of a six-hospital healthcare network so this is an important strategic step for Deltex in the US.
Companies: Deltex Medical Group
Motif Bio (LSE: MTFB), is a late clinical stage antibiotic development company. This morning the company reported its final results for the year ended December 31st, 2015 with a cash balance of $28.6m. Motif’s lead drug candidate, iclaprim, is in phase III clinical trials for serious and life threatening bacterial infections, particularly those caused by drug resistant bacteria. Iclaprim, a next-generation antibiotic targeting an under-utilised mechanism of action, causes rapid killing of bacteria making it an attractive candidate for acute infections caused by antibiotic-resistant species. In total Motif raised £23m net of expenses in 2015 enabling it to advance iclaprim into phase III clinical trials. With iclaprim approval and launch on-track for 2018 our risk-adjusted fair value estimate for Motif Bio is £189m (174p per share).
Companies: Motif Bio
AFPO Memorandum of Understanding, AAU Quarterly Newsletter, ATQT Directorate Change, COS Participation, FITB* Board Changes and Appointment of CEO, G4M Trading Update, MARL* Exercise of Warrants, Termination and CPR, MDZ* Final Results, MXO* Nigerian Update, OPTI* Half Yearly Report, PEG* Directorate Change and Half yearly Report, PLI* Expansion of Phase II, SVR Award and Patents, STEL Licence Application, ZEG Intention to Move to Official List
Companies: AFPO AAU ATQT COS KIN G4M MDZ MXO OPTI SVR ZEG STEL MARL