This is a challenge. I joined Brainstorm in late September following four years at Avexis, now Novartis Gene Therapies, where we launched the second gene replacement therapy approved in the United States called Zolgensma for spinal muscular atrophy.
Do you think this is an aggressive or conservative target date?
And obviously it will be data driven.
We will not comment on the precise timing of our filing, but we are doing all that we can to be ready.
Thanks, Chaim. Joining us on the call today will be, Chaim Lebovits, President and CEO of BrainStorm; Dr. Ralph Kern, President and Chief Medical Officer; Dr. Stacy Lindborg, Executive VP and Head of Global Clinical Research; and Preetam Shah, Executive VP and CFO, they will be available to answer your questions during the Q&A session. Do you think a similar type of assay is going to be required for NurOwn BLA filings? The decrease in expenses was partially offset by an increase in material costs, payroll and stock-based compensation expense, and a decrease in proceeds received in connection to the treatment of patients under the hospital exemption regulatory pathway. Thank you. These two most recent appointments are the latest in a series of key senior hires we made throughout 2020.
Yes. We really applaud the opportunity for patients and their families to get treatment.
We believe that a successful outcome for this trial will add a hope to the ALS community and will be a transformative moment for Brainstorm. These novel observations greatly extend our understanding of how NurOwn may modulate an overactive immune system and coupled with its ability to deliver neurotrophic factors helps advance our understanding of NurOwn’s mechanism of action. Maybe we lost David. We are currently engaged with the relevant regulatory agencies to finalize the design and conduct of this clinical trial and we will begin clinical trial enrollment once we receive final regulatory and logistical approvals. There've been rumors of Brainstorm providing expanded-access to the participants in the Phase III trial. But thanks for the question. So it's on our radar screen, but nothing to announce today. Thank you. So with regard to when information is needed, a Biologic License Application, or BLA a request for FDA approval to introduce the product into interstate commerce.
Brainstorm Cell Therapeutics Inc (NASDAQ:BCLI) Q2 2020 Results Conference Call August 5, 2020 8:00 AM ET.
Yes, I think that I'll answer the second part and then I'll return it back to my colleagues about partnerships. FDA has extensive industry guidance regarding the content that's required for a BLA, and that's what we're following.
Our CFO, Dr. Preetam Shah will then provide updates on our financial results before turning it back to me for concluding remarks, and we will then address your questions in the Q&A session. All patients have been enrolled or being treated per the protocol.
And one specific question, would a Japanese study Phase III study be required to get approval in Japan? This concludes today's conference. This double-blind placebo-controlled trial will provide data that hopefully can support registration of NurOwn for ALS. We are working towards treating a maximum number of patients very quickly after an approval. We are focused on the upcoming topline readout for the NurOwn Phase III trial in ALS, which we expect to happen by the end of November. My question has to do – is there any update you could provide, particularly to David on the efforts to find a large commercial partner in any geography.
Thanks. What do you mean by movement in Latin America Aharon? There is a big patient population who really wants to make sure that we know about them.
Results may differ materially from those projected on today’s call. Those patients who don't see at least 1.25 points per month improvement in their ALSFRS-R slope after treatment are defined as non-responders. Yes, I would say that the PLS has much closer resemblance to ALS from a disease perspective. New York, NY 10019
To begin, I want to emphasize the critical role that trial design plays in determining the success of a product. Bill please introduce yourself first and then answer the question. [Operator Instructions] Our first question comes from the line of [Jack Mayer, Private Investor].
[Indiscernible] I am sure we maybe part of this.
So I'm very excited to join Brainstorm and do a similar approach in bringing our novel NurOwn therapy to market.
And the next investor wanted to certainly welcome Mr. William White to the company, and recognizing that his expertise will be very important to the commercial launch of NurOwn.
I think we are done with the written questions.
The first question we have relates to intellectual property. In addition to our preparations for the upcoming data readout, we have been busy planning and executing another pre-BLA activities. Please proceed with your question. Sure. Suite 320 1325 Avenue of Americas
We have time to take three, four or more questions. Additionally, we expect to launch in the U.S. first of course, and then followed by a similar approach in the EU5 and some of the other key global markets. Chaim, please go ahead. Thank you, Chaim. How many patients have been enrolled at this point? Happy to take this. Michael Wood - LifeSci Advisors, LLC.
What I can add is that we've been very thoughtful and deliberate about linking the biological parameters of our cellular product with preclinical studies and then showing a consistent reflection of this biological activity in biomarkers, which we have. On March 6, 2020, we put in place a $50 million ATM facility. David, can you please answer this question? We are in advance discussions concerning our commercial production partners.
Obviously ALS patient preferences and an assessment of benefit risk, which is a moving target as the disease progresses that is continually reevaluated. Melissa, you want to reach out if there are any additional verbal questions. We spent a lot of effort linking to our clinical results.
It is an important consideration and emerging as more and more important recently. General and administrative expenses for the three months ended September 30, 2020 were $2.62 million compared to $1.54 million in the three months ended September 30, 2019.