First, we would like to thank you for your continued interest and support in Savara. We see Savara as an attractive business opportunity as we believe we have a unique pipeline of products with considerable market potential and we can offer investors important value-driving clinical milestones to look forward to. Our niche and expertise is to identify orphan lung product opportunities that are unique, and with no approved alternatives, but ideally ones that already have some form of proof of concept. As examples, AeroVanc and Molgradex are innovative and unique formulations of previously approved active drug substances, applying known treatment principles and established drug delivery technologies. It is important to note that prior to our programs, these concepts had already been pioneered off-label by research minded physicians with encouraging results. We see an exciting future ahead of us and welcome each of you to follow us on our journey in building The Orphan Lung Disease Company.
During the twelve weeks since the closing of our reverse merger which resulted in our public listing on Nasdaq, we have had many notable accomplishments. Some of the highlights include:
- Announcing an expedited U.S. development strategy for our Molgradex program. Based on FDA guidance, our ongoing IMPALA study is being expanded to serve as a global pivotal study for registration in the U.S., Europe and Japan, a major win for the company, which we believe to result in important time and cost savings with this program.
- Through our diligent efforts, the ongoing Phase 3 IMPALA study is now over half way enrolled, with patient enrollment expected to complete in Q1 2018 and top-line data anticipated by the end of 2018.
- We have secured intellectual property protection in the U.S. with the issuance of our Composition of Matter Patent for AeroVanc in Cystic Fibrosis (CF), which together with the Orphan as well as QIDP designations we believe provides us with very robust protection for the program.
- We successfully raised funds which are essential to continued development of our lead programs. The offering was managed by well-known banks including Jefferies as lead book runner, and Canaccord Genuity and JMP Securities as lead managers.
- New Savara investors include experienced institutional healthcare investors as well as an important strategic investor in Zambon. Zambon markets a number of orphan and respiratory products worldwide, including Promixin, an inhaled antibiotic indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in people with CF.
- Notably, as you may have seen, each of Savara’s executive officers as well as certain members of our Board of Directors purchased shares in the offering, along with certain other non-executive team members. This reflects our belief in our business, development plans and strategy.
- We now have research coverage from the team at Canaccord Genuity and we plan to continue to build awareness and interest around Savara in the investment community, including working to add other institutional investors and obtaining research coverage from other well-respected healthcare analysts.
- Savara was added to the Russell Microcap® Index, an important milestone for us which we believe reflects the remarkable progress we have made. As the Russell indexes are widely followed in the investment community, we expect our inclusion will contribute to expanding awareness of the company among institutional investors as well as positively impacting the volume of trading in our common stock.
- Most recently, positive interim results from an ongoing 50-patient open-label Phase 2 study of Aironite in patients with pulmonary hypertension (PH) were presented at the 4th Annual Drug Discovery and Development Symposium for PH. These results demonstrate that Aironite can significantly improve cardiopulmonary hemodynamics in patients with heart failure with preserved ejection fraction (HFpEF) as well as Group 3 PH patients, clinical conditions which are inadequately treated by currently approved medicinal treatments.
- As a reminder, we are in preparation for a pivotal Phase 3 study of AeroVanc for the treatment of MRSA infection in CF patients and we anticipate patient enrollment will begin in Q3 2017.
I am excited about the progress our team has made thus far and I am looking forward to more successes in the future. We are strongly driven to execute our key programs and our growth strategy to transform Savara into a leading specialty pharmaceutical company addressing a range of rare respiratory diseases. We believe we are building an exceptional business and will continue to grow the company and to instill confidence in our investors. We sincerely appreciate your continued support and look forward to keeping you updated through our various communication channels including @SavaraPharma, press releases and our SEC filings.
Savara cautions you that statements herein that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as “expect,” “intend,” “plan,” “anticipate,” “believe,” and “will,” among others. Such statements include, but are not limited to, statements relating to our business opportunity, our product candidates, our strategy, the timing of milestones and regulatory approvals for our product candidates and our future successes. Savara may not actually achieve any of the matters referred to in such forward looking statements, and you should not place undue reliance on these forward-looking statements. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon Savara’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with the outcome of ongoing clinical trials for our product candidates, the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources for Savara’s operations and to conduct or continue planned clinical development programs, the ability to obtain the necessary patient enrollment for our product candidates in a timely manner, the timing and ability of Savara to raise additional equity capital to fund continued operations; the ability to successfully develop our product candidates, and the risks associated with the process of developing, obtaining regulatory approval for and commercializing drug candidates that are safe and effective for use as human therapeutics. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, 10-Q and 10-K. You are cautioned not to place undue reliance on our forward-looking statements herein, which speak only as of July 20, 2017 which is the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after such date, except as may be required by law.