Sentiment Analysis of the earnings transcript to help figure out if there are any bullish or bearish sentiments that could be gathered from it. We're doing ML and AI based analysis on the earnings call to get some more insights.
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| Statement |
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| Our view is that creating new medicines is clearly exciting and rewarding, but we also will never lose sight of the importance of protecting shareholder interest |
| But I am encouraged by the fact that the historic arc of scientific discovery would suggest that there will be improvements that ought to lead to improvements in clinical outcomes for patients |
| We believe this new device will be far superior to the delivery system, which was employed in the first 30 patients |
| And we are even more excited by the opportunity to build upon promising results achieved with OPC1 in previous trials and to continue to seek improvements in how this therapy is manufactured, prepared and administered |
| It's an enormous benefit with vision going in the opposite direction of what is expected |
| Obviously, that's believe that's very promising, and I think this solidifies Roche's investment in new guys for global partnership |
| We believe the OPC1 program is a strong match with CIRM's goals to accelerate the development of regenerative medicine, and we submitted an application for funding support for our DOSED study last month |
| As we've mentioned, last month, we added approximately two quarters worth of cash to our balance sheet and improving our operating runway |
| We also benefit by the fact that we are a multinational organization |
| So I think from a success perspective, we are well positioned |
| And to be a little bit more detailed, I think being able to show a partner that you have an excellent process of manufacturing yourselves and an excellent method to deliver the cells and perhaps even concurrence around a study design, although that one is less -- that one's more debatable, I think that could be an optimal time |
| One, we continue to be extremely happy with our alliance with Roche and Genentech, not only for their commitment to advancing OpRegen through the clinic, but also for enhancing awareness of the program at medical and scientific meetings |
| What I feel particularly good about is that the clinical benefit that we're showing has been very significant the product to date has been well tolerated in the patients that have received it |
| I believe Lineage continues to be well positioned to advance our business and become a very important company in the years ahead |
| Their foundational work provides us with a significant advantage because, while other cell therapy companies are just now beginning their human studies and don't yet know how their cells will behave in people |
| As you may have seen in our announcement, we raised approximately two additional quarters of cash, which improves our balance sheet and provides additional operating runway |
| Beginning with our balance sheet, I'm happy to report that we remain well capitalized to conduct the near-term activities which Brian just outlined |
| We continue to have many reasons to be excited about our future |
| And what makes it particularly exciting is that a chronic patient is going to, by definition, have reached a plateau in their recovery |
| And one of the messages I sought to deliver today is that the Phase 1/2a, which we conducted is still generating new information, which continues to be directionally positive for this program |
| And in at least one instance, we are making an additional edit that is intended to confer clinical differentiation and a competitive advantage in the applicable indication |
| We believe this will continue to support our plan towards making important progress through reaching meaningful milestones and creating value for shareholders from our continued investment in our programs |
| Our team's success, the details of which we have only partly shared publicly permitted us to invest next in developing a new delivery system |
| So I would be delighted to be able to have that opportunity |
| But as many of you may have seen, the success of the CIRM program has led to a surge of funding applications |
| And we're fortunate that the economics of that deal were so favorable to the company |
| So it was a good starting point |
| Our plan is to continue to maintain the same level of spending discipline, which has served us well to date |
| It was a wonderful success and we currently are in the planning stages for the second annual Spinal Cord Injury Investor Symposium, which is being expanded and planned to be a two-day event, held on June 26 and 27, here in San Diego |
| And it's memorable and it's powerful and emotional and fantastic and probably very unrealistic given the severity of the damage, at least where technology resides today |
| Statement |
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| So the CHMP issued a negative opinion attributable to the lack of a functional benefit |
| If it can be unlocked, and we have, as a field, been unsuccessful in not figuring out how to do that |
| For example, to illustrate this point, if a company is getting down to approximately a year of cash and has a going concern, it might get flagged as attractive short for some investors |
| Total revenues were $8.9 million, a decrease of $5.8 million, as compared to $14.7 million for the same period in 2022 |
| The process by which the cells were made did not meet our vision for a commercially successful product candidate and the method by which they were delivered was too cumbersome and inefficient |
| I am, of course, disappointed on behalf of the Lineage team, which put a lot of work in to prepare the grant, but I'm confident because CIRM has informed us that they are striving to reopen the CLIN1 and CLIN2 programs, as soon as reasonably possible suggesting to us that this is simply a pause to address workload issues and to our knowledge, is not specific to our application in any way |
| There's continued degradation presumably happening in other areas, not with our healthy transplanted cells, but perhaps in other areas where the cells are -- where our cells are not delivered |
| Consequently and quite unexpectedly, Late last month, the CIRM board of directors announced that they would be halting the acceptance of new applications with an effective date of January 31 |
| With respect to the ongoing war in Israel, we initially had a very brief disruption, which would not be surprising |
| Thus, a small risk is causing a lot of heartache for that program |
| Loss from operations were $6.4 million, a decrease of $0.2 million, as compared to $6.6 million for the same period in 2022 |
| And frankly, in light of the interest, enthusiasm around the OpRegen program, I'm not sure we get much recognition |
| We have been satisfied with the results from those early studies |
| But I think it's premature to -- I don't want to be overstating the things that we're doing |
| The net loss was $4.8 million or $0.03 per share, compared to a net loss of $6.4 million or $0.03 per share for the same period in 2022 |
| If so, the overall impact looks simply to be a one and half quarter delay to potentially receiving funding for the DOSED study |
| One is we were very early to react one of our board members' insights helped us anticipate that there would be disruptions to supply chains and they are continuing in different ways with tanker, shipments, et cetera |
| But I do think that going to a potential partner and saying, I've solved these problems is a more interesting proposition than saying, I have a program that's available, but it has these problems |
| The net loss was $21.5 million or $0.12 per share, compared to a net loss of $26.3 million or $0.15 per share for 2022 |
| And my general question about the program is, I mean, look, everyone's going to be looking towards Phase 2a data at a Roche and my difficult or extremely difficult question to you is any visibility of when that might happen? Which is everyone's question on the street |
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