Dynavax Technologies Corporation (NASDAQ:DVAX) Q2 2023 Earnings Call Transcript

Ryan Spencer: Rob, do you want to answer that one.

Rob Janssen: Yes, we did. The Grade 3 and 4 were similar between the two groups. And the ones that lead there was one that led to discontinuation in the lowest detainee teen group, but it wasn’t related to vaccine. It was — sorry, it was thought to be related to vaccine from a third-party by the investigator, by the sponsor we would not consider to be related.

Ernesto Rodriguez-Dumont: Got it. Okay. Thank you. Appreciate it. Congrats again.

Ryan Spencer: Thank you.

Operator: Thank you. [Operator Instructions] Our next question comes from the line of Roy Buchanan with JMP Securities. Your line is now open.

Roy Buchanan: Hi. Thanks for taking the question. Great quarter. First one, I guess on the [indiscernible] that the new grant just how much was left in the original part of the grant. Do you have access to that entire amount? And then how far does the new total get you? I think the TR says, starting the nonhuman primate challenge trial. But seems like it probably gives you quite a bit beyond that. And then I guess, can you just help us understand what’s the loss in the nonhuman primate challenge trial are — as far as getting you to an approval?

Ryan Spencer: Roy, thank you. If you recall, the original contract is about $22 million, that we will have full access to that contract. That was to focus on the completion of the Phase 2 trial. So there’s a number of amendments that expanded the contract by about $11 million in total, with the largest piece being non human primate study, which is, I think, to get to a real the crux, the real question is how far does that get us that’s one component of a longer term pathway to support eventual approval that would leverage non human primate challenge studies. And so that’s the first step in that process, which is covered by this particular contract expansion.

Roy Buchanan: Okay, great. Then it’s a quick one on shingles. I know you guys still need to talk to the FDA and probably will have more to say after that, but I guess I’m just curious, your thoughts around if you have to go ex U.S for the next trial? Is that leverageable for a U.S approval? Or is it base case assumption that you might have to forego U.S market? And if the latter is the case? Does it make the most sense to license that candidate out?

Ryan Spencer: Now, our current strategy is definitely to include the U.S market. So as you indicated, we’ll have to still talk to the agency about our opportunities for a pathway in the U.S. But anything any sort of strategy that took us to the ex U.S markets for efficacy would be part of a plan to utilize that data to support U.S licensure.

Roy Buchanan: Okay, thank you.

Operator: Thank you. [Operator Instructions] Our next question comes from the line of Jon Miller with Evercore ISI. Your line is now open.

Jonathan Miller: Hey, guys, thanks so much for taking my question. I guess I’ll join everybody else in congratulating you on a great quarter. As the new analysts covering the story, I can only assume every quarter will be as exciting as this one. Thanks, Jon. Appreciate that.

Ryan Spencer: That’s my question. No, maybe just one or two from me. When you say you’re optimizing your commercial efforts for retail IDN segments as the fastest growing segments can maybe give me a little more color on what levers are available to their front versus other segments and maybe what the biggest drivers of shared growth there will be and given the rapid growth you’ve seen since the ASAP rack. Are you seeing any signs that have pushed back from pairs, price sensitivity or anything like that in the retail segment that may be influencing further growth there Why don’t we break this up? I’ll take the second question quickly. And then let Donn provide some more insight around the optimization within retail. But in general, this is really important as it relates to the vaccine business.