Yahoo Finance Capricor Therapeutics Inc (CAPR) Q1 2024 Earnings Call Transcript Highlights: Strategic ...
Cash Position: As of March 31, 2024, totaled approximately $39.9 million.
Revenue: Received a $10 million milestone payment from Nippon Shinyaku in Q1 2024.
Research and Development Expenses: Approximately $10.1 million in Q1 2024, up from $7.2 million in Q1 2023.
General and Administrative Expenses: Approximately $1.8 million for Q1 2024, consistent with Q1 2023.
Net Loss: Approximately $9.8 million in Q1 2024, compared to $7.8 million in Q1 2023.
Additional Funding: Raised approximately $3.5 million through an at-the-market program at an average price of $5.75 per share.
Financial Outlook: Cash runway expected to extend into Q1 2025, excluding potential additional milestone payments.
Release Date: May 13, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
Completed enrollment for Cohort A in the HOPE three Phase three pivotal trial, with positive interim analysis indicating potential efficacy of CAP 1002 in treating Duchenne muscular dystrophy (DMD).
Received a $10 million milestone payment from distribution partner Nippon Shinyaku, enhancing financial stability.
FDA approval to transition to the San Diego manufacturing facility without additional site-specific clinical data, saving time and resources.
Strong safety profile and quarterly infusion schedule of CAP 1002 expected to encourage rapid adoption within the DMD community.
Strategic advancements in exosome platform technology, positioning the company for future clinical trials and potential new therapy developments.
Negative Points
Increased research and development expenses, rising by $2.9 million from the previous year due to clinical and manufacturing costs associated with the HOPE three trial.
Uncertainty and risks highlighted in forward-looking statements, which could affect future results and company performance.
The need for further discussions with the FDA to finalize the regulatory pathway for CAP 1002, including a pre-BLA meeting and rolling BLA submission.
Ongoing need to raise capital, as evidenced by the utilization of an at-the-market offering program to fund operations.
Dependence on regulatory and market acceptance for the new San Diego manufacturing facility to meet projected market demand for CAP 1002.
Q & A Highlights
Q: Hi, everyone. Good afternoon. Thanks for taking the questions and congrats on all the progress that you've on and the trial as well as your regulatory interaction of. So So first, thanks for helping us with the launching of new economics, very hopeful the breakout and then people appreciated higher royalties than what you typically see in a deal. Is it fair to say you've noted $90 million in regulatory related milestones for potential approval. Is it fair to say that there's a trigger that could occur if you have positive data in the fourth quarter? A: A good to hear from you. Thank you for your kind words. We're not at liberty to announce yet sort of the tenor of the milestone payments. But suffice it to say that we plan on them being able to strengthen our balance sheet as we move from approval through BLA.
Q: Okay. Fair enough. And then can you remind us of what the latest interaction has been with any regulatory agency ex U.S., you've clearly been aligning very well with them. They're very much sounding committed to working with you. But I'm wondering what the tone has been for any of the other agencies? A: Yes. So we've had, you know, some initial retails mostly through our consultants in terms of strategizing to how to approach both the EMA and then the Japan regulatory authorities, the PMDA, we have a strategy that we've been building as we've been thinking of the idea of a partnership. We're still trying to figure out how to move as rapidly as possible worldwide.
Q: Okay, thanks. And maybe if I could just ask one more big picture question. I think when when considering the valuation here cash and the PRV voucher alone could essentially support the current market cap. So what do you think it is that the investment community is missing out considering it's a late-stage asset with some data already in place. Thank you so much again. A: Thank you. So this is the big conundrum that I as CEO, our management team and our Board has done a lot of time thinking about, we have a late-stage asset. We have on really lovely clinical data that's been supported by publication in the highest ranked journals, for instance, the Lancet with our Phase two data. We have long term safety and efficacy with the hope to have the HOPE two open-label extension data. We have a fully enrolled Phase three.
Q: Thank you very much for taking the question. Really having all the progress you guys are making on question on kind of Cox was on a relative sense, give us a sense for what it might cost to make pass or watch on cost of goods sold could ultimately be assuming on premium pricing in this orphan disease? A: Yes, I said great to hear from you. So in terms of COGS, our still sort of firing away here, manufacturing and trying to come up with some final numbers. We've been a little bit quiet on that because building a new manufacturing plant that is much more efficient, takes advantage of higher scale manufacturing methods and ways to significantly reduce costs that's helping with the COGS.
Q: Please ask your question and then Ajay, good afternoon. Thanks for taking the questions. So two questions, please. So first, obviously, you've alluded to your ongoing discussions with regard to the EU for partnering and potentially beyond, should we be looking for that same type of approximate deal structure as an S? Or are you looking at the various options. A: Thanks, Joe. Great to hear from you always really excited. We've been building this therapy alongside you for a long time. So we appreciate your continued support. Some analysts took a risk with us with an asset that was not nearly as de-risked as it is today.
Q: No, that's helpful. Thank you. And then off of your recent FDA update call, we started the discussions about the potential of cardiovascular, and I wanted to dive into that just a little bit more about its potential role, not necessarily in the label, but potentially in the label, but also for patient benefit. A: Yes. So I mean, you had my sweet spot I just back late last week, the PPMD Parent Project Muscular Dystrophy hosted a meeting that's become annual on the comp, the topic of the cardiomyopathy associated with Duchenne muscular dystrophy.
Q: Good afternoon, Linde AG. Congratulations for the progress this quarter. A couple of questions from me. So first, I want to ask you about the Cohort B enrollment. So it seems to be pretty fast. I think it mentioned on you're going to wrap it up by next month, 44 patients. So could you share with us any feedback related to this apparent enthusiasm of physicians and patients and also clarify on how many or if any, of those patients had on prior therapies such as exon skippers? A: Yes. So, I think the rapid enrollment speaks for itself. Let me just remind you that our patients that we're treating in Cohort A. and Cohort B, our late-stage ambulance are not a non-ambulant patients with the attenuated upper limb function. As I've mentioned many times, there is nothing for these guys literally nothing there's not clinical trials and there's no approved therapeutics beyond steroids and potentially the exon skippers so on.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
This article first appeared on GuruFocus.
