Akebia Therapeutics (NASDAQ: AKBA), a Massachusetts-based biotechnology company focused on kidney disease, announced positive results from the phase 3 trial of vadadustat for the treatment of anemia due to chronic kidney disease (CDK). The investigational vadadustat therapy achieved the program’s primary efficacy and cardiovascular safety endpoints in adult patients on dialysis.
Anemia is a commonly occurring condition in people with CDK because their kidneys do not produce enough of a hormone that regulates red blood production. It can cause fatigue, dizziness, shortness of breath, and cognitive dysfunction and is associated with increased mortality rates in people with CDK.
Akebia’s vadadustat is an oral inhibitor that is designed to mimic the physiologic effect of altitude on oxygen availability. It has been shown to increase red blood cell production and improve oxygen delivery to human tissues.
President and CEO John P. Butler stated, “We are very excited about the positive top-line results from INNO2VATE and expect to build on this momentum with many potentially transformational near-term milestones. We believe we’ve developed an exciting path forward for vadadustat and although the COVID-19 environment remains unpredictable, we continue to execute and deliver solid progress against these initiatives.”
Through its partnership with Japanese pharmaceutical company Mitsubishi Tanabe, Akebia is expecting vadadustat’s first regulatory approval to occur later this year in Japan.
Revenue Growth, Solid Cash Position Highlight Q1 Results
The company also reported first quarter 2020 financial results for the period ending March 31st, 2020. Revenue increased 22% to $88.5 million driven by a 20% increase in collaboration revenue to $59.3 million and a 26% increase in net product revenue. The performance surpassed the consensus expectation for revenue of $77.5 million.
It recorded a narrower net loss of $60.7 million compared to the $72.4 million loss posted in the first quarter of 2019. This was due to lower cost of goods sold (COGS) as well as slightly lower research and development (R&D) expense than the same period a year ago.
Management noted that it has not experienced any significant adverse effects from the COVID-19 pandemic and that its cash runway now extends well into 2021. Akebia exited the quarter with a cash balance of $115.4 million. Included in the cash runway forecast is a $15 million payment it expects to receive from Mitsubishi Tanabe for reaching a regulatory milestone.
Looking ahead
The positive late-stage kidney drug results could bode well for Akebia’s future as it continues to pursue the development of novel kidney-related therapies. The trial is one of two late-stage clinical studies underway for vadadustat.
Akebia has solid business fundamentals but like many small cap biotechnology companies has been unable to offer insight into near-term demand for its products and payments from insurance companies due to the coronavirus crisis.
The stock market reacted favorably to the kidney trial data and quarterly results. Shares of Akebia jumped 38% to $11.95 in heavy volume in the May 5th trading session reaching their highest level since early 2018.
