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.
Written by
Celyad |
Allogeneic trial approved in colorectal cancer |
Allo IND approval |
Pharma & biotech |
2 August 2018 |
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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.
Year |
Revenue (€m) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/16 |
8.52 |
(20.00) |
(2.09) |
0.0 |
N/A |
N/A |
12/17 |
3.54 |
(26.80) |
(2.79) |
0.0 |
N/A |
N/A |
12/18e |
0.00 |
(27.25) |
(2.43) |
0.0 |
N/A |
N/A |
12/19e |
0.00 |
(28.50) |
(2.38) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
Leading position in solid cancers and allogeneic cells
NKR CAR T-cell therapy is a generalised approach targeting “stressed” cancer cells, for example, after chemotherapy like FOLFOX. Combined with an allogenic approach, this offers a more affordable, rapid -response potential therapy for many thousands of patients. This gives Celyad the dominant position in solid cancers, an area other CAR therapies find hard to access (see report). Celyad is already evaluating autologous (customised) CYAD-01 with FOLFOX in the SHRINK trial and the approved IND mirrors that trial design. SHRINK seeks to optimise the safe CYAD-01 dose and dose schedule. We are not aware of any other allogeneic CAR T-cell therapy in solid cancers and only three in haematological cancers.
Technical details – TIM to stop GvHD
A key issue for any allogeneic therapy is the potential to trigger Graft vs Host Disease (GvHD) as the CAR T-cells could, in theory, attack normal patient tissues, skin, liver and the GI tract, if they have functional T-Cell receptors. GvHD is hard to manage and can become chronic. Celyad’s technology uses T-cell receptor Inhibitory Molecules (TIM) (peptides), the genes for which are included in the viral transfection of the T-cell line (Michaux et al 2018) to make an NKR CAR. TIMs stop the production of functional TCR so, in theory, stopping any GvHD. One allogeneic cell line can be cultured to produce therapy for multiple patients so cutting costs and enabling faster treatment. A factor may be the need for multiple cell lines of differing HLA-type lines to minimise host immune destruction of the CAR T-cells. Celyad holds key patents in allogeneic therapy (licensed by Novartis).
Valuation: Nominal increase to €89 per share
The nominal allogeneic value has been increased from €50m to €100m pending further data; it may come to dominate the valuation. This increases the overall indicative value to €1,090m (formerly €1,040m), €89 per share (formerly €84). Allogeneic therapy is currently a highly-active investment area, for example, the April deal involving Pfizer and pre-clinical Allogene (US$300m start-up funding).
Exhibit 1: Financial summary
€000s |
2016 |
2017 |
2018e |
2019e |
||
Year end 31 December |
IFRS |
IFRS |
IFRS |
IFRS |
||
PROFIT & LOSS |
||||||
Revenue |
|
|
8,523 |
3,540 |
0 |
0 |
Cost of Sales |
(53) |
(515) |
(500) |
(500) |
||
Gross Profit |
8,470 |
3,025 |
(500) |
(500) |
||
EBITDA |
|
|
(21,246) |
(22,317) |
(26,500) |
(27,750) |
Operating Profit (before amort. and except). |
|
|
(22,006) |
(23,283) |
(27,500) |
(28,750) |
Intangible Amortisation |
(756) |
(748) |
(750) |
(750) |
||
Other income and charges |
0 |
(26,273) |
0 |
0 |
||
Share-based payments |
(2,847) |
(2,569) |
(2,600) |
(2,600) |
||
Operating Profit |
(25,609) |
(52,873) |
(30,850) |
(32,100) |
||
Net Interest |
1,997 |
(3,521) |
250 |
250 |
||
Profit Before Tax (norm) |
|
|
(20,009) |
(26,804) |
(27,250) |
(28,500) |
Profit Before Tax (FRS 3) |
|
|
(23,612) |
(56,394) |
(30,600) |
(31,850) |
Tax |
6 |
1 |
0 |
0 |
||
Profit After Tax (norm) |
(20,003) |
(26,803) |
(27,250) |
(28,500) |
||
Profit After Tax (FRS 3) |
(23,606) |
(56,393) |
(30,600) |
(31,850) |
||
Average Number of Shares Outstanding (m) |
9.3 |
9.6 |
11.2 |
12.0 |
||
EPS - normalised (c) |
|
|
(209) |
(279) |
(243) |
(238) |
EPS - (IFRS) (c) |
|
|
(253) |
(586) |
(273) |
(267) |
Dividend per share (c) |
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 |
|
|
53,440 |
41,232 |
40,492 |
39,752 |
Intangible Assets |
49,566 |
36,508 |
35,768 |
35,028 |
||
Tangible Assets |
3,563 |
3,290 |
3,290 |
3,290 |
||
Investments |
311 |
1,434 |
1,434 |
1,434 |
||
Current Assets |
|
|
85,366 |
36,393 |
50,659 |
22,149 |
Stocks |
0 |
0 |
0 |
0 |
||
Debtors |
1,359 |
233 |
233 |
233 |
||
Cash (cash plus deposits) |
82,587 |
33,905 |
48,171 |
19,661 |
||
Other |
1,420 |
2,255 |
2,255 |
2,255 |
||
Current Liabilities |
|
|
(11,275) |
(7,944) |
(7,944) |
(7,944) |
Creditors |
(9,960) |
(7,509) |
(7,509) |
(7,509) |
||
Deferred revenue |
0 |
0 |
0 |
0 |
||
Walloon loans and bank loan |
(1,315) |
(435) |
(435) |
(435) |
||
Long Term Liabilities |
|
|
(36,646) |
(22,146) |
(22,146) |
(22,146) |
Loans (non-current) Bank and Walloon |
(7,866) |
(1,870) |
(1,870) |
(1,870) |
||
Other long term liabilities |
(28,780) |
(20,276) |
(20,276) |
(20,276) |
||
Net Assets |
|
|
90,885 |
47,535 |
61,061 |
31,811 |
CASH FLOW |
||||||
Operating Cash Flow |
|
|
(26,695) |
(46,027) |
(26,514) |
(27,471) |
Net Interest |
1,997 |
(3,521) |
264 |
(29) |
||
Tax |
0 |
0 |
0 |
0 |
||
Capex |
(1,782) |
(858) |
(1,010) |
(1,010) |
||
Acquisitions/disposals |
(1,561) |
0 |
0 |
0 |
||
Financing |
0 |
625 |
46,140 |
0 |
||
Dividends |
0 |
0 |
0 |
0 |
||
Other |
3,109 |
1,099 |
(4,614) |
0 |
||
Net Cash Flow |
(24,932) |
(48,682) |
14,266 |
(28,510) |
||
Opening net debt/(cash) |
|
|
(96,131) |
(73,406) |
(31,600) |
(45,866) |
HP finance leases initiated |
0 |
0 |
0 |
0 |
||
Loan and finance movements |
2,207 |
6,876 |
(0) |
0 |
||
Closing net debt/(cash) |
|
|
(73,406) |
(31,600) |
(45,866) |
(17,356) |
Source: Edison Investment Research estimates, Celyad reports and announcements
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