Nasdaq price, page-30

Hello from Stuart Roberts in Sydney, Last week the big news from Prima BioMed was our receipt of ‘Scientific Advice’ from the European Medicines Agency for our lead candidate, IMP321. Scientific Advice is a procedure offered by the EMA where companies like Prima can ask questions of the Agency regarding development strategies for new drugs. It’s a great system because it helps drug developers get an idea of what the Agency may be looking for, before the developers spend their valuable shareholder dollars on the relevant clinical work. Scientific Advice is legally non-binding because scientific knowledge changes over time – indeed, rather quickly these days – and the regulator rightly needs as much flexibility as possible to ensure that the drugs they are evaluating are safe and effective. However it’s reasonable to say that Scientific Advice gets taken into consideration once developers are actually asking for approval of their products. We were asking the EMA for Scientific Advice related to IMP321, where we have just unveiled a 200-patient Phase IIb study in HER2-negative metastatic breast cancer that is expected to start in late 2015. After a shorter safety run-in phase, this study will randomise patients 1:1 to either standard-of-care paclitaxel plus placebo or paclitaxel plus IMP321. We’re optimistic about the study’s prospects because when we ran Phase I/IIa we doubled the response rate from the 25% expected of paclitaxel (a historical control) to 50% with paclitaxel plus IMP321. Mind you, response rate, which is the percentage of patients whose tumours shrank by 30% or more over the six months measurement window, was the main measurement we got from Phase I/IIa. The Phase IIb study we’ll be running, called AIPAC (Active Immunotherapy PAClitaxel), will have Progression-Free Survival as its Primary Endpoint, where we will be measuring how long the patients can live without the tumour increasing in size. Response rates, Progression-Free Survival and Overall Survival are different measures of the effectiveness of a cancer therapy and they don’t always move in lockstep. That said, with Phase IIb we think we’re off to a good start. We estimate that AIPAC could take around three years to run. The other big development of last week was our announcement of the long-awaited Share Purchase Plan. We flagged our intention to do an SPP when we announced the Ridgeback transaction back in mid-May, and many shareholders have been asking about this in the meantime. We’ve now priced the SPP at 5 cents per share for all eligible shareholders on the register as at 6 July 2015. The issue will raise up to AS$5m or, at the discretion of the board, any amount up to A$10m. Our share registry, Boardroom, is mailing the relevant paperwork today so you’ll likely have it by the middle of this week. This week will be an important one for Prima because we will be presenting our story at the annual Bioshares meeting in Queenstown, New Zealand. Bioshares is a weekly publication based in Melbourne that focuses on the biotech and medical device industry in this part of the world. It’s a great read and I would encourage you, if you want to educate yourself about Life Science investment opportunities in Australia beyond Prima, to think about taking out a subscription (see www.bioshares.com.au). The annual conference of the publication – the Bioshares Biotech Summit - has in recent years turned into a mecca for Life Science investors – kind of like the ‘JP Morgan for the Southern Hemisphere’ (the Annual JP Healthcare Conference in San Francisco, held every January, is the No 1 event for the industry globally, so that anyone who is anyone in biotech has to be San Francisco that week). It attracts institutional and private investors as well as leading industry professionals from all over the world. The meeting is noted for the depth of its presentations and its serious consideration of industry trends and issues, as well as company-specific matters, and presentation at the event is by invitation only. So we’re privileged to be given a chance to speak. I’ll be on stage during the Friday afternoon session on cancer immunotherapy, and therefore I may not have time to send a shareholder message that day, however I’ll give you a run-down of some of the things I will have learned relevant to Prima BioMed when I get back. Have a great week Stuart

Wizza, Stuarts in NZ at the moment doing a presentation.......