Research, Charts & Company Announcements
Research Tree provides access to ongoing research coverage, media content and regulatory news on Celyad. We currently have 24 research reports from 2 professional analysts.
Data at ASH on 3 December confirmed that CYAD-01 T-cells can destroy acute myeloid leukaemia (AML) blast (cancer) cells. In eight reported AML patients, there was a 62% (5/8) response rate across three dose levels. As preconditioning was not used, this rate is impressive. Safety was excellent with only one dose-limiting toxicity event at a high dose. The good safety profile should now enable faster progress to determine the optimal dose schedule. Further data are promised in H119, probably mid-year. A study combining CYAD-01 with preconditioning is underway and may be crucial. The indicative value is still €1,090m (€89 per share) pending further data.
The allogeneic version of NRK CAR T-cell therapy, CYAD-101, is underway with the first patient dosed. The study mirrors the current colorectal SHRINK trial in combining NKR CAR cell therapy with FOLFOX chemotherapy. This gives Celyad the lead in a potential high-value mass-market solid cancer where allogeneic therapy is likely to be essential. The indicative value is €1,090m (€89 per share) pending further data.
Celyad has presented an update on its CYAD-01 solid cancer trials with haematological data due in early December. There are strong indications that optimal effects can be gained by use of high doses, possibly with Cy-Flu preconditioning, or by combining CYAD-01 with chemotherapy in solid cancer. An allogenic colorectal trial will start in early 2019; an allogeneic product (CYAD-101) could have a major market in multiple cancer types. Our indicative value remains at €1,090m (€89/share) pending more data.
The FDA’s sign off on Celyad’s first clinical trial design for its allogeneic NRK CAR T-cell therapy (CYAD-101) is an important milestone. The study, possibly staring in Q4 2018, mirrors the current colorectal SHRINK trial a combination of autologous CYAD-01 therapy with FOLFOX chemotherapy. This gives Celyad the lead in a mass-market solid cancer where allogeneic therapy is likely to be essential. The indicative value has been increased to €1,090m (€89 per share) from €1,040m (€84 per share) pending further data.
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.
Research Tree provides access to ongoing research coverage, media content and regulatory news on Celyad. We currently have 24 research reports from 2 professional analysts.
Bioventix delivered a strong set of interims, with revenues up 21%. Given the 9% decline in operating expenses, this resulted in a 31% increase in adjusted EBITDA, with adjusted pre-tax profit also rising 31% to £4.4m (52% of full-year forecasts) and adjusted EPS up 29% to 69.4p. An interim dividend of 36p was declared (+20%) with net cash at period end of £5.5m. Growth was driven by both Vitamin D antibody sales/royalties (+c.25%), its portfolio of other antibodies (+c.12%) and a more meaningful contribution from troponin. Given the inevitable disruption that COVID-19 will have to some testing volumes (although tests such as NTproBNP are likely to benefit from high risk COVID patients), we leave forecasts unchanged, confident that the strong H1 and weaker sterling in H2 should offset any potential H2 trading shortfall. We leave our forecasts unchanged and reiterate our 3750p target price. At this level, the stock would trade on a 30x FY 2020 P/E with a free cashflow yield of 3.1x
Novacyt* (NCYT.L): COVID-19 test update | Futura Medical (FUT.L): Confirmation of FDA minutes
Companies: Novacyt Futura Medical
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ReNeuron has provided an update in light of the Covid-19 pandemic. Current day-to-day disruption has been minimised. However, ReNeuron did flag likely delays to its two ongoing clinical studies for Stroke Disability and Retinitis Pigmentosa (RP) and when top-line data will be made available. We believe this delay risk is more pertinent in the Stroke programme, given the RP trial is not enrolling patients at this point awaiting the approval of clinical trial protocol adjustments (including approval to enrol an additional 9 patients). We previously expected additional Phase I/IIa data for RP in H2 2020 and interim results of the Phase IIb Stroke trial in mid-2021, and the company will provide further guidance on the timing of interim data from the studies in due course. The Fosun Pharma collaboration remains on track with initial focus on the Stroke programme, for which clinical trial applications have been filed to open clinical sites in China. This may help offset any possible disruption to the Stroke programme patient enrolment at US and UK clinical sites. Lastly, in an intriguing development, ReNeuron has initiated a research project exploring the use of its exosomes as a delivery vehicle for viral vaccines to increase the potency of Covid-19 vaccines in development. The project is understood to be at an early stage but could accelerate quickly in the current regulatory climate, and possibly lead to commercial partnering opportunities and upside not reflected in our forecasts.
Companies: Reneuron Group
Futura has released its 2019 preliminary results this morning, updating the market after a very busy 12 months with its all important FM57 study delivering exciting and commercially relevant data in December. On this front management is hosting a webcast presentation that will be available on the company website later this morning to provide more colour on the study.
Companies: Futura Medical
Avacta announced that it is raising £2m by way of a subscription for 11.1m ordinary shares at 18p (follows £9m raise in October 2019 at 15p per share), subject to a general meeting. Given the current economic uncertainty and disruption caused by the coronavirus outbreak, we think this is prudent as it extends the cash runway further into 2021. Not only does this create a cash buffer for any unseen disruption, but it also provides additional time to advance its immunotherapy pipeline with partners (fully funded by the partners), as well as delivering further commercial progress for both therapeutics and diagnostics. Avacta confirmed that it will file a CTA application as soon as possible, seeking the UK regulator’s permission to commence a Phase I safety study for its lead drug candidate (AVA6000 – pro-doxorubicin). This is on track to start in late 2020, having made good progress in manufacturing drug product. We retain a target price of 76p.
Companies: Avacta Group
Further to the announcement on 2 April, indicating that the company was raising £2m through a subscription of shares at 18p, and in response to substantial institutional interest, Avacta has conditionally raised further gross proceeds of £3.75m at 18p per ordinary share. These funds will be put towards the key objectives outlined in October 2019, primarily to complete the Phase I clinical trial of AVA6000 (pro-doxorubicin) as well as strengthening the balance sheet in light of the uncertainty that the coronavirus pandemic brings. We expect cash at 31 December 2020 to be c.£8.7m, which provides a runway into late 2021/early 2022 at the current monthly cashburn. Despite the dilution afforded by the additional shares, we retain a target price of 76p, which implies an enterprise value of c.£150m, and is supported by the notion that the company is fully funded to complete the Phase I trial of its lead asset, AVA6000 (pro-doxorubicin).
Companies: Avacta Group
Novacyt S.A* (NCYT.L): COVID-19 test update | Redx Pharma (REDX.L): Short term loan agreement
Companies: Novacyt Redx Pharma
SDI was selected in finnCap’s Slide Rule QVGM+ top 30 stocks in Q1 2020, reflecting the projected strong sales and EPS growth over the next two financial years of 30% and 31% respectively, buoyed by recent acquisitions but more importantly the rising ROCE. The prospect of sustainable organic growth is considered likely for this buy-and-build model given ongoing investment to support portfolio companies’ ambitions. These quality metrics are also seen in Judges Scientific (a larger buy-and build investment story), which despite three-year 9% EPS CAGR, trades on a FY 2020 P/E of c.25x and FCF yield of 4.2%. Given the successful acquisition and integration of 11 businesses over the past six years, and mindful of opportunities that still exist for SDI, we are raising our target price to 105p, which brings the valuation into line with Judges. This implies FY 2021 EV/EBIT and P/E multiples of 19.6x and 24.5x, respectively.
Companies: Scientific Digital Imaging
With the moratorium on publishing audited preliminary results in place, EKF has instead provided a comprehensive trading update with headline FY19 financials and an update on the outlook, including regarding the potential impact of Covid-19. In short, no impact has been seen to date and, whilst ordering patterns may experience some short term disruption, the testing of vulnerable groups such as Diabetes and Anaemia patients is more important than ever. Added to that, EKF has recently entered into a contract manufacturing agreement to produce sample collection tubes for Covid-19 testing in the US, with initial orders of $1m expected to grow significantly in the coming weeks. At the very least, this should compensate for any short term hiatus in ordering patterns in the core business. Net cash of £14.3m gives a substantial financial buffer and news the board still intends to pay a maiden dividend of 1p (>5% yield) is a strong signal of confidence. In short, we remain extremely confident in EKF’s business model and prospects.
Companies: EKF Diagnostics Holding
Much of the UK’s privatisation programme took place between the early 1980s and the mid-1990s: subsequent sales have been few. Undoubtedly, privatisation attracted many private investors to the market, many for the first time.
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Revenue growth of 10% in H2 brought FY results in line and the company was looking well set for strong progress in FY20. However, Covid-19 presents a significant short term challenge, given SUN’s focus on elective surgeries. The Board has moved quickly to enact cash preserving and cost saving measures, whilst continuing to supply essential products. Cash on the balance sheet and support from the group’s bankers provides short term liquidity and other indications of financial support are being actively considered.
Companies: Surgical Innovations Group
In an important step for Medicare coverage determination, Renalytix has been granted a Medicare Provider Transaction Access Number (PTAN) for its Salt Lake City Utah clinical laboratory. This effectively means Renalytix is now qualified as a billable provider and can initiate a ‘Local Coverage Determination’ process to establish US national Medicare coverage and reimbursement for KidneyIntelX testing. Medicare and Medicaid insurance programmes are estimated to represent 50-60% of chronic kidney disease patients likely to benefit from KidneyIntelX. Medicare coverage determination expected by calendar H1 2021 is not presently reflected in our current forecasts and remains a substantial value creation event if achieved. Over the last week we also saw impressive healthcare economic data published by Boston Healthcare supporting KidneyIntelX use in large healthcare systems, and Renalytix AI also featured in N+1 Singer’s Stocks in Unprecedented Times – Part 2 handbook.
Companies: Renalytix AI
Omega Diagnostics provided a trading update for FY 2020 that is broadly in line with expectations, confirming also that it had received Chinese approval for the laboratory version of the Food Detective Test that we had expected in January. Under the current circumstances of an almost global lockdown due to coronavirus, we consider this to be a positive outcome. First shipments of VISITECT CD4 (both 350 and Advanced Disease tests) were also confirmed (albeit lower than forecast due to delays in Nigeria and as a result of the coronavirus outbreak), but are expected to be deferred into FY 2021. We have made minor forecasts changes to FY 2020 but leave FY 2021 and our target price unchanged.
Companies: Omega Diagnostics Group
OptiBiotix ("OPTI") has had a strong start to 2020, with partners Agropur (US), Holland & Barrett (UK) and most recently Alfasigma (Italy) launching new products containing the company's microbiome-modulating functional ingredients. As an increasing number of products move to market, we remain positive as to the commercial potential of OPTI's functional ingredients as consumer awareness grows. The recent launches indicate growing momentum into 2020, when we expect existing agreements to start delivering substantial revenue streams and further demand for OPTI's products. We reiterate both our OUTPERFORM recommendation and 97p target price, based on our view that OPTI is at the beginning of a long-term revenue growth cycle.
Companies: Optibiotix Health