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CMRX: Efficacy Across A Broad Range Of Double-Stranded DNA Viruses.

|Includes: Chimerix Inc (CMRX)

Chimerix is, as of 2/26/2016, likely trading at a 60% discount to current cash liquid assets. (378m cash, cash equivalents, and liquid assets as of Q3 2015) That means that it has an enterprise value of perhaps -$130 to $-150m as of 2/26/2016. In other words, if someone were to buy out the company at the current price of 4.72 a share, they would net the drug program, plus about $130m, essentially for free.

Chimerix's brincidofovir has statistically proven efficacy in HSV, adenovirus, CMV, BK, and smallpox.

In the February 22 presentation, the company showed that there was anti-viral activity against BK with statistical significance at p=.06, or a 94% probability that the drug and not random chance caused this outcome. (files.shareholder.com/downloads/AMDA-1QN..., page 38)

The company would not be running another (pill-only form) trial on CMV because this last trial statistically proved efficacy with a solid theory. Corticosteroids always increase immunosuppression. Besides this, 36% of docs not following SMMP (safety monitoring and management plan), after seeing that diarrhea misdiagnosed as GVHD failed, added even more powerful immunosuppressants to the mix.

For patients where SMMP was followed (as it should have been according to trial parameters), patients experienced a rate of infection and lower mortality (and, lower GVHD/diarrhea rates) that seemingly would have allowed the trial to succeed.

The FDA are not stupid and they would approve for CMV if the company applied for an NDA according to a surrogate endpoint.

Chimerix has an open-label Phase 3 adenovirus trial (for young children with extremely deadly adenovirus infections) that showed clear efficacy in several preliminary readouts:

ir.chimerix.com/releasedetail.cfm?Releas...

ir.chimerix.com/releasedetail.cfm?Releas...

Preliminary results from the initial 85 subjects enrolled show a mortality rate of less than 40 percent for bone marrow transplant recipients with disseminated disease and for the patient population overall. This mortality rate has clinical implications for the potential utility of brincidofovir in this indication as compared with the published mortality rates of up to 80 percent for transplant recipients with disseminated disease.

Liver transplant recipients with adenovirus had a much lower mortality rate. In liver transplant recipients with an adenovirus infection, 1 out of 13 patients died, and 2 had clinically significant diarrhea -- but it's better than death, which is at 80%, according to historical control rates. Chimerix should be filing an NDA with the adenovirus indication based on full results in the second half of this year. The company states in its presentations that adenovirus viral load reduction is at 96%+.

In December, the company complied with 80 emergency requests for brincidofovir - this is ramping up monthly. (see Feb. 22 presentation, page 8)

The company has said that it expected another $13m in Q3, from DARPA as part of DARPA's smallpox bioterrior preparedness program -- this was delayed due to budget approval delays. The company has the potential of getting ~$430m over 5 years on this program, if all options are exercised by BARDA. It has been in collaboration with BARDA since 2011. (It and one other smallpox antiviral company provide the doses under the program.) (ir.chimerix.com/releasedetail.cfm?releas...)

Recently, the company showed 100% survival for animals treated immediately after smallpox exposure and 93% survival for those treated after a 24- or 48-hour delay, compared to 50% treated with placebo. These results were statistically significant. (ir.chimerix.com/releasedetail.cfm?releas...)

During ASH in December 2015 (www.chimerix.com/wp-content/uploads/2015...), the company provided data showing anti-HSV (herpes simplex virus) and anti-VZV (varicella zoster) efficacy, as an alternative to acyclovir prophylaxis.

If anyone is interested in reading a Monday, Feb. 22, 2016 conference call transcript, I created one and posted it to SA here:
seekingalpha.com/instablog/1021634-agame....

Disclosure: I am/we are long CMRX.