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Shares of Advaxis, Inc. (NASDAQ: ADXS), a clinical-stage biotech developing novel cancer immunotherapies, are sinking after the company provided a business update along with a third-quarter earnings report after the bell yesterday. Investors weren't impressed with the amount of progress achieved so far this year, driving the stock 16.4% lower as of 11:50 a.m. EDT during Tuesday's trading session.
Advaxis' core technology involves altering a strain of Listeria bacteria in a way that stimulates patient immune cells to recognize and attack cancer cells. The company is still preparing a marketing application submission for European regulators that it expects to complete by the end of the year. If accepted, it could lead to conditional approval to treat certain forms of cervical cancer.
This July, the company bid adieu to CEO Daniel J. O'Connor, and it's been troubling that a permanent replacement has not been found. Tony Lombardo, who joined the company earlier in the year, quickly stepped in as interim CEO. Comments from the chairman stating he would remain in his position for the foreseeable future suggest qualified applicants aren't exactly beating a path to Advaxis' human resources department.
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Advaxis intends to begin a combination study with Opdivo from Bristol-Myers Squibb that could lead to another application for treatment of cervical cancer, but the study isn't slated to begin until next year. The company also has another candidate, ADXS-PSA, in early-stage combination therapy trials with Keytruda from Merck & Co. that could lead to a prostate cancer application. Unfortunately, it will be a long time before we can make any conclusions about Advaxis' novel immunotherapies ability to boost the efficacy of blockbuster drugs from its big pharma peers.
The company finished its fiscal third quarter with about $89.4 million in cash and investments after losing $70.2 million during the nine months leading up to the end of July. At this rate, it looks like investors should brace for another share offering before European regulators issue a decision regarding an application that hasn't even been submitted yet. With this in mind, it might be best to watch this show from the sidelines.
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