Prima BioMed has presented encouraging early signs of efficacy from the TACTI-mel trial of IMP321 in combination with Keytruda, with one of the six melanoma patients in the first (1mg/kg) cohort experiencing a complete response. Recruitment in the second cohort is complete and the final cohort is expected to be fully recruited by Q317. Preliminary efficacy data from the 15-patient, run-in phase of the AIPAC breast cancer study are expected mid-year (recruitment in the 226-patient Phase IIb component is ongoing). Our valuation is unchanged at A$252m (12c per share).
Written by
Prima BioMed |
Initial LAG-3 combo data presented |
Initial TACTI-mel data |
Pharma & biotech |
22 March 2017 |
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Prima BioMed is a research client of Edison Investment Research Limited |
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Prima BioMed has presented encouraging early signs of efficacy from the TACTI-mel trial of IMP321 in combination with Keytruda, with one of the six melanoma patients in the first (1mg/kg) cohort experiencing a complete response. Recruitment in the second cohort is complete and the final cohort is expected to be fully recruited by Q317. Preliminary efficacy data from the 15-patient, run-in phase of the AIPAC breast cancer study are expected mid-year (recruitment in the 226-patient Phase IIb component is ongoing). Our valuation is unchanged at A$252m (12c per share).
Year |
Revenue |
PBT* |
EPS* |
DPS* |
P/E |
Yield |
06/15 |
1.3 |
(12.9) |
(0.9) |
0.0 |
N/A |
N/A |
06/16 |
1.9 |
(13.7) |
(0.6) |
0.0 |
N/A |
N/A |
06/17e |
1.3 |
(12.7) |
(0.6) |
0.0 |
N/A |
N/A |
06/18e |
10.6 |
(4.0) |
(0.2) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
A complete response in low-dose TACTI-mel cohort
The TACTI-mel trial is using IMP321 (Prima’s LAG-3-based antigen presenting cell activator) to enhance efficacy in melanoma patients who have had a suboptimal initial response to the PD1 immune checkpoint inhibitor Keytruda. A presentation to the Immune Checkpoint Inhibitors conference in Boston showed that that one of the six patients (17%) in the first cohort experienced a complete response (CR). Even though there is only one patient with a CR, the initial CR rate compares favourably with rates of 2-6% seen in Merck’s Phase III trials of Keytruda monotherapy in melanoma. The combination has been well tolerated so far. Recruitment in the third and highest (30mg) dose cohort is expected to complete in Q317, so we expect efficacy data from the final cohort in H118.
Initial efficacy data from AIPAC run-in due mid-year
Initial efficacy data are expected mid-2017 (possibly at ASCO in June) from the 15 metastatic breast cancer patients treated with IMP321 in combination with paclitaxel during the safety run-in phase of the AIPAC study (the response rate in a previous Phase I study was 50%). Dosing began in January in the 226-patient randomised Phase IIb component of AIPAC; top-line PFS data could mature sometime between late 2018 and mid-2019. Patients will receive either 30mg of IMP321 or placebo, in combination with paclitaxel.
Valuation: Unchanged at A$252m, 12c per share
Our valuation is unchanged at A$252m, which is equal to 12c per share on an undiluted basis or 8c per share after accounting for dilution from options, warrants and convertible notes. Guidance is that the cash balance of A$16.6m at 31 December will be sufficient to fund operations through Q1 CY18, excluding any milestone payments from partners Novartis and GSK. Milestone revenue (we model ~A$9m in FY18) would extend the cash runway.
Complete responder in first TACTI-mel cohort
On 16 March Prima’s chief medical and scientific officer, Dr Frédéric Triebel, presented an update on the Phase I TACTI-mel trial, including preliminary efficacy data from the first cohort, at the Immune Checkpoint Inhibitors conference in Boston, Massachusetts. This study will test three doses of IMP321 (1, 6 and 30mg/kg) in combination with the anti-PD-1 immune checkpoint inhibitor Keytruda (pembrolizumab, Merck) in 18 patients with advanced melanoma. Recruitment in the first two cohorts is complete, as shown in Exhibit 1.
The trial is investigating IMP321 in subjects who have had a suboptimal response to initial treatment with Keytruda. Subjects are assessed after they have undergone three cycles (nine weeks) of treatment with Keytruda; patients with stable disease or slow progression not requiring urgent intervention are eligible to participate in the trial and receive IMP321, starting with the fifth Keytruda cycle at week 13.
Six patients were enrolled in the first dose cohort (1mg/kg every two weeks), which began in Q216. The second cohort of six patients is fully recruited, and all subjects continue to receive three-weekly injections of Keytruda and fortnightly injections of IMP321 at 6mg/kg. No clinically significant adverse events related to IMP321 or the combination of IMP321 with Keytruda have been observed at either dose level so far. Recruitment in the third and highest (30mg) dose cohort is expected to complete in Q317.
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Exhibit 1: TACTI-mel Phase I status and preliminary results |
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Source: Prima BioMed presentation at Immune Checkpoint Inhibitors conference, Boston, Massachusetts |
One of the six patients receiving the lowest dose of IMP321 experienced a complete response (CR, Exhibit 2). After the completion of four cycles (12 weeks) of Keytruda monotherapy there was no shrinkage in this patient’s tumours, but after four cycles of combination therapy with Keytruda and low dose IMP731 the lung metastases had shrunk by 73%; 23 weeks after initiation of IMP321 combination therapy the tumours had disappeared altogether. Of the other five patients, two experienced disease progression (tumour growth), one withdrew due to unrelated sepsis and there is no information about the other two, although they appear to have completed 26 weeks of treatment with IMP321 without disease progression. One should not read too much into a single tumour response, particularly given that the dose of IMP321 was low and delayed responses are a well-recognised feature of therapy with ICI, but it is encouraging that the tumour shrinkage appears to have coincided with the initiation of combination therapy. Again, while the number of patients is small, the preliminary CR rate of 17% (1/6) compares favourably with CR rates of 2-6% seen in Phase III trials of Keytruda monotherapy in melanoma.
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Exhibit 2: TACTI-mel first cohort (1mg/kg IMP321) complete responder and preliminary results |
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Source: Prima BioMed presentation at Immune Checkpoint Inhibitors conference, Boston, Massachusetts |
Exhibit 3: Financial summary
A$'000s |
2014 |
2015 |
2016 |
2017e |
2018e |
||
Year end 30 June |
IFRS |
IFRS |
IFRS |
IFRS |
IFRS |
||
PROFIT & LOSS |
|||||||
Revenue |
|
|
2,020 |
1,336 |
1,949 |
1,253 |
10,564 |
R&D expenses |
0 |
(8,952) |
(7,060) |
(7,271) |
(7,489) |
||
SG&A expenses |
2,020 |
(5,723) |
(6,983) |
(7,122) |
(7,336) |
||
EBITDA |
|
|
(14,003) |
(13,345) |
(12,093) |
(13,141) |
(4,262) |
Operating Profit (before GW and except.) |
|
(14,395) |
(13,671) |
(12,275) |
(13,144) |
(4,269) |
|
Intangible Amortisation |
(54) |
(1,015) |
(1,993) |
(1,877) |
(1,708) |
||
Exceptionals |
0 |
(18,338) |
(47,468) |
0 |
0 |
||
Operating Profit |
(14,450) |
(33,024) |
(61,736) |
(15,021) |
(5,976) |
||
Other |
407 |
538 |
(1,716) |
0 |
0 |
||
Net Interest |
713 |
192 |
256 |
418 |
244 |
||
Profit Before Tax (norm) |
|
|
(13,275) |
(12,940) |
(13,735) |
(12,727) |
(4,025) |
Profit Before Tax (IFRS) |
|
|
(13,330) |
(32,294) |
(63,196) |
(14,603) |
(5,732) |
Tax |
(14) |
142 |
1,181 |
0 |
0 |
||
Profit After Tax (norm) |
(13,289) |
(12,798) |
(12,554) |
(12,727) |
(4,025) |
||
Profit After Tax (IFRS) |
(13,343) |
(32,152) |
(62,015) |
(14,603) |
(5,732) |
||
Average Number of Shares Outstanding (m) |
1,220.1 |
1,490.1 |
2,236.3 |
2,061.6 |
2,073.1 |
||
EPS - normalised (c) |
|
|
(1.1) |
(0.9) |
(0.6) |
(0.6) |
(0.2) |
EPS - IFRS (c) |
|
|
(1.1) |
(2.2) |
(2.8) |
(0.7) |
(0.3) |
Dividend per share (c) |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
||
Gross Margin (%) |
N/A |
N/A |
N/A |
N/A |
N/A |
||
EBITDA Margin (%) |
N/A |
N/A |
N/A |
N/A |
N/A |
||
Operating Margin (before GW and except.) (%) |
N/A |
N/A |
N/A |
N/A |
N/A |
||
BALANCE SHEET |
|||||||
Fixed Assets |
|
|
694 |
22,960 |
20,883 |
19,031 |
17,347 |
Intangible Assets |
117 |
22,662 |
20,852 |
18,975 |
17,267 |
||
Tangible Assets |
577 |
298 |
32 |
56 |
79 |
||
Other |
0 |
0 |
0 |
0 |
0 |
||
Current Assets |
|
|
24,684 |
8,023 |
21,671 |
8,919 |
4,871 |
Stocks |
0 |
0 |
0 |
0 |
0 |
||
Debtors |
196 |
315 |
168 |
168 |
168 |
||
Cash |
23,200 |
6,760 |
20,880 |
8,128 |
4,080 |
||
Other |
1,287 |
948 |
623 |
623 |
623 |
||
Current Liabilities |
|
|
(2,771) |
(4,380) |
(1,472) |
(1,472) |
(1,472) |
Creditors |
(2,669) |
(2,791) |
(1,444) |
(1,444) |
(1,444) |
||
Short term borrowings |
0 |
(1,508) |
(0) |
(0) |
(0) |
||
Short term leases |
0 |
0 |
0 |
0 |
0 |
||
Other |
(102) |
(80) |
(28) |
(28) |
(28) |
||
Long Term Liabilities |
|
|
(15) |
(1,914) |
(5,765) |
(5,765) |
(5,765) |
Long term borrowings incl. conv. note |
0 |
0 |
(5,027) |
(5,027) |
(5,027) |
||
Long term leases |
0 |
0 |
0 |
0 |
0 |
||
Other long term liabilities |
(15) |
(1,914) |
(737) |
(737) |
(737) |
||
Net Assets |
|
|
22,592 |
24,690 |
35,317 |
20,714 |
14,981 |
CASH FLOW |
|||||||
Operating Cash Flow |
|
|
(14,908) |
(7,785) |
(11,594) |
(13,141) |
(4,262) |
Net Interest |
705 |
0 |
284 |
418 |
244 |
||
Tax |
(24) |
(2) |
0 |
0 |
0 |
||
Capex |
(104) |
(49) |
(27) |
(28) |
(30) |
||
Acquisitions/disposals |
0 |
(20,913) |
130 |
0 |
0 |
||
Financing |
6,845 |
7,745 |
27,229 |
0 |
0 |
||
Dividends |
0 |
0 |
0 |
0 |
0 |
||
Other |
(158) |
(164) |
0 |
0 |
0 |
||
Net Cash Flow |
(7,643) |
(21,168) |
16,022 |
(12,752) |
(4,048) |
||
Opening net debt/(cash) |
|
|
(30,023) |
(23,200) |
(5,251) |
(15,852) |
(3,100) |
HP finance leases initiated |
0 |
0 |
0 |
0 |
0 |
||
Other |
820 |
3,220 |
(5,421) |
0 |
0 |
||
Closing net debt/(cash) |
|
|
(23,200) |
(5,251) |
(15,852) |
(3,100) |
948 |
Source: Company accounts, Edison Investment Research
|
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QinetiQ CEO Steve Wadey has now got the bit between his teeth and is on a mission to expand the company internationally while exploiting growth opportunities in the core UK business. The recent acquisition of Meggitt Target Systems (MTS) seems to make strategic sense, both industrially and financially. This note introduces our FY18 numbers for the first time. Our new FY17 forecasts reflect the purchases of MTS and Rubikon and the £1bn amendment to the Long Term Partnering Agreement (LTPA) with the UK Ministry of Defence (MOD).