Research, Charts & Company Announcements
Research Tree provides access to ongoing research coverage, media content and regulatory news on Celyad. We currently have 16 research reports from 2 professional analysts.
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.
Management has indicated that the C-Cure cardiac regeneration project (Phase III data in mid-2016) might be fully partnered from 2017. This will enable the main focus to move onto Chimeric Antigen Receptor (CAR) Tcell cancer therapies and the associated allogeneic development. The new indicative value of €88/$95 per share is an interim assessment while Phase III CHART-1 C-Cure data, due mid-2016, is awaited and before the Phase I CAR T-cell study completes. C-Cure partnering is not expected till 2017. Edison estimates that 2015 year-end cash was about €107m.
Celyad has reported that all three patients in the first CAR dose cohort have completed the three-month safety follow up. This means a second, higher dose can now be tested. Importantly for future commercial developments, Celyad now holds a granted US patent on a method for producing allogeneic CAR T-cells. This could expand the market, while reducing the cost of goods compared to current autologous approaches. Celyad may license this technology at a premium. The updated indicative value of €953m or €99 per share rests on C-Cure cardiac cell therapy plus clinical CAR T-cell AML and MM therapies. Cash at 30 June 2015 was €124m.
Research Tree provides access to ongoing research coverage, media content and regulatory news on Celyad. We currently have 16 research reports from 2 professional analysts.
Keywords Studios (KWS): Ticking every box (except valuation) (HOLD) | OptiBiotix* (OPTI): SlimBiome commercial update (CORP) | Surface Transforms* (SCE): Steady progress (CORP) | Gem Diamonds (GEMD): Recovery of high quality 115 carat diamond (BUY) | ClearStar* (CLSU): Record H1 driven by direct sales and medical business (CORP)
Companies: KWS OPTI SCE GEMD CLST
President Energy* (PPC): Initiation of coverage: Argentina has the best stakes (CORP) | SCISYS* (SSY): ANNOVA’s success underpins a strong H1 (CORP) | Cambridge Cognition* (COG): Interims – looking behind the numbers (CORP) | Hurricane Energy (HUR): H1 2017 results (BUY) | Quixant* (QXT): Exceptional H1 performance with H2 caveat (CORP)
Companies: SSY COG HUR QXT
Anpario (ANP LN) Impressive growth highlights strategic initiatives bearing fruit | Augean (AUG LN) H1 results in line with expectations | Brady (BRY LN) Contract win | First Derivatives (FDP LN) Investment in Machine Learning | Northgate (NTG LN) In line AGM statement, but higher H2 weighting now expected | Sinclair Pharma (SPH LN) H1’s in line; growth expected to accelerate in H2 | Speedy Hire (SDY LN) H1 update slightly ahead of expectations driven by further cost savings | Swallowfield (SWL LN) Strong progress in FY17 and positive outlook | Yu Group (YU LN) Strong interim results – expectations increased
Companies: AUG NTG SPH SDY SWL FDP BRY ANP YU/
Ergomed’s interim results highlight continued progression and impressive growth (net service revenue +53%, 36% organic) propelled by Drug Safety Monitoring and Medical Information, which nearly doubled YoY. New service contracts worth £23m were signed through to 31 July with an impressive backlog of contracted work of over £70m, providing the group with a high degree of revenue visibility. Following patient recruitment into the group’s Phase IIb trial evaluating PeproStat™ completing around six months ahead of schedule we now look forward to top-line data in late October. We reiterate our highly positive stance on Ergomed.
Amino Technologies (AMO LN) German contract win | City of London Investment Group (CLIG LN) In line with Q4 update: earnings grow, small increase in dividend | Ergomed (ERGO LN) Strong H1 growth; PeproStat™ Phase IIb data expected in October | Itaconix (ITX LN) A period of meaningful commercial progress | Retail Recovering sector indicators for 2018 likely to trigger outperformance
Companies: CLIG FDL HFD BWNG AMO ERGO ITX
BEXIMCO PHARMACEUTICALS (BXP.L) | MOTIF BIO (MTFB.L) | VELTYCO GROUP (VLTY.L)
Companies: BXP MTFB VLTY
Anpario’s interim results highlight a period of strong growth putting the group on track to beat our full year sales estimate. The strategic initiatives the group implemented in 2016 are bearing fruit with Asia, the Americas and the Middle East all reporting significant growth. The group has introduced an interim dividend, reflecting its confidence of growth continuing in the future. H2 has reportedly started well and we remain at Buy.
Headline performance at the H1’17 results illustrated total revenue growth of 7% from £2.7m to £2.9m continuing from H2’16 the export-led return to growth. As flagged, performance in RoW territories was affected by ordering patterns, with order flow £0.1m lower than during the last period. Cost savings in probe tip assembly contributed to an increase in gross margin from 64% to 76%, and to a narrowing loss from £1.7m in H1’16 to £1m in H1’17.
Companies: Deltex Medical Group
Interim results are in line with expectations, with a first significant contribution from US sales of Silhouette Instalift™. Top line growth of +6% YoY in constant currency is expected to accelerate in H2, and the Group continues to target EBITDA profitability for the full year. We reiterate Buy.
Companies: Sinclair Pharma
CareTech has announced in line interim results and the acquisition of an Adult Learning Disabilities business which adds circa £2.4m to EBITDA. Investment in management and infrastructure ahead of further scaling of the business tempers our upgrades but CareTech remains well positioned to take advantage of the consolidation in this expanding sector. We increase our target price to 470p (previously 458p) and reiterate of BUY recommendation.
SDI is acquiring Applied Thermal Control (ATC), a manufacturer and supplier of chillers, coolers and heat exchangers used within the scientific instrument support market and based in the UK. ATC is a growing, profitable business with c.30% of sales exported, mainly to the US. The maximum consideration is £1.2m, representing prospective EV/Sales and EV/EBIT of 0.8x and 4.0x, respectively. The acquisition is being funded by a mixture of shares (£200k to the vendor), cash (£550k, assuming the earn out is met) as well as a new five-year term loan of £450k. We expect the acquisition to be 6% accretive to adjusted EPS (excluding acquisition costs) in FY 2018 and 8% in FY 2019. We are raising our target price by 7% to 32p, which places SDI on a FY 2018 P/E of 16.5x, falling to 14.4x in FY 2019, and FY 2018 EV/EBITDA of 10.1x, falling to 8.9x in FY 2019.
Companies: Scientific Digital Imaging
AFC Energy (AFC.L) | Touchstone Innovations (IVO.L) | 4D Pharma (DDDD.L) | FairFX (FFX.L) | Versarien (VRS.L) | Abzena (ABZA.L) | MetalNRG (NEX:MNRG) | Valiant Investments ( N E X : V A L P ) | Vernalis (VER.L) | Satellite Solutions (SAT.L)
Companies: AFC IVO DDDD FFX VRS ABZA VER SAT
Futura Medical (FUM LN) All set for MED2002 Phase III trial start in H1 2018 | Horizon Discovery Group (HZD LN) Forecast update post Dharmacon acquisition | IndigoVision Group (IND LN) Strategic objectives progressing; strong H2 expected | Realm Therapeutics (RLM LN) H1 results and proposed £19m equity fundraise | St Ives (SIV LN) Trading update
Companies: SIV IND FUM HZD PURI
Abzena’s (ABZA) recent trading update indicated slower than expected revenues in H1 FY18. The primary reasons for this slower than expected start to the year include lower volumes in certain business areas as well as project delays causing revenues to be recognised in H218 and FY19. Our FY18 sales forecast of £30.2m is lowered to £24.7m with adj. LBT and adj. LPS also increasing from £9.3m and 4.2p to £13.0m and 5.9p, respectively. The long-term investment case for ABZA, however, remains intact. Forecasts are inherently sensitive to project timings with management perhaps having been too optimistic in scheduling new project starts with the existing capacity. As new equipment is brought online, these challenges should ease. We reinstate our Buy recommendation but lower our target price from 80p to 70p to reflect the near-term impact on forecasts.
Shield Therapeutics (STX) has released H117 interims that show in-market Feraccru sales of £0.2m (flat YoY) with an adj. net loss of £8.4m (+65% from H1-16). Sales & marketing costs have been increased in response to management identifying commercialisation headwinds. Net cash of £21.5m takes STX through to AEGIS-CKD readout in Q118, after which management will have clearer visibility on marketing cash outflows going forward. We revise FY17/18 sales forecasts down by 37% and 4% respectively, highlighting the strong investment outlook that remains given the significant opportunity within US-CKD. We reduce our target price by 2% to 265p and maintain our Buy recommendation post interims.
Companies: Shield Therapeutics