Received another report from Ord Minnet today so the word is...

Received another report from Ord Minnet today so the word is spreading about the upcoming interim data. Not long to wait now.


Prima BioMed Limited (PRR - Spec. Buy) - Interim Results Data Imminent

Prima BioMed Limited (PRR)
Spec. Buy / Higher risk
Last: $0.17 / Price target (risk adjusted): $0.53

Interim Results Data Imminent
§ Prima BioMed (PRR) is due to release interim data from the CAN-003 trial (a 63 patient Phase IIb study) on 15 October 2012 in Vancouver, Canada (16 October Australian time). The presentation will provide valuable early insights into:
- Safety – There has not been any significant issues with regard to safety in the small test populations to date. Because of its autologous nature, patient immune systems have generally tolerated CVac well to date.
- Efficacy – This will be measured using progression-free survival (PFS, see Appendix 1), which monitors how long CVac can stabilise certain immunological markers related to disease progression. Importantly, while early data suggested a ~20% response rate, the patient population exhibited a much later stage of disease relative to participants in CAN-003.
- Biological Activity – This will be measured by Intracellular Cytokine Staining (ICS, see Appendix 2), a technique to show whether CVac has stimulated the appropriate immune response. The results here will also determine whether the CVac process could be applied to other cancers which overexpress the mucin-1 antigen.
§ The company is tracking to our expectations with regard to the timing of the interim data, having met all recruitment and dosing timetables (last patient received final dose of CVac in early October 2012). From Ord Minnett’s perspective, we would be very encouraged by: 1) a broad immune response from those in the CVac group (ie: greater than 20% response rate), 2) any evidence of survival advantage relative to the control group (measured in months of immune marker reduction or stabilisation), and 3) ICS results that indicate potential for CVac in other indications (colon, breast, lung, etc.)
§ Concurrently, recruitment continues in the pivotal CANVAS study (also known as CAN-004), with last patient expected to be admitted to the study by the end of calendar 2013. As part of this trial, PRR will continue to develop and improve its manufacturing, logistics and quality control procedures.
§ We maintain our Speculative Buy with higher risk. PRR has the requisite talent, resources and technology to execute a high quality clinical program. Fundamentally, however, the company’s success is dependent on clinical trial results which are inherently uncertain.
Key Financials
Year-end Jun (A$)
FY11A
FY12A
FY13E
FY14E
FY15E
Revenue ($m)
1.1
1.5
3.5
6.3
37.5
EBITDA ($m)
-21.0
-22.2
-23.7
-25.9
7.1
Net profit after tax ($m)
-21.1
-19.9
-23.2
-26.0
4.9
EPS (¢)
-3.7
-1.9
-2.1
-2.2
0.4
P/E (x)
-4.5
-8.9
-8.0
-7.9
41.5
EV/EBITDA
-2.4
-7.2
-6.6
-7.7
28.3
Dividend (¢)
0.0
0.0
0.0
0.0
0.0
Net Yield (%)
0.0
0.0
0.0
0.0
0.0
Franking (%)
na
na
na
na
na
Normalised NPAT ($m)
-22.5
-19.9
-23.2
-25.9
4.9
Fully Diluted EPS (¢)
-4.0
-1.9
-2.1
-2.2
0.4
EPS Growth (%)
-9.9
52.0
-10.2
2.3
119.0
Normalised P/E (x)
-4.3
-8.9
-8.0
-7.9
41.3
Normalised ROE (%)
-40.8
-53.6
-47.4
-112.9
17.7
Source: IRESS, Company data, Ord Minnett estimates