Advaxis Takes Its First Step Towards Regulatory Approval

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About: Advaxis Inc. (ADXS), Includes: RHHBY
by: Terry Chrisomalis
Summary

Advaxis filed its Marketing Authorization Application to the EMA for European marketing approval for its metastatic cervical cancer treatment axalimogene filolisbac.

Phase 2 data produced a 12-month overall-survival rate of 38% for second-line metastatic cervical cancer patients.

There will likely be a cash raise performed at least by mid-2018 so that Advaxis can have a comfortable cash position heading into 2019.

EMA approval for axalimogene filolisbac in patients with second-line metastatic cervical cancer will help those who have not been able to adequately respond to prior treatments.

Advaxis (ADXS) announced recently that it had filed its application for approval for its lead immunotherapy product known as axalimogene filolisbac. This application was filed so that the company could gain European marketing approval to treat patients with recurrent/metastatic cervical cancer who progress beyond first-line treatment.

Application For Approval

The submission of the Marketing Authorization Application (NYSE:MAA) for European approval is the first step for the company to have its first clinical candidate reach the market. That is a good step, however, there is something else that is more important to note here. That is the fact that there needs to be a more effective treatment for these women with metastatic cervical cancer who progress past first-line therapy. What that means, is that a lot of patients that take first-line therapy don't respond to treatment. That leaves the door open for axalimogene filolisbac to help these patients. The truth is that more therapies were needed for this indication. To put this into perspective, consider how long its been since another adequate therapy has been brought to market for cervical cancer. It has been more than 30 years since there has been a breakthrough treatment for these patients that really does make a difference.

Phase 2 Data

Advaxis was able to file for European approval based on phase 2 data that was highly positive. This data stemmed from a phase 2 study known as GOG-0265, which recruited a total of 50 women. The primary endpoint was the 12-month overall-survival rate. It was noted that the primary endpoint was the 12-month overall survival rate for women who took axalimogene filolisbac. It was shown that 19 out of 50 patients or 38% of patients were alive past the 12-month time point. Why is this rate significant? That's because it was a 55% improvement over the typical expected 12-month survival rate in this patient population of 24.5%. Another thing to point out is that at least 50% of patients recruited into the study had received more than one prior therapy before being recruited. One such treatment given as a prior therapy was with bevacizumab, which is marketed as Avastin. That's a huge feat, because Avastin is marketed by Roche (OTCQX:RHHBY). The fact that axalimogene filolisbac achieved what Avastin couldn't in allowing patients to respond to therapy is remarkable.

Financials

As of October 31, 2017 Advaxis had cash and cash equivalents of $79.1 million. The company expects that it has enough cash to fund operations until 2019. Having said that, the company will also receive a tax credit from the NJEDA's NOL program of $4.8 million by the end of the fiscal Q1 of 2018. Considering that Advaxis just filed its MAA application it will likely move in anticipation to build its cash position. In addition, a biotech with one year's worth of cash does not wait until the last minute to dilute. In my opinion, I believe that Advaxis will likely raise cash sometime in mid-2018 if not sooner.

Risks

The biggest risk here would be that despite being able to file the MAA to the EMA, there is a chance that the drug may not be approved. I think it has a good shot at approval based on the data reported for second-line therapy, but to be honest it just depends how the regulators view the results themselves. Another risk to point out is what I have mentioned above with respect to the possibility of dilution by mid-2018. That will likely cause the stock to drop as a one time-event and then it should recover thereafter.

Conclusion

Advaxis has a good chance at receiving EMA approval for its metastatic cervical cancer product axalimogene filolisbac. That is evidenced by the positive clinical data from the phase 2 GOG-0265 study. Since some patients don't respond well to first-line therapy, then this treatment from Advaxis will be a welcomed treatment option for these patients. The best part of all is that the treatment is safe and tolerable. There were some grade 1 and 2 adverse events of flu-like symptoms stemming from cytokine release, but that was easily dealt with by treating patients with standard of care.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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