Savara Inc. (SVRA) stock prices were down by 3.95% as of the market closing on May 4th 2021, bringing the price per share down to USD$1.70 at the end of the trading day.
11th Hour Failure
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SVRA announced near the end of 2020 that the Phase 3 trial of AeroVanc did not meet its primary endpoint of mean absolute change from baseline to FEV percent predicted analyzed sequentially at the ends of varying cycles. The trial consisted of patients with cystic fibrosis who also had an MRSA lung infection undergoing multiple dosing cycles, with one cycle consisting of 28 days of treatment followed by 28 days of observation.
Dissolution of AeroVanc
Despite being well-tolerated, AeroVanc did not show a statistically significant improvement in the sequence of analysis ends. Furthermore, the treatment failed to result in a decrease in the frequency of pulmonary exacerbations as compared to placebos. The development of AeroVanc has been discontinued based on the results of the trial, with the company hoping the data collected will benefit future research in the field.
Strong Liquidity Position
As the financial reports for the fourth quarter of the fiscal year 2020 are being tabulated, SVRA forecasts a solid liquidity position at the end of the year. The company anticipates USD$25 million in debt and USD$82 million in cash, cash equivalents, and short-term investments. To facilitate this strategy, SVRA has implemented a plan focusing on the reduction of overall operating expenses. Making the company’s cost structure leaner and more effective will also require a reduction in SVRA workforce.
Reallocation of Resources
2021 saw the company entering the new year with a shifting in their priorities, with a renewed focus on key value drivers such as Molgradex in aPAP as well as the successful execution of the IMPALA 2 trial. In the interest of SVRA’s pipeline simplification strategy and the reallocation of existing resources, the company has discontinued the Apulmiq clinical development program.
Phase 3 IMPALA 2 trial
The continued vice grip of the global Covid-19 pandemic has presented challenges in the conducting of SVRA’s clinical trials. Nevertheless, the company continues to facilitate the initiation of the Phase 3 IMPALA 2 trial across Europe, North America, and Asia. As the effects of the pandemic continue to develop, SVRA focuses on conducting its clinical trial safely and quickly. The resulting Covid-19 mitigation strategies have pushed the expected start date for the trial from the end of Q1 2021 to the start of Q2 2021.
Future Outlook for SVRA
Armed with the capital generated from the closing of their USD$130 million public offering, SVRA is poised to allocate its resources towards projects that have a probability of profitability. With the third phase of the IMPALA 2 trial looming just ahead, current and potential investors are hopeful that the company will leverage its strengths to usher in a period of significant and sustained increases in shareholder value.