Immutep Ltd · ASX:IMM
Immutep — Prima BioMed — Investor Presentation (February 2013)
26 slides from Immutep's investor presentation, Feb 4, 2013
Slide 1: Prima BioMed Ltd Investor presentation February 2013
ASX:PRR; NASDAQ:PBMD; ISIN:US74154B2034 Prima BioMed Ltd The leader in developing personalized immunocellular therapeutics Investor presentation February 2013 Exhibit 99.2
Slide 2: Important Notice
Important Notice The purpose of the presentation is to provide an update of the business of Prima BioMed Ltd ACN 009 237 889 (ASX:PRR and NASDAQ:PBMD). These slides have been prepared as a presentation aid only and the information they contain may require further explanation and/or clarification. Ac
Slide 3: Investor Update
Investor Update 1. Company strategy 2. CVac clinical development 3. Manufacturing & technology 4. Business development 5. Investor relations 6. Business matters
Slide 4: Company Strategy
Company Strategy Consolidate our leadership position in the development of immunocellular therapeutics for cancer Continued investment in our technology, operational platform, and product development to further increase value Be “best-in-class” in 5 key areas of our business: Human resources Asset p
Slide 5: CVac clinical trials by phase and population
Phase Pro’ | Population Patients 1 CAN-001 Terminal cancer adenocarcinoma (breast, 10 ovarian, fallopian tube, colon, lung, oesophageal) 2 CAN-002 Ovarian cancer patients with no further 28 treatment options 2 CAN-003 Ovarian cancer patients in remission 63 after 1st or 2nd line therapy 2 CAN-003x O
Slide 6: CVac clinical building blocks
CVac clinical building blocks CAN-001 data (2005) CAN-002 data (2007) CAN-003 interim data (2012) CAN-003 final data (2013) CAN-004 top line data (2015) Start new indications (2013) CAN-003X case data (2014)
Slide 7: CAN-001 & CAN-002
CAN-001 & CAN-002 Demonstrated the technological feasibility of CVac production in Australia Demonstrated the safety of CVac in a small population Demonstrated that CVac can stimulate an immune response in cancer patients Indications of clinical efficacy in late stage ovarian cancer patients
Slide 8: CAN-003 outcomes to date
CAN-003 outcomes to date Manufacturing comparability between Australia and US established CVac safety profile continues to be attractive Interim immune monitoring data (intracellular cytokine staining) indicates a mucin 1 specific t-cell response Interim progression free survival data show encouragi
Slide 9: CAN-003 upcoming data
CAN-003 upcoming data 3Q CY13 - Full immune monitoring profile of 63 patients over multiple time points during and after dosing 4Q CY 13 – Final protocol analysis of progression free survival and first evaluation of overall survival Goal – to evaluate the clinical endpoints & to explore the relation
Slide 10: CAN-003X
CAN-003X Small extension trial for patients who progress during the CAN-003 trial Evaluate longer-term safety of CVac & interactions with other therapeutic agents 9 patients enrolled. Closed for further enrollment
Slide 11: CAN-004 (CANVAS) status
CAN-004 (CANVAS) status Approved by regulators in 9 countries (including Australia, USA, Belgium, Bulgaria, Belarus, Lithuania, Poland, Ukraine and Germany) Ethics committee approvals in 14 countries 46 cell collection centers inspected & trained; 28 activated to start the trial (26 Jan 2013) 14 cli
Slide 12: CANVAS goals
CANVAS goals Validate and plan for a commercial-ready manufacturing process in 3 global regions Validate a companion Mucin 1 diagnostic test Confirm acute and longer-term safety and tolerability of CVac in a larger patient population Establish CVac efficacy by PFS and/or OS Investigate CVac impact o
Slide 13: CANVAS considerations
CANVAS considerations Learning from previous industry experience in commercial scale-up and manufacturing challenges Careful scale up of global manufacturing for the largest autologous cell therapy trial undertaken Harmonization of global regulatory demands for a comparable product (blood collection
Slide 14: CANVAS expectations
CANVAS expectations Start recruitment in Europe early 2013 Significant scale up of clinical centers and patients through 2013 Recruitment complete half of – Prima is controlling the rate of recruitment carefully and will keep everyone informed Top line data approximately 2015 – pending recruitment a
Slide 15: CVac in new indications
CVac in new indications Prima believes the interim immune data demonstrate the activity of CVac and believes it has potential applications in addition to ovarian cancer Plan to initiate 2-3 pilot trials in additional cancer targets in 2Q CY 2013 pending the appropriate funding Goal is to expand the
Slide 16: Manufacturing & technology milestones
Manufacturing & technology milestones Scale up and characterization of M-FP Product comparability in 3 global facilities Automated logistics management Customization & validation of shipping materials and cold supply chain Securing & obtaining regulatory approval of supply chain of starting producti
Slide 17: CVac manufacturing building blocks
CVac manufacturing building blocks Production feasibility (2004) Professional manufacturing Australia (2006) Tech transfer to USA facility (2009) Aus-USA comparability (2010) Tech transfer to Germany (2011) Aus-USA-Germany comparability (2012) Manufacturing scale-up (2013-14) Manufacturing validatio
Slide 18: CVac manufacturing overview
CVac manufacturing overview http://primabiomed.com.au/movies/movie_5.php
Slide 19: Manufacturing & technology plans
Manufacturing & technology plans Long term planning for commercial scale up – own facilities or partnership Expand cell collection network Continuous improvement & efficiency in logistics management Optimize production processes Enhance quality control testing – significant area for cost reduction a
Slide 20: Business development plan
Business development plan Bring in complementary technologies that can benefit from Prima’s expertise: – Antigen targets in addition to mucin 1 – Immune cell products for clinical development Partner products in late stage development for commercialization: – Robust clinical proof of concept – Clear
Slide 21: Investor relations
Investor relations Committed to consistent and clear communication about the development of the business and our programs Continuation of quarterly shareholder newsletters Initiation of quarterly conference calls starting with the December 2012 half year report in a few weeks
Slide 22: Business matters: ADR programs
Business matters NASDAQ ADR program: – poor trading liquidity and increased expense for accounting and compliance – increased awareness in the US and higher level of transparency because of SEC – Prima will evaluate this program in 2013 Frankfurt/XETRA ADR listing: – nominal expense – directly tied
Slide 23: Business matters: Finances
Finances: – A$ 28 million in cash as of 31 December 2012 – Cash burn of approximately A$ 5 million per quarter – Cash support expected from Australian R&D tax credit, Saxony Development Bank and bank interest – CANVAS increased recruitment could moderately accelerate cash burn from the current proje
Slide 24: Pending investment projects
Pending investment projects: – Pilot CVac trials in additional cancer indications – Manufacturing optimization – Potential addition of new clinical products Monitoring capital needs: – Grant and subsidy programs – Raising capital from placement of new shares – Longer term - outlicensing/partnering/m
Slide 25: Investment thesis
Investment thesis Leadership position in an emerging field of immunocellular therapeutics for cancer Significant market potential to help cancer patients with less toxic therapies and benefit shareholders Discipline of continuous improvement in our technology and manufacturing for improved quality a
Slide 26: Company catalysts & milestones
Indicative timing Event Continuous improvement Quality production Cost efficiency Company catalysts & milestones 2Q CY 2013 Announce pilot trials of CVac in new cancer targets 3Q CY 2013 CAN-003 immune monitoring (ICS) final data 4Q CY 2013 CAN-003 progression-free survival final data and initial ov