Based on remarkable progress across the business in the last two years, we’ve now completed two recent and unprecedented private financings – both in size and valuation. With this, Intarcia has significantly extended our runway, preserved our independence, and retained full strategic control of our wholly owned assets. With the most recent $200M private financing just completed, together with the last $210M round of equity and debt financing in November of 2012, this puts Intarcia in a very strong position for future growth and value creation. And staying private during this critical period is allowing us to keep 100% focused on excellence in execution toward key milestones leading to our target approval for ITCA 650 in type 2 diabetes.
As a small marker of our progress, it is nice to have our newest round of financing establish us as the most highly valued privately held biotech in history. However, our mission is far from complete, and we know we are just scratching the surface of our mission and our true potential to change lives. That potential will be unleashed by fulfilling our foremost priority … introducing a potential new standard of care in the huge global type 2 diabetes market, and thereby creating meaningful value for patients, payors and providers alike. This is what drives us and expresses who we are at our core. The new capital also enables us to leverage our proprietary platforms by advancing some focused efforts and collaborations to build similar excitement and potential in our pipeline.
We are innovating truly disruptive advances for which there are no analogues – not for our products, not for how we finance the company, and certainly not for how our products will be brought to the market and commercialized. Doing things disruptively different is who we are and it is fundamental to our culture and our mission to bring transformational medicines to patients who are in great need. We are here to make a very important difference for all our stakeholders – especially patients. When we do that exceptionally well, the rest always follows for building a sustainably successful company. Therefore we eschew analogues and the “play-not-to-lose” mentality they tend to attract. Pharma analogues are not what healthcare needs, and when there are too many good analogues, it usually means one is working very hard to be a follower (a “me-too” product) or settling up for only incremental progress.
Instead, at Intarcia, we aim to open up a whole new way of delivering medicines that have the potential to transform outcomes. Our first interim phase 3 data in type 2 diabetes presented at the JP Morgan Healthcare Conference in January this year gave us an exciting glimpse of the real potential we have to make a huge difference for patients, payors and providers alike. The interim data was instrumental in earning our record-breaking new financing. Much more data on this trial and our FREEDOM phase 3 program will be announced at major medical meetings throughout the rest of 2014 and 2015.
ITCA 650, our novel once-yearly GLP-1 for type 2 diabetes, is being investigated in a global phase 3 clinical trial series called FREEDOM in which we have already well over half of the 4,000 plus patients we will enroll in total. We are fully on track with our schedules for the four phase 3 clinical trials that make up the FREEDOM program. This is a testament to our people and the collaboration we have with Quintiles as our global development partner.
Results from the first pivotal clinical trial (FREEDOM 1) will be available at the end of September of this year. Results from the High Base Line (HBL) trial are also expected in late September. The head-to-head trial vs. sitagliptin and the cardiovascular outcomes trial are expected to complete enrollment in 2Q and 4Q of 2014, with final results needed to support regulatory filings by early 2016.
An absolutely critical point – and an exciting one for those of us who work within Intarcia – is that through all our funding to date, our Company retains independence and full control of our lead product candidate ITCA 650. We believe this level of strategic independence is essential to our ability to optimally deliver ITCA 650’s full clinical potential to patients, payors and providers who are eagerly waiting for new solutions to the management of type 2 diabetes. We will partner our product outside the US but this puts us in a strong position to select the very best partner, one that we can be assured is fully aligned and committed to the vision we have for ITCA 650.
We are also proud to have Quintiles, Inc., as our strategic partner on our FREEDOM clinical trial program – the world’s leading biopharmaceutical service provider, and a company that has helped develop or commercialize 18 of the 20 best-selling diabetes products. If approved, ITCA 650 will be the first and only once-yearly, injection-free GLP-1 therapy for the treatment of type 2 diabetes.
I’d also like to welcome our new shareholders who joined us and contributed to this new $200M round of financing. RA Capital led the round as a new investor and was joined by a mix of new and prior investors such as Fred Alger Management, Farallon Capital Management, Franklin Templeton, LLC, Foresite Capital, Quadrille Capital, Quilvest, and three additional top-tier institutional investors in Boston and New York that were in the last round.
Intarcia achieved several additional key milestones in the past year, strengthening its Board of Directors and bringing on new talent to increase the breadth and depth of its Leadership Team and other key positions needed as the company advances. New headquarters were opened in 3Q of last year at Boston’s Seaport Innovation Center, while the world-class technology and manufacturing capabilities were scaled up and dramatically strengthened in Hayward, California. Most recently, the Company has begun to differentiate itself by hiring a new officer to create new best-practice standards in training and driving pro-active strategies to ensure optimal Customer Experiences and Outcomes, an area where continuous improvements would be of particular value for consistent optimal use and outcomes for patients, payors and providers using ITCA 650, as well as subsequent Intarcia products.
Most of all, I’d like to personally thank the people I’m privileged to work with both inside and outside our Company – each of our employees, our partners, our advisors, and our investors. Collectively we are working to change lives. There is nothing more rewarding or exciting than that.
I look forward to my next update on our Company. While there are always challenges to overcome and opportunities to capture, I see many exciting milestones ahead and continued excellence in execution will be mission critical to keep this pace of progress. On behalf of the company and all our people, you have my assurance we will continue to work with the urgency, care, and skill these opportunities to change lives deserve.
Chairman, President and CEO
Intarcia Therapeutics, Inc.