With 2018 coming to a close, it’s a good time to look back and reflect on Savara’s progress over the last 12 months. It’s also a good time to look forward to the remarkable opportunities that lie ahead.
As an orphan lung disease company, Savara has a unique opportunity to develop differentiated therapies for people suffering from devastating, and often chronic, lung conditions. Of course, our ability to deliver innovative therapies and improve patient outcomes is dependent on the achievement of our corporate objectives. I am pleased to say that 2018 was a year of solid execution during which we advanced our programs in line with guidance, launched an exploratory pipeline, strengthened our management team across key functions and ended the year in a strong cash position.
Key accomplishments included:
- Enrollment completion in the two Molgradex studies, IMPALA and OPTIMA,
- FDA’s acceptance of the IND application for a Phase 2 study of Molgradex in people with cystic fibrosis (CF) who have NTM lung infection,
- Acquisition of the Phase 2-ready amikacin/fosfomycin product candidate,
- Partnering with the PAP Foundation to unite and support the PAP patient community
- Joining the broad-market Russell 3000® Index,
- Filling leadership roles in Business Development and Commercial Operations and
- Successfully raising $48.9M in a public offering.
Savara’s final major milestone for this quarter 2018 is the announcement of interim results from OPTIMA, our Phase 2a clinical study evaluating Molgradex for the treatment of NTM lung infection. This interim read-out will include data from approximately 10-15 patients, with 6-month smear and 3-4-month culture results, as well as safety data. I look forward to sharing these data with you soon.
While 2018 was busy, 2019 is shaping up to be even busier. As illustrated in the milestone chart below, we are entering unprecedented territory in Savara’s evolution as a company. With our growth drivers clearly in focus ― data read-outs expected from three studies, one of which could facilitate the submission of a BLA in 2020, and two new study-starts anticipated ― 2019 will be a transformative year for the company.
Collectively, these catalysts keep us on track to develop a strong portfolio of best-in-class therapeutics that address a broad range of rare lung diseases.
Savara has a chance to fundamentally improve quality of life for people living with these rare afflictions and I couldn’t be more proud and humbled to be a part of this amazing company. 2018 was a year of many achievements and I believe the best is yet to come! On behalf of the entire team, we thank you for your interest in the company and wish you a happy and healthy holiday season. I look forward to connecting with you again in the new year.
Chief Executive Officer
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 Savara’s unique opportunity to develop differentiated therapies for people suffering from devastating, and often chronic, lung conditions, our ability to deliver innovative therapies and improve patient outcomes being dependent on the achievement of our corporate objectives, the timing of the announcement of interim results from our OPTIMA study and the data included in that announcement, that Savara is entering unprecedented territory in its evolution as a company, the timing of our key clinical milestones in 2019, including data read-outs and study-starts, that one of the data read-outs could facilitate the submission of a BLA in 2020, that 2019 will be a transformative year for Savara, that these catalysts keep us on track to develop a strong portfolio of best-in-class therapeutics that address a broad range of rare lung diseases, that Savara has a chance to fundamentally improve quality of life for people living with these rare afflictions, and the belief that the best is yet to come. 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. 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 as needed 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, Form 10-Q and Form 10-K. You are cautioned not to place undue reliance on our forward-looking statements herein, which speak only as of December 13, 2018 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.