Research, Charts & Company Announcements
Research Tree provides access to ongoing research coverage, media content and regulatory news on Celyad. We currently have 20 research reports from 2 professional analysts.
Celyad has reached the potentially crucial three billion natural killer receptor (NKR) CAR T-cell dose (CYAD-01) in acute myeloid leukaemia (AML) with the first patient showing no signs of toxicity. If responses are seen in several patients, an expansion phase could start; a strong response was seen in November at the 300 million cell dose. Interim data are promised by Celyad in late 2018, probably at ASH. There are now several studies running or starting including using two courses of CYAD-01 in AML (after an initial response), evaluation of conditioning therapy with AML and combinations of CYAD-01 with chemotherapy in colorectal cancer. The indicative value remains at €1,040m, €84 per share.
The placing has given Celyad a cash boost of €46.1m gross adding to the €34m on 31 December 2017. Celyad is designing a set of sophisticated clinical trials to expand understanding of its novel NKR CAR T-cell therapy. The THINK study, focused on AML and colorectal cancers, showed a near complete response (CR) in AML in Q417 plus two other AML responses and two colorectal stable disease cases. The highest THINK dose range should complete in H218. The SHRINK study, NKR CAR T-cells plus chemotherapy in metastatic colorectal cancer (mCRC), has dosed its first patient. The indicative value has been adjusted to €1040m, €85 per share.
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.
Research Tree provides access to ongoing research coverage, media content and regulatory news on Celyad. We currently have 20 research reports from 2 professional analysts.
In January, we highlighted the progress that AIM had made in H2 2017. We now review the performance in H1 2018. The latest AIM Statistics published on Friday showed that there are currently 944 companies, with 38 new issues so far in 2018, raising £781m and secondary issues raising a further £2.4bn. However, with 51 companies cancelling their listing there was a net fall in H1 2018 of 13 companies. That said, new listings appear to have accelerated recently. In Share News & Views, we comment on Braemar*, Cohort, Cropper*, GetBusy*, IG Design, Lakehouse* Porvair and Wynnstay Group.
Companies: AOR APC BMS CRPR DMTR ECSC ESC EUSP FDM GETB PCF SNX TCN W7L
In Q2, UK equities regained some of their poise after the draw down in Q1, although uncertainty around Brexit continued to grab the headlines. On the back of this, investor concern about the UK economy has been understandable in recent months given a number of negative data points. However, we see reasons for optimism for UK Plc with wage growth supporting an improving outlook for the consumer and business investment holding up. That said, continuing UK political disruption clearly remains a risk going forward.
Companies: AMER EMR HMI JOG PDG ABBY AMS AVON BLVN PIER CGS CALL CSRT TIDE DTG DEMG ELM EMR FPM FPO GTLY GENL GOR GEEC HDY HMI HAYD HEAD HILS HTG HUR IBPO IOG INDI JHD JOG LAM MACF MKLW NAH OXIG PCA PKG CAKE PDG RBW REDD RSW RNO RKH ROR SUS SCPA SHG SIV TRAK TRI VTC ZTF
Having completed the transformational Vocare acquisition and added to its already well experienced management team, Totally is now tasked with grasping a very significant opportunity within UK healthcare. The NHS' direction of travel has been to address the impact of non-acute presentation at its hospitals. Totally is committed to building a business which provides this triage and a range of support services including, but not limited to, urgent care. While the company has not yet completed the “buy” component of its “buy and build” strategy, it has made significant strides while retaining a key cash generative quality. Final results, for the 15-month period to March 2018, highlight great progress and prospects. We believe that the share price does not reflect this, offering an equity value only just over the current net cash position. It is time for the market to reflect on the prospects for a unique company operating in high growth markets.
ReNeuron ended FY18 with a healthy cash balance and the 11 July announcement of an exclusivity agreement worth up to US$5m with a US specialty pharmaceutical company for the evaluation of ReNeuron’s hRPC platform now leaves it well-funded through to FY20. A key milestone is the imminent start of the US Phase IIb PISCES III placebo-controlled study in chronic stroke disability, which heralds the later stages of clinical development for ReNeuron.
Companies: Reneuron Group
Best Ideas - 2018 H1 Review
Companies: SAA VP/ GLE AMO IOM HSP CVSG EKF PGIT VRP RLM AVG SOG DNLM SFR YU/ CBP
We have analysed every IPO on the London Stock Exchange (LSE) between January 2015 and February 2018. Our analysis proves that, as expected, liquidity does dry up after float. The scale varies between markets and sectors.
Companies: OPM AGY ARBB AVCT BNO CMH COS DNL EVG GTLY GDR INL KOOV MCL MUR NSF OXB PHP RE/ REDX SCLP SIXH TRX TON VAL W7L
Bioventix reported a strong set of interim results, with EPS rising 40% boosted by the unexpected inclusion of £0.8m of back-dated royalties from one of its customers. Underlying revenue growth was still robust, rising 13% (c.18% at constant exchange rates (CER)), driven by both Vitamin D antibody sales/royalties and other antibodies which offset a c.£0.4m reduction in revenues from one customer following the termination of the licence. This, in turn, led to a 39% increase in pre-tax profits and a 40% increase in adjusted EPS. An interim dividend of 25p was declared (+25%) with net cash at period end of £5.6m (excludes £0.8m of back-dated royalties). We have increased FY 2018 EPS by 15% to take account of the back-dated royalty and 2019 by 2%, which reflects the underlying performance. Consequently, we raise our target price to 2650p, at which level the stock trades on a 26.5x FY 2019 P/E and an EV/EBITDA of 20.1x.
Totally has reported results to 31 March 2018, a year in which it made the transformational acquisition of Vocare. Underlying, we believe the 15-month period was largely in-line with our expectations, though are affected by the unusual reporting period and significant exceptional write back. Separately the group has invested heavily in its quality systems and processes which is reflected in the improvement in its CQC ratings. Work remains to be undertaken on integrating Vocare, although we believe the company has made significant progress and is set to win new contracts and assess M&A opportunities. We maintain our Buy recommendation.
A trading update for the year ending 30 June 2018 indicates revenues of £68.3m, some 2.5% (£1.8m) below our forecast, although the 0.7% market share increase during a weak pollen season underlines the continued positive momentum of its franchise. However, with costs in line with expectations and working capital benefits, year-end cash was £3m better than our forecast, coming in at £15.5m (net debt of £12.4m). We keenly await the Phase III European Birch trial results, which are still expected to report in August. We make modest changes to our forecasts (-£0.5-0.6m at the pre-tax level) but retain a target price of 47p.
Companies: Allergy Therapeutics
In its Q1 18 trading update, Hikma put on a brave face and maintained its FY 18 guidance – group level. The injectables business is expected to deliver sales of $750-800m, but the core operating margin is likely to retreat to low-to-mid 30s from the earlier level of the 40s, as the shortage-driven growth moderates and pricing power diminishes. The pressure in the generics business is unlikely to dissipate with additional expenses towards repeat trials for generic Advair Diskus. FY18 revenue is likely to come in at $550-600m, with core operating margin in the low single-digits. The branded segment, as usual, is expected to be H2-heavy with the full-year revenue growth expectation of mid single-digits.
Companies: Hikma Pharmaceuticals
We upgrade AVO to OUTPERFORM with a fair value of 155 GBp. The company has significant growth potential in the nascent Proton therapy ("PT") industry. The dented growth trajectory from the industry leaders in PT signals the limitation of the conventional cyclotron technology in PT. We are encouraged by AVO's technology to benefit from this bottleneck through delivery of a better and easier-to-install technology with its PT Linac. Execution on scaling up production will easily lower machine prices and therefore represents a significant opportunity to expand margins on the services business, which will remain at a higher price level. We are also encouraged by an upgraded management team, which is experienced in installations, service and sales - OUTPERFORM.
Companies: Advanced Oncotherapy
When we last published the FTSE 100 was reaching an all-time high of 7877. We have subsequently seen increased volatility and some of the previous progress made by markets surrendered. The escalation of the potential trade war between the US and China and the imposition of more tariffs has unnerved markets. At home, we have continued to see M&A activity. While company results have largely been as anticipated, the outlook in some sectors looks less promising. In Share News & Views, we comment on Aortech*, ECSC*, Location Sciences*, Norcros, NWF, Tricorn* and Warpaint London*.
Companies: AOR APC BMS CRPR DMTR ECSC ESC EUSP FDM GETB LSAI SNX SPRP TCN W7L
As indicated in its recent trading statement Collagen Solutions revenues for FY18A were below FY17A. While this is clearly a disappointing result we believe it masks a number of positive underlying trends which point to an improving performance in future years. Four customer issues affected FY18A revenues; offsetting these to some extent was a >200% increase in Development revenues which in conjunction with 16 new customers secured, points to improving future performance. We re-instate our Buy recommendation on the stock.
Companies: Collagen Solutions
We initiate coverage of Mauna Kea Technologies with an OUTPERFORM recommendation and a target price of €4.10 per share. Mauna Kea is a commercial stage medical device company headquartered in Paris, France. The company's main product, Cellvizio, is a market-leading confocal laser endomicroscopy system used for in-depth analysis of cellular microstructure, facilitating the real-time identification of pre-cancerous lesions in anatomical tracts such as the gastrointestinal and pulmonary tract. In addition to Cellvizio, the company markets Cellvizio Dual Band for pre-clinical, non-human research, as well as a range of disposable probes for each of its systems. We believe the company is well-positioned to enter a period of accelerated growth, driven mainly by Mauna Kea's new business model in the US and improved reimbursement structures for procedures involving Cellvizio. We forecast strong revenue growth at a 2018E-2022E revenue CAGR of 27% and expect profitability from 2022E.
Companies: Mauna Kea Technologies SAS
Eisai / Biogen recently reported positive top-line data for the 856-patient Phase II trial Study 201 for the anti-amyloid beta ("Abeta") protofibril mAb BAN2401 in early Alzheimer's disease ("AD"). This is the first time a late-stage trial in AD shows disease-modifying effects with regard to both Abeta reduction in the brain and an improvement of clinical function. Importantly, the data supports the Abeta hypothesis for AD therapy and is a much-needed development following a string of late-stage failures. This is good news for Probiodrug, whose lead asset PQ912 has a unique mechanism of action that inhibits the formation of toxic products of Abeta without interfering with important physiological processes. We understand that Probiodrug is exploring multiple options to finance the PQ912 Phase IIb trial that is expected to start enrolling patients in Q4/2018E. We maintain our OUTPERFORM recommendation.