Celyad is in an interesting position with very promising initial results in AML and emerging responses in solid tumors – although both are at an early stage of clinical development. It was pointed out in the recent Edison report (27 September 2017) on T-cell cancer therapies that NKR CAR T-cells therapy by targeting ubiquitous ‘stress’ ligands could potentially target a number of solid and haematological tumors. The first indications from the clinic that this might be a reality have now been seen. It will be important to build on the successes so far with more consistent clinical responses at higher dose levels in the THINK study. The Therapeutic Immunotherapy with NKR-2 (THINK) study (NCT03018405) is an open-label, multiple-dose US and European study currently in a dose escalation phase (Exhibit 1).
Exhibit 1: THINK trial detail
Aspect |
comment |
Dose level |
3x108, 1x109, 3x109 of the natural killer receptor CAR T-cell product, CYAD-01. |
Dosing |
Three doses of cells are given, each 14 days apart. |
Preconditioning – lymphodepletion |
Preconditioning is not used with CYAD-01 although potential combinations will eventually be explored. Prior chemotherapy is essential for standard CAR-T therapies such as Kymriah (tisagenlecleucel, Novartis) and Yescarta (Axicabtagene Ciloleucel, Gilead (Kite)). Preconditioning enables rapid expansion of the transfused CAR T-cells and also reduces the tumor burden of the patient. |
Dose ranging phase |
This phase is at least 12 patients each in the haematological and solid cancer arms, respectively. If toxicity is seen, extra patient is recruited at that dose level. If the dose is safe, the next dose cohort is recruited. At the highest dose, an extra three patients are recruited. |
Cohort expansion phase |
Once a dose is established, the trial is planned to expand into separate cohorts, each with specific cancer indications. One of these cohorts will now definitely be colorectal cancer. The plan sizes 14 patients at the highest dose per cancer. However, with the revised clinical trial emphasis, it is possible that only some of these cancers will be pursued in the near term. In theory, this stage of the trial should have 98 patients in total made of 86 further patients plus the 12 at the highest dose cohort. However, under the revised strategy, not all these indications may be pursued initially. |
Haematological indications |
The haematological arm of the trial will recruit AML and multiple myeloma (MM) patients. Priority will now be given to AML patients. |
Solid cancers |
The trial is recruiting patients in the dose escalation phase with colorectal, ovarian, pancreatic, bladder and triple-negative breast cancers. So far, colorectal, pancreatic and ovarian cancer patients have been recruited. The dose escalation phase will now preferentially recruit colorectal cancer patients. |
Toxicity seen to date |
To date, Celyad has reported one Grade 3 toxicity in an ovarian cancer patient and one Grade 4 toxicity in a MM patient. The observed toxicities might indicate that the NKR CAR T-cells are attacking the cancer. Toxicities in approved CAR-T therapies have been linked to an immune attack on the cancer burden. However, there is no clear link between toxicities and response in CAR-T therapies like Kymriah; this might be because of preconditioning which may be a confounding factor. |
Readout |
As THINK is an open-label study, Celyad will report significant events as they happen. The six-month dose data are possible in H218. The two-year primary endpoint data could be due in mid-2020. However, the revised clinical strategy may mean that these dates vary for different cancer indications. |
Source: Edison Investment Research based on Celyad reports and management information
THINK cohort expansion in colorectal cancer and AML will start once a clear dose has been established. Unlike the cautious safety-first approach in dose escalation, cohort expansion should be relatively rapid as there is no need for significant delays between patient dosing. AML in particular is an intractable condition. So far, T-cell therapies are early in development with no other reported therapies impact. If the pattern of complete response is maintained at higher doses, then Celyad should have no trouble in recruiting patients. Currently, Celyad has no complete responses in colorectal cancer – but then CAR T-cell therapy has no complete responses in any solid tumor type at present.
The issues around solid tumor therapy and the probable need for combination therapy are explored in detail in the report T-cell cancer therapies. Part 1 of this report provides an overview. Part 2 provides detailed investigation into multiple aspects of T-cell therapies including in solid tumors.
The Celyad natural killer (NKG2D) receptor CAR T-cell approach, CYAD-01, targets the ubiquitous stress ligands expressed by many cancers. These stress ligands are upregulated in response to chemotherapy. However, they are also expressed by normal cells exposed to toxic agents, if only for a short period. Chemotherapy might make the tumor more stressed and so more susceptible to CYAD-01 targeting. It might also expose some normal tissues to CYAD-01, so timing of dosing is important to allow enough normal tissue recovery post chemotherapy. In the real world, most solid cancer patients will receive chemotherapy and knowing how to combine standard chemotherapy with CAR T-cell therapy is crucial. If it proves to be synergistic, it would be a major cancer therapy breakthrough as most chemotherapy regimens show limited survival gains in a minority of patients.
The SHRINK trial is being in metastatic colorectal cancer, which is located in the liver. About 20-30% of colorectal cancer cases are found to have metastatic disease on diagnosis. SHRINK has not yet been posted on the clinical trials databases but is approved by the Belgian regulator.
Aspect |
comment |
Dose level |
CYAD-01 doses will be adjusted to body weight and escalate from 3x108 to 1x109 to 3x109. |
Dosing |
Three doses of cells are given, each 14 days apart. |
Preconditioning – lymphodepletion |
Preconditioning is not used to deplete the patient’s immune system. However, this trial combines CYAD-01 with chemotherapy which should deplete the tumor burden. |
Combination |
Patients will be given prior treatment with FOLFOX chemotherapy. FOLFOX is a combination of folinic acid (leucovorin), fluorouracil (5FU) and Oxaliplatin. FOLFOX is not a regimen that targets the immune system, unlike the preconditioning regimen used in B-cell CAR T-cell therapies. |
Dose ranging phase |
This phase will recruit at least 18 patients, six at each dose level. If the dose is safe, the next dose cohort is recruited. Note that timing between FOLFOX and CYAD-01 will also be evaluated. |
Cohort expansion phase |
Once a dose is established, the trial is planned to expand to 21 patients at the highest dose. |
Readout |
Unknown, but this trial will be a priority. Overall survival will be crucial for widespread use, but will take some years to determine. FOLFOX alone gives median overall survival of about two years vs six months on supportive care. |
Source: Edison Investment Research
Although we have not made any substantive changes to the currently broad cancer indications forecast, we have adjusted our valuation and made some detailed adjustments to some probabilities and timings and also to price expectations. In addition, we have rebased evaluation to January 2018. These changes make a substantial difference to the indicative value.
The changes are as follows:
■
AML has an increase in the probability of success from 20% to 25%. The revised probability is still cautious as only one near complete response has so far been seen. A consistent pattern of complete responses at higher doses would encourage us to raise this probability further. The expected launch date remains at 2022, although noting that the FDA has rapidly reviewed the first two CAR T-cell therapies does raise the possibility that a more rapid approval could be obtained if the clinical data warrants it, particularly as refractory AML is an intractable condition.
■
Colorectal cancer was formerly treated as one of five solid tumors, for which an average weighted value was estimated. As it has become a priority for Celyad, it is now treated separately. The probability was adjusted in August 2017 from 10% to 20% in view of two stable disease cases reported in June. As yet, no complete responses have been seen in colorectal cancer so this probability is maintained for the moment, but we would expect to increase this if complete responses are seen at higher dose levels. In this context, the AML response is very encouraging but there is no guarantee of a direct read-across. The expected colorectal launch date remains 2023. Since colorectal cancer is a major solid tumor indication, splitting it out from the average of solid tumors has a high impact on the overall indicative value. Only refractory colorectal cancer is taken into account.
■
Multiple myeloma remains unchanged but as it is potentially a lower priority project. We have pushed the launch date back to 2024. Probability remains at 20% given that other CAR-T therapies, notably Bluebird’s bb2121, have shown good success to date in multiple myeloma. Our assessment of multiple myeloma will be adjusted as more clinical data is disclosed. There was Grade 4 toxicity seen which is an indicator that the infused CYAD-01 cells might be having some clinical effect.
■
The remaining four solid cancers are still treated as a weighted average with unchanged probabilities. There have been some signs of efficacy with a Grade 3 toxicity in ovarian cancer. Two other cancer types, bladder and triple-negative breast cancer have not as yet been explored as no patient has yet been recruited. We have pushed all these cancer indications back to an expected launch date of 2025; this will be regularly reviewed.
■
The price assumed was $150k as this approximated to immunomodulatory checkpoint inhibitor therapies. However, with Kymriah listed at $475K and Yescarta at $373k, this price is clearly too low. The eventual pricing of CAR T-cell therapies is going to be complex and will relate to efficacy, as yet unknown. We have therefore used $200k as a current target price for CYAD-01 but this will be revised as further data emerges.
■
We have taken the decision to put a nominal value for the C-Cure cardiac therapy into the model. The Phase III data showed a subgroup where efficacy was noted. Celyad decided to explore strategic options for the project and put development on hold although a US Phase III trial has been approved. The value was $191m but as no deal has been concluded we have reduced this to a nominal $12m. This will be revised when further information is available.
■
We have not made any adjustments to expected trial costs as management has indicated that current financial resources are adequate to pursue the revised clinical program. However, we note that a broader program with faster recruitment to develop the large potential of NKR CAR T-cells therapy could perhaps be pursued if greater financial resources were available.
■
The financial model has been rebased to January 2018. This has a significant impact by itself as the discount rate is 12.5% before probability adjustment.
Exhibit 3 shows the cancer numbers and revised NPV values. Note that the other four solid cancers are weighted as we are not at this time clear that they will all progress.
Exhibit 3: Revised CYAD-01 NPV estimates
|
Indication |
Deaths |
Peak share |
Peak US sales ($m) |
Probability |
NPV (US) |
Global ($) |
Lead indications |
|
|
|
|
|
|
|
|
AML |
10,460 |
39% |
851 |
25.0% |
178 |
237 |
|
Colorectal |
50,310 |
36% |
3,628 |
20.0% |
500 |
667 |
|
|
|
|
|
|
|
|
Exploratory |
|
|
|
|
|
|
|
|
MM |
11,240 |
39% |
915 |
20.0% |
113 |
151 |
|
Solid tumors, weighted average |
|
|
|
|
|
|
Ovarian |
14,180 |
69% |
1,951 |
20.0% |
217 |
289 |
|
Bladder |
16,390 |
69% |
2,255 |
10.0% |
125 |
167 |
|
Breast |
40,000 |
36% |
2,884 |
10.0% |
157 |
210 |
|
Pancreatic |
39,590 |
69% |
5,448 |
5.0% |
151 |
202 |
Total other solid cancers |
110,160 |
|
12,539 |
|
651 |
868 |
Weighted average |
|
|
|
|
158 |
211 |
Source: Edison Investment Research
The revised valuation based on these numbers is shown in Exhibit 4.
Exhibit 4: Revised valuation
Item |
|
Probability |
Value ($m) |
Lead projects |
AML |
25.0% |
237 |
|
Colorectal |
20.0% |
667 |
|
|
|
|
Exploratory trials |
MM |
20.0% |
151 |
|
Solid tumors (average of 4) |
Variable |
211 |
|
Allogeneic |
|
59 |
Total CAR value |
|
|
1,325 |
C-Cure Partnered value (milestones plus royalties) |
|
Nominal |
12 |
Net operating costs |
(Risk adjusted 2018-2023) |
|
-126 |
Additional royalties |
|
|
25 |
Total indicative value |
|
|
1,236 |
ADRs |
|
|
9.86m |
Warrants and options |
|
|
0.3m |
Core value per ADR ($) |
|
|
122 |
Source: Edison Investment Research
A faster and more comprehensive clinical development up to 2023 could be more expensive but benefit from a higher payback rate.
The value has risen significantly indicating $122 per ADR (formerly $61), but this is mostly due to the change in price assumption from $150k to $200k. If the price was left at $150k, the value would be about $91/ADR. If the efficacy is robust, the price could be higher than this.
Celyad has reported H117 results. Revenues were €3m in grants with R&D expenses of €11.1m. The operating loss was €13.7m and the net cash burn was €13.8m. On 30 June 2017, Celyad had €68.8m of cash. This is expected by management to be sufficient to fund the company through the first half of 2019. We have not made any changes to financial forecasts (Exhibit 5). Celyad might benefit from an enhanced cash basis to develop its cancer portfolio.
Exhibit 5: Financial summary
|
|
US$'000s |
2015 |
2016 |
2017e |
2018e |
Year end 31 December |
|
|
IFRS |
IFRS |
IFRS |
IFRS |
PROFIT & LOSS |
|
|
|
|
|
|
Revenue |
|
|
3 |
9,461 |
9,191 |
9,990 |
Cost of Sales |
|
|
(1) |
(59) |
0 |
0 |
Gross Profit |
|
|
2 |
9,402 |
9,191 |
9,990 |
EBITDA |
|
|
(30,907) |
(26,712) |
(29,659) |
(27,417) |
Operating Profit (before amort and except) |
|
|
(31,210) |
(27,556) |
(30,503) |
(28,261) |
Intangible Amortization |
|
|
(844) |
(839) |
(839) |
(839) |
Other income and charges |
|
|
0 |
(578) |
0 |
0 |
Share-based payments |
|
|
(882) |
547 |
0 |
0 |
Operating Profit |
|
|
(32,936) |
(28,426) |
(31,342) |
(29,100) |
Net Interest |
|
|
619 |
2,217 |
278 |
278 |
PTP (norm) |
|
|
(30,590) |
(25,339) |
(30,225) |
(27,983) |
PTP (FRS 3) |
|
|
(32,317) |
(26,209) |
(31,064) |
(28,822) |
Tax |
|
|
0 |
7 |
0 |
0 |
PAT (norm) |
|
|
(30,590) |
(21,625) |
(30,225) |
(27,983) |
PAT (FRS 3) |
|
|
(32,317) |
(26,203) |
(31,064) |
(28,822) |
|
|
|
|
|
|
|
Average number of ADRs outstanding (m) |
|
|
8.7 |
9.3 |
9.5 |
9.5 |
EPADR - normalized ($) |
|
|
(3.52) |
(2.32) |
(3.17) |
(2.94) |
EPADR - (IFRS) ($) |
|
|
(3.72) |
(2.32) |
(3.26) |
(3.03) |
Dividend per ADR ($) |
|
|
0.0 |
0.0 |
0.0 |
0.0 |
|
|
|
|
|
|
|
Gross Margin (%) |
|
|
N/A |
N/A |
N/A |
N/A |
EBITDA Margin (%) |
|
|
N/A |
N/A |
N/A |
N/A |
Operating Margin (before GW and except) (%) |
|
|
N/A |
N/A |
N/A |
N/A |
|
|
|
|
|
|
|
BALANCE SHEET |
|
|
|
|
|
|
Fixed Assets |
|
|
55,617 |
59,318 |
81,399 |
79,883 |
Intangible Assets |
|
|
54,156 |
55,018 |
77,776 |
76,937 |
Tangible Assets |
|
|
1,261 |
3,955 |
3,278 |
2,601 |
Investments |
|
|
200 |
345 |
345 |
345 |
Current Assets |
|
|
121,456 |
94,756 |
52,177 |
23,636 |
Stocks |
|
|
0 |
0 |
0 |
0 |
Debtors |
|
|
609 |
1,508 |
1,508 |
1,508 |
Cash |
|
|
119,339 |
91,672 |
49,093 |
20,551 |
Other |
|
|
1,507 |
1,576 |
1,576 |
1,576 |
Current Liabilities |
|
|
(12,754) |
(12,515) |
(12,229) |
(11,640) |
Creditors |
|
|
(11,757) |
(11,056) |
(11,056) |
(11,056) |
Deferred revenue |
|
|
0 |
0 |
0 |
0 |
Walloon loans for cash payment |
|
|
(997) |
(1,460) |
(1,173) |
(585) |
Long Term Liabilities |
|
|
(40,583) |
(40,677) |
(39,734) |
(39,090) |
Walloon loans (non-current) |
|
|
(11,637) |
(8,731) |
(7,788) |
(6,844) |
Other long term liabilities |
|
|
(28,945) |
(31,946) |
(31,946) |
(32,246) |
Net Assets |
|
|
123,736 |
100,882 |
81,614 |
52,788 |
|
|
|
|
|
|
|
CASH FLOW |
|
|
|
|
|
|
Operating Cash Flow |
|
|
(30,927) |
(29,625) |
(30,184) |
(27,282) |
Net Interest |
|
|
619 |
2,217 |
956 |
293 |
Tax |
|
|
0 |
0 |
0 |
0 |
Capex |
|
|
(930) |
(1,978) |
(23,763) |
(167) |
Acquisitions/disposals |
|
|
(5,756) |
(1,733) |
0 |
0 |
Financing |
|
|
121,162 |
0 |
11,798 |
0 |
Dividends |
|
|
0 |
0 |
0 |
0 |
Other |
|
|
(3,649) |
3,451 |
(1,386) |
(1,386) |
Net Cash Flow |
|
|
80,519 |
(27,668) |
(42,579) |
(28,541) |
Opening net debt/(cash) |
|
|
(17,847) |
(106,705) |
(81,481) |
(40,132) |
HP finance leases initiated |
|
|
0 |
0 |
0 |
0 |
Walloon loan recognition (non-cash) |
|
|
8,339 |
2,443 |
1,230 |
1,532 |
Closing net debt/(cash) |
|
|
(106,705) |
(81,481) |
(40,132) |
(13,122) |
Source: Edison Investment Research estimates, Celyad reports and announcements. Note: The $25m 2017 payment is treated as an intangible asset expected to be amortized against sales income. The equity component is shown as an equity investment. The actual accounting treatment by Celyad may differ.
Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world-renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisers and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting. Edison is authorised and regulated by the Financial Conduct Authority. Edison Investment Research (NZ) Limited (Edison NZ) is the New Zealand subsidiary of Edison. Edison NZ is registered on the New Zealand Financial Service Providers Register (FSP number 247505) and is registered to provide wholesale and/or generic financial adviser services only. Edison Investment Research Inc (Edison US) is the US subsidiary of Edison and is regulated by the Securities and Exchange Commission. Edison Investment Research Limited (Edison Aus) [46085869] is the Australian subsidiary of Edison and is not regulated by the Australian Securities and Investment Commission. Edison Germany is a branch entity of Edison Investment Research Limited [4794244]. www.edisongroup.com DISCLAIMER Copyright 2017 Edison Investment Research Limited. All rights reserved. This report has been commissioned by Celyad and prepared and issued by Edison for publication globally. All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report. Opinions contained in this report represent those of the research department of Edison at the time of publication. The securities described in the Investment Research may not be eligible for sale in all jurisdictions or to certain categories of investors. This research is issued in Australia by Edison Aus and any access to it, is intended only for "wholesale clients" within the meaning of the Australian Corporations Act. The Investment Research is distributed in the United States by Edison US to major US institutional investors only. Edison US is registered as an investment adviser with the Securities and Exchange Commission. Edison US relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. As such, Edison does not offer or provide personalised advice. We publish information about companies in which we believe our readers may be interested and this information reflects our sincere opinions. The information that we provide or that is derived from our website is not intended to be, and should not be construed in any manner whatsoever as, personalised advice. Also, our website and the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. This document is provided for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. 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Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world-renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisers and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting. Edison is authorised and regulated by the Financial Conduct Authority. Edison Investment Research (NZ) Limited (Edison NZ) is the New Zealand subsidiary of Edison. Edison NZ is registered on the New Zealand Financial Service Providers Register (FSP number 247505) and is registered to provide wholesale and/or generic financial adviser services only. Edison Investment Research Inc (Edison US) is the US subsidiary of Edison and is regulated by the Securities and Exchange Commission. Edison Investment Research Limited (Edison Aus) [46085869] is the Australian subsidiary of Edison and is not regulated by the Australian Securities and Investment Commission. Edison Germany is a branch entity of Edison Investment Research Limited [4794244]. www.edisongroup.com DISCLAIMER Copyright 2017 Edison Investment Research Limited. All rights reserved. This report has been commissioned by Celyad and prepared and issued by Edison for publication globally. All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report. Opinions contained in this report represent those of the research department of Edison at the time of publication. The securities described in the Investment Research may not be eligible for sale in all jurisdictions or to certain categories of investors. 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