Cytosorbents Corp Q3 2023 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Yuan Zhi - B. Riley - Analyst : Thank you for taking our questions. And congrats on a good quarter. On the STAR-T file [anapoint]. The component two of the complete anapoint, can you talk about how did you arrive at the assumption of 40% UDPB Class II events in the control arm versus 24% in the DrugSorb-ART? Was it based on data from the open label trial or was it from real-world experience? Thank you.

Question: Yuan Zhi - B. Riley - Analyst : Got it. And then a follow-up question on the STAR-T trial. So for the analysis timeline, can you talk about how long does it take for the database lock the analysis? Basically, can you talk about your confidence to share that data by year end, which is very important to the stock? Unidentified Participant Yes. Thank you for the question. I think as Phil presented in the prepared remarks, the process leading to database lock is progressing well. And as we already stated, we think the lock is actually bearing. Once that happens, then the analysis process begins, which by itself requires time. It's not an instantaneous process results. During this time, all the parties remain blinded. Regarding the release of the data, we plan to follow the conventional roads of reviewing the data internally, but also considering the submission for a major cardiovascular (technical difficulty). Should we proceed that route, we would have to then obey the requirement relating to the embargo and the silent period of this conferences, when they consider original results of presentation. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 09, 2023 / 9:30PM, CTSO.OQ - Q3 2023 Cytosorbents Corp Earnings Call However, as Phil again stated in the prepared remarks, we believe that by the end of this year, we will be able to provide to the public -- make a public press release with our initial assessment of whether we believe the data will allow us to proceed to the next step, which is basically the submission to the FDA.

Question: Tom Kerr - Zacks Investment Research - Analyst : Good afternoon, guys. Any update on the European ICU bed market, particularly in Germany? Has that opened up anymore?

Question: Tom Kerr - Zacks Investment Research - Analyst : Okay. Thanks for that color. And a couple of financial questions. The quarterly burn rate expected to be around the same in the mid $4 million range, or does it go up or down the next let's two to three quarters?

Question: Tom Kerr - Zacks Investment Research - Analyst : But the submission on the START-T does it maintain or increase the burn rate in the first couple of quarters or is that a low cost type activity?

Question: Tom Kerr - Zacks Investment Research - Analyst : Right. Okay. One more financial one, why would you guys look for equity offering if you have a ATM equity program in place or is that the same thing you're talking about?

Question: Tom Kerr - Zacks Investment Research - Analyst : Got it. And there's still roughly $23 million availability on the ATM, if I recall, if necessary.

Question: Tom Kerr - Zacks Investment Research - Analyst : Okay. That's all I have for now. Thank you.

Question: Sean Lee - H.C. Wainwright - Analyst : Good afternoon, guys, and thanks for taking my questions. My first one is on the START-T. So with the potential for data by the end of this year and the regulatory submission next year, what needs to be done before you can file for submission? And in terms of commercialization, have you done any -- started building out any structures in the US?

Question: Sean Lee - H.C. Wainwright - Analyst : Yes. I was just wondering what preparations have you made so far in terms of for commercialization in the US, assuming that the study and the submission goes well. Yeah. So Vincent, would you like to take that question? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 09, 2023 / 9:30PM, CTSO.OQ - Q3 2023 Cytosorbents Corp Earnings Call

Question: Sean Lee - H.C. Wainwright - Analyst : Yes, that's very helpful. I've had a follow up for the START-T, I know you guys have a CE Mark approval for ticagrelor removal already in Europe, would the results from this T -- from STAR-T be useful for you to secure reimbursement in the major European countries?

Question: Sean Lee - H.C. Wainwright - Analyst : Great. That's all I have. Thanks again for taking my questions.

Question: Josh Jennings - TD Cowen - Analyst : Hi, good afternoon and thanks for the questions. Wanted to ask about potential reimbursement for DrugSorb and how you envision coverage in the early commercial period after approval. Will that be reimbursed through DRG? And is with breakthrough designation, can you -- are you anticipating a filing for an end cap and potentially having the technology add-on payment in place for launch or shortly thereafter? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 09, 2023 / 9:30PM, CTSO.OQ - Q3 2023 Cytosorbents Corp Earnings Call

Question: Josh Jennings - TD Cowen - Analyst : Great. Thanks for that. And just I think the press release your team has called out a TAM for DrugSorb for the ticagrelor removal indication. The US and Canada, around $650 million. It seems like a little bit of a tick-up. Is there any new market analysis or is that the addition of Canada into that TAM. But just wanted to just regroup on the TAM that you guys are putting forward for ticagrelor removal indication? Thanks so much.