Biotech Values

[dangerM]

DVAX cost savings, not much more info

... the good news: no purely financial investor, the bad news: no cooperation partner either.

I listened to the conference call, but there was not much information in addition to the press statement. As well, before AACR 2017 (for the IO programs) there will not be much more info.

For anyone who is interested, a raw collection of tidbits follows:


For a) Helipsav B the main points in the CC were:

~ "The FDA asked about safety data across different time periods" (I assume they delivered too few information about patient cases with AEs that happened late, after several months after immunisation.)

~ they expect a full 6 month review period after submission of their answers, meaning a decision about end of July

~ 1mn doses of Helipsav B with shelf life of 36 months exist, sounds like enough for start of commercialisation or another study, should this be needed and a cooperation partner be found (cf. 2mn annual production capacity that will be shut down now)


For b) company strategy / becoming a pure IO company:

Not much new info except for the cost savings.

What did I wonder was about the role of Dynavax U.S. vs. Dynavax "Europe" in Duesseldorf. How dependent are they on their subsidiary for the IO-programs (SD-101, cooperation with AZN, ...)?

Some very old presentation presents a quite equal role with manufacturing expertise only in Duesseldorf and R&D in both (p. 13, http://corvay.de/wp-content/uploads/2015/05/geschaeftsmodelle-technologieplattform.pdf).

The latest 10Q is still a bit ambivalent, since Duesseldorf and outside providers are both named in the same sentence for production. However, disclosure for calender year 2014 in German business registers* speaks about refocusing there on Heplisav B only, i.e. giving up contract work & being sidelined in regard to new programs. I might ask IR, maybe waiting somewhat for the disclosure of their subsidiary about 2015 (which is a week overdue now :).

In short, not much new info.

If anyone wants to read about their running IO trials, there is

NCT02266147 -> https://ash.confex.com/ash/2016/webprogram/Paper98386.html

NCT02731742 -> we don't know much about, since it is sponsored by Merck (so on the one hand not only one of the several hundred (often worthless) Keytruda & [anything, did they try jelly bellys yet?] studies ... but because of Merck being a big corporate without much interim info)

NCT02521870 --> https://www.melanomacongress.com/docs/late_breaking_abstracts.pdf (data from 2 cohorts at 2 mg (5 pts) and 4 mg (5 pts), of whom 50% are pts who previously progressed on anti-PD-1 ... the best overall response observed were for anti-PD-1 naïve CR 20%, PR 60%, SD 0%, PD 20% and for anti-PD-1 progressor CR 0%, PR 0%, SD 60% (= 3 patients), PD 40%" (= 2 patients)."

plus NCT02927964 and NCT03007732 which only recently started/will recently start


* btw, old data about the subsidiary for 2014, certainly not representative after ramping up production capabilities in 2015/2016
13.9mn EUR total opex
of which
5.6mn EUR personnel expense
3.7nm EUR outside services (mock inspection, open positions)
1.2mn EUR rent
78 employees