Page 1 of 2 PO Box 42 Toowong BC, Queensland, Australia, 4066 Phone: +61 (0) 7 3870 8933 [email protected]www.qbiotics.com AUGUST 2018 SHAREHOLDER NEWSLETTER Dear Shareholder, Following is a brief update on major activities in the QBiotics Group over the last quarter. 1. Partnering for veterinary marketing and distribution to maximise value I am delighted to announce that we have reached a significant milestone towards commercialisation of tigilanol tiglate into global veterinary markets. QBiotics Group has now signed a marketing and distribution agreement with Virbac, one of the largest dedicated animal health companies, with offices in all major global markets. Virbac has the expertise and global footprint to maximise the commercial success of tigilanol tiglate. In addition, they share our passion forthe drug and recognise its potential to transform the treatment of canine cancer with clear benefits for patients, veterinary practitioners and dog owners. 2. Veterinary oncology program progress Preparation of the report on the pivotal field study of tigilanol tiglate for treatment of canine mast cell tumour (MCT) in the USA is now well advanced. This report is the final document to complete our MCT registration application for submission to the USA Food and Drug Administration-Centre for Veterinary Medicine (FDA-CVM). This report also supports our European Medicines Agency (EMA) application for the drug to treat canine MCT. Due to a minor delay in securing the necessary data selection meeting with the FDA-CVM, submission of the USA applications, which was to be in the third quarter 2018, is now planned for the fourth quarter. The EMA submission is still on track for the fourth quarter 2018. 3. Human oncology program progress Results for the human oncology program have now been reported. Our Clinical Phase I/IIA study was a dose escalation study with a primary focus on assessment of the safety parameters of the drug in humans. To establish safety dosing, this study needed to be based on patient weight and not on the size of tumours as would be the protocol for an efficacy trial. I am very pleased to report that the drug was well tolerated by patients and a maximum tolerated dose (where the study is stopped due to the drug reaching a tolerated limit) was not reached. In addition, signs of efficacy were reported in 8 different tumour types with full tumour destruction (Complete Response under the standard oncology clinical measuring system) achieved at the higher dose cohorts. These results are impressive for a first in human study and support the potential for tigilanol tiglate to address a range of AUGUST 2018 QBiotics Group Shareholder Newsletter Page 2 of 2 tumour types. We are now preparing to undertake a Clinical Phase IIA efficacy trial with the drug. 4. Institutional support for QBiotics Group One important step for the QBiotics Group in moving towards a successful IPO and public listing, at a sound company valuation, is to attract reputable institutional investors with experience and a track record in the life sciences sector. The presence of such investors on the Company’s register will provide a clear validation of QBiotics as we are now, as well as an endorsement of our plans and vision for the Company’s future. During the past quarter we continued to work with our advisory firm WG Partners to build our profile with institutional groups both in the UK and Australia. Follow up meetings were held with groups in London, who continue to show enthusiasm for the company. Preliminary meetings have also now been held in Sydney and Melbourne with good reception. To address our pre-IPO objectives, the Board is now considering a capital raise which will provide an opportunity for institutional involvement, and will deliver funding for additional product development of our human pharmaceutical programs which will underpin a substantial Company IPO valuation. A letter will shortly be sent to shareholders outlining the Board’s thoughts on this approach and seeking your input. If you have any questions please contact our Investor Relations Manager, Mr Ken Pointon. Mr Pointon can be contacted by telephoning (07) 3870 8933 or emailing [email protected]. Thank you for your ongoing support, together we are building an extraordinary company. As always, it is a pleasure to share the journey with you. Dr Victoria Gordon Chief Executive Officer & Managing Director QBiotics Group Limited
